Office for Human Research Protections
| Agency overview | |
|---|---|
| Formed | June 2000 |
| Preceding |
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| Headquarters | 1101 Wootton Parkway, Suite 200 Rockville, MD 20852 |
| Parent department | United States Department of Health and Human Services |
| Website | http://www.hhs.gov/ohrp/ |
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), 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 (NIH).
The office's primary duty is the implementation of 45 C.F.R. 46, a set of regulations for Institutional Review Boards (IRB) that mirrors the U.S. Food and Drug Administration (FDA) 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" (FWA), 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.
Unethical human experimentation in the United States has been practiced in the United States for a long time prior to creation of the OHRP. A major characteristic of experimentation done during this time was the disregard for suffering inflicted on patients. In the 1840s, J. Marion Sims performed hundreds of surgical operations on enslaved African women without using anesthesia.Robert Bartholow applied electric currents into the exposed brain matter of patients. One egregious example was in 1874 when a lady came in for treatment of a cancerous ulcer on her skull that made a 2-inch hole. Bartholow inserted electrodes into her brain and caused her great distress. The lady went into a coma and died 4 days later. Another theme of human experimentation in the 19th and early 20th century was the unjust treatment of ethnic minority patients. At the turn of the 20th century, US Army doctors infected 34 Filipino prisoners with bubonic plague and beriberi. Between 1932 and 1972, the Tuskegee syphilis experiment injected 400 African American males with syphilis to study the effects of the disease. Several of the test subjects died.
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