WORKSHOP PROCEEDINGS

Table of Contents

ACKNOWLEDGEMENTS

The COPR would like to take this opportunity to thank each and every person who contributed to the success of this workshop on public trust in clinical research. We particularly wish to recognize the participants who traveled from various parts of the country to the NIH campus in Bethesda to share your experiences, your perspectives, and your ideas. We know that many of you took personal leave from your positions to spend the day with us. Your input led directly to the recommendations found in this report. In addition, we are grateful for the guidance provided by NIH leadership, particularly Raynard Kington, M.D., Ph.D., Deputy Director of the NIH; Patricia A. Grady, Ph.D., R.N., FAAN, Director, National Institute of Nursing Research (NINR), Co-Chair, NIH Public Trust Initiative; Yvonne T. Maddox, Ph.D., Deputy Director, National Institute of Child Health and Human Development (NICHD), Co-Chair, NIH Public Trust Initiative; Dushanka Kleinman, D.D.S., M.Sc.D., Associate Director, Roadmap Coordination, Office of the Director (OD), NIH; and, of course, Jennifer Gorman Vetter, COPR Executive Secretary and NIH Public Liaison Officer, without whom we would not have been able to achieve our goal of holding this workshop in 2004. Thanks go also to the NIH Public Liaison Officers who so graciously volunteered to facilitate the breakout sessions: George Gaines, NICHD; James Hadley, National Cancer Institute (NCI); Elisabeth Handley, NCI; Jean Horrigan, National Eye Institute (NEI); Lisa Kaeser, NICHD; Cindy Palace, National Heart, Lung, and Blood Institute (NHLBI); and Shelly Pollard, OD, NIH, who also contributed to the planning of the workshop. Finally and most importantly, we wish to thank the NIH Director, Elias A. Zerhouni, M.D., who has shared his vision with us and has invited our input on this most important of issues in medical research: public trust.

NIH DIRECTOR'S COUNCIL OF PUBLIC REPRESENTATIVES

NATIONAL INSTITUTES OF HEALTH STAFF

NIH Senior Staff
Elias A. Zerhouni, Director
Raynard S. Kington, Deputy Director
John Burklow, Associate Director for Communications, Office of Communications and Public Liaison, Office of the Director
Marin Allen, Ph.D., Deputy Director, Office of Communications and Public Liaison, Office of the Director
Patricia Grady, Director, National Institute of Nursing Research
Dushanka Kleinman, Assistant Director, Roadmap Coordination, Office of the Director
Yvonne Maddox, Deputy Director, National Institute on Child Health and Human Development
Jennifer Gorman Vetter, COPR Executive Secretary and NIH Public Liaison Officer, Office of Communications and Public Liaison, Office of the Director

NIH Public Liaison Officers and Workshop Facilitators
George Gaines, National Institute of Child Health and Human Development
James Hadley, National Cancer Institute
Elisabeth Handley, National Cancer Institute
Jean Horrigan, National Eye Institute
Lisa Kaeser, National Institute of Child Health and Human Development
Cindy Palace, National Heart, Lung, and Blood Institute
Shelly Pollard, Office of the Director

NIH Scientific Advisors
Lauren Aaronson, Scientific Advisor, National Institute of Nursing Research
Barbara Alving, Acting Director, National Heart, Lung, and Blood Institute
Michaele Christian, Associate Director, Cancer Therapy Evaluation Program, National Cancer Institute
Sharon Hrynkow, Acting Director, Fogarty International Center
Amy Patterson, Office of Biotechnology Activities, Office of the Director
Audrey Penn, Deputy Director, National Institute of Neurological Disorders and Stroke
Alan Sandler, Scientific Advisor, Office of Human Subjects Research, Office of the Director
Joan Schwartz, Scientific Advisor, Office of Intramural Research, Office of the Director

EXECUTIVE SUMMARY

The NIH Director's Council of Public Representatives (COPR) held a workshop, Inviting Public Participation in Clinical Research: Building Trust through Partnerships, on October 26, 2004, at the Natcher Conference Center on the NIH campus in Bethesda, Maryland. At the workshop, more than 80 participants, representing the various communities who are involved or have an interest in clinical research, met to discuss issues related to public participation and trust. In a full day of interactive sessions, the attendees discussed the public's perception of medical research and explored both the barriers to and opportunities for enhancing public participation and trust in clinical research within the context of partnerships. The communities represented at the workshop included former and/or current clinical trial participants, health care professionals, researchers, research administrators, constituency group leaders, community health and outreach experts, and members of the media. The information that was shared represented diverse ethnic, racial, cultural, and geographic perspectives.

