Full Text NOT-97-001
 
TROPICAL MEDICINE AND PARASITOLOGY - NIH EXTRAMURAL REINVENTION PILOT STUDIES
 
NIH GUIDE, Volume 26, Number 1, January 10, 1997
 
P.T. 34

Keywords: 
  Grants Administration/Policy+ 

 
Office of Extramural Research
Division of Research Grants
Tropical Medicine and Parasitology Study Section
National Institute of Allergy and Infectious Diseases
 
BACKGROUND
 
The information in this notice is primarily directed to applicants,
peer reviewers, awardees, and NIH staff in Tropical Medicine and
Parasitology (TMP).
 
The National Institutes of Health (NIH) has been designated an
Extramural Programs Reinvention Laboratory.  A series of experiments
have been and are being undertaken in a partnership between the
Office of Extramural Research (OER), Division of Research Grants
(DRG), and National Institute of Allergy and Infectious Diseases
(NIAID) to test ways to simplify and expedite the grant application
submission, review, and award processes.  This notice describes a
series of interrelated pilot studies to (1) test methods for
shortening the interval from application submission to grant award
and (2) assess methods for reducing the amount of information
provided by applicants.
 
THE FIVE INTER-RELATED STUDIES
 
The major objectives of these studies are to:  (1) determine if the
first and second levels of peer review of grant applications can be
completed in a shorter interval of time (as little as four to five
months compared with the current eight to eleven months) without loss
of quality; (2) determine if less information can be obtained from
applicants without impeding the review of applications and award of
grants; and (3) assess changes in patterns and levels of effort of
NIH staff, peer reviewers, and applicants that would be needed to
make these types of changes across the NIH.  In addition to the study
specific evaluations outlined above, focus groups of applicants, peer
reviewers, and NIH staff will be convened to assess this group of
interrelated studies.
 
ISSUES
 
1.  NIH ASSIGNMENT OF ALL GRANT APPLICATIONS REQUIRES ABOUT SIX
WEEKS.  NIH receives about 40,000 grant applications annually.  Under
the current procedure, a DRG referral officer reviews each
application and assigns it both to a study section for review and to
one or more NIH Institutes or Centers for potential funding.  For
standard receipt dates, it takes up to six weeks for the referral
officers to complete review and assignment of all applications.
Elimination or reduction of this time period would reduce the time
interval between receipt of applications and their peer review.
 
2.  PEER REVIEW GROUP ADDRESSES ALL APPLICATIONS AND ISSUES DURING
THE MEETING - THIS DELAYS SUMMARY STATEMENT PREPARATION AND LENGTHENS
STUDY SECTION MEETINGS.  Study section members receive applications
for review at least a month before the study section meets.  Although
designated reviewers complete their reviews and written comments
before the meeting, this information is not available to other study
section members until the dates of the meeting.  Making written
comments of reviewers available to all study section members before
the meeting could (1) enable a portion of the process to be completed
earlier, (2) reduce the duration of study section meetings, (3) focus
the meetings on important issues regarding each application, and (4)
expedite the preparation and release of summary statements.
 
3.  HUMAN SUBJECTS ASSURANCES AND CERTIFICATIONS ARE REQUIRED TO BE
SUBMITTED WITH THE GRANT APPLICATION OR WITHIN 60 DAYS OF ITS
SUBMISSION AND PRIOR TO PEER REVIEW).  Twenty to 25 percent of
research grant applications reviewed by a study section are funded.
The time and effort required for applicant institutions to complete
Institutional Review Board (IRB) activities for the 70 to 75 percent
of applications unfunded may be unnecessary and inefficient.
 
4.  WHEN REVISED APPLICATIONS ARE NECESSARY, ENTIRE APPLICATIONS ARE
RESUBMITTED - THIS REQUIRES SUBSTANTIAL APPLICANT TIME AND EFFORT AND
DELAYS THE RE-REVIEW OF REVISED (AMENDED) APPLICATIONS.  The current
process for revision, resubmission, and re-review of grant
applications requires all applicants to resubmit entire applications.
Generally, this means that revised applications are re-submitted and
re-reviewed two review cycles (eight months) later.  Applicants who
need to address or clarify only minor points are treated the same as
applicants who must address significant concerns with extensive
revisions of their applications.  This delays reconsideration of
highly meritorious applications and impedes their potential funding.
 
