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

Publication ,  Journal Article
Beskow, LM; Dombeck, CB; Thompson, CP; Watson-Ormond, JK; Weinfurt, KP
Published in: Genet Med
March 2015

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

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Published In

Genet Med

DOI

EISSN

1530-0366

Publication Date

March 2015

Volume

17

Issue

3

Start / End Page

226 / 233

Location

United States

Related Subject Headings

  • Practice Guidelines as Topic
  • Middle Aged
  • Male
  • Informed Consent
  • Humans
  • Genetics & Heredity
  • Female
  • Comprehension
  • Biomedical Research
  • Biological Specimen Banks
 

Citation

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Chicago
ICMJE
MLA
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Beskow, L. M., Dombeck, C. B., Thompson, C. P., Watson-Ormond, J. K., & Weinfurt, K. P. (2015). Informed consent for biobanking: consensus-based guidelines for adequate comprehension. Genet Med, 17(3), 226–233. https://doi.org/10.1038/gim.2014.102
Beskow, Laura M., Carrie B. Dombeck, Cole P. Thompson, J Kemp Watson-Ormond, and Kevin P. Weinfurt. “Informed consent for biobanking: consensus-based guidelines for adequate comprehension.Genet Med 17, no. 3 (March 2015): 226–33. https://doi.org/10.1038/gim.2014.102.
Beskow LM, Dombeck CB, Thompson CP, Watson-Ormond JK, Weinfurt KP. Informed consent for biobanking: consensus-based guidelines for adequate comprehension. Genet Med. 2015 Mar;17(3):226–33.
Beskow, Laura M., et al. “Informed consent for biobanking: consensus-based guidelines for adequate comprehension.Genet Med, vol. 17, no. 3, Mar. 2015, pp. 226–33. Pubmed, doi:10.1038/gim.2014.102.
Beskow LM, Dombeck CB, Thompson CP, Watson-Ormond JK, Weinfurt KP. Informed consent for biobanking: consensus-based guidelines for adequate comprehension. Genet Med. 2015 Mar;17(3):226–233.

Published In

Genet Med

DOI

EISSN

1530-0366

Publication Date

March 2015

Volume

17

Issue

3

Start / End Page

226 / 233

Location

United States

Related Subject Headings

  • Practice Guidelines as Topic
  • Middle Aged
  • Male
  • Informed Consent
  • Humans
  • Genetics & Heredity
  • Female
  • Comprehension
  • Biomedical Research
  • Biological Specimen Banks