CASE REPORT Open Access

Institutional review board challenges related tocommunity-based participatory research onhuman exposure to environmental toxins:A case studyPhil Brown1, Rachel Morello-Frosch2*, J G Brody3, Rebecca Gasior Altman4, Ruthann A Rudel3, Laura Senier5,Carla Pérez6, Ruth Simpson7

Abstract

Background: We report on the challenges of obtaining Institutional Review Board (IRB) coverage for a community-based participatory research (CBPR) environmental justice project, which involved reporting biomonitoring andhousehold exposure results to participants, and included lay participation in research.

Methods: We draw on our experiences guiding a multi-partner CBPR project through university and stateInstitutional Review Board reviews, and other CBPR colleagues’ written accounts and conference presentations anddiscussions. We also interviewed academics involved in CBPR to learn of their challenges with Institutional ReviewBoards.

Results: We found that Institutional Review Boards are generally unfamiliar with CBPR, reluctant to overseecommunity partners, and resistant to ongoing researcher-participant interaction. Institutional Review Boardssometimes unintentionally violate the very principles of beneficence and justice which they are supposed touphold. For example, some Institutional Review Boards refuse to allow report-back of individual data toparticipants, which contradicts the CBPR principles that guide a growing number of projects. This causes significantdelays and may divert research and dissemination efforts. Our extensive education of our university InstitutionalReview Board convinced them to provide human subjects protection coverage for two community-basedorganizations in our partnership.

Conclusions: IRBs and funders should develop clear, routine review guidelines that respect the unique qualities ofCBPR, while researchers and community partners can educate IRB staff and board members about the objectives,ethical frameworks, and research methods of CBPR. These strategies can better protect research participants fromthe harm of unnecessary delays and exclusion from the research process, while facilitating the ethicalcommunication of study results to participants and communities.

BackgroundIn 1979 the Belmont Report established principles forthe use of human subjects in scientific research. Devel-oped partly in response to the Tuskegee syphilis study,Belmont identified three basic principles governing theethical use of human research subjects. The first of

these, “respect for persons,” stressed that an individual’sdecision to become a research participant must bevoluntary, and called for special protection for thosewho lacked the capacity to make such a decision them-selves. The second principle, “beneficence,” called onresearchers to “do no harm” or barring that, to maxi-mize the benefits of their research while reducing asmuch as possible the risk to the subject. Finally, theprinciple of “justice” required careful attention to thefair distribution of risks and benefits, calling on

* Correspondence: rmf@berkeley.edu2University of California, Berkeley School of Public Health and Department ofEnvironmental Science, Policy and Management, 137 Mulford Hall, BerkeleyCA 94720-3114, USA

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© 2010 Brown et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.

researchers to select subjects only “for reasons directlyrelated to the problem being studied” and to vigilantlyavoid the selection of subjects for “their easy availability,their compromised position, or their manipulability.”Justice also required that those who bear the risks ofresearch should, whenever possible, be among the firstto benefit from its insights [1].Implementation of the Belmont Report principles fell

to institutional review boards (IRBs) that protect indivi-dual research participants through confidentiality,informed consent, and oversight. But while IRBs havebeen the traditional enforcers of the Belmont principles,they are not the only place where those principles havefound expression. Those same principles form the basisof community-based participatory research (CBPR), amethod that has become increasingly important in thework of environmental justice and environmental publichealth activists who are engaging more directly in scien-tific research design and the collection and analysis ofindividual-level human data [2-5]. CBPR explicitlyfocuses on problems that affect whole communities–environmental toxins, for example–and thus is differentfrom most biomedical research which takes the indivi-dual as its primary subject. In CBPR projects, research-ers work closely with community members andcommunity-based organizations to develop appropriateresearch agendas, conduct analyses, and disseminateresults and information. This merging of communityinterests and community action reflects another distinctquality of CBPR: its commitment to advocacy for thepublic good and creating open access to information.CBPR takes “respect for persons” to a new level: not

only do study participants voluntarily participate inresearch, they actively participate in research design,data collection, analysis, implementation, and dissemina-tion. This inclusion reflects CBPR’s commitment to theprinciples of “beneficence” and “justice,” as the activeinvolvement and scrutiny of study participantsencourages the fair assessment and distribution of theresearch’s risks and benefits. Further, the practice of giv-ing research participants the decision to have full accessto research results helps ensure they have sufficientinformation to make informed choices during and afterthe study, and is thus consistent with Belmont’s empha-sis on informed consent. In the process, research “sub-jects” are transformed into research “participants.”Ironically, however, IRB review of CBPR projects can

result in unintended violations of the very principles theyseek to uphold. This is due in part to implicit assump-tions embedded in the Belmont Report that wereadopted by IRBs but that contradict other CBPR princi-ples. For example, IRBs, following Belmont, assume thatthe research participant is an individual, whereas CBPRsees research participants as both individuals and as a

community of individuals [6]. This difference has pro-found implications for confidentiality, the disseminationof information, and the assessment of risks and benefits.Similarly, CBPR’s inclusion of laypersons and others tra-ditionally outside the research process means universityIRBs must consider people who are traditionally outsidetheir review process (such as community-based organi-zations with no formal relationship to the university),which can lead to misunderstandings and unnecessarydelays as IRBs deliberate whether and how to extendtheir jurisdiction into new territory. These differencesand the general unfamiliarity of many IRBs that wesampled with the CBPR approach can result in undueobstacles and extensive delays, and hence can reducethe benefit of the research for the research participantsand even cause them harm as they anxiously wait unne-cessarily long to receive results that may directly affecttheir own well-being and that of their families and theircommunities, or are “protected” from information thatcould inform their own decisions about their futurehealth and welfare. A third example arises when com-munities request that studies be conducted, and workwith scientific collaborators to design and fund the pro-ject, but when IRBs either delay, or deny, oversight, hin-dering communities from investigating environmentalproblems in their communities.The increasing use of CBPR in the work of environ-

