Center for Scientific Review Advisory Committee Meeting

National Institutes of Health

U.S. Department of Health and Human Services

January 27 - 28, 2003

The Center for Scientific Review (CSR) convened the 31st meeting of its
Advisory Committee at 8:30 a.m. on Monday, January 27, 2003, in
Conference Room 6087, Rockledge II Building. The entire meeting was held
in open session. Dr. Karen Matthews presided as Chair.

## Members

Karen Matthews, Ph.D., Chair Susan Berget, Ph.D.

Michael Colvin, M.D. Lucia Rothman-Denes, Ph.D.

David Soybel, M.D. David Williams, Ph.D., M.P.H.

## Ad Hoc Advisors

Michael Berns, Ph.D. Michael Leon, Ph.D.

Marvin Wickens, Ph.D.

Dr. Brent Stanfield was the Executive Secretary for the meeting.

**Welcome and Opening Remarks**

Dr. Matthews welcomed members of the CSR Advisory Committee (CSRAC) and
asked them to consider the minutes from the September 30 - October 1,
2002 CSRAC meeting. CSRAC members approved the minutes without
discussion, and Dr. Matthews then asked Dr. Ellie Ehrenfeld, CSR
Director, to present her update.

**CSR Update**

*CSR Creates a New Review Division*

Dr. Ehrenfeld said that CSR has restructured its three review divisions
into four divisions to better manage the growing volume and complexity
of applications reviewed. The divisions and their directors are as
follows: (1) Division of Molecular and Cellular Mechanisms---

Dr. Donald Schneider, (2) Division of Biologic Basis of Disease---Dr.
Elliot Postow,

\(3\) Division of Physiology and Pathology---Dr. Michael Martin, and (4)
Division of Clinical and Population-Based Studies---Dr. Anita Miller
Sostek. In this reorganization, Dr. Sostek was promoted and Dr. Postow
moved from the Division of Clinical and Population-Based Studies to the
new division, the Division of Biologic Basis of Disease. Dr. Ehrenfeld
explained that

Dr. Sostek had been the chief of the Biobehavioral and Behavioral
Processes Integrated Review Group (IRG). She holds a Master\'s degree in
developmental psychology from the University of Rochester and a Ph.D. in
developmental psychology from the State University of New York-Buffalo.
Before coming to CSR, she was an associate professor at Georgetown
University Medical School.

*Personnel Changes at the Institutes*

Dr. Ehrenfeld briefly discussed other personnel changes at the National
Institutes of Health (NIH). The National Institute on Drug Abuse has
named a new director: Dr. Nora Volkow, who has been the Associate
Director for Life Sciences at the Brookhaven National Laboratory in
Upton, New York. The National Institute of Mental Health also has
selected a new director:

Dr. Thomas Insel, who was Director of the Center for Behavioral
Neuroscience at Emory University School of Medicine in Atlanta. Two
other NIH Institutes are looking for directors: the National Institute
of Neurological Diseases and Stroke, and the National Institute of
General Medical Sciences.

*Budget and Workload Issues*

Congress has not yet passed a 2003 budget for NIH, so it has been
operating under a continuing resolution since last October 1. As a
result, NIH funding is frozen at 2002 levels, making it difficult for
NIH to fund new grants and plan the fiscal year 2004 and 2005 budgets.

Dr. Ehrenfeld explained that CSR is particularly concerned since it is
experiencing a large and unexpected increase in application submissions.
In the first 3 months of the fiscal year, CSR received 4,000 more
applications than it did in the first 3 months of last year. This
increase could be due to an attempt by applicants to submit applications
before the doubling of NIH\'s budget is completed. Whatever the reason,
Dr. Ehrenfeld expects that CSR will continue to receive increasing
numbers of applications as pay lines get tighter and more applicants
submit amended applications.

*CSR Internship Program*

For 2 years, CSR has piloted a Review Internship Program that recruited
interns from the NIH intramural community. Dr. Ehrenfeld said that the
2003 program was opened to applicants from outside NIH. Three interns
were recently hired, and CSR expects to receive additional applications
by February 1 and hire three more interns this year. While this is a
training program, it is helping CSR manage its increasing workload and
providing a ready pool of qualified applicants for permanent scientific
review administrator (SRA) positions.

*Electronic Grant Submission*

Dr. Ehrenfeld described recent advances in developing the infrastructure
for electronic grant submission. The NIH Commons Web site has been
revised and expanded, and since January 13, all institutions have been
able to register their applicants so they may access application
information---scores, summary statements, etc.---via the Web. She
explained that a small-scale pilot will be conducted between May and
July to use the system to submit grant applications.

A larger pilot will be conducted later in the year. NIH hopes to avoid
the problems the National Science Foundation and others experienced when
their systems were suddenly opened up to huge numbers of applications.
NIH is exploring the possibility of distributing \"time-stamped
electronic tickets\" to institutions so they would submit their
applications to NIH at different specified times during a receipt day.
Dr. Ehrenfeld said that a Commons working group is developing plans in
collaboration with the NIH Office of Extramural Research (OER) and
offices of sponsored research at institutions across the country. To
secure some input from investigators, a small number of researchers at
the University of California at Irvine and Riverside, including Dr.
Leon, were invited to a meeting of the Commons working group.

Dr. Leon said that they discussed the timing of submission of thousands
of applications. He also said that investigators at the meeting could
not agree if it would be possible to have applicants submit all their
appendices, photos, etc. via the Web. Despite these concerns, he said
that he was impressed with how well this initiative has been developed.

*Addressing Data Sharing in Applications*

At the last CSRAC meeting, members discussed a draft NIH statement
requiring applicants to address the need to share data. This statement
was posted on the Web for public comment. Many comments were received,
and NIH Institute and Center (IC) directors also provided input. The
statement currently is being revised, and a plan is being developed to
implement it by October 1, 2003. Dr. Ehrenfeld said that it appears that
data-sharing plans or an explanation why data-sharing is not appropriate
will be required from all investigators submitting NIH applications for
\$500,000 or more in direct costs per year. This requirement will
address the major concern regarding the need to improve access to large
clinical databases that cannot be reproduced. She said she did not
expect that reviewers will be required to evaluate proposed data-sharing
plans or factor them into their scores. Program staff will likely be
responsible for overseeing compliance. The burden on CSR and its
reviewers should be minimal.

*K Award Data*

Dr. Ehrenfeld addressed a question Dr. David Soybel asked at the last
CSRAC meeting regarding the efficacy of K awards. She focused on
mentored clinical scientist development awards (K08) because of his
interest in this area and because there is more K08 data available to
examine as these awards have been made since 1995. She explained that
4,047 K08s were reviewed between 1996 and 2002, and 1,969 were funded.
Researchers who were M.D.s represented

86 percent of the applicants and 88 percent of the awardees. M.D.s had a
50 percent success rate. Of the 275 M.D.s who received K08s in 1996, 168
submitted R01 applications between 1999 and 2002, with a 53.6 success
rate. The 1996 K08 awardees who submitted R01 applications in 2002 had a
success rate of 32.4 percent. M.D.s who never received a K08 award and
applied for R01 funding in 2002 had a success rate of 28.4 percent. Dr.
Ehrenfeld said that the data available were limited but they suggest
that the program may be effective.

*Senior Reviewers*

While some study sections have large numbers of well-recognized
reviewers, other study sections may not. Dr. Ehrenfeld noted previous
CSRAC discussions on the merits of recruiting senior reviewers by
offering them reduced terms of service. These senior reviewers could
help set a good tone for their review meetings, train new reviewers, or
assist in other ways. She informally polled a few study section chairs
to see if they thought creating a new class of reviewers could alienate
some senior reviewers who serve full terms. Most told her that it would
be hard to judge the idea without trying it. CSR thus intends to conduct
a small pilot developed by a CSR committee chaired by Dr. Ann Hardy,
SRA, Social Sciences, Nursing, Epidemiology and Methods 5 Study Section.
About six study sections will participate in this pilot, beginning with
the October review round.

