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Office for Human Research Protections (OHRP)

News

Recent Announcements

(October 14, 2010) Revised Frequently Asked Question Regarding Engagement in Research

In the FWA frequently asked questions (FAQs), at http://www.hhs.gov/ohrp/FWAfaq.html, OHRP has revised the answer to Question #4: When is an institution considered to be "engaged in research"? The revisions include:
Adding obtaining informed consent as an activity that can make an institution engaged;
Removing the statement that pertained to awardee institutions bearing the ultimate responsibility for protecting human subjects, even when all human subjects activities are carried out by other institutions; and
Correcting the link at the end of the FAQ to link to the current guidance document.

This FAQ was revised to be consistent with OHRP's October 16, 2008 guidance document on the Engagement of Institutions in Human Subjects Research. Specifically, consistent with OHRP's 2008 engagement guidance document, the FAQ was modified to clarify that an institution is generally considered to be engaged in human subjects research when its employees or agents obtain the informed consent of human subjects. OHRP also removed the statement in the FAQ that pertained to awardee institutions bearing the ultimate responsibility for protecting subjects involved in the research conducted under the award, even when all human subjects activities are carried out by other institutions. OHRP removed this statement to be consistent with OHRP's 2008 engagement guidance, which reflects OHRP's broader goal of directing communication about noncompliance to the institution or IRB most directly involved in any regulatory noncompliance with 45 CFR part 46 as appropriate. For an example of the application of this concept, see OHRP's recent determination letter at http://www.hhs.gov/ohrp/detrm_letrs/YR10/sep10b.pdf.

The revised FAQ answer is:

Question 4:
When is an institution considered to be "engaged in research"?

Answer:
In general, an institution is considered to be engaged in human subjects research when its employees or agents:

(1) obtain data about living individuals for research purposes through intervention or interaction with them,

(2) obtain individually identifiable private information for research purposes (45 CFR 46.102(d),(f)) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102; or

(3) obtain the informed consent of human subjects.

Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.

In general, an institution is considered to be engaged in human subjects research whenever it receives a direct HHS award to support such research, even if all of the human subjects activities will be performed by agents or employees of another institution. In general, simply informing potential subjects about a research study is not considered engagement in research. Also, providing written information about a research study, including how to contact the investigators for information and enrollment, and seeking and obtaining prospective subjects' permission for investigators to contact them are not considered engagement in research. However, seeking or obtaining informed consent from a research participant is considered engagement in research.

For details, please see OHRP guidance on this topic at; http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html specifically, Section (B)(4).

(October 4, 2010) Clarification of "noninvasive" in expedited review category 3

OHRP has posted a new item of correspondence on its view about the meaning of "noninvasive" as the term is used in expedited review category 3, which is the expedited review category that applies to the prospective collection of biological specimens for research purposes by noninvasive means. OHRP's statement can be viewed at http://www.hhs.gov/ohrp/policy/correspond/. Specifically, that statement clarifies that OHRP agrees with the Food and Drug Administration's position that for purposes of expedited review category 3, the following procedures are considered noninvasive:

* Vaginal swabs that do not go beyond the cervical os;

* Rectal swabs that do not go beyond the rectum; and

* Nasal swabs that do not go beyond the nares.

(September 23, 2010) Comments Requested on Proposed Revisions in FWA Documents

OHRP is announcing the availability of the draft revised Federalwide Assurance (FWA) form and Terms of Assurance, and is seeking comment on these draft documents. OHRP is proposing several changes to simplify and shorten the FWA form and Terms of Assurance. Institutions engaged in non-exempt human subjects research conducted or supported the Department of Health and Human Services must hold an OHRP-approved FWA. The draft revised FWA form and Terms of Assurance, when finalized, will supersede the current FWA documents available on the OHRP website at http://www.hhs.gov/ohrp/assurances/assurances_index.html. The current FWA form has been approved by the Office of Management and Budget for use through May 31, 2011. Links to the draft revised FWA documents and the Federal Register notice announcing the availability of these draft documents can be found on OHRP's website at http://www.hhs.gov/ohrp/requests/com0910rev.html. Instructions for submitting comments are provided on the OHRP website. The Federal Register notice of availability describes key changes in the draft revised FWA documents in comparison to the current FWA documents.

(September 21, 2010) Guidance on Withdrawal of Subjects from Research

OHRP has posted on its website a finalized guidance document entitled, "Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues." The guidance document provides OHRPís first formal guidance on this topic and finalizes the draft guidance entitled, "Guidance on Important Consideration for When Participation of Human Subjects in Research is Discontinued," that was made available for public comment through a notice in the Federal Register on December 1, 2008 (73 FR 72804). The public comments submitted on our draft document were very helpful to us as we finalized this guidance document, and we thank those of you who took the time to provide us with your feedback. The finalized guidance document is available on the OHRP website at http://www.hhs.gov/ohrp/policy/subjectwithdrawal.html or http://www.hhs.gov/ohrp/policy/subjectwithdrawal.pdf. The Federal Register notice announcing the availability of this new guidance document can be found at http://edocket.access.gpo.gov/2010/2010-23517.htm or http://edocket.access.gpo.gov/2010/pdf/2010-23517.pdf.

(September 3, 2010) Determinations related to allegations regarding dexamethasone use in pregnant women

The Office for Human Research Protections (OHRP) posted on its website OHRP's September 2, 2010 letter of determination along with a U.S. Food and Drug Administration (FDA) memorandum. OHRP received allegations concerning activities conducted by Dr. Maria New at Weill Cornell Medical College and Mount Sinai School of Medicine involving the use of dexamethasone in pregnant women at risk of carrying a female fetus with congenital adrenal hyperplasia.

During OHRPís review, OHRP had numerous discussions with staff at FDA, and determined that the allegations raised by the complainants are unproven and did not find any evidence that Dr. Maria New violated the Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR Part 46).

(July 14, 2010) OHRP Videos on YouTube

OHRP is pleased to announce the availability for the first time of educational videos on the HHS YouTube channel. The videos are accessible through the OHRP playlist at http://www.youtube.com/user/USGOVHHS#g/c/5965CB14C2506914 and include "Research Use of Human Biological Specimens and Other Private Information" and "Reviewing and Reporting Unanticipated Problems and Adverse Events," (both of which premiered and are still available also in RealPlayer format), in addition to two new videos "Institutional Review Board (IRB) Membership" and "General Informed Consent Requirements Parts I (Research Investigator)and II (Research Subject)."

(June 30, 2010) Agenda & Registration for the OHRP Research Community Forum in Cleveland, Ohio on September 16, 2010

Register NOW for the OHRP Research Community Forum entitled "Building Harmony: Enhancing Human Subject Protections through Coordinated Regulatory Oversight" sponsored by University Hospitals and Case Western Reserve University in Cleveland, Ohio on September 16, 2010. For program information, agenda, and registration, see: http://www.uhhospitals.org/Research/OHRPResearchCommunityForum/tabid/7356/Default.aspx

(May 10, 2010) OHRP Posts Correspondence Regarding Use of Central IRB in Multi-site Research

OHRP has posted on its website OHRP's April 30, 2010 response to a medical center regarding the use of a central IRB, as well as the incoming letter to OHRP. We have chosen to make these letters available since they address an issue that may be of interest to others (see http://www.hhs.gov/ohrp/policy/correspond/CIRB20100430.html).

The OHRP letter clarifies that OHRP fully agrees with the Food and Drug Administration's position on the benefits of relying on a single central IRB for multi-center research. In addition, OHRP's letter clarifies that the advance notice of proposed rulemaking on IRB accountability that OHRP issued on March 5, 2009, was proposed to address this issue. Even in the absence of new regulation, the OHRP response also notes that OHRP is taking steps to address institutions' concerns about relying on an IRB external to the institution.

(May 6, 2010) Save-the-Date for the Upcoming OHRP Research Community Forum in Cleveland, OH on September 16, 2010

Save-the-Date for an upcoming  OHRP Research Community Forum entitled, "Building Harmony:  Enhancing Human Subject Protections Through Coordinated Regulatory Oversight," sponsored by University Hospitals and Case Western Reserve University at Severance Hall, in Cleveland, Ohio on September 16, 2010.  For additional information see the flyer at: http://www.hhs.gov/ohrp/education/pn091610.pdf.

(March 29, 2010) OHRP Posts Revised Set of Frequently Asked Questions and Answers) on IRB Registration

OHRP posted on its website a revised set of Frequently Asked Questions and Answers (FAQs) on Institutional Review Board (IRB) Registration.

These revised FAQs include guidance on the Department of Health and Human Services IRB requirements found in subpart E of 45 CFR 46 that were adopted on July 14, 2009. The use of the word "must" in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word "should" in OHRP guidance means that something is recommended or suggested, but not required. The revised OHRP IRB Registration FAQs can be accessed at: http://www.hhs.gov/ohrp/IRBfaq.html

(March 16, 2010) Availability of OHRP Educational Videos

OHRP is pleased to announce the availability of two educational videos developed by the Division of Education and Development that provide information on topics regarding the Department of Health and Human Services (HHS) regulations for the protection of human subjects of research described at 45 CFR part 46. One video discusses research use of human biological specimens and other private information; it can be accessed at: http://videocast.nih.gov/ram/ohrp_kaneshiro.ram. The second video discusses reviewing and reporting unanticipated problems and adverse events; it can be assessed at: http://videocast.nih.gov/ram/ohrp_carome.ram

Each video is approximately 20-25 minutes in length. An institution may reproduce or share these materials for educational purposes and may wish to consider incorporating the materials in their training programs.

OHRP anticipates the release of additional educational videos in the future on a variety of topics including IRB membership, general informed consent requirements, IRB records, and complex issues with research involving vulnerable populations. Additional information on OHRP's educational videos can be found at: http://www.hhs.gov/ohrp/education/#materials

(February 24, 2010) Research Grant Opportunity

The Department of Health and Human Services has published a Funding Opportunity Announcement (FOA) titled “Research on Integrity in Collaborative Research (R21)”, with the Office for Human Research Protections (OHRP) listed as one of the participating organizations, along with the Office of Research Integrity (ORI) and the National Institutes of Health (NIH). In part, the purpose of this program is described as follows:

“Applications must address the influence of collaborative interactions and/or activities on research integrity in at least one of the following areas that are of particular interest to the ORI and NIH: the clarification of community norms and standards, the effectiveness of self-regulation, the societal, organizational, group, or individual factors that affect integrity in research, both positively and negatively, or the impacts of non-adherence to accepted codes of conduct.”

While OHRP is not participating in funding the opportunities described in the FOA, OHRP supports the importance of this program and the potential for research activities that could shed light on the operation of human research protection programs and how they could be improved. OHRP notes that research activity proposals addressing the areas of particular interest in this program could include investigations of various aspects of collaborative activities related to or including the protection of human subjects in research. OHRP hopes that high quality research proposals of this kind will be submitted for consideration. The opening date is March 7, 2010 (the earliest date an application may be submitted to Grants.gov), the Letters of Intent receipt date is also March 7, 2010, and the Application due date is April 7, 2010. Interested parties should review the announcement, which is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-10-001.html.

(January 29, 2010) FDA Guidance Regarding IRB Continuing Review

The following notice is being sent on behalf of the Food and Drug Administration (FDA):

On January 13, the FDA announced in the Federal Register the availability of a draft guidance entitled, "Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval." (http://edocket.access.gpo.gov/2010/2010-426.htm, or http://edocket.access.gpo.gov/2010/pdf/2010-426.pdf)

The draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review.

Persons with access to the Internet may obtain the document at http://www.regulations.gov, or at http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm. (If hyperlink does not work because address wraps to next line, copy and paste entire URL in your browser's address window to reach the document.)

Written or electronic comments on the draft guidance should be submitted by March 15, 2010.

(January 11, 2010) Student Pools and Use of Penalties

OHRP has posted on its website a January 8, 2010 letter to a commercial company, which provides a web-based system for managing student subject pools, in the belief that others may find the content to be useful (see http://www.hhs.gov/ohrp/policy/correspond/OHRP20100108.html). This letter clarifies that imposing penalty credits on students who fail to show up for scheduled appointments with investigators without cancelling by a specified deadline violates the requirement of Department of Health and Human Services (HHS) regulations at 45 CFR part 46.116(a)(8). Such penalties may not be implemented for non-exempt human subjects research conducted or supported by HHS or for non-federally supported research to which an OHRP-approved Federalwide Assurance (FWA) applies. OHRP’s determination in this matter applies to any system used for managing student subject pools, not just the commercial web-based system referenced in OHRP’s letter.

(January 5, 2010) OHRP Archives Two Guidance Documents on Multicenter Clinical Trials

OHRP has moved two guidance documents to its archive of guidance documents no longer in effect. The two documents are “Local IRB Review of Multicenter Clinical Trials” and “Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID).”

These documents have been archived because OHRP's policy regarding local IRB review has changed and they no longer represent OHRP's policy. OHRP policy continues to be that a reviewing IRB should have knowledge of the local context for studies it reviews, but that review by a local IRB is not favored over review by a non-local IRB.

All archived OHRP documents may be accessed on the OHRP Web site at: http://www.hhs.gov/ohrp/policy/archive.html.

(November 6, 2009) Draft OHRP Guidance Documents for Public Comment

On November 6, 2009, the Office for Human Research Protections (OHRP) announced in the Federal Register the availability of two draft guidance documents. The first is entitled "Guidance on IRB Continuing Review of Research,” and the second is entitled “Guidance on IRB Approval of Research with Conditions.” OHRP is inviting public comments on both draft documents. Background information, the Federal Register notices of availability, the draft guidance documents, and instructions for how to submit comments can be accessed on the OHRP website at http://www.hhs.gov/ohrp/requests/.

(October 15, 2009) New OHRP Frequently Asked Questions and Answers on Exempt Research Determination

OHRP posted on its website a new set of Frequently Asked Questions and Answers (FAQs) on Exempt Research Determination. These FAQs provide guidance on OHRP's current thinking on exempt research determination and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word "must" in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word "should" in OHRP guidance means that something is recommended or suggested, but not required. The Exempt Research Determination FAQs can be accessed at: http://www.hhs.gov/ohrp/faq.html

(September 24, 2009) Upcoming OHRP Research Community Forum in Seattle, WA

Save-the-date for an upcoming OHRP Research Community Forum entitled, "Protecting Research Participants: Ethical Challenges Within a Regulatory Framework," sponsored by the Northwest Association for Biomedical Research at the Bar Harbor Conference Center in Seattle, Washington on February 4, 2010. For program information, see the Publicity Notice and Flyer at: http://nwabr.org/takepart/irb.html

(September 17, 2009) REMINDER: IMPORTANT NOTICE REGARDING REGISTRATION OF IRBs REVIEWING FDA-REGULATED RESEARCH - COMPLIANCE DATE OF SEPTEMBER 14, 2009

The following notice is being sent out on behalf of the Food and Drug Administration (FDA):

We believe there may be some confusion in the IRB community regarding IRBs currently reviewing FDA-regulated research who were registered in the OHRP database before July 14, 2009.  If those IRBs had voluntarily provided information concerning FDA-regulated studies, it will be visible when their information is accessed in the modified database, but that does not mean the IRB is registered with FDA.  All previous IRB records were migrated as "OHRP only" into the new registration database, which was activated on July 14, 2009.  This designation must be updated to read "OHRP/FDA" (or "FDA only," if that is the case) to register the IRB with FDA.  In addition, any existing FDA-specific information should be reviewed to determine if an update is necessary.  (FDA-specific information includes an estimate of the number of active FDA-regulated studies and a checklist for choosing the type of FDA-regulated research - drugs, biologics, devices, etc.)

