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Enhancing
Public Input and Transparency in the National Institutes of Health Research
Priority-Setting Process
A Report by the NIH Director’s Council of Public Representatives
(COPR)
Acknowledgements
COPR would like to acknowledge the efforts of many individuals in the
Institute and
Center Offices of Public Liaison who participated in teleconferences and
meetings and by
e-mail to support this work group’s efforts. This report could not
have been completed
without the hard work and background information provided by Institute,
Center, and
Office of the Director staff.
Executive Summary
Engaging the public is a major priority, it is a national priority,
it is not an option.
—Elias Zerhouni, M.D.
The National Institutes of Health (NIH) Director's Council of Public
Representatives (COPR) was established by the NIH Director in 1998 in
response to a need identified in the Institute of Medicine (IoM) report,
Scientific Opportunities and Public Needs: Improving Priority Setting
and Public Input at the National Institutes of Health. The COPR was
established in recognition of the need for a forum through which the NIH
leadership could interact with representatives of the public. To review
the state of public input and participation at the NIH, COPR designated
a Public Input and Participation Work Group (PIPWG) to gather information.
In April 2003, PIPWG identified the two areas that would be the primary
focus of this report: public input and transparency. PIPWG also found
it necessary to define the term public. At its most encompassing, the
public is everyone outside the NIH. COPR believes that the NIH, in its
worthy goal of improving quality of life for all Americans, should facilitate
the flow of information to and from all members of the public who are
interested in a particular subject area. The NIH should also understand
that the composition of the public varies, and strive to use the broadest
practical definition.
Public Input
Because its $27 billion budget is derived from taxes, the NIH has a duty
to educate members of the public about its mission and operations and
solicit their input and participation in the research priority-setting
agenda. The COPR believes members of the public should be recognized as
equal participants in open discussions and should be one essential component
in the research priority-setting process. In their examination of the
state of public input and participation in the NIH research priority-setting
process, COPR identified seven principles as important in reaching the
public and facilitating its input.
1. Go Beyond the NIH Campus
The town hall meeting is a proactive outreach method that takes NIH officials
off campus to cities and towns nationwide and gives average citizens access
to top scientists and decision makers. Several Institutes and Centers
use the town meeting strategy to disseminate their message, solicit input,
and enhance access to NIH decision makers.
Recommendation 1: Go beyond the NIH campus to engage the American
public where they live.
2. Partner with Communities
Forming continuing partnerships with local communities, grassroots organizations,
and leaders creates an important conduit for ideas and input that builds
lasting relationships. It is no small task to effectively engage local
communities, their leaders, and grassroots groups in providing input on
the complex issues involved in medical research. Institutes and Centers
should seriously consider using best practices for actively seeking input
from local community leaders and grassroots organizations, where appropriate.
Recommendation 2: Partner with local communities, grassroots organizations,
and community leaders.
3. Use Proactive Outreach, Including High- and Low-Technology Approaches
Proactive outreach involves actively soliciting public input, such as
sending e-mails and other information out for comment and distribution.
The NIH should consider this approach to enhancing the transparency of
its operations and increase public participation. Two NIH entities use
media technologies to increase awareness and solicit feedback, and the
NIH Director's Office of Communications and Public Liaison has a multimedia
kit called the NIH Talking Points Toolkit. It is also important
to continue to use and not abandon low-tech approaches for communication
and comment, like printed material and annual reports.
Recommendation 3: Use proactive outreach, and provide access for
non-Web users.
4. Increase Cross-Institute Communication
The Institutes and Centers use Working Groups and Progress Review Groups
to focus resources, technology, and scientific opportunity on a specific
disease or disorder. The National Heart Lung and Blood Institute, the
National Institute of Neurological Disorders and Stroke (NINDS), and the
National Cancer Institute (NCI) have all participated in such efforts.
NIH staff members have also developed novel resources and methods for
public outreach.
Recommendation 4: Develop more partnerships among Institutes and
Centers and foster cross-Institute communication on crosscutting diseases
or issues. COPR strongly encourages all Institutes and Centers to work
together to share information throughout the NIH.
5. Promote Bidirectional Communication
Setting NIH research priorities should be a collaborative process in
which the public is involved from the outset. For example, the National
Institute of Arthritis and Musculoskeletal and Skin Diseases Community
Health Care Center provides health care services related to arthritis,
lupus, and other rheumatic diseases. The National Institute of Mental
Health Regional Outreach Dialogue meetings are town hall meetings held
in locations across the country. The National Institute of Diabetes and
Digestive and Kidney Diseases is developing an education program to reduce
morbidity and mortality caused by kidney disease.
Recommendation 5: Foster two-way communication and dialogue on an
individual level and with communities where research is performed.
6. Make Sure Public Input Reaches Decision Makers
It is important that senior decision makers actively demonstrate a commitment
to public input. One way to make this happen is to hold listening circles
where directors and senior decision makers are present and can hear public
input. Listening circles are forums in which people come together to share
information and knowledge about a topic. As one example, National Library
of Medicine (NLM) listening circles seek to share information about NLM.
Recommendation 6: Ensure that senior decision makers receive and
fully consider public input.
7. Fully Utilize Advisory Councils and Their Public Members
Each Institute and Center charter mandates that persons who represent
the general public fill a certain number of advisory council seats. Beyond
the selection of advisory council public
members is the issue of identifying those members as such. The National
Institute on Deafness and other Communication Disorders, NCCAM, and NINDS
routinely consult their advisory councils in the priority-setting and
planning processes. The COPR urges Institutes and Centers to enhance the
role of public members on Institute and Center advisory councils and consider
creating new mechanisms to empower them.
Recommendation 7: Ensure that advisory council public members represent
a broad range of public constituencies and that the councils are fully
used as an important avenue for public input.
Transparency
In considering public input into the research priority-setting process
at NIH, one issue warrants special focus-transparency. To study the transparency
of the NIH research priority- setting process, COPR examined the activities
and practices of various Institutes and Centers. In general, the results
of these interviews were consistent with and significantly confirmed major
conclusions and observations reached as a result of COPR's other investigations.
