MARC record from Internet Archive

LEADER: 05783cam a22006017i 4500
001 2014434348
003 DLC
005 20150626082102.0
008 150220t20142014dcua b 100 0 eng d
010 $a 2014434348
020 $a9780309306669 (pbk)
020 $a0309306663 (pbk)
035 $a(OCoLC)ocn892020536
040 $aUNL$beng$cUNL$erda$dKSU$dIXA$dDLC
042 $alccopycat
043 $an-us---
050 00 $aR853.H8$bN38 2014
100 1 $aNass, Sharyl J.,$erapporteur.
245 10 $aContemporary issues for protecting patients in cancer research :$bworkshop summary /$cSharyl J. Nass and Margie Patlak, rapporteurs ; National Cancer Policy Forum, Board on Health Care Services, Institute of Medicine of the National Academies.
246 30 $aProtecting patients in cancer research
264 1 $aWashington, D.C. :$bThe National Academies Press,$c[2014]
264 4 $c©2014
300 $axvii, 74 pages :$billustrations ;$c22 cm
336 $atext$btxt$2rdacontent
337 $aunmediated$bn$2rdamedia
338 $avolume$bnc$2rdacarrier
520 $a"In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges"--$cPublisher's description.
504 $aIncludes bibliographical references (pages 63-65).
505 0 $aIntroduction -- Current regulatory arena -- Common rule and HIPAA -- Shortcomings of current regulations and guidances -- Context -- Data deindentification -- Impediment to quality improvement and learning -- Varied interpretation -- Misaligned incentives -- Lack of harmonization with international standards -- Informed consent forms -- Informed consent process -- Consent tools -- Beyond consent -- HITECH -- Advanced notice of proposed rulemaking -- Patient perspectives on research protections -- Ethical challenges of genetic advances -- Patient consent for use of archived biospecimens -- Return of research results -- Clinically actionable findings -- Context matters -- Who pays -- Biospecimens from deceased participants -- The changing context of research and care -- Oversight in a learning health care system -- Oversight of pragmatic trials -- Multisite studies and IRB review -- Central IRBs -- New England Reliance Agreement -- Value of local IRBs -- Educational needs -- Research needs -- Wrap-up.
530 $aAlso available via the World Wide Web.
650 0 $aHuman experimentation in medicine$zUnited States$vCongresses.
650 0 $aHuman experimentation in medicine$xMoral and ethical aspects$zUnited States$vCongresses.
650 0 $aPatients$xCivil rights$zUnited States$vCongresses.
650 0 $aClinical trials$zUnited States$vCongresses.
650 0 $aCancer$xResearch$zUnited States$vCongresses.
650 0 $aMedical ethics$zUnited States$vCongresses.
650 12 $aHuman Experimentation$xstandards$zUnited States$vCongresses.
650 12 $aClinical Trials as Topic$xstandards$zUnited States$vCongresses.
650 22 $aPatient Rights$zUnited States$vCongresses.
650 22 $aNeoplasms$zUnited States$vCongresses.
650 22 $aEthics, Research$zUnited States$vCongresses.
650 22 $aEthics Committees, Research$zUnited States$vCongresses.
650 22 $aInformed Consent$zUnited States$vCongresses.
650 22 $aResearch Subjects$zUnited States$vCongresses.
650 22 $aConfidentiality$xstandards$zUnited States$vCongresses.
650 22 $aElectronic Health Records$xstandards$zUnited States$vCongresses.
650 22 $aPrivacy$zUnited States$vCongresses.
650 22 $aResearcher-Subject Relations$zUnited States$vCongresses.
700 1 $aPatlak, Margie,$erapporteur.
710 2 $aNational Cancer Policy Forum (U.S.),$eissuing body.
711 2 $aContemporary Issues in Human Subjects Protections (Workshop)$d(2014 :$cWashington, D.C.)
856 40 $3National Academies Press$uhttp://www.nap.edu/catalog.php?record_id=18823
856 41 $uhttp://www.nap.edu/openbook.php?isbn=0309306663$zConnect to this title online: http://www.nap.edu/openbook.php?isbn=0309306663