To determine if a recent update accomplished the required change, you can search for your IRB information at http://ohrp.cit.nih.gov/search/.  An IRB search with your IRB # will display basic information including "type" near the far right.  If it does not read "OHRP/FDA" or "FDA only" you need to submit a new update (see below).

If you are updating your information to provide/update the FDA-specific information, use the electronic submission system page for updating registrations at  http://ohrp.cit.nih.gov/efile/IrbRnwStart.aspx.  After obtaining a submission number from the system, you will begin the update process.  To enter information for each separate IRB, access the pull-down list of IRB type and select "OHRP/FDA" or "FDA only."  If you had already registered, the information previously entered will appear when you "save and continue," along with data-entry fields to enable you to enter or update the FDA-specific information required by the new IRB registration rule.

For further information on FDA's IRB registration requirements contact Jean Toth-Allen, Ph.D., Office of Good Clinical Practice, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, HF-34, Room 16-85, Rockville, MD 20857, telephone (301) 827-1585, e-mail jean.toth-allen@fda.hhs.gov.

(July 17, 2009) Availability of OHRP’s updated web-based electronic submission system for Federalwide Assurance (FWA) and Institutional Review Board (IRB) registration documents

OHRP’s updated web-based electronic submission system for submitting Federalwide Assurance (FWA) and Institutional Review Board (IRB) registration documents is now available at http://ohrp.cit.nih.gov/efile .

We understand that some users are experiencing technical difficulties when attempting to access and use the enhanced electronic submission system. 

We apologize for these technical difficulties and are working to resolve them. We encourage institutions and IRBs that do not immediately need to update an IRB registration or FWA to wait to submit any update while we focus our efforts on debugging the electronic submission system.   Please be aware that OHRP will take into account the various problems with the implementation of the enhanced electronic submission system, and will use available flexibility in its decision making if an entity is unable to comply with registration and FWA submission requirements due to these implementation issues. This flexibility will continue until the implementation issues with the electronic submission system are resolved.

If you have any questions about, or problems in attempting to use, the electronic submission system, please contact your regional/country coordinator listed at www.hhs.gov/ohrp/daqi-staff.html#staff

(July 8, 2009) Register Now !! OHRP Research Community Forum in New York, NY on September 11, 2009

REGISTER NOW for an upcoming OHRP Research Community Forum entitled, "On The Legal and Ethical Frontline," sponsored by The City University of New York, State University of New York at Stony Brook, Columbia University in the City of New York, and the Research Foundation of The City University of New York on September 11, 2009 in New York, New York. 

For program information and agenda, see the brochure at: 

http://web.cuny.edu/research/human-subjects-research/Events.html

(July 8, 2009) OHRP Electronic Submission System for FWAs will be Shut Down during the period of July 8 through July 13, 2009)

OHRP's current web-based system for electronic submission of Federalwide Assurance (FWA) documents (and Institutional Review Board (IRB) registration documents) will be shut down during the period of July 8 through July 13, 2009 to migrate the current FWA records to an updated electronic submission system.  During that period, new FWAs, or updates to, and renewals of, existing FWAs cannot be submitted, nor can they be processed by OHRP.  In addition, individuals will not be able to access the list of OHRP-approved FWAs on the OHRP website or view the list of FWA documents received by OHRP during the last 60 days. The updated web-based electronic submission system for FWAs and IRB registrations will be available on July 14, 2009.

(July 8, 2009) Effective Date of New OHRP Institutional Review Board Registration Requirements Approaching

On July 14, 2009, the new Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) regulations requiring registration of institutional review boards (IRBs) that were published in the Federal Register on January 15, 2009 (74 FR 2399 and 74 FR 2358) will go into effect.  The Office for Human Research Protections' (OHRP's) IRB registration system will be compatible with the requirements of both the HHS and FDA regulations

The HHS IRB registration requirements were added as a new subpart E to the HHS protection of human subjects regulations (45 CFR part 46).  Subpart E requires all IRBs that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use (i.e, a Federalwide Assurance (FWA)) by OHRP to register with HHS.  Required IRB registration information includes: contact information for the person providing the registration information; approximate numbers of all active protocols and active protocols involving research conducted or supported by HHS; and, approximate number of full-time equivalent positions devoted to the IRB's administrative activities. 

For any IRB currently registered with OHRP, the institution or organization operating the IRB must submit all information required under HHS regulations at subpart E of 45 CFR part 46 by the current expiration date previously assigned by OHRP or within 90 days of any changes regarding the contact person who provided the IRB registration information or the IRB chairperson.  Institutions or organizations operating IRBs currently registered with OHRP that review FDA-regulated research will need to update registration information to include FDA-specific information once the registration rule is effective.  For IRBs that only review FDA-regulated research, an initial registration is required.  [For questions regarding registration of IRBs that review FDA-regulated research, see FDA contact information below].

For any IRB not currently registered with OHRP, the IRB must be registered with OHRP before being designated on an FWA and reviewing research conducted or supported by HHS.

Note that beginning on July 14, 2009, institutions and organizations needing to register a new IRB, or update or renew an existing IRB registration, must do so electronically via the OHRP website at http://ohrp.cit.nih.gov/efile/ unless the institution or organization lacks the ability to register its IRBs electronically.  OHRP's current electronic IRB registration submission system is being updated so that it corresponds to the requirements of both IRB registration rules.  The updated registration system will "go live" on July 14, 2009.  In addition, the Office of Management and Budget (OMB) recently approved the information collection requirements in both rules.  Thus, beginning on July 14, 2009, IRB registration information for both rules will be collected on the OMB-approved modified IRB registration form (OMB No. 0990-0279), which will be posted on the OHRP website.

In order to implement the changes required to update the system for registering an IRB electronically via the OHRP website, the system will be shut down during the period of July 8 through July 13.  During that period, new IRB registrations, or updates to, and renewals of, existing IRB registrations cannot be submitted, nor can they be processed by OHRP.  In addition, individuals will not be able to access the list of OHRP registered IRBs on the OHRP website; or view IRB registration documents received by OHRP during the last 60 days.

The final IRB registration rule that was published in January as the new subpart E addition to 45 CFR part 46 can be accessed at: http://edocket.access.gpo.gov/2009/E9-588.htm. The FDA IRB registration final rule (new 21 CFR 56.106) can be accessed at http://edocket.access.gpo.gov/2009/E9-682.htm.

For further information on OHRP's IRB registration requirements contact Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, telephone (240) 453-6900, email Irene.Stith-Coleman@hhs.gov

For further information on FDA's IRB registration requirements contact Jean Toth-Allen, Ph.D., Good Clinical Practice Program, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, HF-34, Room 16-85, Rockville, MD 20857, telephone (301) 827-1585, email jean.toth-allen@fda.hhs.gov

(April 7, 2009) - Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards

OHRP has posted on its website a finalized guidance document entitled, “Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards.” The guidance document provides OHRP’s first formal guidance on this topic. The document, which is available on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html and http://www.hhs.gov/ohrp/humansubjects/guidance/gina.pdf, is intended primarily for investigators who conduct, and institutional review boards (IRBs) that review, non-exempt human subjects research involving genetic testing or collection of genetic information. The guidance document provides background on protections provided by the Genetic Information Nondiscrimination Act of 2008 (GINA) and discusses some of the implications of GINA for investigators who conduct, and IRBs that review, genetic research, particularly with respect to the criteria for IRB approval of research and the requirements for obtaining informed consent under the Department of Health and Human Services regulations for the protection of human subjects (45 CFR part 46). The Federal Register notice announcing the availability of this new guidance document can be found at http://edocket.access.gpo.gov/2009/E9-7782.htm or http://edocket.access.gpo.gov/2009/pdf/E9-7782.pdf.

OHRP welcomes comments on this new guidance document. Please send any comments to OHRP by e-mail at ohrp@hhs.gov, with citation of the specific document related to the comments in the subject line.

(March 5, 2009) - Request for information and comments on IRB accountability

The Office for Human Research Protections (OHRP), has issued a Federal Register notice requesting information and comments from the public about whether the office should pursue a notice of proposed rulemaking to enable OHRP to hold IRBs and the institutions or organizations operating the IRBs directly accountable for meeting certain regulatory requirements of 45 CFR part 46.

More complete information regarding the request for comments is available at http://www.hhs.gov/ohrp/requests/.

(February 18, 2009) - Register Now for the OHRP Research Community Forum in Ann Arbor, MI on May 14, 2009

Register NOW for the OHRP Research Community Forum “Reducing Regulatory Burden: Real Strategies for Real Change” in Ann Arbor, MI on May 14, 2009. This forum is being co-sponsored by the University of Michigan – Ann Arbor. For the agenda and all program information, see the brochure at: http://www.research.umich.edu/hrpp/event.html.

(February 13, 2009) - OHRP Posts Revised Compilation of Recent Determinations of Noncompliance

OHRP has revised its 2005 document "Significant Findings and Concerns of Noncompliance," to delete determinations that have not been made recently, add new determinations that have been made since 2005, and provide additional regulatory citations. The revised document, "OHRP Compliance Oversight Activities: Determinations of Noncompliance," can be found at http://www.hhs.gov/ohrp/compliance/findings.html.

(February 4, 2009) - Upcoming OHRP Research Community Forum in Ann Arbor, MI

Save-the-date for an upcoming OHRP Research Community Forum entitled, "Reducing Regulatory Burden: Real Strategies for Real Change," sponsored by University of Michigan in Ann Arbor, Michigan on May 14, 2009. For program information, see the brochure at: http://www.research.umich.edu/hrpp/event.html

(January 29, 2009) - OHRP Posts Correspondence on Engagement in Research

OHRP has posted a new item of correspondence on “Determining When Institutions Are Engaged in Research” dated January 13, 2009. This OHRP correspondence comments on several issues raised in an on-line discussion of the “IRB Forum,” to which a number of people post messages related to implementation of human subjects protections. OHRP's response can be viewed at http://www.hhs.gov/ohrp/policy/correspond/. Among the topics addressed in the correspondence are the differences between an interaction and an intervention, and how to determine when the employees of a contractor should be considered agents of the FWA-holding institution that hired the contractor.

(January 15, 2009) - New Institutional Review Board Registration Requirements

The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), has added a new subpart E to the HHS protection of human subjects regulations (45 CFR part 46). This new subpart requires institutional review boards (IRBs) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use by OHRP to register with HHS. The registration information includes contact information, approximate numbers of all active protocols and active protocols involving research conducted or supported by HHS, and staffing for the IRB. The registration requirements will make it easier for OHRP to convey information to IRBs and will support the current IRB registration system operated by OHRP. Under this final rule, the IRB registration system will be compatible with the IRB registration requirements of the Food and Drug Administration (FDA), which are simultaneously published as a final rule in this issue of the Federal Register, allowing the operation of a single HHS IRB registration system.

Note that the rule is effective July 14, 2009. This delayed effective date is necessary to (a) allow refinement of the electronic registration system so that it corresponds to this final rule and the FDA's final rule, and (b) obtain Office of Management and Budget review and approval for the information collection requirements of this rule.

Initial registration with all required information must be submitted within 60 days of the effective date of the rule, by September 14, 2009. For any IRB registered with OHRP as of September 14, 2009, the institution or organization operating the IRB must submit all information required under this rule by the three-year expiration date previously assigned by OHRP or within 90 days of any changes regarding the contact person who provided the IRB registration information or the IRB chairperson.

Note that prior to the effective date of the new rule, the requirements and process for registering an IRB with OHRP will remain unchanged. Organizations and institutions with IRBs that are currently registered with OHRP do not need to take any action at the present time. OHRP will provide additional instructions and guidance prior to the effective date of the new rule.

Also, note that once the rule becomes effective, institutions and organizations needing to register an IRB, or update or renew an existing IRB registration, will be required to do so electronically via the OHRP website, unless the institution or organization lacks the ability to register its IRBs electronically.

The final rule can be accessed at: http://edocket.access.gpo.gov/2009/E9-588.htm. The FDA's IRB registration final rule can be accessed at http://edocket.access.gpo.gov/2009/E9-682.htm.

(January 5, 2009) - OHRP Asks for Comments on its Website

OHRP plans to revise its website (www.hhs.gov/ohrp). We want to make the site easier to use and more useful to you. We welcome any feedback or suggestions on content, format, navigation or any other aspect of the site from web visitors.

Please send your comments to
OHRPWeb@hhs.gov

If you would prefer to send in your comments anonymously, please go to
http://transparency.cit.nih.gov/ohrp/feedback.cfm

(December 30, 2008) - New OHRP Frequently Asked Questions and Answers on Quality Improvement Activities

OHRP has posted a new set of Frequently Asked Questions and Answers (FAQs) on quality improvement activities. These FAQs provide guidance on OHRP's current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited. The quality improvement activities FAQs can be accessed at http://www.hhs.gov/ohrp/qualityfaq.html#q2

(December 01, 2008) - Draft Guidance for When Participation of Human Subjects in Research Is Discontinued

On December 1, 2008, the Office for Human Research Protections (OHRP) announced, in the Federal Register, the availability of a draft guidance document entitled "OHRP Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued." The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document is intended primarily for institutional review boards, investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by the Department of Health and Human Services.

The proposed guidance document would provide guidance on important considerations for when participation of human subjects in research is discontinued, either because a subject voluntarily chooses to discontinue participation during the course of the research, or because an investigator terminates a subject's participation in the research without regard to the subject's consent. OHRP will consider comments received before issuing the final guidance document.

OHRP requests that written comments on the draft guidance document be submitted by January 30, 2009. Comments may be submitted by any of the following methods: (1) E-mail to discontinueparticipation@hhs.gov and include "Guidance on Discontinuation of Subject Participation" in the subject line; (2) Fax: 301-402-2071; (3) Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

The draft guidance can be accessed at: http://www.hhs.gov/ohrp/requests/200811guidance.html or http://www.hhs.gov/ohrp/requests/200811guidance.pdf.