In considering the goal of enhancing transparency, three types of activities
were identified as fundamentally important: education, access, and active
listening. It is not enough that transparency exists in the system in
the form of opportunities for education and points of access.
8. Educate the Public about the NIH
The National Institute of Child Health and Human Development (NICHD)
NIH 101 program helps educate the public about the NIH. NIH 101 includes
a brief history of NIH and NICHD, information about how budgets and research
priorities are set, a breakdown of the grant review process, information
about how NICHD communicates research findings, and instructions for finding
other NIH information. NICHD should be applauded for its innovation and
initiative in engaging groups and responding to requests for information.
Recommendation 8: Actively develop tools and materials that help
educate the public about the research priority-setting process and opportunities
for public input.
9. Enhance Access
One transparency-enhancing activity that improves public access is the
NCCAM Stakeholder Forums. During the forums, participants testified about
their experiences and opinions related to developing the NCCAM Strategic
Plan. Another example of improved access is the www.getinvolved.nih.gov
Web site. NIH Institutes and Centers contribute information about public
outreach events, public resources, and special public announcements. Such
continual improvement of access for members of the public to learn about
input opportunities and provide input should be maintained and supported.
Recommendation 9: Continue to search for mechanisms that encourage
public input into the research priority-setting process and that are
easily accessible and provide information-sharing opportunities.
10. Practice Active Listening
A transparency-enhancing activity related to active listening is the
2003 Survey of Cancer Advocacy Organizations conducted on behalf of the
NCI and the NCI Director's Consumer Liaison Group (DCLG). The survey solicited
information about each organization and its familiarity with NCI, thoughts
about future DCLG direction, and preferred communication methods. NCI
transparency was not the survey's main purpose, but some information was
directly relevant. The survey was laudable in its use of an approach that
actively solicited information from this sector of the public.
Recommendation 10: Actively solicit information from constituents
and the general public about the public's experiences and perceptions
of transparency at the NIH.
Support and Funding
11. Provide Adequate Resources
Implementing some of the above recommendations will require a significant
investment of funding, staffing, and support.
Recommendation 11. Provide adequate resources in terms of funding,
support, and staffing to allow for the successful accomplishment of
these recommendations.
Conclusions
The guarantee of public input and participation in the NIH research priority-setting
process and the transparency of that process are essential to promoting
public trust in the research enterprise. The COPR recognizes that significant
opportunities exist for public input and transparency that are not identified
in this report. Support for and belief in the importance of public input
into the NIH research priority-setting process must be embraced from the
top down. It is clear that many Institutes and Centers at the NIH take
the issue of public input and transparency seriously, but more could be
done.
Introduction
Never doubt that a small group of thoughtful committed citizens can change
the world. Indeed, it is the only thing that ever has. -Margaret Meade
The National Institutes of Health (NIH) Director's Council of Public Representatives
(COPR) was established by the NIH Director in 1998 in response to a need
identified in the Institute of Medicine (IoM) report, Scientific Opportunities
and Public Needs: Improving Priority Setting and Public Input at the National
Institutes of Health.1
The COPR was established in recognition of the need for a forum through
which the NIH leadership could interact with representatives of the public.
COPR is the primary mechanism by which public representatives can provide
their perspective on matters of public interest and work with NIH leadership
to increase public awareness of NIH and how it functions. The COPR is
the primary mechanism for providing public input to NIH decision makers
at the highest level. In recent efforts, COPR identified several areas
in which the Council might be uniquely effective in helping the NIH Director
understand the public perspective.
The IoM report examined four issues related to setting research priorities
at NIH: allocation criteria, the decision-making process, the impact of
congressional directives, and mechanisms for public input into the research
priority-setting process. In the four years since the release of the IoM
report, NIH has enhanced many activities related to public input and participation.
In this 2004 report, COPR examines the results of those changes and makes
recommendations for improvement.
To review the state of public input and participation at the NIH, COPR
designated a public input and participation work group (PIPWG) to gather
information. The work group began by educating itself about the flow of
information between NIH and the publics it serves.
Between October 2002 and April 2003, through the work of PIPWG and with
much collaboration with the Institute and Center Officers of Public Liaison
(OPLs) and Communication Directors, COPR determined that many opportunities
exist at the Institutes and Centers for transmitting information to the
public. COPR also determined that there is substantial disparity between
public participation at NIH in general, and public participation in the
research priority-setting process identified in the IoM report. Further,
the public tends to perceive the NIH research decision-making process
as "secretive," difficult to understand, and ambiguous, resulting
in a serious lack of transparency at the NIH from the public's perspective.
In April 2003, PIPWG identified the two areas that would be the primary
focus of this report:
- Public input. Identify best practices for obtaining and using
public input and participation in the research process.
- Transparency. Consider practices that enhance public examination
and awareness of the process of making research choices and that enhance
the access of senior NIH decision makers to public input into this process.
During this time, PIPWG also frequently found it necessary to define
the term public. In reality, there are many types of publics. At its most
encompassing, the public is everyone outside the NIH. More specific publics
may include groupings of the following:
- Patients
- Patient advocates
- Constituency groups and organizations
- Nonprofits
- Health care providers
- Health care practitioners
- Investigators
- Research organizations
- Educators
- Media
- Congress
COPR believes that NIH, in its worthy goal of improving quality of life
for all Americans, should facilitate the flow of information to and from
all members of the public who are interested in a particular subject area.
In facilitating this information flow, NIH should take special care to
accommodate those who do not have ready access to computers.
NIH should also understand that the composition of the public varies,
and strive to use the broadest practical definition. COPR urges that NIH
carefully and regularly monitor which public is being served with regard
to a particular subject and determine whether patients, patient advocates,
constituency groups, and related organizations have appropriate roles.
COPR believes these publics can and should play a broader role and that
NIH should tailor its activities appropriately.
Public Input
Because its $27 billion budget is derived from taxes, the NIH has a duty
to educate members of the public about its mission and operations and
solicit their input and participation in the research priority-setting
agenda. Methods for accomplishing this goal differ based on the needs
of diverse constituency groups that work with the 27 Institutes and Centers.
