서브메뉴
검색
Contemporary issues for protecting patients in cancer research : workshop summary
Contemporary issues for protecting patients in cancer research : workshop summary
상세정보
- 자료유형
- 단행본
- Control Number
- n883575949
- International Standard Book Number
- 9780309306676 electronic bk.
- International Standard Book Number
- 0309306671 electronic bk.
- International Standard Book Number
- 9780309306669 (paperback)
- International Standard Book Number
- 0309306663 (paperback)
- Library of Congress Call Number
- R853.H8-C66 2014
- Dewey Decimal Classification Number
- 174.28 23
- Main Entry-Meeting Name
- Contemporary Issues in Human Subjects Protections (Workshop), (2014. Washington, D.C.) author.
- Physical Description
- 1 online resource (xvii, 74 pages) : illustrations
- Summary, Etc.
- 요약"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"--Publisher's description.
- Bibliography, Etc. Note
- Includes bibliographical references.
- Formatted Contents Note
- 완전내용Introduction -- 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.
- Subject Added Entry-Topical Term
- Human experimentation in medicine United States Congresses
- Subject Added Entry-Topical Term
- Human experimentation in medicine Moral and ethical aspects United States Congresses
- Subject Added Entry-Topical Term
- Patients Civil rights United States Congresses
- Subject Added Entry-Topical Term
- Clinical trials United States Congresses
- Subject Added Entry-Topical Term
- Cancer Research United States Congresses
- Subject Added Entry-Topical Term
- Medical ethics United States Congresses
- Subject Added Entry-Topical Term
- Human Experimentation standards United States Congresses
- Subject Added Entry-Topical Term
- Clinical Trials as Topic standards United States Congresses
- Subject Added Entry-Topical Term
- Patient Rights United States Congresses
- Subject Added Entry-Topical Term
- Neoplasms United States Congresses
- Subject Added Entry-Topical Term
- Ethics, Research United States Congresses
- Subject Added Entry-Topical Term
- Ethics Committees, Research United States Congresses
- Subject Added Entry-Topical Term
- Informed Consent United States Congresses
- Subject Added Entry-Topical Term
- Research Subjects United States Congresses
- Subject Added Entry-Topical Term
- Confidentiality standards United States Congresses
- Subject Added Entry-Topical Term
- Electronic Health Records standards United States Congresses
- Subject Added Entry-Topical Term
- Privacy United States Congresses
- Subject Added Entry-Topical Term
- Researcher-Subject Relations United States Congresses
- Subject Added Entry-Topical Term
- BUSINESS & ECONOMICS / Business Ethics
- Subject Added Entry-Topical Term
- Clinical trials.
- Subject Added Entry-Topical Term
- Human experimentation in medicine.
- Subject Added Entry-Topical Term
- Human experimentation in medicine Moral and ethical aspects.
- Subject Added Entry-Topical Term
- Medical ethics.
- Subject Added Entry-Topical Term
- Patients Civil rights.
- Subject Added Entry-Geographic Name
- United States.
- Added Entry-Personal Name
- Nass, Sharyl J.
- Added Entry-Personal Name
- Patlak, Margie
- Added Entry-Corporate Name
- National Cancer Policy Forum (U.S.)
- Electronic Location and Access
- 로그인을 한후 보실 수 있는 자료입니다.
- Control Number
- joongbu:442189
MARC
008140708s2014 dcua ob 000 0 eng d■001ocn883575949
■00520150319113222.0
■006m o d
■007cr cnu---unuuu
■040 ▼aCOO▼beng▼erda▼cCOO▼dMMU▼dCUS▼dN$T▼dYDXCP▼dOCLCF
■020 ▼a9780309306676▼qelectronic bk.
■020 ▼a0309306671▼qelectronic bk.
■020 ▼z9780309306669 (paperback)
■020 ▼z0309306663 (paperback)
■035 ▼a(OCoLC)883575949
■043 ▼an-us---
■050 4▼aR853.H8▼bC66 2014
■060 4▼aW 20.55.H9
■072 7▼aBUS▼x008000▼2bisacsh
■082 4▼a174.28▼b23
■1112 ▼aContemporary Issues in Human Subjects Protections (Workshop)▼d(2014▼cWashington, D.C.)▼jauthor.
■24510▼aContemporary issues for protecting patients in cancer research ▼bworkshop summary▼dSharyl J. Nass and Margie Patlak, rapporteurs; National Cancer Policy Forum, Board on Health Care Services, Institute of Medicine of the National Academies
■24630▼aProtecting patients in cancer research
■264 1▼aWashington, D.C.▼bNational Academies Press▼c[2014]
■264 4▼c©2014
■300 ▼a1 online resource (xvii, 74 pages) ▼billustrations
■336 ▼atext▼btxt▼2rdacontent
■337 ▼acomputer▼bc▼2rdamedia
■338 ▼aonline resource▼bcr▼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"--Publisher's description.
■588 ▼aDescription based on online resource; title from resource home page (National Academies Press, viewed September 23, 2014).
■504 ▼aIncludes bibliographical references.
■5050 ▼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.
■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
■65012▼aHuman Experimentation▼xstandards▼zUnited States▼vCongresses
■65012▼aClinical Trials as Topic▼xstandards▼zUnited States▼vCongresses
■65022▼aPatient Rights▼zUnited States▼vCongresses
■65022▼aNeoplasms▼zUnited States▼vCongresses
■65022▼aEthics, Research▼zUnited States▼vCongresses
■65022▼aEthics Committees, Research▼zUnited States▼vCongresses
■65022▼aInformed Consent▼zUnited States▼vCongresses
■65022▼aResearch Subjects▼zUnited States▼vCongresses
■65022▼aConfidentiality▼xstandards▼zUnited States▼vCongresses
■65022▼aElectronic Health Records▼xstandards▼zUnited States▼vCongresses
■65022▼aPrivacy▼zUnited States▼vCongresses
■65022▼aResearcher-Subject Relations▼zUnited States▼vCongresses
■650 7▼aBUSINESS & ECONOMICS / Business Ethics▼2bisacsh
■655 4▼aElectronic books.
■655 7▼aConference proceedings.▼2fast▼0(OCoLC)fst01423772
■650 7▼aCancer▼xResearch.▼2fast▼0(OCoLC)fst00845497
■650 7▼aClinical trials.▼2fast▼0(OCoLC)fst00864429
■650 7▼aHuman experimentation in medicine.▼2fast▼0(OCoLC)fst00963042
■650 7▼aHuman experimentation in medicine▼xMoral and ethical aspects.▼2fast▼0(OCoLC)fst00963051
■650 7▼aMedical ethics.▼2fast▼0(OCoLC)fst01014081
■650 7▼aPatients▼xCivil rights.▼2fast▼0(OCoLC)fst01055036
■651 7▼aUnited States.▼2fast▼0(OCoLC)fst01204155
■7001 ▼aNass, Sharyl J.▼erapporteur.
■7001 ▼aPatlak, Margie▼erapporteur.
■7102 ▼aNational Cancer Policy Forum (U.S.)▼eissuing body.
■85640▼3EBSCOhost▼uhttp://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=867638
■938 ▼aEBSCOhost▼bEBSC▼n867638
■938 ▼aYBP Library Services▼bYANK▼n12112208
미리보기
내보내기
chatGPT토론
Ai 추천 관련 도서
Info Détail de la recherche.
- Réservation
- 캠퍼스간 도서대출
- 서가에 없는 책 신고
- My Folder
