The institutional review board (IRB) is charged with protecting the rights and welfare of human subjects who participate in research. When research is subject to federal regulations, institutions must follow the Code of Federal Regulations. Most research institutions customize their policies and procedures within the framework of these regulations. Two agencies of the federal government that are involved with the IRB are the Office of Human Research Protections (OHRP) and the Food and Drug Administration.1 This article will focus on the OHRP.

WHAT IS THE OHRP?

As promulgated by the US Department of Health and Human Services (HHS), the primary function of the OHRP is to support, strengthen, and promote compliance and provide leadership in protecting and monitoring volunteers who are participants of a research. Other functions include clarifying and providing guidance to research institutions and developing education programs to assist those conducting research using human subjects. Nearly 10,000 institutions and hospitals in the United States and abroad have a contract (called an assurance that is signed by a high-level representative of a facility) with OHRP to demonstrate that the entire institution, institutional officials, IRBs, research investigators, and all employees demonstrate compliance with ethical practices and regulations pertaining to research involving human subjects.2

AUDITING

The OHRP does not routinely audit institutions for compliance without provocation. Adverse events that receive national attention, a complaint by a research subject or someone connected with the research program, or review of publications that are of concern to the OHRP officials will provoke an investigation. The OHRP will accept complaints in writing, via e-mail, or by a telephone call.

Upon receiving an allegation of noncompliance, the OHRP will review the allegation to determine if it has jurisdiction over the institution (is there an OHRP-approved assurance?) The OHRP will notify the complainant that the office will open a compliance oversight evaluation and send a notice to the officials of the institution in question. Because OHRP will not take action against an institution without affording the institution an opportunity to offer an explanation, the OHRP asks the institution for the following information.

1. an investigation into potential noncompliance,

2. a written response to the allegations of noncompliance including supporting documentation, and

3. a corrective action plan if the investigation reveals noncompliance.

Once this information is received, the OHRP sends a letter to the principal investigators, evaluates the documentation to determine if additional information is needed, and, if questions still remain, sends a follow-up letter to the institution. The OHRP will only make an on-site visit if it continues to have serious concerns about the allegations. If, however, OHRP determines that concerns have been adequately addressed through the corrective action plan, it will conclude its evaluation and send a letter informing the institution of this final outcome of the investigation.1,2

Maintaining compliance with OHRP and HHS standards is a strong motivating factor for many research institutions. Determination of an institution's noncompliance with its OHRP assurance means that, with stroke of a pen, all HHS funding for ongoing or previously approved research is suspended.

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