*Reviewer Assignment Lists*

Dr. Ehrenfeld noted concerns about reviewer assignment lists that are
usually distributed to study section members. Reviewers are obliged to
keep these lists confidential, but other individuals may have unintended
or improper access to them and seek quid pro quo arrangements or
reprisals. Giving reviewers only lists of the applications assigned to
them to review could reduce these risks. She noted that a third of the
SRAs at CSR distribute such individualized lists. Some of their
reviewers, however, have complained about not knowing the other
assignments.

Dr. Michael Berns said that reviewers should not be concerned with other
assignments and suggested that all study sections should adopt the same
practice. Dr. Rothman-Denes said that there are times when reviewers
feel more comfortable reviewing an application when they know a reviewer
with complementary expertise is also reviewing it. Dr. Postow noted that
reviewers could be given lists that indicate the assignments for just
the grants they review.

Dr. Leon said that reviewers do not need this information to perform
their reviews. A consensus was reached that CSR SRAs should only provide
study section members lists of reviewers for the grants they review.

*Reviewing Complex Multidisciplinary Applications*

Dr. Ehrenfeld followed up previous CSRAC discussions on the review of
complex multidisciplinary applications. She explained that 609
applications were randomly selected and studied by Dr. Janet Newburgh,
Deputy Director, CSR Division of Receipt and Referral, and

Dr. Gillian Einstein, SRA, CSR Molecular, Cellular and Developmental
Neuroscience 2 Study Section. Their data suggest that a third of all
applications are multidisciplinary. They do not appear to cluster in any
specific area of science, IRGs, or NIH Institutes. Dr. Ehrenfeld was
surprised to hear that 33 percent of these applications scored in the
top 25th percentile. She noted that the data set was small and that CSR
must decide if it needs to gather additional data or simply monitor
these kinds of applications.

**Small Business Innovative Research (SBIR) Study Sections**

Dr. Matthews welcomed Dr. Berns, who was invited to assist Dr. Schneider
in discussing the SBIR study sections. It was noted that he is a
professor at the University of California in Irvine, and he covers a
number of fields: surgery, bioengineering, developmental biology, and
cell biology.

Dr. Schneider began by noting that there are two types of SBIR awards
and both of them emphasize innovation: Phase I awards provide up to
\$100,000 for 6 months to investigators who may not have submitted data
but who submit a proposal with a strong rationale. Phase II awards
provide up to \$750,000 for 2 years to investigators who submit an
application with appropriate data and plans for developing a commercial
product. SBIR investigators must devote more than half their time
working for their small business. Investigators who spend more of their
time in academic research may apply for a Small Business Technology
Transfer Research (STTR) award.

A member of the CSR working groups evaluating existing study sections
suggested that CSR take a crosscutting look at SBIR reviews. CSR thus
developed an SBIR Working Group to examine SBIR reviews in CSR\'s
Molecular and Cellular Mechanisms Division. Five working group chairs
who coordinated previous study section evaluations and three working
group members with SBIR review experience joined the SBIR Working Group.
It was asked to consider nine issues: (1) the mix of SBIR reviewers, (2)
the streamlining of application reviews, (3) the focus on an
application\'s strengths vs. weaknesses, (4) the problem of derivative
applications, (5) the emphasis to be given to a final product, (6) the
need for proprietary information, (7) the inclusion of business plans,
(8) the appropriate numbers of SBIR reviewers who are clinicians, and
(9) the fast tracking of applications.

*SBIR Working Group Deliberations*

Dr. Schneider explained that the SBIR Working Group members made seven
recommendations:

[1. Charter SBIR Study Sections]{.underline}: Working Group members were
unanimous in this recommendation. They noted that the SBIR program had
been in existence for over 10 years, it has a stable workload, and about
two-thirds of the reviewers have attended recent reviews. Chartering
these study sections was seen as a way to ensure the regular turnover of
members, promote consistency in review of business practices and plans
as well as other aspects, and promote multidisciplinary reviews.

[2. and 3. Involve Industry and Clinician Reviewers]{.underline}:
Reviewers from large businesses were recognized for the valuable input
they can provide about product development issues. Working Group members
noted that these reviewers are more informed about patent rights and
other product development issues. The SBIR Working Group recognized that
clinical reviewers are well-represented on many study sections, and it
encouraged greater participation by these reviewers. CSR subsequently
examined 477 SBIR reviewers from across its review divisions and found
reviewers with M.D.s were reasonably represented on SBIR study sections,
with a

20 percent participation rate. In addition, reviewers with industry ties
were also reasonably represented on these study sections, with a 20
percent participation rate.

[4. Consider Product Issues]{.underline}: While Phase I SBIR
applications are reviewed according to the standard five review
criteria, Phase II SBIR applications are reviewed for their product
development plan and whether the proposed product has a high degree of
commercial potential. Most Working Group members felt a research tool or
kit should be considered an appropriate product, but a minority felt
that the goal of any SBIR grant should be the development of a
commercial product. To see if SBIR reviews showed any prejudice against
product development, CSR selected 413 applications from six SBIR study
sections and sorted them by four categories: prevention, diagnosis,
therapy, and other. Scoring differences among these groups did not
appear to be significant. However, the number of applications in the
\"other\" category could be a significant problem.

[5. Readdress the Intent of Fast Tracking]{.underline}: Despite the fact
that NIH created a \"Fast Track\" approach for reviewing and funding
Phase I/II applications, very few of these applications are submitted.
Most SBIR applications (80 to 90 percent) are Phase I applications.
Working Group members felt that the hurdle to the Fast Track is too high
and recommended increasing the duration and funding for Phase I awards.

[6. Identify Derivative Applications]{.underline}: Though NIH has ruled
that derivative applications should be considered less innovative,
reviewers often are not informed when they are asked to review a
derivative application. The Working Group members recommended that CSR
do more to identify these applications.

[7. Improve Feedback to New Investigators]{.underline}: While Working
Group members recognized the value in streamlining the review of
applications, they said that new investigators deserved to receive
better feedback than that given when applications are streamlined.

Dr. Berns began the discussion by focusing on the recommendation to
charter the SBIR study sections. He asked if chartered study sections
had the kind of turnover and flexibility necessary to review SBIR
applications. After noting that SBIR study sections require more
industry representatives, Dr. Berns asked how difficult it was to
recruit these individuals. He then focused on derivative applications,
suggesting that applicants be required to list pending grants. Since
concerns about how new investigator applications are reviewed transcend
SBIR reviews, CSRAC should hold a lengthy discussion at another time.
Dr. Berns also asked how well the SBIR program is working.

Dr. Michael Colvin asked if there was a difference in the science
proposed in SBIR proposals vs. traditional proposals. Dr. Berns said
that he thought SBIR applications contained less basic science due to
their focus on producing a product. Dr. Colvin continued by saying that
he thought the SBIR program was worthwhile, and it might be useful to
see a list of the SBIR awards and their topics so that CSRAC could
better assess the program. Dr. Soybel said that it also would be useful
to have a list of the patents, products, and license sales resulting
from the SBIR program. He then said he strongly supported chartering the
SBIR study sections. Doing so would make them more accountable and
reduce potential conflicts of interest.

