Research project developed active, engaged consumer advisory board

CAB helped with recruitment, IC issues

When a Boston, MA, research team decided to study HIV/AIDS prevention among the mentally ill, a group that is particularly vulnerable to infection with the disease, they had to ensure their research volunteers were recruited with appropriate privacy safeguards and thoroughly understood their research participation.

"We're targeting a population of people who by the nature of psychiatric disorder are vulnerable, and we're targeting the prevention of a disease where there's a lot of stigma," explains Stephen Brady, PhD, an associate professor of psychiatry and graduate medical sciences and the director of the mental health and behavioral medicine program at Boston University School of Medicine in Boston. Brady is the principal investigator of the study on HIV prevention with the mentally ill.

So investigators created a consumer advisory board (CAB), which along with the IRB, provided guidance in recruitment and informed consent.

"The consumer advisory group was our idea, and it was encouraged by the National Institute of Mental Health," Brady says. "You don't have to have a consumer advisory board, but, increasingly, I think CABs are going to become the standard for these kinds of studies."

The CAB consists of 8-10 people, who either have a mental illness, are HIV-positive, or are impacted by these illnesses. Members meet monthly and have contact between sessions, he says.

The board has even assisted research staff with pilot testing the study's assessment instruments, says Jori Berger-Greenstein, PhD, an academic rank assistant professor in the department of psychiatry at Boston University School of Medicine. Berger-Greenstein is the project director of the HIV prevention study.

CAB members were recruited through a consumer advisory group of people with mental illness in Massachusetts and from a center for HIV/AIDS care and research.

"We brought the two groups together to create a unique consumer advisory board," Brady says.

A leaders in advocacy for mental illness aggressively recruited CAB members and even escorted people to the meetings, and HIV/AIDS advocates also were very helpful, he notes.

The board has changed and evolved as some people left the area or their mental illness or disease proved too burdensome, Brady says.

"I've been on other studies and have had experience with other boards," Berger-Greenstein says. "Often it's something researchers do to say they're doing it, but they don't take it very seriously."

Likewise, the people running the CABs often lack active interest in the study and their role, she says.

But the CAB for the mental health and HIV prevention study has been extremely engaged and helpful to the research team, Berger-Greenstein says.

One key has been Brady's active participation.

"It is important to them that the head scientist in the study cares about them and wants to hear from them," Brady says.

"A lot of time people do the boards, and then they aren't given much to do,"" Brady says. "Our board is very active."

For instance, the CAB has helped with interviewing and training direct care staff for the study and vetted subject recruitment materials, Brady says.

CAB members also have helped pilot test the assessment instruments by pretending to be potential subjects and answering instrument questions. They gave researchers feedback on whether an instrument was too long or intrusive, he says.

"They did the initial outreach at various community organizations where they thought there'd be large numbers of people with mental illness and who were at risk for HIV," he adds. "They went to women's shelters and talked to the staff they knew there, or they put up fliers for us, sometimes giving a talk themselves."

The CAB also has helped provide additional safeguards for participants recruited in the trial.

Here are some the ways the research team has ensured maximum human subjects protection:

Protect identities: The IRB required that researchers not identify potential participants by name in the screening process, Brady says.

"We don't identify people by name at all, and we think it is a good idea," he adds.

"We only ask people if they have a mental illness, and we give them a menu of illnesses," Brady explains. "We don't ask them which illness they have, and we don't ask about specific HIV risk behaviors, but give them a menu of behaviors and ask if they've engaged in those."

This way, researchers can gather important screening information without potentially harming the potential participants, he says.

And this is done before people agree to enroll and informed consent is provided.

Do not recruit directly: It's important to many IRBs that researchers do not directly approach potential participants and request their participation, Brady says.

"We can use general advertising, and people can self-refer and providers can self-refer," he adds. "But we don't approach patients directly to solicit their participation."

Instead, researchers relied on referrals and advertising and assistance from the CAB.

Assess participants' understanding of the informed consent language: "We go to great lengths to make sure our informed consent document is detailed, but also we spend a lot of time discussing that with patients," Brady says.

"We ask them questions about what they understood about the study, and we engage in an ongoing dialogue to make sure they understand the particulars of this study," he adds.

Researchers focus on making certain participants understand that their treatment will not be impacted by their participation in the study.

"We want them to know they can get out of the study at any time and change their mind," Brady says.

Investigators evaluate potential participants' appropriateness for being enrolled during the informed consent process, as well, Berger-Greenstein notes.

"When we do informed consent, we have them repeat things back," Berger-Greenstein says. "We're very careful to make sure they're intact enough to participate."

For example, one young woman who wanted to enroll in the study was discovered to be suicidal, so she was referred to a psychiatric emergency room rather than being enrolled in the study, Brady says.

"The welfare of the people we're helping takes precedence," Berger-Greenstein says.

If participants are determined during the informed consent or screening processes to need medical help, they can be referred to nearby services since the research is taking place within a large medical campus, Brady says.

"Another way to look at this safeguard is that we're a full service agency campus that can triage people appropriately if their mental health status is unstable," he adds.