6

Improving the IRB Process

It is people in organizations who act upon and implement regulations. In the case of the Federal Regulations for human subjects protection, it is the administrators and staff of institutional review boards (IRBs), IRB members, and institutional officials who work in the trenches of human subjects protection and social-behavioral research facilitation. This chapter presents broader procedural issues not covered elsewhere in the report. Guidance and recommendations focus on improving the IRB process through the efforts of IRB staff, members, and institutional officials.

THE SCOPE OF FEDERAL REGULATORY AUTHORITY

Since the 1970s, federal regulation of research involving human participants has been limited to two categories: (1) research conducted or supported by various agencies of the federal government and (2) research subject to regulation by the U.S. Food and Drug Administration (FDA). Beginning in the 1970s, various commentators and some national advisory bodies have made appeals to extend the scope of regulation to involve all research involving human participants without regard to the source of funding. These appeals have generally been rejected on grounds that they exceed the statutory authority of the federal executive branch, authority ultimately grounded in the conditional spending authority clause of the Constitution. This is the key point on which the 1974 mandate turns, and it has therefore also figured in the constitutional law arguments against IRB reviews.

The Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services (HHS), the successor office to the



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6 Improving the IRB Process It is people in organizations who act upon and implement regulations. In the case of the Federal Regulations for human subjects protection, it is the administrators and staff of institutional review boards (IRBs), IRB mem- bers, and institutional officials who work in the trenches of human subjects protection and social-behavioral research facilitation. This chapter presents broader procedural issues not covered elsewhere in the report. Guidance and recommendations focus on improving the IRB process through the ef- forts of IRB staff, members, and institutional officials. THE SCOPE OF FEDERAL REGULATORY AUTHORITY Since the 1970s, federal regulation of research involving human par- ticipants has been limited to two categories: (1) research conducted or supported by various agencies of the federal government and (2) research subject to regulation by the U.S. Food and Drug Administration (FDA). Beginning in the 1970s, various commentators and some national advisory bodies have made appeals to extend the scope of regulation to involve all research involving human participants without regard to the source of fund- ing. These appeals have generally been rejected on grounds that they exceed the statutory authority of the federal executive branch, authority ultimately grounded in the conditional spending authority clause of the Constitution. This is the key point on which the 1974 mandate turns, and it has therefore also figured in the constitutional law arguments against IRB reviews. The Office for Human Research Protections (OHRP) in the U.S. De- partment of Health and Human Services (HHS), the successor office to the 135

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136 PROPOSED REVISIONS TO THE COMMON RULE Office for Protection from Research Risks, requires that any institution that engages in research involving human subjects that is conducted or supported by executive branch agencies that have adopted the Common Rule must file a document called a “Federalwide Assurance” (FWA), a statement that the institution will comply with the requirements of the Common Rule.1 Furthermore, OHRP asks institutions to include in their FWA a statement that they will extend their application of Common Rule requirements to all research conducted within the institution without regard to source of funding. Institutions that include such a statement in their FWA essentially agree to extend the federal regulatory authority to all research involving human participants within the institution. Institutions may decide not to include such statements but many do. However, those that do not include such statements decline on grounds that they do not want to be bound to all the burdensome details of compliance. Refusal to include such statements is referred to as “unchecking the box.” Between 2006 and 2010, 162 colleges and universities unchecked the box, declining to apply the regulations to non-federally funded research (Schrag, 2010b, 2012). More recent OHRP data indicate that 37 percent of research organizations with federalwide assurances “unchecked the box” (Association for the Accreditation of Human Research Protection Pro- grams, 2013). The American Association of University Professors has long recommended that universities “uncheck the box” as a first step toward devising procedures less burdensome than those specified in the regulations (Schrag, 2010a). Such efforts have led to the formation of a national coali- tion of institutions known as the “Flexibility Coalition.”2 Note, however, that some state institutions are not permitted to “uncheck the box.” In its briefest section (76 Fed. Reg. 44,528, “IV Extension of Federal Regulations”), the Advance Notice of Proposed Rulemaking (ANPRM) acknowledged that most institutions “voluntarily extend the applicability of their FWAs to all the research” conducted by their members regardless of funding. While it points out that a number of parties have “called for legislation that would extend the Common Rule protections to all research with human subjects conducted in the U.S., regardless of funding source,” the ANPRM makes “an alternative regulatory proposal”: to require U.S. in- stitutions “that receive some Federal funding from a Common Rule agency 1  See the OHRP Terms of the Federalwide Assurance for the Protection of Human Subjects guidance, which is available at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html [February 2014]. 2  The Flexibility Coalition was started in 2011 at the University of Southern California and includes more than 50 research organizations, including the Association for the Accreditation of Human Research Protection Programs, Inc. The stated goal of the coalition is to identify ways in which research institutions can implement flexibility without diminishing human subjects protection.