Some Institutes and Centers are more proactive and targeted than others,
depending on several factors, including the nature of their mission, the
constituencies they serve, and the amount of their appropriation.
A proactive approach gives the public a greater awareness of NIH's desire
for and openness to public input, and ultimately works to enhance transparency
by promoting greater public awareness of and involvement in the research
enterprise.
The vision of the IoM report1 (p. 61) was that the COPR recognize and
identify "channels through which the public can provide broad
input into the NIH priority-setting processor or through which NIH can
respond clearly and authoritatively to the public on issues of mutual
concern."
The COPR does not envision nor does it intend that members of the public
are the sole determinants of the research priorities that are chosen at
each Institute and Center. Rather, the COPR believes members of the public
should be recognized as equal participants in open discussions, and one
essential component in the research priority-setting process.
Improving Input at NIH
In their examination of the state of public input and participation in
the NIH research priority-setting process, COPR identified the following
seven principles as important in reaching the public and facilitating
its input. Cited are some examples of best practices that represent these
principles as carried out by selected individual Institutes and Centers.
It should be noted, however, that this is in no way an exhaustive attempt
to identify all effective practices conducted at all Institutes and Centers.
1. Go Beyond the NIH Campus
The town hall meeting is a proactive outreach method that takes NIH officials
off campus to cities and towns nationwide and gives average citizens access
to top scientists and decision makers. The public hears firsthand about
NIH initiatives, and decision makers receive direct feedback about NIH
work.
Several Institutes and Centers use the town meeting strategy to disseminate
their message, solicit input, and enhance access to NIH decision makers.
This strategy has been so successful for the National Institute of Environmental
Health Sciences (NIEHS) that it recently published its experience with
town meetings in the journal Environmental Health Perspectives.2
The NIEHS found town meetings to be "a successful model for bringing
academic researchers together with community residents, state and local
departments of health, and community-based organizations to foster greater
awareness of community needs, public health needs, and environmental health
science research." Since 1998, the NIEHS has sponsored 16 town meetings
nationwide and strongly supports this avenue for public input.
Another Center that has used the town meeting approach is the National
Center for Complementary and Alternative Medicine (NCCAM). NCCAM has held
three town meetings nationwide in collaboration with existing NCCAM research
centers. The purpose of these town meetings was to give the public an
opportunity to learn about the latest research being conducted and ask
questions, and for the Institute to answer questions and obtain input
from the public. The meetings were attended by the Institute Director
and included an address by him. There were 700 to 800 attendees at the
most recent meeting.
The benefits of going beyond the NIH campus include:
- Receiving ideas from a new perspective.
- Creating new methods of working with the community.
- Strengthening public good will and support.
- Enhancing public access to NIH decision makers.
Recommendation 1: Go beyond the NIH campus to engage the American public
where they live.
NIH Institutes and Centers should take their message to and solicit ideas
from the American public through the use of regional forums and town meetings.
The NIH Office of the Director and Institutes and Centers should collaborate
to reduce costs.
2. Partner with Communities
Forming continuing partnerships with local communities, grassroots organizations,
and leaders creates an important conduit for ideas and input that builds
lasting relationships.
Much is said in the NIH Roadmap for Medical Research about the need for
collaboration between important entities to advance the research enterprise.
An element of such collaboration that requires involvement but is sometimes
overlooked is partnering with local communities and grassroots organizations.
A grassroots organization is a group that is in touch with members of
the local community. Especially important are groups from rural or non-urban
areas that often represent particular interests of local community members.
It is no small task to effectively engage local communities, their leaders,
and grassroots groups to provide input on complex issues like medical
research. A commitment is needed and resources must be expended to ensure
that grassroots organizations, their leaders, and their communities are
consulted. They must be assured that their input will be thoroughly considered
and incorporated.
Several Institutes and Centers underscore the value of such involvement
in their research-setting process. One example involves the work of the
National Eye Institute and the National Library of Medicine. Both held
listening circles in areas where the predominant population was Native
American and Native Hawaiian. The goal of these meetings was to seek input
from constituencies that are traditionally underserved but represent an
important viewpoint.
Another NIH effort to partner with population groups at a local level
involves the National Cancer Institute (NCI). The NCI, through grant funding,
sponsored the development of a video program to help physicians learn
culturally sensitive communication techniques for talking about cancer
and the importance of clinical trials with low-income African Americans.
The project centered on direct focus group input from public housing
residents in Cleveland, Ohio.
The benefits of partnering with local communities and grassroots organizations
include:
- Receiving immediate feedback on important issues.
- Creating a sense of connection with policy and decision makers.
- Forming an open conduit for continuing dialogues.
- Accessing viewpoints from those outside the mainstream.
Institutes and Centers should seriously consider using the best practice
of actively seeking input from local community leaders and grassroots
organizations, where appropriate. Significant and important ideas exist
beyond the NIH campus that decision makers should hear. Cost considerations
may present a challenge but, by working together wherever possible, Institutes
and Centers may be able to manage the associated costs.
Recommendation 2: Partner with local communities, grassroots organizations,
and community leaders.
NIH should consider forming or enhancing partnerships with local groups
and leaders to help foster an atmosphere in which ideas and input can
be shared.
3. Use Proactive Outreach, Including High- and Low-Technology Approaches
Proactive outreach involves actively soliciting public input, such as
sending out e-mails and other information out for comment and distribution.
Proactive outreach increases opportunities to build closer working relationships
by taking NIH access to the public, not waiting for the public to come
to the NIH. New technologies create new opportunities for soliciting public
input; COPR encourages aggressive use of these pathways.
In 1979, telephone company ads encouraged the use of long-distance telephone
service to "reach out and touch someone." NIH should consider
the same approach in its effort to enhance the transparency of its operations
and increase public participation. By using accepted, proactive public
outreach tactics such as push e-mails, direct mail, response cards, and
videotapes, the NIH can solicit input related to the research priority-setting
process.
