Under what conditions can researchers enroll individuals who lack the capacity to consent?

Enrolling individuals who lack the capacity to consent requires careful consideration of ethical and regulatory guidelines. When there are direct benefits to the research participants, and appropriate safeguards are established to protect their welfare, it creates a situation where their enrollment can be justified. This is rooted in the ethical principle of beneficence, which emphasizes the importance of maximally promoting well-being and minimizing harm.

In circumstances where the research provides direct benefits to the participants, researchers are more likely to justify the inclusion of those unable to provide consent themselves. Safeguards may include oversight by an ethics review board, informed consent from legal guardians or surrogate decision-makers, and continuous monitoring of the participants’ welfare throughout the study.

While obtaining approval from guardians may be a part of the process, it does not, by itself, ensure that the ethical standards are met for the protection of individuals lacking capacity. Similarly, claiming that no other participants are available or deeming a study low risk are insufficient grounds for enrolling individuals who cannot consent, as these options do not adequately consider the potential impacts on the participants' rights and welfare. The combination of direct benefits and appropriate safeguards ensures that participation is both ethical and responsible.