Fall
2006 Meeting Minutes
November 3, 2006
Building 31, C-Wing, Conference Room 6, NIH Campus
Bethesda, Maryland
NIH Participants
- Elias A. Zerhouni, M.D., Director, National Institutes of Health (NIH)
- Raynard S. Kington, M.D., Ph.D., Deputy Director, NIH
- John T. Burklow, Director for Communications and Public Liaison, Office
of the Director, NIH
- Jennifer E. Gorman, M.P.A., COPR Coordinator and NIH Public Liaison
Officer, Office of Communications and Public Liaison, Office of the
Director, NIH
COPR Members Attending
- Syed M. Ahmed, M.D., Dr.P.H., M.P.H.
- James J. Armstrong
- Nicole Johnson Baker, M.A., M.P.H.
- Craig T. Beam
- Ruth C. Browne, Sc.D., M.P.H., M.P.P.
- Barbara D. Butler
- Wendy Chaite, Esq.
- Christina Clark, M.A., M.B.A.
- Linda Crew, M.B.A., R.N.
- Frances J. Dunston, M.D., M.P.H.
- Valda Boyd Ford, M.P.H., M.S., R.N.
- R. Mike Hill
- James Kearns
- Nicolas Linares-Orama, Ph.D.
- Cynthia Lindquist, Ph.D.
- Michael Manganiello, M.P.A.
- Marjorie Mau, M.D., M.S.
- Ann-Gel S. Palermo, M.P.H.
- James H. Wendorf
ACD Liaison
COPR Alumnus/Special Expert
- Lawrence B. Sadwin, President/CEO, Landmark HealthCare Foundation
Other Speakers
- Amy L. McGuire, Executive Director, The Foundation for the NIH
- Barbara B. Mittleman, M.D., Director, Public-Private Partnership Program,
NIH
- Susan B. Shurin, M.D., Deputy Director, National Heart, Lung, and
Blood Institute
Please note: The following speakers contributed informational
expertise during the Council’s work group day discussions. The information
provided during these informational exchanges is reflected in the COPR’s
comments and suggestions during their Work Group Day Reports provided
to the NIH Director during the November 3, 2006 COPR Meeting.
The Council would like to thank the following speakers for the time and
expertise they provided to the Council during the work group day exchanges.
How Public and Research
Interaction Takes Place in the Clinical Research Process: How Does
a Clinical Research Trial Come to Life?
- Susan P. Buchbinder, M.D., Director, HIV Research, San Francisco Department
of Public Health
- Steven F. Wakefield, Legacy Project Director, HIV Vaccines Trial Network
Core Operations, Fred Hutchinson Cancer Research Center
- Mary A. Allen, R.N., M.S., Medical Officer/Nurse Consultant, Vaccine
Clinical Research Branch, Vaccine Research Program, Division of AIDS,
NIAID, NIH
How Do Researchers Involve the Public in Research? Lessons
Learned
- George W. Zipf, M.S., Chief, Operations Branch, Division of Health
and Nutrition Examination Surveys, National Center for Health Statistics,
Centers for Disease Control and Prevention (CDC)
- Kathryn S. Porter, M.D., Senior Medical Officer, Division of Health
and Nutrition Examination Surveys, National Center for Health Statistics,
CDC
A Success Story: Building Bridges between Diverse Community Partners
and Academic Research Institutions
- Sora Park Tanjasiri, Dr.P.H., M.P.H., Director, Center for Cancer
Disparities Research; Associate Professor, Department of Health Science,
California State University, Fullerton
- Lourdes Flores Quitugua, Guam Communications Network Training Coordinator,
Tri-County Pacific Islander HIV Capacity Building Project
CONTENTS
Executive Summary
Welcome and Introductions
Dr. Elias A. Zerhouni
NIH Director’s Update
Dr. Elias A. Zerhouni
Juggling Participant Privacy, Public Benefit, and Intellectual
Property: The Brave New World of Genetic Data
Dr. Susan B. Shurin
The Foundation for the NIH Efforts and Activities
Ms. Amy L. McGuire
Biomarkers of Disease
Dr. Barbara B. Mittleman
COPR Work Group Day Report for the NIH Director
Mr. Craig Beam and Ms. Christina Clark
Role of the Public in the Research Process: Work Group
Efforts
Ms. Valda Boyd Ford
NIH Communications Update
Mr. John T. Burklow
COPR Communications Work Group Report
Ms. Nicole Johnson Baker
Public Comment
ACD Liaison Report
Dr. Annelise Barron and Ms. Wendy Chaite
NIH Director and COPR Member Summary and Next Steps
Adjournment
List of Abbreviations and Acronyms
EXECUTIVE SUMMARY
The meeting of the National Institutes of Health (NIH) Director’s Council
of Public Representatives was held on November 3, 2006. NIH Director
Elias A. Zerhouni, M.D., welcomed the participants and reported on continuing
efforts to increase the transparency of the work of the NIH. During the
past year, the number of scientists applying for NIH funding continued
to rise while the NIH budget remained flat. The NIH Pathways to Independence
Awards have addressed a need to sustain the careers of new and young investigators.
