Secondary Logo

Journal Logo

Research Reports

How Single Institutional Review Boards Manage Their Own Conflicts of Interest: Findings From a National Interview Study

Pivovarova, Ekaterina PhD; Klitzman, Robert L. MD; Murray, Alexandra MPA; Stiles, Deborah F. JD; Appelbaum, Paul S. MD; Lidz, Charles W. PhD

Author Information
doi: 10.1097/ACM.0000000000002762

Abstract

The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research,1 effective on January 25, 2018, requires that all multisite studies funded by the NIH use a single IRB (sIRB). Similarly, the Federal Policy for the Protection of Human Subjects2 (the Revised Common Rule) states that all U.S.-based institutions “engaged in cooperative research must rely upon approval by a single IRB.” These policy changes will lead to rapid growth in the use of sIRBs. In response to increased centralized review of research protocols, we undertook to study IRBs already operating as sIRBs (previously referred to as central IRBs [CIRBs]). Here we examine how conflicts of interest (COIs) of the IRBs themselves are managed by sIRBs.

COIs are an important ethical concern because their presence may affect scientific decision making, research integrity, and the safety and fairness of studies.3–6 COIs are “conditions in which professional judgment tends to be unduly influenced by secondary interest.”7(p3) COIs can be financial (e.g., consulting fees)3,8–10 and nonfinancial (e.g., prestige), the latter being more difficult to delineate.11,12 Much of the research in the area has focused on researchers’ COIs.3,13,14 However, there are also important issues relating to COIs of IRBs themselves—specifically, concerns that financial and nonfinancial COIs will influence research review and IRB determinations.15–17

In 1998, the Department of Health and Human Services (DHHS) Office of the Inspector General (OIG) recognized that for-profit IRBs “may compromise the review process to please their sponsors/customers and to advance their financial well-being.”18 Nevertheless, the OIG recommended continued use of for-profit IRBs so long as those conflicts did not compromise research safety. In contrast to for-profit sIRBs, limited if any attention has been paid to potential COIs of not-for-profit sIRBs. Here we report on how three types of sIRBs—commercial, government, and academic—manage their COIs. Our findings are based on interviews with 103 sIRB administrators, chairs, members, and staff about their experience with multisite research review.

Although sIRB (previously CIRB) review of multisite research dates back decades,18 it was not until adoption of the NIH sIRB Policy that academic institutions were mandated to rely on them. Despite encouragement by the Food and Drug Administration,2,19 before the NIH sIRB Policy, most academic institutions continued to use their local IRBs (LIRBs) to conduct reviews of multisite research at their sites, even when already reviewed by other IRBs. In contrast, pharmaceutical companies and device makers quickly adopted use of commercial sIRBs whenever feasible.20,21 More recently, government and academic institutions developed their own sIRBs. There are now three types of sIRBs: commercial, government, and academic (see Table 1).

Table 1
Table 1:
Descriptions of Types of sIRBs

Guidelines about COIs of sIRBs

Few guidelines exist for identifying and managing COIs of sIRBs. The Association for the Accreditation of Human Research Protection Programs (AAHRPP), an accrediting body for human research protection programs, including IRBs, requires that all IRBs “separate competing business interests from ethics review functions.”22 Compliance with AAHRPP guidelines is voluntary, but many IRBs think it is important. For commercial (i.e., for-profit) sIRBs, this means that “IRB or Executive Committee (EC) members should not own equity in the company and senior officers … responsible for business development should not be involved in the daily operation of the review process.”22 For not-for-profit sIRBs (i.e., government and academic), the AAHRPP (Element II.1.C) states that the “director of grants and contracting, the vice president for research, or deans of research … should not serve as IRB or Executive Committee members or be involved in the daily operations.”22

For academic sIRBs, additional guidelines come from the Association of American Medical Colleges,23,24 addressing management of COIs for the institution in general, albeit not specific to IRBs. However, research suggests that many institutions do not follow these guidelines and lack policies for disclosure of their COIs.25

Here, we sought to address the dearth of research on how COIs are handled by different types of sIRBs by conducting a qualitative study of 20 sIRBs using semistructured interviews with sIRB personnel, including chairs, members, staff, and business directors. Specifically, our aims were to document existing processes for managing COIs and compare them across commercial, government, and academic sIRBs.