A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed at: http://edocket.access.gpo.gov/2008/E8-28369.htm or http://edocket.access.gpo.gov/2008/pdf/E8-28369.pdf.

Please note that elsewhere in the December 1, 2008 issue of the Federal Register, the Food and Drug Administration (FDA), announced the availability of a final guidance document entitled "Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trial."

A copy of the Federal Register notice announcing the availability of the FDA final guidance can be accessed at: http://edocket.access.gpo.gov/2008/E8-28387.htm or http://edocket.access.gpo.gov/2008/pdf/E8-28387.pdf.

(November 26, 2008) - OHRP Career Opportunity

Join the Office for Human Research Protections staff. There is currently a GS-15 Supervisory Public Health Analyst vacancy announcement posted for the Division of Education and Development. The announcement closes December 26, 2008. The website link to this announcement is: http://jobsearch.usajobs.gov/getjob.asp?JobID=77722700&AVSDM.

You can also find this announcement by going to the USAJOBS website: http://jobsearch.usajobs.opm.gov/ and entering the announcement number: HHS-OS-2009-0096 in the Keyword Search field.

(November 20, 2008) - ACT NOW & SAVE on the Upcoming OHRP Research Community Forum in Glendale, AZ

Register NOW to avoid higher registration costs. Early registration ends on January 1, 2009! Don’t miss this unique opportunity to attend the upcoming OHRP Research Community Forum entitled, "Human Subjects Protections: Bridge to the Future," at the Renaissance Glendale Hotel and Spa in Glendale, Arizona on January 30, 2009. This forum is being co-sponsored by Banner Health. For agenda and all program information, see the brochure at: http://www.bannerhealth.com/Research/_Research+Institute.htm

(October 31, 2008) - Join the Office for Human Research Protections (OHRP) staff

There is currently one GS-13/14 Public Health Analyst vacancy announcement posted. This announcement closes November 28, 2008. The website link to this announcement is: http://jobsearch.usajobs.gov/getjob.asp?JobID=77101967&brd=3876&AVSDM

(October 20, 2008) - OHRP Career Opportunity

Join the Office for Human Research Protections (OHRP) staff. There is currently a GS-13/14 Public Health Analyst vacancy announcement posted for the Division of Policy and Assurances. This announcement closes November 20, 2008. The website link to this announcement is: http://jobsearch.usajobs.gov/getjob.asp?JobID=76760748&AVSDM=2008%2D10%2D20+00%3A03%3A01&Logo=0&sort=rv&vw=d&brd=3876&ss=0&customapplicant=15513,15514,15515,15669,15523,15512,15516,45575&q=ohrp

Interested persons can also find this announcement by going to the USAJOBS website: http://jobsearch.usajobs.opm.gov/ and entering the announcement number: HHS-OS-2009-0037 in the Keyword Search field.

(October 24, 2008) - Jerry Menikoff to Head Office for Human Research Protections

HHS Assistant Secretary for Health Joxel García, M.D., M.B.A., today announced the appointment of Jerry A. Menikoff, M.D., J.D, as the director of the Office for Human Research Protections (OHRP), part of the Office of Public Health and Science, in the Office of the Secretary.

Prior to joining OHRP, Dr. Menikoff served as the director of the Office of Human Subjects Research and a bioethicist, both at the National Institutes of Health. He has written extensively on research and human subject protections, including several books and numerous journal articles, over the past fifteen years.

Previous to his NIH appointments, Dr. Menikoff served for nine years as the chair of the human subjects committee and the hospital ethics committee at the University of Kansas Medical Center. His educational background includes an M.D. from Washington University and law and public policy degrees from Harvard. In addition, Dr. Menikoff has held academic positions in schools of law at the University of Akron, the University of Chicago, and Hofstra University, Hempstead, NY. He is on leave from the position of associate professor of law, ethics and medicine at the University of Kansas.

Dr. Ivor Pritchard, who had served as OHRP’s acting director since September 2007, will return to his position as senior advisor to the OHRP director.

(October 23, 2008) - Finalized Guidance on Engagement of Institutions in Human Subjects Research and Revised Guidance Involving Coded Private Information or Biological Specimens

OHRP has posted on its website a finalized guidance document entitled, “Guidance on Engagement of Institutions in Human Subjects Research.” The public comments submitted on our draft document were very helpful to us as we finalized this guidance document, and we thank those of you who took the time to provide us with your feedback. The finalized guidance is on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html. This new guidance document replaces two prior OHRP guidance documents on the engagement of institutions in human subjects research: (1) the January 26, 1999 document on “Engagement of Institutions in Research,” and (2) the December 23, 1999 document on “Engagement of Pharmaceutical Companies in HHS Supported Research.” The Federal Register notice announcing the availability of this new guidance document can be found at http://edocket.access.gpo.gov/2008/E8-25177.htm or http://edocket.access.gpo.gov/2008/pdf/E8-25177.pdf.

OHRP has also posted a revised version of the “Guidance on Research Involving Coded Private Information or Biological Specimens” that includes minor changes that were made for consistency with the new guidance document on the engagement of institutions in human subjects research. The revised “Guidance on Research Involving Coded Private Information or Biological Specimens” is on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm. Only the following two substantive changes have been made to this guidance document: (1) under the section heading, “Guidance,” OHRP has clarified its interpretation of “obtaining identifiable private information or identifiable specimens;” and (2) in the list of examples of when investigators would not be able to readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain (see page 3), the first example has been deleted. The deleted example had addressed the circumstance when the key to decipher the code was destroyed before the research began. Since this was not an example of research involving coded private information or specimens, this example was deleted for clarity.

OHRP welcomes comments on these guidance documents. Please send any comments to OHRP by e-mail at ohrp@hhs.gov, with citation of the specific document related to the comments in the subject line.

(October 10, 2008) - Federal Register Notice of Federal Advisory Committee Meeting, October 27-28, 2008

The Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Human Research Protections (SACHRP) will meet on Monday, October 27, 2008, from 8:30 a.m. to 4:30 p.m. EDT, and on Tuesday, October 28, 2008, from 8:30 a.m. to 4:30 p.m. EDT, at the Sheraton National Hotel Arlington, located at 900 S. Orme Street, Arlington, Virginia 22204. The meeting will be held on the 16th floor in the Galaxy Ballroom.

The Federal Register Notice containing additional information for this meeting is available in at http://edocket.access.gpo.gov/2008/E8-24169.htm or in PDF format at http://edocket.access.gpo.gov/2008/pdf/E8-24169.pdf.

(October 2, 2008) - Addition of OHRP Correspondence to Web Site

OHRP has added a category of "OHRP Correspondence" to the Regulations and Policy Guidance portion of its Web site (http://www.hhs.gov/ohrp/). In this category OHRP will occasionally post correspondence with institutional review boards (IRBs), investigators, research institutions, or federal agencies when the correspondent gives OHRP permission, and the discussion of issues referenced in the correspondence may be useful to others for understanding the applicability and interpretation of the Department of Health and Human Services (HHS) regulations for the protection of human subjects in research (45 CFR part 46).

Two pieces of correspondence have been included, a September 29, 2008 Memorandum to the National Cancer Institute regarding IRB review of protocol and informed consent changes, and a July 30, 2008 letter regarding quality improvement activities designed to reduce catheter-related infections.

(October 1, 2008) - Upcoming OHRP Research Community Forum in Ann Arbor, MI

Save the date for an upcoming OHRP Research Community Forum entitled “Human Subject Protections,” sponsored by University of Michigan in Ann Arbor, MI on May 14, 2009. View the Publicity Notice.

(September 30, 2008) - Upcoming OHRP Research Community Forum in Glendale, AZ

Save the date for an upcoming OHRP Research Community Forum entitled “Human Subject Protections: Bridge to the Future,” sponsored by Banner Health in Glendale, AZ on January 30, 2009. View the Publicity Notice.

(August 11, 2008) - OHRP Career Opportunity

Join the Office for Human Research Protections (OHRP) staff. There is currently one GS-9/11 Program Analyst vacancy announcement posted. This announcement closes September 11, 2008. The website link to this announcement is: http://jobsearch.usajobs.gov/jobsearch.asp?q=HHS-OS-2008-0579&salmin=&salmax=&paygrademin=&paygrademax=&FedEmp=N&tm=&sort=rv&vw=d&brd=3876&ss=0&FedPub=Y&SUBMIT1.x=0&SUBMIT1.y=0

Interested persons can also find this announcement by going to the USAJOBS website: http://jobsearch.usajobs.opm.gov/ and entering the announcement number: HHS-OS-2008-0579 in the Keyword Search field.

(July 7, 2008) - ACT NOW & SAVE on the OHRP Research Community Forum on September 16

It's Not Too Late to Register and Avoid Higher Registration Fees for the OHRP Research Community Forum "Informed Consent and More: Improving Human Research Protections" in Richmond, VA on September 16, 2008. Register before August 25 and enjoy savings. This forum is being co-sponsored by Virginia Commonwealth University. For the agenda and all program information, see the brochure at: http://www.research.vcu.edu/irb/conference/index.htm.

(July 2, 2008) - Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs.

The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments from affected entities and individuals about (a) whether OHRP should issue additional guidance recommending that institutions engaged in human subjects research conducted or supported by the Department of Health and Human Services (HHS) implement training and education programs for certain individuals involved in the conduct, review, or oversight of human subjects research, or (b) whether HHS should develop a regulation requiring the implementation of such training and education programs. This request for information and comment stems from the 1998 report from the HHS Office of Inspector General (OIG) recommending that Federal requirements be enacted to help ensure that investigators and institutional review board (IRB) members be adequately educated about, and sensitized to, human subjects protections. More recently, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommended that OHRP require institutions to ensure that initial and continuing training is provided for IRB members and staff, investigators, and certain institutional officials. The implementation of such training and education programs might help to ensure that individuals involved in the conduct or review of human subjects research at institutions holding OHRP-approved Federalwide Assurances (FWAs) understand and meet their regulatory responsibilities for protecting human subjects.

Submit written or electronic comments by September 29, 2008. Comments may be submitted by any of the following methods: (1) E-mail: humansubjectstraining@hhs.gov. Include “Human Subjects Protection Training and Education” in the subject line; (2) Fax: 301-402-2071; (3) Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

Comments received within the public comment period, including any personal information, will be make available to the public upon request. The notice can be accessed at: http://www.hhs.gov/ohrp/documents/fedreg20080701.htm or http://www.hhs.gov/ohrp/documents/fedreg20080701.pdf.

FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Michael.Carome@hhs.gov

(June 23, 2008) - Federal Register Notice of Federal Advisory Committee Meeting, July 15-16, 2008

The Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Human Research Protections (SACHRP) will meet on Tuesday, July 15, 2008, from 8:30 a.m. to 4:30 p.m. EDT, and on Wednesday, July 16, 2008, from 8:30 a.m. to 4:30 p.m. EDT, at the Sheraton National Hotel Arlington, located at 900 S. Orme Street, Arlington, Virginia 22204. The meeting will be held on the 16th floor in the Galaxy Ballroom.

The Federal Register Notice containing additional information for this meeting is available at http://www.hhs.gov/ohrp/documents/20080623.htm or in PDF format at http://www.hhs.gov/ohrp/documents/20080623.pdf.

(March 12, 2008) - Federal Register Notice of Federal Advisory Committee Meeting, March 27-28, 2008

The Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Human Research Protections (SACHRP) will meet on Thursday, March 27, 2008, from 8:30 a.m. to 5:00 p.m. EDT, and on Friday, March 28, 2008, from 8:30 a.m. to 4:30 p.m. EDT, at the Sheraton National Hotel Arlington, located at 900 S. Orme Street, Arlington, Virginia 22204. The meeting will be held on the 16th floor in the Galaxy Ballroom.

The Federal Register Notice containing additional information for this meeting is available at http://www.hhs.gov/ohrp/documents/20080311.htm or in PDF format at http://www.hhs.gov/ohrp/documents/20080311.pdf.

(March 6, 2008) - Federal Advisory Committee Meeting, March 27-28, 2008

The Department of Health and Human Services’ (HHS) Secretary’s Advisory Committee on Human Research Protections (SACHRP) will meet on Thursday, March 27, 2008, from 8:30 a.m. to 5:00 p.m. EDT, and on Friday, March 28, 2008, from 8:30 a.m. to 4:30 p.m. EDT, at the Sheraton National Hotel Arlington, located at 900 S. Orme Street, Arlington, Virginia 22204. The meeting will be held on the 16th floor in the Galaxy Ballroom.

The SACHRP March 2008 meeting agenda is posted at: http://www.hhs.gov/ohrp/sachrp/mtgings/mtg03-08/agenda.htm

(March 6, 2008) - Unique Agenda Topics !! OHRP Research Community Forum in New Orleans, LA - Register NOW before hotel rates increase on March 17, 2008 !!

This dynamic forum provides presentations on "Risk-benefit Evaluations From Initial Approval to Adverse Events," "Sometimes QA Activities Are Also Research - Understanding When, Why, And What to Do," "FDA Guidance on Challenging Issues in Drugs, Biologics, and Pharmacy Compounding," "HBCUs/Minority Populations - Unique Research Challenges and Possible Solutions," and "Human Specimen and Data Repositories: Legal and Ethical Challenges." Register NOW before hotel rates increase on March 17, 2008 for the OHRP Research Community Forum "From the Past to the Future: Protecting Research Subjects as Times Change," in New Orleans, LA on April 4, 2008.
This forum is being co-sponsored by the Ochsner Health System.
For the agenda and all program information, see the brochure at:
www.ochsner.org/cme

(February 15, 2008) - OHRP Concludes Case Regarding Johns Hopkins University Research on Hospital Infections

Encourages Continuance of Work to Reduce Incidence of Catheter-Related Infections; Offers New Guidance for Future Research

The Office for Human Research Protections (OHRP) -- part of the U.S. Department of Health and Human Services -- has concluded that Michigan hospitals can continue implementing a checklist to reduce the rate of catheter-related infections in intensive care unit settings (ICUs) without falling under regulations governing human subjects research. Dr. Kristina C. Borror, director of the office’s Division of Compliance Oversight, sent separate letters to the lead architects of the study, Johns Hopkins University and the Michigan Health & Hospital Association, outlining findings and offering researchers additional guidance for future work.

"We do not want to stand in the way of quality improvement activities that pose minimal risks to subjects," said Dr. Ivor Pritchard, acting director of OHRP. "HHS regulations provide great flexibility and should not have inhibited this activity. The regulations are designed to protect human subjects."

The Johns Hopkins study demonstrated that a comprehensive five-step program can dramatically reduce the incidence of catheter-borne infections in ICUs. HHS strongly encourages hospitals nationwide to adopt the program, which can save thousands of lives and millions of dollars each year.

