Proposed revisions to the common rule : (Record no. 31943)
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| fixed length control field | 05589nam a2200493 i 4500 |
| 001 - CONTROL NUMBER | |
| control field | EBC3379263 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | MiAaPQ |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m o d | |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cnu|||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 140306t20132013dcu ob 100 0 eng|d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 0309288231 (pbk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9780309288231 (pbk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780309288248 (e-book) |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (MiAaPQ)EBC3379263 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (Au-PeEL)EBL3379263 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (CaPaEBR)ebr10863920 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)880439903 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | MiAaPQ |
| Language of cataloging | eng |
| Description conventions | rda |
| -- | pn |
| Transcribing agency | MiAaPQ |
| Modifying agency | MiAaPQ |
| 043 ## - GEOGRAPHIC AREA CODE | |
| Geographic area code | n-us--- |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | H62 |
| Item number | .W67 2013 |
| 111 2# - MAIN ENTRY--MEETING NAME | |
| Meeting name or jurisdiction name as entry element | Workshop on Proposed Revisions to the Common Rule in Relation to the Behavioral and Social Sciences |
| Date of meeting or treaty signing | (2013 : |
| Location of meeting | Washington, D.C.), |
| Relator term | issuing body. |
| 245 10 - TITLE STATEMENT | |
| Title | Proposed revisions to the common rule : |
| Remainder of title | perspectives of social and behavioral scientists / |
| Statement of responsibility, etc. | Robert Pool, rapporteur ; 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, Division of Behavioral and Social Sciences and Education, National Research Council of the National Academies. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Washington, District of Columbia : |
| Name of producer, publisher, distributor, manufacturer | The National Academies Press, |
| Date of production, publication, distribution, manufacture, or copyright notice | [2013] |
| 264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Date of production, publication, distribution, manufacture, or copyright notice | �2013 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (109 pages) |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Source | rdacarrier |
| 500 ## - GENERAL NOTE | |
| General note | "Workshop summary." |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc. note | Includes bibliographical references. |
| 505 1# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | 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. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site 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 ... [The 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. 6. The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight. -- |
| Assigning source | Source other than Library of Congress. |
| 588 ## - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | Description based on print version record. |
| 590 ## - LOCAL NOTE (RLIN) | |
| Local note | Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Social sciences |
| General subdivision | Moral and ethical aspects. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Human experimentation in medicine |
| General subdivision | Law and legislation |
| Geographic subdivision | United States. |
| 655 #4 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Pool, Robert, |
| Dates associated with a name | 1955- |
| Relator term | contributor. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | National Research Council (U.S.). |
| Subordinate unit | Board on Behavioral, Cognitive, and Sensory Sciences, |
| Relator term | sponsoring body. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | National Research Council (U.S.). |
| Subordinate unit | Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, |
| Relator term | issuing body. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| Main entry heading | Workshop on Proposed Revisions to the Common Rule in Relation to the Behavioral and Social Sciences |
| Title | Proposed revisions to the common rule : perspectives of social and behavioral scientists. |
| Place, publisher, and date of publication | Washington, District of Columbia : The National Academies Press, [2013] |
| Physical description | x, 99 pages ; 24 cm |
| International Standard Book Number | 9780309288231 |
| Record control number | (OCoLC)ocn857966216 |
| -- | (DLC)18058300 |
| 797 2# - LOCAL ADDED ENTRY--CORPORATE NAME (RLIN) | |
| Corporate name or jurisdiction name as entry element | ProQuest (Firm) |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://ebookcentral.proquest.com/lib/nird-ebooks/detail.action?docID=3379263">https://ebookcentral.proquest.com/lib/nird-ebooks/detail.action?docID=3379263</a> |
| Public note | Click to View |
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