page_title: Office for Human Research Protections
section_title: Notable Precursory Research Ethics Entities
hierarchical_section_title: Office for Human Research Protections / History / Notable Precursory Research Ethics Entities
caption_attribution_description: Official portrait of then-HHS Secretary Donna E. Shalala. Donna Shalala is currently the president of the University of Miami.
context_page_description: The Office for Human Research Protections is a small office within the United States Department of Health and Human Services, specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the Department, mostly through the National Institutes of Health.
  The office's primary duty is the implementation of 45 C.F.R. 46, a set of regulations for Institutional Review Boards that mirrors the U.S. Food and Drug Administration regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the guidance of the Federal Policy for the Protection of Human Subjects, which is also known as the "Common Rule".
  Institutions that conduct DHHS-sponsored research must have a "Federal-Wide Assurance", an agreement with OHRP regarding ethical oversight. OHRP also provides education for IRBs, gives guidance on research ethics, and advises the HHS Secretary on issues of medical ethics.
context_section_description: Before the founding of the OHRP, the United States went through several precursory entities whose goals were to handle ethics in human experimentation. Many were transitory committees that lasted no more than a year or two, such as the Advisory Committee on Human Radiation Experiments and the Ethics Advisory Board. One of the early and longstanding groups concerned with experimental subject safety was the American Psychological Association (APA), who first published their “Ethical standards of psychologists” in 1953. The APA has since published many versions of their Ethics Code and currently operate under the code passed in 2002 The National Research Act then established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was the first national commission whose entire focus was the protection of experimental subjects. In 1978, the Food and Drug Administration added their first regulations protecting human research subjects, which were revised in 1981. The National Bioethics Advisory Commission was signed into existence by President Bill Clinton in October 1995 and was terminated in October 2001.
caption: Donna Shalala during her term as a Secretary of Health and Human Services.
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