mental justice and environmental public health activists,scholars, and practitioners makes it particularly impor-tant that researchers, funders, community members, anduniversity administrators work towards defining IRBoversight procedures that will advance CBPR projectsinstead of inadvertently hindering them. We draw onour own experiences to highlight problems that arisewhen Belmont principles meet the IRB review process,and how those problems undermine rather than supportthe spirit of the Belmont Report. We supplement thoseaccounts with reports from other CBPR researchers, andpropose procedures that will allow IRBs and CBPRresearchers to work together in a review process thatpromotes their shared goal of ethical, principled, andbeneficial research.

MethodsWe draw our data from our own experiences with theIRB process and from the experiences of other research-ers using CBPR to examine issues of environmental jus-tice. Our research collaborative involves a partnershipbetween four institutions: Brown University, SilentSpring Institute (a non-profit environmental healthresearch organization based in Massachusetts), the Uni-versity of California, Berkeley, and Communities for aBetter Environment (CBE; a California environmentaljustice organization that combines organizing, advocacy,

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litigation, and research). Our project entails sampling ofhousehold air and dust in three study sites: Richmondand Bolinas in California, and Cape Cod in Massachu-setts. We also conducted human biomonitoring on CapeCod. In response to community concerns about envir-onmental justice and about environmental links tobreast cancer, we tested for endocrine-disrupting com-pounds and for additional pollutants from industry andtransportation corridors near the Richmond site. Theproject reports individual results to study participantswho choose to receive them, and aggregate resultsthrough community meetings, peer-reviewed publica-tions, and media outreach. Brown University’s IRB wasinitially reluctant to oversee the researchers in the com-munity partner organizations, but ultimately facilitatedan effective human subjects protection oversight strategyfor the entire collaborative. Hence, our experience servesas a model for others, and adds weight to a changingresearch protection paradigm that understands andvalues community-based participatory research.We also incorporate consultations with twelve other

colleagues collaborating on CBPR projects at other insti-tutions. We selected these colleagues from the list ofcurrent projects funded by the National Institute ofEnvironmental Health Sciences (NIEHS) EnvironmentalJustice Program. Because we were, at the time, onlyseeking information to guide our own IRB request, wewere not subject to human subjects protection oversightfor these consultations. Therefore, we report on lessonslearned without direct reference to the researchers ortheir institutions. While preparing for a research propo-sal to study these IRB issues in greater depth, we spokewith four additional researchers involved in biomonitor-ing and household exposure studies.We also draw data from participants at a workshop we

led at the NIEHS Environmental Justice Program gran-tees conference in Talkeetna, Alaska [7] in September2005, and our own participation in a workshop on com-munity review boards led by West Harlem Environmen-tal Action (WEACT) at the NIEHS EnvironmentalJustice Program grantees conference in Boston inDecember 2007. Uncited material stems from our inter-views, conversations, and observations.

ResultsIn their frustration with IRBs, CBPR researchersreported to us that they have joined a growing group ofscholars concerned that the review process has becometoo formulaic and inflexible. Designed around biomedi-cal and behavioral research, IRB review is often inap-propriate to the methods, challenges and objectives ofother approaches to research from across the disciplines.Social scientists, for example, have criticized the applica-tion of stringent informed consent procedures for low

risk, non-intrusive interview research, such as interview-ing public officials, who are legally obligated to reply tocitizen queries [8].CBPR researchers told us they face a unique set of

challenges in the IRB process. The differing assumptionsthat CBPR researchers and IRBs bring to the processcome into sharpest relief regarding IRB’s opposition totwo particular CBPR practices: (1) layperson participa-tion in the research process and (2) the report-back ofindividual results to study participants. Laypeople andcommunity organizations who are involved in CBPRresearch are outside the conventional jurisdiction ofinstitutional IRBs. Meanwhile, the CBPR practice ofreport-back, and especially the philosophy of opennessthat informs it, challenges IRB assumptions about whocontrols the flow of data produced in human subjectsresearch, when and whether those data should be madeavailable to members of an affected community, andwhat the nature and duration of the researcher-subjectrelationship should be.In recent practice, some traditional clinical research

has led to inclusion of community advisory boards andto explicit assumptions about the need to considerbroad community benefits. For example, some AIDSresearch and breast cancer research has involved com-munity members in central ways [7]. Indeed, this mayhave helped some IRBs understand the need to trans-cend traditional models for human subjects review. Inthis light, the distinctions between traditional researchand CBPR may seem to be more blurred. Still, ourexperience, combined with our familiarity with manyCBPR projects, leads us to believe that CBPR representsa major shift in research and engagement with studycommunities that makes it qualitatively different, evenfrom the occasional community-oriented AIDS andbreast cancer studies that exist under the umbrella ofclinical research. These issues are highlighted and dis-cussed below.

