4
Mechanisms for Public Input

Public input is an essential and integral part of any democratic process. Done well, it can improve the knowledge base for decisions, clarify the nature and extent of agreements and disagreements (e.g., among participants and between participants and agencies), and yield more widely accepted decisions (National Research Council, 1989, 1996). In the case of NIH, public participation can help leaders better understand the public's view of health research issues and help citizens better understand critical research policy issues.

Clearly, the public is intensely interested in health, particularly in diseases that affect them personally or those close to them. There is broad agreement among the public, the U.S. Congress, and the executive branch that investing in biomedical research is the right thing to do. Based on the record thus far, Americans hold high expectations for the future achievements of biomedical science, which will provide the return on that investment.

Beyond that apparent consensus, however, are deeply held and sometimes divisive convictions about how research dollars should be spent. Advocates for cancer patients want resources devoted to cancer prevention and treatment just as strongly as advocates focused on effective therapies for diabetes, stroke, or arthritis, for example, or improved research and therapeutic interventions for underserved portions of the population want resources devoted to those causes. With limited funds for health research, various disease-specific interest groups sometimes find themselves at odds with NIH or with each other about the relative size and dimension of the biomedical research portfolio and how it should be apportioned. In some cases, more than one advocacy group might be formed around a given disease, for example, diabetes, Lyme disease, or AIDS. These



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--> 4 Mechanisms for Public Input Public input is an essential and integral part of any democratic process. Done well, it can improve the knowledge base for decisions, clarify the nature and extent of agreements and disagreements (e.g., among participants and between participants and agencies), and yield more widely accepted decisions (National Research Council, 1989, 1996). In the case of NIH, public participation can help leaders better understand the public's view of health research issues and help citizens better understand critical research policy issues. Clearly, the public is intensely interested in health, particularly in diseases that affect them personally or those close to them. There is broad agreement among the public, the U.S. Congress, and the executive branch that investing in biomedical research is the right thing to do. Based on the record thus far, Americans hold high expectations for the future achievements of biomedical science, which will provide the return on that investment. Beyond that apparent consensus, however, are deeply held and sometimes divisive convictions about how research dollars should be spent. Advocates for cancer patients want resources devoted to cancer prevention and treatment just as strongly as advocates focused on effective therapies for diabetes, stroke, or arthritis, for example, or improved research and therapeutic interventions for underserved portions of the population want resources devoted to those causes. With limited funds for health research, various disease-specific interest groups sometimes find themselves at odds with NIH or with each other about the relative size and dimension of the biomedical research portfolio and how it should be apportioned. In some cases, more than one advocacy group might be formed around a given disease, for example, diabetes, Lyme disease, or AIDS. These

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--> groups do not always agree on the best research approach to better health. In some cases they may even be diametrically opposed on any given issue. At other times, diverse groups unite on issues of common interest, such as more overall funds for research or reduced regulatory constraints on the conduct of research. PUBLIC INPUT INTO PRIORITY SETTING Advocacy is an important and vital part of the biomedical research environment. Disease-specific interest groups have long been a valuable source of support for NIH and its budget (Strickland, 1972). In many ways, advocacy efforts such as those that began in the late 1960s created the modern NIH. When NIH's budget began to stagnate after 1966 (it actually fell for several years), a coalition of disease-specific interest groups and clinical researchers led by Mary Lasker and Sidney Farber mobilized to push through greatly expanded powers and budgets for NCI as part of a "War on Cancer" (Rettig, 1977). After 1970, NIH's budget began to grow again (doubling by 1980 and doubling again by 1990), and the number of research grants went up accordingly. At the same time, disease-specific interest groups, working through Congress, became much more involved in organizational and budget allocation decision making. As a result, the number of institutes increased by seven and the share of funding aimed at specific diseases (as distinct from funding for undirected basic research) grew as other groups sought to achieve the levels of funding achieved by the National Cancer Program. Advocacy on behalf of health research needs reflects representative democracy and a sense of the public good. It has also shaped NIH's priorities in a way that can be hard to follow or that can lead to abrupt changes in funding patterns—changes that vary in how well they fulfill NIH's own criteria for setting priorities. In addition, specific advocacy efforts can succeed in gaining large increases in funding for certain diseases (e.g., AIDS and breast cancer) at the expense of funding for others.1 This is especially true when the overall NIH budget has been level or growing slowly. Thus, in addition to advancing the nation's overall investment in health research, advocacy efforts can create a contentious environment for those trying to set research priorities, be it Congress or NIH. Moreover, interest groups have often produced extensive data sets on disease-specific research spending in an 1   In 1993, for example, NCI allocations for breast cancer research increased by $53 million, cervical cancer research funding increased by $10 million, ovarian cancer research funding increased by $6 million, and prostate cancer research funding increased by $7 million. To achieve these increases, NCI had to cut basic research funding for leukemia, non-Hodgkin's lymphoma, and cancers of the colon, bladder, kidney, and brain, as well as for public information and chemoprevention (Stephens, 1993).