COPR members Rafael Gonzalez-Amezcua, M.D., and Ruth Browne, Sc.D., served as co-chairs of the COPR Public Trust Workshop Work Group. COPR members Debra Hall, Ph.D., and Rafael Gonzalez-Amezcua, M.D., served as the workshop moderators.

The workshop goals were to:

• Identify guiding principles that all involved communities can use to build trust and enhance participation in clinical research.
• Develop recommendations for the Director, NIH, and partnering organizations.

The workshop objectives were to:

• Provide an overview of the current status of public participation and trust in clinical research.
• Learn about past interrelationships and some proven strategies to build partnerships and engender trust.
• Explore, in highly interactive sessions, the barriers to and opportunities for building trust and enhancing public participation.

Workshop events included:

• Opening remarks by Raynard Kington, M.D., Ph.D., Deputy Director, NIH.
• An introduction and explanation of how the workshop evolved by COPR members Drs. Gonzalez-Amezcua and Hall.
• An overview of the NIH Public Trust Initiative by co-chairs Patricia Grady, Ph.D., R.N., FAAN, Director, National Institute of Nursing Research, and Yvonne Maddox, Ph.D., Deputy Director, National Institute of Child Health and Human Development.
• Three keynote speakers and a question and answer period.
• Claudia Baquet, M.D., M.P.H., Associate Dean for Policy and Planning, Associate Professor of Epidemiology and Preventive Medicine, University of Maryland School of Medicine and the Greenebaum Cancer Center.
• Robert Beall, Ph.D., President and CEO, Cystic Fibrosis Foundation.
• Neil Calman, M.D., President and CEO, Institute for Urban and Family Health.
• A series of breakout sessions in which workshop attendees actively discussed challenges and questions related to the workshop topic.
• Session One: Expectations for collaboration:
• What do patients and other study participants want from scientists?
• What do scientists want from patients and other study participants?
• Under what circumstances do partnerships build trust?
• Session Two: Information and education:
• What kinds of information and education have the potential to build trust?
• Session Three: The experience of participation in clinical research:
• How can research design (the experience of participation) and the use of research results have a positive or a negative impact on the potential to build trust or mistrust?
• A closing session with all participants led by workshop facilitator Rob Williams, Ph.D.
• Closing remarks by Dr. Kington.

On Wednesday morning, October 27, 2004, COPR members convened as a working group and reviewed the information derived from the previous day's discussions. During this review, COPR drafted a set of preliminary recommendations, which they presented to the NIH Director at the COPR public meeting that afternoon.

The final recommendations resulting from the COPR workshop are as follows.

Introduction
The basic premise that evolved from the workshop and COPR's related research into the issue of public trust in clinical research is the following:

Thus, the recommendations fall into the following areas which refer to the various stakeholders in the clinical research process:

• Building trust through community partnerships
• Building relationships with patients
• Building partnerships with community providers
• Building trust in scientists
• Building trust in the NIH and scientific research

Building trust through community partnerships

Building relationships with patients. True partnerships with patients may not be possible, but bidirectional relationships must be enhanced.

Building partnerships with community providers

Building trust in scientists

Building trust in the NIH and scientific research

WORKSHOP PARTICIPANTS

OPENING REMARKS

Welcome and Workshop Overview
Raynard Kington, M.D., Ph.D., Deputy Director, NIH

Rafael Gonzalez-Amezcua, M.D., Co-Chair, Public Trust Workshop Work Group and Workshop Moderator, COPR
Debra Hall, Ph.D., Member, Public Trust Workshop Work Group and Workshop Moderator, COPR

Dr. Kington opened the workshop by welcoming participants and providing a brief overview of the NIH Director's two advisory groups, the Advisory Committee to the Director (ACD) and the Director's Council of Public Representatives (COPR). He briefly described two major NIH initiatives that have direct relevance to the workshop topic: the NIH Roadmap for Medical Research and the Public Trust Initiative.

Drs. Gonzalez-Amezcua and Hall made brief introductory remarks about COPR, reviewed the workshop agenda, and emphasized the day's goal of exchanging information, building on collective experiences, and allowing all who have a stake in the future of medical research to speak and be heard.

WORKSHOP PRESENTATIONS AND CHARGE

NIH Public Trust Initiative
Patricia A. Grady, Ph.D., R.N., FAAN, Director, National Institute of Nursing Research, and Co-Chair, NIH Public Trust Initiative
Yvonne T. Maddox, Ph.D., Deputy Director, National Institute of Child Health and Human Development, and Co-Chair, NIH Public Trust Initiative

The NIH Public Trust Initiative aims to improve the public's health by promoting public trust in biomedical and behavioral research. In this endeavor, the NIH defines the "public" as individuals, patients, families, and communities, and it defines "trust" as confidence placed by the people in an institution or process. While the NIH recognizes that it cannot control the public's perceptions in the area of research, NIH researchers do have the ability to improve how they communicate and interact with the public.

