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Report
and Recommendations on Public Trust in Clinical Research
for the NIH Director from the Director's Council of Public Representatives
(COPR)
Presented to the Advisory Committee to the Director, December 2, 2004
Revised and approved by the COPR based on ACD Discussion, January 14,
2005
Preface
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.
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.
In the days following the workshop, COPR conducted a careful analysis
of the input from the workshop participants 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.
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:
To improve and enhance the state of clinical research in this country,
it is essential to build trust and relationships among all stakeholders.
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.
Building trust through community partnerships
Concept: The public has a perception that researchers conducting
clinical trials tend to disregard the perspective of the community and
the public at large. It is important to change this perception. The workshop
participants suggested that researchers should look at each community
as if it were their own, and then ask the question: What should the research
look like? At least part of the answer is that the community members would
want a well-designed study in which the issues were ethical, family and
neighbors were treated respectfully and with equality, and that there
was benefit to the community.
Community participation can be enhanced and public trust in medical research
can be improved by addressing these factors. Rather than having researchers
enter communities with a predefined definition of what the research should
be, they should ask the local community "What makes people healthy?"
and/or "What does your community need?" Then they should design
the study around the preferences of the local people rather than around
an agenda unrelated to the needs of the community. They should also include
an economic benefit to the neighborhood by investing in the community
to support the trial.
Recommendation 1: Incorporate into the NIH mission and philosophy
that it values the involvement of the community in research and create
language that expresses this value.
Action Items:
- Establish grant criteria that require community involvement in the
clinical trial. Where appropriate, require researchers to demonstrate
active involvement with the community in issues it considers important.
- Assign a task force to identify barriers in the funding mechanisms
for research that involves communities. One example of a barrier is
a lack of researchers with expertise in this type of research who can
serve on peer review groups.
- Formally broaden the definition of "NIH-funded research"
to embrace the concept of research that involves communities as a viable
and legitimate method of research.
- Require a fair distribution of grant funding so that community collaborators
share in the financial support awarded to the research institution or
entity.
- Establish a category of grants that funds series of community studies
rather than one study at a time.
- Encourage Institute and Center Directors to include in their annual
strategic plans ways to enhance public trust in clinical research.
- Reward NIH employees and NIH grantees for outstanding, replicable
efforts related to enhancing public trust and/or improved communications
in communities (e.g., Director's Awards).
This recommendation and the action items correspond to the NIH
Roadmap for Medical Research, particularly the section, Reengineering
the Clinical Research Enterprise. Many of these initiatives are already
in the planning stages.
Recommendation 2: Encourage change in the culture of the scientific
community to ensure that medical research is viewed in the context of
a long-term commitment to the community, not a one-time research study.
Action Items:
Recommendation 3: Investigate ways to provide mechanisms that
allow for follow-up health care when a clinical trial or treatment ends.
Action Items:
- Encourage research institutions to look for new partnerships and other
ways to bridge the gap between clinical trial treatment and options
for additional treatment in the local health care system beyond the
clinical trial.
- Partner/work with appropriate Federal agencies (e.g., Medicare, HRSA)
to address the insurance issues that are barriers to participants agreeing
to sign up for trials.
- Create an inter-governmental task force to study the depth and breadth
of the problem of continuity of health care when a clinical trial ends,
and suggest remedies and/or find ways to integrate medical research
into the primary health care delivery system. This solves several problems—including
patient recruitment, dealing with access issues (such as participants
finding and negotiating their way to and from unfamiliar research facilities)
vesting practicing physicians, relying on known community leaders and
partners, developing partnerships within the community to help with
continuity of care, managing dropouts, and so on.
Building relationships with patients. (True partnerships
with patients may not be possible, but bidirectional (two-way) relationships
must be enhanced.)
Concept: Besides a cure, what do patients want?
- Honesty about the study (true benefits/risks).
- To know the relevance of the study to themselves and/or their community.
- To know that their own health is important and will be considered.
- To be treated with empathy (as a person, not a case number).
- To be invited, not coerced.
- To know they are protected (DSMB or other monitoring boards).
- To know that the researcher has fully disclosed any inherent conflicts
of interest related to the study and to know that these conflicts of
interest have been managed in an open and appropriate way.
- To have their privacy/confidentiality protected.
- To have their participation facilitated where possible, i.e., remove
roadblocks such as inconvenience, long waits, no parking.