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--> effort to make the case that too little money is being spent on a given disease, that too much is being spent on another, or that the emphasis of research on a given disease is inappropriate or unbalanced. 2 However, as discussed in Chapter 2, NIH's own criteria for setting priorities recognize that there is no simple metric that can be used to guide how allocations should be set. (Recommendations on better data collection and presentation were presented earlier in this report.) When a disease-specific interest group believes that insufficient resources are being devoted to its cause, that research emphases are inappropriate, or that there is no mechanism by which it can have input in the priority-setting process, it has two possible courses of action. First, interest groups representing various factions of the public can approach Congress in an attempt to achieve their goals and objectives. Members of Congress have the prerogative of selecting the interests that they wish to serve. In the past, lobbying of members of Congress has been an effective mechanism for disease-specific interest groups. There is no reason to expect that this strategy will not continue to be an effective and legitimate mechanism for public input into the process. The second course is to approach NIH directly, seeking additional or redirected resources for research important to the group. As with Congress, NIH's responsiveness to interest groups has varied. As a result, some groups feel that their concerns are being heard, whereas others believe either (1) that they cannot gain access to NIH leaders or (2) that when they do gain access, they are met with resistance. To some extent, these variations in perception might be attributable to personalities, differences in leadership, and inconsistent messages on the part of both the interest groups and NIH. In some instances, the perceived lack of responsiveness by NIH to interest group requests is attributable to authentic voids in scientific opportunity or limited resources. In some cases, NIH may simply be unresponsive. RECENT CHANGES In recent years, several events have changed the environment in which Congress, NIH, and interest groups interact. First, in 1994, congressional leadership changed for the first time in nearly four decades. Thus, the leadership and staffing of congressional NIH authorization and appropriations committees changed. Well-established alliances and 2   For example, at the public hearing on April 3, 1998, advocates made various points about research emphases. A representative from the American Heart Association talked about the need for greater emphasis on prevention and compliance research. A representative from the National Alliance for the Mentally Ill asked for a greater focus on biological research and suggested that much of the behavioral research at the National Institute of Mental Health did not reflect patients' priorities.

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--> negotiating tactics were, in some cases, eliminated. Further, in recent years some congressional leaders have called for a cessation in the earmarking of funds for specific diseases. This has frustrated some disease-specific interest groups, who find themselves operating in an environment where the rules have changed; that is, the door appears to have closed before they were able to get inside. Others feel that they have never been able to get their foot in the door. Second, a new NIH director was appointed in 1993. His immediate goal was to shore up the scientific quality of the nation's biomedical research establishment, because for several years prior to his appointment there had been growing concern that the quality and innovativeness of NIH had sagged (Cohen, 1993a,b; Nature, 1993). The new director adopted a more centralized approach to managing the many institutes and other organizational entities that constitute NIH, and he used new authorities granted the director by Congress to set priorities. This management style had been recommended by numerous advisory groups convened over the past 20 years (Institute of Medicine, 1988; Klausner, 1992; National Institutes of Health, 1994a; U.S. Department of Health, Education, and Welfare, 1976). Although most observers agree that vesting the director with more authority has been a positive change, it has also placed the current director's office more in the spotlight, resulting in the perception that he should be better able to consider and respond to public input than previous directors. Third, for some time representatives of some disease-specific interest groups had worked together to seek increased overall funding for NIH, the proverbial "rising tide that lifts all the boats." In the meantime, certain disease-specific interest groups—notably, advocates for AIDS and breast cancer research—were extremely successful in achieving large increases in the NIH budget for research in those areas. This apparent success led other groups to pursue the same tactics to receive equitable funding for their causes. There has also been growth in the use of professional lobbyists, many of them former congressional staff members, by voluntary groups to make their case in Congress. Together, these trends have fueled the perception of some that at times NIH funds research on diseases with the most active groups behind them rather than those diseases for which the needs are greatest in terms of suffering and cost or diseases for which scientific opportunities are the greatest. In 1997 the Congressional Research Service described the perception of some members of Congress and the public that NIH spending often follows current politics and political correctness or responds to media attention to certain diseases which results in unacceptable disparities in spending. For example, the Parkinson's Action Network claimed that in 1994 NIH spent more than $1,000 per affected person on AIDS research, $93 on heart disease, and $26 on Parkinson's disease. The American Heart Association contended that while overall NIH funding has increased 36 percent in constant dollars since 1986, funding for the heart disease research program at NIH has declined 5.5 percent.

