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Info on 1946-48 U.S. PHS STD Inoculation Study


Office for Human Research Protections (OHRP)


Related Resources

Other HHS human-subject protection regulation sites

FDA (Food and Drug Administration)

ORI (Office of Research Integrity)

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Common Rule Agencies/Departments

Human subject research conducted or supported by each federal department/agency listed below is governed by the regulations of that department/agency. The head of that department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research.

The federal department/agency that conducts or supports research retains final authority for determining whether an institution has complied with its regulations for the protection of human subjects. If HHS receives an allegation or indication of noncompliance related to human subject research that is conducted or supported solely by a Common Rule department/agency other than HHS, HHS will refer the matter to that department/agency for review and action as appropriate.

Department of Agriculture

Department of Energy

National Aeronautics and Space Administration

Department of Commerce

Consumer Product Safety Commission

Agency for International Development (USAID)

Department of Housing and Urban Development

Department of Justice

Department of Defense

Department of Education

Department of Veterans Affairs

Environmental Protection Agency

National Science Foundation

Department of Transportation

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Historical Documents/Information

Statutory Basis for 45 CFR Part 46

Nuremberg Code

Declaration of Helsinki

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978)

Protection of Human Subjects (1994 Presidential Memorandum)

Henry Beecher 1966 New England Journal of Medicine article "Ethics and Clinical Research" [PDF]

Ethical Issues in Research Involving Human Participants, Bibliography

Ethical and Legal Aspects of Human Subjects Research in Cyberspace; a report from the AAAS Program on Scientific Freedom, Responsibility and Law, in collaboration with NIH/OPRR (http://www.aaas.org/spp/sfrl/projects/intres/report.pdf)

Evaluation of NIH Implementation of Section 491 of the PHS Act, Mandating a Program of Protection for Research Subjects - "Bell Report"

National Bioethics Advisory Commission (http://www.georgetown.edu/research/nrcbl/nbac/)

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Human Subjects Protection Federal Register Notices

2009  2008  2007  2006  2005  2004  2003  2002  2001  2000 
1999  1998  1997  1996  1995  1994  1993  1992  1991  1990 
1989  1988  1987  1986  1985  1984  1983  1982  1981  1980 
1979  1978  1977  1976  1975  1974  1973  1972  1971  1970 
1969  1968  1967  1966  1965  Before 1965

2009

November 6, 2009 – Notice, HHS, Draft Guidance on Institutional Review Board Continuing Review of Research [PDF - 60KB]

November 6, 2009 – Notice, HHS, Draft Guidance on Institutional Review Board Approval of Research With Conditions [PDF - 52KB]

October 13, 2009 – Notice, HHS, October 28-29 Meeting of Secretary's Advisory Committee on Human Research Protections [PDF - 46KB]

July 14, 2009 – Notice, FDA, Guidance for Institutional Review Boards, Frequently Asked Questions--Institutional Review Board Registration; Availability [PDF - 44KB]

July 6, 2009 – Notice, HHS, July 21-22 Meeting of Secretary's Advisory Committee on Human Research Protections [PDF - 44KB]

April 23, 2009 – Notice, HHS, NIH, Draft National Institutes of Health Guidelines for Human Stem Cell Research [PDF - 53KB]

April 7, 2009 – Notice, HHS, Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards [PDF - 51KB]

March 24, 2009 – Notice, HHS, Agency Information Request; 30-Day Public Comment Request, IRB Registration Form [PDF - 47KB]

March 5, 2009 – ANPRM, HHS, Institutional Review Boards Accountability, Request for Comments [PDF - 60KB]

February 12, 2009 – Notice, HHS, March 3-4 Meeting of the Secretary's Advisory Committee on Human Research Protections [PDF - 43KB]

January 15, 2009 -- Final Rule, OPHS, Institutional Review Boards: Registration Requirements [PDF - 160KB]

January 15, 2009 -- Final Rule, FDA, Institutional Review Boards: Registration Requirements [PDF - 239KB]

2008

October 23, 2008 -- Notice, HHS, Final Guidance on Engagement of Institutions in Human Subjects Research [PDF - 54KB]

August 27, 2008 -- Notice, HHS, Agency Information Collection Request; 60-Day Public Comment Request for Former Optional Form 310 [PDF - 51KB]