Institutional review board oversight of community-basedparticipatory researchCBPR researchers reported being informed by a majorshift in research ethics. Unlike conventional research inwhich the researcher’s relationship with the subject isunilateral and unidirectional, CBPR is collaborative,inviting community members and community-basedorganizations to work alongside the scientists, socialscientists, and medical professionals studying that com-munity. Laypersons help define the research agenda,form research questions, carry out the study, and disse-minate results and information back to the communityand other relevant parties, such as public health practi-tioners and social service agencies [5,9]. CBPR thusenters a “post-Belmont era”, blurring the traditional

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roles of researcher and subject and taking seriously theinsight, energy, and objectives that members of theaffected community bring.The lay involvement is one way CBPR expresses the

Belmont principle of “respect for persons,” intended toprotect research participants from being objectified anddehumanized. By encouraging the active involvement ofresearch participants in the research process, CBPRgreatly reduces the chances that they will be objectifiedin the first place. As participants in the design andimplementation of the research plan, members of theaffected community have a level of “informed consent”far deeper than typically occurs in conventionalresearch. Thus CBPR achieves “respect for persons” bydemocratizing the research process and encouragingscientific and medical experts to work alongside layper-sons, rather than treating them as objects of study.Facilitating collaboration and communication among

scientists, medical professionals, and laypersons has itsown challenges, but often the biggest hurdle CBPRresearchers discussed was how to introduce IRBs to theidea. In our and our colleagues’ experiences, IRBs areuneasy when community-based organizations (CBOs)serve as formal partners in a research initiative. Themain problem is jurisdictional: university IRBs are reluc-tant to oversee human subjects protection compliancefor partner organizations outside the university. Thatdiscomfort is sometimes magnified by the routine activ-ities of the CBO. For example, a CBO’s process of seek-ing feedback from its constituency–evaluating whether aconference had successfully reached its target audience,for example–could appear to an academic IRB ashuman subjects research requiring review. This couldappear to the CBO as an unwelcome intrusion into itsinternal affairs (exceptions for such routine activitiesalready exist in federal regulations and could be a basisfor exempting CBO educational evaluations, althoughIRBs are not always aware of this). IRBs may be particu-larly disturbed when a CBO challenges traditional aca-demic norms by engaging in both research andadvocacy, leading IRBs to attempt to influence activitiesthat many CBOs believe should be under their owncontrol.Many of these problems were apparent when we

sought human subjects review from Brown University’sIRB for a project that involved two CBO partners: SilentSpring Institute and Communities for a Better Environ-ment. Silent Spring Institute was the principal investiga-tor for two reasons. First, Silent Spring Instituteoriginated the study of large numbers of diverse analytesin homes, and are the foremost researchers in this expo-sure assessment field; as a result, are the only partnerson this team with the established capacity to design andimplement its core exposure assessment science, and

originated the idea of studying participants’ report-backexperiences. Second, NIEHS had encouraged CBPR pro-ject teams to promote leadership by CBO partners. TheIRB was initially reluctant to oversee human subjectsprotection for researchers outside the university, doubt-ing its own capacity to oversee and hold accountablethe research work of independent organizations thatwere not legal entities of the university. But in fact, thisand other IRBs routinely oversee research conducted inother countries by locally hired researchers. Of primaryconcern was the possibility that some CBO activitiesmight violate federal standards and jeopardize federally-funded research activities and the reputation of the uni-versity as a whole.From our standpoint, their concerns about jurisdiction

were unfounded. The Department of Health andHuman Services’ Policy for the Protection of HumanSubjects makes clear that CBOs can be reprimandeddirectly by the HHS Office for Human Research Protec-tion (OHRP) for a violation of federal regulations forthe protection of human subjects [10]. Brown’s IRBcould have contacted the OHRP directly with any con-cern about a CBO partner’s ability to conduct researchor the CBO’s ability to ensure the protection of humansubjects in federally funded research. All CBOs conduct-ing research are required to obtain and periodicallyupdate an OHRP assurance of compliance with humansubjects protection guidelines and must report any sus-pension or termination of research by an IRB.To allay IRB concerns, we demonstrated that our

community partners were experienced in scientificresearch and well-versed in human subjects protectionprotocols. Silent Spring Institute has a long track recordof obtaining state IRB approval for environmental healthresearch supported by state, federal, and private funds.Communities for a Better Environment (CBE) is a long-established organization whose research using secondarydata (such as oil refinery emissions, for example) waswell-known to academic institutions and governmentagencies. Moreover, individual CBE staff members hadprevious experience working for universities and healthproviders where they had participated in human subjectsresearch. Further, staff from both Silent Spring and CBEcompleted human subjects protection training throughthe National Institute of Health’s online certificationtraining and exam.Despite these credentials, the Brown University IRB

remained reluctant. Deciding NIH certification wasinsufficient, it required that staff from both organiza-tions also take the Collaborative Institutional TrainingInitiative (CITI) online course and exam, even though itdoes not address the human subjects issues unique toCBPR projects. In addition, the training moduleassumed familiarity with online electronic systems,

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comfort with multiple-choice test-taking skills, andstrong English literacy-all potentially disruptive to anenvironmental justice project, for example, if staffed bypeople who speak English as a second language or havelittle or no experience navigating web-based programs.The five or six hours required to complete the trainingadded to the frustration of already over-extended CBOs.At the NIEHS Environmental Justice grantees confer-ences and other events, our colleagues described similarproblems, revealing that we were not alone in thisexperience.Ideally we would have turned to NIEHS for help get-

ting community partners through our university IRBprocess. Unfortunately, although NIEHS promotesCBPR research, it does not offer guidance to IRBs forreviewing academic-community partnerships. The lackof guidance from NIEHS meant that both researchersand IRB staff members were on their own to resolveunique and sometimes conflicting institutional concerns.For example, we developed procedures making BrownUniversity faculty partners responsible for protectingstudy participants in interviews, human and householdsample collection, and record-keeping activities. Facultypartners agreed to make quarterly visits to Communitiesfor a Better Environment and Silent Spring to checkrecord-keeping and data storage protocols, and reportedto the IRB on the collaborative’s adherence to approvedstudy protocols.In the end, the IRB agreed to provide oversight for

our research collaborative, but at first approved over-sight for only eighteen months of a four-year project.After continued dialogue and negotiation, the IRB ulti-mately agreed to continue for the full duration of theproject. While we were pleased to have obtainedapproval, the many problems in the process caused sub-stantial delays before the project could begin and alsoduring critical phases of the project as it progressed.