Changes in the peer review process also are addressing the need to help
new investigators.
The NIH Reform Act of 2006, which authorizes
$30,331,309,000 for FY 2007, $32,831,309,000 for FY 2008, and such sums
as may be necessary for FY 2009 and the establishment of a common
fund to support trans-NIH research was passed by the House of Representatives.
Senate activity is pending.
Dr. Zerhouni reported that the NIH has taken a lead in creating a repository
of genome-wide association information and making it public. In
October 2006, the NIH announced the launch of
a new national consortium to transform clinical research using the Clinical
and Translational Science Awards (CTSA) funding. Also in October,
it announced the creation of a consortium to stimulate the development
of biomarkers.
The Nobel Prizes for 2006 featured NIH-supported investigators, including
Roger D. Kornberg, Ph.D., of Stanford University School of Medicine, Andrew
Z. Fire, Ph.D., of Stanford University School of Medicine, and Craig C.
Mello, Ph.D., of the University of Massachusetts Medical School. NIH
scientists also received Albert Lasker Medical Research Awards and induction
into the National Institute of Medicine.
Dr. Zerhouni noted that the Director’s Pioneer Awards program continues
to receive high-quality applicants. He also announced that John Niederhuber,
M.D., had been appointed Director of the National Cancer Institute, and
that eight COPR members will be rotating off of the Committee in 2007.
Susan B. Shurin, M.D., Deputy Director of the National Heart, Lung, and
Blood Institute, described the NIH’s endeavor to ensure that the investment
in genomic research is best utilized by developing a central repository
of data from genome-wide association studies. The NIH is currently accepting
public comments on the proposed data sharing policy, and anticipates having
the policy in place for the June 1, 2007 application deadline.
Amy L. McGuire, Executive Director of the Foundation for the National
Institutes of Health, described the work of the Foundation, whose mission
is to support the mission and priorities of the NIH, including the NIH
Roadmap for Medical Research. Ms. McGuire reviewed current projects,
including those funded by a large grant provided by the Bill & Melinda
Gates Foundation.
Barbara B. Mittleman, M.D., Director of the NIH’s Public-Private Partnership
Program (PPP), discussed biomarkers and the Biomarker Consortium. The
PPP Program facilitates NIH partnerships to leverage NIH expertise and
resources in a synergistic fashion with any of a range of outside entities.
The PPP Program serves as a neutral broker, brings parties together, fosters
open access to data, and coordinates activities. The Biomarker Consortium,
launched in October 2006 and managed by the Foundation for the NIH, is
a partnership of the NIH, FDA, Centers for Medicare & Medicaid Services
(CMS), industry, and nonprofit patient-advocacy groups, and is devoted
to developing and qualifying biomarkers so that new treatments can be
developed and approved as rapidly as possible.
The COPR members reported on their work group meeting of the previous
day (November 2), which focused on the issue of advancing public participation
in the clinical research process. They presented a series of suggestions
for increasing that participation and will offer a formal report and recommendations
at the next COPR meeting.
John T. Burklow reviewed the NIH’s communication goals and reported on
communications resources, recent presentations, media efforts, and other
community outreach. The Office of Science Policy worked with the NIH
Institutes and Centers to develop fact sheets employing a theme of comparing
medicine of the past and medicine of the future. The NIH garnered strong
national media coverage of the launch of the Clinical and Translational
Science Awards program and the Biomarkers Consortium. OCPL worked across
the agency with ICs to partner with the Discovery Channel to host its
Young Scientist Challenge, which will air in February 2007. The NIH Discovery
Young Scientist Challenge is the final step in a year-long effort to identify
40 finalists from several million middle schoolers who participate in
national science fairs across the country. They compete in teams and individually
through a final series of challenges that were developed by NIH scientific
leadership and in collaboration with OCPL who led the effort.
The COPR Communications Work Group reported on a recommendation that
the COPR develop a series of publications for wide distribution focusing
on the role of the public in research. In addition, the Work Group continued
to urge the development of the COPR Ambassadors Program to link COPR Alumni
and current COPR members in the planning of and/or participation in NIH
and Institute and Center outreach programs planned all over the U.S..
The COPR members received updates from the liaison to the Advisory Committee
to the Director (ACD) and heard public comments.
WELCOME AND INTRODUCTIONS
Elias A. Zerhouni, M.D.
The 16th meeting of the National Institutes of Health (NIH) Director’s
Council of Public Representatives was held on November 3, 2006. NIH Director
Elias A. Zerhouni, M.D., welcomed the COPR members and presenters and
recognized COPR alumnus Lawrence B. Sadwin, who attended the meeting.
Dr. Zerhouni also noted the previous day’s (November 2) work group session,
in which the COPR members heard from a variety of outside experts.