*Chartering the SBIR Study Sections*

Dr. Matthews further focused the discussion on the issue of chartering
SBIR study sections by asking CSR staff to comment on the down side of
making this change. Dr. Suzanne Fisher, Director, CSR Division of
Receipt and Referral, said that the range of science covered by SBIR
applications is quite different from that covered by other types of
applications. It would be a challenge to develop appropriate SBIR
referral guidelines. Dr. Sostek added that chartering these study
sections would require a lot of work, although having reviewers with
4-year commitments would be a benefit. She suggested that chartering
some SBIR study sections would be more of a burden than chartering
others. One of the biggest problems would be developing slates with
appropriate demographic distributions. Dr. Marcia Steinberg, Chief, CSR
Cell Development and Function IRG, added that it would be difficult to
recruit small business reviewers for chartered study sections because of
the service terms---three meetings a year for

4 years.

Dr. Matthews said that it was important to work through these issues,
given the importance the SBIR Working Group gave to chartering SBIR
study sections. Dr. Eileen Bradley, Chief, CSR Surgery, Radiology and
Bioengineering IRG, spoke in support of chartering. She said the
community needs to see who is serving on the SBIR study sections in
order to identify potential conflicts of interest. She added that some
SBIR study sections lend themselves to chartering.

Dr. Soybel asked if SBIR study sections could be integrated with the R01
study sections.

Dr. Bradley said that CSR has integrated SBIR and R01 reviews in some
areas but that doing so would be impossible in other areas where SBIR
applications are too diverse. Dr. Colvin agreed with Dr. Soybel on how
chartering the SBIR study sections could help NIH be more accountable.
Dr. Schneider said that the SBIR Working Group saw chartering as part of
a maturation process that would give more legitimacy to the program. Dr.
Marvin Wickens asked if there was another way to do this that would let
the program remain flexible. Dr. Matthews asked if it would be possible
to charter some SBIR study sections and not others. Dr. Ehrenfeld said
that it would be. Dr. Berns emphasized the importance of determining
whether or not chartering will actually improve reviews. Dr. Ehrenfeld
agreed, saying that more data would be helpful in determining the
quality of SBIR reviews and the level of industry participation in these
reviews. She noted that the SBIR Working Group was formed with outside
experts associated with Dr. Schneider\'s division, and it might be worth
trying to get a broader perspective on these issues. Dr. Susan Berget
agreed and noted that the Working Group concerns about the lack of
turnover contrasts with the concerns she just heard about the need for
flexibility. Dr. Matthews suggested that CSRAC discuss chartering the
SBIR study sections at its next meeting after additional data can be
collected.

*Derivative Applications*

Dr. Ehrenfeld spoke about derivative applications, i.e., applications
that seek funding to support identical or very similar research
projects. She said the problem is more difficult to deal with when
applications are assigned to different study sections.

Dr. Ehrenfeld added that applicants are no longer required to list
pending applications. The 398 application form would have to be revised
to change this policy. Dr. Steinberg explained that it is the program
director\'s job to find out what other funding an applicant has. It was
noted that identifying derivative applications is also made difficult
when the same company submits similar applications using two different
principal investigators. Dr. Matthews said that it would be important to
know how frequent the problem occurs to know how important it might be
to address it.

**Evaluating Innovation in Grant Applications**

Dr. David Armstrong, Chief, CSR Brain Disorders and Clinical
Neuroscience IRG, responded to a previous request to define the word
\"innovation\" by discussing the definitions in the Oxford Dictionary:
\"1. The action of innovating; the introduction of new elements or
forms. 2. A change made in the nature or fashion of anything . . . 3.
The action of introducing a new product into the market . . . \"

He said he gained additional insight by participating in a workshop
sponsored by the Smithsonian\'s Lemelson Center, which focuses on
innovation and invention. Most of the participants agreed that
entrepreneurship or commercial success was an important aspect in
defining innovation. Dr. Armstrong explained that \"innovation\" was
never defined when it was inserted into the 398 grant application form,
and the term remains problematic; hence, other words such as
\"creativity\" are being used by the NIH Innovation Workgroup.

Since the last CSRAC meeting, an NIH Innovation Workgroup was formed
with representatives from CSR, the National Cancer Institute (NCI), the
National Institute of Allergy and Infectious Diseases (NIAID), and the
NIH Office of the Director. The Workgroup has (1) developed a statement
of mission, problem, and historical perspective of the problem; (2)
discussed the solicitation and review of innovative applications with
NCI and NIAID staff; (3) discussed the individual elements required for
high-impact applications; (4) drafted language to be included in the
instructions to applicants; and (5) started developing plans for a
workshop to implement a pilot program. CSRAC members received copies of
the draft documents produced.

Dr. Armstrong noted that the Workgroup agreed that research should be
problem and/or opportunity based rather than hypothesis driven. The
Workgroup's proposals will be offered to the outside community for
comment before proceeding.

Dr. Armstrong said that the new NIH Director, Dr. Elias Zerhouni, has
taken a personal interest in this initiative. Dr. Ehrenfeld explained
that Dr. Zerhouni has held a number of meetings with outside experts to
develop a \"road map\" for NIH\'s future. In most of these meetings, he
has heard the same concerns: NIH is too conservative, and its review
process kills truly innovative research. She said that Dr. Zerhouni has
raised the possibility of launching a trans-NIH effort instead of an
initial pilot study. He has asked her to help come up with a proposal to
do this.

Dr. Ehrenfeld said that discussions are ongoing as to whether NIH should
launch a large trans-NIH effort or start with a small pilot. If there
are only a small number of truly innovative ideas, it would take a
trans-NIH effort to identify them. On the other hand, there are many
challenges to creating a large trans-NIH program that would serve the
varied needs of 20-25 Institutes. She said that it would be difficult to
imagine what would come in if NIH told the research community it wanted
\"smart, clever, and novel ideas\" submitted on a five-page application.
NIH would have to develop new review committees with the breadth and
scope of those that review SBIR applications. Dr. Ehrenfeld said that it
was important for NIH to take an approach that can be successful, and
she invited CSRAC members to comment.

Dr. Berget said that NIH could easily be overwhelmed with applications
if the initiative was launched NIH-wide, and she suggested that a
smaller pilot might be more useful. She then focused on the pilot
proposed earlier, saying that she had difficulty conceiving of a
research proposal that was not in some way hypothesis-driven. Dr.
Wickens shared Dr. Berget\'s concerns, but he encouraged NIH to go
forward boldly whether it decides to start with a pilot or trans-NIH
program. Dr. Armstrong said that the Innovation Workgroup had drafted
applicant instructions with the intent that they would limit the number
of inappropriate applications.

Dr. Berns added to the discussion by saying that he thought the
five-page application should serve as a pre-application. If one shows
promise, NIH could request a more detailed application to be sure the
proposed research is worthwhile. He said he supported a trans-NIH
program if appropriate resources are provided to implement it. Dr. Leon
suggested that NIH begin with a small pilot program so that it could
learn from its inevitable mistakes. He also encouraged NIH to look for
new ways to review these proposals. Traditional review committees are
likely to perform traditional reviews. Better decisions could be made if
one person at NIH made them. As for a trans-NIH initiative, Dr. Leon
suggested that NIH would do better to focus on improving how well
innovation is recognized and assessed in current review groups.

Dr. Matthews said that Dr. Zerhouni\'s interest provided a unique and
exciting opportunity, and she encouraged NIH to pursue the innovation
initiative. She particularly liked the draft documents produced by the
Workgroup, although she said that she also had concerns about the
language on hypothesis-driven research. Dr. Matthews suggested that the
regular 398 application form could be improved if it asked applicants to
explain how their proposed project would be innovative, advance research
in the short- or long-term, or alter current scientific thinking or
capabilities. Dr. Anthony Coelho, OER Review Policy Officer, explained
that the former NIH Director, Dr. Harold Varmus, established the current
criteria and that they could be changed. Dr. Matthews then asked Dr.
Armstrong about the proposed planning workshop. He said that workshop
members would be asked to help address outstanding issues and finalize
an implementation plan. Dr. Ehrenfeld added that the type of workshop
held would be influenced by the type of program NIH decides it wants---a
small pilot program or a trans-NIH program.

