Preparing and Complying with Institutional Review Board Protocols ...

Journal of Ethics and Entrepreneurship, Vol. 2, No. 1 (Spring 2012), pp. 21-35©Gardner-Webb University. All rights reserved.21Preparing and Complying with InstitutionalReview Board Protocols for IntegratedResearch and EntrepreneurshipVentures in Developing CountriesCarey Bell, Rachel Dzombak, Tara Sulewski, and Khanjan MehtaaBstraCtIncreasing numbers of colleges and universities are designing academic research andentrepreneurial engagement programs to engage students in developing solutions foralleviating global poverty. While these efforts have potential for dramatic positive impact,they can also result in enormous and unintended negative consequences. To guard againstthis, Institutional Review Boards (IRBs) evaluate proposed research projects to ensure thesafety of participants and their communities as well as the scientific and ethicalappropriateness. e Humanitarian Engineering and Social Entrepreneurship (HESE)Program at Penn State is engaged in several student ventures that integrate teaching, research,and entrepreneurial outreach to educate entrepreneurial global citizens and create sustainablevalue for developing communities. is paper shares insights into planning and executingIRB-approved international research ventures with similar programs at other universities.Based on their experiences conducting multiple IRB-approved research ventures in Kenya,the authors provide recommendations for navigating the process of gaining IRB approval andconducting research in developing communities as well as discuss some of the larger conflictsthat researchers and entrepreneurs will have to face in their own ventures.CarEY BEll is a J.D. candidate at the University of Pennsylvania Law School with an expected graduationdate of May 2014. Email: bellca@law.upenn.eduraCHEl dzomBak is pursuing a B.S. in Bioengineering at the Pennsylvania State University with anexpected graduation date of May 2012. Email: rvd5040@psu.edutara sulEwski is a graduate student in the MNE Department and an Instructor of Engineering Designat the Pennsylvania State University, 213W Hammond Bld, University Park, PA 16802, Telephone:419.367.9392 Email: tls5001@psu.edukHanJan mEHta is the Director of the Humanitarian Engineering and Social Entrepreneurship (HESE)Program at the Pennsylvania State University, 213U Hammond Building, University Park, PA 16801.Telephone: 814.863.4426 Email: khanjan@engr.psu.edu

22 Journal of Ethics and EntrepreneurshipintroduCtionSignificant and unchecked levels of human deprivation in developing communitiesrepresent one of the world’s greatest challenges. Almost half the world’s population lives onless than $2.50 per day. Millions of people do not have access to clean water, sufficientamounts of food or adequate health care services (Shah, 2010). Engineers have the power toameliorate this situation by melding technological innovation with contextually appropriatedesign. However, 90% of the world’s engineering efforts currently impact only 10% of theworld’s population (Smithsonian, 2010).In an effort to address this discrepancy and foster innovation and global awareness in theirstudents, increasing numbers of colleges and universities are designing academic programsthat engage students in developing solutions to these complex problems. e collective powerof these efforts has the potential to create dramatic, positive global impact. However, thesesame ventures, regardless of their intentions, also have the potential to result in negativeconsequences in the communities where they are undertaken. Lack of familiarity with, andthe inherent unpredictability of, these foreign environments can further complicate thedesign and implementation of integrated research and outreach projects.Universities and research institutions have set up Institutional Review Boards (IRBs) toevaluate proposed research projects involving human participants for scientific and ethicalappropriateness. is paper discusses the issues encountered, lessons learned, and conflictsexperienced by a team of Penn State students while designing and implementing four IRBapprovedresearch and entrepreneurship ventures in Kenya in the summer of 2010.One team, comprised of both students and healthcare professionals, field-tested Mashavu:Networked Health Solutions, a telemedicine system that connects rural communities withdoctors. Another team field-tested a cell-phone based social networking system calledWishVast: Building Trust and Social Capital using Cellphones. A third team constructedvarious appropriate technologies including low-cost anaerobic digesters, greenhouses andirrigation systems. Each project had several research studies associated with them, with thepurpose of informing the design of the system and generating and sharing knowledge toencourage and inspire more entrepreneurs. Besides these integrated research andentrepreneurship efforts, two research-only efforts were also undertaken. Both of the researchprojects were related to entrepreneurship among street-dwelling youth in the urban area ofNairobi. Our primary host in Kenya was the Children and Youth Empowerment Center(CYEC), a public-private organization that cares for former street-dwelling youth in Nyeri,Kenya. Several CYEC youth between the ages of 18 and 26 worked shoulder-to-shoulderwith the Penn State team.similar EFFortsIn recent years, several academic programs have emerged to help meet the needs ofunderserved populations. Academic programs like Humanitarian Engineering and SocialEntrepreneurship at Penn State are also on the rise. e Humanitarian EngineeringLeadership Projects program at Dartmouth, the D-Lab at MIT, the HumanitarianEngineering program at the Colorado School of Mines, Global Resolve at Arizona State, andthe Mortenson Center in Engineering for Developing Communities at the University ofColorado at Boulder are some examples. Students and faculty from these programs have beeninvolved in numerous ventures such as working to provide clean water in regions of Tanzania