The NIH Public Trust Initiative includes representatives from all Institutes and Centers (ICs) and addresses perspectives from publics including patient advocates, special populations, international groups, communicators, educators, and clinical researchers. These representatives address five categories of public trust:

• Involving and protecting human participants in clinical research.
• Including the public in IC business.
• Promoting the visibility of NIH.
• Teaching and developing course materials for science and education.
• Education and outreach programs for extramural and intramural clinical research communities.

BREAKOUT SESSIONS—AN OVERVIEW

Three distinct breakout sessions focused on a challenge or question related to building public trust in clinical research. The participants were asked to report on the state of clinical research from their perspectives. Several cross-cutting themes emerged from these discussions. A number of participants noted instances whereby investigators come into a community only to conduct their research, stay long enough to achieve their research agenda, and then leave immediately after the grant has ended. The community is left with a sense of abandonment. This practice is especially problematic in low-income communities, where clinical studies might be seen as the only way to obtain good health care. Workshop participants agreed that funding mechanisms should be revised so that partnerships between researchers and the communities in which they work are encouraged or even required. The participants also suggested educating research peer reviewers so that they not only will understand the importance of researchers establishing relationships with the community, but also would require researchers to address this issue in their research planning.

Workshop participants also suggested educating local physicians and other community members about research design. This step would allow the community to play a role in designing research and being an integral part of the process. They emphasized the need to increase the amount and types of community-based research and research that is not community-based, but that should involve community members when it is being planned and conducted.

The workshop participants strongly agreed that communication was of central importance. They stated that researchers should strive to be honest, forthcoming, and culturally sensitive, and should always use plain language. The participants further suggested that researchers might use patient advocates, constituency groups and/or community members to help them communicate with the communities in which they work. Likewise, they suggested that liaisons between individual researchers and their patients, as well as between research institutions and the community, be established. These liaisons could help researchers stay in touch with the community, help community members identify clinical studies in which to participate, and help community members find their way through the enrollment and informed consent process. Researchers also should communicate with and involve local physicians in their research design, thus alleviating any fears among physicians that clinical researchers intend to "steal" their patients.

Workshop participants noted that not enough people outside the Washington, D.C., area know the NIH and its work. A number of participants suggested that the NIH work to enhance on-going and proactive relationships with the media and partner with outside organizations to educate people about the NIH and its mission. They suggested that the NIH find more ways to present the agency in a light that will serve to enhance confidence in the nation's medical research efforts. Furthermore, they suggested that the NIH use different and creative routes to communicate with the public, including television, radio, flyers, faith-based organizations, and print materials, and rely less on the Internet.

While recognizing that NIH's primary purpose is research on disease processes and treatment, several workshop participants suggested that NIH look at the way that the Centers for Disease Control and Prevention (CDC) has a presence in the community. The NIH does not have the same roots at the community level, and establishing those roots would help to build trust in medical research. Because CDC already has a network of community connections, the participants strongly encouraged interagency partnerships between the NIH and the CDC, as well as partnerships between the NIH and other federal agencies, to enhance NIH's community-level involvement.

Many workshop participants acknowledged that patients and study participants often want to understand the science behind the study. They would like to know how the research affects them personally and how it might affect their community at large. Other motivations for participating in clinical research include monetary compensation, a sense of helping the greater good, the possibility of obtaining cutting-edge treatment, having access to otherwise unaffordable treatment, and learning how to better manage chronic disease.

Workshop attendees strongly emphasized the importance of the relationship between study participant and researcher. Several workshop participants noted that study participants need to feel as if they are "more than a number." In addition to wanting the researchers to be technically skilled, study participants would like researchers to communicate empathy toward them-to understand and care about their illness or condition. Others noted that patients and other study participants are concerned about safety and want a sense that someone (the researcher and reviewers) is "looking out" for them.

In addition, some participants expressed concern that clinical trials are sometimes presented as "the next big breakthrough," rather than as an opportunity to learn more about a treatment, disease, or condition. Thus, study participants who feel desperate about their illness or their lack of access to other medical care enter a clinical trial more because they feel they have no options other than agreeing to participate in the possibly risky clinical trial.

