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


Office for Human Research Protections (OHRP)

Some of these archived documents may not currently be accessible to persons using assistive technology. If you need access to the information in these files, please contact OHRP at 240-453-6900 for assistance.

Compliance Oversight

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Overview

OHRP's Division of Compliance Oversight (DCO) reviews institutional compliance with the federal regulations governing the protection of human subjects in HHS-sponsored research 45 CFR 46.

DCO evaluates all written substantive allegations or indications of noncompliance with the HHS regulations. If complaints or concerns arise regarding an institution's human subject protection practices, OHRP opens a formal evaluation and, if necessary, requires corrective action by the institution.

During the course of an evaluation DCO issues findings of noncompliance in the form of determination letters. OHRP makes these determination letters available on our website, either 10 days after the letter is issued or when the first Freedom of Information Act (FOIA) request is made, requesting that letter. These publicly available determination letters are edited to remove those portions that relate to issues still under discussion with the institution.

Case materials from DCO evaluations are available, through a Freedom of Information Act (FOIA) request, once the investigation is complete. Such FOIA requests should be directed to the Public Health Service FOIA Office, Parklawn Building, Room 17A-46, 5600 Fishers Lane, Rockville, MD 20857, telephone (301) 443-5252; fax (301) 443-0925.

Contacting OHRP’s Division of Compliance Oversight

Determination Letters

Compliance Oversight Procedures [PDF | HTML]

Recent Compliance Oversight Determinations [PDF | HTML]

For more information on how to make required reports to OHRP, see Guidance on Reporting Incidents to OHRP [PDF - 51.6KB]




Last Updated: February 9, 2009

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