LEADER 04839nam 2200541 450 001 9910811817703321 005 20230803205625.0 010 $a0-309-30669-8 010 $a0-309-30667-1 035 $a(CKB)3710000000260769 035 $a(MiAaPQ)EBC3379386 035 $a(Au-PeEL)EBL3379386 035 $a(CaPaEBR)ebr10951340 035 $a(OCoLC)883575949 035 $a(EXLCZ)993710000000260769 100 $a20141017h20142014 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 10$aContemporary issues for protecting patients in cancer research $eworkshop summary /$fInstitute of Medicine (U.S.) ; Sharyl J. Nass and Margie Patlak, Rapporteurs National Cancer Policy Forum Board on Health Care Services 210 1$aWashington, District of Columbia :$cNational Academies Press,$d2014. 210 4$dİ2014 215 $a1 online resource (92 pages) $cillustrations 311 $a0-309-30674-4 311 $a0-309-30666-3 327 $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. 330 $a"In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges"--$cPublisher's description. 606 $aHuman experimentation in medicine$zUnited States 606 $aHuman experimentation in medicine$xMoral and ethical aspects$zUnited States 606 $aPatients$xCivil rights$zUnited States 615 0$aHuman experimentation in medicine 615 0$aHuman experimentation in medicine$xMoral and ethical aspects 615 0$aPatients$xCivil rights 676 $a174.28 700 $aNass$b Sharyl J.$0857626 702 $aNass$b Sharyl J. 702 $aPatlak$b Margie 712 02$aNational Cancer Policy Forum (U.S.), 712 12$aContemporary Issues in Human Subjects Protections (Workshop)$f(2014 :$eWashington, D.C.) 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910811817703321 996 $aContemporary issues for protecting patients in cancer research$94038964 997 $aUNINA