Public perception about clinical trials led to considerable discussion. For example, the participants stated common misperceptions that some researchers merely "do the work for drug companies to make more money," or are conducting the research for personal benefit, among other problems. The workshop participants emphasized through a number of different statements the importance of researcher communication, honesty, and transparency, and of using language that reflects respect for study participants.

What do scientists want from patients and other study participants?

The researchers in the workshop agreed that they want better communication with patients and better interactions with the communities in which they work. They also noted that they want to see better coverage of research than the often-negative press they see in the mainstream news. They further noted that they would like to hear back from the patients and the community regarding how the study affected them. Several agreed that if a study was worthwhile, then patients or study participants should be compensated for their time. Researchers further noted that they would like to see improved compliance with and adherence to study protocols, and they pointed to retention as an overwhelming problem in clinical research.

Workshop participants suggested that researchers tailor their messages to reflect partnerships between the researcher and the study participants. Others suggested that researchers educate physicians, involve them in conducting research, and address their fear that research scientists will "steal" their patients.

Under what circumstances do partnerships build trust?

Workshop participants agreed that funding strategies could ensure a balance of power among partners in clinical research. They noted that the researchers are funded, but that they rely upon members of the community to recruit participants and to participate, and only the researchers benefit in any notable way from the grant funding.

Workshop participants also strongly agreed that partnerships between the researchers and the community should be built to last beyond the completion of the grant and/or study. They emphasized that trust will be promoted when the research-community partnerships are viewed as other than short-term or temporary. Workshop participants also noted that successful partnerships involve mutual respect and give all partners a sense of ownership, which includes involving the community in research design and implementation.

Several workshop participants noted that partnerships between researchers and the community should be established long before the grant is in place, and that researchers will find the most successful partnerships with organizations that residents already know and trust. Workshop participants specifically suggested that researchers conduct their studies in local medical facilities with which residents are already familiar. Several instances were noted in which individuals decided not to participate in a clinical trial because the trial facility was too far away, unknown, did not offer parking (or parking was too difficult), or because the layout of the medical center was too confusing. Convenience and familiarity were important factors encouraging participation in clinical trials.

Breakout Session Two: Information and Education
What kinds of information and education have the potential to build trust? Does the type of information and education needed to build trust vary depending on which specific audience is being addressed?

Many workshop participants emphasized that trust, information, and education must be two-way. Information and education should be focused on teaching communities about the various components of research, including research design, the importance of participation by healthy volunteers, and the role of placebo groups. Researchers, on the other hand, should be trained to interact with community residents in a manner that is respectful and sensitive to the communities' needs.

Most workshop participants agreed that information should be culturally sensitive and should be disseminated by various means, including television, radio, church pulpits, community advocates, and even door-to-door discussion. Communicating in plain language rather than scientific terms is critical. Some workshop participants suggested providing materials that are written in simpler terms than those commonly found today. Others suggested creating a glossary of common scientific terms for use by community residents. However, some participants cautioned against oversimplifying information to the point of making it inaccurate.

Several discussions focused on the attitudes of both researchers and study participants. It was noted that study participants rely too heavily on expecting someone to "take care of them." They seem unwilling to take control of their own decision making. On the other hand, academic researchers are perceived as unwilling to truly engage with community residents because they believe that the communities "have nothing to teach them." Several models of successful interactions between the medical or research community and the public were described.

When asked about current information, workshop participants noted that the NIH relies more than it should on the Internet. They mentioned the "digital divide" and reminded colleagues that not everyone has access to the Web.

Workshop participants seemed to agree on the need to significantly improve informed consent documents. They noted that these documents are too long. They suggested that such lengthy documents sometimes raise suspicion; others noted that the length discourages people from reading them. They noted that many patients simply put these documents aside, or ask their physician to explain the research to them. There was considerable discussion regarding the perceived purpose of consent documents. A number of participants stated that informed consent forms are often viewed as documents to protect the researchers or the research facility from litigation. Ironically, they said, the documents are supposed to be for the participants and yet the forms do not effectively communicate the purpose of the study and what to expect in a way that participants can actually understand. Workshop participants suggested that this problem could be remedied if researchers involved the lay public in the review of informed consent documents as part of the development process.