Who gets to know? Conflicts over dissemination of studyresultsAs we learned from interviews, IRBs frequently clashwith CBPR researchers over their practices for the disse-mination of information and results. IRBs are accus-tomed to overseeing conventional research projectswhere study participants often are not informed of per-sonal results that lack regulatory or clinical significance.The CBPR practice of having study participants workalongside researchers confounds assumptions about whoshould 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 fun-damental than their own participation in the researcheffort. CBPR posits that primary ownership of collecteddata logically lies with the participants from whom the

original samples were taken [11]. From the CBPR per-spective, it would be inappropriate and unjust to denyfull access to information that came from their ownbodies, homes, and communities, and that owes its exis-tence to their willing participation.Researchers told us that IRBs frequently express con-

cerns that disseminating uncertain data may harmhuman subjects. For example, the participant might bepsychologically harmed by receiving results if their clini-cal significance is unknown or if no valid options existto address the potential health risks they reveal [12].Indeed, the National Bioethics Advisory Committee [13]issued guidelines directing researchers to report biomar-kers only when health implications are significant andrecourse is available. These discussions may not, how-ever, have adequately considered the distinction betweencommunications related to genetic biomarkers, whichare not modifiable, and chemical exposures, many ofwhich are modifiable. When these clinical guidelines areapplied to chemical exposure research, people are leftunaware of the presence in their own bodies of foreignsubstances known to be harmful in animal studies, andsometimes in in vitro and human studies. From the per-spective of CBPR, such guidelines are an affront to indi-viduals’ and communities’ right-to-know, and byextension 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 ofsubjects and to maintain the confidentiality of data(emphasis added).” (45 CFR 46.111(a)(7)). This phrase,“when appropriate,” is highly germane to CBPR, andIRBs have flexibility in determining when confidentialityis appropriate. If people want their personal data madepublic, there is no appropriate reason to restrict therelease of that information.In CBPR, “respect for persons” requires and reinforces

a commitment to “report-back,” an ethical practice thatencourages as much as possible the dissemination ofindividual and aggregate-level results to those study par-ticipants who want to have them. This openness isvalued because it democratizes knowledge productionand helps restructure unequal power relationships [14],especially disparities in access to knowledge that tradi-tionally characterize lay-professional relationships [15].CBPR also assumes that the sharing of knowledgebetween researchers and participants empowers commu-nities and individuals to use scientific evidence to advo-cate for their own interests [11]. Report-back thusupholds the principle of beneficence by giving partici-pants access to information crucial for their health andwell-being, and by empowering them to act [2]. From abeneficence perspective, even information about anexposure for which a corresponding risk relationship is

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not available can have some benefits to participants,such as enabling personal exposure reduction. Throughthe sharing of aggregate-level data, report-back can alsomake communities aware of a problem in their midst,and give them both the motivation and the evidencethey need to organize community members into collec-tive action. Our project has spent considerable effortreporting data to individual participants and to commu-nity gatherings, in order to advance general knowledge,build local capacity for community improvement, andhelp 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 toIRB conceptions of confidentiality. For example, in the“Body Burden” study (a joint project of EnvironmentalWorking Group, Mt. Sinai School of Medicine, andCommonweal [18]) researchers discovered 167 pollu-tants (out of the 211 tested) in the blood and urine ofnine volunteers, with an average of 56 carcinogens ineach person. Aggregate study results appeared in PublicHealth Reports [19], but study participants voluntarilyplaced their individual data on the internet, with photosand personal biographies to accompany the contaminantdata [18]. Voluntary though it was, the website wouldnot have sat well with most IRBs, who would perceivethat as a violation of confidentiality.Similarly, we learned from colleagues that IRBs were

frequently bothered by the interactive researcher-partici-pant exchange typical of CBPR, one which can changeas the project develops. For example, community resi-dents’ requests for information to reduce exposure, andour own sense of responsibility, led us to build into ourproject an intervention phase for reducing householdtoxics use. We also distributed information sheets toparticipants about non-toxic alternatives and environ-mental organizations. We saw our actions as akin tohealthcare workers providing treatment and preventionadvice in medical screening.The changing relationship between researcher and

study participant is crucial to CBPR but can be trouble-some to IRBs accustomed to a more traditionalresearcher-subject relationship. For example, someresearchers noted that academic IRBs require “passive”individual report-back protocols that restrict researchersfrom proactively asking participants if they want toreceive and discuss results. Instead, researchers mayonly inform study participants how they can contactresearchers should they wish to receive individualresults. The organic and dynamic nature of researcher-participant interaction in CBPR may be problematic fora review process that assumes all researcher-subjectinteractions will be planned and obliges the reviewboard to oversee all such exchanges. IRBs may feel

