In their frustration with IRBs, CBPR researchers reported to us that they have joined a growing group of scholars concerned that the review process has become too formulaic and inflexible. Designed around biomedical and behavioral research, IRB review is often inappropriate to the methods, challenges and objectives of other approaches to research from across the disciplines. Social scientists, for example, have criticized the application of stringent informed consent procedures for low risk, non-intrusive interview research, such as interviewing public officials, who are legally obligated to reply to citizen queries .
CBPR researchers told us they face a unique set of challenges in the IRB process. The differing assumptions that CBPR researchers and IRBs bring to the process come into sharpest relief regarding IRB's opposition to two particular CBPR practices: (1) layperson participation in the research process and (2) the report-back of individual results to study participants. Laypeople and community organizations who are involved in CBPR research are outside the conventional jurisdiction of institutional IRBs. Meanwhile, the CBPR practice of report-back, and especially the philosophy of openness that informs it, challenges IRB assumptions about who controls the flow of data produced in human subjects research, when and whether those data should be made available to members of an affected community, and what the nature and duration of the researcher-subject relationship should be.
In recent practice, some traditional clinical research has led to inclusion of community advisory boards and to explicit assumptions about the need to consider broad community benefits. For example, some AIDS research and breast cancer research has involved community members in central ways . Indeed, this may have helped some IRBs understand the need to transcend traditional models for human subjects review. In this light, the distinctions between traditional research and CBPR may seem to be more blurred. Still, our experience, combined with our familiarity with many CBPR projects, leads us to believe that CBPR represents a major shift in research and engagement with study communities that makes it qualitatively different, even from the occasional community-oriented AIDS and breast cancer studies that exist under the umbrella of clinical research. These issues are highlighted and discussed below.
Institutional review board oversight of community-based participatory research
CBPR researchers reported being informed by a major shift in research ethics. Unlike conventional research in which the researcher's relationship with the subject is unilateral and unidirectional, CBPR is collaborative, inviting community members and community-based organizations to work alongside the scientists, social scientists, and medical professionals studying that community. Laypersons help define the research agenda, form research questions, carry out the study, and disseminate results and information back to the community and other relevant parties, such as public health practitioners and social service agencies [5, 9]. CBPR thus enters a "post-Belmont era", blurring the traditional roles of researcher and subject and taking seriously the insight, energy, and objectives that members of the affected community bring.
The lay involvement is one way CBPR expresses the Belmont principle of "respect for persons," intended to protect research participants from being objectified and dehumanized. By encouraging the active involvement of research participants in the research process, CBPR greatly reduces the chances that they will be objectified in the first place. As participants in the design and implementation of the research plan, members of the affected community have a level of "informed consent" far deeper than typically occurs in conventional research. Thus CBPR achieves "respect for persons" by democratizing the research process and encouraging scientific and medical experts to work alongside laypersons, rather than treating them as objects of study.
Facilitating collaboration and communication among scientists, medical professionals, and laypersons has its own challenges, but often the biggest hurdle CBPR researchers discussed was how to introduce IRBs to the idea. In our and our colleagues' experiences, IRBs are uneasy when community-based organizations (CBOs) serve as formal partners in a research initiative. The main problem is jurisdictional: university IRBs are reluctant to oversee human subjects protection compliance for partner organizations outside the university. That discomfort is sometimes magnified by the routine activities of the CBO. For example, a CBO's process of seeking feedback from its constituency--evaluating whether a conference had successfully reached its target audience, for example--could appear to an academic IRB as human subjects research requiring review. This could appear to the CBO as an unwelcome intrusion into its internal affairs (exceptions for such routine activities already exist in federal regulations and could be a basis for exempting CBO educational evaluations, although IRBs are not always aware of this). IRBs may be particularly disturbed when a CBO challenges traditional academic norms by engaging in both research and advocacy, leading IRBs to attempt to influence activities that many CBOs believe should be under their own control.
Many of these problems were apparent when we sought human subjects review from Brown University's IRB for a project that involved two CBO partners: Silent Spring Institute and Communities for a Better Environment. Silent Spring Institute was the principal investigator for two reasons. First, Silent Spring Institute originated the study of large numbers of diverse analytes in homes, and are the foremost researchers in this exposure assessment field; as a result, are the only partners on this team with the established capacity to design and implement its core exposure assessment science, and originated the idea of studying participants' report-back experiences. Second, NIEHS had encouraged CBPR project teams to promote leadership by CBO partners. The IRB was initially reluctant to oversee human subjects protection for researchers outside the university, doubting its own capacity to oversee and hold accountable the research work of independent organizations that were not legal entities of the university. But in fact, this and other IRBs routinely oversee research conducted in other countries by locally hired researchers. Of primary concern was the possibility that some CBO activities might violate federal standards and jeopardize federally-funded research activities and the reputation of the university as a whole.
