Individuals with reduced decision-making capacity require special protections. Investigators may decide to exclude or include them from their research. This section is intended to provide researchers with guidance to cover both situations.
All adults (including those with cognitive impairment) should be presumed able to provide consent unless there is a reasonable and sufficient indication to suggest otherwise. Cognitive impairment is not limited to a specific disease or medical condition and may result from a psychiatric, organic, developmental or other disorder that affects cognitive or emotional functions, or from the effect of drugs or alcohol. The impairment may be temporary, permanent, or may fluctuate. Inclusion of subjects with cognitive impairment presents a risk that their current mental state may compromise their capacity to make a reasoned decision about participation in a research study. Decision-making capacity should not be determined by a patient’s diagnosis or membership in a particular group, but by characteristics unique to that person and the context and complexity of the proposed research.
Deciding to Include/Exclude Subjects with Reduced Capacity in Research
Investigators must carefully consider whether to include or exclude individuals who have reduced decision-making capability, or who might develop reduced capabilities during a study. In research, such as longitudinal studies, investigators must also consider whether or not to remove a subject from the study if they become decisionally impaired.
COUHES may consider the inclusion of individuals with reduced decision-making capacity in research studies if:
1. The research bears a direct relationship to the individual’s condition or circumstance, and;
2. The research meets one of the following:
- Presents no greater than minimal risk;
- Presents an increase over minimal risk, but offers the potential for direct benefit to the subject;
- Presents a minor increase over minimal risk to the subject, and does not have the potential for direct individual benefit, provided that the knowledge sought has direct relevance for understanding or eventually alleviating the subject’s disorder or condition.
If an investigator cannot meet this threshold COUHES will exclude individuals with reduced decision-making capacity from human subjects research.
When submitting a COUHES application, the Principal Investigator should include:
- Why inclusion of individuals with reduced decision-making capacity is essential to the purpose of the research.
- How the ability to consent will be assessed prior to participation. Make sure to include qualifications of personnel doing the assessment and the method/tools to be used in the assessment.
- How the consent and assent process will prevent undue influence and coercion.
- Whether surrogate consent provided via Legally Authorized Representative (LAR) will be obtained in cases of diminished capacity, and how a specific LAR will be identified.
- Whether the study population is expected to include persons whose decision-making capacity may fluctuate during the course of the research, a description of plans for assessing decision-making capacity over time and obtaining re-consent from the LAR and/or subject to continue in the research when appropriate.
Assessing Decision-Making Capacity in Subjects
The process of assessing decision-making capacity is protocol specific. This assessment should take into consideration the study risk level, the vulnerability of the study population, the complexity and the context of the proposed research. Research involving greater than minimal risk, inclusion of vulnerable populations or a complex study design may require additional assessment, and in some cases, it may be necessary to re-assess capacity at multiple points throughout the study. Investigators must ensure that subjects not only comprehend the information provided, but also use reasoned logic in order to weigh the decision to voluntarily participate or not. Common standards that a subject should meet in order to consent for themselves include:
- The subject is able to communicate a yes or no decision.
- The participant is able to comprehend relevant study details and can recount what the consent form and study procedures include.
- The participant has the ability to appreciate the situation and its likely consequences.
- The participant has the ability to manipulate information rationally.
Individuals assessing capacity and obtaining consent should be qualified to assess capacity. COUHES will consider their qualifications prior to the start of research.
Examples of methods to assess capacity include:
- A pre-participation open-ended discussion/quiz documenting an individual’s knowledge of critical elements in the consent process
- Standardized and validated instruments tailored to the specific study protocol;
- Clinician certification/clearance for participating in a research study; or
- Alternatives methods developed by the researcher and approved by COUHES for their specific protocols.
Obtaining Informed Consent and Assent
Informed consent is designed to ensure study subjects understand what they are being asked to do and that they are voluntarily agreeing to do it. The informed consent process goes beyond obtaining a signature. As such, investigators must describe all elements of the consent form to potential subjects, and, where appropriate, LARs including clear information on the purpose, procedures, requirements, potential risks and other relevant information associated with participation in a study.
Prospective subjects should be given sufficient time to consider the research and ask questions. To increase the subject’s comprehension of the research, communications should occur close to the start of the research.
Continued assessment of a subject’s comprehension and willingness to continue participating in the research is essential. Investigators and surrogates, where applicable, must continuously assess a subject’s comprehension throughout the research. If decision-making capacity may fluctuate over time, re-consent/assent should be obtained from the subject and their LAR to continue in the research.
In addition to LAR consent, subject assent is required. Assent is characterized by affirmative agreement to participate in research and can be obtained verbally or written depending on the context of the research. Failure to object does not qualify as assent. If the subject objects at any time to continuing in the research, this objection must be respected.
- In cases where the cognitively impaired subject is determined to have decision-making capacity to consent, he/she should sign the informed consent document.
- In cases where the cognitively impaired subject is determined to have some decision-making capacity, informed consent must be obtained from a LAR while assent must be obtained from the subject.
- In cases where the cognitively impaired subject is determined not to have decision-making capacity to consent, informed consent must be obtained from the LAR. Note: In these rare cases, COUHES will, in discussion with the PI and investigator, determine if a LAR appropriate.
Who can qualify as a Legally Authorized Representative (LAR)?
When it is determined that a research subject is cognitively impaired, Federal regulations permit researchers to obtain surrogate consent from a LAR.
“Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective participant to the participant’s participation in the procedure(s) involved in the research. 45CFR.46.102(i).”
Research Conducted in Massachusetts
Where investigators are conducting research with individuals with reduced decision-making capacity within Massachusetts the order of priority for seeking informed consent is as follows:
- Agent named in the potential subject’s advanced health care directive;
- Conservator or legal guardian;
- Spouse or domestic partner, unless an action for divorce is pending, and the adult children of the principal are not the children of the spouse;
- Adult child;
- A parent (natural or adoptive);
- Adult sibling;
- Adult grandchild
Research Conducted Outside of Massachusetts
Because the definition of LAR varies widely by state, investigator conducting research outside Massachusetts must consult with the Office of the General Counsel to determine the appropriate LAR for each site: https://ogc.mit.edu/contact .
For research conducted online, investigator must follow the local law where the subject is physically residing to determine the appropriate LAR.