Obtaining valid consent for the collection and storage of biospecimens and data for future, unspecified research use remains a significant challenge. Numerous studies have documented that research participants in a variety of settings-including biobanking-do not understand important aspects of the research to which they consented. To correct this problem, two major challenges must be overcome. First, there is no consensus on what constitutes 'adequate'understanding in biobanking consent, creating uncertainty about when valid consent has been obtained and hampering efforts to devise and assess interventions to improve comprehension. Second, the overall quality of the evidence concerning the effects of interventions to enhance comprehension is poor. Prior studies have suffered from small sample sizes, non-randomized designs, limitations related to the characteristics of the study population, questions about how 'comprehension'was defined and measured, and a narrow focus on only selected elements of the consent process. Given the ubiquity of biobanking research, there is a critical need to overcome these challenges by defining the threshold of knowledge needed to provide truly informed consent, and developing and rigorously studying interventions to promote comprehension in the context of a complete informed consent process. Our objective for this application is to develop and assess an informed consent process for biobanking that involves a simplified consent form and an interactive test/feedback procedure to enhance comprehension. To achieve this objective, we will pursue the following aims: (1) Systematically determine the threshold of knowledge needed to demonstrate adequate biobanking consent comprehension;(2) Refine a teach-back tool to improve comprehension during the biobanking consent process;(3) Conduct a national, multisite, randomized trial to determine the individual and combined effects of a teach-back intervention and a simplified consent form on comprehension in biobanking consent;(4) Explore the individual and combined effects of a teach-back intervention and a simplified consent form on secondary consent process outcomes. The expected outcomes include a systematically-developed definition of 'adequate'understanding and high quality data demonstrating the effect of improvements to forms and processes on biobanking consent comprehension, as well as model consent forms, teach-back tools, and measures that could be readily adapted for use in any biobanking context.

Public Health Relevance

Many potentially high-impact research initiatives are significantly hindered by the limited availability of high- quality biospecimens and data. Ensuring that valid informed consent is obtained by accurately assessing and promoting comprehension is critical for protecting the rights and welfare of participants as well as preserving the integrity of research involving biobanking. The successful completion of the proposed study will lead to significant improvements in the way informed consent is conducted and evaluated for biobanking research.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Research Project (R01)
Project #
1R01HG006621-01
Application #
8242522
Study Section
Special Emphasis Panel (ZRG1-SEIR-B (01))
Program Officer
Lockhart, Nicole C
Project Start
2012-08-14
Project End
2016-05-31
Budget Start
2012-08-14
Budget End
2013-05-31
Support Year
1
Fiscal Year
2012
Total Cost
$342,711
Indirect Cost
$124,424
Name
Duke University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Beskow, Laura M; Dombeck, Carrie B; Thompson, Cole P et al. (2015) Informed consent for biobanking: consensus-based guidelines for adequate comprehension. Genet Med 17:226-33