- To receive interim information about the study progress.
- Advice about patients' post-study options for medical care.
- To hear about the study results.
Recommendation 4: Educate and reorient the current research community
to the importance of treating the public as a partner in the research
process.
Action Items:
Recommendation 5: Set the expectation across the entire research
community, NIH funded research and beyond, that study results and outcomes
should be shared with the research participants and the larger community
promptly and consistently. This will ensure translational research.
Action Items:
Building partnerships with community providers
Concept: Practicing health care providers are a critical factor
in patient trust related to medical research. Workshop participants reported
that, in their experience, community providers are not currently involved
in clinical research but they should be. The public looks to their physicians
and other providers for advice about clinical research and are often counseled
not to become involved. Studies indicate that many practicing physicians
do not initiate discussions about clinical trials or other research with
their patients. Maryland surveys indicate that reasons include the physicians'
lack of understanding of potential benefits and risks, concern about reimbursement,
and, sometimes, concern that researchers would "steal" patients.
Recommendation 6: Take action to interest community providers
in clinical research and maintain their involvement.
Action Items:
Recommendation 7: Provide incentives (not just financial) for
primary health care providers and community specialists to play a role
in clinical trials.
Action Items:
- When approving grants for clinical research that involves communities,
provide additional funding for ways to make participation in clinical
trials easier for local providers who could refer patients into the
trials.
- Consider funding the development of software that local providers
could access so that when a patient is visiting and presents with symptoms,
the providers could check to see if the person meets criteria for local
clinical trials. This would help providers with limited time refer patients
to appropriate trials if desired. NIH could also educate providers about
accessing www.clinicaltrials.gov.
- Require researchers to include input from community healthcare providers
in the trial design.
- Create safeguards to preserve relationships between primary care providers
and patients/participants.
- Share the data from the patient's clinical trial with community healthcare
providers.
- Ask the Institutes and Centers or research institutions to publish
a grid (quarterly or semi-annually) of the research that is in process
in local communities and send it to physicians.
Building trust in scientists
Concept: An increasing portion of the public perceives scientists
as not having the training and perspective that they need to build public
trust in clinical research. Current training for scientists doesn't seem
to address issues related to considering community participants as partners
in the research process. This makes it difficult to expect scientists
to view community health in the same way as the community itself views
local health issues. Also, scientists are trained to act as authority
figures at the same time that they encounter patients who do not understand
clinical research and who are expecting the "authority figure"
to protect them, tell them what to do, and cure them. Improvements in
the status quo and/or in these perceptions are needed if clinical research
is to be enhanced at the community level.
Recommendation 8: Engage researchers, educators, and academic
institutions in incorporating the public's perspective consistently at
every level of training and in both the conduct of clinical research and
the publication of findings from that research.
Action Items:
Recommendation 9: Focus on educational strategies to help patients
and communities better understand clinical research. This will help scientists
because educating the public will empower and prepare individuals to be
informed partners in the clinical research process. An informed and trusting
public will enhance research participation.
Action Items:
- Enhance relationships with the media and find opportunities to broadcast
information about clinical research (e.g., create one-minute radio programs
about health, similar to Our Ocean World from the National Oceanic
and Atmospheric Administration, and Star Date from the McDonald
Observatory).
- Take note of how the service industry reaches its public with messages
and duplicate the successes; keep the message simple but fill the information
void—people are hungry for medical research information.
- Create through public service announcements a "sense of pride"
associated with participating in a clinical trial—it is a form
of service to the country. People who participate in clinical trials
could wear pins (badges of honor). (Dispel the notion of "guinea
pig" and replace it with the notion of "contributor"
to the nation's health.)
- Communicate the importance of normal, healthy people also contributing
to the nation's health through clinical trials.
- Educate the public (particularly research participants) about the
changing and evolving nature of research findings and why findings are
sometimes in conflict. Educate the public about as to why this happens.
- Engage elected officials to educate the public about research.
- Recognize that lay people can understand and are interested in science
(examples include Howard Hughes' journal and Science magazine).
- Encourage disease-specific magazines (e.g., on diabetes, heart disease)
to publish information about clinical trials (e.g., what constitutes
good clinical research; research results, negative as well as positive,
and contact information—how to get involved).
- Communicate frequently and in plain language.