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--> The Juvenile Diabetes Foundation asserted that funding at the National Institute of Diabetes and Digestive and Kidney Diseases increased only 53 percent over a 10-year period when overall NIH funding increased 97 percent (Johnson, 1998). Finally, some interest groups that have always felt disenfranchised from the biomedical research enterprise continued to feel that their concerns were not being met. Thus, in the process of setting priorities, Congress and NIH have received input from a large and diverse, although by no means comprehensive, group of organizations and interest groups. Recent disagreements between NIH and these groups over priorities may be due in part to substantive differences in opinion or limitations in the mechanisms for these opinions to be heard and considered by NIH. Although some mechanisms for public input, both formal and informal, currently exist, sufficiently recognizable and accessible points of entry do not exist for those who wish to provide public input but who are unfamiliar with the intricacies of NIH's current complex and varied priority-setting processes. This flaw has exacerbated long-term, unresolved issues about the relative influence of disease-specific interest groups on the NIH priority-setting process. It has also contributed to newer and more acute issues raised by the changes in the environment in which disease-specific interest groups and members of Congress are now operating. It is clear that broader involvement of the public in discussions about NIH priority setting can result in positive outcomes by enhancing the relevancy of research programs, improving the design and conduct of research, particularly patient-oriented studies, and assuring all those with an interest in NIH research that there is an opportunity to be heard. TWO-WAY COMMUNICATION BETWEEN NIH AND THE PUBLIC In addition to conducting and supporting research and training to improve health, NIH has a major responsibility for informing the public about biomedical research and for responding to the views of various publics on research priorities. An important part of this responsibility is the communication or dissemination of research results and health information, which, done well, involves active outreach to and involvement of the public in planning and evaluation. The committee was not, however, in a position to evaluate NIH's performance in these areas, its use of current communications or education research, or the quality of its own evaluations. Instead, it focused on the public role in the research priority-setting process at NIH. Specifically, the committee reviewed the "transparency" of the priority-setting process—that is, making clear how NIH makes decisions and allocates resources, how interested citizens may become involved in programs of interest to them, and how public interests are incorporated in NIH's external advisory system.

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--> For example, one function that does not seem to have been addressed very fully is explaining the mission and workings of NIH and, especially, how it sets priorities. NIH's recent booklet "Setting Research Priorities at the National Institutes of Health" (National Institutes of Health, 1997b) describes the system, but the explanation is complicated and does not indicate how concerned people can provide input to the priority-setting process, especially those who would not naturally have easy access to this process. NIH interacts with various constituencies, including extramural research scientists, non-research-oriented clinicians who apply research results and who can identify research needs (physicians, including specialized physicians, nurses, dentists, pharmacists, social workers, psychologists, public health practitioners, and other allied health practitioners), organized voluntary groups and individuals active in advocating for those with specific diseases or medical conditions, and organizations and individuals who represent population groups with special or disproportionate health problems (members of particular ethnic groups, low-income populations, women, elderly people, children, etc.). The institutes and centers have different priority-setting processes, that is, they differ in how they plan research programs and allocate resources among them, and they also differ in the extent and nature of public involvement in their advisory systems. Where to go to find out about NIH's programs or to express interests and concerns would not always be obvious to an interested individual or group. The situation is further complicated when an issue involves multiple institutes, and the Office of the Director is not always equipped to handle public input about issues that cut across NIH or involve several institutes. NIH has long-standing mechanisms by which to include public or lay members on top-level advisory bodies. In most institutes, for example, 6 of 18 membership slots of the national advisory council are reserved for public representatives. These councils provide to the institutes advice and guidance on their research programs and funding decisions by providing the second layer of review (the first being peer review through the study sections). Thus, public representatives play a role in the priority-setting process and provide advice on funding decisions. Review of the memberships of these councils reveals that some institutes do not appear to be filling these reserved slots with enough public members representing the last two groups in the list above, that is, representatives of patients and their families and of populations with special health problems. Not doing so is a missed opportunity and has resulted in the perception of some groups that NIH does not encourage public input at the highest levels of its advisory processes.