Bell, Dzombak, Sulewski, and Mehta23and Kenya, generating solar power in Belize, designing solar ovens and drip irrigation systems,and producing hydroelectricity and biogas in Rwanda (Dartmouth HumanitarianEngineering Projects, 2008; MIT: About D-Lab, 2010; Humanitarian Engineering:Colorado School of Mines, 2010; Arizona State University, 2011). Several programs integrateapplied research initiatives with the entrepreneurial ventures. Research projects span frominnovative technologies to appropriate business models, effective stakeholder managementstrategies and design tools.In an effort to guide researchers working in developing communities, Desai & Potter(2006) and Scheyven & Storey (2003) provide introductory guides to the numerouspractical, ethical, and contextual issues of performing research in developing communities.Oakes (2002) and Gordon (2003) identify problems typically encountered by internationalresearchers seeking IRB approval and ways to overcome them. Cargo & Mercer (2008)evaluate existing participatory research literature and provide recommendations. is paperbuilds upon these efforts by sharing insights into issues encountered in the IRB approvalprocess and practical challenges encountered while conducting the studies in East Africa. eauthors believe that the IRBs serve a very important function by protecting participants andhelping researchers preserve the integrity of their research endeavors. At the same time, theIRBs are not fundamentally designed for developing country contexts and hence presentunique challenges that researchers must navigate.tHE institutional rEviEw BoardInstitutional Review Boards (IRBs) are “responsible to review and approve, requiremodifications in, or withhold approval of research involving human participants.” An IRBcommittee is composed of five or more individuals of diverse backgrounds. ough typicallya part of a research organization such as a university, these bodies operate independently fromtheir parent structure and in compliance with federal regulations in order to maintainlegitimacy (Oakes, 2002).History of irBse initial drive for human research protections arose out of the horrors of Naziexperimentation revealed at the Nuremberg trials following WWII. In the wake of the trials,the Nuremberg Code was draed to set guidelines for human research (Oakes, 2002). In1964, the World Health Organization endorsed the use of review boards to protect humansubjects from risk in the Declaration of Helsinki (Hamburger, 2004). Pressure for humansubject protections in the US grew as the public became increasingly aware of unsafe andunethical research practices then in wide use, particularly with the exposure of the Tuskegeesyphilis study. us, in the 1970s, the US government began to require research studies to begranted IRB approval in order to receive federal support (Hamburger, 2004). Since then,IRBs have proliferated and are now a mainstay at most research institutions (Oakes, 2002).Benefits of irBsFirst and most obviously, IRBs help ensure the safety of human research participants, aconsideration which should be foremost in the mind of any researcher. Furthermore, IRBshelp to standardize research methods and protocols for addressing ethical dilemmas. IRBapproval lends credibility to research and helps teach students proper research methods.Despite numerous efforts on the part of a team of investigators, subject risks and liabilities

24 Journal of Ethics and Entrepreneurshipcan find their way into the research design unnoticed. In the case of international research,attention to cultural norms and local authority structures in experiment design is paramountand can be improperly treated due to the researcher’s unfamiliarity with the context. Whenfaced with such diverse constraints, fundamental human participant rights such as voluntaryinformed consent can be compromised. IRBs exist as a check against such naturally occurringlapses in judgment. A simple but significant issue is that IRBs are responsible for appropriateconduct of research, and are not directly providing oversight for publication.e many current controversies surrounding practices in human subject research in thedeveloping world point to the continued need for rigorous ethical evaluation of proposedprojects. e debates over proper research participant compensation and the use of placebocontrolsin clinical trials like those undertaken by US Centers for Disease Control andPrevention and National Institutes of Health sponsored trials of Zidovudine serve as primeexamples (Shaffer, et al., 2006; Levine, 1998). By applying uniform regulations drawn largelyfrom federal guidelines, the IRB serves to eliminate discrepancies in the application ofresearch protections which, if unchecked, could ultimately harm human subjects (Oakes,2002).e exact number of IRBs currently in existence is unclear; however, Oakes cites Amdurand