A growing number of Americans rely on the Internet to acquire information,
do business, or stay in touch. According to a February 2004 survey by
the nonprofit Pew Internet and American Life Project, 63% of American
adults have access to the Internet. A July 2003 survey by the same group
indicated that 80% of American Internet users have searched online for
information on at least one of 16 major health topics. Based on these
statistics, a successful organization would try to engage this growing,
technologically astute population segment to solicit feedback and ideas
or build organizational awareness. The NIH should use these tools to strive
for continuity with the public, and develop standard practices to make
public interaction user friendly and build closer working relationships
with constituency groups and the public.
Two NIH entities already take advantage of media technologies to increase
awareness and solicit feedback. The NIH Director's Office of Public Liaison
is developing a constituency outreach database to build organizational
awareness on activities and topics related to central NIH issues. This
database will provide information to targeted and broad-based constituencies
and NIH stakeholders through push e-mail. The content will include information
on the NIH Roadmap for Medical Research, the evolving NIH Public Trust
Initiative, and special staffing alerts from the NIH Director.
In addition, the NIH Director's Office of Public Liaison has a multimedia
kit called the NIH Talking Points Toolkit. The kit was originally designed
as a guide for COPR members who spoke to groups about the NIH. COPR believes
its use might be broadened and expanded as a resource for the public that
could be adapted by each Institute. The boxed kit's centerpiece is a professionally
produced videotape that chronicles the NIH history and mission and helps
convey the importance of NIH's work to outside groups. The video is accompanied
by paper copies and disk copies of NIH 101 and COPR 101 PowerPoint presentations,
a disk copy of the NIH Almanac (a multimedia resource), and resource lists
of NIH Web links that include information such as toll-free numbers for
questions about specific diseases; Web site locations for learning more
about NIH-funded institutions, research centers, hospitals, and universities
by state; and highlights of recent NIH research advances.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is using
the Internet to solicit feedback on its annual report. This effort uses
push e-mails, which are distributed to people on a specific mailing list
to invite them to read the annual report online and comment on it. The
e-mail describes the project's background, states the intent to solicit
an opinion, and includes the annual report's Web address. This has been
a successful tactic for NIAAA.
Additionally, it is important to continue to use and not abandon low-tech
approaches for communication and comment, like printed material and annual
reports. While the Internet provides an instant means for bidirectional
communication with a large portion of the public, traditional modes of
communication remain an effective method for engaging important segments
of the public that may be less involved with newer technologies. Maintaining
a low- tech approach while exploring newer communications strategies and
technologies will ensure broad public involvement.
The benefits of using proactive outreach include:
- Building trust through transparent efforts to seek and consider the
public perspective.
- Gaining immediate feedback from targeted groups.
- Increasing public input with maximum cost efficiency.
- Enhancing and developing new relationships with constituency groups
and the public.
The best practice of increasing the use of innovative public outreach
techniques and using them proactively will strengthen NIH transparency
and benefit the institution and the public.
Recommendation 3: Use proactive outreach, and provide access for non-Web
users.
New technologies provide more opportunities for soliciting public input.
NIH is encouraged to continue and enhance aggressive proactive outreach
to the public, such as sending out e-mails and other solicitations for
comment. At the same time, NIH should create alternative outreach methods
to Web- based systems, such as printing and mailing annual reports to
constituency groups for comment.
4. Increase Cross-Institute Communication
The Institutes and Centers use Working Groups and Progress Review Groups
to focus resources, technology, and scientific opportunity on a specific
disease or disorder. The Neuro- Oncology Program by the NCI and the National
Institute on Neurological Disorders and Stroke (NINDS) is an example of
cross-Institute collaboration at NIH.
Research into many diseases is carried out simultaneously at several
Institutes and Centers. Collaboration is generally desirable but does
not always occur in individual laboratories. Working Groups and Progress
Review Groups bring together scientists and clinicians from many disciplines
and intra- and extramural institutions. NIH emphasizes investigator-initiated
proposals and research, but collaborative work on specific diseases has
had significant results. Including public members in these bodies offers
a critical perspective and demonstrates the strong interest and shared
commitment that patients, their families, and other members of the public
have in addressing issues and solving problems.
In 2002, the National Heart Lung and Blood Institute organized a workshop
on sarcoidosis, a disease that causes inflammation of the body's tissues.
Investigators and clinicians from other Institutes and Centers and from
universities and research centers nationwide were invited. A sarcoidosis
Patient Interest Organization (PIO) was also invited to participate. These
representatives attended an evening presentation before the workshop to
learn about the most recent treatment advances. During the workshop the
next day, the representatives shared patient perspectives and added to
the information available to scientific members.
From 2000 through 2003, NINDS supported a Public-Private Working Group
devoted to Parkinson's disease. This group meets annually in person and
telephones biweekly to discuss research advances and priority-setting
processes. This group includes NIH scientific staff, industry representatives,
patients, and caregivers.
In 2000, the NCI and NINDS jointly held a broadly focused Brain Tumor
Progress Review Group. Attendees included NCI and NINDS senior staff and
researchers, and clinicians from both Institutes and from U.S. and Canadian
universities and medical centers. Patients, patient advocates, and industry
representatives were also invited. A priority of the Progress Review Group
was to improve communication among the represented communities and examine
the state of the research.
NIH staff members have developed novel resources and methods for outreach
to the public. In 2002, the Offices of Public Liaison formed a Regional
Outreach Work Group to identify ways to enable NIH outreach staff to share
information on regional outreach efforts, best practices, and lessons
learned.
The benefits of using Working Groups and Progress Review Groups include:
- Bringing the public perspective directly to scientists and decision
makers.
- Enhancing trust among researchers, patients, families, and groups.
- Facilitating information sharing across NIH.
- Promoting the replication of best practices and successful activities
across NIH.
Recommendation 4: Develop more partnerships among Institutes and Centers
and foster cross-Institute communication on crosscutting diseases or issues.
COPR strongly encourages all Institutes and Centers to work to share information
throughout NIH.
NIH should consider developing a mechanism similar to Working Groups
and Progress Review Groups that promote sharing resources, technology,
and scientific opportunity on a specific disease or disorder. Tools and
resources for sharing information such as those developed by the Regional
Outreach Work Group are only as useful as the information that is provided
by the individual Institutes and Centers. To foster cross-Institute communication,
each Institute and Center must commit to active participation in all information-sharing
efforts.