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--> Each institute also has a National Council or a Board of Scientific Counselors, which provides advice on and reviews the intramural research program, and a Board of Scientific Advisors, which provides advice on the extramural programs. (Appendix A lists the advisory boards for each institute.) In addition, institute directors often form working groups and ad hoc panels to address key issues in their research programs. Institutes frequently engage in program or progress reviews to determine whether the institute is investing in the appropriate areas of research. Some institutes have offices for consumer and public issues (see Box 4-1 for a description of the NCI Director's Consumer Liaison Group as an example of an exemplary public advisory body at NCI). BOX 4-1 The NCI Director's Consumer Liaison Group The NCI Director's Consumer Liaison Group was formed to help NCI develop mechanisms to increase the level of representation of the cancer advocacy community on NCI advisory committees and to increase consumer-advocate involvement in NCI's program and policy development (National Cancer Institute. 1997). To form the Director's Consumer Liaison Group, a consultant was hired and charged with the responsibility of contacting individual scientists, health care provider organizations, disease-specific interest groups, community-based organizations, and minority and nonminority science organizations and soliciting nominations. Eligibility requirements included the following: A "public individual" who has experience with either a specific disease or disabling condition or with disease prevention and health maintenance, for example, a disease-specific interest group, a person affected by the consequences of a disease or disability, a professional or volunteer who works with survivors or those affected, or a member of community-based organization dealing with health issues of a particular community. Someone who represents a constituency (formally or informally) with which she or he regularly communicates on issues pertaining to clinical care or research and who is able to serve as a conduit for information both to and from his or her constituency. Someone with a commitment to working with NIH on issues relevant to care for people with a particular disease or disabling condition and research on a disease or disability. In addition, ACD of NIH reserves 5 of its 16 slots for public members. Unlike the national councils at each institute, ACD does not oversee or advise the director on a specific research portfolio, except for whatever advice it provides on the use of the director's discretionary funds, transfer authority, or Areas of Research Emphasis (see Chapter 3). Presumably, the NIH director may consult with ACD on the overall NIH budget or new initiatives as he or she sees

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--> fit. As with the national councils at each institute, it appears that the "public" slots of ACD are sometimes not filled by individuals one would commonly consider to represent the public. It is recognized that identifying individuals who can broadly represent the public's interest is a difficult task, but it is nonetheless a worthy goal to be pursued because of the importance of a public presence on the advisory committee closest to the director of NIH. The committee believes that priority setting at NIH would be improved and its outcomes would be better understood and accepted if advisory bodies had more consumers and advocates from among all of the categories of constituencies listed above. Although many of the institutes primarily rely on scientists and health professionals for external advice, the committee encountered a number of examples in which institutes and offices have incorporated a broader range of external inputs, including the involvement of patients and their advocates, in their priority-setting processes. For example, in addition to NCI's consumer liaison group, it also invites advocates and consumer groups to sit on panels reviewing organizational and disease-specific components of its research program, such as, cancer centers or progress in prostate cancer research. NIAID has a broad-based formal planning process that is not only transparent (that is, clearly described in documents and charts) but that also involves a range of public viewpoints, including those of patients and advocates who participate in planning retreats and other forums. NIAID has also established the extensive use of community advisory boards in its clinical trials, cohort studies, and other clinical research groups "to bring about greater involvement of community advocates and potential [clinical] trial participants in scientific and protocol planning . . . and provide a forum for concerns that may arise among trial participants and the local community" (National Institutes of Health, 1998d: 10). The National Institute on Aging developed a book on exercise for older people after receiving numerous inquiries from the public and is working with the Alliance on Aging Research in disseminating the book to the public and health care providers (National Institutes of Health, 1998d: 14). The Office of AIDS Research holds an annual planning workshop that includes nongovernment experts and AIDS community representatives. The NIH AIDS research program recently underwent a thorough evaluation by a group of scientists and community activists. That study, which also relied on the findings of a series of review panels consisting of scientists from industry and academia and community advocates, resulted in a number of major changes. The report of the NIH AIDS Research Program Evaluation Working Group describes the process and lists the participants (National Institutes of Health, 1996). The National Institute of Environmental Health Sciences and the Office of Minority Health have each held town meetings around the country to increase public understanding of NIH programs and solicit public input.

