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Suggested Citation:"RECOMMENDATIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"RECOMMENDATIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"RECOMMENDATIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"RECOMMENDATIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"RECOMMENDATIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"RECOMMENDATIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"RECOMMENDATIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"RECOMMENDATIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"RECOMMENDATIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"RECOMMENDATIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

EXECUTIVE SUMMARY 10 In the course of the second, more comprehensive, phase of the committee's work, the committee may or may not revisit HRPPP accreditation. The future report will certainly address other strategies for improvement to supplement this report, such as educating investigators, augmenting resources for research oversight (at both the federal and the local levels), enhancing oversight of ongoing research (including monitoring bodies and reporting mechanisms), and other strategies. RECOMMENDATIONS Recommendation 1: Pursue Accreditation Through Pilot Testing as One Approach Accreditation of HRPPPs should be pursued as one promising approach to improving the human participant protection system. The first step is implementation of pilot programs to test standards, establish accreditation processes, and build confidence in accreditation organizations. This effort should be evaluated for its impact on protecting the rights and interests of participants in 3 to 5 years. The process of establishing an accreditation system typically takes many years, and it must be continually adjusted, particularly in its initial phases. Current efforts to establish accreditation systems are just under way, and the proposed standards are new and untested. The process for the accreditation of HRPPPs is still being configured, and the organizaitons thus far identified to carry it out are taking on an unprecedented task. Two specific approaches have been presented to the committee. The process that is furthest along is a nascent accrediation process for the VA medical facilities being conducted by NCQA under a contract with the VA. That contract commenced in May 2000. Another organization, the Association for the Accreditation of Human Research Protection Programs (AAHRPP), was originally incorporated in March 2000, but its formal establishment is still under way (see Chapter 2). These emerging accreditation programs are best viewed as pilot projects that will have to be evaluated in light of experience. Any accreditation system must be constructed as an evolving tool and part of a long-term strategy and cannot be expected to immediately correct deficiencies in the HRPPP system. As a component of a long-term strategy to improve the quality of research oversight, however, a nongovernmental accreditation process has promise and should be tested as soon as possible. The logical first step is to continue the VA accreditation program. The second step is to pilot test accreditation in academic health centers and private research organizations whose HRPPPs conform to the organizational structures for which both sets of draft standards were formulated: those that conduct research, directly employ investigators, and have IRBs. The

EXECUTIVE SUMMARY 11 NCQA standards appear to be closer to adaptation for such use than the PRIM&R standards do (see Recommendation 9). Recommendation 2: Establish a Nongovernmental Accreditation Organization (s) Organizations formulating accreditation standards and carrying out the accreditation process should be independent, nongovernmental organizations. These organizations should include within their programmatic leaderships the perspectives of the relevant stakeholders in the applicant HRPPP community (i.e., institutions, investigators, sponsors, and participants). An accreditation process is only as credible as the organizations that carry it out. The foremost criterion is independence (Hamm, 1997). Organizations formulating standards and conducting the accreditation process should 1. be national in scope; 2. be familiar with the operations of institutions that apply for accreditation; and 3. incorporate the perspectives of research participants within their programmatic leadership. An accreditation process should directly involve the kinds of institutions being accredited, but an accreditation organization should not be beholden to any particular stakeholder or interest group. Accreditation bodies for HRPPPs will require input from academic health centers, organizations representing research sponsors, nongovernmental research organizations, private firms developing products and services tested in studies with humans, participants, IRB members and staff from both academic and nonacademic institutions, research administrators in both academic and nonacademic institutions, and individuals from a range of research fields appropriate to the intended range of applicant institutions. Research participant representatives will be particularly important in formulating the overall goals of the HRPPP systems, and their perspectives should be systematically solicited in both the formulation of standards and the execution of the accreditation process. This involvement will also include representation on groups that set standards and teams that conduct external evaluations and site visits. National accreditation bodies should seek to involve organizations that have both a genuine national constituency that corresponds to the interests of the research participants4 and a demonstrated familiarity with the research process and research protection rules and regulations (see Recommendation 8). 4 In the case of the VA, for example, this would include national veterans organizations; for medical research, this would include health advocacy organizations; and for community-based or population-based research, this would include organizations representing the communities or the full range of subpopulations sampled.

