Specialized IRB could help community-based studies
Different membership, ethical principles required, argues researcher
Community-based research requires a special type of review, and so should have its own type of review board, one that balances the responsibilities that IRBs have to individuals with an appreciation for the needs of the community in which research is conducted.
That's the proposal of a toxicologist who has conducted environmental community research. Stephen G. Gilbert, PhD, DABT, is director and founder of the Institute of Neurotoxicology and Neurological Disorders, Seattle WA.
Gilbert says his new approach to community-based research in part was prompted by studies he conducted of environmental toxins such as lead and mercury and their role in child development.
He published his proposed community-based research review model in the October issue of the journal Environmental Health Perspectives.
Community-based participatory research, which involves community members in various phases of the planning and execution of studies, brings special challenges for both researchers and those reviewing the proposed research.
It can be difficult to determine who within a community should be included in a project, and how their ideas and concerns should be addressed
"Looking at community-based research is a really different approach than what traditional IRBs are usually focused on," Gilbert says. "You're trying to figure out nuances, bringing the business community in there, other community members."
IRBs are required to have a diverse membership, including non-scientific and non-affiliated members. But Gilbert says fulfilling that requirement alone doesn't help an IRB prepare to deal with community-based research — in part because many of those "lay members" aren't really from the communities being studied.
"They're usually chosen from members of the clergy or somebody from an academic background, somebody highly educated who's really not a community member in that sense," he says.
He proposes an entirely different board — an environmental health and community review board (EHCRB), with a different type of membership and even different standards for reviewing research proposals.
While his chief interest is in environmental work, Gilbert says he could see this type of board in other areas of community-based research as well.
"You take work on asthma, for example," he says. "For a drug trial on asthma, if a certain community has high rates of asthma, it might have implications for a community like that, too."
Who is affected?
Gilbert uses a study of blood lead levels in children as an example of how community-based research has special needs that might be better addressed by an EHCRB.
"You want to go in there and sample children," he says. "That's got enormous implications for the community. Let's say you've got an apartment building with seven or eight units and a couple of kids in those units are showing up with lead exposure.
"What are the implications for the other renters of those apartments, what are the implications for the apartment owner? And the whole area could be redlined (discriminated against for home loans or insurance). There are implications for the school system."
There are privacy issues involving how much families need to know about other families' results.
Gilbert says all of these questions bring different constituencies to a discussion of a study, and should be considered by the board.
An EHCRB that might handle such issues ideally would be based in the community, rather than at a large academic medical center or university, Gilbert says. It could be sponsored by a non-governmental organization or associated with a local medical clinic.
He says it's important that it meet in the community, so that residents and other interested people don't have to travel outside their community and navigate a complicated bureaucracy to be heard.
"If an institution has six or seven different IRBs, it doesn't build capacity within a community to understand these issues or figure out how to work with the IRBs," he says.
Since the board would function in place of an IRB, it would need the same sort of human subjects protection expertise, and would need members who understand how research is conducted, Gilbert says.
"(Community members) don't even need to be the dominant members, but I think you need to have more than just one," he says. "You need at least two or three, so you've got a group there that can lend support to each other and ask the questions.
"Things move very quickly, there's a lot of specialized language that gets used," he says. "And one individual, unless they're extremely strong-willed, has a very hard time slowing them down and asking them questions."
Gilbert says he would like to adapt even the ethical principles established in the Belmont Report to deal with the special concerns of community-based research. Gilbert sees this not as a replacement for Belmont's principles, but as an expansion of them. His list of principles includes:
- Dignity, which Gilbert defines as not only respect for individual autonomy, but the recognition of the worth of an individual within the community. "This acknowledges that people, especially children, have a right to develop in an environment in which they can reach and maintain their full potential," Gilbert writes.
- Veracity, or a requirement to present all the relevant facts. "At all times, there must be a commitment to a right to know and a right to understand." Gilbert sees the community using this approach to use the facts to determine beneficence in research. It requires that communities learn all the necessary facts, even those that individuals or businesses might not wish to share.
- Justice, which Gilbert says needs to be expanded beyond the individual to ensure justice for the community in which research is conducted.
- Sustainability, a new concern that an EHCRB would bring to its decision-making. Gilbert says a board would have to determine whether actions being contemplated would help sustain the community in the long term.
"You don't just have somebody plop in there, do a study and then bail out of the community," he says. "They need to be looking toward what they're doing to help and sustain the worth of that community, improve the capacity of that community. And to sustain the research, too. Can you really work with the community so you can go back and they respect what you're trying to do?"
IRBs can adopt idea
While the establishment of a new type of review board would require regulatory intervention, Gilbert says there are elements of his approach that could be instituted at a local level by individual IRBs.
At a minimum, he says, research institutions could create their own separate community-based research IRBs, to handle these types of studies.
"It would be helpful to have a long-term commitment to do that, bringing in more community members and trying to go to the community for your meetings, instead of putting them downtown where it's a little more difficult for community members to get there," Gilbert says. "I want to shift the burden of responsibility to the IRBs in a sense to reach out to the community, to include them, not just as a token effort."
"We need to consider the overall worth of the community and individuals, not just respect for the decision-making," he says. "How we support and grow our communities, respect the community and the culture in which people live."
Reference
Gilbert SG. Supplementing the Traditional Institutional Review Board with an Environmental Health and community Review Board. Environmental Health Perspectives 2006 Oct;114(10):1626-9. An online version of the article is available at no charge at www.ehponline.org
Community-based research requires a special type of review, and so should have its own type of review board, one that balances the responsibilities that IRBs have to individuals with an appreciation for the needs of the community in which research is conducted.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