obliged to review each phase of that relationship andany and all communications between researcher andparticipant before the research can proceed. This causesdelays for CBPR projects that can delay the research,prevent study participants from getting informationnecessary for their health and well-being, and maythreaten the development of a successful academic-com-munity 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 identifiedthrough the Massachusetts Cancer Registry, the Depart-ment of Public Health’s Research and Data AccessReview (RaDAR) Committee had jurisdiction over theproject. As a result, any later stages of work with theseparticipants (such as developing protocols to informthem of their individual household sampling and biomo-nitoring results) had to be cleared by the RaDAR Com-mittee. Unfortunately, that review process took manymonths, and significant difficulties arose with how theRaDAR Committee and others within the MassachusettsDepartment of Public Health (DPH) approached ourCBPR project. One delay occurred when Cape Codhomes with high levels of chemicals were retested to getmore detailed measurements that could potentiallydetermine sources of contamination and point to possi-ble remediation strategies. The DPH Bureau of Environ-mental Health Assessment initially asked to review eachletter that went to every one of these households, raisingthe possibility of protracted negotiation about the scien-tific interpretation of each individual’s finding. Finally,after a meeting with Silent Spring Institute and BrownUniversity researchers, they approved a prototype letterthat would be tailored by the research team for eachindividual’s results.The DPH action was an example of IRB review threa-

tening the very principles it hopes to uphold–in thiscase the principles of beneficence and justice. Recurringdelays from lengthy reviews, on top of funding cuts,kept study participants from getting their results in atimely fashion and jeopardized relations between theresearch team and participants, thus threatening goodCBPR practice. Women who had provided human tissueand household dust and air samples for the study wereunderstandably disconcerted with the delay in receivingtheir results. Fortunately, Silent Spring Institute’srespected status in the community and its skillful hand-ling of the delay enabled participants to stay informedon the progress of the research.IRB reluctance concerning ongoing researcher-subject

interaction was also manifest in its resistance to storingsamples in this study. Exposure assessment research is arapidly evolving field where new analytical methods andknowledge about chemicals in consumer products are

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constantly improving. Stored samples provide an oppor-tunity to re-analyze data as new research methodsbecome available and more cost-effective. For example,a major breast cancer study published in 2007 usedstored samples to show the effects of early exposure toDDT. The study reanalyzed blood samples that hadbeen donated between 1959 and 1967 for a child healthand development study. The results showed that womenexposed to the highest levels of DDT before mid-adoles-cence had a five-fold increase in breast cancer risk [20].As many women heavily exposed to DDT in childhoodare still under fifty, we may see startling effects in thecoming decades. Had those samples been destroyed, theloss to public health would have been monumental.In one instance during the Cape Cod project, the DPH

threatened to require the destruction of environmentaland biological samples immediately after the first labora-tory chemical analyses were completed, even thoughstudy participants had even given informed consent toallow their household air, dust, and tissue data to beretained for ten years for further analysis. The DPHrequirement would have undermined one of the criticalgoals of the research project - to identify sources ofendocrine-disrupting compounds in homes; new assaysmight be developed in the future to detect additionalEDCs, and if samples were destroyed, researchers wouldmiss the opportunity to analyze them. After much nego-tiation, the RaDAR Committee required the researchteam to get new consent from study participants inorder to continue storing their samples at the researchlaboratory.The Cape Cod case demonstrated how maintaining

such samples can become crucial for reasons unforesee-able at the time of IRB review. During the research, thestudy team unexpectedly found breakdown products ofa banned flame retardant. Had the samples beendestroyed, researchers would have been unable to retestthe samples to confirm the parent flame-retardant asthe source of the residues. When research participantswant their own samples destroyed, their wishes should,of course, be respected, but in the absence of thosewishes, IRB requirements to destroy biological speci-mens can in fact contravene the Belmont principles tomaximize research benefits for study participants. Thelast few years have seen a dramatic increase in knowl-edge about flame retardants, especially PBDEs, makingthese samples retroactively part of the front line of pub-lic health [21-23].Despite significant obstacles and delays related to IRB

review, our collaborative moved the MassachusettsRaDAR Committee on several critical issues, throughcontinual pressure by academic partners, Silent SpringInstitute, supporters from the Massachusetts BreastCancer Coalition, pro bono legal representation, and

state legislators. The Brown University IRB found theexperience valuable, too, and they invited us to give apresentation at a statewide research conference theyorganized in 2007.

Educating the institutional review board aboutcommunity-based participatory researchWhile attempting to shepherd CBPR projects throughthe IRB process, we and our colleagues at other institu-tions employed a range of strategies with varyingdegrees of success. For example, to help the Cape Codproject through Brown University’s IRB process, we pre-pared extensive memos to our university IRB that laidout the history and practices of CBPR, bolstered byextensive in-person dialogue and email with IRB staff.We demonstrated precedent by showing that otherresearchers at prominent institutions had successfullycarried out this kind of collaborative work while obser-ving sound ethical practices, and that another institu-tional review board had approved such multi-partnercollaborative research.One collaborative researcher we consulted suggested

researching IRB members in order to assess their famil-iarity with CBPR. At one western state university, onefaculty member invited the IRB and human subjectsadministration to an all-day CBPR workshop to improveoverall understanding of the principles of CBPR and toestablish regular communication between researchersand IRBs. Despite the many real and potential obstaclesto collaborative projects, some academic IRBs under-stand the unique circumstances inherent in CBPR work,and go out of their way to facilitate human subjects pro-tection oversight. Still, in our consultations with otherCBPR initiatives, we learned of only one case other thanours where the IRB of a major research universityagreed to be the IRB of record for a CBO partner thatwas a principal investigator in a community-academicresearch collaborative.