EXECUTIVE SUMMARY 12 Recommendation 3: Articulate Sound Goals Within Accreditation Standards The goals of accreditation standards should be to ensure 1. That the proposed research promises to contribute knowledge sufficient to justify research involving human participants; 2. independent review of research by a board knowledgeable about protection standards and the fields of research being reviewed; 3. that the perspectives of participants are represented on IRBs, on research monitoring bodies, and throughout the research oversight system; 4. that IRB members do not review protocols with which they have financial or nonfinancial conflicts of interest;5 5. that investigator and institutional conflicts of interest, both financial and nonfinancial, are disclosed to IRBs and participants and are managed responsibly by research institutions; 6. a review process that balances risks and potential benefits, keeps risks to the minimum necessary, and monitors research on a continuing basis; 7. that an effective process for obtaining voluntary informed consent of participants is in place; 8. that policies and procedures are in place to assess the quality of HRPPP operations, enhance accountability, and improve performance; 9. there is fairness in recruitment and selection of participants; 10 . that the privacy and confidentiality of research participants are protected; and 11 . that the HRPPP is transparent so that participants can judge the research process to be trustworthy. Recommendation 4: Establish Flexible, Ethics-Based, and Meaningful Standards Accreditation standards should meet the following minimal criteria: 1. They should be based on sound and widely accepted ethical principles.6 5 The committee does not mean that any member who could have a conflict with any conceivable protocol coming to an IRB for review should be excluded from service on an IRB but, rather, means that the individual should recuse himself or herself from reviewing such protocols.

EXECUTIVE SUMMARY 13 6. They should be flexible and adapted to different kinds of research and different research institutions. 7. They should encourage accredited organizations to shift from a culture that relies on external compliance checks to a culture that puts safety and voluntary participation foremost. 8. They should facilitate compliance with federal regulations but should aim to move an organization toward having stronger protection of human research participants. 9. To the extent possible, they should focus on the use of meaningful measures of how well the rights and interests of research participants are being protected rather than simple determination of whether informed-consent statements have been signed or IRB meetings were duly constituted. The committee believes that the draft NCQA standards are close to meeting the criteria in Recommendations 3 and 4 for pilot testing in VA facilities, and if they are modified as suggested under Recommendation 9, they could be used as the basis for pilot tests of HRPPP standards outside VA facilities. Recommendation 5: Accommodate Distinct Research Methods and Models Within Accreditation Programs The accreditation process should accommodate other research organizations in addition to the traditional models provided by academic health centers and VA facilities. The accreditation process should also cover research other than clinical research. Proposed NCQA standards were designed for VA facilities only. PRIM&R standards were prepared with a broader range of institutions in mind, but the committee heard strong, consistent comments that they do not fully recognize either the diversity of institutions or the full range of research (IOM, 2001). The standards proposed by NCQA and PRIM&R focus on HRPPPs that comprise a research institution, investigators, and IRBs. These elements are present in VA 6 The principles laid out in The Belmont Report are one foundation (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Accreditation standards, however, should also incorporate the recommendations of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission, 1981, 1983), the recommendations of the Advisory Committee for Human Radiation Experiments (ACHRE, 1995), recommendations presented in reports of the National Bioethics Advisory Commission (NBAC, 1998, 1999a,b, forthcoming-a, forthcoming-b), the recommendations of the Office of the Inspector General of DHHS (DHHS OIG, 1998b, 2000b), and the recommendations of the General Accounting Office (GAO, 1996). In addition, recommendations from reports and declarations of private bodies and independent scholars should be incorporated. This presupposes that an advisory apparatus is available to cull this literature.