The breakout session attendees also discussed physician involvement. Although local physicians are the most trusted source of health information, participants noted that local physicians often are "out of the loop" when it comes to clinical research. The participants told a number of anecdotes about physicians who actually counseled their patients not to participate in clinical research because they knew nothing about the research or had reservations that they might lose their patients. In other stories, a physician referred a patient to a research center that provided impersonal care. The patients then switched physicians because they felt that their original provider did not have their best interests at heart. Other participants mentioned the impact of the Tuskegee Syphilis Study and the Health Insurance Portability and Accountability Act (HIPAA) as barriers to participation in clinical research. Workshop participants suggested that the research community needs to find ways to include physicians in clinical research and to make sure that local physicians have routine access to clinical research being conducted in their local communities. It was also suggested that NIH establish or endorse providing incentives for physicians to refer patients to clinical trials, although it was recognized that this idea presents an added opportunity for potential conflict of interest.

Other suggestions included streamlining the recruitment process to make it less burdensome for physicians to refer patients to clinical trials, and to find ways to involve physicians while keeping in mind their busy schedules.

Breakout Session Three: The Experience of Participation
How can research design (the experience of participation) and the use of research results have a positive or negative impact on the potential to build trust or mistrust?

Participants stated that a major barrier to trust and participation in clinical research is the legacy of previous trials inappropriately conducted with children, women, and some minority groups. Another barrier is the amount of time and paperwork, involved in enrolling in a trial. Strict eligibility criteria are yet another. Attendees again emphasized problems inherent in the current informed consent process. They noted that researchers tended to provide too much information in the consent form, but to spend too little time with potential study participants explaining the study and what to expect. It is too difficult for study participants to make an informed decision.

Others observed in this session as well that the language in consent forms is often too technical and therefore difficult to read. Suggestions for the informed consent process included using patient advocates to assist potential study participants, setting standards to develop informed consent documents at a sixth-grade reading level, and providing a mechanism to obtain ongoing informed consent so that participants have the option to remove themselves from a study at any time. Other suggestions for increasing recruitment included raising greater awareness about NIH and its work and mission, increasing physicians' roles in recruitment, and relaxing eligibility criteria. Reimbursing physicians was another suggestion.

What should NIH consider if mistrust arises?

Participants noted that mistrust might arise because of differences in expectations between researchers and study participants. For example, the announcement for a study on Duchenne muscular dystrophy read like an advertisement: "From the Bench to the Badminton Court." This approach created a false expectation. Researchers can address this problem by changing the way they present information about a pending study.

In addition, researchers too often convey that they have all the answers, when realistically knowledge evolves with each new finding. Others noted that the timing of the release of information may contribute to mistrust. For example, the Arthritis Foundation learned that Vioxx was to be removed from the market only two hours before the news was made public. Although the Foundation has established lines of communication, it did not have time to plan a response for the many calls and the correspondence received about this development.

Workshop participants also noted that "bad news travels quickly," i.e., the media seem to focus on negative study results much more than on the positive ones. For example, one participant mentioned the Time magazine cover that featured a woman in a cage with the caption, "Guinea pigs advance science." Some participants expressed the opinion that the research community should have responded to that cover so that the public heard about the positive side to research efforts as well.

When asked how the NIH should respond when mistrust arises, most participants agreed that the NIH should be honest, forthcoming, and transparent, even with negative information. They stated that the public can understand science and that they want health information, even when the news is not always good.

Should all patients be notified of their research results and the implications of those results, and if so, how?

Workshop participants agreed that research results should be communicated to patients. Study participants should, at a minimum, receive a thank you letter and a summary of study results, where the results will be published, and whom to contact if the participant wanted more information. Others suggested that even if the results were not directly helpful to participants, their family members might benefit from the knowledge. Researchers also complained about the lack of feedback, particularly for trials sponsored by pharmaceutical companies. Some mentioned reading in the media about a study they had participated in and never heard directly from the sponsor. Workshop participants stated that there were several models for successfully disseminating research findings to the study participants and to the public, including ways to convey how the results applied to different populations.

Some workshop participants noted that researchers might be required by law or regulations to keep some information confidential, such as the results of genetic tests. Attendees suggested that in such cases, investigators should state the constraints at the beginning. Others cautioned that a balance needed to be found between conveying interim research results versus final results, because interim results could create expectations that might prove false by the study's end. They also stressed the importance of communicating negative information to the community that participated in the study before it is released to the general public.

Others noted the problem created when researchers share breakthroughs from which certain communities will not be able to benefit. For example, if an expensive drug turns out to be lifesaving, the information means nothing if the community members cannot afford the drug.

What differences exist among groups that inform how NIH can approach them (e.g., groups that are focused on communities more than on individuals)? How can NIH tailor approaches for building trust for each type of group?

Communication, spreading the word about NIH, and building partnerships were the primary themes in the responses to these questions. Communication included the need to convey honest expectations to the community, informing research participants and the community of research results, and approaching potential study participants in a sensitive manner (for example, focusing on "healthy weight" rather than "obesity"). Workshop participants suggested the need for researchers to understand the community's perspective. For example, educational outreach should teach community members about the scientific process and explain, for example, what a placebo is and why one might be used.