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IMPROVING THE IRB PROCESS 137 for research with human subjects to extend the Common Rule protections to all research studies conducted at their institution.” If this proposal were enacted into the Federal Regulations, the option to “uncheck the box” would no longer exist. In view of the foregoing discussion, and particularly in support of the proactive efforts by IRB professionals to reduce unnecessary regulatory burden, the committee disagrees with this ANPRM proposal, and makes the following alternative recommendation: Recommendation 6.1: In revising the Common Rule, HHS should keep the scope of coverage by the Common Rule within the present bound- aries: “all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy ap- plicable to such research” (45 C.F.R. § 46.101(a)). INNOVATIVE PRACTICES In accord with the ANPRM, the preceding chapters of this report estab- lish an environment for IRBs and their institutions to develop procedures that maximize flexibility, efficiency, and timeliness in the review process. Already, a few research programs and IRBs have been focusing on stream- lining their human-subjects research programs in an attempt to respond to investigator concerns, to provide greater flexibility and streamlining of the review process, or both (Bechert, 2011; Cola et al., 2013; IRB Advisor, 2013; National Research Council, 2013). This committee recognizes and supports this shift in perspective, especially the combined efforts of institu- tions, investigators, and IRBs to align responsible conduct of research with an efficient and flexible IRB process. Its recommendations aim to estab- lish an environment for institutions and their IRBs to develop procedures and implement best practices that both rationalize the review process and engage together with investigators in the ethical conduct of research. In- vestigators, institutions, IRBs, and IRB staff can contribute to this shift by extending their efforts in several key arenas: (1) shared ethical responsibil- ity, (2) flexibility and streamlining, (3) reliance agreements and memoranda of understanding to protect local population concerns, (4) single IRBs of record for multisite studies, and (5) appeal processes. Shared Ethical Responsibility Indisputably, investigators, institutions, and IRBs share an obligation to the protection of human subjects through the responsible conduct of research. Shah (2013, p. 397) argues, however, that “[t]he Common Rule

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138 PROPOSED REVISIONS TO THE COMMON RULE fails to acknowledge that investigators and sponsors regularly face sig- nificant ethical challenges that go beyond obtaining informed consent and IRB review,” and that the current Common Rule places more of the ethical responsibilities on IRBs than investigators. All researchers must take re- sponsibility for the ethical conduct of their research, even beyond securing IRB approval. The new excused category particularly relies on this point in that researchers will have responsibility for determining the level of IRB oversight needed for their studies. As one example, new research technologies and data sources will de- mand more attention to the shared ethical obligations of researchers and IRBs. To respond to the challenges presented by Internet research in par- ticular, the Association of Internet Researchers (2012) has developed a decision-making heuristic for researchers and IRBs that presents a broad array of questions to consider in the research design and implementation phases, depending on the type of data collected and the types of venues or contexts. For example in personal spaces or blogs, where the data are in text form, the ethical questions pertain to the authors’ or participants’ ex- pectations regarding whether the site is public or private; whether their per- sonal network of connections contains sensitive information; and whether analysis, publication, redistribution, or dissemination of the content could harm participants in any way. Another example of shared ethical responsibility pertains to consider- ations in conducting research in which communities are the central topic of inquiries, and where ethical questions therefore relate to risks for both individuals and communities. Risks to communities could take the form of possibly disrupting important structures and functions of the community because of differences in community member opinions about participating in the research, differences in expectations of community members regard- ing how the results will be used, or differences in how results are actually interpreted or reported (Anderson et al., 2012). Anderson and colleagues (2012) are developing an ethics curriculum for IRBs and researchers that is specifically focused on community-engaged research methods. Guidance Recommended: OHRP should provide guidance that re- emphasizes the joint obligations of the investigator, the institution, and the IRB to protect human subjects through the responsible conduct of research. Flexibility and Streamlining of the IRB Process Flexibility in the regulations as one means of reducing burden, while equally protecting human participants, has been a focus of many insti- tutions for the past several years. This approach is exemplified in the

