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Contemporary issues for protecting patients in cancer research : workshop summary /
"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 archiv...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor Corporativo: | |
| Otros Autores: | , |
| Formato: | Electrónico Congresos, conferencias eBook |
| Idioma: | Inglés |
| Publicado: |
Washington, D.C. :
National Academies Press,
[2014]
|
| Colección: | Online access: National Academy of Sciences National Academies Press.
Online access: NCBI NCBI Bookshelf. |
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 111 | 2 | |a Contemporary Issues in Human Subjects Protections (Workshop) |d (2014 : |c Washington, D.C.), |j author. | |
| 245 | 1 | 0 | |a Contemporary issues for protecting patients in cancer research : |b workshop summary / |c Sharyl J. Nass and Margie Patlak, rapporteurs ; National Cancer Policy Forum, Board on Health Care Services, Institute of Medicine of the National Academies. |
| 246 | 3 | 0 | |a Protecting patients in cancer research |
| 264 | 1 | |a Washington, D.C. : |b National Academies Press, |c [2014] | |
| 264 | 4 | |c ©2014 | |
| 300 | |a 1 online resource (xvii, 74 pages) : |b illustrations | ||
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| 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 | 0 | |a Online resource; title from resource home page (National Academies Press, viewed September 23, 2014). | |
| 504 | |a Includes bibliographical references. | ||
| 505 | 0 | |a Introduction -- 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. | |
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Human experimentation in medicine |z United States |v Congresses. | |
| 650 | 0 | |a Human experimentation in medicine |x Moral and ethical aspects |z United States |v Congresses. | |
| 650 | 0 | |a Patients |x Civil rights |z United States |v Congresses. | |
| 650 | 0 | |a Clinical trials |z United States |v Congresses. | |
| 650 | 0 | |a Cancer |x Research |z United States |v Congresses. | |
| 650 | 0 | |a Medical ethics |z United States |v Congresses. | |
| 650 | 0 | |a Informed consent (Medical law) | |
| 650 | 0 | |a Institutional review boards (Medicine) | |
| 650 | 1 | 2 | |a Clinical Trials as Topic |x standards |
| 650 | 1 | 2 | |a Human Experimentation |x standards |z United States |v Congresses. |
| 650 | 2 | 2 | |a Patient Rights |z United States |v Congresses. |
| 650 | 2 | 2 | |a Neoplasms |z United States |v Congresses. |
| 650 | 2 | 2 | |a Ethics, Research |z United States |v Congresses. |
| 650 | 2 | 2 | |a Ethics Committees, Research |z United States |v Congresses. |
| 650 | 2 | 2 | |a Informed Consent |z United States |v Congresses. |
| 650 | 2 | 2 | |a Research Subjects |z United States |v Congresses. |
| 650 | 2 | 2 | |a Confidentiality |x standards |z United States |v Congresses. |
| 650 | 2 | 2 | |a Electronic Health Records |x standards |z United States |v Congresses. |
| 650 | 2 | 2 | |a Privacy |z United States |v Congresses. |
| 650 | 2 | 2 | |a Researcher-Subject Relations |z United States |v Congresses. |
| 650 | 1 | 2 | |a Clinical Trials as Topic |x standards |z United States |v Congresses. |
| 650 | 2 | 2 | |a Researcher-Subject Relations |
| 650 | 2 | 2 | |a Informed Consent |
| 650 | 2 | 2 | |a Ethics Committees, Research |
| 650 | 2 | 2 | |a Confidentiality |x standards |
| 650 | 2 | 2 | |a Electronic Health Records |x standards |
| 650 | 2 | 2 | |a Privacy |
| 650 | 2 | 2 | |a Patient Rights |
| 650 | 2 | 2 | |a Neoplasms |
| 650 | 2 | 2 | |a Ethics, Research |
| 650 | 1 | 2 | |a Human Experimentation |x standards |
| 650 | 2 | 2 | |a Research Subjects |
| 651 | 2 | |a United States | |
| 650 | 2 | |a Truth Disclosure | |
| 650 | 6 | |a Expérimentation humaine en médecine |z États-Unis |v Congrès. | |
| 650 | 6 | |a Expérimentation humaine en médecine |x Aspect moral |z États-Unis |v Congrès. | |
| 650 | 6 | |a Patients |x Droits |z États-Unis |v Congrès. | |
| 650 | 6 | |a Études cliniques |z États-Unis |v Congrès. | |
| 650 | 6 | |a Cancer |x Recherche |z États-Unis |v Congrès. | |
| 650 | 6 | |a Éthique médicale |z États-Unis |v Congrès. | |
| 650 | 6 | |a Consentement éclairé (Droit médical) | |
| 650 | 6 | |a Comités d'éthique de la recherche. | |
| 650 | 7 | |a BUSINESS & ECONOMICS |x Business Ethics. |2 bisacsh | |
| 650 | 7 | |a Institutional review boards (Medicine) |2 fast | |
| 650 | 7 | |a Informed consent (Medical law) |2 fast | |
| 650 | 7 | |a Cancer |x Research |2 fast | |
| 650 | 7 | |a Clinical trials |2 fast | |
| 650 | 7 | |a Human experimentation in medicine |2 fast | |
| 650 | 7 | |a Human experimentation in medicine |x Moral and ethical aspects |2 fast | |
| 650 | 7 | |a Medical ethics |2 fast | |
| 650 | 7 | |a Patients |x Civil rights |2 fast | |
| 651 | 7 | |a United States |2 fast |1 https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq | |
| 655 | 2 | |a Congress | |
| 655 | 7 | |a proceedings (reports) |2 aat | |
| 655 | 7 | |a Conference papers and proceedings |2 fast | |
| 655 | 7 | |a Conference papers and proceedings. |2 lcgft | |
| 655 | 7 | |a Actes de congrès. |2 rvmgf | |
| 700 | 1 | |a Nass, Sharyl J., |e rapporteur. | |
| 700 | 1 | |a Patlak, Margie, |e rapporteur. | |
| 710 | 2 | |a National Cancer Policy Forum (U.S.), |e issuing body. | |
| 758 | |i has work: |a Contemporary issues for protecting patients in cancer research (Text) |1 https://id.oclc.org/worldcat/entity/E39PCGKGx7HbkRPTvdB68TRkDq |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Erscheint auch als: |n Druck-Ausgabe |a Institute of Medicine (U.S.). Contemporary issues for protecting patients in cancer research . |t Workshop summary |
| 830 | 0 | |a Online access: National Academy of Sciences National Academies Press. | |
| 830 | 0 | |a Online access: NCBI NCBI Bookshelf. | |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=3379386 |z Texto completo |
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