From our standpoint, their concerns about jurisdiction were unfounded. The Department of Health and Human Services' Policy for the Protection of Human Subjects makes clear that CBOs can be reprimanded directly by the HHS Office for Human Research Protection (OHRP) for a violation of federal regulations for the protection of human subjects . Brown's IRB could have contacted the OHRP directly with any concern about a CBO partner's ability to conduct research or the CBO's ability to ensure the protection of human subjects in federally funded research. All CBOs conducting research are required to obtain and periodically update an OHRP assurance of compliance with human subjects protection guidelines and must report any suspension or termination of research by an IRB.
To allay IRB concerns, we demonstrated that our community partners were experienced in scientific research and well-versed in human subjects protection protocols. Silent Spring Institute has a long track record of obtaining state IRB approval for environmental health research supported by state, federal, and private funds. Communities for a Better Environment (CBE) is a long-established organization whose research using secondary data (such as oil refinery emissions, for example) was well-known to academic institutions and government agencies. Moreover, individual CBE staff members had previous experience working for universities and health providers where they had participated in human subjects research. Further, staff from both Silent Spring and CBE completed human subjects protection training through the National Institute of Health's online certification training and exam.
Despite these credentials, the Brown University IRB remained reluctant. Deciding NIH certification was insufficient, it required that staff from both organizations also take the Collaborative Institutional Training Initiative (CITI) online course and exam, even though it does not address the human subjects issues unique to CBPR projects. In addition, the training module assumed familiarity with online electronic systems, comfort with multiple-choice test-taking skills, and strong English literacy-all potentially disruptive to an environmental justice project, for example, if staffed by people who speak English as a second language or have little or no experience navigating web-based programs. The five or six hours required to complete the training added to the frustration of already over-extended CBOs. At the NIEHS Environmental Justice grantees conferences and other events, our colleagues described similar problems, revealing that we were not alone in this experience.
Ideally we would have turned to NIEHS for help getting community partners through our university IRB process. Unfortunately, although NIEHS promotes CBPR research, it does not offer guidance to IRBs for reviewing academic-community partnerships. The lack of guidance from NIEHS meant that both researchers and IRB staff members were on their own to resolve unique and sometimes conflicting institutional concerns. For example, we developed procedures making Brown University faculty partners responsible for protecting study participants in interviews, human and household sample collection, and record-keeping activities. Faculty partners agreed to make quarterly visits to Communities for a Better Environment and Silent Spring to check record-keeping and data storage protocols, and reported to the IRB on the collaborative's adherence to approved study protocols.
In the end, the IRB agreed to provide oversight for our research collaborative, but at first approved oversight for only eighteen months of a four-year project. After continued dialogue and negotiation, the IRB ultimately agreed to continue for the full duration of the project. While we were pleased to have obtained approval, the many problems in the process caused substantial delays before the project could begin and also during critical phases of the project as it progressed.
Who gets to know? Conflicts over dissemination of study results
As we learned from interviews, IRBs frequently clash with CBPR researchers over their practices for the dissemination of information and results. IRBs are accustomed to overseeing conventional research projects where study participants often are not informed of personal results that lack regulatory or clinical significance. The CBPR practice of having study participants work alongside researchers confounds assumptions about who should control and have access to the resulting data.
But in CBPR, the participants' right to have access to the results of research derives from a source more fundamental than their own participation in the research effort. CBPR posits that primary ownership of collected data logically lies with the participants from whom the original samples were taken . From the CBPR perspective, it would be inappropriate and unjust to deny full access to information that came from their own bodies, homes, and communities, and that owes its existence to their willing participation.