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IMPROVING THE IRB PROCESS 139 procedures developed by the Flexibility Coalition.3 Flexibility Coalition collaborators have implemented initiatives that target studies that pose no-greater-than-minimal risk and that provide equivalent protections to subjects commensurate with risk level. Institutions such as the University of Michigan, the University of Southern California, and the University of Minnesota have developed policies, known as “flex policies,” that specifi- cally address research not covered under their FWAs. Members of the Flex Coalition worked with the Federal Demonstration Partnership in develop- ing a website guide to reducing regulatory burden.4 In her presentation to the National Research Council Workshop on Proposed Revisions to the Common Rule: Perspectives of Social and Be- havioral Scientists (March 22, 2013), Lois Brako described the University of Michigan’s Flex Initiative/Demonstration Project. This 4-year innovation and demonstration initiative was launched to add flexibility and reduce ad- ministrative burden for certain types of minimal risk research that are nei- ther federally sponsored nor have sponsor or other contractual restrictions requiring adherence to federal regulations, do not contain FDA-regulated components, do not have prisoners as subjects, and do not include a Certifi- cate of Confidentiality issued by the National Institutes of Health. Further, 2-year approval periods are granted, and a new exemption category was created for research involving the analysis of identifiable data where there is no direct interaction or intervention with human subjects. Institutional risk concerns are addressed, and investigator education is provided through policies, standard operating procedures, templates, and guidelines that focus on helping the investigator. The informed consent process makes use of available waiver elements, including application of flexibility available in regulations for child assent. IRB members and institutional staff work together in a division of labor that allows IRBs to focus on greater-than- minimal-risk studies and studies that truly require their attention, while institutional staff support the process using mechanisms and metrics for routine monitoring and annual auditing of “flexed” studies. All these ini- tiatives are important efforts, but their progress will be restricted without complementary changes in the regulations recommended by the ANPRM and this report. Guidance Recommended: OHRP should provide guidance to promote flexibility in institutions for determining what types of research activi- ties call for review by entities other than IRBs (for examples, see Annex 6.1) and to promote flexible, equivalent streamlined protections for subjects commensurate with risk level. IRBs should be encouraged to 3  See http://oprs.usc.edu/initiatives/flex/ [February 2014]. 4  See http://sites.nationalacademies.org/PGA/fdp/PGA_061067 [February 2014].

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140 PROPOSED REVISIONS TO THE COMMON RULE apply such flexibility to research covered by the Common Rule. OHRP should also provide clear guidance, with examples, concerning what IRBs are no longer required to do. Collaborative and Sharing Mechanisms A variety of institutional and collaborative initiatives have streamlined IRB review when investigators at multiple institutions are involved. In in- stances when one IRB serves as the designated IRB and local stakeholders have concerns about specific populations, reliance agreements and memo- randa of understanding can help assure them that the rights and protec- tions of the local populations are covered, while investigators can avoid duplicative IRB review. Other examples include the “facilitated review” model established by the Clinical Translational Science Awardees and “In- stitutional Authorizations” between collaborating organizations, whereby one organization can authorize a second organization’s IRB to act as the IRB of Record for one or more studies conducted at their organization” (Cola et al., 2013). Some institutions provide a checklist for the informed consent process to ensure that the participants have the local context and contacts to be truly informed about the study.5 Procedural Improvements Needed: Researchers, IRBs, and institutions should be encouraged to employ IRB collaboration models for research involving multiple investigators and institutions. Single IRB of Record for Multisite Studies Beyond collaborative agreements and memoranda of understanding, the committee endorses the specific proposal in the ANPRM to establish single IRBs of record for multisite research projects. We believe this pro- posal is long overdue as formal guidance. That formal guidance might build on the experience of those institutions that have already been reviewing multisite projects through one IRB: for example, collaborating institutions that agree to have one of those institutions’ IRB function as the IRB of re- cord for the study in question. We address this best practice at some length because of its importance. Researchers have for many years complained strenuously about the burdens of review by multiple IRBs as they conduct multisite studies. Many 5  Although the ANPRM was not directed to international multisite research programs, this topic was covered in the workshop presentation by Dr. Thomas Coates to the Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences (National Research Council, 2013, p. 69).