Building trust in the NIH and scientific research
Concept: Even though the NIH is the premier medical research agency
in the nation, the NIH needs a much stronger community presence. Many
participants spoke to the fact that the NIH is not as well known as it
should be; what it stands for and what it does are a mystery not only
to the public, but also to many providers and health professionals. COPR
heartily endorses what the NIH is already doing to improve public awareness
of the NIH. Continued efforts at two-way communication between the NIH
and the public are important.
Recommendation 10: Continue to develop and fund efforts to build
a national identity for the NIH based on what the NIH does best—research
and education—as a basis for enhancing public trust in clinical research.
Action Items:
- Continue and expand the outreach projects that the NIH has initiated
which bring NIH into the community.
- Continue to create opportunities to educate journalists about the
NIH and its relationships to research institutions and researchers in
communities.
- Continue to support a network of health and science journalists, and
host a conference once a year during which the NIH is clearly explained,
that year's medical advances are showcased, and promising areas of "science
to watch" are identified.
Recommendation 11: Review the role and impact of Institutional
Review Boards and other patient protections in the clinical research process
because the public views these protections as less effective than they
should be.
Action Items:
Recommendation 12: Document and publish "best practices"
from efforts to reengineer the clinical research enterprise as soon as
the NIH begins to see results, so that progress in improving public trust
in medical research grows rapidly and steadily.
Conclusion
The National Institutes of Health, as the most prestigious medical research
agency in the world, has already taken many positive steps toward addressing
the issues related to public trust and public participation in clinical
research. In the broader context, the NIH is also making strides in improving
public confidence in medical research in general. The NIH Roadmap for
Medical Research and the Public Trust Initiative are two significant and
major efforts that are leading toward enhancements and innovations in
the conduct of clinical trials. We hope COPR's recommendations will complement
and inform NIH's ongoing work in these areas.
Within that context, we also wish to note that these recommendations
represent major shifts in the culture and perspective of the medical research
community that falls under the purview of the NIH. The Director and the
top level of NIH leadership might benefit from engaging experts in change
management to help make the transitions that these recommendations indicate.
We anticipate that there may be strong institutional resistance throughout
the clinical research community, as there always is when change is in
the wind. COPR understands this difficulty and encourages the NIH to anticipate
and take steps to overcome resistance, because in the long run, every
citizen in the nation will benefit from successfully addressing the issue
of public trust in clinical research.
Summary of Recommendations
Building trust through community partnerships
Recommendation 1: Incorporate into the NIH mission and philosophy
that it values the involvement of the community in research and create
language that expresses this value.
Recommendation 2: Encourage change in the culture of the scientific
community to ensure that medical research is viewed in the context of
a long-term commitment to the community, not a one-time research study.
Recommendation 3: Investigate ways to provide mechanisms that
allow for follow-up health care when a clinical trial or treatment ends.
Building relationships with patients. (True partnerships with patients
may not be possible, but bidirectional relationships must be enhanced.)
Recommendation 4: Educate and reorient the current research
community to the importance of treating the public as a partner in the
research process.
Recommendation 5: Set the expectation across the entire research
community, NIH funded research and beyond, that study results and outcomes
should be shared with the research participants and the larger community
promptly and consistently. This will ensure translational research.
Building partnerships with community providers
Recommendation 6: Take action to interest community providers
in clinical research and maintain their involvement.
Recommendation 7: Provide incentives (not just financial) for
primary health care providers and community specialists to play a role
in clinical trials.
Building trust in scientists
Recommendation 8: Engage researchers, educators, and academic
institutions in incorporating the public's perspective consistently
at every level of training and in both the conduct of clinical research
and the publication of findings from that research.
Recommendation 9: Focus on educational strategies to help patients
and communities better understand clinical research. This will help
scientists because educating the public will empower and prepare individuals
to be informed partners in the clinical research process. An informed
and trusting public will enhance research participation.
Building trust in the NIH and scientific research
Recommendation 10: Continue to develop and fund efforts to build
a national identity for the NIH based on what NIH does best—research
and education—as a basis for enhancing public trust in clinical
research.
Recommendation 11: Review the role and impact of Institutional
Review Boards and other patient protections in the clinical research
process because the public views these protections as less effective
than they should be.
Recommendation 12: Document and publish "best practices"
from efforts to reengineer the clinical research enterprise as soon
as the NIH begins to see results, so that progress in improving public
trust in medical research grows rapidly and steadily.
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