Several workshop participants admitted that they or others in their community did not know what NIH is and does. The importance of building stronger relationships between the NIH and the media was stressed. This discussion included the importance of increasing the education of the media about the NIH to reduce the tendency to "bash" clinical research. Other suggestions included creating public information shows for radio and television, developing media programs that air "every day like weather or sports," and tailoring messages to various communities.

The culture at NIH was discussed in great detail. The discussion focused on the need to encourage research that involves the community and to ensure that all parties—from those who review the research, to those who approve/fund the research, to those who actually do the research at the community level—understand the importance of involving the community throughout the process.

CLOSING SESSION

All Workshop Participants with Dr. Rob Williams, Workshop Facilitator

Workshop participants reconvened in an afternoon session to discuss their impressions of the overarching themes that arose in the breakout discussions. The balance (or imbalance) between research that is conducted with the community and research that is conducted by a research institution "on" the community was one such theme. Participants noted that the current system does not foster research that is conducted in partnership with the community, and they expressed uncertainty about whether researchers are willing, in the present paradigm, to support increased research with the community as a partner in the process. They agreed that academic research should continue, but that research involving the community should be developed further.

The discussion during this closing session echoed the breakout sessions. Specifically, the participants emphasized the importance of providing study participants with results from the studies in which they participated, increasing the education of communities about the NIH and the importance of clinical research, involving community members in developing research questions, and building sustainable relationships between researchers and community residents and health care professionals. Workshop participants also noted that receiving a copy of the report stemming from this workshop would be a good starting point. They requested feedback on their ideas, even the ones the NIH chooses not to address directly.

The development of community-involved research also should address and seek to reverse the perception by some that the relationship between physicians and patients can never be a true partnership. Workshop participants cited changes in NIH funding mechanisms as one way to promote community-involved research. An international participant stated that other nations were highly familiar with the NIH and based their research agendas on what the NIH did.

Workshop participants noted that passion and science both have a place in policy, and that it must be a 50-50 partnership. One scientist observed that scientists are very passionate. However, the community might not see the scientist's passion because scientists are trained to behave objectively. Other workshop participants noted the disservice done to research by designating it either "academic" or "community-based." They stated that all research was academic and should be weighted equally. Communication, as well as integration of community passion and scientific merit, would address the perceived chasm between academia and the community.

Workshop participants reiterated the opportunity for partnership between the CDC and the NIH. Research Applied to National Needs (RANN), which was developed by the National Science Foundation to promote community partnerships, was cited as a model for NIH funding mechanisms. One participant noted a bill recently passed by Congress to establish sickle cell anemia treatment centers across the country. This bill mandated that these centers must conduct community-based research. Finally, workshop participants re-stated the suggestion that academic centers not serving their communities should be held accountable. They also emphasized that the NIH should develop stronger partnerships with the media as a conduit for educating the public about the importance of clinical research and the role that the NIH plays in the nation's health.

CLOSING REMARKS

Raynard Kington, M.D., Ph.D., Deputy Director, NIH

Dr. Kington noted that most of the suggestions he had heard during the day fell into the following categories:

• Changing NIH practices, policies, and procedures.
• Using the power of the NIH to encourage researchers to "do the right thing."
• Changing several cultures, including the NIH, the extramural research community, and relationships among researchers, patients, and communities.

He assured workshop participants that the NIH wanted to change the way it does business and noted the number of senior NIH leaders at the workshop as a good sign. Dr. Kington ended the meeting by promising that workshop participants would hear from the NIH as it synthesized the information from this workshop. He also assured participants that the NIH would inform them of policy changes resulting from the day's discussions.

COPR DELIBERATIONS AND PUBLIC MEETING

On Wednesday morning, October 27, 2004, COPR members met to review and analyze the information derived from the previous day's discussions. During this preliminary review, COPR drafted a set of preliminary recommendations and prioritized them.

COPR's 12th meeting began at 3:00 p.m. in the Natcher Conference Center. Dr. Debra Hall, the workshop moderator, and Dr. Rafael Gonzalez-Amezcua, co-chair of the COPR Public Trust Work Group, presented the preliminary recommendations developed by COPR in the morning session. These initial recommendations were divided into the following broad categories:

• Clear Communication of Intent Leads to Trust.
• Community Partnerships Help To Build Capacity.
• Public Trust and Communications Are a Shared Responsibility.

