Broad Consent for Research With Biological Samples: Workshop Conclusions

Am J Bioeth. 2015;15(9):34-42. doi: 10.1080/15265161.2015.1062162.


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.

Keywords: Keywords:; biomedical research; informed consent; regulatory issues; research ethics.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Biological Specimen Banks / ethics
  • Biological Specimen Banks / organization & administration
  • Biological Specimen Banks / standards
  • Biological Specimen Banks / trends
  • Biomedical Research / ethics*
  • Biomedical Research / legislation & jurisprudence
  • Communication*
  • Congresses as Topic
  • Ethical Analysis
  • Ethics, Research
  • Humans
  • Informed Consent / ethics*
  • National Institutes of Health (U.S.)
  • Personal Autonomy*
  • Tissue Donors*
  • United States