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IMPROVING THE IRB PROCESS 141 people believe that the proposal to permit or mandate a single IRB of record in the ANPRM is designed to facilitate multicentered randomized clinical trials. In an article in which they review various features of the ANPRM, Emanuel and Menikoff (2011, p. 3) refer to “evidence [that] suggests that multiple IRB reviews lead to unjustified variation in assessments without enhancing protections for research subjects.” Of the three articles they cite as sources of such evidence, two are concerned with randomized clinical trials and one with health services research. The committee notes, however, that the multiple IRB problem is also a serious issue for social and behav- ioral research.6 In practice, IRBs may issue conflicting advice on many aspects of re- search protocols. Conflicting opinions may be issued on substantive mat- ters. Consider, for example, a survey of IRB chairs conducted by Shah and colleagues (2004). The respondents read several hypothetical scenarios of research involving children and categorized the risk level of each scenario. Here are some of the results: Venipuncture for a single blood sample was rated minimal risk by 81 percent of IRB chairs and a minor increase above minimal risk by 19 percent. Magnetic resonance imaging (without sedation) was rated a minimal risk by 48 percent of IRB chairs, a minor increase over minimal by 35 per- cent, and more than a minor increase over minimal by 17 percent. Weekly blood draw of 10 ml for 6 months was rated a minimal risk by 15 percent of IRB chairs, a minor increase over minimal by 51 percent, and more than a minor increase by 34 percent. Such inconsistencies wreak havoc with investigators and sponsors. Each change required by one IRB may call for resubmission to each of sev- eral IRBs to secure approval of the final protocol. Some IRB inconsistencies call for changes that may require prolonged and complex negotiations, with repeated re-review by each IRB. One approach to dealing with these problems has been to develop cen- tral institutional review boards (CIRBs), a name given to IRBs that have the same purpose as those described in the ANPRM as the “single IRB 6  In fact, the first detailed documentation of the burdens associated with multiple IRB review—significantly titled We shall overcome: Multi-institutional review of a genetic coun- seling study—was published by a team of social scientists who reported on their complex negotiations with multiple IRBs in getting an initial approval and periodic reapproval of their interview research, which was carried out at multiple genetics counseling clinics. They said, “At times, we found ourselves wandering through bureaucratic mazes that made us think we were re-enacting Franz Kafka’s classic novel, The Trial, rather than engaging in social science research” (Kavanagh et al., 1979, p. 1).

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142 PROPOSED REVISIONS TO THE COMMON RULE of record.” Oncologists have developed a voluntary program, the CIRB Initiative, that is administered by the National Cancer Institute.7 The U.S. Department of Veterans Affairs (VA) has developed a mandatory central IRB program for all research carried out within the VA system,8 although it does not allow cooperative IRB review between VA facilities and local non-VA institutions. Wagner and colleagues (2010) compared the efficiency of CIRB review in the field of oncology with that of local review. The CIRB (as compared with local) review reduced the time of initial approval by 44 percent and the time of “facilitated approval” by 63 percent. The cost of IRB approval was reduced by 39 percent. The advantages to sponsors and institutions of the single IRB of record, or CIRB, system are obvious. There are not only substantial savings in costs but also a vast reduction in the administrative burden because their communications with IRBs regarding multisite studies are reduced dramati- cally. The single IRB assumes the responsibility for communications with sponsors and institutions on behalf of all of the local-institution IRBs for institutions participating in the program. This feature substantially reduces the paperwork and other administrative burdens of the sponsoring agencies. Some commentators have expressed concerns about potential hazards of adopting a single-IRB-of-record system. These concerns include but are not limited to (a) a potential for IRB shopping; (b) increased exposure of the local institutions to liability; and (c) difficulty incorporating complex, multiple, local IRB systems into a single system (National Research Coun- cil, 2013; Secretary’s Advisory Committee on Human Research Protections, 2011). Each of these concerns is addressed below. IRB Shopping One concern is that sponsors and investigators engaged in the devel- opment and execution of a multisite study could “shop around” seeking a relatively permissive IRB: one that is likely to provide a “rubber stamp” approval of researcher or sponsor plans. Although IRB shopping is pos- sible, it is no more likely to occur with a single IRB of record than it is in the current system, in which researchers may sometimes be able to choose among relevant IRBs.9 7  See the National Cancer Institute’s Welcome to the Central IRB Initiative webpage at https://ncicirb.org [November 2013]. 8  See the Veterans Health Administration Central IRB webpages: http://www.research.va.gov/ vacentralirb/#.UsSLGrTOS8A [December 2013]. 9  Indeed, IRB shopping may be less likely to occur in a CIRB system. Many of the multisite studies will be funded by the federal government, and it is unlikely that the various commit- tees and officials who review federally funded research will tolerate inadequate IRBs. They are more likely to follow the model of the current oncology and Veterans Affairs CIRBs, which

