Informed Consent in Biobank Research

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Genetic biobanks, storage facilities for DNA, genetic data and tissue samples, are becoming more prevalent in the rare disease community.   The information and samples can be made available to approved researchers for clinical studies, but unlike clinical trials, there is usually no personal benefit or follow-up provided to participants.  New models for biobank research have altered this paradigm, however, and may include the possibility of contacting participants with information that could be relevant to their healthcare.

The cornerstone of ethical genetics research using data from biobanks is a proper informed consent process that ensures patients and parents understand the potential advantages, limitations, and risks of participation.  A recent study found that parents who consented for their child’s participation in a biobank for congenital cardiovascular malformations did not understand the fine details of how their child’s samples would be used and stored.  Although most parents did understand that participation was voluntary and for research, many thought that the intention was to treat their child’s heart defect.  There was also lack of understanding that their child’s DNA would be stored indefinitely.

Researchers are exploring the use of visual aids and other communications tools to try to improve understanding and obtain true informed consent.  These methods have not been extensively studied in biobanking consent, but clearly there is a need to investigate alternatives to the standard written informed consent form.

Have you consented to participation in a biobank for yourself or your child?

What was the process and how do you think it could be improved?