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--> CONCLUSIONS AND RECOMMENDATIONS Given the changes in the environment in which Congress, NIH, and the interest groups are now operating, NIH faces a special challenge to better interact with the public, receive public input, and demonstrate that such input is fully considered, even though it is not necessarily adopted. To this end, the committee recommends three approaches to improving NIH's interface with the public. The committee reached these recommendations after concluding that NIH, especially the Office of the Director, does not have adequate channels through which the public can provide broad input into the NIH priority-setting process or through which NIH can respond clearly and authoritatively to the public on issues of mutual concern. The committee based its conclusions on several findings. First, patient advocacy groups have become better organized and more proactive on behalf of their interests and have greatly increased their appeals to Congress to intervene to adjust NIH research priorities. Second, congressional leaders have expressed a strong desire to avoid mandates and earmarks in favor of particular diseases and to let NIH set research priorities. Third, the NIH director has increased his role in priority setting (partly by exercising additional authorities granted to him by Congress), but a formal mechanism through which the public can inform the priority-setting process is lacking. This confluence of events highlights the need for improved communication between the public and NIH. The following recommendations are not intended to replace the existing criteria for priority setting. They are intended to provide new mechanisms or reinforce existing NIH mechanisms through which public voices can be heard in a constructive and open manner. The committee believes that public input, which has been important in sustaining the growth and stature of NIH, is an essential component of the priority-setting process and if used wisely will make for a stronger and more responsive NIH. It also recognizes that although these recommendations, if implemented, will improve the priority-setting process at NIH, they will not supersede or remove the potential for alternative approaches to public input, such as appeals to Congress. NIH should engage the public to a greater extent in informing the process by which NIH sets its research priorities. The following three recommendations are intended to provide the public with more opportunities to present their views regarding research needs and to receive information about research and the priority-setting process at NIH. Recommendation 7. NIH should establish an Office of Public Liaison in the Office of the Director and, where offices performing such a function are not already in place, in each institute. These offices should document, in a standard format, their public outreach, input, and response mechanisms. The director's Office of Public Li-

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--> aison should review and evaluate these mechanisms and identify best practices. Recommendation 8. The director of NIH should establish and appropriately staff a Director's Council of Public Representatives, chaired by the NIH director, to facilitate interactions between NIH and the general public. Recommendation 9. The public membership of NIH policy and program advisory groups should be selected to represent a broad range of public constituencies. Offices of Public Liaison: Rationale, Roles, and Responsibilities Establishing an Office of Public Liaison within the Office of the NIH Director will facilitate and enhance two-way communication with the public and go far toward addressing the concerns of Congress and the public about how NIH sets research priorities. As a staff operation, the key functions of the Office of Public Liaison should include the following: Receiving input from a broader range of constituencies, disease-specific interest groups, and those concerned about underserved or underrepresented populations that are (or that have the potential to be) interested in the prioritization and results of NIH research. Although no parallel structure is in place to represent various scientific interest groups, the committee believes that effective mechanisms to represent those interests are already in place. Organizing this input in a way that can be informative in priority setting. Documenting the ways in which input is provided to those involved with NIH decision-making processes and NIH's responses to this input. Involving NIH leadership in receiving and responding to input from the public. Advising the Office of Communications so that NIH maximizes its resources by providing information and programs that are most responsive to the public. Evaluating the activities listed above. In addition, because public input can be directed either to the Office of the Director or to a specific institute, it is important that each institute have an office or officer responsible for public liaison. The existence of such staff offices in each institute—with a common and understandable name or title—will provide a visible place for the public to go when seeking input or information. The key functions of each institute's Office of Public Liaison would be similar to those