Following this presentation, Drs. Hall and Gonzalez-Amezcua invited meeting attendees to discuss first impressions, what was missing, suggestions for improving these draft recommendations, perspectives and opinions, areas of disagreement, the preferred format for the refined recommendations, and the strongest possibilities for improving trust.

POST-WORKSHOP NOTE

In the days following the workshop, COPR conducted a careful analysis of the input from the workshop participants (which are only summarized in this report) and refined the recommendations. This report provides a context for those final recommendations, as well as ideas for actions that the NIH could consider. The COPR acknowledged that the NIH has already made notable progress in some of the areas contained in this report as part of the NIH Public Trust Initiative and the NIH Roadmap for Medical Research. COPR's hope is that this report will reinforce those efforts and stimulate additional, complementary actions that will further the goal of enhancing public trust in the clinical research enterprise.

REPORT AND RECOMMENDATIONS ON PUBLIC TRUST IN CLINICAL RESEARCH

NIH Director's Council of Public Representatives (COPR)

Introduction
The basic premise that evolved from the workshop and COPR's related research into the issue of public trust in clinical research is the following:

Thus, the recommendations fall into the following areas which refer to the various stakeholders in the clinical research process:

• Building trust through community partnerships
• Building relationships with patients
• Building partnerships with community providers
• Building trust in scientists
• Building trust in the NIH and scientific research

The term community is used throughout this report. For purposes of this report, COPR defines "community" as an association of people who gather together to share a common interest and/or relevancy during a period of time. The term community is seen as dynamic depending on the reference and context. For example, different contexts and references for the term community that arose during the workshop included references to communities that were geographic, cultural, interest-based, and organizational in nature.

Summary of Recommendations

Building trust through community partnerships

Building relationships with patients. True partnerships with patients may not be possible, but bidirectional relationships must be enhanced.

Building partnerships with community providers

Building trust in scientists

Building trust in the NIH and scientific research

APPENDIX A

Director's Council of Public Representatives (COPR) Workshop

Inviting Public Participation in Clinical Research:
Building Trust through Partnerships

Tuesday, October 26, 2004
Lower Level, Natcher Conference Center, NIH Campus, Bethesda, MD

AGENDA

APPENDIX B

Director's Council of Public Representatives (COPR) Meeting

Wednesday, October 27, 2004
Conference Room D, Natcher Conference Center, NIH Campus, Bethesda, MD

AGENDA

APPENDIX C

Director's Council of Public Representatives (COPR) Workshop
Inviting Public Participation in Clinical Research:
Building Trust through Partnerships

Challenges and Questions for the Three Small Group Breakout Sessions

Breakout Session One: Expectations of Collaboration

• What do patients and other study participants want from scientists?
• What do scientists want from patients and other study participants?
• Under what circumstances do partnerships build trust?

Additional Questions to Consider:

• How do prior experiences with health care affect public trust in clinical research?
• What role do non-scientists play in strengthening public trust (policymakers and other opinion leaders)? How can NIH work with these leaders more effectively?

Breakout Session Two: Information and Education

• What kinds of information and education have the potential to build trust?

Additional Questions to Consider:

• Does the type of information and education needed to build trust vary depending on which specific audience is being addressed?
• What is your reaction to NIH's information materials on clinical research (e.g., informed consent process)?

Breakout Session Three: The Experience of Participation

• How can research design (the experience of participation) and the use of research results have a positive or a negative impact on the potential to build trust or mistrust?

Additional Questions to Consider:

• What should NIH consider if mistrust arises?
• Should all patients be notified of their research results, and the implications of those results, and if so, how?
• What differences exist among groups that inform how NIH can best approach them (e.g., groups that are focused on communities more than on individuals)? How can NIH tailor approaches to building trust for each type of group?
• How can the NIH be helpful to the media in improving public trust?

NIH BACKGROUNDER

NIH Roadmap for Medical Research

Overview

Soon after becoming the Director of the National Institutes of Health (NIH), in May 2002, Elias A. Zerhouni, M.D., convened a series of meetings to chart a "roadmap" for medical research in the 21st century. The purpose was to identify major opportunities and gaps in biomedical research that no single Institute at NIH could tackle alone, but that the agency as a whole must address to make the biggest impact on the progress of medical research.

Developed with input from meetings with more than 300 nationally recognized leaders in academia, industry, government, and the public, the NIH Roadmap provides a framework of the priorities NIH as a whole must address in order to optimize its entire research portfolio. It lays out a vision for a more efficient and productive system of medical research. The NIH Roadmap identifies the most compelling opportunities in three main areas: new pathways to discovery, research teams of the future, and re-engineering the clinical research enterprise.