Dr. Matthews summarized the discussion, saying that the majority of
members thought it was worthwhile to pursue a trans-NIH program,
although it might be more appropriate to begin with a pilot program.
CSRAC members would be pleased to have an opportunity to provide further
input as the initiative advances. In addition, the standard grant
application process could be improved if reviewers and applicants were
asked to focus more on innovation.

**Implementation of the Study Section Reorganization**

Dr. Schneider said that CSRAC members were going to be asked to review
recently developed guidelines for four new IRGs: (1) Bioengineering
Sciences and Technologies; (2) Surgical Sciences, Biomedical Imaging,
and Bioengineering; (3) Cardiovascular Sciences; and

\(4\) Digestive Sciences. He briefly explained that these guidelines
were developed by CSRAC subcommittees called study section boundary
teams and then further refined following public comment periods. CSRAC
members were asked to provide a concept review of these guidelines to
ensure that they lived up to the vision of the Panel on Scientific
Boundaries for Review (PSBR). CSRAC members were specifically asked to
ensure that the proposed guidelines

\(1\) describe a cohesive area of science not too broad and not too
narrow, (2) provide sufficient overlap with other study sections in the
IRG, (3) provide a home for review of basic science in context of
biological questions, and (4) appropriately cluster clinical research
applications.

*Bioengineering Sciences and Technologies (BST) IRG*

The BST boundary team met along with the Sciences, Biomedical Imaging,
and Bioengineering (SBIB) IRG in November 2001. Following PSBR guidance,
the BST boundary team developed an IRG focused on basic bioengineering
research in the biological context. Six study sections were proposed:
(1) Gene and Drug Delivery Systems, (2) Multidimensional Imaging,

\(3\) Modeling and Analysis of Biological Systems, (4) Biodata
Management and Analysis,

\(5\) Instrumentation and Systems Development, and (6) Biomaterials and
Biointerfaces. The BST boundary team was then asked what should be done
if there were not enough applications to justify all six study sections.
The team suggested that the Modeling and Analysis of Biological Systems
Study Section could be combined with the Biodata Management and Analysis
Study Section. The Multidimensional Imaging Study Section also could be
combined with the Instrumentation and Systems Development Study Section.

Dr. Schneider discussed public comments CSR has received on the BST
guidelines:

There is a need for this basic bioengineering IRG, and BST should focus
on the development of new tools not hypotheses. He added that the
imaging community favors the crosscutting review structure, but some
question the need for two IRGs, and the genomic community believes
bioinformatics should be a part of genetics, and all bioengineering
should be considered in the biological context. He also discussed some
comments that were specific to individual study sections. There were
concerns that the guidelines for the Modeling and Analysis of Biological
Systems Study Section may restrict the integration of modeling and
experiment, and the guidelines may be too narrowly focused to anticipate
future research. Similar comments were made about the Biodata Management
and Analysis Study Section, which seems to uncouple bioinfomatics and
experiments. This concern could be addressed if this study section is
merged with the Modeling and Analysis of Biological Systems Study
Section. Dr. Schneider also highlighted comments on the Instrumentation
and Systems Development guidelines: instrument development needs a
biological problem/context, and some analytical chemistry belongs in the
Biophysical and Chemical Sciences IRG, which has not yet been developed.

CSR proposes to modify the draft guidelines to include a paragraph at
the beginning about boundary teams that have not yet met, and to add or
modify shared interest statements for each of the BST study sections
covering areas they share with other IRGs. Dr. Schneider briefly
discussed some of the specific overlaps: BST and the Biological
Chemistry and Macromolecular Biophysics IRG share an interest in
analytical chemistry, e.g., mass spectrometry. BST and the Genes,
Genomes and Genomics IRG share interest in gene therapy, and both
boundary teams have designed similar study sections to cover this area.
BST and SBIB share an interest in molecular imaging and biomaterials.

Dr. Schneider concluded his presentation by saying that the BST
guidelines were consistent with PSBR recommendations and that this IRG
will welcome basic bioengineering applications in a way that NIH has not
done before.

Dr. Matthews began discussions by seeking input from three consultants
attending the meeting: Dr. Dan Roden, Vanderbilt University Medical
Center; Dr. Raj Goyal, Johns Hopkins University School of Medicine; and
Dr. Alan Snyder, Penn State University. Dr. Snyder said that this IRG
was most interesting for the way it will create new homes for growing
communities of bioengineers. Dr. Roden asked about the applications that
had a major computational focus as well as an organ-system focus. Dr.
Schneider said that they would likely be reviewed in organ-specific
study sections. Dr. Roden then asked about bioengineering approaches to
monitor or understand disease pathophysiology. Dr. Postow echoed Dr.
Schneider\'s response, saying that organ-specific study sections would
review those applications with an organ system focus.

Dr. Soybel said that he was concerned about the large overlap between
the proposed BST and SBIB IRGs, and he wondered about the difficulty of
sorting applications consistently.

Dr. Schneider said that it would be difficult to predict the future, and
he noted that these IRGs were designed with the belief that it was good
to build two homes and let them evolve.

Dr. Berns raised a concern about the way the BST guidelines discourage
\"hypothesis-driven\" applications. He also questioned the name proposed
for the \"Multidimensional Imaging Study Section,\" because it does not
fully describe its scientific scope. Dr. Berns also said the
Biomaterials and Biointerfaces Study Section should include enough
reviewers who can adequately cover the biological dimensions of its
research area. He concluded by asking why BST and SBIB could not be
merged into one IRG. Dr. Schneider suggested that the field of basic
bioengineering could be better served by having its own IRG.

Dr. Matthews moved that CSRAC members endorse the BST guidelines with
the recommendations that CSR drop the language discouraging
hypothesis-driven applications, reconsider the name for the
Multidimensional Imaging Study Section, and add an emphasis on the
biological components to the Biomaterials and Biointerfaces Study
Section. She proposed that members could still discuss concerns they may
have about the overlap between BST and SBIB later in the meeting. All
the other CSRAC members agreed.

*Surgical Sciences, Biomedical Imaging and Bioengineering IRG*

Dr. Postow explained that the SBIB boundary team designed 11 study
sections but 3 were dropped because organ-specific applications the team
thought would come to this IRG will go to study sections in
organ-specific IRGs. He then briefly described the SBIB study sections:

\(1\) Biomedical Imaging Technology; (2) Medical Imaging; (3) Biomedical
Computing and Health Informatics; (4) Bioengineering, Technology, and
Surgical Sciences; (5) Surgery, Anesthesiology, and Trauma; (6) SBIR
Biomedical Imaging; (7) SBIR Bioengineering, Surgical Sciences, and
Technology; and (8) SBIR Biomedical Sensing, Measurement, and
Instrumentation.

