This section addresses adults whose ability to understand, appreciate, and weigh the risks and benefits of a study and knowingly give consent to participate is in question. Some may lack this ability from birth while others may inherit it with age. Assessing capacity to consent is not only vital for including these participants in a study but also for treating them with an appropriate level of care and respect.
The rules for including children in a research study are clear: anyone under the legal age for consent must have parental/ legally authorized representative consent. However, the dividing line for determining the capacity to consent for adults with a diminished mental capacity is not as easy to define. The level of risk presented in the study coupled by the capability of the person to understand the risks will vary with each study and study population. For example, an adult with mild dementia may be capable of consenting to a minimal risk survey but may not be capable of consenting to a complex clinical trial. Researchers and the IRB-SBS must walk a careful line in order to protect participants but not to stigmatize them or diminish their capability for participating in a study. This section provides a general guideline for adults where capacity to consent is in question; if you need further assistance, contact our office so that we can better address your specific needs.
Please note that there is additional guidance for abused adults with diminished capacity to consent.
As it is with minors, adults with diminished mental capacity may not have the legal ability to consent. These individuals will likely have a legally authorized representative who will be able to act in the participant’s best interests. However, there may be other participants who still retain the legal right to consent but may not have the cognitive capability to consent. For example, an elderly person may retain the right to consent but may need assistance from a caretaker in order to make the decision to participate. During the consent process, you may need to assess each individual’s needs on a case-by-case basis, part of which may be assessing the participant’s capacity to consent or even to participate.
According to the Code of Virginia, “‘Legally authorized representative’ means, in the following specified order of priority:
- the parent or parents having custody of a prospective subject who is a minor,
- the agent appointed under an advance directive, as defined in § 54.1-2982, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject's participation in human research,
- the legal guardian of a prospective subject,
- the spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final,
- an adult child of the prospective subject,
- a parent of the prospective subject when the subject is an adult,
- an adult brother or sister of the prospective subject or
- any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective subject. This person(s) cannot have any association with the agency conducting the human research.
No official or employee of the institution or agency conducting or authorizing the research shall be qualified to act as a legally authorized representative” (32.1-162.16).
Ultimately, the legally authorized representative should be a person who can act in the best interests of the participant and who can make decisions that are in line with the religious, ethical, and political views of the participant.
The following rules mirror those used for minors and assume that the individual participating requires surrogate consent. For adults with diminished mental capacity, these rules may not always be appropriate and the Board will grant flexibility where justifiable.
- Research is not greater than minimal risk. You are required to obtain permission from the legally authorized representative and assent from the participant.
- Research is greater than minimal risk but presents direct benefit to participant. In order for the Board to approve this study, you must demonstrate that the risk is justified by the anticipated benefit to the participant and the relation of the anticipated benefit to the risk is at least as favorable to the participant as another approach. You are required to obtain permission from the legally authorized representative and assent from the participant.
- Research is greater than minimal risk but will yield generalizable knowledge about disorders or conditions affecting the participant. In order for the Board to approve this study, you must demonstrate that the risk is only a minor increase over minimal risk, the procedure could reasonably occur in the participant’s normal care (i.e. medical, dental, psychological, social, or education situation), and the information gathered from the study will provide valuable information for the participant’s condition or disorder. You are required to obtain permission from the legally authorized representative and assent from the participant.
- Research not otherwise approvable but presents opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of participants with similar disorders or conditions. In order for the Board to approve this study, you must justify that this study presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of participants with similar disorders and the research will be conducted in accordance with sound ethical principles. You are required to obtain permission from the legally authorized representative and assent from the participant.
For some studies, the Board may require that you have a procedure in place to assess the capacity of your participants to consent. In the consent section of the protocol, you will need to describe your procedure for assessing capacity to consent. Depending on the level of risk in the study, the Board may require an independent assessment of capacity. The Board will expect you to develop a procedure that is appropriate for the participants, and they will also expect that you (or a member of your research staff) will have the expertise to assess competency.
Assessing capacity may vary depending on the participants. Often, the participant is questioned or given an examination to determine competency. Capacity can be documented by the participant’s signature on the consent form, or if there is an independent assessment of the participant, a formal note should be included with the participant’s consent form. You will need to provide an instrument that you will use to determine competency. The Mini Mental State Examination, for example, could be used for appropriate participants.
The following list outlines various standards that a participant must meet in order to consent for him or herself.
- The participant has the ability to communicate a yes or no decision. This standard is applicable to all risk/benefit levels.
- The participant has the ability to understand relevant information; the person can tell you what the research procedures involve and what the consent information includes. This standard applies to all risk/benefit levels.
- The participant has the ability to appreciate the situation and its likely consequences. This standard applies to all research involving more than minimal risk.
- The participant has the ability to manipulate information rationally. This standard focuses on process, not outcome. For example, are decisions consistent with the religious, moral, and other beliefs of the person? This standard is critical for the most unfavorable risk/benefit levels.
If the participant does not meet the standard of capacity required for the level of risk in your study, the Board asks that you seek consent from the appropriate legally authorized representative.
Please note that there is additional guidance for abused adults with diminished mental capacity.
Which participants require surrogate consent?
The issue of consent here is similar to that of parent consent/child assent. If an individual is found not competent to legally consent, then a legally authorized individual can provide surrogate consent for the individual. A surrogate is usually a family member, though it could be a state appointed representative as well. If the participant does not have a legal representative and if there is a possibility that the cognitive capacity of the participants could be in question (i.e. elderly population with possibility of dementia), it may be necessary for the researcher to determine a participant’s competency to consent. The Board will expect you to develop a procedure that is appropriate for the participants, and they will also expect that you (or a member of your research staff) will have the expertise to assess competency. You will need to provide an instrument that you will use to determine competency. The Mini Mental State Examination, for example, could be used for appropriate participants.
What forms should I use?
The IRB does not have a specific template for a surrogate consent form, but the Parent Consent/ Minor Assent templates can act as guide. In general the surrogate receives a surrogate version of the consent form, while the participant receives an assent form. Both forms should be written to the reader’s comprehension level. Some participants may not have the capacity to read and sign a form. However, it is generally appropriate to explain to the participant what you are doing and ask if they want to participate.
In some studies, the surrogate may act as a participant in the study as well as allowing the adult with diminished cognitive capacity to participate. If so, it may be necessary to provide a separate consent form document that more clearly explains what the surrogate will do as a participant in the study (although one consent document can usually provide adequate information). Also, if the study requires that you provide additional forms (i.e. materials release forms, debriefing documents), you should provide a surrogate version as well as a participant version.
If you need to determine capacity to consent, please see the Capacity to Consent template. This is a sample document that will help you to develop your capacity assessment procedures.
For some participants, providing them with a written document does little to prepare them to give full consent. However, this does not mean that they are incapable of providing full consent, only that the approach is inefficient. Taking the initiative to enhance the participant’s comprehension may make it possible for a participant to fully consent. For example, consider using other forms of media (i.e. video, photography) to convey the message of the consent form. Involve family members and/or care takers in the process. Talk to the participants and ask them open-ended questions to determine if they understand the consent information. When the participant demonstrates that he or she understands the study, you can then proceed with documenting consent.