EXECUTIVE SUMMARY 14 facilities, academic health centers, and some other research organizations. Many organizations that might reasonably apply for HRPPP accreditation, however, do not conform to the traditional research organization model. Independent IRBs do not directly conduct research, for example, and so entire sections of the proposed standards are inapplicable to them. To be credible, the accreditation process should expand to include independent IRBs; cooperative groups; contract research organizations; site management organizations; units within federal research agencies that conduct their own research; and units of pharmaceutical, medical device, and biotechnology firms that carry out research with human participants. The accreditation process must be sufficiently elastic to accommodate all major organizational structures involved in research with humans. Failure to cover the full range of research organizations under an accreditation program would undermine the credibility of the accreditation process so essential to the program's success in two ways. First, it would eliminate a large and growing fraction of research with humans, and second, it could be perceived as a subterfuge to protect the competitive advantage of academic health centers to the detriment of private independent IRBs on the basis of categorical exclusion rather than quality. Yet, neither NCQA nor PRIM&R draft standards can be directly applied to many organizations conducting research with humans. Discovering how to do this with one or several sets of standards, whether under one accreditation body or a few, will be an important question to address in pilot tests. Accreditation of an independent IRB, for example, might use only the subset of standards pertinent to IRBs, but doing so would also require assurance regarding the functions covered by proposed standards that pertain to investigators, research institutions, and research participants, as well as standards not yet incorporated into NCQA or PRIM&R standards (but covered by the guidelines of the International Conference on Harmonisation; see Chapter 3) pertaining to sponsors. Independent IRBs could be accredited with such assurances, perhaps on the basis of binding written agreements between the independent IRB and the research sponsors contracting for its services. Another approach would be to accredit the organization that does directly control all the relevant elements of an HRPPP (e.g., a contract research organization that has a formal agreement with an independent IRB to review all its protocols, the research unit of a private firm, the unit of a federal agency that performs research, or a clinical trials cooperative group). These approaches are not mutually exclusive, but neither approach is reflected in the NCQA and PRIM&R draft standards. One of the virtues of a nongovernmental voluntary accreditation process is its flexibility, and nongovernmental accreditation bodies should not find it difficult to accommodate disparate organizational structures, but it is not yet clear how the current proposed standards or accreditation processes would do so.

EXECUTIVE SUMMARY 15 How to apply the proposed standards to nonmedical research institutions7 is also controversial and should be explicitly addressed in pilot accreditation programs. Commentary at the committee's January 2001 public forum stressed that proposed HRPPP standards focus almost entirely on clinical research. Although the proposed PRIM&R standards include many that would be used only “if applicable” to a given applicant organization, a set of standards developed for the social and behavioral sciences or for population-based studies ab initio would not include many of the “if applicable” standards and would expand or rephrase other standards. The committee believes that the same principles for protection of the rights and interests of research participants apply to all research, and in that sense the same general standard of conduct should prevail. It is an open question, however, whether the best accreditation strategy would be to use one set of operational standards for all research. That might well prove viable, but it also might prove better to encourage the evolution of different specific standards for different kinds of research institutions. Those in the best position to judge this will be organizations devising the accreditation processes, not this committee or the federal government. Whether to develop one set of standards or a few sets of standards specific to a few different classes of research organizations should not be decided by fiat but should be decided in light of experience gained through pilot accreditation programs that include medical and nonmedical sites. Accreditation demonstration programs can begin by focusing on the research institutions for which they were designed, but they might evolve in many different ways. In the future, there could be one or a few accreditation bodies and one or a few sets of accreditation standards, and many different kinds of organizations will continue to be involved in research with human participants. Recommendation 6: Base Standards on Existing Regulations Accreditation standards should start from federal regulations for the protection of human research participants but should augment those regulations. The process should be iterative and continual, with evolution of both accreditation standards and the operations of accredited organizations, creating incentives for accredited organizations to improve. 7 By “nonmedical institutions,” the committee refers to organizations that conduct or review research that is not primarily clinical. Some research institutions, for example, concentrate on national surveys or demographic research; others mainly review student research projects. Entire research centers are devoted to epidemiology, population and community-based research, or public health. Some academic and independent private research institutes focus on studies in anthropology, oral history, sociology, psychology, journalism, law, and political science. These fields have widely different norms and methods, and the nature of the risks for participants also differs.

