How Volunteers are Protected
- To protect the rights and welfare of clinical research participants, U.S. Federal Agencies including the Food and Drug Administration (FDA) & the National Institutes of Health (NIH) oversee much of the medical research in the U.S.
- Institutional Review Boards (IRBs) oversee the centers where clinical research studies are conducted. IRBs review and approve study protocols to ensure that a clinical trial is ethical and that volunteers’ rights are protected.
- A participant in a clinical trial has access to the IRB that is overseeing the research and access to a volunteer advocate, the physician and staff conducting the trial.
- Federal agencies inspect individuals and institutions conducting research. They also inspect IRBs.
- Some IRBs are accredited much like hospitals can be “accredited” and some research investigators and staff are “certified” as research professionals.
For more information on becoming a research volunteer, please visit the Center for Information and Study on Clinical Research Participation's website at: www.smartparticipant.org . ___ *Source: http://www.smartparticipant.org/patient/educ_materials/brochures/Brochure_English_web.pdf
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