Center for Scientific Review Advisory Committee Meeting

National Institutes of Health

U.S. Department of Health and Human Services

January 26-27, 2004

The Center for Scientific Review (CSR) convened the 34th meeting of its
Advisory Committee at 8:30 a.m. on Monday, January 26, 2004, at the
Bethesda Marriott, Bethesda, Maryland. The entire meeting was held in
open session. Dr. Michael Leon presided as Chair.

## Members

Michael Leon, Ph.D., Chair Lucia Rothman-Denes, Ph.D.

Susan Berget, Ph.D. David Williams, Ph.D., M.P.H.

Edward Pugh, Jr., Ph.D. Matt Winkler, Ph.D.

## Ad Hoc Advisors

Robert Hammond, Ph.D. Franklyn Prendergast, M.D., Ph.D.

Anne Sassaman, Ph.D.

Dr. Karl Malik was the Executive Secretary for the meeting.

**Welcome and Opening Remarks**

Dr. Leon welcomed members and participants to the CSR Advisory Committee
(CSRAC) meeting. He then asked CSR's Acting Director, Dr. Brent
Stanfield, to present his update.

## CSR Update

Dr. Stanfield noted that Dr. Karl Malik was now serving as the CSRAC
Executive Secretary.

# Institute and Center Representatives

Dr. Stanfield announced that he had invited two representatives from the
Institutes and Centers (ICs) of the National Institutes of Health (NIH)
to serve as temporary CSRAC members at this meeting: Dr. Robert Hammond,
Director of the Division of Extramural Activities at the National
Institute of Diabetes and Digestive and Kidney Diseases; and Dr. Anne
Sassaman, Director of Extramural Research and Training at the National
Institute of Environmental Health Sciences. Dr. Stanfield explained that
the funding ICs, as well as extramural scientists, are customers of CSR
and their perspectives should inform and enhance CSRAC discussions. He
further explained that a new Extramural Activities Working Group has
been formed to provide advice to the IC Directors serving on the
steering group that advises the NIH Director on different policy and
management issues. One of the charges given this working group is to
advise on matters related to CSR and peer review. Dr. Stanfield said he
hoped that a couple of working group members eventually would serve as
CSRAC members to facilitate communication between CSR\'s internal and
external advisory committees.

# Increases in CSR Workload and Staff

Between fiscal year (FY) 2002 and 2003, the number of NIH applications
CSR received jumped

24 percent. Dr. Stanfield explained that similar increases appear to be
continuing. In the first

3 months of FY 2004, the number of applications received increased 15
percent over the comparable period last year.

Between January 2003 and January 2004, CSR hired 56 professional review
staff members, including 39 permanent Scientific Review Administrators
(SRAs), 6 previously retired CSR/NIH scientists, and 11 SRA interns.
Accounting for retirements etc., the number of SRAs at CSR jumped from
151 to 200 during this time period. Dr. Stanfield noted that the number
of new Federal positions at NIH is very limited, but CSR recently
received permission to hire additional staff members. Because of its
increasing workload, however, CSR is again near its hiring limit and may
need yet again to request additional resources.

# CSR's Reorganization

The design stage of the reorganization proposed by the Panel on
Scientific Boundaries for Review (PSBR) will be completed if CSRAC
members approve the guidelines for the remaining integrated review
groups (IRGs) that will be presented at this meeting. Dr. Stanfield
explained that, if everything goes as scheduled, all of the reorganized
IRGs will have held at least one meeting by March 2005.

# CSR's Internship Program

Dr. Stanfield reviewed the success of the CSR Internship Program. All of
the four interns who entered the program in August 2001 have found jobs:
three were hired by CSR and one was hired by industry. Dr. Stanfield
then discussed a survey of CSR interns. Two-thirds said the mentoring
and supervision they received were excellent, and 70 percent said the
overall program was excellent. Dr. Stanfield noted that there is an
interest in establishing an NIH-wide internship program.

# The New Deputy Director for the NIH Office of Extramural Research

Dr. Norka Ruiz Bravo has been named the new Deputy Director for the NIH
Office of Extramural Research (OER). She previously was Director of
Extramural Activities at the National Institute of General Medical
Sciences. Dr. Ruiz Bravo will be invited to a future CSRAC meeting.

*A-76 Initiative*

Dr. Stanfield provided an update on the Government\'s A-76 initiative,
which led NIH to consider outsourcing work performed by extramural
administrative support staff. He noted that NIH won a competitive
bidding process for these services, and it is working to implement "the
most efficient organization" (MEO). The winning proposal calls for NIH
to (1) reduce the number of support staff members who provide these
services from 919 to 677, (2) reduce the average pay grades of the new
positions, and (3) consolidate and centralize these services in OER. He
explained that CSR is the largest customer of the MEO, and 84 of its
Federal staff members and 64 of its contractors will be
affected―approximately one-third of CSR's current Federal and contract
staff. Dr. Stanfield said that CSR hoped that some of its skilled
contract workers will be able to continue supporting CSR in some
capacity outside the scope of the MEO.

# Ethics and Conflict of Interest at NIH

Dr. Stanfield noted that the outside activities of former and present
NIH employees have been scrutinized by members of Congress and the
press. He said that the NIH Director, Dr. Elias Zerhouni, has
aggressively sought to address these issues and ensure that NIH research
and funding decisions are not subject to any influences that are
inappropriate or perceived as inappropriate. CSR carefully reviews the
outside activities of its employees and holds them to a very high
standard because of the important role they play in the peer review
process.

# Mock Study Section Video

With guidance from CSRAC members, CSR has worked with OER to complete a
video of a mock study section: "Inside the Grant Review Process." The
video is now available online via CSR's Web site:
http://www.csr.nih.gov/video/video.asp.

# Follow-up on Previous CSRAC Concerns

Dr. Stanfield discussed several issues raised at recent CSRAC meetings:

#### 

#### New Investigator Success With R21s. It was previously noted that new investigators were submitting an increasing number of R21 grant applications, and CSRAC members asked if new investigators were more successful in receiving these grants. Dr. Stanfield said that the numbers of R21 applications have been rising for both new and experienced investigators, and overall the success rates for new investigators is no different from their rates of success in receiving R01 grants. He suggested that the ICs may be encouraging more new investigators to submit R21 applications because they require less ambitious proposals and preliminary data.

1.  [Human Subjects Summary Sheet]{.underline}. Ambiguities in this
    document were corrected by Dr. Elliot Postow, Director of the CSR
    Division of Biologic Basis of Disease, and it has been posted on
    CSR's Web site: http://www.csr.nih.gov/Guidelines/Template.HS.pdf

#### Check-Sheet for Human Subjects Concerns. After incorporating proposed changes, this check-sheet for reviewing grant applications that involve the use of human subjects is now being made available to any SRA who sees a need for it in his or her study section. http://www.csr.nih.gov/Guidelines/Template.HS.pdf. 