OHRP noted that the Johns Hopkins project has evolved to the point where the intervention, including the checklist, is now being used at certain Michigan hospitals solely for clinical purposes, not medical research or experimentation. Consequently, the regulations that govern human subjects research no longer apply and neither Johns Hopkins nor the Michigan hospitals need the approval of an institutional review board (IRB) to conduct the current phase of the project.

In addition, the letters offer new guidance for future quality improvement research that poses minimal risk to human subjects, such as the Johns Hopkins study. Dr. Borror wrote that such research would likely have been eligible for both expedited IRB review and a waiver of the informed consent requirement.

In response to a written complaint about this research, OHRP opened a compliance oversight evaluation with the Johns Hopkins University and the Michigan Health & Hospital Association, regarding allegations of non-compliance with HHS regulations for the protection of human subjects (45 CFR part 46, see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). The complainant alleged that the research was conducted without prior review and approval by an IRB and without the informed consent of the human subjects who participated.

HHS is reviewing the application of these rules to evidence-based quality improvement activities, like the Johns Hopkins project, and whether any changes are needed to encourage such work while safeguarding the rights and welfare of human subjects in research.

(February 13, 2008) - Register Now & Avoid Higher Registration Fees and Hotel Costs for the OHRP Research Community Forum in New Orleans, LA

It's Not Too Late to Register and Avoid Higher Registration Fees and Hotel Fees for the OHRP Research Community Forum "From the Past to the Future: Protecting Research Subjects as Times Change," in New Orleans, LA on April 4, 2008. Please register before March 4th. This forum is being co-sponsored by the Ochsner Health System. For the agenda and all program information, see the brochure at:

http://academics.ochsner.org/EducationContent.aspx?id=7440

(February 11, 2008) - OHRP Spanish Pamphlet Now Available

OHRP is pleased to announce that its pamphlet "Becoming a Research Volunteer: It’s Your Decision" is now available in Spanish, "Ser Voluntario en Estudios Clínicos: Es Su Decisión."

You may order up to 50 (fifty) free copies by calling OHRP's toll-free number, (866) 447-4777. You may also download at no charge an electronic copy at http://www.hhs.gov/ohrp/espanol/OHRP3PanelSpanish.pdf for your own reprinting and distribution.

OHRP would like to hear about your experiences with the Spanish pamphlet. Please tell us about them at ohrp@hhs.gov.

The English version of the pamphlet remains available, and may be obtained at the same telephone number, or downloaded from http://www.hhs.gov/ohrp/outreach/documents/3panelfinal.pdf.

(January 15, 2008) - OHRP Statement Regarding The New York Times Op-Ed Entitled "A Lifesaving Checklist"

Following the publication of an op-ed entitled "A Lifesaving Checklist" in the December 30, 2007, edition of The New York Times, some readers have contacted the Office for Human Research Protections (OHRP) concerning OHRP's activities referenced in the op-ed. While some expressed concern that OHRP has prohibited hospitals in Michigan and elsewhere from implementing a program intervention consisting of a checklist and other measures to prevent certain hospital-acquired infections, OHRP has taken no such action. On the contrary, if any hospital or intensive care unit decides to implement the use of checklists or other measures only for the reason that they believe those measures will improve the quality of care provided, they may do so without consideration of the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46).

We note that the op-ed also inaccurately characterized certain facts of the case involving the Michigan hospitals and how the regulations apply. In the case the op-ed refers to, the HHS regulations for the protection of human research subjects applied in an earlier time period when the use of a checklist was originally implemented as part of a multi-component program intervention being evaluated in a research study funded by HHS. The purpose of the study was to find out whether that intervention decreased the rate of certain infections, which had not previously been proven. In research studies where the regulations apply, an institutional review board (IRB) must review the study before it begins to ensure that the appropriate protections for the prospective subjects are in place. For example, the IRB looks to see whether the risks to the subjects participating in the research study have been minimized, and whether the informed consent of the subjects must be obtained before participation or whether the proposed research satisfies the regulatory criteria for waiver of informed consent (see 45 CFR 46.116(d)). OHRP received a complaint about the research study and determined that no such IRB review had taken place before the research study began. The institutions were notified, and a corrective action plan was developed and is being implemented. OHRP is working with the institutions involved to resolve this situation and to take action to avoid having this problem happen again.

As stated above, the regulations do not apply when institutions are only implementing practices to improve the quality of care. At the same time, if institutions are planning research activities examining the effectiveness of interventions to improve the quality of care, then the regulatory protections are important to protect the rights and welfare of human research subjects. OHRP continues to work to develop guidance to assist institutions in determining when the regulatory protections are required and appropriate and when they are not. OHRP will not stand in the way of practitioners who are only carrying out the important task of providing the highest quality of care.

To better inform interested individuals about the human subjects research referenced in the December 30 New York Times op-ed and OHRP's compliance oversight evaluation of that research, OHRP notes the following:

(1) The research was described in an article published in the December 28, 2006 edition of the New England Journal of Medicine (Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med 2006;355:2725-32). (http://content.nejm.org/cgi/content/full/355/26/2725 )

(2) The research was supported by a grant from the Agency for Healthcare Research and Quality, Department of Health and Human Services (HHS).

(3) In response to a written complaint about this research, OHRP opened a compliance oversight evaluation with the Johns Hopkins University and the Michigan Health & Hospital Association, regarding allegations of non-compliance with HHS regulations for the protection of human subjects (45 CFR part 46, see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). The complainant alleged that the research was conducted without prior review and approval by an institutional review board and without the informed consent of the human subjects who participated.

(4) The determination letters issued by OHRP so far during its compliance oversight evaluation of the research in this case can be found at:
http://www.hhs.gov/ohrp/detrm_letrs/YR07/jul07d.pdf
http://www.hhs.gov/ohrp/detrm_letrs/YR07/nov07c.pdf
http://www.hhs.gov/ohrp/detrm_letrs/YR07/nov07b.pdf

(5) OHRP is working closely with Johns Hopkins University and the Michigan Health & Hospital Association to resolve the outstanding issues expeditiously, as it does in all compliance oversight investigations.

Information about how OHRP conducts compliance oversight investigations can be found at http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf.

Please feel free to contact Pat Elhinnawy, public affairs specialist, by telephone (202-253-0458) or e-mail (pat.elhinnawy@hhs.gov) if you have further questions regarding this matter.

(January 7, 2008) - Registration is Closing on January 31, 2008 for the OHRP Research Community Forum in Sacramento, CA

Registration is Closing on January 31, 2008 !! Don't Miss This Unique Opportunity to attend the OHRP Research Community Forum in Sacramento, CA "Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008" in Sacramento, CA on February 8, 2008. This forum is being co-sponsored by the University of California Davis. If you do not register by January 31st, you will have to register on-site. For the agenda and all program information, see the brochure at:

http://www.research.ucdavis.edu/ohrpconference/home.cfm?id=HRP,33

(December 20, 2007) - OHRP Career Opportunity

Join the Office for Human Research Protections (OHRP) staff. There is currently one GS 9 vacancy announcement posted for the Division of Policy and Assurances. This announcement closes January 21, 2008. The website link to this announcement is: http://jobsearch.usajobs.gov/jobsearch.asp?sort=rv&vw=d&brd=3876&ss=0&customapplicant=15513,15514,15515,15669,15523,15512,15516,45575&q=HHS-OS-2008-0163.

Interested persons can also find this announcement by going to the USAJOBS website: http://jobsearch.usajobs.opm.gov/ and entering the announcement number: HHS-OS-2008-0163 in the Keyword Search field.

(December 17, 2007) - Register NOW for the OHRP Research Community Forum in Sacramento, CA

Register NOW to avoid higher registration costs. Early registration ends on December 21, 2007! Don’t miss this unique opportunity to attend the upcoming OHRP Research Community Forum entitled, "Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008," at the Doubletree Hotel Sacramento in Sacramento, California on February 8, 2007. This forum is being co-sponsored by the University of California Davis. For agenda and all program information, see the brochure at:

http://www.research.ucdavis.edu/ohrpconference/home.cfm?id=hrp,33

(November 30, 2007) - OHRP Career Opportunity

Join the Office for Human Research Protections (OHRP) staff. There is currently one GS 13/14 vacancy announcement posted for the Division of Compliance Oversight. This announcement closes December 28, 2007. The website link to this announcement is: http://jobsearch.usajobs.opm.gov/getjob.asp?JobID=65845637&AVSDM

Interested persons can also find this announcement by going to the USAJOBS website: http://jobsearch.usajobs.opm.gov/ and entering the announcement number: HHS-OS-2008-0128 in the Keyword Search field.

(November 29, 2007) - Extension of Comment Period

Notice! The Office for Human Research Protections (OHRP), Office of Public Health and Science, is extending the public comment period for the previously announced REQUEST FOR INFORMATION ON RESEARCH THAT INVOLVES ADULT INDIVIDUALS WITH IMPAIRED DECISION-MAKING CAPACITY. Written or electronic information and comments should be received by January 14, 2008.

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research, as announced in Federal Register Vol. 72, No.171, page 50966- 50970, dated September 5, 2007. This request for information and comments stems from the recommendation of an HHS working group, generated in response to the report published by the National Bioethics Advisory Commission entitled “Research Involving Persons With Mental Disorders That May Affect Decision-making Capacity”(December 1998), and from subsequent recommendations by the National Human Research Protections Advisory Committee and the current work of the Secretary’s Advisory Committee for Human Research Protections.

Written comments may be sent to REQUEST FOR INFORMATION ON RESEARCH THAT INVOLVES ADULT INDIVIDUALS WITH IMPAIRED DECISION-MAKING CAPACITY, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to impairedcapacityohrp@hhs.gov, or via facsimile at 301-402-2071. Comments received within the comment period, including any personal information provided, will be made available to the public upon request. The notice can be accessed at: http://www.hhs.gov/ohrp/documents/20070905.htm or http://www.hhs.gov/ohrp/documents/20070905.pdf.

(November 9, 2007) - OHRP Career Opportunity

Join the Office for Human Research Protections (OHRP) staff. There is currently one GS 9/11 vacancy announcement posted for the Division of Compliance Oversight. This announcement closes December 7, 2007. The website link to this announcement is: http://jobsearch.usajobs.opm.gov/getjob.asp?JobID=65060888&AVSDM

Interested persons can also find this announcement by going to the USAJOBS website: http://jobsearch.usajobs.opm.gov/ and entering the announcement number: HHS-OS-2008-0064 in the Keyword Search field.

(October 31, 2007) - Upcoming OHRP Research Community Forum in New Orleans, LA

Save the date for an upcoming OHRP Research Community Forum entitled “From the Past to the Future: Protecting Research Subjects as Times Change,” sponsored by Ochsner Health System in New Orleans, LA on April 4, 2008. For program information see the brochure at:

http://academics.ochsner.org/EducationContent.aspx?id=7440

(October 31, 2007) - OHRP Career Opportunity

Join the Office for Human Research Protections (OHRP) staff. There is currently one GS 7/8 vacancy announcement posted for the Division of Policy and Assurances. This announcement closes November 27, 2007. The website link to this announcement is: http://jobsearch.usajobs.opm.gov/jobsearch.asp?sort=rv&vw=d&brd=3876&ss=0&customapplicant=15513,15514,15515,15669,15523,15512,15516,45575&q=ohrp

Interested persons can also find this announcement by going to the USAJOBS website: http://jobsearch.usajobs.opm.gov/ and entering the announcement number: HHS-OS-2008-0008 in the Keyword Search field.

(October 26, 2007) - Request for Comments on Categories of Research That May Be Reviewed By the Institutional Review Board (IRB) Through an Expedited Review Procedure.

The Office for Human Research Protections (OHRP) is requesting comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998 (63 FR 60364). It has come to OHRP's attention that there has been confusion in the research community about expedited review category 5. OHRP is proposing to amend expedited review category 5 to clarify that the category includes research involving materials that were previously collected for either nonresearch or research purposes, provided that any materials collected for research were not collected for the currently proposed research. Expedited review category 5 also includes research involving materials that will be collected solely for nonresearch purposes.

In addition, OHRP is requesting comments on the entire expedited review list that was last published in the Federal Register on November 9, 1998 (63 FR 60364) to determine if other changes are needed. OHRP is also specifically requesting comments on the Secretary's Advisory Committee on Human Research Protections recommendation to revise expedited review category 7.

As required under 21 CFR 56.110(a), FDA also will publish in the Federal Register a list of categories of research that may be reviewed by the IRB through an expedited review procedure. FDA intends to issue the list concurrently with OHRP’s issuance of its final notice, and in compliance with 21 CFR 10.115 (good guidance practice regulations). This approach maintains FDA’s practice of moving in tandem on this issue with OHRP.

Submit written or electronic comments on this notice by December 26, 2007. Written comments may be sent to EXPEDITED REVIEW, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to expeditedreviewohrp@hhs.gov, or via facsimile at 301-402-2071. Comments received within the comment period, including any personal information provided, will be made available to the public upon request. The notice can be accessed at: http://www.hhs.gov/ohrp/documents/20071026.htm.

(October 25, 2007) - Mark Your Calendars for These Upcoming OHRP Educational Conferences

Feb 8, 2008

"Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008"

Sponsor

University of California, Davis

Location

Doubletree Sacramento Hotel, Sacramento, CA

Apr 4, 2008

"From the Past to the Future: Protecting Research Subjects as Times Change"

Sponsor

Ochsner Health System

Location

Sheraton Hotel at the French Quarter, New Orleans, LA

Sept 16, 2008

"Informed Consent and More: Improving Human Research Protections"

Sponsor

Virginia Commonwealth University

Location

Sheraton Richmond West, Richmond, VA

Additional information can be accessed at: http://www.hhs.gov/ohrp/education/conference.html

(September 5, 2007) - Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research, as announced in Federal Register Vol. 72, No.171, page 50966-50970, dated September 5, 2007. This request for information and comments stems from the recommendation of an HHS working group, generated in response to the report published by the National Bioethics Advisory Commission entitled “Research Involving Persons With Mental Disorders That May Affect Decision-making Capacity”(December 1998), and from subsequent recommendations by the National Human Research Protections Advisory Committee and the current work of the Secretary’s Advisory Committee for Human Research Protections.

Submit written or electronic information and comments by December 4, 2007. Written comments may be sent to REQUEST FOR INFORMATION ON RESEARCH THAT INVOLVES ADULT INDIVIDUALS WITH IMPAIRED DECISION-MAKING CAPACITY, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to impairedcapacityohrp@hhs.gov, or via facsimile at 301-402-2071. Comments received within the comment period, including any personal information provided, will be made available to the public upon request. The notice can be accessed at: http://www.hhs.gov/ohrp/documents/20070905.htm or http://www.hhs.gov/ohrp/documents/20070905.pdf.