Method

Participant recruitment

From March 2015 until August 2017, we conducted in-depth interviews with 103 individuals involved with reviews of multisite research at 20 sIRBs (commercial, government, and academic). Eligible sIRBs were identified from multiple sources, including the AAHRPP, DHHS, published literature, and personal communications with LIRBs and sIRBs. For study inclusion, we required registration with the DHHS as an active sIRB. We excluded all sites that did not currently conduct sIRB reviews or were based outside of the United States.

We recruited sIRBs by emailing an introductory letter detailing the study to a senior administrator. We subsequently followed up with a phone call or another email. We contacted 49 eligible sIRBs, of which 30 were commercial and 19 were not-for-profit (government or academic) (see Figure 1). We enrolled 7 commercial sites (23.3% of those contacted) and 13 not-for-profit sites (68.4% of those contacted). One commercial site initially agreed to participate, but withdrew after one interview was conducted, without providing an explanation. We attempted to recruit all sizes of sIRBs, including the 4 largest commercial U.S. sIRBs. However, after initially providing us with letters of support, all 4 large commercial sIRBs ultimately declined to participate.

Figure 1
Figure 1:
Interviewee recruitment and enrollment summary, from a national study of conflict of interest management at sIRBs, 2015–2017. Abbreviation: sIRB indicates single institutional review board.

Once a site was enrolled, we sought to interview all personnel with knowledge and experience about sIRB processes. To minimize the burden on the sIRB, we used whatever format for recruitment of interviewees the site preferred. Our interviewees comprised four groups: chairs (n = 20; 19.4%), members (n = 30; 29.1%), staff (n = 26; 25.2%), and directors (n = 27; 26.2%). Two interviewees withdrew after completing interviews, one because of concerns that the interview data might be identifiable and another because their site withdrew from the study. We also observed 19 sIRB meetings at 10 different sIRBs from which interview participants were enrolled.

Procedures

Participants completed a one-hour, semistructured interview conducted by phone (n = 93; 89.4%) or in person (n = 10; 10.6%) that was audio recorded. They were interviewed by two of the coauthors—a clinical psychologist (E.P.) and a psychiatrist (R.K.). We offered participants each a $20 gift card for participation, but many declined payment. Participants were also asked to provide demographic information (see Table 2 for summary).

Table 2
Table 2:
Demographic Characteristics of 103 Interviewees, From a National Study of Conflict of Interest Management at sIRBs, 2015–2017

The interview protocol was informed by prior research with IRBs by Lidz et al26 and Klitzman17,27–30 and pilot interviews. Broadly, the interview examined sIRB processes; the impact of changing sIRB policies; COIs; relationships with local institutions, researchers, and funders; differences between single/central and local IRB reviews; and organizational issues relating to sIRB operations at their organizations and other types of sIRBs. The full interview script can be found in Supplemental Digital Appendix 1, available at http://links.lww.com/ACADMED/A676.

Coding and data analysis

We transcribed all interviews and then redacted all identifying information. A detailed codebook was developed, based on previous studies of local IRBs26 and modified with data from interviews for this study. The development of the codebook was an iterative, collaborative process involving all authors and three coders, all master’s-level research personnel. Adequate interrater reliability was established using Cohen kappa, which ranged from 0.71 to 0.85. Any coding disagreements were reviewed by the coding team and investigators. To address our study’s purpose, we reviewed all codes associated with COIs.

This study was approved by the University of Massachusetts Medical School (UMMS) and New York State Psychiatric Institute IRBs. We collected and managed study data using REDCap electronic data capture tools hosted at UMMS (Vanderbilt University, Nashville, Tennessee). Quantitative data were analyzed using SPSS statistical software, version 24 (IBM Corp., Armonk, New York).