Bankert as putting the figure at over 4,000 in the year 2002 (Amdur & Bankert, 2002;Oakes, 2002). e growing use of IRBs as a means of research approval and standardizationlends increased credibility to IRB- approved research studies while casting doubt on thosewithout it. A 2001 report by the National Bioethics Advisory Commission called for an endto government funding of any clinical research in the developing world that is not approvedby an ethics committee or fails to conform to a number of Belmont Report inspired, IRB-likeregulations (NBAC, 2001). At Penn State, any research requiring IRB approval, conductedwithout securing such approval, is not generally publishable. Such an act might jeopardizefuture use of the data and also lead to disciplinary sanctions against the researchers. oughthere are some situations where the data might still be used, it is at the discretion of the IRB,and cannot be taken for granted. IRB approval is thus a critical step in the legitimization ofany research effort. Additionally, by guiding students step by step through the design of aresearch study, the IRB process helps teach students the fundamental considerations involvedin that process. As a result of the pre-planning required by the IRB process, studies are betterdesigned, and for those being conducted internationally, more ready for implementationimmediately upon arrival in the host country.Critiques of irBDespite the long and positive history of IRBs in guiding research and protecting humansubjects, much of the literature surrounding them focuses on ways the regulatory efforts ofthese committees impede research, particularly in the social sciences. Part of this problemstems from the fact that the regulations upon which IRBs are based were written bybiomedical researchers who consider only applications within their own field of research. issort of regulation is considerably less applicable to social science research (Oakes, 2002).Some researchers fear that the labor-intensive IRB process could have a “chilling effect” onsocial science investigation by thwarting efforts at research, particularly the efforts ofundergraduate and graduate students who find themselves under strict time constraints(Barzilai, 2007, p. 6). e IRB approval process can take months and in some instances citedby Barzilai (2007), years. is could be due to the nature of the study, or the responsiveness of

Bell, Dzombak, Sulewski, and Mehta25the researchers and/or the IRB. As a result, students might shy away from research for whichthey feel they cannot gain timely approval. Attempts to circumvent the IRB either by alteringresearch methods or ignoring it altogether can create further problems through less accurate,less contextually and ethically appropriate research (Barzilai, 2007).research in developing Communitiesere is growing concern that research undertaken by industrialized country organizationsand institutions in developing communities exploits participants. Researchers in both the USand developing countries have expressed concern that US IRBs are too procedurally-orientedand focus insufficiently on content. Many cite IRBs’ frequent insistence on individual’swritten consent as an example. Researchers have also questioned whether US IRBs aresufficiently familiar with the cultural contexts in these communities to effectively guideresearch initiatives (Hyder, 2004) (Kass, Dawson, & Loyo-Berrios, 2003).Related works have discussed many of the difficulties that can arise while conductingresearch in developing communities. Anokwa et al. detail the most common challengesencountered by a group of nine North American researchers in developing communities.Chavan (2005) emphasizes the importance of contextually appropriate design and Russo &Boor (2003) provide insights into communicating through translation. Other commonlyhighlighted issues include: written vs. oral consent, levels of risk, use of audiotapes,recruitment of subjects, vulnerable populations, and de-identification and destruction of data.navigating tHE irB proCEss ForrEsEarCH in dEvEloping nationsIn many ways, the frustration with the IRB process stems from an incompleteunderstanding of it (Oakes, 2002). is section details key points in the IRB-approvalprocess.irB structures and timelinee IRB process can be extremely time-consuming. For instance, IRB committees meet ona pre-determined schedule and review a number of studies each time. e frequency ofmeetings depends on the size and nature of the institution. As a result, reviews andmodifications may take weeks or months, not days. is is particularly true in the springsemester when IRB committees receive large numbers of submissions for research to takeplace in the summer. It is best to begin the IRB process as early as possible to ensure timelyapproval.research approval at the local levelAs per federal regulations, the IRB application requires researchers to explain how they willgain local approval for the proposed research. An IRB will ask for documentation of thisapproval prior to the departure of the research team. is requirement can prove exceedinglydifficult as many cultures rely largely on oral communication and face-to-face meetings thanon written letters and email. ough some countries have their own IRBs, these are devotedto medical research and the timelines and procedures for social science research may, as aresult, require several months or years. Many of these IRBs do not review social scienceprotocols.

