In the process of conducting research for a project, I have recently encountered “opt-out” provisions in two separate contexts: medical research and organ donation. An opt-out provision presents a situation where consent is assumed, and in order to not participate in the research/procedure/donation an individual must take active steps to refuse consent. This stands in stark contrast with informed consent where before any type of procedure is done, the patient (or donor/donor’s next of kin) must affirmatively agree to any type of procedure being done to him/her. The National Institutes of Heath defines informed consent to mean “You are informed: you have received information about your health condition and treatment options. You understand your health condition and treatment options.You are able to decide what health care treatment you want to receive and give your consent to receive it.”(see here). Informed consent is the standard in the United States for both research and treatment. Beyond being just an example of the value placed on autonomy in the United States, it is our response to past harms and proactive approach to prevent exploitations of people in the future (think of the Tuskegee experience, for example).
So why are opt-out provisions even being considered? In both of the spaces where I have seen opt-out provisions being implemented (see this article) or proposed (see this article regarding a bill in Vermont), the commonality seems to be an extreme need and not enough resources to meet it. However, despite the extreme need, I believe we can come up with solutions that are not at the expense of informed consent.
I believe we need to be very cautious about adopting opt-out provisions. While I understand the need to find a creative approach to meet a need where there is a major lack of resources, I think that opt-out provisions present many other, and potentially more serious, concerns. What are your thoughts on opt-out provisions? Can you think of situation where they have been used in an ethical manner? Can you think of other creative approaches to dealing with meeting a lack of resources that maintains the standard of informed consent? I’m interested to learn more about your interactions with consent in an opt-out format.