**NIH Update**

Dr. Raynard Kington, NIH Deputy Director, discussed four major
developments at NIH: (1) the creation of the NIH Steering Committee, (2)
the advancement of efforts to address ethical concerns, (3) the
development of an Administrative Restructuring Advisory Committee, and

\(4\) the implementation of the NIH Roadmap initiative.

*NIH Steering Committee*

To improve the efficiency of how NIH makes corporate decisions, a new
ten-member NIH Steering Committee was formed. The members of this
committee include the NIH Director,

Dr. Elias Zerhouni, and nine IC Directors. Three directors of the
largest ICs will be permanent members of this committee: the directors
of the National Cancer Institute; the National Institute of Allergy and
Infectious Diseases; and the National Heart, Lung and Blood Institute.
Three IC directors from medium-sized ICs and three directors from
smaller ICs will serve on a rotating basis. Dr. Kington said that the
committee and its five working groups appear to be working well and hold
great promise for improving the NIH decision-making process.

*Ethical Concerns*

Dr. Kington noted ethical concerns that were raised by a recent article
in the *LA Times*, which questioned the outside activities of some NIH
senior scientists. He explained that an initial NIH review has revealed
that the outside relationships cited did not cause any patients to be
harmed, and did not appear to alter any NIH decisions. He said that Dr.
Zerhouni has aggressively instituted a systematic review of all outside
activities involving senior NIH scientists.

Dr. Kington said that NIH strongly believes that its scientists need to
maintain relationships with the outside world because they help NIH in
its efforts to advance public health. He added that NIH is exploring
possible changes in regulations on outside activities and the disclosure
of related financial arrangements. For guidance on what should be done,
NIH has formed a blue ribbon panel, which will be cochaired by Dr. Bruce
Alberts, President of the National Academy of Sciences; and Mr. Norm
Augustine, a noted leader in corporate ethics who is a professor of
engineering at Princeton and who was CEO of Lockheed Martin.

*Administrative Restructuring and Advisory Committee*

Following discussions with officials at the Department of Health and
Human Services (DHHS), in Spring of 2003, NIH formed an Administrative
Restructuring Advisory Committee to improve efficiencies at NIH
consistent with the President\'s management agenda and the efficiency
goals established by DHHS. Eight working groups of this committee
developed reports addressing the following areas: (1) Personnel, (2)
Grants Management, (3) Budget, (4) Acquisitions,

\(5\) Information Technology, (6) Facilities, (7) Financial Management,
and (8) Equal Employment Opportunity. The DHHS Secretary has approved
these reports as the outline of a plan to improve efficiency at NIH
while maintaining or improving effectiveness. NIH is working to
implement their recommendations with oversight by working groups of the
NIH Steering Committee and advice from the National Academy of Public
Administration.

*NIH Roadmap Initiative*

Dr. Kington discussed ongoing efforts to implement the NIH Roadmap
initiative, which was developed to jumpstart the NIH research
enterprise, with a focus on pathways to discovery, interdisciplinary
research, and developing the clinical research infrastructure. He
explained that the initiative involves about 28 different activities,
and CSR will play an important role in the evolution of related review
activities. A new unit is being created within the NIH Office of the
Director to manage this initiative, and NIH expects to ramp up these
activities in the next few years.

*Discussion*

[Increasing Review Workloads]{.underline}: Dr. Leon asked about the new
grant programs and CSR\'s ability to review additional applications. Dr.
Kington said that NIH anticipated that additional resources and
personnel would be needed to implement the Roadmap initiative. He
explained that CSR had received a substantial increase in its allocation
of full-time equivalents (FTEs) needed to hire new employees. He said
the new NIH Steering Committee has developed a process for allocating
FTEs where they are most needed, and he emphasized that NIH is committed
to ensuring that CSR has the resources it needs to review NIH grant
applications. Dr. Stanfield said CSR has worked with the ICs to divide
review responsibilities for the different initiatives, so the Roadmap
review burdens will not all come to CSR.

[Conflicts of Interest]{.underline}: Dr. Edward Pugh said that he was
impressed by the development of the blue ribbon panel that will provide
NIH guidance on conflicts of interest. He said reviewer conflicts was a
topic often discussed by CSRAC members, and they might find the insights
of the panel useful for future discussions. Dr. Kington said that the
panel will release its report within 90 days of its first meeting. It
was noted that Dr. Cheryl Corsaro, SRA, CSR Mammalian Genetics Study
Section, serves on the NIH Ethics Advisory Committee, and she will
ensure that important information flows back to CSR.

[Institute of Medicine (IOM) Report]{.underline}: Dr. Franklyn
Prendergast asked Dr. Kington to comment on the recent IOM report, which
made recommendations on how NIH sets research priorities.

Dr. Kington said the NIH Director\'s Council of Public Representatives
recently prepared its response to the IOM report, and NIH is working to
respond to each recommendation in the report. He explained that new
efforts, such as the Roadmap initiative, are already addressing some of
these recommendations. It was noted that many of the recommendations
could impact upcoming congressional reauthorization hearings. Dr.
Kington said that NIH will work aggressively to ensure that appropriate
action is taken.

**Review of the September Meeting Minutes**

Dr. Leon asked CSRAC members to consider the minutes from their
September 2003 meeting. Dr. Pugh moved that they be approved, and the
remaining CSRAC members agreed.

**Shortening the Grant Review Cycle**

Dr. Suzanne Fisher, Director, CSR Division of Receipt and Referral, said
that she would describe the current receipt and referral process at CSR
so that CSRAC members will understand the complexity, volume, and scope
of the work as well as possible options available for future changes.
She explained that Dr. Donald Schneider, Director, CSR Division of
Molecular and Cellular Mechanisms, will provide a similar presentation
on the review process.

*CSR Receipt and Referral---Current Process*

Dr. Fisher said that CSR expects to receive approximately 20 percent
more applications this fiscal year for a total of 75,000. She explained
that NIH decided many years ago to have three overlapping submission and
review cycles. In addition, NIH decided to have different kinds of
applications come in at different times. For instance, new institutional
training grants are due January 10; new applications for most grant
mechanisms are due February 1; and continuation, revised, or
supplemental applications for most grant mechanisms are due March 1.
There are three receipt dates in April for small business, individual
fellowship, and conference grant applications; and AIDS research
applications are due May 1. She continued by saying that there are 40 to
45 regular and special application receipt dates a month. However,
workload volume is much higher in February and March. She noted that
AIDS research applications have a compressed review cycle due to their
expedited review or \"delayed receipt.\" It would be impossible to
expedite many more applications without greatly increasing the resources
devoted to the receipt, referral, and review process.

Dr. Fisher then summarized the multiple tasks involved in processing
applications

: (1) opening boxes, (2) manually processing applications and related
reference letters and bulky appendix materials, (3) entering multiple
bits of data from different parts of the applications into the NIH
grants data system, (4) making assignments for review location and
funding consideration,

\(5\) checking data and preparing applications for scanning and
duplication, (6) sending notification letters to investigators and
institutions, and (7) interacting with applicants and their institutions
to fix problems.