26 Journal of Ethics and EntrepreneurshipInstitutional IRB approval also requires documentation of research approval from any localIRB or ethics committees and mandates compliance with any locally-established researchprotocols. In the absence of any such local body, IRB will require letters of collaboration fromlocal partners. Some institutions may require letters of local collaboration in addition todocumented compliance with the requirements of local protocols. Our projects received IRBapproval only aer collaboration letters from our local partner - the Children and YouthEmpowerment Center (CYEC) were submitted. e CYEC obtained verbal approval fromappropriate authorities in the Ministry of Public Health and Sanitation before providing thesupport letters to us.Conducting appropriate and ethical research requires going beyond IRB stipulations.Although we had already obtained verbal consent for the study through our partner, our firststep in Kenya before conducting any research was to meet with local and provincialgovernment officials. Details of the studies were discussed with several local, district andprovincial chiefs. A letter of approval, draed by our team was edited and signed by theseofficials and then forwarded to all local entities. is was the actual protocol for localapproval – which could be conducted only when we were actually on site and ready toconduct the study.letters of CollaborationLetters of collaboration are required to document the understanding and willingcooperation of research partners in the host country. is documentation is oen difficult toobtain since the required level of understanding and cooperation can be difficult toadequately convey through a letter. e letter must bear an original signature and that mayprove problematic as well. Most US institutional IRBs do not oen realize that developingcountries have unreliable courier and postal services. When working in rural, developingcountry communities, it may take a very long time to get a letter with an original (ink)signature. Oen, local authorities will expect to meet with researchers once they arrive in thecountry, rather than having to sign-off on a project months in advance. e IRB must also beassured that the local collaborator possesses adequate authority to consent to the proposedresearch and provide assistance to the researchers. A classic catch-22 situation happens whenthe IRB needs letters from local partners while the local partners are waiting on letters fromIRB. In a situation like this, the IRB might be able to grant approval with stipulations that thenecessary letters be turned in at a later date, but before commencing the research study.Providing detailed information about the larger picture of the study is likely to alleviate IRB’sconcerns and increase the likelihood of approval.We obtained one letter of support from our local partner at the primary research site. Wewere unable to provide additional letters of support because, at the time of IRB application,we were unsure of the additional locations in which we might be working. Our team hadpreviously conducted research studies in several other countries and we knew it is customaryfor the local partners to request us to dra the support letters and provide them in a ready-tosignformat. Typically, the local partners do not seriously review the research protocol or offersuggestions; but merely conduct a perfunctory review, then sign and return the letters.location of researchIRB requires that the location of proposed research be provided along with relevantcontact information. Determining research locations oen requires additional coordinationwith local partners aer arrival in the host country. In these instances, providing an exact

Bell, Dzombak, Sulewski, and Mehta27location in advance can be impossible. We knew prior to departure that we would be workingextensively at a specific site in Nyeri and we provided that information in our proposal.However, we knew that we would be holding clinics in additional locations to reach a largerand more diverse sampling of participants. Our application stated that we would beconducting research in two additional locations and was approved. Without one concreteaddress and local contacts, it is doubtful that the protocol would have been approved. eIRB is likely to approve studies where altering the exact location (within a larger defined area)does not affect the nature of the study and the participants, or does not lead to a substantialchange in the demographic or the topic.Biomedical devices and researchDepending on the kind of biomedical device incorporated into research, the IRB mightrequire that a non-biased, non-affiliated expert write a letter certifying the device(s) as lowrisk.A key factor is whether the researchers are using FDA-approved devices in their intendedway. In our case, an electrical engineer provided validation of the medical devices used as partof the telemedicine system. e IRB will also question whether or not a device requires FDAapproval to be included in the study. We were initially required to gain FDA approval for ourdevices. is requirement was removed once we explained that we would be using FDAapproved devices to support our own low-risk, proof-of-concept devices and that healthinformation provided to participants would always be drawn from the FDA-approvedcommercial devices.data storage, de-identification, and disposalIRB requires that proposals describe the exact means of data storage, de-identification anddisposal. Researchers are allowed to keep the data indefinitely, with or without identifier.However, the researchers must make their intent very clear and provide sound rationale.ese are seemingly small issues but procedures must be put in place to secure IRB approval.We detailed all of this information, including the building and room number of the computerat Penn State where the data would ultimately