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Author Notes:

Correspondence to Christine Grady RN PhD, National Insitutes of Health, Dept. of Clinical Bioethics, Building 10, Room 1C118, 10 Center Drive, Bethesda, MD 20892-1156, USA, cgrady@nih.gov.

The authors acknowledge the helpful contributions of the following workshop participants, who chose not to be authors: Jeffery Botkin MD MPH, University of Utah; Ellen Wright Clayton JD MD, Vanderbilt University; Tom Tomlinson PhD, Michigan State University

The views expressed are those of the authors and do not represent the official policies or positions of the Department of Health and Human Services, NIH, or the Public Health Service.


Research Funding:

The workshop was funded by the NIH CC Department of Bioethics.


  • Social Sciences
  • Science & Technology
  • Life Sciences & Biomedicine
  • Ethics
  • Medical Ethics
  • Social Issues
  • Social Sciences, Biomedical
  • Social Sciences - Other Topics
  • Biomedical Social Sciences
  • biomedical research
  • informed consent
  • regulatory issues
  • research ethics

Broad Consent for Research With Biological Samples: Workshop Conclusions

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Journal Title:

American Journal of Bioethics


Volume 15, Number 9


, Pages 34-42

Type of Work:

Article | Post-print: After Peer Review


Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.

Copyright information:

© 2015, Taylor & Francis Group, LLC.

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