Applications must also be checked to be sure they comply with multiple
policies and procedures. Dr. Fisher then discussed the three major
assignment decisions that she and her staff must make: (1) the grant
mechanism appropriate to the proposal---NIH has about 100 different
grant mechanisms with about 40 of them in common use, (2) the IC that
will consider funding an application---there are 24 funding ICs and dual
assignments may be appropriate when ICs share research interests, and
(3) the location where the application will be reviewed---30 percent of
the applications go to ICs for review while the remainder must be
assigned to one of CSR\'s two dozen IRGs.

Dr. Fisher said that NIH is making plans for the electronic application
submission, and she discussed the opportunities it holds for shortening
the receipt and referral cycle: (1) integrating business/policy rules
into the system will reduce applicant mistakes that need to be
corrected,

\(2\) fewer processing steps will reduce processing time, (3) the use of
knowledge management software could speed decision making, and (4)
notification via the Commons computer system will allow more time to
identify assignment problems. She said that CSR hopes that electronic
submissions will compress the time between application submission and
review. Dr. Fisher continued by explaining that CSR was working with a
contractor to see if the referral process could be hastened by a
computer program that identified key words in an application and
compared them to CSR\'s referral guidelines.

If the receipt and referral cycle is shortened, there would be a number
of consequences.

Dr. Fisher said that there would be a reduction in CSR\'s ability to
accommodate late applications, make assignment changes, and accommodate
special receipt dates. There may be a need for more referral staff that
will likely have less time to make referrals. She also questioned
whether applicants would be better served by a shortened cycle, since it
would shorten the time they would have to revise their applications.
Since the number of revisions is limited to two, applicants need to use
them to their best advantage.

*CSR Peer Review---Current Process*

Dr. Schneider said that each CSR review cycle takes about four months:
(1) 5-6 weeks for the SRA to become familiar with applications and
recruit needed reviewers, (2) 5-6 weeks for the reviewers to study their
assignments and prepare their critiques, and (3) 5-6 weeks for the SRAs
to finalize their reports and summary statements. He explained that the
review cycles overlap, noting that SRAs were currently mailing
applications to reviewers while reading new applications and recruiting
temporary reviewers for a second meeting.

Dr. Schneider noted that 25 percent of the AIDS research applicants
manage to resubmit their applications in the following review round,
while other applicants must sit out the following review round because
they do not receive their summary statements soon enough. In an attempt
to address how well applicants might respond to a shortened review
cycle, he presented

data on the success rates of amended AIDS applications. In general,
these data show that applications submitted for the following two review
cycles do equally as well, even if their initial scores were not good
ones. He suggested that this result provided support to the effort to
shorten the review cycle.

Shortening the time for reviewer recruitment and assignment could help
shorten the review cycle. Dr. Schneider suggested a number of ways this
could occur. The number of meetings per SRA could be reduced, and SRAs
could employ knowledge management software to more quickly identify
reviewers and assign applications. He added that it might be possible to
reduce the time reviewers have to prepare their reviews, although
program staff and many scientists in the community strongly feel that
quality reviews requires that reviewers have ample time to assess their
assigned applications. Dr. Schneider noted that some ICs speed reviews
by having their advisory councils use \"electronic council books\" to
review applications before their meetings. In addition, the ICs could
reduce the time they take to make awards after council decisions are
made.

Dr. Schneider discussed ways CSR might shorten the review cycle by
reducing the number of cycles from three to two. SRAs would not have to
contend with overlapping cycles so they could process applications
faster. He said that receipt and referral and review elements of the
cycle could be shortened, and the whole process could be shortened more
if all ICs switched to using electronic council books.

*Discussion on Shortening the Review Process*

Dr. Leon said that colleagues frequently tell him that the most
important issue they have with NIH is the length of the review process.
His goal in leading this discussion was to begin to find ways to cut the
time in half. He noted that the assignment process took a significant
amount of time and suggested that CSR consider employing a presubmission
process to make assignments before applications are submitted and have
the applications go directly to the assigned SRA.

Dr. Fisher said there would be reluctance to do this before CSR staff
could see the whole application. In addition, having a centralized
referral office affords a certain about of uniformity to the referral
process. She suggested the referral process might be hastened if more
information were given to applicants that enabled them to provide useful
assignment suggestions. Dr. Leon said that a large number of applicants
routinely have their applications assigned to the same study sections
and IC, and if CSR took this information into account it could likely
speed the processing of new submissions from these applicants.

Dr. Stanfield said that he did not think regulations would prevent CSR
from using a presubmission process to assign applications to the ICs and
CSR study sections. He suggested that such an approach should be
considered carefully because it may introduce additional complexities.
Dr. Schneider said that it would be helpful if SRAs knew what
applications they would receive sooner, but the flow of applications
directly to SRAs might slow their work significantly because they would
likely become involved in many negotiations to decide which applications
should really be reviewed by their study sections. Dr. Leon said that he
expected that these negotiations would occur before the applications are
submitted.

Dr. Pugh proposed that CSR consider running a pilot where applicants
would be asked to provide an intent-to-submit proposal abstract and
indicate their preferred assignments before they submitted their
application. A knowledge-based system could be used to check the
assignments, and applicants could receive feedback via e-mails and check
their assignments via the Web.

Dr. Sassaman said that it would be important to consider complexities
related to IC assignments, because ICs share interests, and their
paylines can change from year to year. As a result, applicants would
need up-to-date information on these issues to suggest the best
assignments. She added that ICs frequently negotiate application
assignments between themselves, and the need for these negotiations
should be considered if the referral process is changed.

Dr. Stanfield said that all applicants would have to provide
intent-to-submit notifications for this new approach to referral to
work. Dr. Hammond suggested that these notifications could be subject to
the Paperwork Reduction Act. Dr. Fisher explained that some requests for
applications (RFAs) ask for letters of intent. Dr. Hammond said that the
U.S. Office of Management and Budget prevents NIH from requiring
applicants to submit letters of intent, but it might be persuaded to
permit them if convinced they are in the applicant\'s best interest. He
noted, however, that the value of the intent-to-submit letters NIH
currently receives is mixed. Sometimes they are good indications of the
applications later received and sometimes they are not.

Ms. Victoria Levin, SRA, CSR Psychosocial Development, Risk and
Prevention Study Section, focused on the idea of reducing the number of
review cycles from three to two. She questioned how CSR\'s current staff
and reviewers could handle two large review meetings.

Dr. Leon said that he did not favor the two-cycle schedule, because it
would mean that applicants would have to wait 6 months to resubmit
applications. He again emphasized his goal of shortening the review
cycles, suggesting that there may be ways to cut the time it takes to
produce summary statements. For instance, it may not be necessary to
provide detailed summary statements for grants that have good scores.

Dr. Stanfield said that summary statements must adequately address the
many regulations that have to be considered; hence, reducing the
attention given to summary statements could be problematic. He added
that reducing the time spent on the summary statements for the best
grant applications would not save significant time, since they are the
easiest ones to write.