(July 9, 2007) - Agenda & Registration for the DHHS & OHRP National Conference on Native Health in Denver, CO

Register NOW! Don’t miss this unique opportunity to attend the upcoming DHHS & OHRP Conference entitled, "Research for Native Health: Strengthening Partnerships, Promoting Trust and Increasing Communication," at the Adams Mark Hotel in Denver, Colorado, on August 22-23, 2007. This two-day conference will provide valuable opportunities for improving the dialogue between tribal nations, academic researchers, institutional review boards, federal government officials, and community representatives with regard to research involving American Indian and Alaska Native people. This conference is being hosted by the Department of Health and Human Services’ Office of Public Health and Science’s Region VIII, in collaboration with Regions VI and IX, the Office for Human Research Protections (OHRP), the Indian Health Service, the Office of Minority Health, and other partners. Registration Deadline is August 8, 2007. For agenda and all program information, see the brochure at: http://www.omhrc.gov/templates/content.aspx?ID=5042&lvl=1&lvlID=11

(June 18, 2007) - New OHRP Frequently Asked Questions and Answers on Informed Consent

OHRP posted on its website a new set of Frequently Asked Questions and Answers (FAQs) on informed consent. These FAQs provide guidance on OHRP’s current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. The informed consent FAQs can be accessed at: http://www.hhs.gov/ohrp/faq.html

(June 7, 2007) - Agenda & Registration for the DHHS & OHRP Conference in Denver, CO

Register NOW, spaces are filling rapidly for this exciting DHHS & OHRP Conference entitled, “Research for Native Health: Strengthening Partnerships, Promoting Trust, and Increasing Communication,” hosted by the Department of Health and Human Services’ Office of Public Health and Science’s Region VIII, in collaboration with Regions VI and IX, the Office for Human Research Protections (OHRP), the Indian Health Service, the Office of Minority Health, and other partners. The two-day conference will be held at the Adams Mark Hotel in Denver, Colorado on August 22-23, 2007. For program information see brochure at: http://www.omhrc.gov/templates/content.aspx?ID=5042&lvl=1&lvlID=11

(May 1, 2007) - Register NOW for the OHRP Research Community Forum in Pittsburgh, PA

Register NOW to avoid higher registration costs. Early registration ends May 11, 2007. Don’t miss this opportunity to attend the OHRP Research Community Forum “Advancing Human Subject Protection” in Pittsburgh, PA on June 22, 2007. This forum is being co-sponsored by the University of Pittsburgh. For the agenda and all program information, see the brochure at: https://ccehs.upmc.edu/courses/brochure_825.pdf

(February 21, 2007) - Register Now for the OHRP Research Community Forum in Pittsburgh, PA

Register NOW for the OHRP Research Community Forum “Advancing Human Subject Protection: Here and Now” in Pittsburgh, PA on June 22, 2007. This forum is being co-sponsored by the University of Pittsburgh Medical Center. For the agenda and all program information, see the brochure at: https://ccehs.upmc.edu/courses/brochure_825.pdf

(January 24, 2007) - Register Now for the OHRP Research Community Forum in Orlando, FL

Register NOW to avoid higher registration and hotel room costs. Early registration ends February 10, 2007. Don’t miss this opportunity to attend the OHRP Research Community Forum “Challenges in Protecting Human Subjects in Research - Seven Years into the New Millennium” in Orlando, FL on February 26, 2007. This forum is being co-sponsored by the Florida Hospital. For the agenda and all program information, see the brochure at: http://www.flhosp.org/irb/forum/

(January 22, 2007) - New OHRP Frequently Asked Questions and Answers on Prisoner Research

OHRP posted on its website a new set of Frequently Asked Questions and Answers (FAQs) on prisoner research. These FAQs provide guidance on OHRP’s current thinking on research involving prisoners and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word “must” in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word “should” in OHRP guidance means that something is recommended or suggested, but not required. The prisoner research FAQs can be accessed at: http://www.hhs.gov/ohrp/faq.html.

(January 18, 2007) - New OHRP Guidance

OHRP posted on its website OHRP’s formal “Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events” (dated January 15, 2007). The guidance can be found by going to the Policy Guidance [by topics] page on the OHRP website at http://www.hhs.gov/ohrp/policy/index.html, and clicking on either “Adverse Events” or “Unanticipated Problems” from the list of guidance topics.

OHRP has also posted newly revised versions of the following two guidance documents:

(1) “Guidance on Continuing Review” (this guidance can be found by clicking on “Continuing Review” from the list of guidance topics at the top of the Policy Guidance [by topics] page on the OHRP website). This guidance has been revised to be consistent with the content of OHRP’s January 15, 2007 “Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events.”

(2) “Guidance on Written IRB Procedures” (this guidance can be found by clicking on “IRBs” from the list of guidance topics at the top of the Policy Guidance [by topics] page on the OHRP website, and then clicking on the last bullet under the heading “IRB (Institutional Review Board).” This guidance has been updated to include the following changes: (1) the content regarding continuing review has been revised to be consistent with the content of OHRP’s January 15, 2007 “Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events;” (2) paragraph A.(4) under “ADDITIONAL OHRP GUIDANCE RELEVANT TO WRITTEN IRB PROCEDURES” has been revised to be consistent with OHRP’s position regarding when IRB’s must defer approval of research; and (3) formatting changes.

OHRP welcomes comments on these guidance documents. Please send any comments to OHRP by e-mail at ohrp@hhs.gov, with citation of the specific document related to the comments in the subject line.

(January 9, 2007) - Archiving of Two Outdated OHRP Guidance Documents

OHRP has recently moved two guidance documents from its set of active documents to its archive of guidance documents no longer in effect. The content of Designation of an Independent IRB and Reliance on Another Institution’s IRB has been rendered unnecessary and inaccurate by the provisions of the Federalwide Assurance (FWA), which permits designation of an independent IRB and reliance on another institution’s IRB as a matter of course. Those who maintain a printed collection of OHRP guidance documents may wish to remove these two documents from their collection, or mark the documents as being no longer in effect. Current guidance documents are available on OHRP’s website at http://www.hhs.gov/ohrp/policy/index.html#topics.

(January 8, 2007) - OHRP Career Opportunity

Join the Office for Human Research Protections (OHRP) staff. There is currently one GS 13/14 vacancy announcement posted for the Division of Education and Development. The announcement closes February 5, 2007. The website link for this announcement is: http://jobsearch.usajobs.opm.gov/getjob.asp?JobID=52125550&AVSDM=2007%2D01%2D05+16%3A05%3A31&Logo=0&q=HHS-OS-2007-187&FedEmp=N&sort=rv&vw=d&brd=3876&ss=0&FedPub=Y&SUBMIT1.x=0≠&SUBMIT1.y=0

Interested persons can also find this announcement by going to the USAJOBS website: http://jobsearch.usajobs.opm.gov/ and entering the announcement number: HHS-OS-2007-0187 in the Keyword Search field.

(December 8, 2006) - Request for Public Comment on OHRP Draft Guidance Document on Engagement of Institutions in Human Subjects Research

On December 8, 2006, the Office for Human Research Protections (OHRP) announced, in the Federal Register, the availability of a draft guidance document entitled "OHRP Guidance on Engagement of Institutions in Human Subjects Research." The draft guidance would revise and replace two existing OHRP guidance documents on engagement of institutions in human subjects research: (1) the January 26, 1999 document on "Engagement of Institutions in Research," and (2) the December 23, 1999 document on "Engagement of Pharmaceutical Companies in HHS-Supported Research." To facilitate public review of the draft guidance document, OHRP has developed a table presenting a side-by-side comparison of OHRP’s draft guidance document with the current guidance documents on the engagement of institutions in human subjects research. Both the draft guidance document and the side-by-side comparison table can be accessed at: http://www.hhs.gov/ohrp/requests/. A copy of the Federal Register notice can be accessed at: http://www.hhs.gov/ohrp/documents/20061208.pdf

OHRP requests that written comments on the revised draft guidance document be submitted by February 6, 2007 to: ENGAGEMENT GUIDANCE COMMENTS, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent to engagementohrp@hhs.gov or via facsimile at 301-402-2071.

(November 30, 2006) - Upcoming OHRP Research Community Forum in Orlando, FL

Register NOW for an upcoming OHRP Research Community Forum entitled "Challenges in Protecting Human Subjects in Research: Seven Years into the Millennium," sponsored by the Florida Hospital on February 26, 2007. For program information see the brochure at: http://www.flhosp.org/irb/forum/.

(October 25, 2006) - OHRP Frequently Asked Questions (and Answers) Page Now on OHRP’s Website

The Office for Human Research Protections (OHRP) has added a Frequently Asked Questions page on its website. This FAQ page includes a new set of FAQs on Investigator Responsibilities. The investigator responsibilities FAQs are in addition to FAQs on the following topics: Assurance Process; IRB Registration Process; 45 CFR part 46; and, Research with Children, that are posted on the FAQ page. These FAQs provide guidance on OHRP’s current thinking on these topics and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required.

The FAQ page can be accessed at: http://www.hhs.gov/ohrp/ by clicking the Frequently Asked Questions (FAQ) tab (5th) in the left margin.

(August 31, 2006) - Notices announcing a Food and Drug Administration Public Hearing on Emergency Research Conducted Without Informed Consent Under FDA’s Emergency Research Rule and the Availability of Draft Guidance

On August 29, 2006, the Food and Drug Administration (FDA) announced that it will hold a public hearing on emergency research conducted without informed consent under FDA’s emergency research rule. The public hearing will be held on October 11, 2006, from 8 a.m. to 6 p.m. at the University System of Maryland Shady Grove Center, 9630 Gudelsky Drive, Rockville, MD 20850. FDA is seeking input on a number of specific questions regarding aspects of emergency research and additional human subject protections. A copy of the Federal Register notice announcing this meeting can be accessed at http://www.hhs.gov/ohrp/references/emer_rsch_mtg_notc.pdf.

In the same issue of the Federal Register, FDA also announced the availability of a draft guidance document entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research.” FDA has requested that written or electronic comments on the draft guidance be submitted to the agency by October 30, 2006. A copy of the FDA guidance availability notice can be accessed at http://www.hhs.gov/ohrp/references/emer_rsch_drft_guid.pdf.

(August 28, 2006) - Register for the OHRP National Human Subjects Protections Conference in Durham, NC

It’s Not Too Late to Register and Avoid Higher Registration Fees for the OHRP National Human Subjects Protections Conference “Crossing the Line: What is Acceptable Risk” in Durham, NC on September 25-26, 2006. This conference is being sponsored by the Duke University School of Medicine. For the agenda and all program information, see the brochure at: http://dukeohrp2006.org/

(August 2, 2006) - OHRP Career Opportunities

Join the Office for Human Research Protections (OHRP) staff. There are currently two GS 13/14 vacancy announcements posted for OHRP, one in the Division of Education and Development and one in the Division of Compliance Oversight.” These announcements close August 29, 2006. Interested persons can find the specific vacancy announcements at the following USAJOBS website:

Division of Education & Development: http://jobsearch.usajobs.opm.gov/jobsearch.asp?q=HHS-OS-2006-0528&lid=316&jbf571=&salmin=&salmax=&paygrademin=&paygrademax=&FedEmp=N&tm=&sort=rv&vw=d&brd=3876&ss=0&FedPub=Y&SUBMIT1.x=65&SUBMIT1.y=10

Division of Compliance Oversight: http://jobsearch.usajobs.opm.gov/jobsearch.asp?q=HHS-OS-2006-0539≠&lid=316&jbf571=&salmin=&salmax=&paygrademin=&paygrademax=&FedEmp=N&tm=&sort=rv&vw=d&brd=3876&ss=0&FedPub=Y&SUBMIT1.x=0&SUBMIT1.y=0

(July 10, 2006) - Notice to Clarify a Requirement in the FWA Form for International (non-U.S.) Institutions Approved by OHRP

The Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services (HHS) is providing public notice to clarify a requirement contained in the Federalwide Assurance (FWA) form for international (non-U.S.) institutions, approved by the Office for Human Research Protections under the HHS protection of human subject regulations, 45 CFR part 46. HHS clarifies that the requirements of HHS regulations must be satisfied for all HHS-conducted or -supported research covered by an FWA, regardless of whether the research is conducted domestically or internationally. To date, HHS has not deemed any other procedural standards equivalent to 45 CFR part 46. The notice can be accessed as a pdf document at: http://www.hhs.gov/ohrp/references/EPClarificationNotice.pdf.

(June 30, 2006) - Agenda & Registration for the OHRP National Conference in Durham, NC

Register NOW for the OHRP National Conference “Crossing the Line: What is Acceptable Risk?” in Durham, NC on September 25-26, 2006. This conference is being sponsored by the Duke University School of Medicine. For program information, see the brochure at: http://dukeohrp2006.org/

(June 7, 2006) - OHRP Guidance on the Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e).

The Office for Human Research Protections (OHRP) has issued guidance on how to determine whether the HHS regulations at 45 CFR part 46 are applicable to the activities covered by the Food and Drug Administration’s interim final rule, "Medical Devices; Exception From General Requirements for Informed Consent" (21 CFR 50.23(e)). Specifically, the document provides guidance on the following: (1) The determination of when institutions conducting activities covered by 21 CFR 50.23(e) would be engaged in non-exempt human subjects research; and (2) The requirements for obtaining or waiving informed consent under 45 CFR 46.116.

This guidance can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/invitrodev.html (HTML format) and http://www.hhs.gov/ohrp/humansubjects/guidance/invitrodev.pdf (PDF format).

OHRP welcomes comments on this guidance document. Please send any comments to OHRP by e-mail at ohrp@hhs.gov, with "OHRP guidance on 21 CFR 50.23(e)" in the subject line.

(April 18, 2006) - Agenda & Registration for the OHRP National Conference in Denver, CO

Register NOW for the OHRP National Conference entitled, "Special Populations/Special Research Situations," co-sponsored by the University of Colorado Health Sciences Center School of Medicine and its Colorado Multiple Institutional Review Board and seven regional academic institutions and hospitals in Denver, Colorado on June 1 and 2, 2006. For program and registration information see brochure at: http://www.ohrpmeetings.org/Denver/default.html

(April 17, 2006) - Documentation of Approval of FWAs and Processing of IRB Registrations

Effective February 1, 2005, OHRP stopped mailing copies of approved Federalwide Assurance (FWA) documents to the Signatory Officials of filing institutions. This was necessitated by the volume of FWA documents OHRP is managing. Over 10,000 FWAs have been approved. OHRP encourages FWA institutions to submit documents (new and updates/renewals) electronically (http://ohrp.cit.nih.gov/efile). When an institution uses the electronic submission system, the person submitting the electronic record, the Human Protections Administrator, and the Signatory Official will receive an automatically generated e-mail notifying them of the approval of the FWA document. This, of course, is dependent upon the electronic file submitted to OHRP providing e-mail addresses as requested.