DiscussionResearch collaborations in the CBPR arena–and espe-cially those dealing with environmental justice–haveencountered obstacles from both university and gov-ernmental IRBs. Unnecessary roadblocks have causedcostly delays for CBPR projects and have led projectpartners to worry that residents in affected commu-nities might lose faith in the researchers and the scien-tific enterprise itself. With the aid of colleagues inother partnerships, we were able to amass supportiveevidence to make our case for our university IRB tocover all three community and academic partners inour project, but only after extensive negotiation andpressure from the Massachusetts Breast Cancer Coali-tion, and other constituents.

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The problems that arise in IRB review of CBPR pro-jects stem from the different assumptions and objectivesof diverse parties. An effective solution requires effortby all involved: IRBs, CBPR researchers, CBO partners,and funding agencies. We suggest the following guidingprinciples for successfully navigating multi-partnerCBPR projects through the IRB process (Appendix 1).

What community-based participatory researchers andtheir community partners can do1) Take time to educate the IRBWe found that helping IRBs learn about the objectivesand methods of CBPR proved useful in the review pro-cess. IRB members may be unfamiliar with CBPR andmight benefit from presentations on the history of thework, its basic principles, the funding agencies that sup-port it, the scientific and community benefits of CBPR,and the unique ethical considerations it raises. Gettingto know the IRB members in advance of the review pro-cess can help researchers assess the extent of educationabout CBPR that may be necessary.2) Make sure academic IRBs know community partnersAcademic researchers should try to connect communitypartners with IRB staff to demonstrate the community’sinvolvement in the research process and how their per-spective on human subjects protection is key to the pro-ject’s success. This might include inviting communitypartners to meetings with the IRB. Research partnerscan include this “community consent” in their IRBapplication. If the IRB lacks the familiarity, experience,or the skill set necessary for assessing the ethical issuesposed by a research project, an outside expert should bebrought in to educate the board [24].

What institutional review boards and funding institutionscan do1) Keep abreast of CBPR and other cutting-edge researchapproachesJust as IRB officials keep up with the literature on con-ventional human subjects research, they need to keepcurrent on the CBPR literature. Rather than waitinguntil they are approached for approval of a CBPR pro-ject, IRBs should prepare themselves in advance forthat encounter. Attending meetings and conferenceswhere CBPR is broadly discussed (e.g. Community-Campus Partnerships for Health, International Societyfor Environmental Epidemiology, International Societyfor Exposure Analysis, National Institute of Environ-mental Health Sciences conferences of their Partner-ships for Environmental Public Health and otherconferences) or inviting CBPR experts to share theirexperiences would help IRBs better understand CBPRapproaches.

2) Develop routine procedures for the review of CBPRprojectsRoutinizing IRB review of CBPR would keep new appli-cants from having to reinvent the wheel and wouldincrease the viability of CBPR projects. The procedurecould be developed incrementally as successful projectsprovide models for others. Alternatively, federal fundingagencies could proactively develop guidelines. For exam-ple, NIEHS could contract out the development of aprotocol to a research institution that deals withongoing CBPR issues (such as Campus-CommunityPartnerships for Health, a nonprofit organization thathas created partnerships between 1,500 communitiesand campuses). The resulting guidelines could be postedon relevant websites and form the basis for trainingsessions.If IRBs are unfamiliar with CBPR, then they are not

conducting their review according to federal regulations,which requires IRBs to be sufficiently qualified throughthe experience and qualifications of its members, includ-ing qualifications and awareness of community attitudes(45 CFR 46.107 (a)). Hence, IRBs are not meeting offi-cial requirements if they are unfamiliar with CBPR pro-cesses and lack members and advisors with suchcompetence.3) Provide clear guidance and tools for navigating IRBissues unique to academic-community collaborativesFunding institutions, especially NIH and NSF, shouldoffer human subjects training specific to CBPR research,and should sensitize universities to the importance ofsupporting community groups. University IRBs shouldbe aware that community organizations may operate ondifferent timelines, and that the intense and lengthy uni-versity IRB reporting process can create conflicts forthem. Even when giving this guidance to IRBs, research-ers doing grant-funded community-based researchwould be wise to include ample time for IRB review intheir grant proposals.Funding agencies should encourage academic institu-

tions to provide IRB oversight to both academic andcommunity partners to avoid unnecessary delays andexpenses in protocol reviews. They may want to pro-mote consortium-based approval whereby one institu-tion’s IRB is accepted by others in the consortium(Silent Spring Institute has had this experience withBoston University, a partner in some of its other pro-jects; indemnification may be necessary so that universi-ties do not bear responsibility for the actions ofcommunity partners). Funding agencies should ensurethat all community partners in the projects they sponsorwill have the resources necessary to complete the IRBprocess and comply with reporting requirements. Inaddition, funding agencies could help communicate to

