Consent process honed for mentally challenged
OHRP recognizes and honors the program
In an ideal world, researchers working with mentally ill subjects would be able to present information about their studies in such clear, comprehensive, and organized ways that IRBs could be assured that participants know exactly what to expect. The ideal world has been achieved, or at least as nearly as it has anywhere, at the National Institute of Mental Health (NIMH) in Bethesda, MD.
NIMH created in 1999 a best practices program called CORE (Central Office for Recruitment and Evaluation). CORE was initiated after problems had occurred at several other psychiatric research programs, and NIMH officials wanted to make certain that there would be no similar problems in the NIMH intramural program, says Catherine Roca, MD, deputy clinical director.
Although NIMH primarily administers grants, CORE is part of the intramural, hospital-based program that has ongoing research with patients. There are about 100 protocols that are run at the NIMH clinical center site, and there are both inpatient and outpatient clinics in which all patients are admitted as part of a research protocol, Roca explains.
Another impetus for CORE was the National Bioethics Advisory Commission report on decision-making impairments. The report recommended that for people with mental illness participating in greater than minimal risk protocols there should be a provision for independent capacity assessment, she adds.
"We were trying to figure out how we could best address some of these issues with our subjects," Roca says. "We wanted something protective of patients to make sure they understood what they were signing up for when volunteering for research."
Since CORE was implemented, the NIMH IRB has been more comfortable with approving the most difficult protocols, he says.
"They know there’s somebody objectively monitoring the protocol, and if there are problems, they come back to the clinical director and to the IRB much more quickly," Roca says. "In the past, the IRB may not have heard about problems until they became a huge issue."
Also, CORE staff give feedback to the IRB chair and the clinical director on a regular basis, and the CORE team attends various unit meetings, providing feedback on participants, she says.
"From the standpoint of the IRB, we have been able to find out if there are any protocol violations or to intervene before protocol violations occur, because we have someone who sits in on the IRB and who looks at protocols," Roca says. "It gives the IRB a sense of comfort that there is a number of protections for patients."
Award-winning process
As a result of CORE, the informed consent process now is considered among the best in the nation for dealing with mentally ill subjects, and NIMH received from the Health Improvement Institute of Bethesda, MD, the 2002 Award for Excellence in Human Research Protection last fall because of the CORE program.
Here’s how the CORE program works:
• Set up a recruitment team. Through CORE, trained staff have a number of sessions with subjects, and they remain available to answer telephone inquiries from both participants and people interested in volunteering for a study, Roca says.
"We did this because we felt informed consent begins right when the person first calls," she says. "And we try to explain what the study involves."
Optimally, the person who first had contact with the participant via telephone will be the same staff person who sits down with the volunteer at the time the informed consent document is explained and signed, Roca adds.
"We try, and we can’t always do it with staffing, but we try to have the person who sat in on the informed consent be the same person who touches base with the participant as he or she proceeds through the protocol," Roca says.
There are six full-time CORE representatives, who answer the phone and assist with all inpatient and the outpatient protocols in cases where the IRB has directed consent monitoring. Their caseloads average seven to 10 patients/subjects.
"Not all protocols are monitored because some involve high-functioning folks, and the protocols are low risk," she says.
CORE representatives are clinically competent in psychiatry and have experience in caring for psychiatric patients. They also have backgrounds in research, she says.
"We’ve tried to not have them specialized within any particular branch so they are aware of what’s going on with all different groups and are not affiliated with any one research group," Roca says. "It is really difficult if you are close within a group and you take an unpopular stance."
The representatives receive bioethics training at the NIMH Clinical Center’s bioethics center and through a course taught by the IRB chairman, who has co-authored articles on psychiatric ethics, she says.
Although CORE is labor-intensive, it can easily be reproduced at other hospitals through the use of hospital social workers, Roca suggests.
It would probably be easier for social workers to remain independent, yet knowledgeable about research protocols, she says.
"If you’re a nurse on a particular unit, it can be difficult to buck the system you’re living in," Roca explains. "The social worker goes to the unit but doesn’t live and work there; so if you had a central social work area and had staff trained in bioethics and performing capacity assessments and doing consent monitoring, then you could really implement this anywhere."
• Assess subject’s capacity for decision making in the informed consent process. CORE representatives perform capacity assessments.
NIMH researchers developed a capacity assessment tool based on the MCAT-CR clinical research capacity assessment tool, Roca says. "They took the MCAT-CR tool and used it for capacity assessment for a schizophrenia population, and modified it depending on the protocol."
Typically, a social worker will modify the capacity assessment tool and show it to the principal investigator (PI) and to make certain the PI has hard data with regard to risks and benefits, she says.
"Then we have the IRB chair look at the instrument, as well, to make certain it covers all bases and is administered by the representative who knows the patient best," Roca says. "Two representatives sit in on the dialogue and rate the patient according to the patient’s ability to give informed consent, and they come to a consensus of the patient’s capacity for understanding, and they tell that to the PI."
If the CORE representatives agree that the patient understood the consent process, then the investigator can proceed with the study, she says. "If the consensus is that the patient didn’t understand what he or she was getting into, then the PI cannot proceed with the research."
The PI may ask the CORE representatives to reassess the volunteer after the person is given more information, Roca notes. "They can have them perform a capacity assessment one more time."
Since the program has begun, PIs have gained a better understanding of what constitutes capacity for making informed decisions, and as a result they most often will screen out the volunteers who would not pass the capacity assessment process, she says.
• Monitor study and ongoing informed consent. After the lengthy informed consent and capacity assessment process, the CORE representatives answer participants’ questions and will meet with volunteers about once a week to see how they’re doing and whether they are experiencing any conflicts, Roca says.
For example, a CORE representative might say to a participant, "I heard you have an MRI scheduled for tomorrow. Do you understand what an MRI involves?" she says.
CORE representatives attend team meetings to hear how the participants are doing, and if they hear that someone is not doing as well as hoped they will talk to the PI and express their concerns, she adds. "There may be a point when someone has a lot of symptoms and is very uncomfortable, and so the CORE representative will bring that to the PI’s attention," Roca says.
CORE representatives will check the PI’s plan for intervening in the case of a subject’s difficulty. For instance, maybe the PI will shorten the placebo washout period and get the patient back on active medications, he reports.
"We’ve had very good luck with our PIs," Roca says. "Usually all it takes is talking with somebody about it, but if ever there is a situation where somebody is not being responsive, then we’ll talk with the clinical director because he has the ability to take someone out of the protocol."
In an ideal world, researchers working with mentally ill subjects would be able to present information about their studies in such clear, comprehensive, and organized ways that IRBs could be assured that participants know exactly what to expect.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content