be stored. is is particularly challenging whenlarge student teams need access to low-risk non-identifiable data.photosAs part of the data disposal procedure, IRB requires that all photos taken of researchparticipants be disposed off as well. However, photography is a standard expectation ofinternational student ventures. ere were numerous instances in Kenya where students tookpictures of participants outside the context of the research, either for personal reasons orbecause the participants themselves requested them. ese photos represent a priceless part ofthe student’s international experience. With the growing popularity of camera-phones, thereis virtually no way to regulate student (and participant) photography and ensure that allpictures are destroyed. Participant permission for using photographs in publications must besought separately than the IRB recruitment and consent processes.managing risk of protocol rejectionIf research projects contain multiple studies, we suggest dividing the activities acrossmultiple IRB applications. By decoupling the sub-projects across multiple protocols, the riskposed by the rejection of a single research protocol is minimized. Rather than an entireproject being disapproved, only one portion of it might be rejected. Since we were working

28 Journal of Ethics and Entrepreneurshipwith a relatively short (two month) timeline, we prepared separate IRB applications for thedifferent portions of our projects depending on the level of risk involved. While many ofthese applications were approved early on, one was not approved until the day of ourdeparture. Had that application not been approved, we would still have been able to continuewith the other aspects of our studies. is would not have been the case had we submitted asingle IRB application for our combined research initiatives.meet with irB staff prior to applicationAn initial face-to-face meeting will help identify any possible issues with your protocol.Eliminating these issues before a protocol is submitted for review can save valuable time.Furthermore, face-to-face meetings provide researchers with an opportunity to allay the fearsand concerns of IRB reviewers. A major source of confusion is the research proposal that isuploaded with the IRB protocol. It is common to have a proposal “spun” in various ways toseek funding from organizations with different objectives. In that case, the research protocolmight not conform completely to the proposal and could lead to confusion and incorrectassumptions. Simple terminology and avoiding jargon help the IRB understand the intentand associated risks better. For instance, initially the IRB assumed that we planned to havesick patients participate in the telemedicine clinic. is would not have qualified it as a lowriskstudy. e protocol would then have gone through a full review and requiredclarifications on patient treatment, access to medical professionals, etc. In fact, we intended toprovide personal health information to healthy patients only. Once this was explained, and aprotocol was designed to provide services for any sick individuals outside the research process,the protocol was approved. e IRB staff was extremely helpful in advising us on the course ofaction. e face-to-face meeting and explaining the potential benefits of the studies to theparticipants helped establish us as socially responsible researchers.issuEs EnCountErEd wHilEConduCting tHE studiEs in kEnYarecruitment and ConsentConsent forms and recruitment scripts are two critical parts of the IRB protocol. For eachportion of a study involving a participant, the individual has to be recruited and provided fullinformation about the study. e participant must understand the information presented andagree to participate. Obtaining written consent is a general standard of IRBs, but in theKenyan context it was not appropriate to request signed consent because it would not beviewed as normal or appropriate in East African culture (Gordon, 2003). Both Gordon andOakes in their discussions of informed consent mention the Euro-centricity of the concept ofwritten consent (Gordon, 2003; Oakes, 2002). In the East African context, the use of writtenconsent would have generated a lot of trust issues. Written and signed documents are mostoen associated with land titles and other legal documents, so research participation formswould have been treated with suspicion, especially considering that they would have beenprinted in English, the second or third language of those individuals recruited for the study.Because of these cultural differences, we used verbal consent rather than written consent. Aletter from our local partner helped make the case for verbal consent to the IRB. e processwas that aer someone went through the recruitment procedure, the investigator reiteratedthe terms of the study and asked “Do you agree to take part in this study? A “yes” constituted

Bell, Dzombak, Sulewski, and Mehta29consent. is process was conducted in English, and when necessary, was facilitated by atranslator to ensure full participant understanding.As per IRB requirements, the recruitment script had to be read verbatim. e approvedrecruitment script was written in very formal English, as is the norm for research conductedin the United States. However, the Kenyan research participants, even those who spokeEnglish very well, oen did not fully understand the recruitment script but agreed toparticipate anyway. is problem became clear almost immediately as individuals arrived atthe first stages of the clinical appraisal still unsure of exactly why they were there. Ifparticipants do not have a clear idea of the research being conducted and their role in it, thenthe principle of informed consent is violated and participants are being taken advantage of.To address this problem, aer reading the official script, the team began to paraphrase therecruitment