.

0 (hodnocen0 x )

EB

ONLINE

Washington, District of Columbia : The National Academies Press, [2013]

1 online resource (109 pages)

ISBN 9780309288248 (electronic bk.)

ISBN 0309288231 (pbk.)

ISBN 9780309288231 (pbk.)

Print version: Workshop on Proposed Revisions to the Common Rule in Relation to the Behavioral and Social Sciences Proposed revisions to the common rule : perspectives of social and behavioral scientists. Washington, District of Columbia : The National Academies Press, [2013] x, 99 pages ; 24 cm ISBN 9780309288231

"Workshop summary."

Includes bibliographical references

Session 1: Review of the Evidence -- Session 2: Risks and Harms -- Session 3: The Consent Process and Special Populations -- Session 4: Data Use and Sharing and Technological Advancements -- Session 5: Multisite and Multidisciplinary Studies -- Session 6: Purview and Roles of Institutional Review Boards -- Appendix A: Workshop Agenda -- Appendix B: Biographical Sketches of Speakers.

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. 6. The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight. -- Source other than Library of Congress..

On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rule-making (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised ... 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.-.

001826342

full

(Au-PeEL)EBL3379263

(CaPaEBR)ebr10863920

(MiAaPQ)EBC3379263

(OCoLC)880439903