In discussing public comments, he said that many people felt that SBIB
will strengthen the review of multidisciplinary research and ensure that
transitional research is adequately evaluated. Some noted that the
application of technology may be innovative while its development is
not; hence, many of these applications would fare better in
organ-specific study sections. On the other hand, some individuals were
concerned that applications on some research topics could suffer if
distributed across many organ-specific IRGs. The importance of having
crosscutting expertise on the study sections was emphasized. Dr. Postow
said that there were many ways to do this and not everyone would likely
be pleased with any one approach. He continued by saying there was great
support for the imaging study sections. There were, however, requests to
combine all imaging in a single IRG. These requests were quite strongly
made, but they could not be accommodated because of opposition from
another IRG boundary team. Dr. Postow then focused on comments made
regarding the bioengineering study section. Some individuals felt that
the distribution of responsibilities between BST and SBIB for cell and
tissue engineering were not clearly defined. Some also felt that tissue
response to foreign material is a general process, and applications in
this area should not be distributed to organ-specific study sections. He
continued by discussing comments related to the field of surgery. Many
individuals thought the proposed changes would foster collaboration with
basic sciences that will advance surgical research. Some endorsed the
idea of creating two homes for transplantation. Other comments focused
on the need to include both scientific/technical and clinical expertise
in the same study section. There also were concerns that assigning a
surgeon to each organ-specific study section will not provide adequate
surgical expertise.

Dr. Postow discussed a number of instances where SBIB shares interests
with other IRGs. SBIB and the Biological Chemistry and Macromolecular
Biophysics IRG have an interest in the synthesis of radiolabeled
compounds. SBIB and the BST share interests in molecular imaging,
informatics, biomaterials and biocompatibility, and device and
instrument development. SBIB and the Immunology IRG share an interest in
transplantation, but it has been largely moved to the Immunology IRG. He
said that applications on surgical procedures applicable to a specific
organ would generally be reviewed in the appropriate organ-specific IRG
unless a request is made for them to be reviewed in SBIB. Medical
imaging applications will go to other IRGs if they propose to use
imaging technology as a study tool. Metabolic or hormonal response to
surgery and nutritional support related to surgical care will be
reviewed in SBIB while other metabolic and nutrition applications will
be reviewed in other IRGs. SBIB also has shared interests with the
Digestive Sciences IRG, such as the toxicity from pharmacokinetics and
pharmacodynamics of contrast agents and drug delivery components. In
addition, SBIB shares an interest in the perception of pain during
anesthesia with the Integrative, Functional and Cognitive Neuroscience
IRG.

Dr. Postow then listed suggested modifications to the proposed
guidelines: (1) adding a paragraph about IRG boundary teams that have
not met, (2) reducing the number of proposed study sections by three,
(3) considering the combination of two SBIB study sections, and

\(4\) adding or modifying statements of shared interests with other
IRGs. CSR is thus proposing to implement eight SBIB study sections
consistent with PSBR recommendations. He noted that the new Immunology
IRG is scheduled to begin reviewing applications a round after SBIB
begins work. A special emphasis panel (SEP) will review the transplant
applications that would be transferred to the Immunology IRG.

Dr. Pedro del Nido, from Harvard University-Children\'s Hospital,
Boston, was invited to comment on the SBIB guidelines. Speaking on
behalf of the cardiac surgery community, he questioned the wisdom of
moving cardiac surgery applications out of SBIB and into the
Cardiovascular Sciences IRG. This group of applications is relatively
small, and they could suffer if spread too thinly across study sections.
Dr. del Nido said that surgery applications in other areas could suffer
a similar fate in the reorganization. He noted that a lot of research
conducted by surgeons is procedure-development work, which is very
similar to bioengineering. Applications from these two fields have been
reviewed together successfully, and he wondered how well surgery
applications would fare if many of them were scattered to organ-specific
study sections.

A few CSRAC members asked how researchers could direct their
applications to study sections to ensure they received the best reviews.
Dr. Fisher said that CSR takes these requests very seriously and tries
to accommodate them. If a request does not seem appropriate, CSR staff
will contact the applicant, discuss the situation, and offer options
when they are available.

Dr. Soybel said that the overlap between SBIB and BST was not clear to
him. He said that there was a two-step process---instrument development
and instrument applications---and he wondered how great a role SBIB
could play in reviewing these applications. Dr. Soybel objected to the
plan to move many of the transplant applications to organ-specific study
sections. Transplantation involves a continuum---from the preservation
of organs to the management and evaluation of acute and chronic
rejection---and these applications should be reviewed together. He
echoed Dr. del Nido\'s concerns about spreading surgery applications too
thinly across organ-specific study sections.

Dr. Ehrenfeld said the community may choose to favor BST study sections
more than SBIB and organ-specific study sections, and CSR could find
that these IRGs merge. She suggested that it would be important to
address concerns from the surgery community when discussing the
Cardiovascular Sciences IRG. She explained that there have been many
discussions about where transplantation reviews are located, and it was
probably important to cluster them as much as possible. Dr. Soybel said
that he did not feel that future innovation in transplantation research
will be in the classical field of immunology, and he again suggested
that transplant applications not be placed in the Immunology IRG. He
said that this was primarily a clinical problem, and that it was
important to review solid organ transplant along with islet cell
transplants and other transplants as a whole. Dr. Colvin said he
strongly supported Dr. Soybel\'s position. After CSRAC members discussed
it, Dr. Soybel moved to approve the SBIB guidelines with the
understanding that the area of transplant research will be tabled for
further consideration at the next CSRAC meeting. He said it would be
helpful to assess all the trends in the transplant applications
submitted in the last year and sort them with respect to the organ
system and Immunology IRGs to get a better understanding of the
situation. Dr. Soybel said it would be useful to invite consultants from
the solid organ transplant and immunology communities to the next CSRAC
meeting. Dr. Matthews called for a vote, and CSRAC members passed

Dr. Soybel\'s motion.

*Cardiovascular Sciences (CVS) IRG*

Dr. Martin described the eight study sections proposed for CVS: (1)
Cardiovascular Differentiation and Development; (2) Cardiac
Contractility, Hypertrophy and Failure;

\(3\) Electrical Signaling, Ion Transport and Arrhythmias; (4) Vascular
Cell and Molecular Biology; (5) Myocardial Ischemia and Metabolism; (6)
Hypertension and Microcirculation;

\(7\) Atherosclerosis and Inflammation of the Cardiovascular System; and
(8) Clinical and Integrative Cardiovascular Sciences.

He then summarized the public comments received. There were a number on
the composition and size of the Clinical and Integrative Cardiovascular
Sciences Study Section. CSR has had an ongoing SEP covering this area
for 5-6 years, which reviews only about 25-30 applications a round. The
boundary team partially addressed this concern by giving this study
section responsibility for the cardiovascular response to exercise. Dr.
Martin said that CSR also received suggestions to create an independent
study section for the study of animal models and integrative physiology.
He explained that there was no clear answer to these concerns,
suggesting that the best thing to do is to monitor how well these areas
blend together.

Dr. Martin continued by focusing on areas CVS shares with other IRGs.
CVS and the Immunology IRG share interests in leukocyte-endothelial cell
interaction and the general inflammatory processes. CVS and SBIB share
an interest in transplantation, and the CVS boundary team recommended
that transplantation be located in CVS. He noted that the CVS boundary
team did not draft a shared interest statement for the Clinical and
Integrative Cardiovascular Sciences Study Section and the SBIB. Such a
statement was drafted recently after discussions with Dr. del Nido, and
it was distributed to CSRAC members at the meeting. Applications that
are clinically or patient oriented would be assigned to the Clinical and
Integrative Cardiovascular Sciences Study Section, while other
applications in the areas of arrhythmia, hypertensive function, and the
use of stents will be assigned to other study sections. He explained
that most surgical applications assigned to CVS would be reviewed by the
Clinical and Integrative Cardiovascular Sciences Study Section. Dr.
Martin then listed additional areas CVS shares with other IRGs: early
development and the effects of aging on the cardiovascular system with
the Biology of Development and Aging IRG; neo-genesis, angiogenesis, and
clinical hematology with the Hematology IRG; obesity, diabetes, and
dietary or metabolic changes with the Endocrinology, Metabolism,
Nutrition, and Reproductive Sciences IRG; and hypertension with the
Renal and Urological Sciences (RUS) IRG. He added that he drafted an
overlap statement for hypertension with input from Dr. Theodore Kotchen,
CSR Special Advisor on Clinical Research, and Dr. Stu Linas, Chair of
the HHHypertension Committee for the American Nephrology Society. This
statement calls for clinical applications related to hypertension to be
assigned to CVS.