Results

Commercial sIRBs

Perceptions of COIs at commercial sIRBs.

Interviewees at academic and government sIRBs expressed concerns that commercial IRBs were “rubber stamps,” driven by economic incentives to please their customers by approving all research they reviewed.

They [commercial IRBs] will basically sign up anyone who wants to pay.… Pay the fee and you’ll get the review…. Does the [commercial] IRB do all the behind-the-scenes work, getting a protocol ready? Probably not. (Member 6, government sIRB 5)

These perceptions remained even when interviewees had direct experience with commercial IRBs, including serving as members. One senior administrator currently at a government sIRB explained,

I’ve worked for commercial IRBs … there’s just something about them … there are too many conflicts of interest, who’s being paid, who’s being paid off. (Member 2, government sIRB 5)

Some interviewees recognized differences among commercial sIRBs.

They [sponsors] are really hiring you because they want an approval and it gets hard to come back and say [“no”].… I know that’s not how [specific large commercial IRB] views it. I know that’s not how [specific medium commercial IRB] views it. They really take it seriously and they’re not just [going to] hand you an approval, but that’s not to say that a lot of the commercial IRBs aren’t doing that. (Director 1, government sIRB 5)

Most interviewees at commercial sIRBs openly acknowledged their potential for COIs.

Financial COIs was something we all talked about.… If you have to pay your panel, … you’re pressured to bring in money. You have to have some kind of revenue.… We thought, “Yes, there’s definitely [going to] be that potential for COIs financially.” (Member 1, commercial sIRB 5)

Managing COIs at commercial sIRBs.

Interviewees at commercial sIRBs described some mechanism for managing potential conflicts, in three broad categories: using firewalls, relying on external reviewers, and turning down potential clients.

The most frequently referenced approach was the use of a “firewall” to separate business from review functions of the sIRB. One example of a firewall, consistent with AAHRPP guidelines, is to prohibit personnel with direct financial stakes in the company from participating in sIRB meetings. Another is to limit reviewers’ knowledge of financial dealings. One business manager, who is also part-owner, explained:

COI.… How do we stop that? Firewalls. I make it really clear that I can talk to them [sponsors] until the day they submit their application. Then it goes to the [research] administrator and I’m out of the picture.… I am no longer welcome at IRB meetings. (Director 1, commercial sIRB 1)

Commercial sIRB members perceived firewalls as effective. Many reported little to no knowledge about financial aspects of their sIRB. In fact, one member was unaware that the sIRB where that participant worked was a for-profit company. A chair of one commercial sIRB remarked:

I have no idea who is on the [business] side. I wouldn’t have any idea if they tripped over me.… They [have] separate emails. They’re a separate division that takes care of it. It’s almost like it’s a separate company. (Chair 2, commercial sIRB 4)

Despite frequent references to firewalls, some commercial sIRBs did not strictly adhere to this practice. For instance, at one commercial sIRB, the business manager sat in the office next to an open conference room where the board was meeting and would periodically chime in. At a different commercial sIRB, which conducted its board meetings by teleconference, the business manager signed on to the call, but did not participate in the meeting. It is unclear whether these instances of “involvement” by business managers had a biasing impact on the reviews.

Interviewees at commercial sIRBs also reported structuring relationships with reviewers so as to minimize their financial COIs. Most of the reviewers were contractors paid to review research and attend board meetings.

We’re not employees of the company. We’re contractors. So, we’re independent and whether we approve or disapprove [the study] … whether we bring [studies under review] back for the discussion, our compensation is the same. (Chair 1, commercial sIRB 1)

Most reviewers did not believe that being paid influenced their work.

I get paid an hourly rate … they just come up with an amount that they feel would be fair to the reviewers. I don’t think in any way that … the money … influence[s] my decision. (Member 5, commercial sIRB 4)

Finally, participants from commercial sIRBs noted that their willingness to turn down potential sponsors exemplified their active management of COIs.