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--> of the Director's Office of Public Liaison. In addition, because it is routine for the Office of the Director to refer ''institute-specific" inquiries to the appropriate institute (e.g., a question about research programs related to prostate cancer would be referred to NCI), the establishment of such offices in each institute and in the Office of the Director would create a coordinated network similar to that which already exists among the offices of communication and the offices of legislative affairs. The Offices of Public Liaison at each institute would routinely report to and meet with the staff of the Director's Office of Public Liaison to share information and develop policy. Through this system each institute director would be served, as would the NIH director. In summary, the Offices of Public Liaison serve several purposes: (1) they provide an easily identifiable point of contact for individuals and groups who have an interest or concern; (2) they are a place where Congress can refer constituents; and (3) they conduct an active program of outreach to and interaction with constituency groups. The Offices of Public Liaison would be staff offices and thus would function every day, unlike advisory groups, and most of their effort would be to provide information to and receive input from interested groups and congressional offices. The committee recognizes that the Offices of Public Liaison might impose additional costs and complicate organizational coordination. However, most institutes already have staff who perform many of the functions, so the net additional cost would not be as large as it might seem. For some of the smaller institutes, the Office of Public Liaison function could probably be performed by one individual. The more complex organizational issue will be to work out clear relationships among Offices of Public Liaison and existing offices of communication and legislative affairs. Given the importance of the public outreach function in NIH's overall mission, especially after it is expanded and reorganized in accord with this recommendation, the director of NIH should consider putting this set of functions of the Office of Public Liaison under an associate director who is on the same functional level as the other associate directors in the Office of the Director. It is also imperative that additional funds and personnel be made available to fulfill the goals of public liaison. Current restrictions on the research management and support budget should be adjusted or the research management and support budget should be increased to accommodate these recommendations. The extra personnel needed to staff the Offices of Public Liaison should be considered exempt if the limits on research management and support persist (see also Recommendation 12 in Chapter 5). Across NIH, the new Offices of Public Liaison would also establish initiatives aimed at reaching out to special populations that would not normally have easy access to these communications processes. Precisely how this realignment of functions would entail the reorganization of current offices of communication, which are responsible for the dissemination of research results and for

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--> patient and provider education, would be left to each institute, depending on its missions and how it is currently organized. Institutes should identify educational, communications, and outreach needs through appropriate research and should pre- and posttest their materials and processes for their effectiveness. The NIH director's Office of Public Liaison should coordinate the development, testing, and dissemination of outreach materials. In addition, staff in the director's Office of Public Liaison should routinely collect from the 21 institutes and centers data relevant to each institute's responsibilities, report their findings to the NIH director, and respond to requests from interest groups that cannot be adequately referred to appropriate institutes and centers or whose interests cross multiple institutes. The director's Office of Public Liaison should ensure that there is an open flow of information among NIH staff and between NIH staff and interest groups (including congressional staff). The staff of the director's Office of Public Liaison would coordinate activities with parallel offices in each of the institutes and centers and with the director's Office of Communications and Office of Legislative Policy and provide staffing for the Director's Council of Public Representatives. Director's Council of Public Representatives: Rationale, Roles, and Responsibilities The recommendation to create a Director's Council of Public Representatives is aimed at addressing a major weakness: the lack of a forum for the director of NIH to interact constructively and in a systematic and regular way with representatives of the public. Clearly, disease-specific interest groups are seeking access to the NIH director in record numbers, especially given the recent reluctance of Congress to respond to their concerns via the earmarking of funds. If the NIH director were to meet personally with each of these groups, he or she would have little time for anything else. Yet, there should be a systematic and well-planned mechanism by which interest groups can have access to the Office of the Director, if not the director personally. Although each institute has its own disease-specific constituencies, particularly the categorical, disease-centered institutes, some interest groups can find no logical home in the NIH federation or find that many institutes conduct research relevant to their interests but that there is no clear lead institute. In addition, when an interest group believes that its needs are not being met at the institute level, that group might identify the Office of the Director as the logical place to register its concerns. The proposed Council is distinct from the Offices of Public Liaison, which are identifiable staff offices that provide full-time points of contact and channels of communication with interested individuals and groups about NIH priorities and programs. Moreover, the Offices of Public Liaison do not provide a mechanism for the direct interaction of the public with the NIH director, as does the Council. It