5. Promote Bidirectional Communication
Setting research priorities at NIH should be a collaborative process
in which the public is involved from the outset. For research priority
setting to be truly collaborative, Institutes and Centers must create
and maximize opportunities for two-way communication and dialogue with
individuals and communities. Three examples of this are the National Institute
of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Community Health
Care Center, the NIMH Regional Outreach Dialogue meetings, and the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National
Kidney Disease Education Program.
The NIAMS Community Health Care Center in Washington, DC, is a medical
and health information center that provides health care services related
to arthritis, lupus, and other rheumatic diseases. Patients who suspect
they have such a disease or who have been diagnosed can receive medical
attention by self referral or referral by a health care provider.
Depending on their medical condition, patients are eligible for primary
treatment, more advanced treatment and testing, or clinical trials and
experimental treatments. In addition to treating an essentially minority
population (African-American and Hispanic), the Center raises awareness
of health disparities in rheumatic diseases, increases minority participation
in research studies, and boosts the number of underrepresented biomedical
researchers in this field. Moreover, patients are empowered to become
participants in their own research protocols.
The NIMH Regional Outreach Dialogue meetings are a series of town hall
meetings held in various locations across the country. They have been
held in Anchorage, San Antonio, Chicago, Pittsburgh, and Albuquerque,
and have addressed topics relating to mental health issues important to
traditionally underserved populations. A primary purpose of the meetings
is to promote two-way communication: not just to disseminate information
about NIMH research, but to hear public input.
Although the dialogue meetings are one-time events, what is notable is
the extensive amount of preparation that goes into each one. Prior to
planning a meeting or setting an agenda, several field visits to the area
are conducted. During these visits, NIMH staff members engage in a dialogue
with local people and representatives of communities of interest. This
give-and-take of information is used to discover local concerns and set
an agenda, and to identify appropriate individuals and groups to invite
to participate. Approximately 300 people participated in the last meeting
in Albuquerque. NIMH is represented by the Director and Deputy Director
and staff and top researchers in areas of interest for that topic or population.
The NIDDK is developing an education program, the national Kidney Disease
Education Program, to reduce morbidity and mortality caused by kidney
disease and its complications. Prior to launching a nationwide program,
a pilot program is currently being implemented. The pilot program is designed
to reach out to African Americans, a group at very high risk for diabetes,
hypertension, and kidney disease. In the process of developing the pilot
program, a series of focus groups was convened to identify channels, intervention
strategies, and messages that would be most effective in increasing awareness
of kidney disease. Additionally, this information was used to develop
culturally appropriate and meaningful materials.
The benefits of two-way communication and dialogue include:
- Developing ongoing relationships between the NIH and local communities
that foster trust and increase engagement in the clinical research enterprise.
- Developing a truly community-based research agenda shaped by meaningful
input and collaboration.
- Increasing the participant investment in the process and outcome.
Recommendation 5: Foster two-way communication and dialogue on an individual
level and with communities where research is performed. COPR encourages
NIH to use a collaborative approach with the public whenever possible,
in particular with research participants. This involves an ongoing process
of two-way communication and dialogue as activities and research are undertaken
and research priorities are set.
6. Make Sure Public Input Reaches Decision Makers
It is important that senior decision makers actively demonstrate a commitment
to public input. This would ensure that future decisions concerning NIH
research and priority setting are transparent, and that public input and
participation are solicited.
One way to make this happen would be to hold listening circles where
directors and senior decision makers are present and can hear public input.
The National Library of Medicine (NLM) holds listening circles with the
Native American population and has arranged for these listening groups
to be held in the Dakotas and other areas, during which senior NIH officials
met with the leadership of the tribal or native nations.
Listening circles are forums in which people come together to share information
and knowledge about a topic. The idea is for everyone to be respectful,
foster dialogue, and listen to each other. The purpose or outcome is to
find common ground from which collaboration may occur or a decision can
be made. Traditionally, circles are planned in advance and the forum convenes
over several days. Contemporary listening circles use invitations and
an agenda and are somewhat more formal, but they have the same purpose.
Every attempt is made to follow the culturally appropriate protocol of
the native community or group.
NLM listening circles seek to share information about NLM. This is accomplished
by informing native leaders about outreach projects with tribal communities
and promoting library science as a career path for Native American students.
NLM also solicits input and feedback about how they can best disseminate
health information and use technology, educate tribes about NLM and NIH
funding opportunities, and identify collaboration and partnership opportunities.
The benefits of ensuring that senior decision makers receive and fully
consider public input include:
- Making the NIH more transparent in its dissemination of information
and education of the public.
- For the NIH leadership, increasing communication with the public by
attending these forums, asking questions, listening, and stating what
NIH can offer.
- For members of the public, learning how to access health information,
leading to healthier communities and reduced health care costs to the
nation.
Recommendation 6: Ensure that senior decision makers receive and fully
consider public input.
COPR encourages NIH to develop a mechanism by which Institute and Center
directors and senior NIH leadership can listen and receive public input
in a way that is similar to the listening circle model used by the Native
American population. If senior decision makers recognize and embrace the
importance of public input, this will ensure that future NIH research
and priority-setting decisions are transparent and public input is solicited.
7. Fully Utilize Advisory Councils and Their Public Members
Each Institute and Center charter mandates that persons who represent
the general public fill a certain number of advisory council seats. The
1998 IoM report noted that slots reserved for public members on some advisory
councils did not always represent the broad range of NIH public constituencies.
According to the report, underrepresented groups included representatives
of patients, their families, and persons with special health problems
(e.g., particular ethnic groups, low-income populations, and women).
In contrast, the NCCAM charter requires that three of six advisory council
slots reserved for public members be filled with persons who represent
the interests of individual consumers of complementary and alternative
medicine. While not necessarily endorsing a rigid mandate for all Institutes
and Centers, COPR supports the inclusive intent that this requirement
represents.