script in simpler understandable English to explain the study to each participantindividually. e participants then understood our goals and their role in our research. As aresult, they began to ask questions and offer feedback even before they went through theMashavu system itself. e simple verbal explanation significantly improved trust andcommunication and was absolutely necessary in order to adhere to the standard of voluntaryinformed consent.Challenge of interviewing individualsIn some situations, it was particularly difficult to interview individuals because oen acrowd would immediately surround the researcher. As a result, questions posed to anindividual were invariably answered by the group. Suggestions to sit down in a restaurant tobe interviewed were not heeded. e participants, in one case, insisted that they livedtogether and were friends, and should therefore be interviewed together.Comfort with conducting medical researchQuestions of a personal nature that would be essential to ask in a real-world telemedicinesystem proved difficult and awkward for students to ask. e doctors we were working withneeded this information, but the students asking those questions were uncomfortable doingso. We resolved this situation by having the doctors ask those questions if they felt themnecessary following their examination of the participants’ health information. In a true trialof the system, the kiosk worker would have asked these questions, but due to the nature ofour research study, this was not feasible.language BarrierWe realized very quickly upon our arrival in Kenya that we would require intermediarieswho spoke both English and the local language to conduct our research. Our belief prior toarrival, and one that was largely validated, was that a majority of the younger Kenyans spokeEnglish. However, we did not consider that we would be hosting clinics primarily onweekdays, when most young people were at work or school. is meant that our primarydemographic for these clinics shied from younger, English-speaking community membersto older individuals from rural areas who spoke significantly less English.Youth affiliated with our local partners facilitated the interviews but a number ofcommunication issues arose. At times, the patient would respond to a question with a longanswer, sometimes speaking for over a minute, and the students would translate the responseas “e patient said he liked it.” One might expect that in the face of this problem,translation would take place sentence by sentence, but this proved a difficult concept toexplain and even more difficult to implement. Medical and technical terms were also a source

30 Journal of Ethics and Entrepreneurshipof difficulty. Translators were at times unable to come up with an equivalent term for somesymptoms during the medical history portion of the exam or had difficulty describing theexact nature of a biomedical device. Any data obtained through incomplete or inaccuratecommunication was not included in our final data set.Community recruiter translation issueTo mobilize research participants we met with local community leaders, explained ourproject and asked that they help us recruit participants. ese community leaders weretypically very excited about the project and helped to spread the word about it. However, theMashavu message was now migrating from English into Swahili and other local languagesthrough multiple intermediaries. As a result, we had numerous potential participants arrivewith a somewhat inaccurate idea of why they were there. e word ‘clinic’ was oen used todescribe our activities, both by us and by those spreading the word about Mashavu. However,‘clinic’ also implied doctors and medicine to local residents. ough two US doctors (withpermission to practice in Kenya) and a local medical professional were with us at all times, ourpurpose was not treatment. is fact was not well communicated to people prior to theirarrival. We solved this problem by communicating to everyone upon their arrival the exactnature of the project, their potential role as participants and the potential benefits of theMashavu telemedicine system.Clinic logisticsOen our community recruiters were so effective that more potential participants arrivedat the telemedicine clinic than we had time or space to accommodate. Because this situationhad occurred in previous years, we prepared in advance for this possibility. Each step of theclinic process, from where participants would line up to the timing of the post-clinicinterviews, was planned and streamlined for efficiency. Even with careful preparation,circumstances required that our plans be continuously modified. For example, we had initiallyset up the two telemedicine booths with only a single person to collect and record medicalinformation. is allowed only two participants to have their medical information collectedand transmitted to a doctor at one time. In our first clinic we changed our approach andemployed multiple operators so that each medical device was continually in use thus allowingus to see considerably more people.However, even with these measures in place, a situation arose at one clinic, where morepeople arrived than we could screen in a single day. We informed attendees, some whom hadtraveled a significant distance for medical advice, that we would not be able to see them.Ultimately, we decided to forgo any further research data collection and focus exclusively oncollecting participant health information and transmitting it to the doctors who could thenprovide health recommendations. While we did not collect nearly as much information thatday as we could have, we were able to connect every participant who arrived with a doctor.is approach also built more trust with the local partners by reinforcing that the socialimpact was more important to us than the research studies.involvement CriteriaCompleting an IRB protocol requires a detailed description of exactly who will participatein the proposed study. Children under the age of 18, currently incarcerated persons, sickpeople, or pregnant women are specially protected and require additional detailedexplanations to justify their inclusion. e age of majority varies across cultures and countriesand hence the age threshold for parental approval varies too. In many cultures it is customary