NIH DIRECTOR’S UPDATE
Elias A. Zerhouni, M.D.
Dr. Zerhouni reported that, during the past year, he and his office reached
out to many groups around the country and around the world, speaking with
scientific associations, advisory councils, and more, and offering transparency
for the work of the NIH.
Status of the NIH Budget
In the past year, the number of scientists applying for NIH funding
has continued to rise rapidly at the same time that the NIH budget increase
remained below the inflation rate. Dr. Zerhouni stressed the need, especially
in times of lean funding, to be clear about the NIH’s work and to make
the best calls based on priorities, fundamental vulnerabilities, and core
values. This requires, for example, a focus on new investigators, who
are most vulnerable to financial constraints and who are also the future
of science.
NIH Pathways to Independence Awards
The NIH created the Pathways to Independence Awards to support young
or new investigators. As science evolves, new fields are often supported
by new investigators. The NIH’s focus on these entrants into scientific
fields represents a strategic vision. The awards will grow into a $400
million program over the next 5 years.
Peer Review
The NIH is examining and revising the peer review process to ensure
that it does not become burdensome for investigators. The NIH directors
have agreed to make peer review a priority during the upcoming year.
In particular, the NIH does not want to lose good investigators who are
up for their first grant renewals.
Legislative Update
It has been almost 15 years since Congress
last reauthorized the NIH. The NIH Reform Act of 2006 authorizes
$30,331,309,000 for FY 2007, $32,831,309,000 for FY 2008, and such sums
as may be necessary for FY 2009, and the establishment of a common
fund to support trans-NIH research. It has a goal of creating better
integration across the Institutes. The House of Representatives
approved the bill in September by a vote of 414 to 2. In passing
the bill, the legislators expressed great enthusiasm for biomedical research
and the NIH. Legislation in the Senate is pending.
In speaking with legislators, Dr. Zerhouni continued to stress the return
on investment that the NIH represents. Public awareness of what the NIH
does—of the research that it supports—is growing, yet remains low. Science
must take risks, and young scientists must be supported.
A Proposed Repository for Genetic Information
The NIH has taken a lead in creating a repository of genome-wide association
information and making it public. It has engaged in a partnership with
industry to make the information available in the PubMed databases.
NIH Launches a National Consortium to Transform Clinical Research
On October 3, 2006 Dr. Zerhouni announced the launch of a new consortium
using the Clinical and Translational Science Awards (CTSA) funding. The
NIH will fund 12 academic health centers as part of the consortium and
allow 52 additional centers to receive planning grants to prepare them
for joining the consortium in the future. The National Center for Research
Resources (NCRR) leads the effort.
Biomarkers Consortium
In October, the NIH announced creation of a partnership to stimulate
the development of biomarkers to identify diseases early and reflect disease
status. The Foundation for the NIH will coordinate the project, which
will include private industry and other government agencies.
Prizes
On October 2, 2006, the Nobel Prize in chemistry was awarded to long-time
NIH grantee Roger D. Kornberg, Ph.D., of Stanford University School of
Medicine, who studied the fundamental process of DNA transcription. Long-time
NIH grantees Andrew Z. Fire, Ph.D., of Stanford University School of Medicine,
and Craig C. Mello, Ph.D., of the University of Massachusetts Medical
School, won the Nobel Prize in Physiology or Medicine for their work on
RNA interference.
On October 9, 2006, three NIH scientists were elected to the Institute
of Medicine and recognized for their contributions to science. They were
Raynard S. Kington, M.D., Ph.D., the NIH Deputy Director, H. Clifford
Lane, M.D., Clinical Science Director of the National Institute of Allergy
and Infectious Diseases (NIAID), and Paul A. Sieving, M.D., Ph.D., Director of the National Eye
Institute (NEI).
All five recipients of this year’s Albert Lasker Medical Research Award
were NIH grantees.
Other News
Dr. Zerhouni thanked the COPR members who participated in the NIH
Roadmap for Medical Research consultation meetings in July and September.
The meetings resulted in a request for information (RFI) to the public
to provide ideas for improving and accelerating biomedical research.
The feedback will become part of the process of identifying a new cohort
of Roadmap initiatives.
The Director’s Pioneer Awards program continued to receive high-quality
applicants. The NIH Institutes now are supporting more awards than were
initially budgeted. The Institutes appear to be open to new ways of performing
the review process. Dr. Zerhouni thanked Jeremy M. Berg, Ph.D., and Judith
H. Greenberg, Ph.D., for managing the program.
Dr. Zerhouni announced that John E. Niederhuber, M.D., had been appointed
Director of the National Cancer Institute (NCI) in October.
Dr. Zerhouni announced that eight COPR members’ terms will expire in
2007: James J. Armstrong, Craig T. Beam, Ruth Browne, Sc.D., M.P.H.,
M.P.P., Barbara Butler, Wendy Chaite, Esq., Frances Dunston, M.D., M.P.H.,
R. Mike Hill, and James Kearns. He thanked them for their service. Jennifer
E. Gorman, M.P.A., recognized the many hours that the COPR members have
given to the process outside the formal meetings.
