Office for Human Research Protections (OHRP)

OHRP Responsibilities

In the year 2000, DHHS's OHRP succeeded the NIH's OPRR (Office for Protection from Research Risks) as the federal office overseeing human subjects research. OHRP responsibilities are as follows:

The Office for Human Research Protections (OHRP) fulfills responsibilities set forth in the Public Health Service Act. These include: (1) Developing and monitoring as well as exercising compliance oversight relative to HHS Regulations for the protection of human subjects in research conducted or supported by any component of the Department of Health and Human Services; (2) coordinating appropriate HHS regulations, policies, and procedures both within HHS and in coordination with other Departments and Agencies in the Federal Government; (3) establishing criteria for and negotiation of Assurances of Compliance with institutions engaged in HHS-conducted or-supported research involving human subjects; (4) conducting programs of clarification and guidance for both the Federal and nonfederal sectors with respect to the involvement of humans in research; and directing the development and implementation of educational and instructional programs and generating educational resource materials; (5) evaluating the effectiveness of HHS policies and programs for the protection of human subjects; (6) serving as liaison to Presidential, Departmental, Congressional, interagency, and non-governmental commissions and boards established to examine ethical issues in medicine and research and exercises leadership in identifying and addressing such ethical issues; and (7) promoting the development of approaches to enhance and improve methods to avoid unwarranted risks to humans participating as subjects in research covered by applicable statutes and regulations.

OHRP IRB Guidebook

OPRR's IRB Guidebook has been adopted and made available by OHRP. The Guidebook covers a variety of human subjects research topics and is considered federal policy for IRB purposes.

NHRPAC

Though its charter was not renewed by the Bush Administration, the National Human Research Protections Advisory Committee (NHRPAC) recently provided advice and views concerning human subjects research oversight to the Secretary of Health and Human Services, the Assistant Secretary for Health, and the Office for Human Research Protections (OHRP).