FDAʼs proposed rules for institutional review boards
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چکیده
منابع مشابه
Transcending Racial and Ethnic Analyses in Clinical Research: A Proposed Model for Institutional Review Boards
In 2005, the Food and Drug Administration’s approval of BiDil for use only in self-identified African Americans brought to the fore the longstanding debate about the use of race and ethnicity in medical research and practice. While this issue has received considerable attention in the science and social science literature, thus far there has been little consideration about the legal and regulat...
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Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) are charged with protecting the rights and safety of clinical trial participants. The regulations that guide the review, approval, and conduct of human research refer to these independent boards as IRBs or IECs. In 2001 the Association for the Accreditation of Human Research Protection Programs (AAHRPP) was formed. Sinc...
متن کاملInstitutional review boards: consideration in developing countries.
547 emphasis on partnerships, decision-making by African scientists, and a strong scientific basis for the funded research. To support a variety of research programs, MIM has also developed the Malaria Research and Reference Reagent Resource Center, which provides high quality reagents and materials to investigators who are, or wish to be, involved in malaria research. NIH's National Library of...
متن کاملThe role of institutional review boards.
The author responds: I totally agree with the reader’s statement that a researcher’s ethics are the first line of research protection for human subjects. However, the IRB mechanism is our regulatory system that attempts to ensure this process. My statement in the article is framed on the basis of the current rash of highly publicized ethical violations by researchers. We need the first line che...
متن کاملInstitutional review boards - a mixed blessing
Institutional Review Boards (IRBs) are an important checkpoint for all types of research in medicine. Although these bodies originated primarily in the developed world, they have special contemporary consideration in the context of developing countries due to the large number of clinical trials being conducted in these regions with the financial support of large pharmaceutical companies. IRBs a...
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ژورنال
عنوان ژورنال: Academic Medicine
سال: 1979
ISSN: 1040-2446
DOI: 10.1097/00001888-197912000-00013