The implementation of the NIH Roadmap vision—including the initiatives under the Re-engineering the Clinical Research Enterprise theme—relies on strong partnerships between researchers, health and medical professionals, and the public.

Re-engineering the Clinical Research Enterprise

Clinical research is the linchpin of the nation's biomedical research enterprise. Before a therapy is approved for general use, it must be studied carefully in the laboratory to understand how the treatment works, how effective it is, and what potential risks may exist. The safety and benefits of the therapy for humans must then be proven through an orderly series of tests in people. Over the years, medical research has succeeded in converting many diseases once considered uniformly lethal into more chronic, treatable conditions. Yet clinical research has become increasingly difficult to do and it has become clear to the scientific community that the United States must recast its entire system of clinical research if such efforts are to remain as successful as they have been in the past.

To accelerate and strengthen the clinical research process, a set of NIH Roadmap initiatives will work toward improving the clinical research enterprise by adopting a systematic infrastructure that will better serve the evolving field of scientific discovery. This effort, which complements the other initiatives encompassed by the NIH Roadmap, will provide the necessary foundation for advancing basic and clinical research. With the NIH Roadmap in action, investigators will be better poised to translate basic discoveries into the reality of better health for our nation. Several initiatives are in place to carry forward this goal:

• Clinical Research Networks and NECTAR.
• Clinical Research Policy Analysis and Coordination.
• Clinical Research Workforce Training.
• Dynamic Assessment of Patient-Reported Chronic Disease Outcomes.
• Translational Research.

The speed at which exciting basic science discoveries emerge from laboratories demands that clinical research continue and even expand, while at the same time be more efficient and better inform basic science efforts. This is undoubtedly the most difficult but most important challenge identified by the NIH Roadmap process.

At the core of this vision is the concept that clinical research needs to develop new partnerships among organized patient communities, community-based health care providers, and academic researchers. In the past, all research for a clinical trial could be conducted in one academic center; that is unlikely to be true in the future. In the Re-engineering the Clinical Research Enterprise Roadmap initiatives, NIH will promote the creation of better integrated networks of academic centers that work jointly on clinical trials and that include community-based health care providers who care for sufficiently large groups of well-characterized patients. Implementing this vision will require new ways to organize the manner in which clinical research information is recorded, new standards for clinical research protocols, modern information technology, new models of cooperation between NIH and patient advocacy alliances, and new strategies to strengthen the clinical research workforce.

NIH BACKGROUNDER

NIH Public Trust Initiative

In the spring of 2004, Elias A. Zerhouni, M.D., Director of the National Institutes of Health (NIH), announced the establishment of the NIH Public Trust Initiative. In doing so, he stated that his goal is to "improve the public's health through promotion of activities and attitudes that will instill confidence in what we do as a premier biomedical and behavioral research enterprise." As envisioned by Dr. Zerhouni, this initiative is an important component of the NIH Roadmap for Medical Research, but it extends beyond the Roadmap as well.

To carry out the Public Trust effort, Dr. Zerhouni appointed Drs. Patricia Grady, Director of the National Institute for Nursing Research, and Yvonne Maddox, Deputy Director, National Institute of Child Health and Human Development. Working with representatives from each of the 27 Institutes and Centers, Drs. Grady and Maddox have been compiling an extensive inventory of activities aimed at enhancing the public's trust that are already being conducted throughout the NIH, and hope to publish a summary in the near future. The Public Trust Steering Committee, comprising some of the most experienced leadership within NIH, are reviewing this compilation to see whether some of the most successful activities might be replicated by other Institutes and Centers.

Through the Director's Council of Public Representatives (COPR), the co-chairs are seeking advice from the public on strategies for increasing the public's trust, with particular emphasis on participation in clinical trials. In October 2004, the COPR is sponsoring, with Dr. Zerhouni's support and working closely with the Public Trust co-chairs, a workshop to examine this issue and to provide recommendations to the NIH. Those recommendations will help to form the underpinning for a five-year plan for the initiative to enhance and maintain the public's trust in the work of NIH.

In addition, the NIH Public Trust Web site is being established, so that NIH's various "publics" will have an easily identifiable place to begin when seeking information about these efforts, to ask questions, and to provide needed input. Numerous other activities, including the identification and addressing of gaps in our efforts, are also under discussion.

Gaining and enhancing the public's trust is a top priority for all of NIH, one that will require a long-term commitment and partnerships with each of NIH's publics. How and why the NIH conducts and supports research, and the outcomes of that research, should be conveyed in such a manner that everyone can understand and use the information to achieve better health.