NWHIC Organizations Directory -- Record Details

Office of Human Subjects Research, DDIR, NIH, PHS, HHS

Mission statement:

The OHSR has been established to help NIH investigators understand and comply with ethical principles and regulatory requirements involved in human subjects research. The OHSR: 1) Assists various NIH components in administering and regulating human subjects research activities so as to promote both the rights and welfare of human subjects and the NIH's research mandate 2) Interprets 45 CFR 46 (the Federal regulations for the Protection of Human Subjects) and works with other NIH groups, as appropriate, to formulate and develop NIH policies and procedures consistent with these regulations 3) Plans, organizes and conducts educational activities for NIH personnel concerning human subject protections 4) Works closely with the NIH's 14 Institutional Review Boards (IRBs) to promote their mandate to protect the rights and welfare of human subjects 5) Assists investigators and others in fulfilling their ethical and regulatory responsibilities when conducting collaborative human subjects research in foreign countries 6) Consults with investigators, upon request, to help identify and resolve ethical and regulatory issues associated with the design and conduct of their human subjects research activities 7) Maintains a database to monitor all NIH collaborative research activities and to record research activities that are exempt from 45 CFR 46 and 8) Assists, at the request of the DDIR, in the conduct of inquiries and/or investigations concerning noncompliance with 45 CFR 46 or NIH policies and procedures that concern the conduct of human subjects research.

Contact Information:

Office of Human Subjects Research, DDIR, NIH, PHS, HHS
The Warren Grant Magnuson Clinical Center Building 10, Room 2C146
Bethesda MD 20892-1154

Internet address: http://ohsr.od.nih.gov/

Phone number(s):

(301) 402-3444

Fax number:

(301) 402-3443

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• RESEARCH

NWHIC record number O-1961