July 1, 2008 -- Notice, HHS, Request for Information Regarding OHRP Education Program [PDF - 66KB]

June 23, 2008 -- Notice, HHS, July 15-16 SACHRP Meeting [PDF]

March 11, 2008 -- Notice, HHS, Meeting of Secretary's Advisory Committee on Human Research Protections [PDF]

January 29, 2008 -- Notice, HHS, Agency Information Collection Request; 30-Day Public Comment Request for Federalwide Assurance (FWA) [PDF]

January 29, 2008 -- Notice, HHS, Agency Information Collection Request; 30-Day Public Comment Request for IRB/IEC Registration [PDF]

January 2, 2008 -- Notice, HHS, Extension of Comment Period of Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-Making Capacity [PDF]

2007

November 14, 2007 -- Notice, HHS, Agency Information Collection Request; 60-Day Public Comment Request for Federalwide Assurance (FWA) [PDF]

November 14, 2007 -- Notice, HHS, Agency Information Collection Request; 60-Day Public Comment Request for IRB/IEC Registration [PDF]

November 7, 2007 -- Notice, HHS, Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections [PDF]

October 26, 2007 -- Notice, HHS, Expedited Review List Request for Comments [PDF]

September 24, 2007 -- Notice, HHS, October 29-309 SACHRP Meeting [PDF]

September 5, 2007 -- Notice, HHS, Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity [PDF]

June 25, 2007 -- Notice, HHS, July 30-31 SACHRP Meeting [PDF]

March 6, 2007 -- Notice, HHS, March 29-30 SACHRP Meeting [PDF]

2006

December 8, 2006 -- Notice, HHS, Request for Public Comment on OHRP Draft Guidance Document on Engagement of Institutions in Human Subjects Research [PDF]

October 31, 2006 -- Notice, HHS, Proposed Information Collection for Evaluation of OHRP Education Program [PDF]

October 24, 2006 -- Notice, HHS, November 2 SACHRP Meeting [PDF]

July 13, 2006 -- Notice, HHS, July 31 SACHRP Meeting [PDF]

July 7, 2006 -- Notice, HHS, Protection of Human Subjects: Interpretation of Assurance Requirements [PDF]

June 7, 2006 -- Interim Final Rule, HHS, FDA, Medical Device Consent Exception [PDF]

April 28, 2006 -- Notice, HHS, NIH, NCI, First-Generation Guidelines for NCI-Supported Biorepositories [PDF]

April 27, 2006 -- Notice, HHS, Solicitation for SACHRP Nominations [PDF]

February 23, 2006 -- Notice, HHS, March 13 SACHRP Meeting [PDF]

February 6, 2006 -- ANPRM Withdrawal, HHS, FDA, Inform IRBs of Prior IRB Review [PDF]

January 17, 2006 -- ANPRM Withdrawal, HHS, FDA, Inform IRBs of Prior IRB Review [PDF]

2005

December 13, 2005 -- Notice, HHS, Proposed Information Collection for Evaluation of OHRP Education Program [PDF]

October 14, 2005 -- Notice, HHS, SACHRP Meeting November 1, 2005 [PDF]

October 7, 2005 -- Notice, HHS, Secretarial Review of Pediatric Gonadotropin-Releasing Hormone Agonist Study [PDF]

September 12, 2005 -- NPRM, EPA, Intentional Dosing Human Testing for Pesticides [PDF]

August 22, 2005 -- Notice, HHS, Solicitation for SACHRP Nominations [PDF]

August 18, 2005 -- Notice, HHS, Proposed Extension of Information Collection for Common Rule [PDF]

July 5, 2005 -- Notice, HHS, August 1 SACHRP Meeting [PDF]

June 23, 2005 -- Final Rule, HHS, Technical Amendments to the Federal Policy for the Protection of Human Subjects [PDF]

May 25, 2005 -- Notice, HHS, Secretarial Review of Pediatric Surfactant Study [PDF]

May 19, 2005 -- Notice, HHS, Proposed Extension of Information Collection - Assurance Identification/Institutional Review Board (IRB) Certification/Declaration of Exemption [PDF]

