Home Ethical Issues Informed Consent Opting In/Out

Opting in/opting out

Opting in describes the standard requirement of informed consent in both the research and clinical setting. This means a person must affirmatively choose to agree to participate in an activity.

Opting out is a practice that presumes consent. An individual who refuses to be a participant in research or to be a tissue or organ donor must act to make his/her refusal known (usually by filling out and signing an opting out form). Opting out is sometimes referred to as universal consent. Repositories (e.g. deCode Genetics, in Iceland) collaborating with countries for large-scale, geographically based collections may practice universal consent. Universal consent along with the commercial aspect of deCode Genetics, has made it controversial in Iceland. U.S. regulations prohibit opting out procedures in human subject research and human organ and tissue donation.

Ethicists deliberate about a moral preference between opting in and opting out. Part of the debate involves the degree to which particular ethicists value collective responsibility over individual autonomy. For instance, an early report, TAWG (2002), advocated for some form of universal consent in order to increase tissue supply, "Broader, perhaps universal, informed consent agreements need to be explored;" and "A cultural paradigm shift may be necessary within IRBs, advocacy groups, and patient populations (reference the Swedish system of universal consent that benefits the social and scientific greater-good)." Even if some ethicists might find that community obligations favor universal consent (e.g., imagine the benefits to potential organ recipients if we had universal consent for postmortem kidney, liver and heart donation for transplantation), others believe that their freedom is compromised when their consent is presumed.