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Human Subjects Division (HSD)


Individuals Incapable of Consenting

Individuals who are declared legally incompetent or who are physically or mentally incapable of providing informed consent should not be recruited to participate in human subjects research, unless the research may directly benefit the population represented and the research cannot otherwise be performed on legally competent persons.

When the Institutional Review Board (IRB) does approve recruitment and participation of subjects who cannot provide informed consent, researchers must obtain informed consent from a guardian or legally authorized representative of the subject in accordance with applicable law. In addition, the researcher must also obtain the assent of the subject, when that subject is able to give assent to decisions made on his or her behalf. Any indication on the part of the subject that he or she is not willing to participate in the research should be honored.

In cases where there is reason to question the competence of a subject who has not been declared incompetent (for example, a subject in the early stages of Alzheimer’s Disease), a subject advocate should be involved in the consent process and throughout the duration of the subject’s participation in the research.

Change Notes

  • Noted 09/01/2010 @ 06:04pm
    Keyword newly added.
    - pmcclure

Related Questions And Answers

  • What is Informed Consent?

    As it relates to the conduct of research within safe and ethical guidelines, informed consent is a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in the research described. In giving informed consent, research subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy; 21 CFR 50.20 and 50.251].

    There are a very few instances in which the requirement to obtain informed consent or in which written documentation of consent might be waived. These might include, for example:

    • Instances in which an investigational drug or device might be used in an emergency situation, the circumstances of which make obtaining informed consent impossible.
    • Research in which information about a potentially illegal activity is being collected and the informed consent could, in and of itself, pose a risk to participants of identification and arrest.
    • In cases where the requirement for informed consent or for written consent is waived, additional protections for research subjects are considered and typically included in the research procedures.
  • Who should be listed on consent forms?

    The principal investigator should always be identified on the consent form. Also listed should be the name and phone number of the contact person for research subjects.