Office for human research protections
Encyclopedia
The Office for Human Research Protections (OHRP) is a small office within the United States
Department of Health and Human Services that deals with ethical oversight of clinical research
conducted by the department, mostly through the National Institutes of Health
.
The office's primary duty is the implementation of 45CFR46, a set of regulations for Institutional Review Boards that directly mirrors the U.S. Food and Drug Administration regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the aegis of the "common rule."
Institutions that conduct Department of Health and Human Services
-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 Secretary on issues of medical ethics
.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
Department of Health and Human Services that deals with ethical oversight of clinical research
Clinical research
Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use...
conducted by the department, mostly through the National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
.
The office's primary duty is the implementation of 45CFR46, a set of regulations for Institutional Review Boards that directly mirrors the U.S. Food and Drug Administration regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the aegis of the "common rule."
Institutions that conduct Department of Health and Human Services
United States Department of Health and Human Services
The United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America"...
-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 Secretary on issues of medical ethics
Medical ethics
Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.-History:Historically,...
.
See also
- Human experimentation in the United StatesHuman experimentation in the United StatesThere have been numerous experiments performed on human test subjects in the United States that have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects....
- Institutional Review BoardInstitutional review boardAn institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
- Medical ethicsMedical ethicsMedical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.-History:Historically,...
- Declaration of HelsinkiDeclaration of HelsinkiThe Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association . It is widely regarded as the cornerstone document of human research ethics...
- OHRP web site