Dr. Martin suggested that the proposed CVS guidelines be modified by
adding a qualifying paragraph about possible changes from boundary teams
that have not yet met and by adding or modifying shared interest
statements for CVS study sections that share interests with other IRGs.
He continued by discussing how well the proposed CVS guidelines follow
PSBR recommendations. CVS will have eight study sections with
substantial overlap. Primary shared interests with other IRGs have been
spelled out, and clinical research has been clustered. The only concern
he raised was that two proposed study sections would be smaller than the
other study sections: the Clinical and Integrative Cardiovascular
Sciences Study Section and the Cardiovascular Differentiation and
Development Study Section. This latter study section includes two
topical clusters: cardiac development and vascular biology. These
clusters could be moved to the Cardiac Contractility, Hypertrophy and
Failure Study Section or to the Biology of Development and Aging IRG.
Drs. Soybel and Roden said that they thought that these areas will
expand rapidly and that it might be best to let them develop in their
own study section.

Dr. Roden said that the location of transplantation remains an issue,
but he was satisfied with the plan to discuss it further. Dr. del Nido
suggested that the term "surgical" be added to the title of the Clinical
and Integrative Cardiovascular Sciences Study Section. Dr. Martin said
that a bullet was added to the guidelines to indicate that CVS has a
home for applications related to cardiovascular system trauma and
surgery. He said that he was reluctant to modify the study section's
title to highlight just one subfield. Dr. Soybel said that the CVS study
sections have been divided into logical categories and he supported Dr.
del Nido's proposal to add the word "surgical" to the title of the
Clinical and Integrative Cardiovascular Sciences Study Section. The
change would ensure that investigators know that this study section
covers invasive interventions. In response to a question from Dr. Goyal,
Dr. Martin said that the Clinical and Integrative Cardiovascular
Sciences Study Section would include most pediatric cardiology research
because it is patient-oriented. Dr. Roden noted that it may be
appropriate to assign pediatric applications to different CVS study
sections, such as those with a significant developmental, arrhythmia, or
genetic component. He suggested that the guidelines mention these areas
of pediatric research.

Dr. Matthews said that CSRAC members appeared ready to accept the CVS
guidelines with the additions Dr. Martin developed describing CVS/SBIB
and CVS/RUS overlaps and with the recommendation that CSR consider
adding text describing pediatric interests. She questioned whether the
title of the Clinical and Integrative Cardiovascular Sciences Study
Section should be altered to indicate its surgery subfield. Dr.
Rothman-Denes also questioned this proposed change. Dr. Leon suggested
that CSRAC members endorse the overlap statements and consider the
inclusion of pediatric interests. Dr. Berget made the motion, and CSRAC
members agreed. Dr. Ehrenfeld asked if the Committee was satisfied that
surgical applications assigned to CVS would go to the Clinical and
Integrative Cardiovascular Sciences Study Section. CSRAC members
indicated that this was the case.

*Digestive Sciences (DIG) IRG*

Dr. Martin described the five study sections proposed for DIG: (1)
Xenobiotic and Nutrient Disposition and Action, (2) Gastrointestinal
Cell and Molecular Biology, (3) Gastrointestinal Mucosal Pathobiology,
(4) Hepatobiology and Pancreas Pathobiology, and (5) Clinical and
Integrative Gastrointestinal Pathobiology.

He explained that public comments focused on the small size of the
proposed study sections, particularly the Gastrointestinal Mucosal
Pathobiology Study Section. When a second mock sort of applications was
conducted, fewer applications were assigned to two other study sections:
Gastrointestinal Cell and Molecular Biology, and Clinical and
Integrative Gastrointestinal Pathobiology. He said that he discussed
this problem with Drs. Goyal and Soybel. They agreed that it was
important to keep a clinical cluster in the IRG even if it was a small
study section, and that it would be best to build the study sections as
proposed and see how the fields mature over time. Dr. Martin then
briefly described other public comments. The community very much
approved moving 50 percent of the applications from the Alcohol and
Toxicology 1 and 4 Study Sections to DIG's Xenobitoic and Nutrient
Disposition and Action Study Section. Approval was also shown for moving
30 percent of these applications to the Pulmonary Sciences IRG. There
was, however, concern about the remaining 20 percent of these
applications, which would go to the Oncology IRG, the Endocrinology,
Metabolism, Nutrition and Reproductive Sciences IRG, or the Immunology
IRG. Dr. Martin explained that he discussed this situation with
representatives of the Society of Toxicology, and they were comfortable
with the approach as long as CSR monitors what happens to these
applications. He also said that CSR received many comments from the
genetics community, which is concerned about the appropriate home for
genotype-phenotype correlations versus functional genomics. He noted
that DIG shared interests in inflammatory bowel disease with the
Immunology IRG; GI, liver, and pancreatic-specific neoplasia with the
Oncological Sciences IRG; and liver transplantation, liver ischemia and
reperfusion injury, and nutritional support with the SBIB IRG. He added
that DIG shared many interests with the Endocrinology, Metabolism,
Nutrition and Reproductive Sciences IRG.

Dr. Martin suggested that the proposed DIG guidelines include a
paragraph at the beginning about boundary teams that have not yet met,
and new or modified shared interest statements for each proposed study
section covering areas shared with other IRGs. He noted that several
study sections may be small and that CSR will consider modifications if
their areas of science do not grow as expected. There appeared to be
healthy overlap between the DIG study sections with no mirror image
study sections. Basic science has a home in the Gastrointestional Cell
and Molecular Biology Study Section, and clinical research is clustered
in the Clinical and Integrative Gastrointestinal Pathobiology IRG.

Dr. Goyal made a series of suggestions: (1) gastric surgery could be
emphasized in DIG, and a shared interest statement should be developed
for it and SBIB, (2) text should be added to the guidelines to include
appropriate pediatric research, and (3) both clinical and nonclinical
pancreatic research should be kept together, because pancreatic
researchers currently work well together. He added that recent Requests
for Applications in the areas of clinical motility and Barrett's disease
may have gathered clinical research applications that would have been
assigned to DIG in the mock sorts. Future applications will likely
return to CSR. Dr. Soybel agreed that pancreatic research should remain
together in the Clinical and Integrative Gastrointestinal Pathobiology
Study Section. He then said that a number of surgical applications such
as those in the area of clinical motility could end up in other study
sections because the surgeons in this field have a keen focus on cell
biology. Nonetheless, he noted that many of his colleagues are concerned
about surgical applications being scattered among the study sections,
and he said that it was likely that most surgical research will be
clustered in the Clinical and Integrative Gastrointestinal Pathobiology
Study Section.

Dr. Soybel moved that CSRAC members endorse the DIG guidelines as
presented by Dr. Martin with the understanding that pancreatic research
is clustered in the Clinical and Integrative Gastrointestinal
Pathobiology Study Section. CSRAC members agreed, and the motion was
passed.

**Informing the Scientific Community About Progress in the
Reorganization of the IRGs**

After noting Dr. Rothman-Denes\' input, Dr. Sostek began a presentation
on CSR\'s efforts to inform the scientific community about its IRG
reorganization.