Dr. Hammond said that summary statements are supposed to be sent to
applicants "as is" unless they contain something that is really
incorrect or inflammatory. He suggested that some SRAs may be spending
too much time rewriting summary statements. Dr. Leon agreed and
suggested that the SRAs write resumes or rewrite summary statements only
if they fail to convey important information from the review meeting.
Dr. Schneider explained that the SRAs would have to do this for about a
third of their applications, which currently are the most time-consuming
summary statements to produce. Another CSR staff member said that it was
important for SRAs to add review discussion resumes to the summary
statements for the large number of applications that fall in the
borderline region. Time could be saved, however, if reviews for the
lower half of the applications submitted were streamlined.

Dr. Leon proposed that CSR staff investigate the possibilities of making
application assignments before applications are submitted and of
shortening the time devoted to producing summary statements. The results
of these investigations could be presented at the next CSRAC meeting.

It was noted that more applicants could seek to appeal their reviews if
CSR spent less time working on their summary statements. Dr. Susan
Berget said there was a balancing act going on between quality and
speed. If applicants were given the choice, they would likely choose
quality. She said it was thus important that changes not impair quality.
Dr. Leon said that he was willing to accept some trade-offs, such as
limiting late submissions. Dr. Pugh said that it would be helpful to
have additional information on the review process and timelines so that
CSRAC members have a better understanding of the time-consuming details.
He said that he did not favor having a two-cycle review schedule.
Further consideration should be given to the possibility of making
presubmission assignments and using knowledge-based systems. In
addition, he said he would like to hear from more SRAs in the future to
understand fully how their time is spent and how proposed changes would
affect them.

**NIH Commons and Electronic Receipt**

*The Commons Web Site*

Mr. David Wright, Acting Chief, Requirements Branch, Division of
Extramural Information Systems, OER, provided an overview of the Commons
Web site, which serves as an information portal for NIH grantees and
their administrators. They may (1) enter profile information on
themselves or their institution, (2) view the status of their
applications and grants, (3) submit noncompeting progress reports, and
(4) provide financial status reports. The Commons also is used for
Internet-Assisted Review, allowing reviewers to submit critiques and
preliminary scores prior to their study section meetings. Mr. Wright
then discussed new and upcoming features. Grantees now may submit
no-cost extension notifications and just-in-time information via the
Commons. Additional features will be added soon: (1) a new
query/reporting tool to generate custom reports, (2) a means for
submitting training grant appointments, (3) an organizational hierarchy
to allow institutions to restrict access at their institutions, and (4)
knowledge management features. As of January 2004, a total of 8,972
individuals at 778 institutions were registered to use the Commons.

*Electronic Grant Applications*

Efforts are underway to expand the Commons to facilitate the electronic
submission of grant applications. Mr. Wright said that the goal of these
efforts is to receive electronic grant applications in XML and PDF
files, process them through receipt and referral without printing them,
and define the requirements for electronic reviews and program and
grants management. He explained that NIH has awarded six grants to small
businesses to help create tools to enable small and mid-sized
institutions to submit their applications electronically. Applicants
also will be able to submit their applications through the Grants.gov
Web site. Larger institutions are expected to develop their own
submission systems.

In fall 2003, NIH conducted a pilot study that involved the electronic
submission of

20 applications. A total of 13 of them were processed through the
receipt and referral processes. Mr. Wright discussed some of the major
issues that surfaced during the pilot: (1) all the key personnel listed
on an application had to be registered via the Commons, and it was often
difficult to locate some of these individuals; (2) applicants had to
wait 24 hours to view and approve their submissions, (3) principal
investigator profiles sometimes did not match information that was
submitted on their grant application, (4) PDF forms did not look exactly
like the paper forms, (5) sometimes the PDF conversions were of a poor
quality, and

\(6\) sometimes the system generated cryptic error messages.

Mr. Wright said that most of these problems had been addressed and NIH
would like to conduct another pilot in March, but doing so depended on
how fast a new contractor could get up to speed. In any event, NIH plans
to conduct an expanded pilot test for the June-July receipt round. One
or two large institutions may participate by becoming their own service
providers. Applicants will be able to provide full budgets and submit
revisions. A system-to-system interface is being developed so that
applications submitted via the grants.gov Web site will flow directly
into the Commons system.

In discussing future challenges, Mr. Wright said there were many
questions to consider regarding high-resolution graphics, though most of
the images submitted during the pilot study were well received. He noted
that applicants were told to submit their appendices directly to the
SRAs, and this practice might be problematic when SRAs receive many of
them. He said it was important that applicants receive notifications and
have an opportunity to view their submissions so they know NIH received
them and that they were not changed during transmission. Mr. Wright
concluded his presentation by talking about the benefits of electronic
submissions: (1) reducing the time of the review cycle, (2) improving
data quality, and (3) reallocating personnel to more value-added jobs.

In response to questions from Dr. Leon, Mr. Wright said that NIH plans
to ramp up e-grant submissions in FY 2005, and his own personal
expectation is that 75-80 percent of NIH applications will be submitted
electronically within 3-5 years. It is assumed that NIH will have to
maintain a dual paper/electronic submission system for many years. Dr.
David Williams asked CSR staff about the possible effects of e-grants.
Dr. Stanfield said his biggest concern during the transition was that an
application might be disadvantaged depending upon the mode of its
submission. Electronic applications will have a higher resolution than
applications submitted on paper and scanned on NIH copiers. He said that
it is important that these applications are reviewed fairly. Dr.
Williams then asked if DHHS would mandate electronic submissions.

Dr. Stanfield and Mr. Wright said they did not think such a mandate
would come in the near term, because of the diversity of the communities
that are served by DHHS grants.

Dr. Prendergast said he had had a long-term interest in these
developments and was concerned about a number of potential problems,
such as how to (1) prevent the system from being clogged by too many
applications, (2) process both electronic and paper applications, (3)
keep the process standardized with multiple contractors and institutions
using different software programs,

\(4\) account for printer differences when reviewers print and review
their assigned applications, and (5) implement these new procedures with
A-76 staff reductions. Drs. Pugh and Berget said they also were
concerned about applicants inserting URLs into their applications to add
supplementary information. Dr. Leon said that these were indeed
important issues and there were multiple groups working to address them.
Dr. Stanfield said that it was important that reviewers not bare the
burden of printing applications, and CSR would develop a way for
reviewers to request high-quality copies of their assigned applications.

##### 

##### Knowledge Management

###### Identifying CSR Reviewers With Knowledge Management

Dr. Arthur Petrosian, SRA, CSR Surgical Sciences, Biomedical Imaging and
Bioengineering IRG, said the development of software to help SRAs
identify potential reviewers and assign applications to them could be
advanced by the development of the Commons and by having it collect
application keywords from applicants. He then described a software
program he developed with his son to identify reviewers with the right
expertise for reviewing the applications assigned to a study section or
special emphasis panel and to facilitate reviewer assignments so that
all scientific areas are covered, the number of reviewers needed is
minimized, and review loads are balanced. This program matches potential
reviewers with a study section's applications using keywords assigned to
scientists whose journal articles are listed in the PubMED database and
whose grants are listed in the CRISP database. Dr. Petrosian said that
he was able to develop a set of keywords that covered 99 percent of the
scientific areas assigned to all the imaging ad hoc study sections in
his IRG. He noted that PubMED and CRISP use two different sets of
keywords, but both could be matched to the set of keywords he developed.
The program allows SRAs to seek for new reviewers that complement those
already recruited and allows SRAs to set the minimum and maximum numbers
of assignments for each reviewer. Using all the data supplied, the
program calculates compatibility scores for each reviewer/potential
reviewer and each application assigned to the study section. As
reviewers are recruited, the program can be run again and again to fill
out the study section roster so that all applications are appropriately
and efficiently reviewed.