Researchers told us that IRBs frequently express concerns that disseminating uncertain data may harm human subjects. For example, the participant might be psychologically harmed by receiving results if their clinical significance is unknown or if no valid options exist to address the potential health risks they reveal . Indeed, the National Bioethics Advisory Committee  issued guidelines directing researchers to report biomarkers only when health implications are significant and recourse is available. These discussions may not, however, have adequately considered the distinction between communications related to genetic biomarkers, which are not modifiable, and chemical exposures, many of which are modifiable. When these clinical guidelines are applied to chemical exposure research, people are left unaware of the presence in their own bodies of foreign substances known to be harmful in animal studies, and sometimes in in vitro and human studies. From the perspective of CBPR, such guidelines are an affront to individuals' and communities' right-to-know, and by extension tarnish the scientific process.
In fact, IRBs' concern with confidentiality may violate federal regulations, which state that " When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (emphasis added)." (45 CFR 46.111(a)(7)). This phrase, "when appropriate," is highly germane to CBPR, and IRBs have flexibility in determining when confidentiality is appropriate. If people want their personal data made public, there is no appropriate reason to restrict the release of that information.
In CBPR, "respect for persons" requires and reinforces a commitment to "report-back," an ethical practice that encourages as much as possible the dissemination of individual and aggregate-level results to those study participants who want to have them. This openness is valued because it democratizes knowledge production and helps restructure unequal power relationships , especially disparities in access to knowledge that traditionally characterize lay-professional relationships . CBPR also assumes that the sharing of knowledge between researchers and participants empowers communities and individuals to use scientific evidence to advocate for their own interests . Report-back thus upholds the principle of beneficence by giving participants access to information crucial for their health and well-being, and by empowering them to act . From a beneficence perspective, even information about an exposure for which a corresponding risk relationship is not available can have some benefits to participants, such as enabling personal exposure reduction. Through the sharing of aggregate-level data, report-back can also make communities aware of a problem in their midst, and give them both the motivation and the evidence they need to organize community members into collective action. Our project has spent considerable effort reporting data to individual participants and to community gatherings, in order to advance general knowledge, build local capacity for community improvement, and help policy shifts in government and corporate practice [16, 17].
As we and our colleagues discovered, sometimes the voluntary sharing of information in CBPR was foreign to IRB conceptions of confidentiality. For example, in the "Body Burden" study (a joint project of Environmental Working Group, Mt. Sinai School of Medicine, and Commonweal ) researchers discovered 167 pollutants (out of the 211 tested) in the blood and urine of nine volunteers, with an average of 56 carcinogens in each person. Aggregate study results appeared in Public Health Reports , but study participants voluntarily placed their individual data on the internet, with photos and personal biographies to accompany the contaminant data . Voluntary though it was, the website would not have sat well with most IRBs, who would perceive that as a violation of confidentiality.
Similarly, we learned from colleagues that IRBs were frequently bothered by the interactive researcher-participant exchange typical of CBPR, one which can change as the project develops. For example, community residents' requests for information to reduce exposure, and our own sense of responsibility, led us to build into our project an intervention phase for reducing household toxics use. We also distributed information sheets to participants about non-toxic alternatives and environmental organizations. We saw our actions as akin to healthcare workers providing treatment and prevention advice in medical screening.
The changing relationship between researcher and study participant is crucial to CBPR but can be troublesome to IRBs accustomed to a more traditional researcher-subject relationship. For example, some researchers noted that academic IRBs require "passive" individual report-back protocols that restrict researchers from proactively asking participants if they want to receive and discuss results. Instead, researchers may only inform study participants how they can contact researchers should they wish to receive individual results. The organic and dynamic nature of researcher-participant interaction in CBPR may be problematic for a review process that assumes all researcher-subject interactions will be planned and obliges the review board to oversee all such exchanges. IRBs may feel obliged to review each phase of that relationship and any and all communications between researcher and participant before the research can proceed. This causes delays for CBPR projects that can delay the research, prevent study participants from getting information necessary for their health and well-being, and may threaten the development of a successful academic-community collaboration.
Such delays and disruptions occurred in the Cape Cod project when we sought to report data to participants. Because many study participants were initially identified through the Massachusetts Cancer Registry, the Department of Public Health's Research and Data Access Review (RaDAR) Committee had jurisdiction over the project. As a result, any later stages of work with these participants (such as developing protocols to inform them of their individual household sampling and biomonitoring results) had to be cleared by the RaDAR Committee. Unfortunately, that review process took many months, and significant difficulties arose with how the RaDAR Committee and others within the Massachusetts Department of Public Health (DPH) approached our CBPR project. One delay occurred when Cape Cod homes with high levels of chemicals were retested to get more detailed measurements that could potentially determine sources of contamination and point to possible remediation strategies. The DPH Bureau of Environmental Health Assessment initially asked to review each letter that went to every one of these households, raising the possibility of protracted negotiation about the scientific interpretation of each individual's finding. Finally, after a meeting with Silent Spring Institute and Brown University researchers, they approved a prototype letter that would be tailored by the research team for each individual's results.