April 15, 2005 -- Notice, HHS, Proposed Extension of Information Collection for Common Rule [PDF]

April 15, 2005 -- Notice, HHS, Proposed Information Collection for the OHRP Fellowship Program [PDF]

March 28, 2005 -- Notice, HHS, April 28, 2005, SACHRP Meeting [PDF]

March 25, 2005 -- Notice, HHS, Availability of Equivalent Protections Working Group Report [PDF]

February 8, 2005 -- Notice, EPA, Human Testing; Proposed Plan and Description of Review Process [PDF]

February 2, 2005 -- Notice, FDA, Anthrax Vaccine Emergency Use [PDF]

February 2, 2005 -- Notice, HHS, Anthrax Vaccine Emergency Use [PDF]

February 2, 2005 -- Notice, HHS, Proposed Information Collection for the OHRP Fellowship Program [PDF]

2004

December 16, 2004 -- Notice, HHS, January 31, 2005 SACHRP Meeting [PDF]

October 25, 2004 -- Notice, HHS, SACHRP Member Solicitation [PDF]

August 4, 2004 -- Notice, OPHS and FDA, Secretarial Review of Pediatric Study of Dextroamphetamine [PDF]

July 6, 2004 -- NPRM, HHS, IRB Registration Requirements [PDF]

July 6, 2004 -- NPRM FDA, IRB Registration Requirements [PDF]

June 25, 2004 -- Notice, HHS, Proposed Extension of Information Collection for Federalwide Assurance (FWA) [PDF]

June 24, 2004 -- Notice, HHS, July 26, 2004 Meeting of SACHRP [PDF]

June 10, 2004 -- NPRM, FDA, Foreign Studies Requirement [PDF]

May 12, 2004 -- Notice, HHS, Final Financial Relationships Guidance [PDF]

February 19, 2004 -- Notice, HHS, SACHRP Nominations [PDF]

February 19, 2004 -- Notice, HHS, March 29, 2004 Meeting of SACHRP [PDF]

2003

November 24, 2003 -- Notice, HHS, SACHRP Meeting December 11-12, 2003. [PDF]

October 22, 2003 -- Notice, HHS, Statement of OHRP Functions [PDF]

July 16, 2003 -- Notice, HHS, Secretarial Review of Pediatric Study of HIV Replication and Thymopoiesis [PDF]

July 3, 2003 -- Notice, HHS, SACHRP Meeting July 22, 2003 [PDF]

June 20, 2003 -- Notice, HHS, Final Action on Epidemiological Waiver [PDF]

June 13, 2003 -- Notice, HHS, Secretarial Review of Pediatric Study of Sleep Metabolism [PDF]

June 13, 2003 -- Notice, HHS, Secretarial Review of Pediatric Study of Cystic Fibrosis Bronchoalveolar Lavage [PDF]

May 7, 2003 -- ANPRM, EPA, Human Research Issues in EPA's Pesticide Program [PDF]

April 14, 2003 - Notice, HHS, Secretarial Review of Pediatric Study of Alcohol, Sleep, and Circadian Rhythms [PDF]

March 31, 2003 -- Notice, HHS, Draft Financial Interest Guidance [PDF]

2002

December 18, 2002 -- Notice, HHS, Secretarial Review of Pediatric Study of Precursors to Diabetes in Japanese-American Youth [PDF]

October 31, 2002 -- Notice, HHS, Secretarial Review of Pediatric Study of Dryvax [PDF]

October 7, 2002 -- Notice, HHS, Proposed Waiver for Epidemiological Studies in Prisoners [PDF]

August 7, 2002 -- Notice, HHS, Secretarial Review of Pediatric Study of Precursors to Diabetes in Japanese-American Youth [PDF]

June 13, 2002 -- Notice, HHS, July 30 NHRPAC Meeting [PDF]

May 8, 2002 -- Notice, HHS, Quality Improvement Instrument Notice [PDF]

April 19, 2002 -- Notice, HHS, Federal-Wide Assurance Notice [PDF]

March 13, 2002 -- Notice, HHS, NHRPAC Meeting April 29-30, 2002 [PDF]

March 6, 2002 -- Notice, HHS, Statement of OHRP Functions [PDF]

