Gathering informed consent from participants is a pillar of biobanking. As ambitious biobanking projects such as All of US and UK biobank proliferate and become ever larger, the benefits and the potential risks for participants also grow. It is therefore critical to communicate the risk/benefit ratio in as clear a way as possible when soliciting consent from biobank volunteers.
Kathleen M. Brelsford of the Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, USA, and colleagues created model consent language drawing on results from a long-standing biobanking consent research program aimed at boosting precision medicine research by keeping participants safe. A survey of 32 Nashville, Tennessee, residents was conducted including questions regarding what information about biobanking they found especially reassuring or concerning, among others. The results were published in the journal BMC Medical Research Methodology.
Model consent language was developed by the researchers for a simulated “Million American Study,” based on best practice guidelines for biobanking, US federal regulations (45 CFR 46.116) and extensive primary research.
The participants were asked for their opinions on the contents of the 215 sentence model consent form. Direct quotations are provided in the paper on the following topics:
- Sentences highlighted as reassuring
- Central storage
- Restricted access to identifiers
- Use of stored materials for research
- Public-access database
- Controlled-access database
- Sentences highlighted as concerning
- Objectionable use
- Non-research use
- Changing socio-political landscape
- Willingness to participate
- Helpfulness of values questions
Around 60–68% of the participants responded favourably overall to the consent model. In general the participants were most reassured by biobank stated aims regarding improving health and maintaining privacy, and were most concerned about potential for use by law enforcement, insurers and employers not covered by GINA; and also the use of medical record information in general.
The study is limited by a small sample size, and the fact the participants knew they were commenting on a hypothetical biobank project consent process.
“Our study contributes to efforts to improve informed consent for genomic and precision medicine research, much of which entails the collection and analysis of multidimensional data and value-laden risks and benefits for participants, families, and communities,” concluded the authors.