Institutional Review Boards, Professionalism, and the Internet

COMMENTARY “ ” POLICY consist of dozens of pages, oft en written in legalese that obscures rather than clari Institutional Review Boards, fi es the nature of the experiment. Senior researchers say morale is low among clini Professionalism, and the Internet cal and translational scientists, especially those early in their careers (5). Robert Martensen Whether cumbersome or not, IRBs tend Published 5 May 2010; Volume 2 Issue 30 30cm15 to vary considerably in their responses to a given protocol, a variation that the Inter Even as the Internet generates pressures that erode professional authorities of all kinds, net easily exposes. Marked variation in IRB it also provides opportunities for researchers and their institutional review boards to responses challenges their professionalism bolster their status as trusted sources. To this end, we must work to improve clinical pro on at least two counts: (i) fairness—that tocol design and approval procedures and maintain the integrity of the study participant like should be treated alike by deliberative recruitment process in clinical trials. bodies operating in the public sphere and (ii) capacity for sound judgments. A study of three Baltimore-area IRB responses to Th e translational enterprise by defi nition re ticipants by the most expedient means pos a single protocol concludes the follow quires collaboration among multiple compo sible that are consistent with the safety of the ing: “Inconsistencies in these reviews raise nents within organizations and between them participants. Clinical principal investigators questions as to the validity and effi ciency and the public. From research design onward (PIs) come from diverse disciplines and en of the IRB process … Validity can be de through study participant recruitment and gage in clinical research with wide ranges of fi ned as the ‘extent to which any measuring physician/patient treatment decisions, trans risk and potential benefi t. Clinical trial pro instrument measures what it is intended lational medicine depends on a modicum of tocols may be devised for a single study or to measure.’ It is important that the IRB trust among the various parties. If an ability may consist of prepackaged documents for process reliably measure with adequate to provide sound judgments in the face of the participation in multicenter trials. Regard validity the degree of safety of scientifi c on May 11, 2010 uncertainties of disease is the sine qua non of less of the risk-to-benefi t ratio or protocol experiments in order to preclude harm to being a professional in health care (1), what type, PIs typically submit their protocols, subjects.” (6) challenges and opportunities does the Inter wait weeks for review by an IRB, receive sug IRB administrators tend to assume that net pose to translational medicine researchers gestions and corrections from the IRB, revise IRB members deliberate within a frame and clinical trial managers and sponsors be and resubmit, wait for another IRB review, work based on logical positivism. Th at is, ing perceived as trusted sources (Fig. 1)? Th is and perhaps revise and resubmit and wait for they believe that members apply fi xed reg Commentary focuses on two: (i) communi an additional review. Most IRB requests for ulations more or less accurately, resulting cation and workfl ow between researchers and revision take one of three forms: (i) changes in objectively right and wrong decisions. stm.sciencemag.org institutional review boards (IRBs) and (ii) the in the logistics and supervision of the re Th e prevalence of variation troubles these fruits of their collaborations—clinical trials search, as in requesting that someone with administrators, as it fl ies in the face of and study participant recruitment. In this con an MD degree be present while participants their positivistic worldview. When looking text, the term IRB represents IRBs as entities undergo a physical test; (ii) alterations in the at examples of variation, physicians and in themselves and also as vital components of research design, such as suggesting that re researchers who are running audits of IRB human research protection programs. searchers collect diff erent data; or (iii) revi studies conclude that variations come from Professionalism in IRB review and re sions to patient consent forms. two sources: dubious application of federal cruitment of clinical trial participants is chal What do researchers say about this pro regulations and hasty judgments made by Downloaded from lenged by the Internet’s ability to expose and cess? Th e phrase “death by a thousand duck overburdened board members and admin create variation, a seemingly innocuous word bites” seems to describe the experience of istrators. In short, they tend to assume that that lies at the heart of science and its man many (3). Writing in the Annals of Inter the variation results from members’ lack agement. According to W. Edwards Deming, nal