Contemporary issues for protecting patients in cancer research : workshop summary

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...

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Bibliographic Details
Main Author: Institute of Medicine (U.S.) (-)
Corporate Authors: National Cancer Policy Forum (U.S.), issuing body (issuing body), Contemporary Issues in Human Subjects Protections (Workshop)
Other Authors: Nass, Sharyl J., rapporteur (rapporteur), Nass, Sharyl J., reporter (Reporter), Patlak, Margie, reporter
Format: eBook
Language:Inglés
Published: Washington, District of Columbia : National Academies Press 2014.
Edition:1st ed
Subjects:
Human experimentation in medicine > United States.
Human experimentation in medicine > Moral and ethical aspects > United States.
Patients > Civil rights > United States.
See on Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820311706719
Table of Contents:
  • 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.

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