OHRP has never mailed any documentation on the registration of an institutional review board/independent ethics committee (IRB/IEC). OHRP encourages organizations to submit IRB/IEC registration documents (new and updates/renewals) electronically (http://ohrp.cit.nih.gov/efile). When an organization uses the electronic submission system, the person submitting the electronic record, the Information Provider, the Chair(s) of the IRB/IEC(s), and the Head Official will receive an automatically generated e-mail notifying them of the processing of the document. This, of course, is dependent upon the electronic file submitted to OHRP providing e-mail addresses as requested.

Institutions that submit FWA and IRB registration documents in hard (paper) copy will need to monitor the OHRP website (http://ohrp.cit.nih.gov/search/) to ensure that their documents have been processed. This website includes information on all OHRP-approved FWAs and registered IRBs. Funding agencies use this website to verify that an institution holds an active OHRP-approved FWA and to ensure IRBs are properly registered and current.

As a reminder, you may check the status of any document submitted to OHRP for processing in the past 60 days at http://ohrp.cit.nih.gov/search/. FWA and IRB documents will be listed at that site within 24-48 hours after receipt and will show you who is reviewing the document and how to reach that person, as well as the status of the review procedure.

General questions regarding FWA and IRB registration processes should be directed to the coordinator for your region. The list of regional coordinators may be found at http://www.hhs.gov/ohrp/daqi-staff.html#staff."

(April 11, 2006) - Agenda & Registration for the OHRP Research Community Forum in Notre Dame, IN

Register NOW for the OHRP Research Community Forum "Bridging The Regulatory Gap: Biomedical &Social/Behavioral Are Closer Than You Think" in Notre Dame, IN on May 16, 2006. This forum is being sponsored by the University of Notre Dame. For program information, see the brochure at: http://ohrpmeetings.org/indiana/overview.html

(March 21, 2006) - Agenda & Registration for the OHRP Research Community Forum in Notre Dame, IN

Register NOW for the OHRP Research Community Forum "Bridging the Regulatory Gap: Biomedical & Social/Behavioral Research Are Closer Than You Think," in Notre Dame, IN on May 16, 2006. This forum is being sponsored by the University of Notre Dame. For program information, see the brochure at: http://ohrpmeetings.org/indiana/overview.html

(February 24, 2006) - SACHRP Advisory Committee Meeting March 13-14, 2006

The Department of Health and Human Services’ (HHS) Secretary’s Advisory Committee on Human Research Protections (SACHRP) will meet on Monday, March 13, 2006, from 8:30 a.m. to 5:00 p.m. EST, and on Tuesday, March 14, 2006, from 8:30 a.m. to 4:30 p.m. EST, at the Radisson Hotel Old Town, 901 North Fairfax Street, Alexandria, Virginia. The meeting will held in the Jefferson Room.

The SACHRP March 2006 meeting agenda is posted at: http://www.hhs.gov/ohrp/sachrp/mtgings/mtg03-06/sagenda.pdf

To view the Federal Register Notice containing additional information for this meeting, go to the URL listed below, use page numbers 9344 and 9345, and click Submit.

http://www.gpoaccess.gov/fr/retrieve.html

Thanks!

For additional information see: http://www.unlv.edu/Research/OPRS/conference/index.html

(February 24, 2006) - Last chance to register for OHRP Conference in Las Vegas, NV

You still have time to register for the human subject protections conference "Creating a Culture of Research Compliance: Challenges & Opportunities," in Las Vegas, Nevada on March 7-8, 2006.

(February 21, 2006) - FWA and IRB Registration - OHRP Electronic Submission System

OHRP strongly encourages all institutions requiring a Federalwide Assurance (FWA) or the registration of an Institutional Review Board (IRB) to use the Electronic Submission System (ESS). Following is guidance on its use. Please know that you may not request a submission number and leave the record inactive for over 30 days, or it will be automatically deleted.

Whenever your institution’s FWA or IRB needs to be updated, please use the ESS. When you use the ESS to request changes, the information OHRP has in its database for an IRB registration and/or an FWA will be visible for you to edit and then submit to OHRP for processing/approval.

a) In the case of the IRB registration, you will have to enter the membership roster(s) on first use, but after the initial use, you will simply edit the roster(s) and other information accordingly. Please note that in order to obtain an electronic submission number to update/renew an IRB registration, you must know the last name only of the Head Official and an IRB Chairperson, as well as the IORG number (not IRB/IEC numbers) associated with the registration. Electronically submitted IRB/IEC registrations should NOT be faxed or mailed to OHRP. Once you have clicked the "Submit" button, there is nothing more to do. Electronic submissions are processed as they are received. The electronic submission area is monitored by OHRP, and if there are any questions about the registration, someone from OHRP will contact the submitter of the electronic document. When the registration is processed by OHRP, the person submitting the electronic registration, the Information Provider, and the Chair(s) of the IRB(s) will receive an automatically generated e-mail notifying them of the completion of the action.

b) Similarly, in order to obtain an electronic submission number to update/renew an FWA, you must know the last name only of the Signatory Official and the Human Protections Administrator, as well as the FWA number associated with the assurance. After you click the "Submit" button, you are asked to print a copy of the FWA. You should have the FWA signed by the Signatory Official and then fax the signature page to ORHP at 240/453-8202. Once the signature page is here, OHRP will take action to review the electronically submitted FWA. All electronic FWA submissions are processed in turn after the signature page is received. When the FWA is approved, the person submitting the electronic assurance, the Human Protections Administrator, and the Signatory Official will receive an automatically generated e-mail notifying them of the approval of the FWA.

Any documents mailed should be mailed to: Office for Human Research Protections, Division of Policy and Assurances, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Please do not fax AND mail documents.

To access the ESS, please go to http://ohrp.cit.nih.gov/efile. Again, please know that you may not request a submission number and leave the record inactive for over 30 days, or it will be automatically deleted.

You may track the receipt of documents on our website at http://ohrp.cit.nih.gov/search/, which also takes you to the name of the reviewer and how to contact that person. Funding agencies obtain information about institutions holding assurances via our website at http://ohrp.cit.nih.gov/search/.

(February 7, 2006) - OHRP Announces New Web Resource Page

We invite you to visit the new OHRP human subject protections resource page at http://www.hhs.gov/ohrp/related.html. This page provides links to reference documents, historical materials and Common Rule departments/agencies. Additional materials will be added as they become available."

(February 6, 2006) - Register for the OHRP Research Community Forum in Las Vegas, NV

It’s Not Too Late to Register and Avoid Higher Registration Fees for the OHRP Research Community Forum "Creating a Culture of Research Compliance: Challenges & Opportunities" in Las Vegas, NV on March 7-8, 2006. This forum is being sponsored by the University of Nevada, Las Vegas. For the agenda and all program information, see the brochure at: http://www.unlv.edu/Research/OPRS/conference/index.html

(January 27, 2006) - Agenda & Registration for the OHRP Research Community Forum in Las Vegas, NV

Register NOW for the OHRP Research Community Forum "Creating a Culture of Research Compliance: Challenges & Opportunities" in Las Vegas, NV on March 7-8, 2006. This forum is being sponsored by the University of Nevada, Las Vegas. For program information, see the brochure at: http://www.unlv.edu/Research/OPRS/conference/index.html

(January 5, 2006) - Expiration of Federalwide Assurances

Each institution with an OHRP-approved Federalwide Assurance (FWA) is responsible for ensuring that its FWA is maintained current. An FWA is approved for a period of 3 years; however, whenever there are changes in the information on file with OHRP, the FWA should be updated/renewed. All FWAs that are allowed to expire will be automatically deactivated the day after the expiration date. You may determine the expiration date for your institution’s FWA via the OHRP website at http://ohrp.cit.nih.gov/search/. FWAs that expire and are deactivated are no longer listed on the website.

Any institution requiring an FWA that has not obtained an OHRP-approved renewal to its FWA prior to the expiration date will no longer be covered by an OHRP-approved assurance of compliance. Therefore, any ongoing human subjects research conducted or supported by the U.S. Department of Health and Human Services (HHS) at your institution that is not exempt will need to be suspended until your institution submits, and OHRP approves, an FWA renewal. Submitting your institution’s FWA in a timely manner for OHRP approval, if needed, will ensure the continuity of human subjects research conducted at your institution under an FWA.

OHRP strongly encourages you to use the Electronic Submission System (ESS) to update/renew an FWA. The ESS may also be used to submit new and update/renewal IRB registrations. (See useful links below.)

Please use the following mailing address or fax number for submission of documents:

Division of Policy and Assurances
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852

Fax: (240) 453-8202

You may track the receipt of documents on our website at http://ohrp.cit.nih.gov/search/, which also takes you to the name of the OHRP reviewer and how to contact that person. Funding agencies obtain information about institutions holding assurances via our website at http://ohrp.cit.nih.gov/search/.

If you have any questions, please go to the OHRP website and identify and communicate with the staff member assigned as the point of contact for your state/region (see http://www.hhs.gov/ohrp/daqi-staff.html#staff).

The following links should be useful in updating/renewing an FWA:

OHRP home page - http://www.hhs.gov/ohrp/

Terms of Assurance - http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm

Instructions for registering a new IRB - http://www.hhs.gov/ohrp/assurances/index.html

Instructions for updating/renewing an IRB - http://www.hhs.gov/ohrp/humansubjects/assurance/renwirb.htm

Instructions for updating/renewing an FWA - http://www.hhs.gov/ohrp/humansubjects/assurance/renwfwa.htm

Electronic submission system with instructions - http://ohrp.cit.nih.gov/efile/

IRB registration form in hard copy - http://www.hhs.gov/ohrp/humansubjects/assurance/regirb.htm

Domestic (U.S.) FWA form in hard copy - http://www.hhs.gov/ohrp/humansubjects/assurance/filasur.htm

International (non-U.S.) FWA form in hard copy - http://www.hhs.gov/ohrp/humansubjects/assurance/ifilasur.htm

(December 2, 2005) - All Multiple Project Assurances (MPA) and Cooperative Project Assurances (CPA) with the Department of Health and Human Services Expire December 31, 2005

Early this year, the Office for Human Research Protections (OHRP) announced the approval of Federalwide Assurance (FWA) forms and related documents and the institutional review board/independent ethics committee (IRB/IEC) registration form by the Office of Management and Budget. Since February 10, 2005 , the FWA is the only type of assurance accepted for review and approval by OHRP.

Institutions still holding a Multiple Project Assurance (MPA) or a Cooperative Project Assurance (CPA) have until December 31, 2005 , to convert to the FWA if an OHRP-approved assurance of compliance is still required. Single Project Assurances (SPA) currently approved by OHRP will remain in effect for the duration of the project and through all non-competitive award renewals.

To date, 96% (510) of the institutions holding an OHRP-approved MPA have converted to the FWA. However, only 58% (1,177) of the institutions holding an OHRP-approved CPA have converted to the FWA.

All institutions engaged in human subjects research, not otherwise exempt, conducted or supported by the Department of Health and Human Services (HHS) must hold an OHRP-approved FWA by December 31, 2005 . On January 1, 2006, any institution that has not obtained an OHRP -approved FWA will no longer be covered by an OHRP -approved assurance of compliance, and therefore, any ongoing HHS-supported human subjects research at such an institution that is not exempt will need to be suspended until the institution submits, and OHRP approves, an FWA. To ensure the continuity of human subjects research conducted at your institution under a previously recognized MPA or CPA, you should submit an FWA immediately.

Before an FWA may be approved, all IRBs/IECs designated on the assurance must be registered with OHRP, and the registration must be current. Please see http://ohrp.cit.nih.gov/search/ to determine the status of any IRB/IEC registered with OHRP. The same website provides a list of all approved FWAs.

You are strongly encouraged to use the OHRP Electronic Submission System (ESS) for any new IRB/IEC registration or new FWA, as well as for all updates/renewals. Complete instructions on how to use the ESS are on the OHRP website at http://ohrp.cit.nih.gov/efile. If you choose to submit an IRB/IEC registration or an FWA in hard copy, the OMB-approved documents are posted on the OHRP website at http://www.dhhs.gov/ohrp.

If you have any questions about registering an IRB/IEC or submitting an FWA, please contact your regional coordinator at OHRP [http://www.hhs.gov/ohrp/daqi-staff.html#staff].

OHRP welcomes comments on the FWA forms and related documents, the institutional review board/independent ethics committee (IRB/IEC) Registration form, and OHRP’s new guidance document, "Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement." To submit comments, please go to the OHRP website at http://www.hhs.gov/ohrp and click on "Public Comments" in the left menu.

(October 20, 2005) - Effects of Hurricanes Katrina and Rita on IRB Operations

OHRP understands that the effects of Hurricanes Katrina and Rita have been devastating to areas in Louisiana, Texas, Alabama and Mississippi, and as a result, some human subject protection programs at institutions in the affected areas are unable to function, and may be unable to for some time. OHRP has prepared information to help institutions and institutional review boards (IRBs) manage the hurricanes’ impact on oversight of research and research subject interventions. This information is available at http://www.hhs.gov/ohrp/policy/hurricane.html.

(October 13, 2005) - Request for public comment on draft OHRP guidance document

The Office for Human Research Protections (OHRP) is soliciting public comment on a draft guidance document for Institutional Review Boards, investigators, research institutions, Department of Health and Human Services agencies that conduct or sponsor human subjects research, and other interested parties, entitled “Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others.” The draft guidance can be viewed on the OHRP website at http://www.hhs.gov/ohrp/requests/com101105.html.

Comments should be submitted by 1/13/06 to OHRP by email at ohrp@osophs.dhhs.gov. Please include the term "Draft guidance on reporting adverse events" in the subject field. Alternatively, comments may be submitted by mail to:

CAPT Michael Carome, M.D.
U.S. Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

(October 7, 2005) - Solicitation of Public Review and Comment on Research Protocol

The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), HHS, are soliciting public review and comment on a proposed research protocol entitled "Gonadotropin Releasing Hormone (GnRH) Agonist Test in Disorders of Puberty." The proposed research would be supported by the National Center for Research Resources, National Institutes of Health, Department of Health and Human Services (HHS). Public review and comment are solicited regarding the proposed research protocol under the requirements of HHS and FDA regulations. That notice can be accessed as a pdf document at: http://www.hhs.gov/ohrp/children/gnrh/solicit.pdf.

FDA has established a public docket where electronic copies of documents to the proposed research can be viewed at the Pediatric Advisory Committee (PAC) Docket site at: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2005 and scroll down to Pediatric Advisory Committee). These documents also are available on OHRP’s website at: http://www.hhs.gov/ohrp/children/gnrh.html .