5.  ADVISORY COUNCILS AND BOARDS PERFORM THEIR SECOND LEVEL OF REVIEW
OF GRANT APPLICATIONS AT COUNCIL MEETINGS - THE SUMMARY STATEMENTS
FOR MANY SCIENTIFICALLY MERITORIOUS APPLICATIONS ARE AVAILABLE TWO TO
THREE MONTHS BEFORE THESE COUNCILS/BOARDS MEET.  As a result,
applicants must wait to hear whether their applications are to be
funded until after the Council meeting.  A process for early Council
review would enable earlier award of grants.
 
THE PILOT STUDIES
 
Each pilot study is outlined in the following paragraphs.  For each,
quantitative evaluation measures are identified.  In addition to
these, an overall evaluation using focus group(s) of applicants, peer
reviewers, and NIH staff will be established.  The members will be
asked to assess  effects of these studies on the application, peer
review process, and award process and to recommend future directions.
 
STUDY 1:  SELF-ASSIGNMENT OF APPLICATIONS TO A STUDY SECTION AND A
FUNDING INSTITUTE.
 
Virtually all applications reviewed by the TMP Study Section have
historically been assigned to the NIAID for potential funding.
 
The TMP study section reviews applications that propose experimental,
epidemiological/field, and clinical studies of parasites and
parasitic diseases.  Studies of the cellular/molecular biology,
biochemistry, genetics, epidemiology, and immunology of these
parasites are reviewed as are projects relevant to the diagnosis,
pathogenesis, prevention and therapy of parasitic infections.  (NOTE:
Studies of the vectors of parasitic diseases are reviewed separately
by a Special Emphasis Panel and will not be considered as part of
this pilot.)
 
During the pilot test, applicants proposing studies in these areas
will be able to submit their applications on SPECIAL later receipt
dates.  It is important that applicants use these special receipt
dates; the applications received on these special receipt dates will
receive expedited handling by DRG.  This will reduce the interval
between application receipt and peer review.  The following are the
SPECIAL delayed receipt dates for all applications (new, competing
renewal, revised, and supplements):
 
USE THE SPECIAL         INSTEAD FOR
RECEIPT DATE OF         REGULAR RECEIPT DATES OF
 
March 7, 1997           February 2, 1997 and March 1, 1997
July 8, 1997            June 1, 1997 and July 1, 1997
November 7, 1997        October 1, 1997 and November 1, 1997
 
Applicants should enter "TMP Pilot" and Institute (almost always
"NIAID") after Title: in item 2 of the PHS 398 face page.  The
original, four copies, and all set of appendices must be sent or
delivered to:
 
DR. SUZANNE FISHER
REFERRAL SECTION
DIVISION OF RESEARCH GRANTS
6701 ROCKLEDGE DRIVE, ROOM 2030 - MSC 7720
BETHESDA, MD  20892-7720
BETHESDA, MD  20817 (for express/courier service)
 
One copy of the application must be sent at the same time to:
 
DR. GERALD LIDDEL
REFERRAL OFFICE
DIVISION OF RESEARCH GRANTS
6701 ROCKLEDGE DRIVE, ROOM 4186 - MSC 7808
BETHESDA, MD  20892-7808
BETHESDA, MD  20817 (for express/courier service)
 
EVALUATION.  Evaluation of Pilot Study results:  (1) The number and
percent of applicants who submitted on the special receipt dates; and
(2) the number and percentage correctly self-assigned to the TMP
Study Section and potential funding Institutes.
 
STUDY 2:  ELECTRONICALLY-ASSISTED PEER REVIEW
 
The NIAID has developed a World Wide Web-based electronic review
system and is testing the system in NIAID-conducted peer reviews.
The system allows study section members to submit their
electronically-encrypted reviews to a password-secured Web server
prior to the Study Section meeting.  When all reviews have been
submitted, only assigned reviewers, other study section members, and
DRG staff can access and consider these reviews.  Special measures
are taken to eliminate conflict-of-interest by prohibiting members
from access to reviews of applications with which they are in
conflict.  The essential components of the peer review system remain
unchanged, and as under current procedures, independent scoring of
applications is done by each review at the meeting.
 
The TMP study section will test this system for review of
applications received on the special receipt dates of March 7, July
8, and November 7, 1997 for final consideration at the June 19-20 and
October 1997 and February 1998 study section meetings.
 