[External Activities]{.underline}: Dr. Ehrenfeld or members of her staff
have conducted 40 talks and face-to-face meetings with professional
societies since January 2000. Dr. Sostek explained that CSR usually
provided an overview of the implementation process and addressed
specific aspects of the reorganization that concerned society members.
In response to requests, CSR also produced articles on the
reorganization for six professional society newsletters.

[Study Section Activities]{.underline}: CSR Division Directors have
convened 24 briefing sessions for study section members to discuss the
impact of the reorganization and to update reviewers on the results of
the boundary team deliberations. Other CSR staff members have held many
more informal discussions with study section members.

[Internal NIH Activities]{.underline}: Early in the PSBR reorganization,
Dr. Ehrenfeld spoke to six NIH Institute advisory councils per year to
increase awareness of the process. Since January 2002, CSR Division
Directors met with two NIH advisory councils to provide updates. In
addition, CSR has participated in nine meetings with NIH Institute
program staff to discuss the reorganization. Dr. Sostek noted that
program staff has a tremendous amount of contact with the external
scientific community and will be instrumental to informing its members.

[CSR Web Information]{.underline}: CSR maintains a reorganization
activities Web page to keep the public informed about both PSBR and
non-PSBR reorganization efforts. Over 30,000 visits have been logged.
This page includes links to background information, a reorganization
timeline, draft IRG guidelines open to public comment, and summaries of
comments received on IRG guidelines now closed to public comment. Dr.
Sostek added that CSR also maintains a LISTSERV to send quarterly PSBR
updates to about 400 subscribers, including 166 contacts at different
professional societies.

[Efforts of the Scientific Community]{.underline}: Dr. Sostek discussed
two case studies in examining how professional societies have worked to
inform their members about CSR\'s reorganization. The American Society
of Microbiology (ASM) has sent its members numerous updates and comments
about these activities in its publications. In addition, ASM has
submitted nominees for boundary teams. The Genetics Society of America
(GSA) also submitted boundary team nominations. GSA subsequently raised
concerns with CSR about adequate representation in the basic sciences
and particular areas of genetics research. GSA has also requested more
direct responses to its concerns.

*Conclusions, Suggestions, and Discussion*

Dr. Sostek said that CSR has widely disseminated extensive information
on its reorganization to NIH staff, applicants, and scientific
societies. It is now beginning to provide rosters for the new study
sections. While CSR has actively involved scientific societies in its
reorganization, several societies have suggested that interaction could
be improved. She noted that many individuals outside NIH may not fully
understand how CSR must balance the interests and perspectives of many
scientific communities and also consider different policy and management
issues.

Dr. Sostek said that it may be useful to let the communities know that
their input will be carefully considered but that it has to be regarded
as advisory input. CSR should continue to provide periodic updates with
links to appropriate Web information. It also should better outline the
timing of events. Finally, she suggested that CSR revisit NIH Institute
advisory councils and program staff as new IRGs are implemented.

Dr. Rothman-Denes shared comments she heard from those wondering if
basic science will be shortchanged by the reorganization. Dr. Ehrenfeld
explained that clinicians, surgeons, and other groups have expressed
similar concerns. CSR has worked to address them, but it would welcome
suggestions on how to improve its communications. Dr. Leon suggested
that each professional society have a contact person at NIH who could
address reorganization questions. A society representative could in turn
inform its members. He also noted that CSR recently produced a report on
the successful reorganization of the neurosciences study sections.
Making this report more available could help reduce anxiety over the
ongoing reorganization process. Dr. Leon also suggested that CSR place a
statement on its reorganization Web page explaining that it must balance
many different interests as it reorganizes. He concluded his comments by
suggesting that the 398 grant application form include a space for
applicants to propose the study section that would review their
applications. Electronic interactions between the applicants and NIH
could sort out any problems. Dr. Ehrenfeld explained that CSR has not
actively encouraged applicants to self-refer their applications because
most of its study sections are being reorganized. Once the process is
complete, CSR may become more proactive in encouraging applicants to
help refer their applications to a study section. Dr. David Williams
returned to CSR\'s outreach efforts and said that it might be useful to
focus on the major professional societies, although he suggested that it
would still be useful to send e-mail updates to all professional
societies. He also wondered if it would be helpful to send an e-mail to
all NIH grant applicants once the reorganization is complete to tell
them about the major changes and refer them to appropriate Web pages for
additional information. He concluded his comments by suggesting that CSR
consider evaluating its outreach efforts in some way.

Dr. Berns said that NIH routinely sends e-mails to every university
grants office, and he suggested that CSR use this mailing list to send
PSBR updates. It was noted that applicants must go to a Web page to
submit applications, and it might be useful to place a link to CSR\'s
reorganization information on this page.

Dr. Wickens asked when the reorganization would be complete. Dr.
Ehrenfeld said that she expects that all the IRGs will be implemented by
late 2004 or early 2005.

**Update on the Mock Study Section Video**

Dr. Michael Sayre, SRA, CSR Cell Development and Function 1 Study
Section, discussed progress on developing a video of a mock CSR study
section meeting to make the review process more transparent to
applicants and new reviewers. He is coordinating this effort with Dr.
Jean Paddock, CSR Associate Director for Program Coordination, and Dr.
Chuck Selden, OER Extramural Staff Training Officer. Dr. Sayre noted
that filming was done last July using real reviewers, real but
\"anonymized\" applications, and a real SRA---Dr. Sharon Gubanich,
CSR\'s Clinical Oncology Study Section. A portion of the video was shown
to CSRAC members at their September 2002 meeting. Dr. Sayre and his
colleagues have worked to address concerns raised at this meeting and to
further develop the video. A longer version of the video was developed
to (1) give it a more positive tone, (2) provide more information about
the time reviewers spend reviewing grants before and during their
meeting, and (3) show a greater connection between the reviewer comments
shown and scores given.

The video will be field tested in February, when it will be shown to
students, post docs, and junior and senior faculty at The Johns Hopkins
University and Georgetown University.

Dr. Sayre said that he and his colleagues had developed a number of
open-ended questions to collect feedback. He offered to provide the
video to interested CSRAC members so that they may provide feedback as
well. A revised video will be presented to CSRAC members at their next
meeting with the hope that it will be posted on CSR\'s Web site in the
summer.

Dr. Sayre then discussed the survey questions. New applicants will be
asked if the video conveys useful information about the peer review
process and provides helpful tips for improving their applications.
Former applicants will be asked if the video gives them a better
understanding of the review and scoring process and if their impression
of the process has been changed by the video. In addition, viewers will
be asked if the video provides useful information about human research
subject protections and the inclusion of women, children, and minority
populations in research involving human subjects. Viewers also will be
asked if they have any unanswered questions about the peer review
process. Current or former reviewers will be asked if the video
adequately represents their experiences serving on study sections and if
they have any suggestions for improving it. Dr. Sayre invited CSRAC
members to ask questions about the effort and comment on the proposed
survey tool.

Dr. Rothman-Denes said that it was a good idea to test out the new
video. Focusing on the proposed survey, she suggested moving up the
question about important issues not addressed by the video so that it
follows the first question for new applicants. Otherwise, these
individuals might not see this important question, which followed
questions directed to experienced applicants and reviewers. Dr. Williams
noted that the survey questions contained multiple questions, and he
suggested decoupling them to better characterize the respondents,
collect the needed information, and look at subgroups. Dr. Ehrenfeld
asked Dr. Williams if he would be willing to examine the resulting
survey form, and he agreed to do so. He and Dr. Rothman-Denes
volunteered to survey individuals at their respective institutions. Dr.
Ehrenfeld said that all CSRAC members would receive a copy of the video
and survey.