Medicine, a Stanford team estimated of time and knowledge. Almost regardless a statistician who wrote extensively on statis that it took $56,000 in administrative costs of the nature of the critique, IRB leaders tics and management: “Th e central problem and over 15,000 pages of paper to tweak tend to propose the same remedy, which is of management in all its aspects, including an already-approved research protocol greater fi nancial support for staff training planning, procurement, manufacturing, re that simply compared the progress made and staff expansion. search, sales, personnel, accounting, and law, by patients who had attended two diff erent But what if the standard administra is to understand better the meaning of varia types of addiction treatment programs (4). tive account of the IRB process is wrong? tion. …” (2) And a 2008 report in Science found that Evidence from interviews with IRB chairs paperwork is among the biggest threats across the United States suggests that dif RESEARCHERS AND IRBS to pricing large clinical trials out of reach ferences in decisions from one board to Most readers would agree, I expect, that re (5). Researchers complain that obtaining the next are products of how boards de searchers want to select clinical research par- participant consent has become onerous liberate, not of board members’ mistaken as well. In cancer drug trials, for exam judgments (7). What matters, it turns out, Offi ce of NIH History, Bethesda, MD, 20892, USA. E-mail: ple, prospective participants are routinely is an IRB’s pattern of “local precedents,” [email protected] asked to sign complicated forms that can which are previous decisions made by the www.ScienceTranslationalMedicine.org 5 May 2010 Vol 2 Issue 30 30cm15 1 COMMENTARY “ ” Fig. 1. Gutenberg to Google. For its potential to transform authority and trust relations of all kinds, nothing like the Internet in scale has occurred since the invention of mass printing by Gutenberg around the year 1440. on May 11, 2010 IRB that board members use to guide their modifi cations to previously approved pro existence of a fi nancial COI is disclosed, evaluations of subsequent protocols. By tocols can diff er substantially across IRBs its amount is not. Th erefore, no one out drawing on them, members tend to read in multicenter trials and can be contradic side the sponsors has the means to assess new protocols as permutations of stud tory. Without disputing the importance of a COI’s potential “oomph” to distort sound ies that they have previously debated and adequate material resources, IRBs seeking judgment in conveying risks and benefi ts settled. Instead of working from general less variability might seek to bolster their to prospective trial participants. According stm.sciencemag.org rules to specifi c cases, these IRB mem conceptual resources (7). to the U.S. Food and Drug Administration bers tend to work from case to case. IRBs (FDA), “Direct advertising for study sub may vary not because their judgments are SPONSOR COMMUNICATION IN jects [is] the start of the informed consent mistaken but because they strive to make PARTICIPANT RECRUITMENT process” (8), and the Offi ce for Human Re locally consistent decisions over time. Lo Once an IRB has approved a protocol, it search Protections, which is part of the U.S. cal precedents tend to be idiosyncratic to makes its way onto the Internet in the form Department of Health and Human Services an individual IRB but stable within each of participant recruitment ads. Operation (DHHS), has stated that “the information board. Th us, when a local precedent has ally, the IRB may believe its work is done, provided on these [patient recruitment] Downloaded from not been established, a PI may help shape but that does not mean the world is done Web sites may constitute the earliest com the solution. Once precedents are set and with the trial or the IRB that approved the ponents of the informed consent process” decision-making inertia is established, fu trial protocol. Although sponsors take over (9). Not surprisingly, recruitment practices ture PIs lose infl uence over decisions made public communication, the Internet pub on the Web vary considerably by sponsor. later on the same recurring issue. lic has little means to make distinctions In a 2002 DHHS study of 22 Web sites for From a local-precedents perspective, between a trial sponsor and the IRB that patient recruitment for 110 clinical trials, two common IRB behaviors may account approved the trial. How does the Internet only a quarter mentioned potential ben for both variability and lengthy review aff ect the perception of sponsors and, by ex efi ts and none mentioned potential risks timelines. First, IRBs disagree as to the tension, the IRB approval process as trusted of the protocol (10). More recent studies amount of scrutiny a given protocol will sources during participant recruitment? (11) suggest that there have been no sig require.

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