Broad Consent for Research with Biological Samples: Workshop Conclusion

Details

Author(s):
  • Christine Grady
  • Lisa Eckstein
  • Ben Berkman
  • Dan Brock
  • Robert M. Cook-Deegan
  • Stephanie M. Fullerton
  • Henry T. Greely
  • Mats G. Hansson
  • Sara Hull
  • Scott Kim
  • Bernie Lo
  • Rebecca Pentz
  • Laura Rodriguez
  • Carol Weil
  • Benjamin S. Wilfond
  • Dave Wendler
Publish Date:
August 25, 2015
Publication Title:
The American Journal of Bioethics
Format:
Journal Article Volume 15 Issue 9 Page(s) 34-42
Citation(s):
  • Christine Grady, Lisa Eckstein, Ben Berkman, Dan Brock, Robert Cook-Deegan, Stephanie M. Fullerton, Henry T. Greely, Mats G. Hansson, Sara Hull, Scott Kim, Bernie Lo, Rebecca Pentz, Laura Rodriguez, Carol Weil, Benjamin S. Wilfond, and Dave Wendler, Broad Consent for Research with Biological Samples: Workshop Conclusion, 15 The American Journal of Bioethics 34 (2015).
Related Organization(s):

Abstract

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 he Common Rule, and new guidance regarding storing and sharing data and
samples, this is an important and timely topic.