Common_Rule - SocialandBehavioralScienceWhitePaperon

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Social and Behavioral Science White Paper on Advanced Notice for Proposed Rulemaking (ANPRM) Federal Register 44512 ­ 531 (July 26, 2011); ID Docket HHS ­ OPHS ­ 2011 ­ 0005 Introduction On behalf of 22 research associations and over 350,000 members, we are pleased to provide this social and behavioral science (SBS) white paper in response to the Advanced Notice for Proposed Rulemaking (ANPRM) requesting comments regarding current regulations for the protecting human subjects in research, as set forth in 45CFR46, Subpart A (the “Common Rule”). We applaud your recognition of the need to modernize and provide for a more effective Common Rule in light of concerns, complexities, and challenges that have arisen during the 20 years since its adoption. We also commend the Department of Health and Human Services (HHS) and the Office of Science and Technology Policy (OSTP) for jointly taking on this task. We hope and urge that this direct collaboration continues not only to conclude successfully this process of rulemaking but also to develop a mechanism that engages the expertise of all relevant science agencies in the implementation, oversight, and evaluation of the regulations that issue. An interagency committee under OSTP would facilitate communication and planning across agencies as new issues arise and ensure that the focus is not predominately biomedical. This white paper addresses the ANPRM from the vantage point of a very large community of concerned scientists with longstanding commitments to and engagement in the ethical conduct of research. In preparing this document, our aim is to foster revisions to the Common Rule that are consistent with the principles set forth in the Belmont Report in 1979 and to offer guidance that can serve to protect the interests of human subjects so that they can safely participate in research with genuine informed consent and a sense of their own interests in advancing knowledge. Although in this white paper we address specifically only social and behavioral science research, we believe much in this document is pertinent to all human subjects research that has found itself overshadowed and limited by regulations drafted with biomedical studies first in mind. We are, in particular, pleased to see specific attention to SBS research and ways that it differs from biomedical research whose potential for physical harm led to the development of the Common Rule. Lest our specific criticisms be taken too broadly, we emphasize at the outset that we strongly support the aims and ambition of this project to revise the Common Rule. We believe that many of the proposed changes will facilitate quality research without diminishing, and in some cases further strengthening, the protections accorded human subjects. In structuring our guidance and comments, we follow the ANPRM systematically in sections II‐VIII. Since our aim is to be educative with respect to the ethical conduct of research, this white paper addresses each topic
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This note was uploaded on 12/09/2011 for the course SP 108 taught by Professor Whittenburg during the Summer '11 term at Montgomery College.

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Common_Rule - SocialandBehavioralScienceWhitePaperon

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