Beyond the selection of advisory council public members is the issue
of identifying those members as such. There are a variety of cultures
and practices among the Institutes and Centers in this regard. Some Institutes
and Centers, perhaps to make sure that all advisory council members are
seen and treated equally, do not identify individuals who fill their public
slots. This interest in equality is legitimate, but care should be taken
that this practice does not obscure the fact that some public slots may
be filled by persons who do not represent what most would consider the
general public. It is therefore essential that each Institute and Center
examine its selection and identification of advisory council public members.
Institutes and Centers should fill those slots with individuals who represent
the sensibilities of a broad range of public constituencies, and consider
identifying them so they might be fully utilized as valuable sources of
public input.
Further, the National Research Council's 2003 report, Enhancing the
Vitality of the National Institutes of Health: Organizational Change to
Meet New Challenges,3 noted that "Advisory councils
should routinely and consistently be consulted in the priority-setting
and planning process of an institute." COPR agrees that advisory
councils and their public members should be recognized as an invaluable
source of and conduit for public input into the Institute and Center priority-setting
process.
Examples of this principle are found in the recent practices of the National
Institute on Deafness and other Communication Disorders (NIDCD) and NINDS.
Public members of the NIDCD advisory council served on the subcommittee
charged with writing the NIDCD Strategic Plan. The day before the group
began writing, public members from many organizations (from small self-help
and advocacy groups to large medical, scientific, and allied health organizations
that certify medical and allied professional programs) provided written
or oral testimony about research needs. Their information and perspectives
influenced the content of the strategic plan. NINDS also involves advisory
council public members in several important subcommittees devoted to key
planning and priority-setting issues, including the subcommittee charged
with developing the NINDS Strategic Plan.
NCCAM also uses its advisory council as a conduit for public input. NCCAM
advisory council meetings include open forums where members of the public
offer input. This is an important, regular access point for the public
to communicate with senior decision makers. COPR strongly urges that each
Institute and Center consider implementing similar practices.
The COPR urges Institutes and Centers to enhance the role of public members
on Institute and Center advisory councils and consider creating new mechanisms
to empower them. One possibility would be to bring the public members
together regularly to discuss their role as public members, further define
their role and how they bring the public perspective to council efforts,
and work to identify new ways they can work together to enhance their
participation on NIH Institute and Center councils. Another possibility
would be to examine the role of Institute and Center Offices of Public
Liaison in orienting public members of NIH advisory councils.
The benefits of ensuring that advisory council public members represent
the public and that advisory councils are used as a resource and conduit
for public input include:
- Offering a permanent, easily identifiable, accessible avenue for public
input at the highest levels of Institutes and Centers.
- Demonstrating to the public that their viewpoints and input are valued
and taken seriously.
- Providing an opportunity for open communication and building public
member partnerships across the NIH at the highest levels.
Recommendation 7: Ensure that advisory council public members represent
a broad range of public constituencies and that the councils are fully
used as an important avenue for public input.
NIH and the Institutes and Centers should ensure that public advisory
council members represent a broad range of public constituencies.
Consideration should be given to the advantages of enhancing transparency
and effectiveness in identifying the public members as such. Steps should
be taken to ensure that public advisory council members are fully used
as an important source of public input into the research priority-setting
process through involvement in activities such as strategic planning.
Finally, public advisory council members should be thoroughly oriented
and empowered in their role as representatives of the public perspective
through training and cross-Institute meetings.
Transparency
In considering public input into the research priority-setting process
at NIH, one issue warrants special focus-transparency. Transparency refers
to how clear, understandable, and accessible to the public is the process
by which NIH sets research priorities, and how much of the process is
open to public examination.
In an age of diminishing budgets, pressure for information about how
research dollars are spent and how such decisions are made will only increase.
One of three themes of the NIH Roadmap is Re-engineering the Clinical
Research Enterprise. This involves, in part, engaging the public more
fully in the clinical research enterprise, which requires the public's
trust. Transparency is an essential ingredient in developing and maintaining
public trust.
To study the transparency of the NIH research priority-setting process,
COPR examined the activities and practices of various Institutes and Centers.
For a perspective external to NIH, interviews were conducted with Voluntary
Health Association (VHA) workers. COPR members asked questions about VHA
experience in working with NIH, and solicited input on transparency and
suggestions for improvement.
In general, the results of these interviews were consistent with and
significantly confirmed major conclusions and observations reached as
a result of COPR's other investigations. In particular, the suggestion
that NIH leadership leave the campus to meet the public through town meetings
and regional outreach activities received nearly universal support. Details
of the interviews are not enumerated here, but the information obtained
is incorporated throughout this report.
Enhancing Transparency at NIH
In considering the goal of enhancing transparency, three types of activities
were identified as fundamentally important: education, access, and active
listening. Education involves teaching the public about how the priority-setting
process works and about what is being done to obtain and use public input.
Access relates to the availability of ways public input can be given that
will influence research priority setting. This includes the public's ability
to observe the process and to see how decisions are made and what factors
are considered.
It is not enough that transparency exists in the system in the form of
opportunities for education and points of access. Active listening relates
to the need to solicit and understand the public's view of the NIH research
priority-setting process. This perspective is essential; the perception
of a lack of transparency is just as damaging to public trust as an actual
lack of transparency. Some representative examples of these three activities
are discussed in the following paragraphs. There is some overlap in the
activities discussed here and those mentioned in the previous section
because best practices for public input also enhance transparency.
8. Educate the Public about the NIH
The National Institute of Child Health and Human Development (NICHD)
NIH 101 program helps educate the public about the NIH. The program is
a seminar conducted as requested by the NICHD Program and OPL staff. Subjects
include presentations from the Institute and Center Office of Budget and
Communications and an optional tour of one of the NICHD intramural labs
on the NIH Bethesda campus.
The NIH 101 presentation includes a brief history of NIH and NICHD, information
about how budgets and research priorities are set, a breakdown of the
grant review process, information about how NICHD communicates research
findings, and instructions for finding other useful NIH information.
The program is offered to non-NIH research advocacy or patient representative
organizations. NICHD publicizes this offering through Friends of the NICHD
and other contacts. Typically, new staff members of research or patient
advocacy groups who need to understand NIH inner workings take advantage
of the program, but other groups can request a presentation. This NIH
101 was developed several years ago, after the IoM report's release, as
an effort to engage interested groups. The presentation is tailored to
audience interests and generally is well received.