# NIH Knowledge Management Initiative

Dr. Richard Morris, Acting Director, Technology Resources, Planning, and
Services, National Institute of Allergy and Infectious Diseases,
described the larger NIH Knowledge Management Initiative, which is part
of the NIH Electronic Research Administration program. He explained that
NIH was working to adapt various off-the-shelf software programs to
extract information from unstructured text to enhance NIH administrative
functions. Knowledge management technologies take a document and create
a conceptual "fingerprint" and then look for comparable documents that
fit that fingerprint using matrix algebra. Dr. Morris said that
knowledge management technologies can be used to locate expertise,
facilitate collaboration, structure and categorize information, and
integrate and provide portals to important data. NIH is seeking to apply
these technologies so it can (1) improve efficiencies in the receipt,
referral, and review of NIH grant applications; (2) better analyze the
level of IC disease research investments;

\(3\) anticipate scientific trends and integrate this knowledge more
swiftly into NIH program formulation; and (4) improve access to clinical
data for interpreting basic research and assessing discoveries. Dr.
Morris then further discussed how knowledge management technologies
could be used to facilitate the referral and review of grant
applications. NIH is currently working with a small company with
software that can create a fingerprint or profile of a grant application
using 50 concept parameters and then rank the frequency of these
concepts. The software can then locate potential reviewers by comparing
the application profile to profiles of CRISP grantees and PubMED
authors.

Dr. Berget said she thought this technology was phenomenal as it could
speed the work of the SRAs and aid them in managing their workloads in
the face of FTE restrictions. Dr. Williams agreed, but said that human
judgment was still important. Dr. Morris explained that all of the
knowledge management technologies are being considered as tools for NIH
administrators.

Dr. Stanfield described a software demonstration he had seen that would
enable SRAs to tweak the ranking of profile elements when the software
failed to find appropriate reviewers for their applications. Dr. Leon
asked if there were plans to allow principal investigators to use this
technology to assess the referral of their applications. Dr. Morris said
that he had recently discussed this idea with Dr. Postow, and it could
be implemented relatively easily although NIH currently is focusing its
efforts on using knowledge management technologies to improve the
quality of congressional reports. Dr. Stanfield said that Dr. Schneider
had already tested a program to facilitate the referral of applications,
and the results have been promising.

**Internet-Assisted Review System**

Dr. Eileen Bradley, Chief, CSR Surgical Sciences, Biomedical Imaging and
Bioengineering IRG, explained how reviewers can submit critiques and
preliminary scores via the Internet-Assisted Review System, which is
part of the NIH Commons Web site. Reviewers may use this system to (1)
electronically submit their critiques and preliminary scores prior to
their study section meeting, (2) read critiques submitted by others
online, (3) modify their critiques after the meeting, (4) view scanned
images online, and (5) maintain their personal information used by the
system. SRAs can use this system to (1) manage meetings and reviewer
access, (2) identify applications for streamlining, and (3) download
preliminary summary statements from submitted critiques.

The Internet-Assisted Review System has been in full production since
August 2003.

Dr. Bradley explained that since then over 19,000 critiques have been
submitted via this system. For the October 2003 Council review round, a
total of 34 study sections used the system with 535 reviewer accounts.
For the January Council review round, a total of 97 study sections used
the system with 1,353 reviewer accounts.

Dr. Bradley showed CSRAC members the various Web pages that reviewers
use to create a Commons account and SRAs use to manage the process as
reviewers use the system to submit critiques and scores, read each
other\'s submissions, and edit their final submissions. SRAs can sort
their lists of applicants and their reviewer submissions in different
ways. In addition, SRAs can use the system to quickly see when
submissions are missing, know when there are significant differences in
preliminary scores, and generate pre-summary statements. Dr. Bradley
encouraged CSRAC members to explore the online demonstration that is
available on the Commons Web site: http://commons.era.nih.gov/commons.

Responding to questions by Dr. Lucia Rothman-Denes, Dr. Bradley said
that reviewers may not review critiques submitted by other reviewers
until they have submitted their own, and the system does not reveal
reviewer assignments. These restrictions prevent reviewers from being
unduly influenced by others. Drs. Rothman-Denes and Sassaman said they
were impressed by the capabilities of this system and the promise it
holds for shortening the review process.

Dr. Rothman-Denes then asked how the Internet-Assisted Review System was
linked to program staff. Dr. Bradley said that program staff and
applicants may both access summary statements and scores when they are
released. Dr. Stanfield explained that the NIH Extramural Programs
Management Committee recently asked for this information to be released
to program staff members 3 or 5 business days early to give them an
opportunity to read and help correct problems before the information is
released to applicants. He added that it might be useful to allow
program staff to view critiques and scores before study section
meetings. Program staff members are often responsible for applications
that go to many study section meetings, and they could better prioritize
these meetings if they had advance knowledge of the critiques and
scores.

Dr. Hammond said it was important for program staff to have an
opportunity to see draft summary statements before they are released;
however, he thought allowing them to see critiques before study section
meetings could undermine the review process.

Dr. Stanfield noted that reviewers need to register on the Commons
system before they can use the Internet-Assisted Review System. Since
doing so often requires support from the NIH help desk, CSR is
implementing this system in stages so as not to overwhelm the help desk
and plans to be at full speed by the June 2004 review round.

**Review and Program Staff Interactions**

Dr. Zakir Bengali, Chief, CSR Biochemical Sciences IRG, explained that
review and program staff play integral roles in the NIH peer review
system, which has two tiers for evaluating grant applications for
scientific merit and then for program relevance. To avoid inappropriate
influences, these two decision-making processes are separated into two
organizational components at NIH. Dr. Bengali said that cooperation
between review and program staff is nonetheless important. To help
facilitate this cooperation, CSR established a committee including two
SRAs from each CSR review division, a lead Grants Technical Assistant,
and four Program Administrators (PAs) from the ICs.

As a first step, this committee distributed a survey to all the SRAs at
CSR. Dr. Bengali said that the results indicated that the majority of
SRAs maintain excellent communication with program staff. The committee
subsequently used the data collected to develop recommendations on the
best practices for developing effective and appropriate cooperation
between review and program staff. These recommendations were organized
according to the three phases of the initial review process:

1\. [Recommendations for Pre-Meeting Interactions]{.underline} provide
guidance on establishing contacts with the different PAs who regularly
attend study section meetings. These individuals may help SRAs identify
potential reviewers for regular and temporary service on CSR study
sections. These recommendations encourage SRAs to provide interested PAs
important information on when and where review meetings will be held,
the tentative order for reviewing applications, and the tentative list
of applications nominated for streamlined review.

