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"Institutional review boards (Medicine) United States History."
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Regulating human research : IRBs from peer review to compliance bureaucracy
This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.
eBook
Access Anxiety: HIPAA and Historical Research
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) establishes new standards for the protection of private health information in the United States. The Privacy Rule, one of the specific regulatory provisions of the act, went into effect 14 April 2003 for covered health care providers, institutions, and businesses. The Privacy Rule directly affected medical archivists and their collections. It has significant implications for historians of health care, as well. The Privacy Rule is the first major regulation that protects the privacy of the deceased in perpetuity. It establishes requirements that researchers must satisfy in order to gain access to “individually identifiable health information” held by HIPAA-protected institutions. While these requirements will burden historians in some cases, the Privacy Rule could open up opportunities for well-prepared historians to work with a more extensive range of twentieth-century documents.
Journal Article
Do We Need Another Advisory Commission on Human Experimentation?
Instead of another federal advisory panel to identify ethical principles governing human subjects research, it is time we had a national board with authority to regulate and review such research.
Journal Article