EXECUTIVE SUMMARY 16 Accreditation standards start from a base of regulations governing research with humans. The regulations, in turn, are based on a set of principles for the ethical conduct of research (see Recommendation 4). The standards proposed by NCQA are tightly coupled to the existing federal regulations, but they also incorporate quality improvement processes that could evolve into a different set of standards over time. The NCQA strategy will therefore focus first on facilitating compliance with existing regulations but, importantly, will provide a means to raise the quality of protection standards over time. By using standards that emphasize processes of continual quality improvement instead of an exclusive focus on regulatory compliance, the way may be open to the development of future standards that center on HRPPP performance, in addition to the current focus on documentation. For example, an HRPPP that demonstrates that it can ensure informed consent because it has data showing that participants understand the protocols in which they are enrolled could begin to supplant or augment paper audits of signed informed-consent forms. This strategy therefore has the potential to introduce the desired flexibility and focus on outcomes into the oversight system. Accreditation will not be successful until it is widely accepted as a mark of excellence. It should also serve as an educational tool to raise the median overall performance. To do this, accreditation standards and the processes in which they will be used must incorporate consistent feedback from the parties involved in the various aspects of an HRPPP. Those who encounter problems in the research system— participants or people who care about them, investigators submitting research for review by an IRB, institutions negotiating agreements to perform sponsored research, anyone who notices something going awry in the course of a study, or data safety and monitoring boards that note a pattern in reported adverse events—need simple, consistent ways to bring their concerns to light. In addition, they need ways to bring relevant information into the procedure for the review of the process, including the functioning of both the HRPPP system and the accreditation process. One of the chief advantages of a voluntary nongovernmental accreditation system over a mandatory government process is that it can evolve over time without requiring new federal regulations at each step. It took 10 years for 18 agencies to adopt the federal Common Rule governing human research (45 CFR 46, Subpart A), and at least 3 agencies that conduct human research remain outside of the rule.8 The current regulatory system is demonstrably unresponsive to dramatic changes in how research is conducted; a nongovernmental accreditation 8 OPRR noted three agencies that appeared to sponsor research with human participants but that were not signatories to the Common Rule: the National Endowment for the Humanities, the U.S. Department of Labor, and the Nuclear Regulatory Commission, as cited in a draft report forthcoming from the National Bioethics Advisory Committee (NBAC, forthcoming-b).

EXECUTIVE SUMMARY 17 system may be more responsive by comparison and would comport with Circular No. A-119 of the Office of Management and Budget, which urges the use of nongovernmental “voluntary consensus standards” where possible (OMB, 1998).9 The committee envisions an accreditation process that will continually evolve, updating standards over time. The operations of organizations seeking accreditation will also evolve. The parallel evolution of accreditation standards and HRPPP operations should be an iterative process, with the formulation of standards efficiently informed by knowledge acquired in the accreditation process. The formulation of standards, the conduct of accreditation site visits, and external evaluation must therefore be intimately linked. Recommendation 7: Incorporate Continuous Quality Improvement Mechanisms into Standards Accreditation organizations should emphasize the process of self-study, evaluation, and continual quality improvement among applicants. They should move beyond documentation of informed consent and protocol review, which, although essential, do not of themselves protect the rights and interests of research participants. Standards should aim to improve outcomes and should not overly prescribe how to achieve the specified objectives. Rather, they should focus on the core standards that apply across programs and that are essential to a quality HRPPP. Current proposed standards generally reinforce the documentation practices required by federal regulations but do not go beyond these regulatory requirements. In general, both entities seeking accreditation and accreditation bodies should identify exemplary performance and best practices, providing benchmarks for the research community at large and making information on organization performance openly available to the public and policy makers. Linkage to quality improvement strategies also offers a path to achievements well beyond regulatory compliance. For example, an HRPPP demonstrating a particularly reliable system for the monitoring of participant safety or the reporting of problems in ongoing research could have a competitive advantage over nonaccredited competitors in seeking support from sponsors or having access to participants, researchers, or students. The committee concurs with this strategy which was incorporated into the standards proposed by NCQA and recommends that it should also be applied to non-VA research organizations. 9 Circular No. A-119 was intended mainly for technical standards pertaining to products, but it also contemplates “related management systems practices.”