2\. [Recommendations for Meeting Interactions]{.underline} note the
valuable role PAs may play assisting review panels in addressing
review-related issues; however, PAs may only speak to a review panel
after first discussing their intentions with the SRA, and PAs should not
have private discussions with reviewers during the meeting and should
never discuss individual applications with reviewers.

3\. [Recommendations for Post-Meeting Interactions]{.underline}
encourage SRAs to contact PAs after review meetings to identify any
perceived problems with the reviews, although PAs are ultimately
responsible for addressing these problems. SRAs also are encouraged to
(1) provide advance copies of summary statements to PAs when
appropriate, (2) work with program staff to address concerns about
summary statements before they are released to applicants, (3) respond
in writing to any review appeals submitted via PAs after consulting with
reviewers, and (4) attend relevant IC pre-council and council meetings.
In addition, PAs should be encouraged to provide advance information on
these meetings. Dr. Bengali concluded his comments by explaining that
these were draft recommendations to be discussed further, and he said
there was a need to develop a complimentary set of recommendations for
PAs.

Drs. Williams and Sassaman said that they were very pleased with this
effort to identify and promote best practices for facilitating review
and program staff cooperation. Dr. Sassaman explained that she was also
pleased with recommendations found in Dr. Bengali\'s committee\'s report
that encouraged face-to-face meetings between review and program staff
and participation in joint workshops. Dr. Williams said that he did not
think there was much interest in giving program staff advance access to
reviewer critiques, but he favored giving them timely information on
applications considered for streamlining. He then asked how CSR intends
to proceed with the recommendations.

Dr. Stanfield said that, once the recommendations were finalized, they
will be posted on CSR\'s intranet and used to instruct new SRAs and to
remind seasoned SRAs on the best practices for review and program
coordination. He noted that it is sometimes difficult for SRAs to
distribute a tentative list of unscored applications to program staff,
because 10 to 20 program officers may have an interest in a review
meeting. The Internet-Assisted Review System could perhaps distribute
this information. Dr. Stanfield also noted that it is sometimes
difficult for SRAs to provide useful review schedules to program staff,
because reviewer travel schedules can change at the last minute, causing
unforeseen schedule changes. He then said that program staff sometimes
say they would like to be consulted earlier when study section slates
are developed. To address this concern, Dr. Stanfield suggested that
program staff be encouraged to send SRAs comments on temporary
reviewers, since they are often considered for regular reviewer
positions. Dr. Hammond endorsed this suggestion and then focused on the
process for addressing potential applicant appeals. He suggested that
SRAs be encouraged to take a more proactive approach when they think a
review might be flawed.

Dr. Leon said that there was general agreement on the value of giving
program staff lists of applications nominated to be unscored. Dr.
Bengali said it would be helpful if these lists were generated and
distributed by the Internet-Assisted Review System. He noted, however,
that it was important for PAs to understand that applications on such
lists may for some reason be discussed or scored. Dr. Everett Sinnett,
SRA Respiratory Integrative Biology and Translational Research Study
Section, explained that the NIH computer system (IMPAC II) would have to
be reprogrammed to provide unscored lists to program staff. He also
noted that the order-of-review lists generated by IMPAC II are often
incorrect, because SRAs find it difficult to sequence their data
accordingly. Dr. Thomas Tatham, SRA, CSR Biobehavioral Mechanisms of
Emotion, Stress and Health, said that some SRAs encode their
streamlining lists by flagging these applications with an asterisk or by
entering the streamlining list at the end of their order-of-review
lists. Dr. Tatham then explained that it is often difficult to provide
proper notification to PAs because their IC takes a long time to assign
program class codes to their applications.

Dr. Hammond explained how his Institute solved this problem. Instead of
having one individual assign program class codes to incoming
applications, his Institute now asks each division to assign these
codes. Dr. Stanfield suggested that this practice should be considered a
\"best practice.\"

**Scoring Streamlined Applications**

Dr. Anita Miller Sostek, Director, CSR Division of Clinical and
Population-Based Studies, noted that CSRAC members had encouraged CSR to
investigate the possibility of scoring streamlined applications.

She then discussed the potential advantages: (1) applicants will have a
better idea of reviewer assessments, (2) the negative impact of
streamlining may be reduced, (3) reviewers may devote more effort to
calibrating scores across the full score range, and (4) reviewers may
become more conscientious about making post-meeting revisions of their
critiques.

Since the last CSRAC meeting, CSR designed a pilot study to assess the
feasibility of having assigned reviewers post scores for applications in
the lower half of the merit range. A total of seven study sections from
CSR\'s four review divisions have volunteered to participate in this
pilot. These study sections vary in their range of science, numbers and
types of applications reviewed, and histories of posting
critiques/scores electronically. These study sections also vary in their
compliance rates for electronic posting (60 to 99 percent) and their
rates for streamlined reviews (38 to 50 percent).

Dr. Sostek continued by discussing concerns about providing scores for
streamlined applications: (1) score ranges will not be refined by
discussion, although assigned reviewers may revise their scores after
reading each other\'s critiques, (2) the current computer system and
vote sheets cannot be used to transmit just the scores of assigned
reviewers, (3) more emphasis will need to be given to post-meeting score
revisions, and (4) reviewers may want to discuss more applications.

The data collected in the pilot study will be used to assess the
feasibility of obtaining scores for streamlined applications in a
significant number of study sections. The study may also help CSR see if
these scores have an informative range or if they hover around 3.0 as
some have suggested. In addition, the pilot study will be used to assess
review compliance in revising their assessments after reading other
critiques on the Web.

In concluding her presentation, Dr. Sostek discussed the remaining tasks
for implementing the pilot study: (1) working out the logistics for
collecting and providing the scores to applicants, (2) determining how
to explain the scores to applicants, (3) working through the impact
these scores may have on percentiling applications, (4) soliciting input
from IC staff, and (5) making sure this new practice is consistent with
current NIH policies.

Dr. Pugh said that he was pleased with the proposed pilot, but he
expressed a concern that only 2-3 reviewers will score each streamlined
application; hence, the resulting scores may suffer from small sample or
social effects. He suggested that CSR track the scoring behavior of
individual reviewers and use this information to identify and address
problems. Dr. Rothman-Denes noted that some scientific journals rate
their reviewers. Dr. Stanfield said that CSRAC members discussed this
issue at their last meeting, and many of them thought it would be
difficult to implement because CSR uses so many temporary reviewers who
do not have a history.