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IRBs that community groups should not have to expendtheir own resources to navigate the review process.Funding institutions could use grant announcementsand descriptions to give clear guidance about the IRBissues that CBPR partners are likely to face (anotherpossible avenue for advocacy work is the AppliedResearch Ethics National Association, an organizationthat provides resources and information about ethicaland procedural issues of campus IRBs [25]).4) Regulate any conflicts of interest IRBs may bring to thereview processFor example, Massachusetts DPH RaDAR Committeehas a role to play in protecting the confidentiality ofdata obtained from the state cancer registry, but its rolein human subjects reviews must be circumscribed toavoid conflicts of interest when the agency might have avested interest in the outcome of a proposed study(because of its implications for public health agencyaction, for example). We should note that the statutoryregulations governing IRBs state that “The IRB shouldnot consider possible long-range effects of applyingknowledge gained in the research (for example, the pos-sible effects of the research on public policy) as amongthose research risks that fall within the purview of itsresponsibility.” (45 CFR 46.111(a)(2)).Creating an independent IRB for such situations

would protect human subjects while avoiding conflictsof interest that could hinder the progress of a worthystudy. That IRBs can have their own conflict of interestis a legitimate concern. A recent survey of 893 IRBmembers at 100 academic institutions found that 36percent of IRB members had at least one relationshipwith industry in the previous year, of which only two-thirds had been disclosed to the IRB. Of those reportingconflicts, nearly one-third had participated in thereviews anyway [26]. Of course, some have argued thatconflicts of interest are widespread even among inde-pendent IRBs [27], so further action may be needed.5) Reassess how IRBs oversee situations in whichparticipants desire access to and disclosure of their ownstudy resultsIn some cases, this necessitates continued interactionbetween researchers and participants, a process thatIRBs may be reluctant to allow and are poorly-designedto manage. Iterative rounds of approval for ongoingcommunication with study participants will result indelays that undermine researchers’ relationships withparticipants, and harms participants’ capacity to takeaction to reduce their exposures. Participants may alsowant to share their personal results with other studyparticipants and have the collective power to dissemi-nate their results through their own networks andbroader public forums. Putting the brakes on individualreport-back could push confidentiality protections to

collide with the principle of beneficence. Thus, CBPRchallenges IRBs to reassess the seemingly contradictoryelements of the Belmont principles, and develop alterna-tives that do not require choosing one principle overanother. Seen another way, IRB perspectives on confi-dentiality may in fact be contrary to federal law, as wenoted earlier in our point on (45 CFR 46.111(a)(7),which approaches confidentiality “when appropriate.” Aswith the earlier regulatory points on competence toreview CBPR proposals and regarding concern for publicpolicy effects, this is one of several issues in which IRBsmay not be properly heeding existing regulatoryrequirements.6) Encourage CBPR researchers and partners to educateIRBs about flexibility in regulationsAs pointed out in two above sections, IRBs are notalways aware of the flexibility in federal regulationsabout confidentiality and about competency to conductcommunity-oriented reviews. We believe that CBPRprojects can make it easier for IRBs to support them ifthey remind IRBs about such flexibility.

Working with community and tribal Institutional reviewboardsAcademic IRBs are not the only forum in which com-munity benefits of the research may be assessed. Somecommunities have convened their own review boards toassess collectively whether proposed research is justifiedand benefits the community [28]. For example, theNavajo Nation maintains its own IRB to protect its peo-ple from research that would not directly help them[29]. The Indian Health Service adds “respect for com-munities“ to the Belmont principles and expects propo-sals to discuss whether there are tribal consultants whocould be involved, whether there are community capa-city-building benefits to the tribe, whether researchershave an understanding of community research priorities,and whether researchers will provide regular and timelycommunity consultations. Similarly, the citizens’ organi-zation that oversees research on residential exposuresfrom the Fernald, Ohio, nuclear weapons plant permitsresearchers access to its records only when there is aconcrete benefit for the community, regardless of aca-demic IRB approval [30].Increasing numbers of researchers involved in com-

munity-based participatory research seek communityreview boards that emphasize community protectionsalongside traditional IRB responsibilities [31]. While tri-bal IRBs have the power of regular IRBs, other commu-nity review boards do not yet meet the requirements foroversight of federally funded research, requiring an addi-tional IRB to provide formal guarantees. Although anincreasing number of communities now overseeresearch, factors such as geographic dispersion, political

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disorganization, and the lack of authority to reviewresearch protocols prevent other communities fromdoing the same. Academic IRBs reviewing research pro-posals on behalf of such communities need to under-stand their form and organization, their communalneeds and vulnerabilities, and their existing governanceand communication structures for disseminatingresearch [32].Community representation in the review process

would be helpful not only to those explicitly engaged incommunity research but also to those engaged in indivi-dual research who may not have considered the effectsof their research on communities. NIH rules were clari-fied in 1998 to ensure that IRBs have “knowledge of thelocal research context,” but while one member of theIRB must be from outside the institution, direct com-munity representation is not required [33]. Communityrepresentation on academic IRBs usually takes the formof large, well-established organizations rather than grass-roots groups, and does not usually reflect the demo-graphic composition of the communities under study[34]. While two 2001 reports from the Office of HumanSubjects Research of NIH and the National BioethicsAdvisory Commission delineate the need to expandcommunity involvement in research beyond mere repre-sentation on IRBs [35], most pressure for deep commu-nity involvement stems from activist groups [25]. Werecommend that IRBs recruit not just any communitymembers, but those that have experience in eitherCBPR or other community-engaged research. This canprovide benefits to many IRB reviews, not only CBPRones, because of the creativity, flexibility, and respect forhuman subjects protection that comes with CBPRexperience.