Bell, Dzombak, Sulewski, and Mehta31for a community elder or person in authority (e.g. tribal chief or school headmaster) to giveapproval for working with minors in a school or community setting. We agreed not toinclude any of these protected groups in our studies. We realized that the stipulation that noparticipants should be under the age of 18 would create some issues because many of theelderly participants are also the primary caregivers for the children in their (extended) family.ese elderly participants would bring the children over with them and expect that theyreceive a consultation too. Declining the children participation altogether would have beenconsidered impolite. To solve this problem, we wrote into our IRB proposal that we would setup a children’s clinic where they could participate in a minor activity and no informationwould be recorded. is simple, IRB-approved solution worked without any problems.research participation incentivesResearch incentives like material compensation and the opportunity to advance knowledgecan be inherent or incidental to participation. One contentious form of incentive is financialcompensation. No federal guidelines exist in regard to financial compensation for researchparticipation and individual institutions have varying regulations. In most contexts,participants expect some form of compensation for participation. Local custom oen dictatesthat a beverage or a meal be shared as part of the (data collection) conversation. Manyparticipants expect some sort of tangible benefit for their time and insights. Typically, weprovided beverages as a part of the participation experience and we also provided allparticipants with a notecard detailing their health measurements. We did not provide directfinancial compensation.Only two issues arose with research compensation over the course of the data-collectionphase. Students from a local university that participated in the studies expected to receivesome sort of letter or certificate documenting their participation. Another situation occurredwith a student conducting interviews with street youth in Nairobi. e researcher would offerto share a soda with the youth while the interview was being conducted. Oen theinterviewee would request alcohol instead, as the price was similar. In these instances theresearcher explained that university regulations would not allow him to purchase the localbrew. In no case did this prove to be a significant barrier to the interview, but it represents animportant contingency not considered in the design and planning phases of the research.largEr ConFliCts and CHallEngEs“Hit-and-run” researchResearch conducted in developing communities has increasingly been accused of being“hit-and-run,” meaning that researchers “parachute in, conduct research on communitymembers, and leave without providing any information or assistance” (Cargo & Mercer,2008, p. 326). Critics also contend that developing countries are oen chosen as the site ofresearch because researchers are subject to decreased legal and financial liability, cheaper costsof conducting research, and less scrutiny in regards to safety and ethics (Mugerwa, Kaleebu,Mugyenyi, & Kotongole-Mbidde, 2002). In such instances, developing communities are notresearch partners, but are the victims of exploitation (Zimmet, 2000). Even when the researchsite is chosen because ultimately the research aim is to benefit that community, it is stillimportant that the host community be engaged in the research process and benefit in thetransfer of knowledge and experience (Cargo & Mercer, 2008). Additionally, communityengagement will increase the likelihood that the host community will embrace and utilizeresearch findings and applications (Cargo & Mercer, 2008).

32 Journal of Ethics and EntrepreneurshipOur research initiatives in Kenya are based upon a four-year collaboration with our primarylocal partner and seven years of engagement in the country. Staff from the partneringorganizations advised us in the development and implementation of the research projectswhile Kenyan youth assisted in the research projects, as well as in the entrepreneurial ventures.Community members who were engaged in the studies saw the potential short-term andlong-term benefits and were happy to participate. e community members trusted our localpartners which helped open doors for our team. e trusting environment and anunderstanding of the perceived benefits helped us connect with more participants and getmore accurate and valid data from them. On the other hand, we have witnessed first-handsituations where participants get agitated because several researchers come knocking on theirdoors. e people do not know who the researchers are, how their communities wouldbenefit, or if their responses might have negative consequences. Situations like these are fairlycommon in some of the well-known slums like Kibera in Nairobi. One of the researchparticipants estimated that on any given day, at least fiy groups of researchers are conductingsome sort of survey in the slum. Such studies have a negative effect on the local people’sinterest and comfort level in participation. It also brings the validity of the data and ethicalappropriateness of the research endeavor into question. e situation is further compoundedwhen a substantial amount of money is paid to participants as compensation. How many ofthese research endeavors lead to any benefits for the people or result in useful publications?e