Our job is to protect the patient, not to make the PI happy, not to make [specific large pharmaceutical company] or whatever drug company happy…. And we have a right to say: “Well, that’s great, but take it to another IRB. We don’t feel like this study is appropriate.” (Member 1, commercial sIRB 2)

One business manager at a commercial sIRB explained that the company occasionally turned down requests for IRB reviews because they conflicted with other services it provided to the sponsor.

We’ve … refused to review protocols. The company—we were helping them design their clinical study … and they said, “Can I just submit it to your IRB?” and we said, “No, we’re too close to it. You need to go to somebody truly independent.” (Director 1, commercial sIRB 1)

COIs at small versus large commercial sIRBs.

A number of our interviewees expressed concerns about large commercial IRBs being owned by financial companies whose primary goal was to make money for investors. A business manager of a small commercial sIRB stated,

A venture capital company [owners of a large commercial IRB] has much clout … and their primary interest is not protection of subjects. (Director 1, commercial sIRB 1)

Interviewees from government and academic sIRBs were similarly worried.

Now many of these IRBs are owned by conglomerates and when you trace the conglomerates and all their connectedness.… They’re connected to the drug companies … to big industries, the pharmaceuticals, to on and on … but not telling anybody that they’re connected … that to me is scary. (Member 2, government sIRB 5)

One reviewer from an academic sIRB was concerned about how research participants would respond.

You go from [academic IRBs] to profit motive, private equity.… Most people, if they ever knew that the organization charged with protecting them is owned by private equity firms, they probably wouldn’t go into the study. (Director 1, academic sIRB 7)

Small commercial sIRBs have their own unique COIs. Large commercial sIRBs are unlikely to be dependent on a single sponsor and, therefore, may be less invested in the outcome for any particular study. Small commercial sIRBs, however, may need to please each sponsor to retain their business.

I suppose the more studies or the more activities that the sIRB is involved in, the more money they’re bringing in.… But any one particular study, or even five studies, aren’t going to make or break the organization. I don’t think that there’s any one person who is going to be hired or fired because there’s that much extra work to do. (Chair 1, commercial sIRB 4)

Government sIRBs

Interviewees at government sIRBs described the potential for COIs because they were paid by the same entity that was funding the research.

There were people who voiced concerns that there was an inherent COI having a central IRB housed, managed, overseen, funded, supported by the same group of people who essentially are funding the studies.… People are keenly aware that when we’re meeting, [next to us] are the people who really want this approved and they’re the funding agency. (Chair 2, government sIRB 13)

Interviewees at government sIRBs described several methods to manage COIs, including openly discussing concerns about COIs, using firewalls, relying on nonaffiliated reviewers, and having broad COI policies for reviewers.

Interviewees at government sIRBs reported discussions with staff, reviewers, researchers, and senior personnel about COIs. A staff member explained that they addressed concerns as follows:

Mainly just talking it through—how it [sIRB] was in a separate part of this organization, that the people that worked on the [research] from [the] organization were not at all part of the IRB, to really assure … [researchers] that it was totally independent. (Staff 2, government sIRB 6)

Some government sIRBs used a firewall between the sponsor of the trial and the sIRB.

None of us are voting members of the board. We participate in the meetings as support staff.… There’s a kind of firewall in place there to really protect the members from the interests of [federal entity].… I think it’s possible for an operations office like this to feel the pressure from the sponsor and from the board. (Director 1, government sIRB 8)

Staff from different government sIRBs explained that having unaffiliated reviewers helped to ensure impartiality of the review.

It’s really, really important to … have representatives on that [IRB] board other than the affiliated members [of the federal entity].… [We don’t want any] bias at all regarding whether this human subject research is approved or not because they’re getting pressure at the [federal entity] to approve it. (Director 1, government sIRB 6)

Many of the government sIRBs had broad COI policies for their reviewers, including exclusion of reviewers who may have informal (nonresearch and nonfinancial) relationships with researchers whose studies are being reviewed.

