Legally Incompetent Subjects in Research

The following information is provided to investigators to assist in the recruitment of subjects to participate in research activities who are incompetent to provide informed consent or whose competence to provide informed consent is in question.

Enrollment of incompetent subjects:
When the Human Subjects Review Committees (HSRC) have approved the enrollment of subjects who have been declared legally incompetent, or who are incapable of providing informed consent, investigators must comply with federal and state regulations and university policy on obtaining consent.

By state statute (RCW 7.70.065), consent may be provided on behalf of the legally incompetent subject by

• the appointed guardian
• the person to whom the subject has given a durable power of attorney including the authority to make health care decisions
• the subject's spouse or state-registered domestic partner
• the adult children of the subject
• the parents of the subject, or
• the adult siblings of the subject, in that order of priority.

If the researcher is unable, after a reasonable effort. to locate and secure consent from a competent person in the first or succeeding class, authorization may be provided by any competent person in the next class in order of descending priority. However, no person may provide consent

• (a) if a person of higher priority has refused to give such consent; or
• (b) if there are two or more available individuals in the same class who disagree about the decision.

Waiver of consent
If none of the above persons are available to provide consent, federal regulation (45 CFR 46.116) allows an investigator to enroll an incompetent subject in a research protocol if the Committee has determines that:

• (a) the research involves no more than minimal risk to the subject;
• (b) the waiver will not adversely affect the subject's rights and welfare;
• (c) the research could not be practicably carried out without the waiver;
• (d) whenever appropriate, subjects will be provided with additional pertinent information after participation.

In addition, federal regulation (21 CFR 50.23) states that if a researcher seeks a waiver of consent for research involving medical treatment or the use of an investigational drug or device, both the investigator and a physician who is not otherwise participating in the clinical investigation must certify in writing all of the following:

• The human subject is confronted by a life-threatening situation necessitating the use of the test article.
• Informed consent cannot be obtained from the subject because of an inability to communicate with or obtain legally effective consent from, the subject.
• Time is not sufficient to obtain consent from the subject's legal representative.
• There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

Enrollment of subjects whose competence is in question -- use of subject advocates:
An investigator may question the competence of a subject who has agreed to participate in the research but who has not been declared incompetent (for example, a subject in the early stages of Alzheimer's Disease, or one who has been sedated). In this case, to protect both the subject and the investigator, a subject advocate should be involved in the consent process.

The desire of the subject to participate should first be ascertained. Any indication on the part of the subject that he or she is not willing to participate must be honored. The subject advocate should be fully informed about the research and be able to attest to the subject's understanding of the research. A subject advocate should be a party to the oral explanation of the research given to the subject and should be involved, insofar as practicable, throughout the duration of the subject's participation in the research.

Investigators should be aware that the subject advocate is not a legal representative and may not provide consent on behalf of the subject. If the investigator finds the subject clearly lacks sufficient understanding or judgment to provide informed consent, the subject may not be enrolled without the consent of the person legally authorized to provide consent on behalf of the subject.

Any questions about the appropriate procedures for enrolling incompetent subjects or subjects whose competence is questionable, should be referred to the Human Subjects Division at 543-0098.