Question 53: What is the function of OHRP, and what is the ‘Common Rule’?

Answer:

According to the OHRP Fact Sheet following are the key functions of OHRP:

The Office for Human Research Protections (OHRP) supports, strengthens and provides leadership to the nation’s system for protecting volunteers in research that is conducted or supported by the U.S. Department of Health and Human Services (HHS).

OHRP provides clarification and guidance to research institutions, develops educational programs and materials, and promotes innovative approaches to enhancing human subject protections.

To carry out their research mission, nearly 10,000 universities, hospitals, and other research institutions in the U.S. and abroad have formal agreements (assurances) with OHRP to comply with the regulations pertaining to human subject protections.

OHRP’s Division of Compliance Oversight evaluates all written substantive indications of noncompliance with HHS regulations-Title 45, Part 46, Code of Federal Regulations (45 CFR part 46). OHRP asks the institution involved to investigate the allegations and to provide OHRP with a written report of its investigation. The Office then determines what, if any, regulatory action needs to be taken to protect human research subjects. (1)

OHRP uses a carrot-and-stick approach that combines education and outreach (below) with an extremely modest compliance program. It’s to the great credit of OHRP that institutions, investigators, and institutional review boards have improved to the extent they have. In fact, given the mis-match between the thousands of studies enrolling millions of research subjects every year and OHRP’s staff of roughly 33 employees, it’s downright miraculous.

Compliance:   OHRP processes Federal Wide Assurances and provides basic information about these nearly 10,000 universities, hospitals, and other research institutions in a searchable public database..

An agreement with OHRP to comply with 45 CFR 46 is required in order for institutions to conduct research in human subjects with federal funds. If OHRPfinds substantial non-compliance the assurance can be suspended, which turn causes suspension of all federally-funded research at the institution. Simply put, the government hopes economic self-interest will help motivate institutions to provide adequate protections for humans in research. Sometimes this doesn’t work out terribly well.

The agency forwards allegations of non-compliance to institutions, and depending upon the institutions’ findings and any on-site inspection, OHRP issues a determination letter describing the issues, and as needed, any necessary actions to be taken by the institution. In rare cases OHRP has suspended assurances.

The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. It does not apply to federal agencies that have not signed the agreement (e.g., Department of Labor, etc.) The main elements of the Common Rule include:

Requirements for assuring compliance by research institutions

Requirements for researchers’ obtaining and documenting informed consent

Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.

The Common Rule includes additional protections for certain vulnerable research subjects.

Subpart B provides additional protections for pregnant women, in vitro fertilization, and fetuses

Subpart C contains additional protections for prisoners

Subpart D does the same for children.