We don’t like people who sit at [university 1] to review studies for a PI who’s at [university 1].… There’s some discussion when something unusual happens, like, “I know this guy at this institution but I have no idea who he is and we don’t.…” We can talk but most of the time we ask them to recuse themselves just to prevent any appearance of conflict even at the … most basic level. (Staff 2, government sIRB 8).

Academic sIRBs

Because all academic sIRB settings took place within LIRB board meetings, it is difficult to distinguish which IRB COI issues are unique to sIRBs. One chair of an academic sIRB noted,

I don’t think there’s any more of a COI [for an sIRB] than there is when we review any of the studies for people who are on committee. (Chair 1, academic sIRB 3)

Yet, interviewees from commercial sIRBs were concerned that reviewers at academic sIRBs could be influenced by their connections to the academic institution itself.

We [commercial IRBs] don’t know these researchers and work with them every day, but we also aren’t involved with any of the politics of dealing with these individuals on a daily basis or perhaps even reporting to them or some of the other political baggage that you get if you’re part of the institution. (Director 1, commercial sIRB 3)

This issue is not unique to sIRB review, but it may be heightened given the associated prestige of serving as the sIRB for research at multiple sites. When queried about how an academic site was selected as the sIRB, one chair reported,

We actually sort of competed for it in the same way that you would for a grant. (Chair 1, academic sIRB 3)

Serving as an academic sIRB generally brings in additional funds to the home university, which can then create financial COIs. Under the newly enacted NIH sIRB Policy, conduct of sIRB reviews can now be included as a direct cost (i.e., funds for the sIRB).1 Several academic sIRBs we interviewed had secured large external funds from sponsors to operate sIRBs. With external funds may come pressures to please the sponsors by not obstructing studies. The secured funds are used to support staff, who may not be covered if contracts were not renewed or additional sIRB contracts were not obtained. However, we also heard that such contracts may not necessarily cover all of the associated costs of an sIRB.

I would caution people that they don’t appreciate the expense of this model [sIRBs] and the expense to us. We are an item in the grant so there was salary and stuff like that for our people. It doesn’t come cheap. (Chair 1, academic sIRB 1)

During our interviews with academic sIRBs, we did not learn of any specific methods participants used to manage potential sIRB COIs. This is particularly problematic because most academic sIRBs we interviewed had AAHRPP accreditation, which prohibits individuals “who are responsible for raising funds” from participating in the reviews. Yet, many of the individuals responsible for securing the sIRB’s funds, including IRB chairs, directed and voted during the review process.

Discussion

To our knowledge, this is the first empirical study of sIRBs’ strategies for managing their own COIs. Our findings demonstrate that different types of sIRBs face unique COIs and therefore may require distinct management strategies. As sIRBs become standard for all federally funded, multisite research, researchers and academic institutions will need to weigh potential COIs of sIRBs and evaluate their management strategies when deciding which type of sIRB to use. As one senior staff member of a government sIRB observed: “I think that inherently the research enterprise has money and pressure running through it. How you handle that I think depends on the institution as well as the central IRB” (Staff 2, government sIRB 8).

Our interviews indicate that long-standing concerns about commercial sIRBs remain, with many interviewees from nonprofit sIRBs believing that commercial sIRBs “rubber stamp” all research. Yet, no study to date has examined whether commercial sIRBs’ determinations are any more biased or of poorer quality than those of other sIRBs, including LIRBs. Furthermore, we learned that COIs for commercial sIRBs may differ by the size of the organization. Some large commercial sIRBs are owned by organizations whose broader goals may be inconsistent with those of traditional sIRBs. Conversely, small commercial sIRBs may be so reliant on each sponsor that they experience greater pressures than large sIRBs to please the sponsor. Accordingly, approaches to managing COIs at commercial sIRBs, including the use of firewalls, reliance on contractors as reviewers, and turning down sponsors to avoid conflicts, may need to be tailored to the size of the sIRB.