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IMPROVING THE IRB PROCESS 143 Increased Liability for Local Institutions There is concern that a faulty judgment reached by a CIRB could re- sult in harm befalling a research participant, and in such a case criticism or litigation would likely be directed at the individual institution in which the mishap occurred. This concern can be divided into two subconcerns. 1. The current practice of OHRP concerning errors in human partici- pant protection is to address criticisms to the institution in which the problem occurred. OHRP may decide to impose sanctions—for example, suspension of research within the institution. The com- mittee proposes that the reasonable way to address this problem is to develop policy that would hold the single IRB of record responsible for the errors it commits and to hold the local institu- tion responsible only for inadequate or negligent actions occurring within the institution. 2. There is concern that injury to a research subject that occurs as a consequence of a faulty judgment by the CIRB would result in litigation by the injured party (or that party’s representatives with legal standing) against the investigator or institution in which the injury occurred. There is no reason to believe it would occur more frequently under a CIRB system. The committee suggests deal- ing with this possibility in much the same way as suggested for criticisms emanating from OHRP—that is, hold the single IRB of record responsible for the errors it commits and hold the local institution responsible only for inadequate or negligent actions oc- curring within the institution. Complexity in Incorporating Multiple IRBs into a Single System Many IRB and institutional Human Research Protection Program per- sonnel have cautioned that converting to a single-IRB-of-record system is likely to be a complex task. On this basis, several representatives of such entities have opposed the development of a CIRB system. Even those who favor single IRBs of record advise that their development is likely to be time-consuming. For example, in her presentation to the Workshop on Proposed Revisions to the Common Rule in Relation to the Behavioral and Social Sciences (March 22, 2013), Pearl O’Rourke presented a detailed account of these complexities. Her presentation was based in part on her have high-quality members, staffs, and procedures. For those CIRBs that are not federally funded, multisite studies are more likely than single-site studies to be relatively highly visible, and the sponsors would rather not be exposed to the criticism likely to be associated with selection of inadequate IRBs.

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144 PROPOSED REVISIONS TO THE COMMON RULE experience with the NeuroNEXT single-IRB-of-record network, a program developed by the National Institute of Neurological Disorders and Stroke to review its Phase II clinical trials involving patients with neurological diseases as trial participants. [Dr.] O’Rourke, who supports the gradual phasing-in of single IRBs of record, cautions that, in their development, one should take care not to underestimate the time required to work out the details of starting up, the long-term costs of central IRB infrastructure, the confusion resulting from discrepancies in the institution-specific conven- tions for assigning of institutional and IRB review responsibility, and the critical role that trust and familiarity play in development and negotiation of IRB reliance relationships. This good advice should be taken seriously. To address this concern about complexity, the committee proposes that the new regulations authorizing the single IRB of record provide for voluntary rather than mandatory use of such a system. This will give spon- sors and investigators the time to engage in the preparations called for by [Dr.] O’Rourke. We believe that, with the passage of time, sponsors and investigators will become increasingly familiar with how the single-IRB-of- record system operates and will take note of its improvements in efficiency and consumer satisfaction. In the long run, they will also take note of the reduction in costs. As a consequence, we expect that the single IRB of record will be employed with increasing frequency in multisite studies by sponsors and investigators. Recommendation 6.2: HHS should adopt the proposal set forth in the ANPRM to establish single IRBs of record for multisite studies, with some conditions. These conditions might include the following: (a) The establishment of single IRBs of record should be voluntary rather than mandatory. (b) Any requirement to use a single IRB of record for multisite studies should be phased in gradually so that individual institutional IRBs and human research protection programs will have time to make necessary changes to adapt to this new system. (c) The charge to the single IRB of record should be limited to mak- ing determinations and meeting the responsibilities set forth in the Common Rule. There are other locally specific functions commonly carried out by IRBs such as specifying (i) who should be contacted in case a participant believes his or her rights have been violated and (ii) where and when to go to participate in various components of the research. Such matters should remain the responsibility of the local institution’s human research protection program.