**Survey of Reviewers**

Dr. Michael Micklin, Chief, CSR Risk, Prevention and Health Behavior
IRG, discussed plans for two studies he is developing with Dr. Matthews
to assess the amount of time study section members devote to their
reviews and to assess the factors that make study section service
attractive or unattractive to successful and experienced scientists. In
the first study, 50 applications from the different IRGs will be
randomly selected. One reviewer for 75 percent of the applications will
be asked to keep a behavior and time diary. All the reviewers of the
remaining 25 percent of the applications will be asked to keep a diary.
These reviewers will be asked to record all the time they spend (1)
preparing to begin their review, (2) reading and taking notes on their
application, and (3) writing and revising their critique.

In the second study, an e-mail survey will be sent to 300 current R01
grantees who are associate professors or who hold a similar or greater
position and who have not served on a study section in the past 3 years.
The data collected will be compared to data from 200 current study
section members. The survey will use a 1-5 point Likert scale to assess
incentives and barriers to study section service. Three time/situation
points will be assessed: the first request for regular study section
membership, a future request to serve as a one-time temporary reviewer,
and a future request to serve as a regular member.

Dr. Micklin proposed studying eight possible incentives: (1) gaining
knowledge about successful grantsmanship strategies and methods, (2)
being exposed to cutting-edge science and methods, (3) working with top
scientists in ones field, (4) fulfilling a duty to serve the scientific
community, (5) advancing ones professional development, (6) building
relationships with NIH staff, (7) increasing the success of ones own
grant applications, and (8) influencing the direction of science. He
then listed 12 possible barriers to be studied: (1) research
responsibilities, (2) the amount of time required to prepare critiques,
(3) teaching responsibilities, (4) family obligations, (5) the length of
study section membership terms, (6) the amount of service already given
to peer review, (7) administrative responsibilities, (8) the risk that
one\'s own grant applications may suffer, (9) other peer review
responsibilities, (10) inadequate knowledge of study section subject
matter, (11) the workload is too high, and (12) the meeting attendance
policy is too rigid.

Dr. Micklin then discussed the next steps in advancing the two proposed
studies: identify a contractor for data collection and analysis, pretest
the data collection instruments, obtain approval from the Office of
Management and Budget, and conduct the study. He proposed conducting the
pretests in the summer of 2003 and the studies themselves in the fall of
2003.

Dr. Williams said that he thought the studies would yield some very
useful information. Focusing on the second study, he suggested altering
the sampling sample to ensure that a proportional number of associate
and full professors are selected. Dr. Berget agreed that these studies
would be useful. She and Dr. Wickens wondered if most of the
disadvantages boil down to an individual not having enough time. Dr.
Stanfield said that knowing the specific time constraints could be
helpful. He noted that NIH is able to recruit many reviewers from some
universities that ease the teaching load of their scientists if they
serve on a study section.

Dr. Williams suggested that the surveys could gather important
information if they included some open-ended questions. Dr. Matthews
said that they would, and she added that the surveys would include
questions about things that could make study section service more
attractive. She then encouraged SRAs to provide any additional input
they can to Dr. Micklin.

**Review of Fellowship Applications**

Dr. Denise Wiesch, SRA, CSR Epidemiology and Disease Control 2 Study
Section, explained how she worked with Dr. Williams to determine if
behavioral science fellowship applications receive consistent and fair
reviews when evaluated in regular study sections along with R01
applications. All other fellowship applications have been reviewed in
dedicated study sections since August 2001. Behavioral fellowship
applications are treated differently because they are small in number
and cover a broad area of science. Dr. Wiesch discussed the potential
advantages of reviewing fellowship applications in study sections that
also review R01 applications: the study sections may be able to provide
more scientifically focused reviews because its members have the
appropriate expertise and they also know the training environment. As
for potential disadvantages, she said that it may be difficult for study
sections to switch from the \"R01 mindset\" and focus on the training
experience. Study sections also may lack experience with fellowships,
and scoring may be inconsistent.

Dr. Wiesch then presented data on the scoring of fellowships in the
three behavioral sciences IRGs from 2000 to 2002: Biobehavioral and
Behavioral Processes; Risk, Prevention, and Health Behavior; and Social
Sciences, Nursing, Epidemiology and Methods. She noted that most of the
applications were assigned to the National Institute of Mental Health
and most of them were for predoctoral (F31) and postdoctoral (F32)
support. Scoring patterns were compared with those for fellowship
applications reviewed in regular study sections. Dr. Wiesch said that
the data suggest that fellowships in the behavioral IRGs receive a
consistent and fair review. The distribution and spread of fellowship
scores in the behavioral IRGs are very similar to those in the
fellowship study sections. In addition, the scoring patterns of
behavioral fellowship applications have been stable over time
(2000-2002).

After discussions with Dr. Williams, Dr. Wiesch developed a list of best
practices for reviewing fellowship applications in regular study
sections: (1) group fellowship applications and review them together;
(2) send fellowship review criteria to reviewers prior to the meeting,
emphasizing the training potential; (3) remind the study section at the
meeting of the different fellowship review criteria and include a
description of it in meeting packages; (4) discuss the importance of
using the full range of scores; and (5) assign fellowship applications
to reviewers with training experience or from institutions with training
centers.

Dr. Soybel initiated a discussion of confounding variables by noting the
median score for fellowship applications reviewed in the behavioral IRGs
was 200, while the median score for those reviewed in regular study
sections was between 220 and 230. He asked if the NIH Institutes had a
system that would adjust for such differences. Dr. Stanfield explained
that the various NIH Institutes may decide whether or not percentiles
are calculated for their fellowship applications. When percentiles are
calculated for those reviewed in regular study sections, they are
percentiled against the R01 base. He also noted that fellowship
applications are not subject to streamlining but that R01 applications
are. Dr. Sostek added that at least half of the fellowship applications
reviewed in the behavioral IRGs are predoctoral fellowships. She added
that the Institutes could elect to percentile their fellowship
applications separately, but that the resulting data would be less than
ideal, since percentiles would not be calculated across the Institutes.
Dr. Matthews suggested that it might be useful to see how well just the
postdoctoral fellowship applications fared across the three behavioral
IRGs. She continued by saying that she was encouraged to see that the
behavioral sciences were not disadvantaged by the way its fellowship
applications are reviewed. The data do not suggest that standing
fellowship committees should be disbanded.

**Agenda for the Next Meeting**

Dr. Matthews listed possible agenda items for the next CSRAC meeting:
(1) SBIR Working Group recommendations, (2) the location of
transplantation in the new IRGs, (3) additional IRG boundary team
reports, (4) mock study section video, (5) innovation initiative, (6)
visit from

Dr. Zerhouni, (7) new investigators, (8) unscoring applications, (9) the
review of clinical research applications, (10) final analysis of the
neuroscience evaluation data, and (11) the behavioral science
evaluation. She then thanked CSR staff and CSRAC members for their hard
work. Dr. Ehrenfeld said that she also was grateful for the
contributions of CSRAC and her staff.

With no other business to address, CSRAC adjourned the meeting at 10:11
a.m.

We do hereby certify that, to the best of our knowledge, the foregoing
minutes of the 31st meeting of CSRAC are accurate and complete. The
minutes will be considered at the 32nd meeting of the Advisory
Committee, and any corrections or comments will be made at that meeting.

> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Brent Stanfield, Ph.D.
>
> Executive Secretary
>
> Center for Scientific Review Advisory Committee
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Ellie Ehrenfeld, Ph.D.
>
> Director
>
> Center for Scientific Review
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Karen Matthews, Ph.D.
>
> Chair
>
> Center for Scientific Review Advisory Committee