Dr. Hammond said he supported the idea of improving the feedback given
to applicants, but he was concerned about the complexity and potential
confusion of having priority scores for both discussed and streamlined
reviews. He suggested that CSR see if the ICs will want to adopt this
practice and if they think it will be appropriate for multiproject
applications. Dr. Leon said that he and the other CSRAC members strongly
favored providing scores to streamlined applications despite the
limitations discussed, because unscoring applications can have a very
negative effect on applicants, particularly junior investigators. Dr.
Stanfield said that CSR will discuss the propose pilot and concerns of
CSRAC members with IC staff. Dr. Sassaman said she shared concerns about
having a dual scoring system and the confusion that might result. She
continued by saying that the value of streamlined scores may be limited
if they become clustered around 3.0. Dr. David Armstrong, Chief, CSR
Brain Disorders and Clinical Neuroscience IRG, said that he encourages
his reviewers to submit scores for all their assigned applications, and
the applications proposed for streamlining receive scores between 4.5
and 3.0. The SRA of another study section, however, reported that its
scores for streamlined applications tend to cluster.

Dr. Stanfield said it will be important to encourage reviewers to spread
their scores appropriately, and Dr. Sostek said that it will be
important to encourage reviewers to revise their scores if they are
inconsistent with their final assessment of a streamlined application.

**General Discussion**

Dr. Stanfield said that an opportunity for a general discussion was
added to the agenda since so many of the topics discussed in the meeting
were interrelated. Dr. Leon started the discussion by suggesting that
CSR make as many changes as it can to speed the receipt, referral, and
review of NIH grant applications without waiting for multiyear
modifications to NIH computer systems to be completed. He suggested that
CSR create two internal task forces to develop creative approaches to
speeding CSR\'s pre-review and post-review efforts. Dr. Leon reiterated
his goal of cutting the review time in half without cutting the time
given to reviewers to assess their assigned applications. In addition,
he suggested that the ICs seek to identify ways of cutting the time they
take to complete council reviews and fund grants.

Dr. Rothman-Denes suggested that summary statement production could be
quickened if reviewers were encouraged to produce summaries of their
reviews and clean up their critiques at their review meetings instead of
leaving this work to the SRA. Dr. Stanfield noted that this is commonly
the practice when reviewers do onsite reviews, but it would be difficult
to have regular R01 reviewers do this extra work during their study
section meetings. Dr. Leon said that perhaps the proposed task forces
could identify novel ways for reviewers to help speed the review
process. He continued by suggesting that time could be saved if study
sections actually streamlined 50 percent of their applications, and he
suggested that there may be more efficient ways to produce summary
statements. In addition, software could be used to help speed summary
statement production by identifying inflammatory statements and
grammatical errors. Dr. Postow explained that one of the most common
editing tasks is revising text written by scientists whose first
language is not English. Dr. Stanfield said that these revisions were
necessary to prevent these reviewers from being identified.

Dr. Sinnett said that it may be feasible for a standing study section to
operate with an accelerated process, but he questioned if SRAs could
accelerate the reviews of the many special emphasis panels (SEPs) they
convene. He explained that he has to defer setting up his SEPs until
after his regular study section is set up. If he accelerated his regular
study section review, he could not also accelerate his SEP reviews. As a
result, applicants whose proposals went to his SEPs could not revise and
resubmit their applications like applicants whose proposals went to his
regular study section. Dr. Stanfield said such an inequity would be a
significant problem and added that it would make it difficult to recruit
reviewers since their applications are usually reviewed in SEPs. Dr.
Leon said there were complexities to address but he was hopeful that
they could be addressed.

*Tuesday, January 17*

**Study Section Reorganization**

*Cell Biology IRG*

Dr. Schneider summarized the recommendations of the working group that
reviewed the cell biology study sections in January 2001: (1)
assignments should be based on research approach rather than organism,
(2) investigator referrals should be encouraged, (3) competitive
applications should be distributed across study sections equitably, and
(4) a good IRG home should be found for the molecular biology study
section.

He then summarized the basic principles developed by the PSBR to guide
CSR's reorganization: (1) study section boundaries should not be too
broad or too narrow; (2) sufficient overlap should exist between other
study sections inside and outside their IRGs; (3) reviews should be
provided in the context of biological questions; and (4) clinical
applications should be clustered when possible.

Dr. Schneider continued by discussing PSBR\'s recommendations for
developing a new Cell Biology IRG: it should consider applications at
the level of the functions, interactions, and regulation of cells and
cellular organelles; and it should cover membranes, protein trafficking,
organelles, cell movement, bioenergetics, signaling, cell cycle, and
cell-cell interactions.

In April 2003, the Cell Biology Study Section Boundaries Team proposed
that there be a single IRG for cell biology made up of five broad study
sections, with significant movement of cell biology applications to the
following related IRGs: Biology of Development and Aging; Bioengineering
Sciences and Technologies; Genes, Genomes and Genetics; and the
organ/disease-related IRGs. The proposed guidelines for the five study
sections were posted on the Web for public comment. Dr Schneider briefly
listed the main comments that were received: (1) biophysical and
computational studies are relevant to cell biology and should be
incorporated into the guidelines, (2) the area of tissue biology is
growing and should be given more emphasis, (3) the list of glycobiology
topics should be expanded and they should be clustered more prominently,
(4) some of the study sections should be renamed, and (5) cell polarity
is a large topic worthy of cross listing in two study sections.

To address these concerns, CSR convened a teleconference with CSR/NIH
staff and external experts, including Dr. Berget. Participants
recommended that CSR (1) rename four of the proposed study sections, (2)
modify the guidelines to emphasize diversity and breadth and avoid
\"hard wiring\" scientific areas, (3) work to ensure that review quality
is consistent across the study sections, (4) carefully develop
provisional rosters to define the study sections, and

\(5\) assess the effects of the reorganization. As a result of these
discussions, the names of the proposed study sections are as follows:
(1) Cellular Signaling and Dynamics, (2) Nuclear Dynamics and Transport,
(3) Intercellular Interactions, (4) Cell Structure and Function, and

\(5\) Membrane Biology and Protein Processing.

Dr. Schneider then discussed how the teleconference participants
addressed other Web comments: (1) tissue biology was focused in the
Intercellular Interactions Study Section;

\(2\) more emphasis was given to membranes by incorporating the word
into the study section title---Membrane Biology and Protein Processing;
(3) cell polarity was listed in two study sections---Cellular Signaling
and Dynamics, and Intercellular Interactions; and (4) biophysics and
computations weres mentioned in the introduction to the guidelines and
also in three study sections---Cellular Signaling and Dynamics, Cell
Structure and Function, and Membrane Biology and Protein Processing.

In discussing other considerations, Dr. Schneider said that the recent
mock sort of applications assigned a nearly ideal number of applications
(305) to this proposed IRG. He added that the area of glycobiology is
now highlighted in the Cell Structure and Function Study Section, and
aspects of cell biology are found in nine organ/disease IRGs. In
addition, the Cell Biology IRG will retain a small business study
section, but a significant fraction of the technology applications
previously reviewed by the cell biology study sections will be assigned
to the Bioengineering Sciences and Technologies IRG.

Dr. Schneider concluded by saying the proposed guidelines were
consistent with the original PSBR principles, and he asked CSRAC members
for their comments.