COPR Member Discussion
In responding to COPR member questions, Dr. Zerhouni noted that progress
in the effort to translate science, for example, through the CTSAs, has
featured one institution creating patient registries and
others working on forging new partnerships with private and public
health care organizations as well as working to develop better designs
for clinical trials to ensure that patients with rare as well as common
diseases benefit from new medical therapies.
Public participation in research can result in improved health care quality.
David B. Abrams, Ph.D., Director of the Office of Behavioral and Social
Sciences Research (OBSSR), noted that the OBSSR has a new strategic plan
that features a focus on strengthening the dissemination or diffusion
of science. Dr. Zerhouni stated the NIH must fight against the inertia
in the health care system that prevents it from absorbing new knowledge.
In response to a COPR member question related to research on health care
delivery, Dr. Zerhouni remarked that many factors mediate health care
delivery, including payment systems, insurance systems, employer and government
policies, and urban policies. Payment systems do not favor prevention.
The Department of Health and Human Services (DHHS) encourages actions
to improve delivery, including the use of electronic health records, patient-centered
systems, reductions in health disparities, and pay-for-performance systems.
During a COPR member inquiry about international research, Dr. Zerhouni
explained that the NIH is a global institution, with a global investment,
excluding work in HIV/AIDS, of about $800 million. Global knowledge and
capacity are important for advances in public health research. Basic
research has global implications.
Another COPR member inquired how might the NIH and patient groups work
better with industry and with venture capitalists? Dr. Zerhouni commented
that the pharmaceutical companies state that the level of basic knowledge
within NIH-based medical research is insufficient for the companies to
use to predictably increase the chances of success of a particular medical
approach. To make investments more productive and less risky, industry
needs better fundamental tools (e.g., biomarkers) that reveal how biological
systems will respond. The NIH offers small-business innovative-research
grants and mechanisms that support collaborations between scientists and
industry.
During a discussion on the importance of training minority scientists,
Council members and NIH leadership commented on the serious need to improve
the science education of young minorities. Some best practices for fostering
scientific careers are effective—especially those that are selective,
focused, and mentor-intensive. Many programs at the university level
(for example, at the University of California, Los Angeles) are achieving
success. The NIH has a large program to support minority grant applicants,
for example, through its diversity supplements.
JUGGLING PARTICIPANT PRIVACY, PUBLIC BENEFIT, AND
INTELLECTUAL PROPERTY: THE BRAVE NEW WORLD OF GENETIC DATA
Susan B. Shurin, M.D.
Susan B. Shurin, M.D., Deputy Director of the National Heart, Lung, and
Blood Institute (NHLBI), described the NIH’s endeavor to ensure that the
investment in genomic research is utilized in a manner which will have
maximum public benefit. Scientists today are generating more data than
can be fully analyzed by the investigators who are performing the experiments.
Genetic data are an especially valuable resource; genomic information
is expensive to obtain, and detailed information about the characteristics
of study participants is uniquely precious. Participants in clinical
research deserve to have their privacy protected and their contributions
maximized. Investigators deserve to get credit for their work, and protection
of intellectual property needs to be carefully managed to ensure maximum
incentives for development of diagnostic and therapeutic uses of information.
Managing these issues, which may not be completely aligned, is a significant
focus of development of the NIH data sharing policy.
Genome-wide association studies are large-scale studies of genetic variation
across the human genome with the goal of identifying association of single
nucleotide polymorphisms (SNPs) with expressed traits (phenotypes). Large
amounts of data are needed to provide meaningful analyses. Analytic methods
and biostatistical approaches are evolving rapidly. For data to be optimally
utilized and analyzed, data should be made available to investigators
who bring unique expertise and new approaches to the analyses. Access
to data must be consistent with the informed consent provided by the participants.
There is an added sensitivity because genetic data from individuals may
affect the individuals’ families and communities.
The NIH believes that data will be most accessible if it resides or is
accessed through a single portal. No other organization or institution
has the long-term commitment to and capacity for serving as a data repository
than that which is provided by the National Center for Biotechnology Information
(NCBI) at the National Library of Medicine (NLM). The NIH is developing
a policy, which will respect the exclusive first-publication rights of
the primary investigators. The policy also aims to ensure that intellectual
property rights, or patenting strategies, for researchers minimize restrictions
on commercial development prior to the point at which an invention
can be said to be unique and commercializable.
The NIH accepted public comments on the proposed repository process through
October 30, 2006. It is asking researchers to retain information on research
subjects at their institutions. Submitted data will be stripped of identifiers
before it will be accepted in the database. Assuring that data is stripped
of identifiers; ensuring that secondary researchers who agree to meet
all requirements for protection of the rights of submitting investigators
and participants have access to the data; dealing with complex publication
and intellectual property issues; and supporting both submitting institutions
and the institutions of secondary users in their obligations to protect
the rights of participants will be a complex process involving many parties.