EVALUATION.  Evaluation of Pilot Study results: (1) percent of
reviewers using the WWW system; (2) percent of critiques finalized
via WWW; (3) percent of reviewers adhering to schedules for
uploading/responding; (4) time savings at peer review meeting; (5)
changes in DRG review workload; and (6) changes in completion
schedules for summary statements.
 
STUDY 3:  IRB DATA FOR ONLY FUNDABLE APPLICATIONS. Applicants who
self-assign for peer review to the TMP study section and for
consideration for funding to the NIAID will have the opportunity to
defer assurances and certifications for human subjects.  NIAID will
request this information only from fundable applicants immediately
after peer review; NIAID already has a process in place to request
needed additional pre-award information.
 
Applicants submitting for the March 7, July 8, and November 7, 1997
receipt dates have the option of deferring submission of the human
subjects information.
 
EVALUATION:  (1) Number and percentage of applicants who elect not to
submit IRB data - i.e., effort saved; (2) time and effort post-peer
review to get IRB data from fundable applicants; and (3) delays in
award, if any, due to deferred receipt of IRB data.
 
STUDY 4:  ABBREVIATED APPLICATION AMENDMENTS
 
At each meeting of study sections, applications ranging from those
with substantial scientific merit and to those of limited scientific
merit are reviewed.
 
A portion of applications may be identified by the study section as
having high scientific merit but needing limited additional
information that, if provided, could substantially improve the
scientific merit of these applications.  The summary statements of
applicants so identified by study section will designate that the
applicants have the opportunity to prepare brief responses to the
critiques.  These abbreviated application amendments would be
three-to-five pages directly related to questions and concerns raised
during the initial review.  Further, these applicants could be
provided their summary statements soon after the meeting and would
have the opportunity to submit their abbreviated amendments directly
to the Scientific Review Administrator of the Study Section for
consideration at the next meeting of the TMP study section.
 
Applications reviewed on February 13-14 and June 19-20, 1997 will be
considered by the study section for eligibility to submit abbreviated
applications.  Those selected will be given the opportunity to submit
the abbreviated amendment if their original application is not funded
by the Institute. Abbreviated amendments will be made available by
DRG to study section members for re-evaluation at the next scheduled
study section meeting.
 
EVALUATION.  Evaluation of the abbreviated application process will
include:  (1) number of applications identified as eligible for
abbreviated amendment; (2) number and percent of applicants who elect
to submit abbreviated applications; (3) DRG staff time required by
abbreviated amendment process; (4) average change in priority score
for abbreviated amendment applications vs. full revision
applications; (5) number and percent of abbreviated applications
funded; and (6) estimated change in time of award date for funding of
resubmission.
 
STUDY 5:  EXPEDITED COUNCIL REVIEW AND NIAID AWARD OF TMP GRANT
APPLICATIONS.  NIAID has WWW-based encrypted password-controlled
electronic system in place to (1) provide Council members with
summary statements for applications within NIAID paylines as soon as
they become available and (2) receive Council comments and complete
the second level of review.  This allows NIAID to make awards to
successful applicants earlier than would otherwise be possible.
 
This NIAID WWW-based system (named Council Action) will access
information directly from the electronically-assisted peer review
(See Study 2 above) for applications within the NIAID payline and
provide it to the NIAID Council for early second level of review to
minimize the interval between peer review completion and Council
second level of review.
 
EVALUATION: (1) Reduction in time interval between study section
meeting and Council review of applications; and (2) acceptability to
Council members of electronically-assisted peer review information as
basis for performing second level of review of grant applications.
 
INQUIRIES
 
Inquiries regarding review and referral may be directed to:
 
Dr. Suzanne Fisher
Referral Section
Division of Research Grants
6701 Rockledge Drive, Room 2030 - MSC 7720
Bethesda, MD  20892-7720
Email:  fys@drgpo.drg.nih.gov
 
Dr. Jean Hickman
Tropical Medicine and Parasitology Study Section
Division of Research Grants
6701 Rockledge Drive, Room 4178 - MSC 7808
Bethesda, MD  20892
Email:  hmj@drgpo.drg.nih.gov
 
Inquiries regarding the coordination of this effort may be directed
to:
 
John J. McGowan,Ph.D.
Acting Deputy Director
National Institute of Allergy and Infectious Diseases
Building 31 Room 7A03
Bethesda, MD  20892
Email:  jm80c@nih.gov
 
.

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