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Broad Consent for Research With Biological Samples: Workshop Conclusions.

Christine Grady1, Lisa Eckstein, Ben Berkman

  • 1a National Institutes of Health Clinical Center.

The American Journal of Bioethics : AJOB
|August 26, 2015
PubMed
Summary

Broad consent for future research on human biospecimens can address confusion and constraints. A workshop proposed broad initial consent with oversight and donor updates, balancing research needs with ethical considerations.

Keywords:
Keywords:biomedical researchinformed consentregulatory issuesresearch ethics

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Area of Science:

  • Bioethics
  • Human Biospecimen Research
  • Informed Consent

Background:

  • Varied consent types for human biospecimens cause confusion and limit future research.
  • Ethical challenges arise from differing consent strategies and potential research without consent.

Purpose of the Study:

  • To explore the ethical acceptability of broad consent for future research on stored biospecimens.
  • To address confusion and constraints associated with current consent practices.

Main Methods:

  • A workshop convened bioethics scholars to discuss consent for future research.
  • Analysis of reasons for consent, consent strategies, and knowledge gaps.

Main Results:

  • Agreement on the need for clear consent processes for biospecimen research.
  • Proposal for broad initial consent combined with oversight and donor communication.

Conclusions:

  • Broad consent, with appropriate safeguards, offers a viable solution to current consent challenges.
  • Further research and dialogue are needed, especially concerning regulatory changes like the Common Rule.