Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists. Workshop Summary

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Autor/in	Pool, Robert
Institution	National Academies, National Research Council; National Academies, National Academy of Sciences
Titel	Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists. Workshop Summary
Quelle	(2013), (100 Seiten) PDF als Volltext Verfügbarkeit
Sprache	englisch
Dokumenttyp	gedruckt; online; Monographie
ISBN	978-0-309-28823-1
Schlagwörter	Social Sciences; Social Scientists; Behavioral Sciences; Social Science Research; Behavioral Science Research; Federal Legislation; Research Methodology; Health Services; Risk; Privacy; Research Administration; Governing Boards; Universities; Informed Consent; Standards; Longitudinal Studies; Data Use; Interdisciplinary Approach + Suchen Sie Ihr Suchwort? Social science; Sozialwissenschaften; Gesellschaftswissenschaften; Social scientist; Sozialwissenschaftler; Social scientific research; Sozialwissenschaftliche Forschung; Bundesrecht; Research method; Forschungsmethode; Health service; Gesundheitsdienst; Gesundheitswesen; Risiko; Privatsphäre; Forschungsadministration; Governing body; Governing bodies; Leitungsgremium; University; Universität; Standard; Longitudinal study; Longitudinal method; Longitudinal methods; Längsschnittuntersuchung; Fächerübergreifender Unterricht; Fächerverbindender Unterricht; Interdisziplinarität
Abstract	On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the regulations was as follows: this ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. "Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary" focuses on six broad topic areas: (1) Evidence on the functioning of the Common Rule and of institutional review boards (IRBs), to provide context for the proposed revisions; (2) The types and levels of risks and harms encountered in social and behavioral sciences, and issues related to the severity and probability of harm, because the ANPRM asks for input on calibration of levels of review to levels of risk; (3) The consent process and special populations, because new rules have been proposed to improve informed consent (e.g., standard consent form, consent for future uses of biospecimens, and re-consenting for further use of existing research data); (4) Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because the ANPRM proposed applying standards for protecting the privacy of healthcare data to research data; (5) Multidisciplinary and multisite studies, because the ANPRM proposed a revision to the regulations that would allow multisite studies to be covered by a single IRB; and (6) The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight. [Robert Pool served as Rapporteur. Contributors to the report include the Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences; Board on Behavioral, Cognitive, and Sensory Sciences; and Division on Behavioral and Social Sciences and Education. Additional sponsors of the study include the American Academy of Political and Social Science (AAPSS) and the Population Association of America (PAA).] (As Provided).
Anmerkungen	National Academies Press. 500 Fifth Street NW, Washington, DC 20001. Tel: 888-624-8373; Tel: 202-334-2000; Fax: 202-334-2793; e-mail: Customer_Service@nap.edu; Web site: http://www.nap.edu
Erfasst von	ERIC (Education Resources Information Center), Washington, DC
Update	2024/1/01