January 9, 2002 -- Notice, HHS, NHRPAC Meeting January 28-29, 2002 [PDF]

2001

November 13, 2001 -- Notice, HHS, Subpart B Final Rule [PDF]

October 3, 2001 -- Notice, HHS, NHRPAC Meeting October 30-31, 2001 [PDF]

July 9, 2001 -- Notice, HHS, NHRPAC Meeting July 30-31, 2001 [PDF]

July 6, 2001 -- NPRM, HHS, Subpart B [PDF]

May 18, 2001 -- Notice, HHS, Subpart B Effective Date Delay [PDF]

March 26, 2001 -- Notice, HHS, NHRPAC Meeting [PDF]

March 19, 2001 -- Notice, HHS, Subpart B Effective Date Delay [PDF]

January 17, 2001 -- Final Rule, HHS, Subpart B [PDF]

2000

July 3, 2000 -- Notice, HHS, Financial Relationships Conference [PDF]

June 19, 2000 -- Notice, HHS, NHRPAC Establishment [PDF]

June 13, 2000 - Notice, HHS, OHRP Establishment [PDF]

1998

November 9, 1998 -- Notice, HHS, FDA, Expedited review List Categories [PDF]

November 9, 1998 -- Final Rule, HHS, Expedited Review Categories [PDF]

May 20, 1998 -- NPRM, HHS, Subpart B [PDF]

1997

December 18, 1997 -- Notice, HHS, Assurance Paperwork Reduction Act [PDF]

November 10, 1997 -- Notice, HHS, FDA, Expedited Review List Revision Proposal [PDF]

November 10, 1997 -- Notice, HHS, Expedited Review List Revision Proposal [PDF]

August 22, 1997 -- Notice, HHS, Assurance Paperwork Reduction Act [PDF]

1996

November 5, 1996 -- Final Rule, FDA, Informed Consent Verification

October 2, 1996 -- Final Rule, FDA, Informed Consent Emergency Research Waiver [PDF]

October 2, 1996 -- Notice, HHS, Informed Consent Exemption for Emergency Research [PDF]

July 8, 1996 -- Notice, HHS, Intent to Propose Revisions in Recombinant DNA Policy [PDF]

1995

December 22, 1995 -- NPRM, HHS, FDA, Informed Consent, Requirement to Date Signature

September 21, 1995 -- NPRM, HHS, FDA, Emergency Research Consent Exception [PDF]

July 26, 1995 -- Notice, HHS, Action Regarding Emergency Research [PDF]

1994

August 12, 1994 -- Notice, OSTP, request for Comment on NBAC Charter [pdf]

June 1, 1994 -- Final Rule, HHS, Delete Ethics Advisory Board [pdf]

January 20, 1994 -- Notice, President, Advisory Commission on Human Radiation Experiments [pdf]

1991

June 18, 1991 -- Final Rule, HHS, FDA, Revisions Conforming to Federal Policy [pdf]

June 18, 1991 -- Final Rule, OSTP, Federal Policy for Protection of Human Subjects [pdf]

1990

December 21, 1990 -- Interim Final Rule, HHS, FDA, Combat Informed Consent Waiver for Drugs and Biologics [pdf]

1988

November 10, 1988 -- NPRM, OSTP, Proposed Model Federal Policy [pdf]

November 10, 1988 -- NPRM, HHS, FDA, Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations

1986

June 3, 1986 -- NPRM, OSTP, Proposed Model Federal Policy [pdf]

1983

July 28, 1983 -- Notice, HHS, President's Commission Availability of Reports [pdf]

March 8, 1983 -- Final Rule, HHS, Research Involving Children [pdf]

March 4, 1983 -- Final Rule, HHS, Additional Exemption for HCFA [pdf]

1982

November 23, 1982 -- Notice, HHS, President's Commission Report Compensating for Research Injuries [pdf]

March 29, 1982 -- Notice, HHS, President's Commission Report Protection of Human Subjects [pdf]

March 22, 1982 -- NPRM, HHS, Additional Exemption for HCFA [pdf]

1981

December 18, 1981 -- NPRM, HHS, FDA, Reproposal Prisoners [pdf]

September 11, 1981 -- Notice, HHS, FDA, request for Comment on Drug Approval Process [pdf]

