Obtaining consent can be multistep process
Here is how it works for one institution
Investigators who spend 15-30 minutes discussing a study and then hand participants an informed-consent paper to sign may be missing the point. Depending on a study’s level of risk and its study population, there probably should be a more thorough and educational approach to obtaining informed-consent, and this is especially true of studies where research subjects have mental health issues.
Research participants need to understand the purpose of procedures, the risks and benefits, have an appreciation of how the study might affect them personally, and how they might reasonably make a choice, says Paul B. Gold, PhD, assistant professor of psychiatry in the department of psychiatry and behavioral sciences for the Medical University of South Carolina (MUSC) in Charleston, SC. (See Informed Consent Checklist: Click here.) Gold, who is a primary reviewer for the MUSC IRB, under the Office of Research Integrity, provides this example and these guidelines to obtaining informed consent through a comprehensive and multistep process:
1. Know the study’s target population.
Gold offers an example of a study involving a population with potential decisional capacity problems. It’s a randomized clinical trial at the Institute of Community Living (ICL) in Charleston that involves vocational rehabilitation interventions used on persons with co-occurring severe substance-use disorders and mental illnesses, including DSM-IV-defined schizophrenia and mood-spectrum illnesses.
2. Set inclusion/exclusion and other enrollment criteria.
Subjects are excluded from the ICL study if they have an acute and severe episode of substance use/withdrawal and/or mental illness. Subjects having an acute and severe episode may later be included in the study with the resolution of their acute illness episode. Subjects who meet the enrollment criteria will be considered for study enrollment only upon completion of 60 days of treatment after initial intake, focused on initial stabilization of their illnesses. The research study coordinator, who has a doctorate in psychology, will inform potential subjects of the study’s purpose, procedures, risk, and magnitude of harms and benefits, alternatives, and other matters.
3. Interview potential subjects.
The research study coordinator of the ICL study will informally assess each client’s capacity to consent along four dimensions: understanding, appreciation, reasoning about risks and benefits of participation, and expressing a clear and unmistakably voluntary choice. Then the research study coordinator will ask clients to summarize the study’s aims and procedures and to articulate their own assessment of the risk/benefit balance of the study as it applies to them personally. They also are asked to indicate if they feel any pressure to volunteer.
"The only way I can get a grip on it is by asking them questions," Gold says of how he typically handles that role. "I have to ask them to summarize for me what I just talked about or, in their own words, tell me what are the potential harms of the study and what we are doing to try to protect them against those harms."
Once Gold has completed the consent discussion, he asks the person what he or she thinks and what are the pros and cons of participating in the study. "I have to rely on my clinical intuition because someone can comprehend and understand and reason quite well, but not be able to give a real personal decision," Gold explains. "People who are catastrophically depressed and who have their wits about them but who don’t care what happens to them should never be enrolled in a study even though they can tell you exactly what’s going on."
4. Decide whether the subject has decisional capacity.
If the research study coordinator doubts that a potential subject’s consent is both informed and voluntary, the coordinator will defer enrollment and ask that the client take extra time to consider. If the research study coordinator believes capacity to consent may be compromised, the coordinator will request an independent clinician to undertake a formal assessment of capacity to consent, using the MacCAT-CR, which typically takes about 20 minutes.
"I’d have the MacCAT administered on a different day, because at this point, the person has sat through an hour to 90 minutes of discussion, and that’s fatiguing," Gold notes. The MacCAT-CR has various questions that the clinician will ask the participant, and the answers are recorded and scored. If the participant’s score is above a certain threshold, then the study coordinator can be more confident that the person has decisional capacity, Gold says.
5. Document the process and findings.
The entire informed consent process will be described in detail by the research study coordinator in an addendum that is attached to the consent document and is stored in each subject’s consent file. The MacCAT-CR assessment would be included with the documentation.
6. Follow up and monitor subjects’ decisional capacity.
After the baseline informed consent process is completed, clients of the ICL study will be encouraged to attend a research induction group meeting held twice a week. These meetings will feature the research study coordinator discussing the informed consent again and encouraging participants to ask questions and to carefully judge the merits of study participation.
Also, it’s important for investigators to monitor these subjects’ decisional capacity over time, especially when studies last more than a year, Gold says. "Interviewers continue to monitor for capacity anyone we thought at baseline might be at risk of fluctuating into a place where they don’t have capacity; and then if we see trouble, we’ll reevaluate," Gold says.
Over a course of two years, investigators may meet with subjects every six months and assess their decisional capacity at these meetings. Another strategy for monitoring decisional capacity is to ask the providers to notify investigators if they believe any of the subjects may be having problems with their mental illness or substance abuse. "We need a lot of thought and consultation with other professionals about these decisions," Gold says. "It’s hard to keep someone in a study if the person has lost decisional capacity, and it’s difficult to take someone out if they want to stay in because that’s also a violation of their autonomy. These are not cut-and-dried issues."
Finally, if investigators and the IRB are in doubt, the subject will be given the MacCAT-CR test.
6. Audit informed consent discussions.
With the ICL study, Gold will evaluate a random sample of 5% of the consent discussions through a combination of in-person observation and a review of audiotaped consent discussions. Research subjects will be given a separate consent form for the audiotaping of the consent discussion, and they will be clearly informed that they may decline the audiotaping and that this refusal will not affect their eligibility for study participation.
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