MARC Record from marc_columbia

LEADER: 05526cam a2200625Ii 4500
001 13613479
005 20181218135042.0
008 180817t20182018dcua b 000 0 eng d
010 $a 2018950906
020 $a9780309475174$q(paperback)
020 $a0309475171$q(paperback)
035 $a(OCoLC)on1048937277
035 $a(OCoLC)1048937277
035 $a(NNC)13613479
040 $aYDX$beng$erda$cYDX$dNRC$dYDX$dSOI$dEEM$dOCLCO$dNDD$dOCLCO$dOCLCF$dKSU$dDLC
043 $an-us---
050 4 $aR853.C55$bR47 2018
060 4 $aW 20.55.C5
082 04 $a615.5072/4$223
245 00 $aReturning individual research results to participants :$bguidance for a new research paradigm /$cJeffrey R. Botkin, Michelle Mancher, Emily R. Busta, and Autumn S. Downey, editors ; Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories; Board on Health Sciences Policy, Health and Medicine Division ; a consensus study report of The National Academies of Sciences, Engineering, Medicine.
264 1 $aWashington, DC :$bThe National Academies Press,$c[2018]
264 4 $c©2018
300 $axxvii, 370 pages :$billustrations (chiefly color) ;$c23 cm.
336 $atext$btxt$2rdacontent
337 $aunmediated$bn$2rdamedia
338 $avolume$bnc$2rdacarrier
490 1 $aConsensus study report of The National Academies of Sciences, Engineering, Medicine.
520 $a"When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research results--such as results with unknown validity--and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholders--investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participants--and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations"--Publisher's description
504 $aIncludes bibliographical references.
505 0 $aSummary -- Introduction -- Principles for the return of individual research results : ethical and societal considerations -- Laboratory quality systems for research testing of human biospecimens -- Processes to enable appropriate decision making regarding the return of individual research results -- Advancing practices for returning individual research results -- Reshaping the legal and regulatory landscape to support return of individual research results -- Appendixes. Study approach and methods -- Public agendas -- Analysis of legal and regulatory landscape relevant to return of individual results generated from biospecimens in research -- The return of individual-specific research results from laboratories: perspectives and ethical underpinnings -- Biographical sketches of committee members, consultants, and staff.
650 0 $aClinical trials$xReporting$zUnited States.
650 0 $aClinical trials$xResearch$zUnited States.
650 0 $aParticipant observation$xMoral and ethical aspects$zUnited States.
650 0 $aMedicine$xResearch$zUnited States.
650 0 $aResearch$xMoral and ethical aspects$zUnited States.
650 0 $aHuman experimentation in medicine$xLaw and legislation$zUnited States.
650 0 $aOutcome assessment (Medical care)$zUnited States.
650 7 $aClinical trials$xReporting.$2fast$0(OCoLC)fst01765737
650 7 $aHuman experimentation in medicine$xLaw and legislation.$2fast$0(OCoLC)fst00963048
650 7 $aMedicine$xResearch.$2fast$0(OCoLC)fst01015059
650 7 $aOutcome assessment (Medical care)$2fast$0(OCoLC)fst01049109
650 7 $aResearch$xMoral and ethical aspects.$2fast$0(OCoLC)fst01095225
651 7 $aUnited States.$2fast$0(OCoLC)fst01204155
650 2 $aClinical Trials as Topic.$0(DNLM)D002986
651 2 $aUnited States.$0(DNLM)D014481
700 1 $aBotkin, Jeffrey R.,$eeditor.
700 1 $aMancher, Michelle,$eeditor.
700 1 $aBusta, Emily R.,$eeditor.
700 1 $aDowney, Autumn S.,$eeditor.
710 2 $aNational Academies of Sciences, Engineering, and Medicine (U.S.).$bCommittee on the Return of Individual-Specific Research Results Generated in Research Laboratories.
710 2 $aNational Academies of Sciences, Engineering, and Medicine (U.S.).$bBoard on Health Sciences Policy,$eissuing body.
710 2 $aNational Academies of Sciences, Engineering, and Medicine (U.S.).$bHealth and Medicine Division,$eissuing body.
776 08 $iOnline version:$aNational Academies of Sciences, Engineering, and Medicine (U.S.). Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories.$tReturning individual research results to participants.$dWashington, D.C. : National Academies Press, [2018]$w(OCoLC)1046985414.
830 0 $aConsensus study report.
852 00 $boff,sci$hR853.C55$iR47 2018g