In examining government sIRBs, we learned that interviewees were knowledgeable and aware about potential COIs, given that the same government agency funding their sIRB also funded the research they were reviewing. They recognized the importance of openly discussing potential IRB COIs with all stakeholders. Government sIRBs also used a number of strategies similar to commercial entities, including firewalls, reliance on nonaffiliated reviewers, and recusal of members based on broadly defined COI policies. In part, government sIRBs’ ability to implement some of these strategies may be due to the ease with which they can engage new unaffiliated reviewers.

For academic sIRBs, we observed the absence of specific management strategies for COIs of sIRBs. This could be a function of the overlap between the work of LIRBs and sIRBs and perceptions that management strategies employed for LIRBs apply equally to sIRBs. Although there are certainly similarities in the process of review, there are unique COIs specific to sIRBs, which include both financial and nonfinancial pressures. Specifically, operating an sIRB at an academic institution can bring in additional operational funds that can also be used to hire staff, update software, and expand the sIRB, as well as providing the prestige of serving as the reviewing sIRB. These benefits may lead to either a willingness or pressure to approve sIRB research, and to do so in an expeditious manner.

The transition to sIRB review for all NIH-funded and ultimately all federal multisite research presents an opportunity to develop and implement guidelines that can help different types of sIRBs manage their COIs. Our research identified at least two methods that commercial and government sIRBs use: firewalls and reliance on nonaffiliated members. To our knowledge, no standard system exists whereby academic sIRBs have firewalls between their IRB senior administrators and chairs, who may be directly responsible for bringing in the sIRB contracts and may therefore have potential COIs.

Accordingly, developing and complying with such guidelines will be the first step. Specifically, academic sIRBs may consider establishing internal guidelines that prohibit individuals directly involved with obtaining or benefiting from sIRB funds from being involved with the review. As with LIRBs, these individuals may need to recuse themselves during voting on sIRB protocols. In line with government sIRBs, academic sIRBs may consider having additional nonaffiliated members. Research has shown that unaffiliated members vary in the frequency of involvement in IRB decisions.26,27 However, if greater numbers of outside reviewers were used, then unaffiliated members may become more active contributors.

Our findings need to be interpreted in the context of certain limitations. First, they are based on self-reporting by interviewees who may have wanted to present themselves and their organizations in a favorable light. Second, reports of strategies for managing COIs could not always be verified and, in some cases, seemed to partly contradict our observations. Third, this study does not document whether the management strategies described actually addressed COIs. Fourth, we were unable to enroll large commercial sIRBs. Nevertheless, this study constitutes the first step in identifying sIRBs’ COIs and should serve to encourage further research on this critical topic, including describing the effectiveness of different procedures for managing COIs in sIRBs, which investigators and institutions will have to face as they select sIRBs for multisite research.

Acknowledgments:

The authors wish to thank all of the study participants and single institutional review boards for their time and important contributions to this research.