EXECUTIVE SUMMARY 18 Recommendation 8: Directly Involve Research Participants in Accreditation Programs and HRPPPs The formulation of accreditation standards, the accreditation process, and HRPPP operations should directly involve research participants.10 Accreditation bodies should formally solicit input from and directly involve the groups of people who will be studied in research carried out by the organizations that they will accredit. Participant perspectives are an essential element in research design, especially as it pertains to informed consent and the minimization of risk, and participant representatives should be directly involved in IRB review and should be members of the programmatic leaderships of accreditation review groups, site visit teams, monitoring boards, and oversight and advisory groups in research institutions. Standards should also reflect stronger participant involvement beyond securing signatures on informed-consent documents. Recommendation 9: Use Modified NCQA Standards to Initiate Pilot Programs Pilot accreditation programs should start from the accreditation standards and processes proposed by NCQA for VA facilities, as adapted for use in other organizational contexts. In expanding the draft NCQA accreditation standards for use beyond VA facilities, the standards should be strengthened in six specific ways as pilot testing commences. The PRIM&R standards were prepared for a broad set of potential applicant organizations, which would include but not be restricted to academic health centers. The NCQA standards were explicitly prepared for accreditation of VA medical facilities. In this instance, the applicant pool is defined, and, in fact, pilot tests that will use those standards are being planned as this report goes to press. As noted throughout this discussion of report recommendations, the committee regards the NCQA standards as an excellent starting point for accreditation of VA facilities. The committee recommends, however, that the NCQA standards be strengthened in six areas, discussed in more detail in Chapter 3, to specify (1) how investigators will be reviewed beyond the review of the protocols that they submit for IRB approval; (2) whether and how research sponsors will be assessed in the accreditation process; (3) how participants will be involved in setting standards and accrediting HRPPPs; (4) how oversight mecha 10 By “participants,” the committee refers to those whose background and expertise are credible to a lay constituency external to the research institution and who are knowledgeable about the research process and research protections. The term is further defined in Chapter 1.

EXECUTIVE SUMMARY 19 nisms can ensure participants' safety in ongoing research; (5) the steps that research institutions and their leadership can take to cultivate a culture that puts the safety and interests of research participants foremost; and (6) mechanisms by which research institutions and, where applicable, research sponsors can be held accountable for ensuring sufficient funding, structural support, and professional rewards for HRPPPs. The NCQA standards, if improved as recommended, could also be used—by NCQA, AAHRPP, or other accreditation organizations—as the basis for the development of accreditation standards for non-VA research organizations. Recommendation 10: Begin Collecting Data and Assessing Impacts of Accreditation Now DHHS should commission studies to gather baseline data on the current system of protections for human participants in the research that it oversees and to assess whether the system is improving over time. Baseline data are needed on the following: • a taxonomy of research institutions: the number of institutions conducting research with human participants and the number of studies of different types (e.g., clinical trials, surveys, student projects, and behavioral studies) approved by their HRPPPs; • a taxonomy of IRBs: the number of IRBs and what fraction of them are primarily devoted to studies of particular types; • a taxonomy of studies with humans: the number and distribution of investigations with humans under way by type of study, for example, clinical trials of various stages, observational studies, cross-sectional and longitudinal surveys, and social science experiments; • the number of people involved in research and, among them, how many are involved in research with more than minimal risk; • the fraction of studies with more than minimal risk that have formal safety monitoring boards and how (and how well) those boards operate; • the type and number of inquiries, investigations, and sanctions by FDA and the Office for Human Research Protections; and • the type and number of serious or unanticipated adverse events attributable to research. DHHS should also commission studies of how the databases for existing clinical trials and other research resources could be used to assess how well the system of research protections is operating and, specifically, whether accreditation is having measurable impacts (e.g., by comparing accredited and nonaccredited institutions or by comparing institutions before and after accreditation). Other studies are needed to bolster the nascent literature on how well research participants understand the studies that they join, which risks matter most

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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