Informed consent for biobanking: consensus-based guidelines for adequate comprehension

Journal name:
Genetics in Medicine
Published online



Federal regulations and best practice guidelines identify categories of information that should be communicated to prospective biobank participants during the informed consent process. However, uncertainty remains about which of this information participants must understand to provide valid consent.


We conducted a Delphi process to define “adequate comprehension” in the context of biobanking consent. The process involved an iterative series of three online surveys of a diverse panel of 51 experts, including genome scientists, biobank managers, ethics and policy experts, and community and participant representatives. We sought consensus (>70% agreement) concerning what specific details participants should know about 16 biobank consent topics.


Consensus was achieved for 15 of the 16 consent topics. The exception was the comprehension needed regarding the Genetic Information Nondiscrimination Act.


Our Delphi process was successful in identifying a concise set of key points that prospective participants must grasp to provide valid consent for biobanking. Specifying the level of knowledge sufficient for individuals to make an informed choice provides a basis for improving consent forms and processes, as well as an absolute metric for assessing the effectiveness of other interventions to improve comprehension.

Genet Med 17 3, 226–233.


biobanking; comprehension; Delphi process; informed consent; research ethics


  1. Vaught JB, Henderson MK, Compton CC. Biospecimens and biorepositories: from afterthought to science. Cancer Epidemiol Biomarkers Prev 2012;21:253255.
  2. Henderson GE, Cadigan RJ, Edwards TP, et al. Characterizing biobank organizations in the U.S.: results from a national survey. Genome Med 2013;5:3.
  3. Baker M. Biorepositories: building better biobanks. Nature 2012;486:141146.
  4. Emanuel EJ, Menikoff J. Reforming the regulations governing research with human subjects. N Engl J Med 2011;365:11451150.
  5. Mello MM, Wolf LE. The Havasupai Indian tribe case–lessons for research involving stored biologic samples. N Engl J Med 2010;363:204207.
  6. Couzin-Frankel J. Ethics. DNA returned to tribe, raising questions about consent. Science 2010;328:558.
  7. Doerr A. Newborn blood spot litigation: 70 days to destroy 5+ million samples. Accessed 17 June 2014.
  8. Callaway E. HeLa publication brews bioethical storm. Accessed 17 June 2014.
  9. Vaught J, Lockhart NC. The evolution of biobanking best practices. Clin Chim Acta 2012;413:15691575.
  10. McGuire AL, Beskow LM. Informed consent in genomics and genetic research. Annu Rev Genomics Hum Genet 2010;11:361381.
  11. Wendler D, Grady C. What should research participants understand to understand they are participants in research? Bioethics 2008;22:203208.
  12. Appelbaum PS. Understanding “understanding”: an important step toward improving informed consent to research. AJOB Prim Res 2010;1(suppl 2):13.
  13. Fink A, Kosecoff J, Chassin M, Brook RH. Consensus methods: characteristics and guidelines for use. Am J Public Health 1984;74:979983.
  14. Black N, Murphy M, Lamping D, et al. Consensus development methods: a review of best practice in creating clinical guidelines. J Health Serv Res Policy 1999;4:236248.
  15. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs 2000;32:10081015.
  16. Hutchings A, Raine R, Sanderson C, Black N. A comparison of formal consensus methods used for developing clinical guidelines. J Health Serv Res Policy 2006;11:218224.
  17. Keeney S, Hasson F, McKenna HP. The Delphi technique in nursing and health research. Wiley-Blackwell: Chichester, West Sussex, UK, 2011.
  18. Graham B, Regehr G, Wright JG. Delphi as a method to establish consensus for diagnostic criteria. J Clin Epidemiol 2003;56:11501156.
  19. The Electronic Medical Records and Genomics (eMERGE) Network Consent & Community Consultation Workgroup Informed Consent Task Force. Model consent language. Accessed 17 June 2014.
  20. U.S. Department of Health & Human Services. Office for Human Research Protections. Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards. Accessed 17 June 2014.
  21. Beskow LM, Check DK, Ammarell N. Research Participants’ Understanding of and Reactions to Certificates of Confidentiality. AJOB Prim Res 2014;5:1222.
  22. Hudson KL, Holohan MK, Collins FS. Keeping pace with the times–the Genetic Information Nondiscrimination Act of 2008. N Engl J Med 2008;358:26612663.
  23. Wendler D. Can we ensure that all research subjects give valid consent? Arch Intern Med 2004;164:22012204.
  24. McCarty CA, Nair A, Austin DM, Giampietro PF. Informed consent and subject motivation to participate in a large, population-based genomics study: the Marshfield Clinic Personalized Medicine Research Project. Community Genet 2007;10:29.
  25. Ormond KE, Cirino AL, Helenowski IB, Chisholm RL, Wolf WA. Assessing the understanding of biobank participants. Am J Med Genet A 2009;149A:188198.
  26. Rahm AK, Wrenn M, Carroll NM, Feigelson HS. Biobanking for research: a survey of patient population attitudes and understanding. J Community Genet 2013;4:445450.
  27. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th Ed. Oxford University Press: New York; 1994.
  28. National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants, Volume 1. US Government Printing Office: Rockville, MD, 2001.
  29. Institute of Medicine. Responsible Research: A Systems Approach to Protecting Research Participants. National Academies Press: Washington, DC, 2002.
  30. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. US Government Printing Office: Washington, DC, 1979.
  31. Sand K, Kaasa S, Loge JH. The understanding of informed consent information—definitions and measurements in empirical studies. AJOB Prim Res 2010;1(suppl 2):424.
  32. Beskow LM, Friedman JY, Hardy NC, Lin L, Weinfurt KP. Simplifying informed consent for biorepositories: stakeholder perspectives. Genet Med 2010;12:567572.
  33. White Paper. Creating a Global Alliance to Enable Responsible Sharing of Genomic and Clinical Data. Accessed 17 June 2014.
  34. Beskow LM, Friedman JY, Hardy NC, Lin L, Weinfurt KP. Developing a simplified consent form for biobanking. PLoS One 2010;5:e13302.
  35. National Cancer Institute. Office of Biorepositories and Biospecimen Research. Custodianship and Ownership Issues in Biospecimen Research. Accessed 17 June 2014.
  36. Department of Health and Human Services. Advance Notice of Proposed Rulemaking: Human Subjects Research Protections-Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. Federal Register 2011;76(suppl 143):4451244531.
  37. Palmer BW, Cassidy EL, Dunn LB, Spira AP, Sheikh JI. Effective use of consent forms and interactive questions in the consent process. IRB 2008;30:812.
  38. Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA 2004;292:15931601.
  39. De Vries R, Stanczyk A, Wall IF, Uhlmann R, Damschroder LJ, Kim SY. Assessing the quality of democratic deliberation: a case study of public deliberation on the ethics of surrogate consent for research. Soc Sci Med 2010;70:18961903.
  40. Kim SY, Wall IF, Stanczyk A, De Vries R. Assessing the public’s views in research ethics controversies: deliberative democracy and bioethics as natural allies. J Empir Res Hum Res Ethics 2009;4:316.
  41. Secko DM, Preto N, Niemeyer S, Burgess MM. Informed consent in biobank research: a deliberative approach to the debate. Soc Sci Med 2009;68:781789.

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  1. Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA

    • Laura M. Beskow,
    • Carrie B. Dombeck,
    • Cole P. Thompson,
    • J. Kemp Watson-Ormond &
    • Kevin P. Weinfurt
  2. Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA

    • Laura M. Beskow
  3. Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina, USA

    • Kevin P. Weinfurt

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