HOW TO PRINT To print this page, use your browser's print button. To print the entire document, download the PDF or click here and use your browser's print button. TOOLS & BACKGROUND MATERIALS 45 CFR 46 Subpart D OHRP Guidance on Participation of Cognitively Impaired Persons in Research (1993) FDA Guidance on Assent of Children OHRP Guidance on Participation of Children in Research (1993) NBAC Report on Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity AAP Statement on Informed Consent, Parental Permission, and Assent in Pediatric Practice ACP Statement on Cognitively Impaired Subjects
MAIN POINTS When a potential participant cannot give consent: A legally authorized representative should be appointed to provide consent on the person's behalf Assent should be obtained when possible Tailor assent form and process to the potential participant's capacities and needs. Minors who give their assent to participate in research must be approached for consent when they reach the age of majority, generally age 18.

NIH GUIDELINES: "If the study involves children or persons with impaired decision-making capacity, how will the assent of each person be obtained?"

DISCUSSION
Gene transfer studies may enroll children or cognitively impaired persons if the investigator can provide justification for their participation in the study. In such instances, investigators must obtain permission from the legally authorized representative of the child or cognitively impaired person. Investigators must also obtain the assent of the potential participant when appropriate.

Permission from Legally Authorized Representatives: For potential participants who cannot give consent, investigators must obtain permission from a legally authorized representative of the potential participant. For children, this is usually the parent. For adults, it may be someone designated as health care proxy. The permission process should include instruction to the parents and/or legally authorized representatives regarding the difference between permission for treatment and permission for research participation. Legal counsel should be consulted to determine who is permitted to act as a legally authorized representative for research enrollment in the state(s) in which participants will be enrolled. It should be noted that authority for treatment decision-making does not always extend to decision-making about research participation.

Cognitively Impaired: If a potential participant is cognitively impaired and judged to be incapable of giving consent, the potential participant must still be asked and agree to participate in the study even though he or she may not fully understand its purpose, benefits, and risks - unless the impairment completely precludes any meaningful communication. The investigator should follow institutional guidelines for obtaining assent and addressing dissent from cognitively impaired individuals.

Minors: Investigators should follow Federal regulations, namely, 45 CFR 46 Subpart D and FDA guidance on assent of children for enrolling minors (generally children under age 18) in research. Investigators should obtain parental permission, and the assent of the minor when appropriate. In addition, investigators should plan how dissent from minors should be addressed - a determination that is specific both to the age of the child and the design and purpose of the study. Information should be appropriate for the developmental age of the child. It is generally a good idea to approach individuals who assented to participate in research as a minor once they reach the age of majority for either continued participation in the study or continuation of long-term follow-up.