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IMPROVING THE IRB PROCESS 145 (d) Approval by the single IRB of record should suffice to inform the sponsor that the proposal has been approved. (e) However, participating institutions should not be allowed to begin their research activities until they have met their local responsibili- ties. Such delays in local participation should not be imposed on those other participating institutions that have already met their own local responsibilities. Appeals The IRB process should allow appeals for review by an authoritative committee. This committee may exist either within the institution or within an outside agency. It should be described in the institution’s FWA. The ap- peals committee may have either or both of two kinds of authority. First, upon review of an IRB’s decision, the appeals committee may find an error in the IRB’s understanding or interpretation of federal or in- stitutional policy.10 In such a case, the appeals committee would return the protocol to the IRB for a re-review guided by the correct interpretation of the regulation or policy. Second, the appeals committee may also be given authority to reverse or alter the decision of the IRB. If it is given authority to approve research projects, then it must be established and perform according to the rules set forth in the Common Rule. Recommendation 6.3: In each institution in which research involving human participants is carried out, a system should be developed for the appeal of IRB decisions. CONCLUSION In closing, the committee has sought to inform the efforts of the federal government in revising the Common Rule that governs the protection of human participants in research within the context of social and behavioral sciences. Several of the proposals put forth in the ANPRM are endorsed, but the committee also makes recommendations to amend some specific ANPRM proposals or to revise the Common Rule in other ways. Impor- tantly, the committee offers examples and strategies for operationalizing the proposed new procedures to assist the federal government in issuing, inter- preting, and implementing the new regulations; and that will support IRBs and investigators in carrying out their responsibilities to protect human 10  Forexample, the survey by Shah and colleagues (2004) found that 10 percent of IRB chairs erroneously considered payments to participants a direct benefit to the participants.

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146 PROPOSED REVISIONS TO THE COMMON RULE research participants and advance social and behavioral sciences. Several topics of research are also recommended by the committee. The committee also aims to assist in developing best practices for implementing the new human research protections and assessing the effectiveness of the rules and their implementation. Thus, the committee recommends that research be conducted on the costs and benefits of regulating social and behavioral re- search for the research participants themselves, and for institutions, IRBs, investigators, and sponsors. ANNEX 6.1 EXAMPLES OF RESEARCH REVIEWABLE BY NON-IRB BODIES Examples include, but are not limited to, quality assurance/improvement (QA/QI) in the field of health care and investigations into the nature, causes, and effectiveness of responses to natural disasters. Why is IRB review not suitable in these fields? Studies in the field of QA/QI are characterized by frequent changes in the interventions utilized in the health care setting. IRBs, in general, lack the expertise to assess the methods employed to evaluate these interventions. Moreover, if each of these changes in the interventions must be reviewed at a convened meeting of the IRB, it would take much too much time to go through the technical IRB process of approval of amendments. Studies of many disasters (e.g., hurricanes such as Katrina on the Gulf Coast or outbreaks of illnesses such as Legionnaires disease) require a very rapid response by an ethical review committee that is knowledgeable about the special problems associated with such studies. IRBs generally lack the requisite knowledge and cannot provide sufficiently rapid responses. By the time they can convene a meeting of the committee, the factors that caused the disaster may no longer exist. What could replace IRB review in the field of QA/QI? While procedural alternatives to IRB oversight are discussed elsewhere in this report, two suggestions related to the examples above are considered here. First, a com- mittee could be established that was made up of experts in QA/QI as well as experts in the cognate medical specialties, ethicists, patient advocates, and persons who have no connection with the institution apart from member- ship on the committee. The investigators would be called upon to submit a general description of their proposed activities to this oversight committee. It would be understood at the outset that the investigators would be unable to identify exactly each of the changes in interventions and the timing of making such changes. Instead they would be required to provide a general description of the nature of the interventions with a clear identification of any risks that might be associated with them. Approval could then be given to the protocol containing the general description, with a plan to repeat