Limitations of this study and recommendations for futureresearchOur understanding of IRB’s lack of familiarity withCBPR principles comes from our knowledge of a smallnumber of IRBs dealing directly with CBPR researchers.We did not conduct a survey that would be representa-tive of all IRBs, and hence our findings are not necessa-rily generalizable. However, we do think that the IRBsdealing with CBPR scholars would be more likely thanother IRBs to have such familiarity, based on past appli-cations by researchers to those IRBs. To better under-stand how IRBs in general deal with CBPR principlesand the right-to-know that we emphasize, we recom-mend broad surveys of IRBs.We recommend that health and social science

researchers study a large sample of scientists working inhuman exposure and related areas to gather moredetailed information on IRB challenges. It is importantto learn whether and how IRBs may have changed their

procedures in response to pressure for individualreport-back and community-level protection, andwhether and how researchers may have changed theirbeliefs about or methods for the reporting of individualdata. Extensive interviews with IRB staff and academicmembers should supplement interviews with research-ers. Future research should study how participantsexperience the process of informed consent in biomoni-toring and household exposure studies, the degree towhich they desire detailed information and supplemen-tary information used for reducing exposure, and theways they use their personal data to explain exposure,understand disease causation, and to seek regulatoryand other changes.

ConclusionsCBPR researchers report that IRBs are not generallyattuned to their particular needs, due to their emphasison individual consent that is based on a clinical modeland their lack of understanding about the importance ofcommunity-level consent and the need to share indivi-dual data with participants. In short, the very CBPRpractices that concern many IRBs are exactly those thatmake community-engaged work so valuable forresearching and addressing environmental justice issues.Resolving this tension requires reforming the humansubjects review process in a way that improves CBPRrather than hinders it. Further, some of the IRB restric-tions on common CBPR practices, such as sharingresults with individual study participants, may actuallyviolate federal regulations on human subjects protectionand counter the ethical concerns of study communities.Efforts to overcome these IRB challenges require a moreholistic understanding of how CBPR researchers andstudy communities (whether defined by geography,class, ethnicity, or other socially salient distinctions) col-laborate in ways that empower community organizationsto play a central role in the research process, whichincludes human subjects protection and ethical over-sight. Ultimately, IRBs will need to go beyond simplymodifying traditional oversight procedures to fundamen-tally incorporating how CBPR ethics redefines theresearch enterprise itself, including researcher-partici-pant relationships, academic-community interaction, andthe right-to-know about chemicals in people’s environ-ments, homes, and bodies.

Appendix 1: Strategies for Advancing Multi-Partner CBPR Projects Through the IRB ProcessStrategies for Researchers and Community Partners

• Educate IRB staff and board members about theobjectives and research methods of CBPR• Make sure academic IRBs know communitypartners

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• Share positive models and problematic experienceswith other teams, IRBs, and funding institutions

Strategies for IRBs and Funding Institutions• Keep abreast of CBPR and other cutting-edgeresearch approaches• Develop routine procedures for the review ofCBPR projects• Provide guidance and tools for navigating IRBissues unique to academic-community collaboratives• Regulate any conflicts of interest IRBs may bring tothe review process• Reassess how IRBs oversee situations in which par-ticipants desire access to and disclosure of their ownstudy results• Encourage CBPR researchers and partners to edu-cate IRBs about flexibility in regulations

AbbreviationsCBE: Communities for a Better Environment; CBO: community-basedorganization; CBPR: community-based participatory research; CITI:Collaborative Institutional Training Initiative; DPH: Department of PublicHealth; EDCs: endocrine disrupting compounds; IRB: Institutional ReviewBoard; NIEHS: National Institute of Environmental Health Sciences; PBDEs:polybrominated diphenyl ethers; RaDAR: Research and Data Access Review

AcknowledgementsThis research is supported by grants from the National Institute ofEnvironmental Health Sciences (1 R25 ES013258-01), the National ScienceFoundation (SES-0450837 and SES-0822724), and the National Heart, Lungand Blood Institute (T15HL069792). No funder had any input into researchdesign, interpretation, analysis, or writing. We thank Crystal Adams, MaraAverick, Angela Hackel, and Elizabeth Hoover for comments on themanuscript.

Author details1Brown University, Department of Sociology and Center for EnvironmentalStudies, Box 1916, Providence RI 02912, USA. 2University of California,Berkeley School of Public Health and Department of Environmental Science,Policy and Management, 137 Mulford Hall, Berkeley CA 94720-3114, USA.3Silent Spring Institute, 29 Crafts Street, Newton MA 02458, USA. 4TuftsUniversity Department of Community Health, 112 Packard Ave., Medford MA02555, USA. 5University of Wisconsin Department of Family Medicine andDepartment of Rural Sociology, 1450 Linden Drive Madison, WI 53706-1522,USA. 6Communities for a Better Environment, 1904 Franklin Street, Suite 600,Oakland CA 94612, USA. 7Bryn Mawr College, Department of Sociology, 101North Merion Avenue Bryn Mawr PA 19010-2899, USA.

Authors’ contributionsPB conceived the study, conducted some of the interviews, made theconference presentation that led to the article, and led the article writing.RMF conducted some of the interviews and played a major role in writingand editing the article. JB led the larger study from which this study arose,conducted some of the interviews, assisted in the conference presentation,and worked on writing the article. RGA conducted some of the interviews,assisted in the conference presentation, and worked on writing the article.RAR played a major role in the conference presentation and assisted withthe article writing. LS researched the background literature and assisted inwriting the article. CP provided data about the community partners’ roles indealing with the IRB, and assisted in the conference presentation. RS playedassisted in editing and writing the final version of the article for submission.

Competing interestsThe authors declare that they have no competing interests.

Received: 15 December 2009 Accepted: 16 July 2010Published: 16 July 2010

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doi:10.1186/1476-069X-9-39Cite this article as: Brown et al.: Institutional review board challengesrelated to community-based participatory research on human exposureto environmental toxins: A case study. Environmental Health 2010 9:39.

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