To be considered, written or electronic comments on the proposed research must be received on or before 4:30 p.m. on November 1, 2005. Submit electronic comments to: http://www.fda.gov/dockets/ecomments. (click on "Docket Search" then at "Docket ID" type in 2005N-0404) or written comments to: the Division of Dockets Management (HFA-305), Docket No. 2005N-0404, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Received comments may be viewed on FDA’s web site at http:///www.fda.gov/ohrms/dockets/05n0404/05n0404.htm or may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The Pediatric Ethics Subcommittee of FDA’s Pediatric Advisory Committee (PAC) will be meeting on November 15, 2005 to discuss the above-cited protocol and develop a recommendation regarding whether the research should proceed. The subcommittee’s recommendation will be presented to the PAC on November 16, 2005. Notices announcing both the subcommittee and PAC meetings, respectively, can be accessed as pdf documents at http://www.hhs.gov/ohrp/children/gnrh/pesmtg.pdf and http://www.hhs.gov/ohrp/children/gnrh/pacmtg.pdf .

For further information contact: Kevin Prohaska, Office for Human Research Protections, The Tower Building, 1101 Wootton Pkwy, Suite 200, Rockville, MD 20852, (240) 453-6900, Fax, (240) 453-6909, email, kprohaska@osophs.dhhs.gov; or Jan N. Johannessen, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 14C-06), Rockville, MD 20857, (301) 827-6687, or by email: jjohannessen@fda.gov

(October 5, 2005) - Revised Announcement on FAQs on Research with Children

THE FOLLOWING REPLACES THE INCORRECT LINKS IN THE MESSAGE ON THE SAME SUBJECT SENT MONDAY, OCTOBER 3:

OHRP announces the availability of a new set of Frequently Asked Questions (FAQs) to help clarify issues related to research involving children.

You may access these FAQs from the OHRP website’s Policy and Guidance page http://www.hhs.gov/ohrp/policy/index.html under the header "children," then "Research with Children FAQs"

The FAQs may also be accessed from the HHS homepage (http://www.hhs.gov), by selecting "Questions" at the top right of the page and then on the "Questions and Answers" page under the "Category" drop-down menu, selecting "Human Research," and sub-menu, selecting "Research With Children."

OHRP plans to continue expanding the number of FAQs on human subject protection issues.

(October 4, 2005) - Guidance on Institutional Review Board Review of Clinical Trial Websites

OHRP has issued guidance on Institutional Review Board (IRB) Review of Clinical Trial Websites, http://www.hhs.gov/ohrp/policy/clinicaltrials.html. The guidance, which applies to HHS-conducted or -supported research, describes the circumstances for which IRB review of clinical trial websites is required and provides some points to consider in the review process. It also describes the circumstances for which IRB review of clinical trial websites is not required.

The guidance document can be accessed from the OHRP website Policy and Guidance page, http://www.hhs.gov/ohrp/policy/index.html under the guidance topic, Clinical Trial Websites.

(October 3, 2005) - FAQs on Research with Children

OHRP announces the availability of a new set of Frequently Asked Questions (FAQs) to help clarify issues related to research involving children, which can be accessed at http://answers.hhs.gov/cgi-bin/hhs.cfg/php/enduser/std_alp.php?p_li=&p_accessibility=0&p_page=1&p_cv=2.119&p_pv=&p_prods=&p_cats=103%2C119&p_hidden_prods=&cat_lvl1=103&cat_lvl2=119&p_search_text=&p_new_search=1

You also may access these FAQs from the OHRP website’s Policy and Guidance page http://www.hhs.gov/ohrp/policy/index.html under the header "children."

The FAQs may also be accessed from the HHS homepage (http://www.hhs.gov), by selecting "Questions" at the top right of the page and then on the "Questions and Answers" page under the "Category" drop-down menu, selecting "Human Research," and sub-menu, selecting "Human Research."

OHRP plans to continue expanding the number of FAQs on human subject protection issues."

(September 20, 2005) - Requests for Public Comment Section Added to OHRP Website

OHRP has added a "Requests for Public Comment" section to its website.

Simultaneously with the addition of the new website section, OHRP invites public comments on the following:

OHRP’s August 31, 2005 Letter to the National Cancer Institute (NCI) on Conflicting Interest and the Pediatric Central IRB (PedCIRB) At http://www.hhs.gov/ohrp/requests/com091505.html, OHRP has requested public comment on a letter to NCI describing the evolution of OHRP’s viewpoint regarding conflicting interests of NCI PedCIRB members for studies reviewed by that IRB.

Over several months, OHRP has discussed with people from NCI, the PedCIRB, the Food and Drug Administration ( FDA), and Children’s Oncology Group (COG), and other groups, the circumstances under which a PedCIRB member who is also a COG investigator would have a conflicting interest for a particular protocol undergoing review by the PedCIRB. The request for comments includes two background documents:

The public comment period is during the 90 days from September 15, 2005 to December 15, 2005

Comments should be submitted to OHRP by email at ohrp@osophs.dhhs.gov. Please include the term "PedCIRB" in the subject field. Alternatively, comments may be submitted by mail to:

Michael Carome, M.D.
CAPT, U.S. Public Health Service
Office for Human Research Protections
1101 Wootton Parkway
Suite 200
Rockville, MD 20852

(August 9, 2005) - Technical Amendments to the Common Rule

OHRP has posted a revised, up-to-date version of the HHS regulations for the protection of human subjects, 45 CFR part 46, at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm on this website. This updated version includes the following technical amendments to the Federal Policy for the Protection of Human Subjects that were announced in the FEDERAL REGISTER on June 23, 2005:

  • Changing references to the "Office for Protection from Research Risks" to "Office for Human Research Protections, or any successor office"
  • Changing the Office of Management and Budget (OMB) control number for the Paperwork Reduction Act clearance from "9999-0020" to the current number "0990-0260"
  • Rewording the footnote to section 45 CFR 46.101(i) to reflect the 2001 change in Subpart B of 45 CFR part 46 that made the exemptions described in section 101(b) applicable to research covered by subpart B.

OHRP has also made typographical and other minor changes to match OHRP’s website version of 45 CFR part 46 with the Code of Federal Regulations (CFR) maintained by the Government Printing Office (GPO) on its website and in published volumes of the CFR.

(July 20, 2005) - International Compilation of Human Subject Research Protections Now Available

Recognizing the continued growth of international research, the Office for Human Research Protections has developed an International Compilation of Human Subject Research Protections. The Compilation lists the laws, regulations, and guidelines of over 50 countries where DHHS funded or supported research is conducted.

The Compilation provides direct web links to each country's Key Organizations and laws, whenever available. OHRP believes this Compilation will help IRBs, researchers, and others to meet regulatory requirements to assure that research studies comply with applicable law.

The Compilation can be accessed on the OHRP website: http://www.hhs.gov/ohrp/international/index.html#NatlPol. To use the Compilation, go to page 3 and then click on the country of interest.

(July 11, 2005) - Agenda & Registration for the OHRP National Conference in Youngstown, OH

Register NOW for the OHRP National Human Subjects Protections Conference entitled "Protecting Human Subjects in a Changing Research Environment" sponsored by the Humility of Mary Health Partners in Youngstown, Ohio on August 15-16, 2005. Additional sponsors include Youngstown State University, Centers for Osteopathic Research & Education, State of Ohio Commission on Minority Health, Aultman Hospital, SUMMA Health System, Akron General Medical Center, Akron Children’s Hospital, Ohio University - College of Medicine, Northeastern Ohio Universities College of Medicine, The University of Akron, and Kent State University. For registration & program agenda see brochure at: http://www.hmpartners.org/body.cfm?id=392

(July 6, 2005) - FAQs on Assurances and IRB Registration

OHRP announces the availability of two new sets of Frequently Asked Questions (FAQs), which help clarify assurance and IRB registration issues.

You may access these FAQs from the OHRP website’s:

The FAQs may also be accessed from the HHS homepage (http://www.hhs.gov), by selecting "Questions" at the top right of the page and then on the "Questions and Answers" page under the "Category" drop-down menu, selecting "Human Research."

OHRP plans to expand the number of FAQs on human subject protection issues in the near future.

(July 5, 2005) - Human Research Protections Educational Opportunities

The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) continues to co-sponsor educational events with institutions conducting HHS-supported human subject research. These educational events address current human subject protection issues and the responsibilities of Institutional Review Boards (IRBs), investigators, coordinators, and institutional officials. OHRP collaborates with the host institution in the development and planning of the event.

For information on hosting a future OHRP-sponsored national or regional educational event, please contact Ms. Darlene Ross at: dross@osophs.dhhs.gov

(June 15, 2005) - New OHRP Outreach Campaign

OHRP announces the launch of a new public education campaign, Taking Part in Research: It’s Your Decision, to provide information about issues to consider when thinking about participating in clinical trials and other research studies.

The centerpiece of the campaign is a one-page pamphlet that guides readers through a series of questions to consider, as they discuss the option of participating in research with their health-care provider, family members and others.

OHRP has distributed copies of the pamphlet to some 6,000 research institutions throughout the country, in order to gain broader access to local communities.

Bulk copies (up to 300 per requestor) are available free by calling 800-444-6472.

A copy of the pamphlet, along with related information, is available at http://www.hhs.gov/ohrp/outreach/ The pamphlet can be downloaded and reproduced locally

(May 26, 2005) - Solicitation of Public Review and Comment on Surfactant Research Protocol

The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), HHS, are soliciting public review and comment on a proposed research protocol entitled "Precursor Preference in Surfactant Synthesis of Newborns." The proposed research would be supported by the National Heart, Lung and Blood Institute, National Institutes of Health, Department of Health and Human Services (HHS). Public review and comment are solicited regarding the proposed research protocol under the requirements of HHS and FDA regulations. That notice can be accessed as a pdf document at: http://www.hhs.gov/ohrp/children/ppssn/solicitnotc.pdf

FDA has established a public docket where electronic copies of documents related to the proposed research can be viewed at the Pediatric Advisory Committee (PAC) Docket site at: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2005 and scroll down to Pediatric Advisory Committee). These documents also are available on OHRP’s website at: http://www.hhs.gov/ohrp/children/surfactant.html

To be considered, written or electronic comments on the proposed research must be received on or before 4:30 p.m. on June 17, 2005. Submit electronic comments to: http://www.fda.gov/dockets/ecomments. (click on "Docket Search" then at "Docket ID" type in 2005N-0184) or written comments to: the Division of Dockets Management (HFA-305), Docket No. 2005N-0184, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Pediatric Ethics Subcommittee of FDA’s Pediatric Advisory Committee (PAC) will be meeting on June 28, 2005 to discuss the above-cited protocol and develop a recommendation regarding whether the research should proceed. The subcommittee’s recommendation will be presented to the PAC on June 29, 2005. Notices announcing both the subcommittee and PAC meetings, respectively, can be accessed as pdf documents at: http://www.hhs.gov/ohrp/children/ppssn/pesdnotc.pdf and http://www.hhs.gov/ohrp/children/ppssn/pacnotc.pdf

(May 6, 2005) - Upcoming ORI and OHRP National Conference in Little Rock, AR

Save the date for an upcoming ORI and OHRP National Conference entitled ABreaking the Barriers of Research: Mentoring and Human Subjects= Protection,@ sponsored by University of Arkansas for Medical Sciences in Little Rock, Arkansas on August 4-5, 2005. For program information see the brochure at: http://www.uams.edu/mentoringconference/

(April 1, 2005) - Upcoming OHRP Research Community Forum in Milwaukee, WI, June 2, 2005

Save the date for an upcoming OHRP Research Community Forum entitled "Human Research Protection: Striving for Excellence," sponsored by the Medical College of Wisconsin in Milwaukee, Wisconsin on June 2, 2005. For program information see the brochure at: http://www.mcw.edu/researchforum

(March 30, 2005) - Advisory Committee Meeting April 18-19, 2005

The Department of Health and Human Services' (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) will meet on Monday, April 18, 2005, from 8:30 a.m. to 5:00 p.m. EST, and on Tuesday, April 19, 2005, from 8:30 a.m. to 4:00 p.m. EST, at the Radisson Hotel Old Town, 901 North Fairfax Street, Alexandria, Virginia. The meeting will held in the Jefferson Room.

The SACHRP April meeting agenda is posted at: http://www.hhs.gov/ohrp/sachrp/mtgings/mtg04-05/agenda4.pdf

To view the Federal Register Notice, go to the URL listed below, put in page number 15625, and hit Submit. http://www.gpoaccess.gov/fr/retrieve.html

( March 25, 2005) - Equivalent Protections--OHRP Solicits Public Comment on Recommendations of HHS Workgroup

OHRP invites public comment on recommendations made by a workgroup formed by the Department of Health and Human Services (HHS). The workgroup examined criteria that HHS might use in implementing the authority in 45 CFR 46.101(h). That authority permits HHS to find that "procedures normally followed in the foreign countries to protect human subjects ... afford protections that are at least equivalent to those provided in" the HHS regulations. Where such a finding is made, HHS "may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in" the HHS regulations.

The Federal Register notice published on March 25, 2005, at 70 FR 15322, solicits public comment on several questions regarding the recommendations made by the workgroup. The public comment period extends through May 24, 2005. A copy of the Federal Register notice, and the full workgroup report, are available on the OHRP website. The Federal Register notice is at http://www.hhs.gov/ohrp/international/EquivProtectNotice.pdf, and the report is at http://www.hhs.gov/ohrp/international/EPWGReport2003.pdf. The report appendix is at http://www.hhs.gov/ohrp/international/EPGWFramework.pdf.

(March 21, 2005) - Registration for the OHRP Research Community Forum in Atlanta, GA

Don’t miss this unique opportunity to register for the upcoming OHRP Research Community Forum focusing on the recruitment and participation of minority populations in social and behavorial research. CME credits will be provided for attendees participating in this Research Community Forum. The Research Community Forum entitled "Social and Ethical Research Issues: Cultural Issues in Minority Populations" is sponsored by the Interdenominational Theological Center on March 30, 2005 in Atlanta, GA.
For registration & program see brochure at:
http://www.itc.edu/ITC/irb/ITC'sWEBSITE/finalnmain_page_.htm

(February 22, 2005) - Agenda & Registration for the OHRP Research Community Forum in At lanta, GA

Register NOW for the OHRP Research Community Forum entitled "Social and Ethical Research Issues: Cultural Issues in Minority Populations" sponsored by the Interdenominational Theological Center in Atlanta, GA on March 30, 2005. For registration & program see brochure at:

www.itc.edu/ITC/irb/ITC'sWEBSITE/finalnmain_page_.htm

(February 17, 2005) - Documentation of Approval of FWAs and Processing of IRB Registrations

"Effective February 1, 2005, OHRP stopped mailing copies of approved Federalwide Assurance (FWA) documents to the Signatory Officials of filing institutions. This was necessitated by the volume of FWA documents OHRP is managing. There are currently over 8,000 approved FWAs. OHRP encourages FWA institutions to submit documents (new and updates/renewals) electronically (http://ohrp.cit.nih.gov/efile). When an institution uses the electronic submission system, the person submitting the electronic record, the Human Protections Administrator, and the Signatory Official will receive an automatically generated e-mail notifying them of the approval of the FWA document. This, of course, is dependent upon the electronic file submitted to OHRP providing e-mail addresses as requested. Institutions that submit FWA documents in hard (paper) copy will need to monitor the OHRP website (http://ohrp.cit.nih.gov/search/) to ensure that their documents have been processed. Funding agencies use the OHRP website to verify that an institution holds an OHRP-approved FWA.

