Find the right CBPR training for your IRB
Consider the roles of community partners, researchers
Community-based participatory research (CBPR) brings members of the community into a study as partners who are involved with subject recruitment, study design, informed consent, and other aspects of research. Community partners can include tribal councils, religious organizations, neighborhood groups, and other social organizations.
IRBs face unique training challenges when engaging in CBPR. Personnel involved in research — including community partners — must complete a human subjects training course before engaging in research.
"Community engagement is becoming a lot more part and parcel of health research," says Emily Anderson, PhD, MPH, assistant professor of bioethics at Loyola University Chicago. "There are more people getting involved in the research enterprise who have not had any previous exposure to or experience with research. There is a growing need for materials used to explain research ethics and integrity."
There may be an increased blurring of research roles in CBPR where community partners could serve in more than one capacity, says Sarena Seifer, MD, senior consultant for Community-Campus Partnerships for Health, based in Seattle. "In conventional research you have more defined roles, but it can get really messy in CBPR," she says. "You might have an agency that’s a co-investigator, and the clients might be participating and also on the advisory committee. There are different roles and more potential for conflict of interest."
Human subjects research training can address many of these concerns and alleviate possible conflicts of interest, experts say. IRBs may face challenges in ensuring community partners receive proper training if the standard human subjects protections training modules, typically used to train and certify IRB members and staff, prove to be too cumbersome for those partners.
"The overwhelming feedback on CITI is that it’s not very helpful [for CBPR training]," Seifer says. "Right now, unfortunately, each IRB has to figure it [education] out by themselves because there is no national standard."
The standard modules can take up a lot of time, can be difficult for community members who don’t have computer access or experience, and could focus on topics and situations community members may not encounter in the field. "We work with a lot of non-English-speaking populations and tribal groups. We also have a huge anthropology school and public health groups that do research — it’s not practical to require people have our training," says Mariette Marsh, MPA, CIP, director of the Human Subjects Protection Program at the University of Arizona in Tucson. In some unique situations, researchers work with community groups from war-torn areas where people have been displaced and don’t have access to technology, she says. "We can’t insist that they take our training," she adds.
In instances where community members cannot take the IRB’s standard training, the University of Arizona IRB works with the principal investigators (PIs) to develop a CBPR training that is specific to the particular study. The training guide would show what the researchers will address with the study population, elements of informed consent, privacy and confidentiality issues, and other materials that would be used. The PI would then document the type of training used and the dates and times on which it was given. "If [the study is] audited, we could see what materials they used," Marsh says. "They’re obligated to work with the participants to understand what the research is about and nuances they have to be aware of. No one method works for all studies," she adds.
When Anderson saw PIs were developing their own training curricula for community members, she saw a gap that needed to be filled. "I wanted to create something to keep people from reinventing the wheel," she says.
Anderson developed the CIRTification training curriculum while she was at the University of Illinois at Chicago, with support from UIC’s NIH-funded Center for Clinical and Translational Science. CIRTification materials can be tailored for the specific needs of project personnel, but the training is meant to be delivered by a facilitator — usually a PI or someone at the IRB office — in sessions totaling a minimum of three hours. The sessions train community members on the history of human subjects protections, privacy and confidentiality, justice and beneficence, informed consent, and other research issues. Sessions include role playing, brainstorming, and case-based discussions. There is also a video series on informed consent. The participant and facilitator workbooks and informed consent videos are free and can be downloaded from www.ccts.edu/content/CIRTification.
The training can be tailored to the needs of the community members depending on what their research roles will be, Anderson says. For example, if community partners will be obtaining informed consent and collecting data, they will need the most training. If partners will be involved in recruitment and not in data collection, training may not have to be as intensive.
Anderson cites a PI who was working with community partners who would only be involved in data analysis by listening to audio recordings of study participants. There was a very small chance that the community partners could recognize participants’ voices in the recordings, but the PI and the IRB both agreed that some training on privacy and confidentiality was necessary. "We did an hour-long modified education explaining the expectations that need to be upheld with privacy and confidentiality," she says. "It wouldn’t have made sense for them to do extensive online training for biomedical issues. We sat with them for an hour and went over the basics of human subjects protections, focusing on privacy and confidentiality, and they learned what they needed to for the project."
