To determine how informed consent is obtained from subjects, the IRB evaluates the investigator’s process of determining “consent capacity, which describes the participant’s ability to understand information relevant to making an informed, voluntary decision to participate in research. Key information reviewed include the purpose of the study, its experimental nature, risks and anticipated benefits, the right to withdraw, alternatives to participation, confidentiality protections, and the safeguards used to minimize risks.
Investigators may propose involving subjects who may not have the capacity to understand the intent of a study or make a meaningful decision to participate. These are persons that may have an identified “cognitive impairment.“ These impairments may include mental disabilities, such as those with a diagnosed psychosis, Alzheimer’s disease or other cognitive disorders. Additional impairments may be a consequence of pain, anxiety or confusion. Persons with these conditions would be considered vulnerable but do retain the capacity to consent, with investigators respecting them as autonomous individuals. Protocol procedures and consent processes must have adequate safeguards to protect a participant’s rights as a human research subject. A protocol must also address how an investigator determines a subject’s decisional capacity in light of these impairments.
The IRB uses sections of the federal regulations ([45 CFR 46.111(a)(3)] to approve a study only when it determines that informed consent will be sought from each prospective subject and that subjects who are considered “vulnerable to coercion or undue influence, such as …mentally disabled persons”, that a study include additional safeguards to minimize risks. Additional federal regulations (45 CFR 46.102(7)(i)) specify the need for an individual authorized, under applicable law, to consent on behalf of a prospective vulnerable subject for that person to participate in procedure(s) involved in the research. That person is considered a “Legally Authorized Representative” or LAR. The IRB also considers elements of Maryland’s 1993 Health Care Decisions Act in the review of a consent document to determine when and where a person, acting as a health care agent can make health care decision-making authority for participants.
How to Assess Decisional Capacity
Investigators must describe in an IRB application how a participant are assessed on their abilities to understand and to express a reasoned choice concerning the nature of the research and the information relevant to participation, the consequences of participation and the consequences of the alternatives to participation.
The IRB recommends using the tools described in Enrolling Individuals With Cognitive Impairments and Assessing Decisional Capacity from the University of California, San Francisco.
To provide final approval, the IRB will determine that:
- protocols do not arbitrarily exclude cognitively impaired subjects if they might be able to give informed consent
- protocols involving subjects with cognitive impairment can only be approved if justified and appropriate additional safeguards are in place
- an additional safeguard for this vulnerable subject population is assessment of decisional capacity, and
- if adequate decisional capacity is not found upon assessment, the investigator justify why a prospective subject should be excluded from the study or seek consent from a LAR for their participation.
Extracted from the University of California, San Francisco IRB web site
Consent forms are provided to participants at the time the consent conversation begins by the person actually administering consent, attesting to the informed consent conversation. The UMBC Office of Research Protections and Compliance assigns an IRB protocol number as well a “valid through” (or “end”) date indicating the end of the IRB approval period; this will appear at the bottom of all pages of the UMBC assent form.
Obtaining and documenting informed consent is required for all participants in a research project. As a general rule, investigators must:
- Provide “key information” to participants essential to decision making;
- Present informed consent information in sufficient detail and in a way that helps with participant comprehension, not just running down a list of risks and procedures;
- Provide a copy of the consent form to the participant and/or legal representative;
- Keep a copy of the consent form for the approved protocol file
- Seek consent only if the potential participant has the decisional capacity to give consent; if not, consent must be obtained by a legal representative;
- Obtain parental permission for minor participants;
- Provide sufficient opportunity to the potential participant or legal representative to consider whether or not to participate;
- Ensure that the possibility of coercion or undue influence is absent;
- Enhance each participant’s comprehension of the information; and
- Utilize a consent form appropriate to the age level.
Choose the below to submit with your IRB application:
Research Adult Assent template
Legally Authorized Representative (LAR) Consent template
return to consent and assent guidelines