Minority research: Engage community and think risk
Experts discuss the key concerns
When IRB members and investigators discuss potential risks and benefits, they typically break down the benefits into two categories: individual and societal. But there is a third category that should be considered for some research projects: community.
Potential community risks and benefits are a very important consideration when a research protocol is being conducted in an area inhabited by a particular culture or ethnic group. It’s up to the investigator to work with the community’s leadership to discuss potential risks and benefits before seeking research volunteers, says William L. Freeman, MD, MPH, CIP, director of Tribal Community Health Programs at Northwest Indian College in Bellingham, WA. He recently spoke about informed consent in communities of color at the 2002 Annual IRB Conference, sponsored by the Boston-based organizations, Public Responsibility in Medicine & Research (PRIM&R) and the Applied Research Ethics National Association (ARENA) in San Diego.
Sometimes investigators will fail to identify a community as such and then fail to give any consideration to their responsibility to the community.
"The biggest problem is taking the community plain and cheap," says Warren K. Ashe, PhD, executive secretary of the Howard University IRB and associate dean for research at Howard University in Washington, DC. He also spoke about informed consent in communities of color at the PRIM&R conference.
"They assume they can go in and leave without doing anything for the community," Ashe says. "In a minority community, investigators will come in and drain the community of its resources, publish a paper, and leave nothing showing they’ve been there." That attitude leaves the community with a distrust for research, making it difficult for the next investigator to enter that community and obtain cooperation, Ashe adds.
Freeman and Ashe offer these suggestions for how an IRB can be certain that research protocols give fair consideration to a community and include some of these considerations in the informed consent:
• Consider the potential harm of stigma. For example, an investigation into an outbreak of syphilis at an Native American reservation resulted in a published report that included enough information that it was easy for the public in the same area as the reservation to identify the reservation, Freeman says.
"Then that information got into the public press around the reservation where there was a fair amount of prejudice in the non-Indian community," he says. "The entire community was stigmatized because of the report."
The stigma resulted in public segregation where gas station owners wouldn’t allow Native American customers to use the restrooms, Freeman adds.
"This was an unintended harm of research, but nonetheless a harm to the group," he says.
A way to prevent this harmful consequence is to engage a community member into the IRB or research process, Freeman suggests.
• Have researchers meet with community leaders. When researchers study HIV/AIDS, they will think nothing of meeting with the HIV/AIDS subgroups, such as the injection drug users, middle-class homosexuals, and female drug users, Freeman notes.
In other words, it’s standard practice to engage all of the stakeholders in a particular research, and investigators have no trouble understanding this when the stakeholders are people infected with HIV, Freeman says.
Yet, when it comes to communities of color, researchers will say they don’t know how to engage the stakeholders and they may balk at spending time doing so, Freeman says.
It’s not that difficult, however. It can be handled by having researchers attend community meetings, hold focus groups, and meet with people who represent the research area of concern, Freeman says.
In Native American communities, it might suffice to meet with the tribal leaders and to seek their approval.
In African-American communities, investigators should meet with religious organizations and cultivate a relationship with them, Ashe says.
"People in science have to come out of their ivory tower and go out and talk with real people," he says. "They need to share information, ask questions, and be open about it."
• Include a minority community member on IRB. Communities of color need an advocate on the IRB, someone who will think to ask questions that may not occur to other IRB members, Ashe says.
While IRBs do include community members, they often are highly educated people who are not in touch with the portion of the community being engaged as research volunteers, he says.
"In our IRB, we have two community laypeople," Ashe says. "One is a lawyer who is very much involved with child welfare, and the other is a retired school teacher who was a former president of civic organizations in Washington, and this man brought to the table an understanding of the community that very few people would have." That’s the kind of IRB community member who is needed, Ashe adds.
• Discourage misuse of information. "One concern that probably affects not just American Indian tribal communities, but others as well is that of private knowledge," Freeman says. "In the past the complaint has been that anthropologists spoke to the people, who didn’t understand that what they were saying was going to be published in a book."
So research subjects would discuss cultural beliefs and understandings that were intended to be kept private within the community, he adds.
To prevent misunderstandings of this type and the misuse of community knowledge, an informed consent process should make it clear how and where the investigator will use the collected information.
• Make certain informed consent is written according to community’s cultural understanding. Informed consent documents should be written in clear, readable, layperson language, but this is just a start.
It’s important for researchers to identify potential misunderstandings due to differences in how a particular community might interpret words based on their own frame of reference.
For example, Ashe says his IRB once approved a research project in which an investigator would give a pen-and-pencil IQ test to children in an upper-class area of Washington, DC.
"Unknown to the IRB, the investigator decided to go to the other extreme and administer the same test to children in a low-income community," he says.
The investigator visited the school, explained that these were IQ tests, and asked that parents contact the IRB if they had any questions.
One night, Ashe was called by a angry mother who asked, "What did you people at Howard do to my child with all these tests?"
The woman assumed that when she was told her child was given a test that it meant a health exam in which the child’s blood was drawn, he explains.
"In her mind, a test was something physical," Ashe says. "That’s a cultural difference in how the woman didn’t know that an IQ test is not like an HIV screening."
The researcher’s project was halted because the investigator failed to seek approval from the IRB for the study’s expansion and, as a result, no one was able to explain to the investigator that a different sort of informed consent would need to be created for that very different community.
"We would have recommended that she revise the consent form and make it more relevant to that population," Ashe says.
• Provide community benefits whenever possible. When investigators use a community for research, it’s good form to provide some sort of benefit in return, Freeman and Ashe say.
This benefit could be as simple as providing the community with information about the study’s results or some education and interventions for helping people who have whatever disease or problem is being investigated.
"I think of research as a gift and [subjects] have given a gift to researchers. It would seem to be appropriate for researchers to reciprocate," Freeman says. "To simply go in and find out there’s a public health problem and then to leave under those circumstances would make me very upset."
Taken to a higher level, investigators can help the community obtain services that otherwise might not be available, Ashe says.
For instance, in one community in which investigators wanted to conduct ongoing research about arthritis and related diseases, research officials obtained a federal grant to build a community clinic where anyone could receive treatment and medication. The people who sought help at the clinic could volunteer for research trials, but were not required to do so, he says.
This type of benefit quickly built up good will in the community and resulted in a steady supply of research subjects for investigators.
"To me it’s very simple," Ashe says. "I believe in respecting the rights of every individual."
When IRB members and investigators discuss potential risks and benefits, they typically break down the benefits into two categories: individual and societal. But there is a third category that should be considered for some research projects: community.
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