July 7, 1981 -- Final Rule, HHS, FDA, Change of Effective Date Prisoners [pdf]

March 27, 1981 -- Final Rule, HHS, FDA, Delay of Effective Date Prisoners [pdf]

January 27, 1981 -- Final Rule, HHS, FDA, Informed Consent, Standards for Institutional Review Boards, Expedited Review List [pdf]

January 27, 1981 -- Final Rule, HHS, FDA, Standards for Institutional Review Boards

January 27, 1981 -- Notice, HHS, FDA, Clinical Investigations Which May Be Reviewed Through Expedited Review Procedure Set forth in FDA Regulations

January 26, 1981 -- Final Rule, HHS, Amendment to Basic Protections for Human Subjects [pdf]

1980

May 30, 1980 -- Final Rule, HEW, FDA, Prisoners [pdf]

1979

August 14, 1979 -- Notice, HEW, Ethical Advisory Board Report - Fetoscopy [pdf]

August 14, 1979 -- NPRM, HEW, Amendment to Basic Protections for Human Subjects [pdf]

May 25, 1979 -- Notice, HEW, National Commission Report Protections of Human Subjects, ELSI [pdf]

April 24, 1979 -- NPRM, HEW, FDA, Children [pdf]

April 18, 1979 -- Notice, HEW, National Commission Belmont Report [pdf]

April 4, 1979 -- Final Rule, HEW, Protection of Identity of research Subjects [pdf]

1978

November 30, 1978 -- Notice, HEW, National Commission Report Institutional Review Boards [pdf]

November 17, 1978 -- NPRM, HEW, Additional Protections for Those Institutionalized as Mentally Disabled [pdf]

November 16, 1978 -- Final Rule, HEW, Additional Protections for Prisoners [pdf]

November 15, 1978 -- Notice, HEW, Determination of Secretary Regarding Psychosurgery [pdf]

November 3, 1978 -- Interim Final Rule, HEW, Amendment to Informed Consent Definition [pdf]

August 8, 1978 -- NPRM, HEW, FDA, Obligations of Clinical Investigators [pdf]

August 8, 1978 -- NPRM, HEW, FDA, Standards for Institutional Review Boards [pdf]

July 21, 1978 -- NPRM, HEW, Research Involving Children [pdf]

May 5, 1978 -- NPRM, HEW, FDA Research Involving Prisoners [pdf]

March 17, 1978 -- Notice, HEW, National Commission Report Research Involving Those Institutionalized as Mentally Infirm [pdf]

January 11, 1978 -- Final Rule, HEW, Additional Protections for Fetuses, Pregnant Women [pdf]

January 5, 1978 -- NPRM, HEW, Proposed Regulations on Research Involving Prisoners [pdf]

1977

May 23, 1977 -- Notice, HEW, National Commission report on Psychosurgery [PDF]

January 14, 1977 -- Notice, HEW, National Commission Report on Research Involving Prisoners [PDF]

January 13, 1977 -- NPRM, HEW, Amendments Concerning Fetuses, Pregnant Women and In-Vitro Fertilization [PDF]

1976

1975

August 8, 1975 -- Final Rule, HEW, Protection of Human Subjects - Fetuses, Pregnant Women, and In Vitro Fertilization [PDF]

July 1, 1975 -- Final Rule, HEW, Confidentiality of Alcohol and Drug Abuse Patient Records [PDF]

March 13, 1975 -- Final Rule, HEW, Technical Amendments to 45 CFR part 46 [PDF]

1974

August 23, 1974 -- NPRM, HEW, Protection of Human Subjects, Proposed Policy [PDF]

May 30, 1974 -- Final Rule, HEW, Protection of Human Subjects [PDF]

1973

November 16, 1973 -- Notice, HEW, NIH, Protection of Human Subjects, Policies and Procedures [PDF]

October 9, 1973 -- NPRM, HEW, Protection of Human Subjects, Proposed Policy [PDF]

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International Documents

Nuremberg Code

Declaration of Helsinki

International Conference on Harmonization - Guideline for Good Clinical Practice

CIOMS International Ethical Guidelines

Canadian Tri-Council Policy Statement

Indian Council of Medical Research

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Last revised: August 16, 2010

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