OHRP has never returned any documentation on the registration of an institutional review board/independent ethics committee (IRB/IEC). OHRP encourages organizations to submit IRB/IEC registration documents (new and updates/renewals) electronically (http://ohrp.cit.nih.gov/efile). When an organization uses the electronic submission system, the person submitting the electronic record, the Information Provider, the Chair of the IRB/IEC(s), and the Head Official will receive an automatically generated e-mail notifying them of the processing of the document. This, of course, is dependent upon the electronic file submitted to OHRP providing e-mail addresses as requested. Organizations that submit IRB/IEC documents in hard (paper) copy will need to monitor the OHRP website (http://ohrp.cit.nih.gov/search/) to determine that their documents have been processed by watching for a change in the expiration date for the registration and/or the date the membership roster(s) was last updated."

(February 10, 2005) - OMB Approval of the Federalwide Assurance (FWA), IRB/IEC Registration Form, and Related Documents

The Office for Human Research Protections (OHRP) is pleased to announce the recent approval of revised Federalwide Assurance (FWA) forms and related documents and the institutional review board/independent ethics committee (IRB/IEC) Registration form by the Office of Management and Budget. Effective immediately, the FWA will be the only type of assurance accepted for review and approval by OHRP.

The approved documents are now posted on our website at www.dhhs.gov/ohrp.

For any institution currently holding an OHRP-approved FWA, the revised Terms of Assurance (www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm) will go into effect with the next update/renewal of its FWA.

Institutions currently holding an OHRP-approved Multiple Project Assurance (MPA) or Cooperative Project Assurance (CPA) are required to submit an FWA to OHRP for approval by the end of this calendar year, December 31, 2005, if the institution is required to have an OHRP-approved assurance of compliance. Any Cooperative Amendment or Inter-Institutional Amendment associated with an OHRP-approved MPA will be deactivated when the institution holding the MPA submits and receives approval of an FWA.

Single Project Assurances (SPA) currently approved by OHRP will remain in effect for the duration of the project and through all non-competitive award renewals.

There are two forms for the FWA - one for institutions within the United States (www.hhs.gov/ohrp/humansubjects/assurance/filasur.htm), and one for international (non-U.S.) institutions (www.hhs.gov/ohrp/humansubjects/assurance/ifilasur.htm). Revised instructions for completing the FWA forms are on our website at www.hhs.gov/ohrp/assurances/assurances_index.html. FWAs and updates/renewals of an existing FWA may be submitted to OHRP in hard copy or electronically at http://ohrp.cit.nih.gov/efile.

All previous types of sample agreements to cover an independent investigator [i.e., Agreement for Independent Investigators (AII), Non-Institutional Investigator Agreement (NIA), and Unaffiliated Investigator Agreement (UIA)] have been replaced by the sample Individual Investigator Agreement (IIA) (www.hhs.gov/ohrp/humansubjects/assurance/unaflsup.rtf). For guidance on the appropriate use of the sample Individual Investigator Agreement please see www.hhs.gov/ohrp/humansubjects/assurance/guidanceonalternativetofwa.htm. Previously executed AIIs, NIAs, and UIAs may remain in effect until all applicable research that has already been initiated is completed or until the previous agreement has been replaced by a new Individual Investigator Agreement or other written agreement developed by an assured institution.

Beginning immediately, the new IRB/IEC Registration form (www.hhs.gov/ohrp/humansubjects/assurance/regirb.htm) must be submitted when registering or updating/renewing an organization’s IRB/IEC. Revised instructions for completing the IRB/IEC Registration form are on our website at www.hhs.gov/ohrp/humansubjects/assurance/regirbi.htm. IRB/IEC Registrations and updates/renewals of existing registrations may be submitted to OHRP in hard copy or electronically at http://ohrp.cit.nih.gov/efile.

The sample IRB/IEC Authorization Agreement (www.hhs.gov/ohrp/humansubjects/assurance/iprotsup.rtf) was revised slightly. This is a sample document to be used when an FWA institution is relying on an external IRB/IEC for review of research covered by the FWA. The agreement may be written as limited or as broadly (e.g., one research project or a program of research) as necessary to outline the relationship between the IRB/IEC and the institution relying on the IRB/IEC’s review. [Note: An FWA institution that relies on an external IRB for review must designate the IRB/IEC on its OHRP-approved assurance.]

OHRP welcomes comments on the revised FWA forms and related documents, the institutional review board/independent ethics committee (IRB/IEC) Registration form, and OHRP's new guidance document, "Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement." To submit comments, please go to the OHRP website at www.hhs.gov/ohrp and click on "Public Comments" in the left menu.

(February 7, 2005) - Upcoming OHRP Research Community Forum in Atlanta, GA

Save the date for an upcoming OHRP Research Community Forum entitled "Social and Ethical Research Issues: Cultural Issues in Minorities", sponsored by the Interdenominational Theological Center in Atlanta, GA on March 30, 2005. For program information see the brochure at:
http://www.itc.edu/itc_press/SAVE_THE_DATE-Atlanta.htm

(January 19, 2005 ) - OHRP National Conference in Houston, TX, April 21-22.

Save the date for an upcoming OHRP National Human Subjects Protections Conference entitled "The Critical Path to New Medical Products: The Challenges in Protecting Human Subjects," sponsored by the University of Houston in Houston, Texas on April 21-22, 2005. For program information see the brochure at http://www.uh.edu/pharmacy/ohrp/.

(January 10, 2005 ) - OHRP Research Community Forum in Ruston, LA, February 24

Save the date for an upcoming OHRP Research Community Forum entitled "Southern Regional IRB/OHRP Educational Research Community Forum," sponsored by Louisiana Tech University, Grambling State University, Louisiana State University Health Sciences Center--Shreveport, Northwestern State University, and the University of Louisiana at Monroe, in Ruston, LA, on February 24, 2005. For program information see the brochure at: http://cenit02.latech.edu/ohrp/index.php.

(January 8, 2005) - Electronic Update of Federalwide Assurances (FWAs) and IRB Registrations is Now Available

The Office for Human Research Protections (OHRP) is pleased to announce the enhancement of our web-based electronic submission system (ESS) for use in submitting Federalwide Assurances (FWA) and Institutional Review Board/Independent Ethics Committee (IRB/IEC) registrations. To date, only users submitting a new FWA or IRB/IEC registration could use the ESS. Effective Monday, January 3, 2005, all institutions holding an OHRP-approved FWA and all organizations with a registered IRB/IEC(s) may use the ESS to submit updates/renewals. Please go to http://ohrp.cit.nih.gov/efile to use the ESS or just browse the system and check it out. If you have any questions about the use of the ESS, please contact your regional/country coordinator listed at www.hhs.gov/ohrp/daqi-staff.html#staff.

(October 26, 2004) - You are invited to the Belmont Commemoration

On behalf of Tommy G. Thompson, Secretary, Department of Health and Human Services (HHS), I invite you to join OHRP on November 16, 2004, as HHS honors the members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-79) and commemorates the 25th anniversary of the publication of the Belmont Report, produced by that Commission.

The event will take place on November 16 in the Great Hall of the Humphrey Building, 200 Independence Avenue S.W., Washington D.C. 20201, 2:30 p.m. - 3:30 p.m.

We hope that you will be able to join us.

Please R.S.V.P. no later than Monday, November 1st at (703) 741-7051.

And plan to arrive between 2:00 p.m. and 2:15 p.m. on November 16th, to allow time to go through security.

I look forward to seeing you then.

Bernard A. Schwetz, D.V.M., Ph.D.
Director
Office for Human Research Protections

(September 9, 2004) - Belmont Commemorative Event, November 16, 2004

Dear Colleagues:

On behalf of Tommy G. Thompson, Secretary, Department of Health and Human Services, I would like to invite you to share in a commemorative event celebrating the 25th anniversary of the Belmont Report, a milestone in Federal responsibility, leadership and commitment to protecting the rights and welfare of those who participate in research. The Report was produced as part of the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-79).

Members of the original Commission will be honored guests at the event, along with the Commission's staff and special consultants. The event will take place on November 16th, 2004, at 2:30 p.m. in the Great Hall of the Hubert H. Humphrey Building, 200 Independence Avenue, S.W., Washington, D.C. 20201.

The Belmont ceremony will include a ten-minute video highlighting those who took part in the creation of the Belmont Report, their work at that time and the importance of that work in today's research environment.

I hope you will be able to join us in November for this special commemoration.

Bernard A. Schwetz, D.V.M., Ph.D.
Director
Office for Human Research Protections

(August 17, 2004) - Guidance on Research Involving Coded Private Information or Biological Specimens

The Office for Human Research Protections (OHRP) has issued guidance on research involving coded private information or human biological specimens. The document also references pertinent requirements of the HIPAA Privacy Rule that may be applicable to research involving coded private information or specimens. You can find the guidance document, Guidance on Research Involving Coded Private Information or Biological Specimens at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf.

OHRP welcomes comments on this document: please go to the OHRP website at http://www.hhs.gov/ohrp and click on "Public Comments" in the left menu.

(August 9, 2004) - As part of their regulatory requirements, the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) are requesting public comments on a proposed research protocol entitled "Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder (ADHD): A Functional Magnetic Resonance Study.

This proposed research would be conducted at the HHS National Institutes of Health (NIH) and supported by NIH's National Institute of Mental Health (NIMH).

Documents related to the proposed research are available at OHRP's website, at http://www.hhs.gov/ohrp/children/adhd.html. The documents are also available via the FDA website: go to http:/www.fda.gov/ohrms/dockets/ac/acmenu.htm then select the year 2004, then scroll to Pediatric Advisory Committee (PAC) meeting at the bottom of the list.

To submit electronic comments, go to http://www.fda.gov/dockets/ecomments then click on Docket Search, then at Docket ID type in "2004N-0337"

Send written comments to the Division of Dockets Management (HFA-305), Docket No. 2004N-0337, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Pediatric Ethics Subcommittee of FDA's Pediatric Advisory Committee (PAC) will meet on September 10, 2004, to discuss this protocol and develop a recommendation as to whether this research should proceed. On September 15, 2004, the PAC will meet to review the recommendation of the subcommittee.

http://www.hhs.gov/ohrp/children/adhd.html To access the Federal Register notices, please see http://www.hhs.gov/ohrp/children/nimh_subcomm.pdf for the PAC subcommittee meeting, and http://www.hhs.gov/ohrp/children/nimh_pac.pdf for the PAC meeting.

(July 13, 2004) - All Federalwide Assurances (FWAs) expire 3 years after their approval date. Of course, updates to FWAs should be submitted throughout the 3 years whenever there are changes in the information provided on the approved FWA. To check your institution's FWA expiration date, go to the OHRP website at http://ohrp.cit.nih.gov/search/.

If your institution needs to renew its FWA, follow the instructions at http://www.hhs.gov/ohrp/humansubjects/assurance/renwfwa.htm, and fax the completed form to OHRP at (301) 402-0438.

If you have any questions, please see the staff assignments on our website at http://www.hhs.gov/ohrp/daqi-staff.html#DC (bottom of page). You may call the staff person using our toll-free number, 866-447-4777.

(July 7, 2004) - The Office for Human Research Protections (OHRP) is proposing to require registration of institutional review boards (IRBs) that review human subjects research conducted or supported by the Department of Health and Human Services (HHS) and that are designated under an assurance of compliance approved for federalwide use by OHRP. The proposed registration requirements will make it easier for OHRP to convey information to IRBs and will support the current IRB registration system operated by OHRP. Under the current OHRP IRB registration system, the submission of certain information is required by the existing HHS human subjects protection regulations, and certain other information may be submitted voluntarily. Under the proposed rule, all registration information will be required, making the IRB registration system uniform with the proposed IRB registration requirements of the Food and Drug Administration (FDA), and creating a single HHS IRB registration system. FDA simultaneously is publishing a proposed rule regarding FDA IRB registration requirements.

Comments on the OHRP notice must be received on or before October 4, 2004. That notice can be accessed as a pdf document at: http://www.hhs.gov/ohrp/news/irbnotice.pdf

The FDA notice can be accessed at: http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2004&mn=7&dy=6.

Please note that the correct URL for viewing the current IRB registration form is http://www.hhs.gov/ohrp/humansubjects/assurance/regirb.htm.

(June 29, 2004) - Advisory Committee Meeting July 26-27, 2004

The Department of Health and Human Services' (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) will meet on Monday, July 26, 2004, from 8:30 a.m. to 5:00 p.m. EST, and on Tuesday, July 27, 2004, from 8:30 a.m. to 4:00 p.m. EST, at the Sheraton Four Points Hotel, 1201 K Street, N.W., Washington, D.C.

For further information, please see the Federal Register announcement: http://www.gpoaccess.gov/fr/retrieve.html and type in page 35348, then click SUBMIT.

The SACHRP July meeting agenda is posted at: http://www.hhs.gov/ohrp/sachrp/mtgings/mtg07-04/agenda0704.pdf

(June 17, 2004) - Registration for the OHRP National Conference in Chicago, IL

Don't miss the unique opportunity to register for the upcoming OHRP National Human Subjects Protections Conference focusing on gene transfer research. Speakers from the U.S. Food and Drug Administration and the NIH's Office of Biotechnology Activities will provide updates on federal oversight activities related to the use of gene transfer products in humans. The conference entitled "Human Subjects Protections in Gene Transfer Research" is sponsored by Rush University Medical Center and the University of Chicago in Chicago, Illinois, on July 9 and 10, 2004. A Pre-Conference Workshop entitled PRIM&R "IRB 101sm On the Road" will be held on July 8, 2004. For registration and program see brochure at: http://www.rush.edu/research/updates.html.

(June 16, 2004) - Registration for the OHRP National Conference in Chapel Hill, NC

Don't miss the unique opportunity to register for the upcoming OHRP National Human Subject Protections Conference focusing on Human Subject Research in the international arena. The faculty for this event will include highly respected national and international speakers. The conference entitled "Roadmap for Success in International Research: Strategies for Protecting Human Research Subjects Globally," is sponsored by RTI International, Family Health International, and North Carolina State University in Chapel Hill, NC, on August 2-3, 2004. Deadline for the reduced registration rate is June 30.

For program information, see the brochure at: https://register.rti.org/internationalirb/

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Last revised: September 28, 2010

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