NICHD should be applauded for its innovation and initiative in engaging
groups and responding to requests for information. The NIH 101 class has
worked well for NICHD, but more could be done to promote the program's
availability. A Web-based version has yet to be developed and most seminars
take place on the NIH campus rather than around the country. Still, this
program is a solid example to be replicated by other Institutes and Centers
in their efforts to engage the public and enhance the transparency of
their work.
The benefits of developing educational tools and materials for the public
include:
- Helping the public better understand the multiple factors and complexity
involved in the research priority-setting process.
- Informing the public about efforts already being made by the Institutes
and Centers to solicit and incorporate public input.
- Helping the public become more effective collaborators with the Institutes
and Centers in the research priority-setting process.
Recommendation 8: Actively develop tools and materials that help educate
the public about the research priority-setting process and opportunities
for public input.
One tool might be a series of Web-based interactive training modules
or tutorials. More specifically, it is recommended that two of these modules
focus on 1) basic information on how the research priority-setting process
works at NIH, and 2) basic information on accessing the NIH and providing
input. While these topics are the focus of this report, it should be noted
that the concept of using this medium need not be confined to these topics,
and tutorials on a variety of subjects would be useful. These subjects
could include basic information about the NIH, the grant process, the
NIH Roadmap, and others. The advantages of this approach are many. The
tutorials are self-paced and individuals can review and refer to them
as often as needed. It is possible to use a broad range of media, including
other Web pages, video, text, and sound. New information and changing
data, such as budget numbers, can easily be incorporated.
9. Enhance Access
One transparency-enhancing activity that improves public access is the
NCCAM Stakeholder Forums. In developing their second 5-year strategic
plan, NCCAM held two open forums, one on the NIH Bethesda campus and one
in Seattle, Washington. People and organizations on NCCAM's mail and e-mail
lists were invited to participate. The forums were publicized through
the media and on the NCCAM Web site.
During the forums, participants testified about their experiences and
opinions related to development of the NCCAM Strategic Plan. A listening
panel of top NCCAM administrators, including the NCCAM Director, heard
the testimony. During this process there was a brief opportunity for questions
and answers and dialogue among participants and the listening panel. At
the end of each forum, the Director summarized major themes and offered
initial thoughts and responses. After the forums, information obtained
was transcribed and incorporated into the strategic planning process.
A draft plan will be posted on the NCCAM Web site and the public will
have another opportunity to comment.
The NCCAM Stakeholder Forums are notable in several ways for their impact
on enhancing transparency. They solicit public input from the beginning
of the strategic planning process and address issues of education and
access. By providing an opportunity for dialogue with and response by
the listening panel, members of the public in attendance received immediate
information and feedback on their input.
The forums also provided a venue for publicizing other opportunities
for public input, such as the ongoing acceptance of written public comments
and the opportunity for online public comment on the draft strategic plan.
Holding one of the forums off campus to increase accessibility was commendable.
COPR feels that such stakeholder forums are worthy of consideration by
all Institutes and Centers in developing their strategic plans.
Another example of improved access and enhanced transparency is the Get
Involved at NIH Web site. The Director's OPL, Institute and Center
OPLs, and Communication Directors have undertaken an extensive effort
to improve the Web interface and make information more accessible about
resources and opportunities for public input and participation. The NIH
Public Bulletin is a product of NIH-wide information sharing and
coordination, and provides a public resource that no single Institute
or Center could offer. Every month, NIH Institutes and Centers contribute
information about public outreach events, public resources, and special
public announcements. The Office of the Director's OPL compiles the submissions
and posts them in the NIH Public Bulletin on the Get Involved
at NIH Web site. The Institutes and Centers can also post items for
public input or comment in this central location.
This is an ongoing process, and the work of continually improving access
for members of the public to learn about input opportunities and provide
input should be maintained and supported.
The benefits of enhancing access to the research priority-setting process
include:
- Allowing the Institutes and Centers to obtain input from a broader
cross-section of the various NIH publics.
- Communicating to the public that its opinions are valued, sought after,
and used as an integral part of the research priority-setting process.
- Building a sense of inclusion and providing opportunities for involvement
among the various NIH publics.
Recommendation 9: Continue to search for mechanisms that encourage public
input into the research priority-setting process and that are easily accessible
and provide information-sharing opportunities.
Seeking ways to promote and facilitate public input into the research
priority-setting process should be an ongoing agenda item for all Institutes
and Centers. In addition to constantly attempting to find new avenues
for public access to the process, existing methods should also be examined,
evaluated, and refined.
10. Practice Active Listening
A transparency-enhancing activity related to the concept of active listening
is the 2003 Survey of Cancer Advocacy Organizations conducted on behalf
of NCI and the NCI Director's Consumer Liaison Group (DCLG). NCI contracted
with an independent market research firm to conduct a survey of 152 cancer
advocacy organizations.
The survey solicited information about each organization and its familiarity
with NCI, thoughts about future DCLG direction and activities, and preferred
communication methods. The survey yielded important information about
respondents' perceptions of and experiences with NCI. Respondents discussed
NCI efforts that were useful and effective and those that needed improvement.
Although NCI transparency and research priority setting were not the
survey's main purpose, some information was directly relevant. An example
is a recommendation that NCI find better ways to communicate to the cancer
advocacy community its strategy and how it prioritizes research.
The survey was particularly laudable in its use of an approach that actively
and thoroughly solicited information from this sector of the public. Such
proactive measures for obtaining public input are worthy of serious consideration
and replication across Institutes and Centers.
The benefits of actively soliciting information from constituents and
the public include:
- Obtaining important information from constituent public members that
otherwise would be missed.
- Using the information regarding experiences and perceptions to enhance
and improve the transparency of the process.
- Improving the perception of NIH and the individual Institutes and
Centers regarding their commitment to and interest in a transparent
process.
- Creating trust by soliciting and valuing public comments.
Recommendation 10: Actively solicit information from constituents and
the general public about the public's experiences and perceptions of transparency
at NIH.