Dr. Shurin reviewed a proposed procedure in which de-identified data will
be submitted with the concurrence of the submitting institution’s Institutional
Review Board, and secondary users will have access to data only after
completing a data-use certification that indicates the research plan and
acknowledgement of submitting investigators and any restrictions on the
use of data. The pharmaceutical industry has expressed interest in and
strong support of the data repository, including a willingness to submit
data obtained with their support. The program will require changes in
the current research culture. Dr. Shurin noted a growing enthusiasm for
the concept of wide data sharing among investigators as long as their
rights and those of study participants are protected.
The NIH has asked for comments from the research community on benefits
and risks of sharing data, protections that are needed, advantages and
disadvantages of a repository, and resources that will be required to
support it. On December 14, the NIH will hold a Town Hall Meeting on
campus and via webcast to discuss the policy. It hopes for final approval
of the program by April 1, 2007, to be applied to all grants submitted
June 1, 2007.
COPR Member Discussion
The COPR members cited a broader challenge of educating the public
about research and genetics. Public trust is another large challenge.
Risk can be managed, but not eliminated. The challenge of intellectual
property needs will be difficult. Marjorie Mau, M.D., cited one case
of local citizens who felt intellectual property should not be owned.
Francis S. Collins, M.D., Ph.D., Director of the National Human Genome
Research Institute (NHGRI), stressed the need to change the culture to
produce openness for data sharing. He agreed on the need to educate the
public and health care officials so that they can incorporate this information
in daily considerations, such as when obtaining medical care. He recognized
the fears that people will have about the potential misuse of genetic
information. Federal legislation to prohibit such misuse likely will
be necessary. The NHGRI has developed a DVD presentation on genetics
for use in high school curricula.
THE FOUNDATION FOR THE NIH EFFORTS AND ACTIVITIES
Amy L. McGuire
Amy L. McGuire, Executive Director of the Foundation for the National
Institutes of Health, described the work of the Foundation which was established
by the United States Congress to support the mission of the National Institutes
of Health (NIH): improving health through scientific discovery. The
Foundation identifies and develops opportunities for innovative public-private
partnerships involving industry, academia, and the philanthropic community.
A non-profit, 501(c)(3) corporation, the Foundation is the sole organization
specifically authorized by Congress to raise private-sector funds that
support a broad portfolio of unique programs that complement and enhance
NIH priorities and activities. The Foundation is governed by an independent
Board of Directors, which includes the directors of the NIH and Food and
Drug Administration (FDA) as ex officio, non-voting members.
Ms. McGuire noted that there are circumstances in which only partnerships
can best accelerate scientific discovery to improve public health. Some
research initiatives, by virtue of their need for speed and immediate
resources, their complexity, and their scale, are beyond the capacity
of any single sector, much less any single institution, to undertake.
They require the resources and expertise of many stakeholders—government,
industry, patient groups, academia, philanthropic institutions or other
private groups.
The launch early in 2006 of the Genetic Association Information Network
(GAIN), and of The Biomarkers Consortium, and the Schizophrenia Metabolic
Initiative later in the year, along with the ongoing work of the Grand
Challenges in Global Health initiative with the Bill & Melinda Gates
Foundation, the Osteoarthritis Initiative, and the Alzheimer’s Disease
Neuroimaging Initiative exemplify the need for partnerships. Each is
unique and unprecedented in its realm, but all point to the special place
cross-sectoral partnerships must occupy in biomedical research. The
research results of partnerships are open to public access.
Preliminary unaudited figures show that during 2006, the Foundation expended
a record $56 million for program services. Ninety-four percent was for
research and 6 percent for other programs such as education, training
and fellowships. In addition, the Foundation expended $2 million during
2006 for supporting services (management, general administration, and
fundraising). For every dollar spent in 2006, 96 cents supported programs
and 4 cents funded administration and fundraising activities, according
to the preliminary figures.
Ms. McGuire suggested that the COPR identify and propose projects that
would benefit from public-private partnerships, suggest new models for
collaboration, suggest new partners, and recommend the FNIH to others.
COPR Member Discussion
Ms. McGuire stated that evidence-based practices are featured in some
current projects. The Foundation’s priorities are determined by the private
funding partners in alignment with NIH priorities. COPR members suggested
that the FNIH consider ways to help develop the pipeline for fostering
science careers, especially for youth from diverse populations, and to
support NIH-funded investigators early in their careers.
Norka Ruiz Bravo, Ph.D., Deputy Director for Extramural Research at the
NIH, reported that the NIH is working to establish a program that will
allow small organizations to fund investigators who have gone through
the NIH peer review process without being awarded grants. This was a
COPR recommendation.
