|
The Common Rule is a rule of ethics regarding biomedical and behavioral research involving human subjects in the United States. These regulations governing Institutional Review Boards for oversight of human research came into effect in 1981 following the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A ("The Common Rule") is the baseline standard of ethics by which any government-funded research in the US is held, and nearly all academic institutions hold their researchers to these statements of rights regardless of funding.〔(【引用サイトリンク】title=Code of Federal Regulations - Title 45 Public Welfare CFR 46 )〕 == Main elements == The main elements of the Common Rule include:〔Korenman, S.G., Teaching the Responsible conduct of Research in humans (RCRH) (Common Rule ), Office of Research Integrity, US Department of Health and Human Services〕 * Requirements for assuring compliance by research institutions * Requirements for researchers' obtaining and documenting informed consent * Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. The Common Rule includes additional protections for certain vulnerable research subjects: * Subpart B provides additional protections for pregnant women, in vitro fertilization, and fetuses * Subpart C contains additional protections for prisoners * Subpart D does the same for children. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Common Rule」の詳細全文を読む スポンサード リンク
|