The DPH action was an example of IRB review threatening the very principles it hopes to uphold--in this case the principles of beneficence and justice. Recurring delays from lengthy reviews, on top of funding cuts, kept study participants from getting their results in a timely fashion and jeopardized relations between the research team and participants, thus threatening good CBPR practice. Women who had provided human tissue and household dust and air samples for the study were understandably disconcerted with the delay in receiving their results. Fortunately, Silent Spring Institute's respected status in the community and its skillful handling of the delay enabled participants to stay informed on the progress of the research.
IRB reluctance concerning ongoing researcher-subject interaction was also manifest in its resistance to storing samples in this study. Exposure assessment research is a rapidly evolving field where new analytical methods and knowledge about chemicals in consumer products are constantly improving. Stored samples provide an opportunity to re-analyze data as new research methods become available and more cost-effective. For example, a major breast cancer study published in 2007 used stored samples to show the effects of early exposure to DDT. The study reanalyzed blood samples that had been donated between 1959 and 1967 for a child health and development study. The results showed that women exposed to the highest levels of DDT before mid-adolescence had a five-fold increase in breast cancer risk . As many women heavily exposed to DDT in childhood are still under fifty, we may see startling effects in the coming decades. Had those samples been destroyed, the loss to public health would have been monumental.
In one instance during the Cape Cod project, the DPH threatened to require the destruction of environmental and biological samples immediately after the first laboratory chemical analyses were completed, even though study participants had even given informed consent to allow their household air, dust, and tissue data to be retained for ten years for further analysis. The DPH requirement would have undermined one of the critical goals of the research project - to identify sources of endocrine-disrupting compounds in homes; new assays might be developed in the future to detect additional EDCs, and if samples were destroyed, researchers would miss the opportunity to analyze them. After much negotiation, the RaDAR Committee required the research team to get new consent from study participants in order to continue storing their samples at the research laboratory.
The Cape Cod case demonstrated how maintaining such samples can become crucial for reasons unforeseeable at the time of IRB review. During the research, the study team unexpectedly found breakdown products of a banned flame retardant. Had the samples been destroyed, researchers would have been unable to retest the samples to confirm the parent flame-retardant as the source of the residues. When research participants want their own samples destroyed, their wishes should, of course, be respected, but in the absence of those wishes, IRB requirements to destroy biological specimens can in fact contravene the Belmont principles to maximize research benefits for study participants. The last few years have seen a dramatic increase in knowledge about flame retardants, especially PBDEs, making these samples retroactively part of the front line of public health [21–23].
Despite significant obstacles and delays related to IRB review, our collaborative moved the Massachusetts RaDAR Committee on several critical issues, through continual pressure by academic partners, Silent Spring Institute, supporters from the Massachusetts Breast Cancer Coalition, pro bono legal representation, and state legislators. The Brown University IRB found the experience valuable, too, and they invited us to give a presentation at a statewide research conference they organized in 2007.
Educating the institutional review board about community-based participatory research
While attempting to shepherd CBPR projects through the IRB process, we and our colleagues at other institutions employed a range of strategies with varying degrees of success. For example, to help the Cape Cod project through Brown University's IRB process, we prepared extensive memos to our university IRB that laid out the history and practices of CBPR, bolstered by extensive in-person dialogue and email with IRB staff. We demonstrated precedent by showing that other researchers at prominent institutions had successfully carried out this kind of collaborative work while observing sound ethical practices, and that another institutional review board had approved such multi-partner collaborative research.
One collaborative researcher we consulted suggested researching IRB members in order to assess their familiarity with CBPR. At one western state university, one faculty member invited the IRB and human subjects administration to an all-day CBPR workshop to improve overall understanding of the principles of CBPR and to establish regular communication between researchers and IRBs. Despite the many real and potential obstacles to collaborative projects, some academic IRBs understand the unique circumstances inherent in CBPR work, and go out of their way to facilitate human subjects protection oversight. Still, in our consultations with other CBPR initiatives, we learned of only one case other than ours where the IRB of a major research university agreed to be the IRB of record for a CBO partner that was a principal investigator in a community-academic research collaborative.