The FNIH performs fundraising, recently creating the Discovery Society
to solicit support, and has plans for giving campaigns. COPR members
encouraged the FNIH to focus on operational research, that is, to study
the research process, and to foster researcher-advocates, perhaps partnering
with the organization Research!America. The FNIH recently supported a
meeting for consumer advocates hosted by the National Cancer Institute.
[Kudzai Makomva, a representative of Families USA, noted that her
group has obtained funding to perform research advocacy work.]
BIOMARKERS OF DISEASE
Barbara B. Mittleman, M.D.
Barbara B. Mittleman, M.D., Director of the NIH’s Public-Private Partnership
Program, discussed biomarkers and the new Biomarker
Consortium. The PPP Program serves as a neutral broker, brings
parties together, fosters open access to data, and coordinates activities.
It facilitates partnerships among academic institutions, foundations,
government agencies (including foreign), patient advocacy organizations,
and industry.
To shift medicine from a curative role to a preemptive role will require
the tailoring of diagnosis and treatment, for which biomarkers will be
needed to determine who will get sick, what illnesses will occur, how
extreme they will be, and what treatments will work. Biomarkers can measure
the risk for disease and the status of disease. Biomarkers can be genetic,
biochemical, or immunological, measurements of health, images, cognitive
measures, and more. As examples, they can be used in research to understand
disease progression in models, in regulation to judge whether drugs are
safe, and in health care to identify risk.
The Biomarker Consortium, launched
in October 2006 and managed by the FNIH, is a partnership of the NIH,
FDA, Centers for Medicare & Medicaid Services (CMS), industry, professional
societies, and nonprofit patient-advocacy groups. The partners
contribute money, intellectual input, reagents, samples and data to the
consortium. They have developed shared policies for addressing the
issues of antitrust, intellectual property, and ethics for activities
within the Biomarker Consortium. The Consortium features an Executive
Committee, steering committees for disease and scientific focus areas,
and project teams for implementation. Initial projects include (1)
qualifying the use of the imaging technology FDG-PET as a marker for tumor
response, (2) identifying genomic markers for depressive disorders and
treatments, and (3) biomarkers for diabetes risk and development.
The Public-Private Partnership Program can be accessed at http://ppp.od.nih.gov.
COPR Member Discussion
The COPR members wondered about the definition of a “proven” biomarker.
Dr. Mittleman responded that biomarkers are not spoken of as validated
or not validated today. Rather, they are considered to be qualified for
particular purposes, and the development of qualification schemes is an
important result expected to come out of the Biomarker Consortium activities.
The COPR members noted that some social determinants appear to act as
biomarkers. Perhaps groups interested in such social factors could join
the Consortium.
The experience of the person or patient is important. Dr. Mittleman
noted that the Consortium is considering patient-reported biomarkers.
Dr. Kington noted that one initiative within the NIH Roadmap for Medical
Research features development of a computer-based tool for patient-reported
outcomes, which will add to the structure of the patient’s medical record.
The COPR members agreed that the Biomarker Consortium could serve as
an excellent model for future trans-DHHS initiatives.
COPR WORK GROUP DAY REPORT FOR THE NIH DIRECTOR
Christina Clark, M.A., M.B.A. and Craig Beam
Christina Clark, M.A., M.B.A., thanked the organizers of the previous
day’s (November 2) work-group session and the expert presenters. The
presenters were George W. Zipf, M.S., and Kathryn S. Porter, M.D., of
the Centers for Disease Control and Prevention, Lourdes Flores Quitugua,
of the Tri-County Pacific Islander HIV Capacity Building Project, Sora
Park Tanjasiri, Dr.P.H., M.P.H., of California State University, Fullerton,
Mary A. Allen, R.N., M.S., of the NIAID, Susan P. Buchbinder, M.D., of
the San Francisco Department of Public Health, and Steven F. Wakefield,
of the Fred Hutchinson Cancer Research Center. Marin P. Allen, Ph.D.,
and John T. Burklow of the NIH Office of the Director, also spoke. During
the session, the COPR members broke into two groups to discuss the role
of the public in research.
Mr. Beam noted that the COPR members were guided by the following considerations
for advancing the role of the public in clinical research:
- To help establish a baseline of NIH community participation.
- To educate researchers about potential roles for the public.
- To provide guidance to grant applicants and enhance training programs.
- To identify and disseminate best practices.
- To bridge a gap, allowing organizations and research institutes to
collaborate.
- To build partnerships that expand community involvement in research.
The COPR members heard about the NIH’s HIV Vaccine Trial Network, the
Centers for Disease Control and Prevention’s National Health and Nutrition
Examination Survey (NHANES), and the Los Angeles–based Guam Communications
Network. They discussed challenges to incorporating the public in the
research process, especially the need to increase the research community’s
understanding of the value of public involvement and the public’s sometimes
negative perception of clinical research. There are a variety of entry
points for public input.
[Note: Ann-Gel S. Palermo, M.P.H., recused herself from participation
in this segment of the COPR meeting, because of a minor
conflict of interest.]