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IMPROVING THE IRB PROCESS 147 committee review at suitable intervals (e.g., every 3 months) or at any time the investigators wanted to use interventions that did not fall within the range of risk defined in the original approved protocol. Second, studies of the nature, causes, and effectiveness of responses to natural disasters could be overseen by similarly constructed committees. In this case, however, the oversight committee would not be called upon to review plans to investigate specific disasters. Rather, it would review general plans of a research group to conduct all of their studies of disasters in the foreseeable future. In this case, however, the committee would be convened to repeat its review of the institution’s actual investigations after each oc- currence. Investigators would know that their actual activities would be reviewed retrospectively and that they would be held accountable for hav- ing adhered to the specifications of the approved general plan, as well as to the general scientific and ethical standards of the institution. REFERENCES Anderson, E., Solomon, S., Heitman, E., Dubois, J.M., Fisher, C.B., Kost, R.G., et al. (2012). Research ethics education for community-engaged research: A review and research agenda. Journal of Empirical Research on Human Research Ethics, 7(2):3-19. Association for the Accreditation of Human Research Protection Programs (2013). 2012 Met- rics on Human Research Protection Program Performance. Washington, DC: AAHRPP. Available: https://admin.share.aahrpp.org/Website%20Documents/2012%20Metrics%20 (2).pdf [November 2013]. Association of Internet Researchers (2012). Ethical Decision-Making and Internet Research. Recommendations from the AoIR Ethics Working Committee (Version 2). Available: http:www.aoir.org/reports/ethics2.pdf [December 2013]. Bechert, T. (2011). Streamlining the IRB process: Avoiding unnecessary deliberation and effort. Journal of Clinical Research Best Practices, 7(6):1-9. Cola, P.A., Reider, C., and Strasser, J.E. (2013). Ohio CTSAs implement a reliant IRB model for investigator-initiated multicenter clinical trials. Clinical and Translational Science, 6(3):176-178. Emanuel, E.J., and Menikoff, J. (2011). Reforming the regulations governing research with hu- man subjects. New England Journal of Medicine, 365(12):1145-1150. Available: http:// www.nejm.org/doi/full/10.1056/NEJMsb1106942 [October 2013]. IRB Advisor. (2013). Experts: Saving time while improving review quality is top priority. IRB Advisor, 13(8):85-88. Kavanagh, C., Matthews D., Sorenson, J.R., and Swazey, J.P. (1979). We shall overcome: Multi-institutional review of a genetic counseling study. IRB: Ethics and Human Re- search, 1(2):1-3. National Research Council. (2013). Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. R. Pool (Rapporteur). Board on Behavioral, Cognitive, and Sensory Sci- ences, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press.

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148 PROPOSED REVISIONS TO THE COMMON RULE Schrag, Z.M. (2010a). AAHRPP and the unchecked box. Institutional Review Blog. Avail- able: http://www.institutionalreviewblog.com/2009/07/aahrpp-and-unchecked-box.html [October 2013]. Schrag, Z.M. (2010b). Unchecked Boxes, 2006 and 2010. Available: http://zacharyschrag.files. wordpress.com/2011/06/unchecked_boxes.pdf [October 2013]. Schrag, Z.M. (2012, May 15). Most universities uncheck their boxes. Institutional Review Blog. Secretary’s Advisory Committee on Human Research Protections. (2011, October 13), ANPRM communication. Available: http://www.hhs.gov/ohrp/sachrp/commsec/sachrpanprm commentsfinal.pdf.pdf [December 2013]. Shah, S.K. (2013). Outsourcing ethical obligations: Should the revised common rule address the responsibilities of investigators and sponsors? Journal of Law, Medicine, and Ethics, 41(2):397-410. Shah, S.K., Whittle, A., Wilfond, B., Gensler, G., and Wendler, D. (2004). How do institutional review boards apply the federal risk and benefit standards for pediatric research? Journal of the American Medical Association, 291(4):476-482. Wagner, T.H., Murray, C., Goldberg, J., Adler, J.M., and Abrams, J. (2010). Costs and benefits of the National Cancer Institute central institutional review board. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 28(4):662-666.