References

1. National Institutes of Health. Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. https://grants.nih.gov/grants/guide/notice-files/not-od-16-094.html. Published June 21, 2016. Accessed March 26, 2019.
2. U.S. Department of Health and Human Services. Federal Policy for the Protection of Human Subjects (‘Common Rule’). 45 CFR §46 subpart b. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html. Revised November 13, 2001. Effective December 13, 2001. Accessed March 26, 2019.
3. Boyd EA, Cho MK, Bero LA. Financial conflict-of-interest policies in clinical research: Issues for clinical investigators. Acad Med. 2003;78:769–774.
4. Field MJ, Lo B. Conflict of Interest in Medical Research, Education, and Practice. 2009.Washington, DC: National Academies Press.
5. Holmes DR Jr, Firth BG, James A, et al. Conflict of interest. Am Heart J. 2004;147:228–237.
6. Korn D. AAMC Task Force on Financial Conflicts of Interest in Clinical Research. Presentation to the National Institutes of Health Department of Clinical Bioethics; November 5, 2003.
7. Elliott KC. Scientific judgment and the limits of conflict-of-interest policies. Account Res. 2008;15:1–29.
8. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: A systematic review. JAMA. 2003;289:454–465.
9. Campbell EG, Weissman JS, Vogeli C, et al. Financial relationships between institutional review board members and industry. N Engl J Med. 2006;355:2321–2329.
10. Kassirer JP. Financial conflict of interest: An unresolved ethical frontier. Am J Law Med. 2001;27:149–162.
11. Bero LA, Grundy Q. Why having a (nonfinancial) interest is not a conflict of interest. PLoS Biol. 2016;14:e2001221.
12. Shawwa K, Kallas R, Koujanian S, et al. Requirements of clinical journals for authors’ disclosure of financial and non-financial conflicts of interest: A cross sectional study. PLoS One. 2016;11:e0152301.
13. DeAngelis CD, Fontanarosa PB, Flanagin A. Reporting financial conflicts of interest and relationships between investigators and research sponsors. JAMA. 2001;286:89–91.
14. Lo B, Wolf LE, Berkeley A. Conflict-of-interest policies for investigators in clinical trials. N Engl J Med. 2000;343:1616–1620.
15. Barnes M, Florencio PS. Financial conflicts of interest in human subjects research: The problem of institutional conflicts. J Law Med Ethics. 2002;30:390–402.
16. Emanuel EJ, Lemmens T, Elliot C. Should society allow research ethics boards to be run as for-profit enterprises? PLoS Med. 2006;3:e309.
17. Klitzman R. The ethics police?: IRBs’ views concerning their power. PLoS One. 2011;6:e28773.
18. Office of Inspector General. Institutional Review Boards: A Time for Reform. 1998.Washington, DC: U.S. Department of Health and Human Services.
19. U.S. Department of Health and Human Services. Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Fed Regist. 2011;76:44512–44531.
20. Myshko D. IRBs the safety gatekeepers. PharmaVOICE. http://www.pharmavoice.com/article/2006-09-irbs-the-safety-gatekeepers. Published September 2006. Accessed March 26, 2019.
21. Farfel G, Neuer A. Faster Study Start-up and Reduced Costs Through the Use of Clinical Document Exchange Portal. 2009.Needham, MA: Cambridge Healthtech Media Group Custom Publishing.
22. Association for the Accreditation of Human Research Protection Programs. Element II.1.C. In: Evaluation Instrument for Accreditation. 2016:58.Washington, DC: Association for the Accreditation of Human Research Protection Programs.
23. Association of American Medical Colleges, Association of American Universities. Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research. 2008.Washington, DC: Association of American Medical Colleges.
24. Task Force on Financial Conflicts of Interest in Clinical Research. Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research. 2002.Washington, DC: Association of American Medical Colleges.
25. Resnik DB, Ariansen JL, Jamal J, Kissling GE. Institutional conflict of interest policies at U.S. academic research institutions. Acad Med. 2016;91:242–246.
26. Lidz CW, Appelbaum PS, Arnold R, et al. How closely do institutional review boards follow the Common Rule? Acad Med. 2012;87:969–974.
27. Klitzman R. Institutional review board community members: Who are they, what do they do, and whom do they represent? Acad Med. 2012;87:975–981.
28. Klitzman R. The myth of community differences as the cause of variations among IRBs. AJOB Prim Res. 2011;2:24–33.
29. Klitzman R. How local IRBs view central IRBs in the US. BMC Med Ethics. 2011;12:13.
30. Klitzman R. From anonymity to “open doors”: IRB responses to tensions with researchers. BMC Res Notes. 2012;5:347.
31. WIRB. https://www.wirb.com/Pages/Default.aspx. Accessed April 1, 2019.
    32. National Cancer Institute. Welcome to the CIRB. https://www.ncicirb.org. Published 2018. Accessed April 1, 2019.
      33. NeuroNEXT. Network for Excellence in Neuroscience Clinical Trials. https://neuronext.org. Published 2018. Accessed April 1, 2019.
        34. U.S. Department of Health and Human Services. Center for Leading Innovation & Collaboration. The Ohio Consortium. https://clic-ctsa.org/about/regional-consortia/ohio. Accessed April 1, 2019.

          Supplemental Digital Content

          Copyright © 2019 by the Association of American Medical Colleges