ROLE OF THE PUBLIC IN THE RESEARCH PROCESS—WORK GROUPS
Valda Boyd Ford, M.P.H., M.S., R.N., reviewed the discussions of the
previous day’s work group session. The participants sought to identify
effective strategies for increasing the ability of researchers to involve
the public in research. The following proposals were made:
- Offer incentives.
- Identify evidence-based research practices for involving communities.
- Develop the evidence for public participation.
- Develop ways to measure efficacy of community involvement in research.
- Build effective collaborations and partnerships.
- Communicate the benefits of community involvement in research.
- Increase the base of support in the public.
- Create tools for educating researchers.
- Provide guidance to grant applicants.
- Reach out to professional organizations.
- Educate deans and academicians about the value of public participation
in research.
- Reach out to study sections and Institutional Review Boards (IRBs).
The Role of the Public in the Research Process Work Group will take the
lead on this topic and work with the full Council to provide additional
detail on these initial and broad based recommendations. The Council will
work to formulate and indicate ways that the NIH might operationalize
or apply, the ideas and recommendations put forward during the meeting.
COPR Member Discussion
The COPR members noted that defining “the public” and “research” is not
easy. The definitions will affect the usefulness of the recommendations
and actions. Perhaps the COPR should work on a single large area, for
example, the culture or mechanisms of long-term support, during the next
6 months. An effort might focus on deans at institutions or on the identification
of scientists who are willing to engage the public. Dr. Zerhouni stressed
the need to allow science to drive the program, offering public participation
as an opportunity or activation energy. Not every science would or should
be involved. Perhaps the COPR could publish an article to stimulate the
process. The NIH has the power to affect the process through grants.
Dr. Zerhouni asked the group to consider ways to encourage relationships
between investigators and communities “up front,” so that the participants
become proactive rather than reactive.
NIH COMMUNICATIONS UPDATE
John T. Burklow
Mr. Burklow reported that, in August 2006, all NIH communications directors
and officers of public liaison attended a training exercise to look at
the possible “tipping points” and concrete changes that show consistent
results. One example was having staff use small stickers that say “Ask
me about the NIH” to wear on nametags at all meetings.
Mr. Burklow reviewed the NIH’s communication goals, which include increasing
the awareness of (1) the benefits that Americans receive from the public
investment in biomedical research, (2) the role research will play in
transforming 21st-century medicine, and (3) the public and private sector
compact to sustain momentum in advancing knowledge and discovery. He
reviewed a wide variety of NIH resources, presentations, media efforts,
and community outreach.
The Office of Science Policy has worked with the Institutes and Centers
(ICs) to develop a large number of fact sheets whose theme is comparing
the medicine of the past with that of the future. These are available
on the NIH Web site created by OCPL “Research Results for the Public”
http://www.nih.gov/about/researchresultsforthepublic/index.htm.
This site includes an interactive state-by-state map that allows the visitor
to find all the research support in his or her state. OCPL has added
many additional resources to this site.
Dr. Zerhouni’s newsletter is also posted and is mailed to more than 40,000
grantees and 350 constituency organizations. Dr. Zerhouni was profiled
in a summer issue of Chemical and Engineering News. He has provided
editorials, interviews, and quotes for other national publications.
In October, the NIH orchestrated strong national media coverage of the
launch of the Clinical and Translational Science Awards program. It also
achieved wide wire-service coverage of the launching of the Biomarkers
Consortium. Dr. Jeremy Berg was instrumental in promoting the role of
the NIH in supporting the careers of the recent Nobel Prize recipients.
The NIH partnered with the Discovery Channel to host its Young Scientist
Challenge. Mr. Burklow presented to the meeting participants a short
video produced by NHRGI of the event. The 1-hour show will air in February
2007. The NIH hopes to support the program again next year.
Mentions of the NIH in the general press steadily increased during 2006,
with, for example, 508 citations from May 18 to May 24. Feature NIH exposure
included Parade Magazine and various consumer magazines, news services,
radio, podcasts, videocasts, and local television. In Jackson, Mississippi,
Mr. Burklow helped to inaugurate an NIH information center in a new medical
mall, which had been developed in an unused shopping mall. In the fall,
the NIH launched MedlinePlus Magazine, a new quarterly, with the
Friends of the National Library of Medicine.
A large number of Spanish-language programs have been developed in collaboration
with the individual ICs. Mr. Burklow thanked the COPR members for their
guidance in developing and realizing the NIH communication plan. He stated
that he would forward to them copies of the NIH public service announcements
that the group watched on the work group day. The NIH podcast is available
on iTunes on the Internet.
COPR COMMUNICATIONS WORK GROUP REPORT
Nicole Johnson Baker
Nicole Johnson Baker, M.A., M.P.H., reported on the progress of the COPR
Communications Work Group. The work group continued to recommend the
COPR Ambassador Program, in which COPR members and alumni, and possibly
even other Advisory Board members, and high-profile volunteers are linked
with NIH outreach programs being planned all over the U.S. They could
be available to provide public input during planning and could be called
upon as “public Ambassadors” to participate in these NIH outreach activities
and events. There are over 35 COPR Alumni already spread out around the
country. Each has served three years on the COPR and has donated hundreds
of hours participating in discussions with NIH leaders. These trained
NIH experts could also personally disseminate information about the NIH,
thereby raising awareness.