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--> is the committee's view that the establishment of a Council elevates the importance of public input in informing the process by which NIH sets its research priorities and provides a more feasible mechanism by which the NIH director can receive and respond to such public input. Currently, the director receives such input on an ad hoc basis and meets with groups independently. The proposed new Council offers an organized, regular mechanism for the director to obtain consumer views by providing an opportunity for various interests to interact directly with the NIH director on issues of mutual concern, discuss the priority-setting process, and suggest constructive measures to improve public input and participation. In addition to substance, establishment of the Council has the advantage of being highly visible and a symbol of NIH's concern about the views of those affected by the health problems that are the focus of NIH-funded research—patients, their families, and those who advocate for them. The committee believes that it would go a long way toward reducing the pressure on Congress to micromanage NIH as well as serving as a valuable forum in which the director and public representatives can share their views and concerns. As an advisory council, the key functions would be to interact on a formal basis three to four times a year and advise the NIH director on how best to develop potential mechanisms for interaction with and engagement of the public in the NIH priority-setting process, including the review of the activities of the Offices of Public Liaison; achieve broad representation of the public on standing and ad hoc policy and program advisory bodies, including national advisory councils; enhance public understanding of the mission and priority-setting process of NIH; consider the health concerns of special populations, for example, members of particular ethnic groups, underserved individuals, elderly people, women, children, and those with chronic diseases or disabling conditions; refine and improve the presentation of data on the allocation of research funds for particular diseases; identify best practices for receiving public input and advocating their replication across NIH; and identify and recruit public members for participation across NIH. Importantly, the Director's Council will not set priorities regarding the NIH budget or its research programs. That is, it is not intended to serve as a forum for advocacy groups to lobby the NIH director for research dollars. Rather it is intended to serve as a mechanism for NIH to receive valuable and thoughtful perspectives on its research programs from those who are in some way affected by disease and disability and who are therefore advocates for a healthy NIH, and to provide information about its research and priority-setting process as part of a two-way exchange of information.

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--> The Director's Council of Public Representatives should be made up of 18 to 25 individuals representing a broad range of public constituencies of NIH (e.g., disease-specific interest groups, ethnic groups, public health advocates, and health care providers). They should be appointed for staggered 3-year terms. The Director's Council of Public Representatives should be chaired by the NIH director and should be staffed by the director's Office of Public Liaison (obviating the need for additional staff to support the Council). The Council should issue an annual report evaluating the progress of public input and activities and whether this input and these activities have had specific effects on the NIH research program. The main potential drawbacks of the Council would be the raised expectations that would result from its establishment and the difficulties of appointing a representative group from among hundreds of constituencies. NIH will have to state and constantly restate that public input is one source of information about public health needs, that public health needs is one criterion among many considered in setting research priorities, and that in any case, the Council is not charged with making decisions about NIH's priorities, only with informing the process. Thus, although the Council will not be able to satisfy all interest groups with the outcomes of NIH's actions, it will increase the chances that all concerned will judge the process to be a fair one in which various views receive a respectful airing and a thoughtful response. Over time, the Council's activities will help to create a common frame of reference through which interest groups and scientists can obtain an understanding of and can articulate their concerns and constraints. Figure 4-1 shows the proposed placement of the Offices of Public Liaison and the Director's Council of Public Representatives within the current organization at NIH. Policy and Program Advisory Group Membership The committee also believes that the NIH priority-setting process would be improved if broader representation were extended to all policy and program advisory bodies at NIH, such as standing and ad hoc advisory groups on programs and research agendas within and across institutes. By this, the committee recommends that NIH use its existing capacity to include public representatives on standing advisory committees (through already mandated reserved seats for public members) and through enhanced public input where appropriate. NCI, NIAID, the National Institute of Environmental Health Sciences, and other institutes, centers, and offices provide good examples, in that they have in place processes and structures for effectively involving consumers in priority setting, policy and program advisory bodies, and the annual budgeting process. The Director's Council of Public Representatives, recommended above, could play a role in identifying best practices and advocating their replication across NIH. In addition, an important responsibility of the Council will be to help identify and recruit public members for participation across NIH.

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--> FIGURE 4-1 Proposed placement of the Offices of Public Liaison and the Director's Council of Public Representatives within the current organization at NIH.

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--> Each institute should aim for public participation that is sufficiently broad, that uses a selection process that is fair and that is perceived to be fair, and that incorporates representatives participants from disease-specific and other interest groups and who bring to the process the kind of knowledge, experience, and perspectives that are needed for the deliberation at hand. Summary The new organizational mechanisms for improving public input proposed here have the potential to increase, in the short term, organizational costs and complexity. In the long run, however, the committee believes that the contribution made by these offices and the Council will prove to be cost-effective in terms of carrying out NIH's mission to improve health through research and will contribute to overall goodwill on the part of the public and Congress toward NIH. Each entity—the Director's Council of Public Representatives, the network of Offices of Public Liaison, and the existing advisory bodies to the director of NIH and the institutes—has its own rationale and roles that should improve NIH's priority-setting process.