When it comes to whole genome sequencing research, consent procedures can be complex, especially for the patient. Some patients could be unaware that their whole genome sequence data might be used in future research without additional consent. To highlight the issue, consider this hypothetical example:
After a painful gallbladder attack, 27-year-old Cindy allowed surgeons to remove her gallbladder. Before the surgery, Cindy read and signed the necessary lengthy consent forms. During surgery, doctors took a blood sample and placed it in the hospital’s stored collection of biological samples. Her de-identified DNA is now available to researchers who have access to that collection.
To determine the type of research consent Cindy signed, we need to look at how researchers structured the consent: Was Cindy required to opt in – to affirmatively choose to allow her data to be used for future research purposes? Or was she required to opt out – a default in which her data is used for future research unless she specifically declines to participate?
If researchers used opt in, Cindy would have been required to consent explicitly to future research. In opt in consent the default is to prohibit the researcher’s use of the samples without an individual’s active consent. If instead researchers obtained opt out consent, the default would be that researchers could use Cindy’s samples in future research. In this type of consent, at the time researchers collected the samples, Cindy must have specifically refused to participate in future research, or her samples could be used in this manner.
In some contexts, it might be more advantageous to use a consent process that makes it easier for individuals to participate. For example, organ donation policies in Europe, which uses an opt out consent model, have donation rates over 99 percent, as opposed to a 44 percent donation rate in the United States, which uses an opt in model. Although the Commission recognizes the substantial public benefit of widespread participation in whole genome sequencing research, the Commission firmly believes that the most important issue in respecting persons is not the type of consent obtained, but rather that the consent is properly informed and consistent with voluntary choice.
In Privacy and Progress in Whole Genome Sequencing, the Commission recommends the evaluation and adoption of “robust and workable consent processes that allow research participants, patients, and others to understand who has access to their whole genome sequences.” The Commission believes that as long as an individual is fully informed in the consent process, and as long as the process does not overly influence an individual’s ability to make genuine and voluntary choices, there is no ethical imperative to use opt in or opt out consent.