The work group recommended that the COPR develop three publications focusing
on the role of the public in research:
- An article for a scientific journal—a review of literature about the
value of public participation in research.
- A newspaper editorial about the value to research of the public perspective.
- A magazine article highlighting success stories.
- A brochure highlighting the value of public participation in research
that could be distributed at appropriate meetings and to constituency
groups and their members.
The work group proposed that a brochure collecting the key points from
those publications be developed and disseminated. It proposed creating
a public service announcement with a broad theme, highlighting the value
of the NIH investment in biomedical research. It proposed developing
an NIH Web site that collects, from all the IC Web sites, materials tailored
for children.
The COPR members raised the challenge of encouraging the people who know
best what the NIH does (e.g., the investigators) to speak in the language
of the general population about that work. Consumer magazines and media
could help. Perhaps the value of the NIH could be emphasized when grants
are given in communities. Perhaps the NIH could develop promotional songs
that target youth. Perhaps the NIH could better place its name/brand
in physicians’ offices.
PUBLIC COMMENT
Sarena D. Seifer, Executive Director of Community-Campus Partnerships
for Health, presented a letter from her organization, supporting the efforts
of the NIH and COPR to increase public participation in research and offering
ideas to do so. She welcomed efforts to energize public participation
in research and to reach out to professional organizations that can help.
NIH funding is a driver for changing the culture of academia. Ms. Seifer
encouraged the NIH to support community-based participatory research (CBPR),
for example, by developing appropriate funding streams, forming a standing
study section, securing reviewers with experience in community engagement,
and perhaps convening a meeting of all NIH grantees who use a CBPR approach.
ACD LIAISON REPORT
Annelise Barron, Ph.D., and Wendy Chaite, Esq., reported on the meeting
of the Advisory Committee to the Director (ACD), which occurred on June
2, 2006. The ACD members and invited speakers discussed the NIH communications
plan (Mr. Burklow), appropriations and budgets (Andrew C. Baldus), the
NIH intramural research program (Michael M. Gottesman, M.D.), the National
Institute of Environmental Health Sciences (David A. Schwartz, M.D.),
and the NIH Office of Technology Transfer (Mark L. Rohrbaugh, Ph.D., J.D.).
The ACD members discussed and approved ongoing NIH efforts, such as the
shortening of the grant application review cycle, support for new/young
investigators, and communications activities.
Dr. Barron suggested that the full minutes of the ACD meeting be placed
in the COPR meeting binder and that the minutes of the COPR meeting be
placed in the ACD meeting binder. She suggested that the NIH consider
appointing to the COPR a member with a strong background in information
technology.
NIH DIRECTOR AND COPR MEMBER SUMMARY
AND NEXT STEPS
Dr. Zerhouni reemphasized the importance of community participation in
research, calling for efforts to reduce fears and myths about research,
to provide leadership, and to provide optimism. The NIH is funding more
grants than ever and with good success rates for applicants. However,
other trends may make it difficult to maintain these results. The NIH
must be vigilant and must plan well, based on good communications—an area
in which the COPR plays an important role. Dr. Zerhouni asked the outgoing
COPR members to stay in touch with the Council and its issues.
Ms. Gorman noted that a call for applications for membership in the COPR
will be posted at the NIH Web site (8 slots are open). Applications will
be due by December 15, 2006.
Dr. Zerhouni thanked the COPR members for their input. The next meeting
of the COPR will take place April 18–20, 2007. The 2007 fall meeting
will take place on October 25–26.
ADJOURNMENT
Dr. Zerhouni and Mr. Beam adjourned the meeting.
LIST OF ABBREVIATIONS
AND ACRONYMS
ACD Advisory Committee
to the Director
ADNIAlzheimer’s Disease
Neuroimaging Initiative
CBPRCommunity-Based Participatory
Research
COPR Council of Public
Representatives
CTSAClinical and Translational
Science Awards
DHHS Department of Health
and Human Services
FDAU.S. Food and Drug Administration
FNIHFoundation for the
National Institutes of Health
GAIN Genetic Association
Information Network
ICs NIH Institutes and
Centers
IRB Institutional Review
Board
NCRRNational Center for
Research Resources
NCINational Cancer Institute
NEINational Eye Institute
NHANESNational Health and
Nutrition Examination Survey
NHLBINational Heart, Lung,
and Blood Institute
NHGRINational Human Genome
Research Institute
NIAIDNational Institute
of Allergy and Infectious Diseases
NIHNational Institutes
of Health
OBSSROffice of Behavioral
and Social Sciences Research
RFIRequest for Information