"Not everyone has the same role in research — IRBs need to think about what every individual person’s role is going to be and what they need to know and don’t need to know," Anderson continues. "What I was trying to do with this curriculum was think of the person who has to go out in their community and knock on people’s doors to get them to do a survey, or people responsible for keeping confidential information safe. What do they need to know? It’s important they understand there are federal regulations in place. What if the person learns something private about someone they know and are asked about it? Those really practical problems are missing from traditional HRPP training. Partners are getting inundated with information that isn’t relevant and missing the relevant and practical stuff. That’s the gap I’m trying to fill."
At Harvard Catalyst — the Clinical and Translational Science Award (CTSA)-funded program at Harvard that helps catalyze research across clinical and translational domains — the community-engaged research subcommittee developed educational materials for community partners and for IRBs in community-engaged research (CEnR). In CEnR, community partners are involved in the research, but not as intensely involved as with CBPR. "Community-engaged research is a broad — and fairly new — umbrella term that encompasses many levels of community engagement including community-based participatory research. That expansiveness leaves a lot of questions for the IRB as to the best and most appropriate ways to review community-engaged research." says Sabune Winkler, JD, director of regulatory affairs operations for Harvard Catalyst at the Harvard Clinical and Translational Science Center in Boston.
Inspired by CIRTification, the Harvard Catalyst CEnR subcommittee developed CEnR-focused training and educational materials for local investigators, community partners, and IRBs. The materials include a Community-Engaged Research 101, a PDF which explains CEnR and the challenges it poses to IRBs as well as potential solutions; Human Subject Training for Community Partners, a training document using case studies focused on the roles and ethical responsibilities of community partners; and Ethical Conduct of Research with Human Participants Training for Youth Audiences, which is geared toward younger community partners. Copies of the content can be requested and downloaded at http://catalyst.harvard.edu/programs/regulatory/cenr.html.
When developing the educational materials, the Harvard Catalyst subcommittee partnered with IRBs to make sure the materials were acceptable. "It wasn’t enough just to develop the training — we had to collaborate with local IRBs to make sure they would accept an alternative training," says Julie Kaberry, IRB administrative chair, Office of Human Research Administration at Harvard School of Public Health, and CEnR co-chair at Harvard Catalyst. "After sharing the final draft with other IRBs with whom we partner for research, they said they would be pleased to accept this in place of CITI when appropriate."
Kaberry and others on the subcommittee are willing to meet with researchers and partners to tailor training to everyone’s specific needs. "We aim to do something more appropriate for the target audience, using the training to focus on their specific roles and responsibilities," she says. "Not everyone has the background knowledge and not everyone is comfortable with high-level computer-based training. We use, for example, lay terminology and real life examples to enhance the training experience."
Community-Campus Partnerships for Health in Seattle developed a curriculum in 2005 entitled "Developing and Sustaining Community-Based Participatory Research Partnerships: A Skill-Building Curriculum." While it was not developed specifically for IRBs, Seifer and colleagues used portions of the curriculum at Public Responsibility in Medicine and Research (PRIM&R) conferences to positive response. Among the units in the curriculum are introduction to CBPR, ethics in CBPR, developing and maintaining partnerships, and disseminating research results. "People have been using pieces of the curriculum as part of graduate-level courses or leadership workshops," Seifer says. The curriculum is free with permission and can be found at http://cbprcurriculum.info.
Seifer also suggests these resources for IRBs looking for CBPR training:
"Human Subjects Protection in Community-Engaged Research: A Research Ethics Framework," published in the March 2010 issue of Journal of Empirical Research on Human Research Ethics.1 "It’s good content if an IRB wants to create its own curriculum — it lays out common CBPR issues and how to work around them," Seifer says. The article can be found at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4004423/
Project TRES (Training in Research Ethics and Standards). This curriculum gives research ethics training to community partners who participate in CBPR in Hispanic/Latino communities. The tutorial is in English and Spanish and can be found at https://nationalethicscenter.org/tres/?view=curriculum.
- Friedman Ross F, Loup A, Nelson R, Botkin JR, Kost R, Smith G, Gehlert S. Human subjects protection in community-engaged research: A research ethics framework. J Empir Res Hum Res Ethics. 2010;5(1):511.