It is not enough to passively await comments from the public regarding
their experiences and perceptions of transparency at NIH. The Institutes
and Centers should actively seek this input on an ongoing basis. If the
costs involved are prohibitive, this may be an opportunity for a number
of Institutes and Centers to pool their resources.
Support and Funding
11. Provide Adequate Resources
Implementing some of the above recommendations will require a significant
investment of funding, staffing, and support. In a period of declining
budgets, this may involve difficult choices. Nevertheless, COPR believes
that the goals of improving public input into the research priority-setting
process and enhancing the transparency of that process are extremely important,
particularly when these goals are considered in light of their impact
on increasing public trust.
Recommendation 11. Provide adequate resources in terms of funding, support,
and staffing to allow for the successful accomplishment of these recommendations.
Whether support is provided by increasing personnel and other resources
within NIH, providing a budget to contract services from outside vendors
or other agencies, or improving resource sharing among Institutes and
Centers, the commitment to improving public input and enhancing transparency
must be serious. Implementation of these recommendations will only be
effective if the level of support is adequate to the tasks involved.
Conclusions
The guarantee of public input and participation in the NIH research priority-setting
process and the transparency of that process are essential to promoting
public trust in the research enterprise. This report identifies seven
principles for improving public input into the research priority-setting
process, and offers examples of best practices that effectively employ
these principles and recommendations related to each. The report also
cites three activities with specific examples that enhance transparency,
and makes accompanying recommendations. Finally, the report addresses
the need for adequate funding and support for implementing the recommendations.
The COPR recognizes that significant opportunities exist for public input
and transparency that have not been identified in this report. We urge
senior staff at each Institute and Center to consider not only the process
for public input, but also the intent of each example cited. The spirit
in which this report is received will determine the effectiveness of the
efforts of each Institute and Center in this regard.
Support for and belief in the importance of public input into the research
priority-setting process at NIH must be embraced from the top down. The
degree to which this occurs will determine the success of attempts to
incorporate public input, how transparent the process is, and ultimately
how trustworthy the NIH, the Institutes and Centers, and the clinical
research enterprise are in the public's mind.
It is clear from our efforts that many Institutes and Centers at the
NIH take the issue of public input and transparency seriously, but more
could be done. The NIH has shown genuine concern for issues of public
input and transparency; however, more coordination of activities and cooperation
between the Institutes and Centers would be beneficial. NIH efforts related
to public input and transparency are improving substantially, but this
is clearly an endeavor for which there is no end.
Appendix
Members of the Director's Council of Public Representatives
April 1, 2003 - March 31, 2004
*Public Input and Participation Work Group Members
†Co-Chair
CHAIRPERSON
Elias Zerhouni, M.D.
Director
National Institutes of Health
Bethesda, MD 20892
COPR MEMBERS
- *James J. Armstrong, Sagamore Hills, OH
- Evelyn J. Bromet, Ph.D., Stony Brook, NY
- Ruth Browne, Sc.D., M.P.H., Brooklyn, NY
- *Nancye W. Buelow, Clyde, NC
- *Barbara D. Butler, St. Louis, MO
- Frances J. Dunston, M.D., M.P.H., Atlanta, GA
- Rafael Gonzalez-Amezcua, M.D., South San Francisco, CA
- *Ellen E. Grant, Ph.D., ACSW, Buffalo, NY
- Debra S. Hall, Ph.D., Lexington, KY
- Kimberley Hinton, Baltimore, MD
- Jim Jensen, Lincoln, NE
- *Theodore A. Mala, M.D., M.P.H., Anchorage, AK
- Rodrigo Munoz, M.D., San Diego, CA
- William D. Novelli, Washington, DC
- Lawrence B. Sadwin, Warren, RI
- *John Shlofrock, Northfield, IL
- Ellen V. Sigal, Ph.D., Washington, DC
- *†Leonard J. Tamura, Ph.D., Lakewood, CO
- *†Zelda D. Tetenbaum, M.Sc., Hinsdale, IL
- Dawna Torres Mughal, Ph.D., R.D., FADA, Eerie, PA
- Donald E. Tykeson, Eugene, OR
COPR EXECUTIVE SECRETARY
Jennifer Gorman Vetter
NIH Public Liaison Officer and Director's Council Coordinator
Office of Communications and Public Liaison
Office of the Director
National Institutes of Health
Bethesda, MD
OFFICE OF THE DIRECTOR PUBLIC LIAISON OFFICER
Shelly Pollard
Coordinator for the Advisory Committee to the Director
National Institutes of Health
Bethesda, MD
References
1. Institute of Medicine. Scientific Opportunities and Public Needs:
Improving Priority Setting and Public Input at the National Institutes
of Health. Washington, DC: National Academy Press, 1998.
2. O'Fallon LR, Wolfle GM, Brown D, Dearry A, Olden K. Strategies for
setting a national research agenda that is responsive to community needs.
Environmental Health Perspectives 2003;111(16):1855-1860.
3. National Research Council. Enhancing the Vitality of the National
Institutes of Health: Organizational Change to Meet New Challenges.
Washington, DC: National Academies Press, 2003.
Acronyms
- COPR NIH Director's Council of Public Representatives
- DCLG NCI Director's Consumer Liaison Group
- ICs NIH Institutes and Centers
- IoM Institute of Medicine
- NIH National Institutes of Health
- NCCAM National Center for Complementary and Alternative Medicine
- NCI National Cancer Institute
- NIAAA National Institute on Alcohol Abuse and Alcoholism
- NIAMS National Institute of Arthritis and Musculoskeletal and Skin
Diseases
- NICHD National Institute of Child Health and Human Development
- NIDCD National Institute on Deafness and other Communication Disorders
- NIDDK National Institute of Diabetes and Digestive and Kidney Diseases
- NIEHS National Institute of Environmental Health Sciences
- NIMH National Institute of Mental Health
- NINDS National Institute on Neurological Diseases and Stroke
- NKDEP National Kidney Disease Education Program
- NLM National Library of Medicine
- OPL Officer of Public Liaison
- PIO Patient Interest Organization
- PIPWG Public Input and Participation Work Group
- VHA Voluntary Health Association
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