Dr. Berget said that the boundaries team that designed the guidelines
for the Cell Biology IRG was very pleased with them, particularly with
the broad way the study sections cover the field. She said she was
concerned about the bioinfomatics grant applications and how well they
will be reviewed clustered in two study sections. She said the placement
of these applications will continue to be a challenge for CSR since
computational biology is a growing part of cell biology. Dr. Schneider
noted that there was a separate IRG with a focus on bioinformatics
(Bioengineering Sciences and Technologies), and he emphasized that two
of the study sections in the Cell Biology IRG will provide good homes to
applications for related bioinfomatic research. Dr. Prendergast said
that it was important to adequately define bioinfomatics, which has a
spectrum of interpretations. He said that he preferred the term
\"computational biology,\" but he emphasized the importance of spelling
out which study sections cover applications in this area so that they
are assigned to the most appropriate reviewers.

Dr. Matt Winkler moved that CSRAC members endorse the Cell Biology IRG
guidelines,

Dr. Pugh seconded the motion, and the rest of the members agreed.

*Biological Chemistry and Macromolecular Biophysics IRG*

Dr. Schneider summarized the observations of the working group that
reviewed the biophysical and chemical sciences study sections in January
2000: (1) these study sections had broad scopes except the organic
chemistry study section; (2) some areas would benefit from new
approaches, e.g., spectroscopy and single molecules; and (3) study
section culture depends on the chair and others minimizing
fractionalism. He then noted the initial PSBR guidance for this IRG: It
should consider applications on detailed structures, chemistry, and
physics of macromolecules and interacting small molecules. It
specifically should cover chemical dynamics and mechanisms; chemical
synthesis; enzymology and catalysis; protein chemistry, structure, and
folding; nucleic acid chemistry, structure and folding; oligosaccharide
and polosaccharide biochemistry; and lipid chemistry.

In February 2003, the Biological Chemistry and Macromolecular Biophysics
Study Section Boundaries Team recommended that there be a single
chemistry, biophysics, and biochemistry IRG with seven broadly defined
study sections: two Synthetic and Biological Chemistry Study Sections (A
and B), three Macromolecular Structure and Function Study Sections (A,
B, C), a Biochemistry and Biophysics of Membranes Study Section, and an
Enabling Bioanalytical and Biophysical Technologies Study Section.

Dr. Schneider said that the proposed guidelines generated many comments.
Several individuals expressed support for the IRG\'s cross-disciplinary
approach. The metallobiochemistry community was concerned that their
applications would be split between two study sections. Some individuals
asked for a greater emphasis on mechanistic enzymology and nucleic
acids. The glycobiology community requested that their applications be
prominently clustered.

Some other individuals suggested that the Enabling Bioanalytic and
Biophysical Technologies Study Section cover related nanotechnology
applications.

To address these concerns, CSR convened a teleconference with CSR/NIH
staff and external experts, including Dr. Prendergast. Participants were
unanimous in supporting the cross-disciplinary approach of the proposed
IRG. Dr. Schneider explained that a mock sort distributed about 70
applications to each of the IRGs study section, although the
Macromolecular Structure and Function Study Sections averaged about 80
applications. It is thus likely that an additional study section will be
needed when the IRG is implemented. The mock sort also revealed that the
metallobiochemistry applications would go to a single study section:
Macromolecular Structure and Function A. The guidelines were modified
accordingly. Teleconference participants agreed that the guidelines
should be further adjusted so that the Synthetic and Biological
Chemistry Study Sections could accommodate evolving research in the area
of function-oriented synthesis. Participants also suggested that the
guidelines for the three Macromolecular Structure and Function Study
Sections be modified so that A includes metals and cofactors, B includes
glycobiology, and C includes protein-protein interactions and
macromolecular assemblies. In addition, emphasis was given to nucleic
acids and mechanistic enzymology. Guidelines for the Enabling
Bioanalytic and Biophysical Technologies Study Section were expanded to
include nanotechnology applications.

Dr. Schneider explained that the teleconference participants had their
own concerns and made additional recommendations: (1) a fourth
Macromolecular Structure and Function Study Section should be designed
when the need arises, (2) a second Enabling Bioanalytic and Biophysical
Technologies Study Section should be created if the one proposed grows
to large, and (3) the IRG should be assessed in 2 or 3 years after it is
implemented. In discussing other considerations, he noted that this was
a large IRG, which includes study sections that will review fellowship
and small business applications. Related small business applications
will also be assigned to the Bioengineering Sciences and Technologies
IRG. Dr. Schneider explained that both IRGs have been partnering well
and they even share one SRA.

In concluding his comments, Dr. Schneider said the proposed guidelines
were consistent with the original PSBR principles, and he asked CSRAC
members for their comments.

Dr. Prendergast said the guidelines were bold and creative, broadening
the areas of focus more on science and less on techniques. He added,
however, that he was pleased with the development of the Enabling
Bioanalytical and Biophysical Technologies Study Section for reviewing
proposed research on emerging technologies in this area. Dr. Prendergast
acknowledged that having broadly conceived study sections may cause both
clinicians and basic scientists to be a little anxious, and CSR should
monitor this IRG to be sure that both their interests are well served.
He said that he was also concerned about there being enough expertise
for these study sections, and he asked about the use of a reviewer pool.
Dr. Berget also endorsed the broad scope of the study sections and the
possibility of having a reviewer pool as well as having simultaneous
study section meetings that utilized some of the same reviewers.

Dr. Stanfield said that CSR has occasionally employed reviewers in this
manner.

Dr. Berget suggested that CSRAC members endorse the Biological Chemistry
and Macromolecular Biophysics IRG guidelines, Dr. Pugh seconded the
motion, and the rest of the members agreed.

Dr. Leon noted that this was the last IRG to be designed in the PSBR
reorganization. He thanked CSR staff members for their efforts, saying
that they had performed a wonderful service to the entire biomedical
community.

**Agenda for the Next Meeting**

Dr. Leon proposed that CSRAC members further their discussions on
shortening the receipt, referral, and review process at their next
meeting. Dr. Pugh asked CSR to present a report on how well the PSBR
reorganization is advancing at the next CSRAC meeting. Dr. Stanfield
explained that CSR will continue convening CSRAC working groups to
review its IRGs, and it expects a working group soon will review the
first reorganized IRG. Dr. Pugh also suggested that these working groups
could benefit from IC program staff involvement. Dr. Prendergast asked
about communications efforts to inform the community about the
implementation of the new IRGs. Dr. Stanfield said that CSR has worked
hard to inform the communities of the ongoing reorganization, such as
sending updates to a long list of professional societies and writing
articles for some of their newsletters.

With no other business to address, CSRAC adjourned the meeting at 8:55
a.m.

We do hereby certify that, to the best of our knowledge, the foregoing
minutes of the 34th meeting of CSRAC are accurate and complete. The
minutes will be considered at the 35th meeting of the Advisory
Committee, and any corrections or comments will be made at that meeting.

> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Karl Malik, Ph.D.
>
> Executive Secretary
>
> Center for Scientific Review Advisory Committee
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Brent Stanfield, Ph.D.
>
> Acting Director
>
> Center for Scientific Review
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Michael Leon, Ph.D.
>
> Chair
>
> Center for Scientific Review Advisory Committee