strictures of the irB and those of a student research BudgetConforming strictly to IRB regulations on the budget of a student venture is virtuallyimpossible. In spite of numerous grants and a substantial amount of self-funding, we foundthe goals of our research to be incompatible with the demands of the IRB. A perfect IRBapplication would have detailed exactly where all of our research would have taken place andexactly who would participate and would include letters of support from all local officialsacross all the research sites. Due to cultural constraints previously mentioned, this would haverequired having a team in Kenya to conduct face-to-face meetings with collaborators andsecuring their written support of the project prior to receiving IRB approval and schedulingthe remainder of the team’s activities. Even then, officials are not likely to have signed supportletters until the full team was in Kenya and a meeting had been held. Once we arrived inKenya we did receive these letters of support and wholehearted collaboration and support ateach of our research sites, but to provide this documentation prior to our departure would nothave been feasible.e IRB asks if researchers speak the same language as participants. We responded yes,bearing in mind that we intended to communicate in English. However, English is not thefirst language of most Kenyans and this poses communication difficulties, especially when anyjargon is involved. All documents provided to participants should have been ideally translatedinto Kiswahili and the three local languages of the regions we intended to visit. Finding fluentspeakers of both English and each of these languages who would be willing to help is animpossible and expensive task. Collecting appropriate and valid data for the study andperfectly protecting participants at the same time are extremely difficult to achieve on ashoestring budget.e Collision of Circumstance and ‘appropriate research’Striking a balance between acting appropriately in an international context, conducting ascientific research experiment, and advancing an entrepreneurial venture can be a very

Bell, Dzombak, Sulewski, and Mehta33complicated task. Each aspect is equally important and needs to be performed with the sameamount of integrity. An IRB protocol strictly outlines the proposed research method.However, in the developing world, chaos and entropy pervade any sort of researchexperiment. Conditions and circumstances influencing the research effort change constantly.Despite all attempts to adhere to the plan outlined in an IRB protocol, it is not alwayspossible.Entrepreneurial ventures are chaotic by nature, requiring fast adaptation to changingcircumstances and demands. Our venture strategy was recalibrated on a daily basis dependingon the accomplishments of the day and partner dynamics. We frequently found ourselvesunder pressure to adapt the IRB protocol in order to gather relevant and useful data.However, IRB requires that any changes to the research plan must be approved by them - atime-consuming process. In the middle of a clinic, circumstances oen arose that required usto alter the procedure or risk neglecting the needs of clinic participants. e incredibleflexibility required by entrepreneurial ventures and developing country research endeavorsdirectly contradicts the stringent requirements of the traditional research methods and theIRB.For example, although we had many partners and connections in Kenya prior to our arrival,the process of making more local connections continued aer we were in Kenya. As a result,we had an opportunity to hold clinics in more locations than just the CYEC and the twoother sites approved by IRB. is would have allowed us to field-test the telemedicine systemfurther and to collect a greater number of responses from a more diverse sampling. From aresearch and business perspective this would have been a positive outcome, but it was notIRB-appropriate. Primarily due to our interpretation of IRB limitations, we were ultimatelylimited to three locations. However, aer return from Kenya, while deliberating with IRBstaff, we realized that we could have held more clinics because we were not altering the studyin any substantive manner. e IRB’s function is to protect all research stakeholders, whichincludes participants, researchers, the institution, etc. e IRBs have a considerable amount ofwiggle room in evaluating and approving protocols. It is essential for researchers to lay out thebig picture about the study and demonstrate a thorough understanding of the culture, abilityto identify risky issues, the probability of risk and impact.ConClusionis paper presented insights and lessons learned from integrated research andentrepreneurship endeavors in developing communities. Several larger themes emerge: theimportance of contextual considerations in any research effort within a foreign culture, theimportance of regulatory oversight, and the inherent contradictions and challenges of theIRB system. A complementary challenge is the lack of accessible educational materials thateducate researchers on how to successfully navigate the IRB process rather than focus on abinary classification of what is allowed and disallowed. New educational initiatives, like theScholarship and Research Integrity (SARI) program at Penn State are being designed to “offergraduate students comprehensive, multilevel training in the responsible conduct of research,in a way that is tailored to address the issues faced by individual disciplines.” An encouragingparadigm shi is the evolution from a ‘culture of compliance’ to a ‘culture of concern’. Severalchallenges remain, but the IRBs are getting friendlier and more approachable as they realizethat being pro-active in working with researchers is the best way to create a win-win situationfor all stakeholders.

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