Full Text NOT-96-001

NIH REINVENTION ACTIVITIES:  STATUS REPORT

NIH GUIDE, Volume 24, Number 40, November 24, 1995

P.T. 34

Keywords: 
  Grants Administration/Policy+ 


National Institutes of Health

This is an update on the progress of the NIH reinvention activities.
A previous report was published in the NIH Guide, Vol. 24, No. 14,
April 14, 1995.

Since April, the NIH has continued to develop and implement several
initiatives under Vice President Gore's National Performance Review
(NPR) plan.  Some of the initiatives described in the previous status
report have been fully implemented, including the streamlined review
process, modified summary statement, identification of high risk/high
impact research applications, and consolidation of the K mechanisms.
Others such as "Just-in-Time," modular grants, and limited electronic
submission are under way as pilot experiments.  This report is a
summary of the fully implemented initiatives, the pilot experiments,
and the concept development.  These initiatives are presented in
three sections:  (1) electronic reporting and submission of grant and
contract materials, (2) peer review and National Advisory Council
review, and (3) application processes and grant mechanisms.  The NIH
reinvention activities have been an open process, based on ideas
contributed by the extramural research community and NIH staff.
Reinvention is an evolving operation, which will continue to rely on
the valued input of all interested parties.  Comments on the
implemented changes and pilot experiments are welcome and may be sent
to the following email address:  DDER@nih.gov.

I.  ELECTRONIC REPORTING AND SUBMISSION OF GRANT AND CONTRACT
MATERIALS

A.  GRANTS

ELECTRONIC RESEARCH ADMINISTRATION:  (expanded pilot project under
way) -- Both the NIH and the grantee community are burdened by
cumbersome communication processes and rely heavily on hard-copy
exchange of essential information.  The Electronic Research
Administration (ERA) initiatives represent a commitment to improve
administrative operations through information technologies and
reengineering of process.  The ultimate goal is to combine more
effective investment of Federal dollars with more efficient
administrative procedures for both the NIH Extramural Program and the
awardee community.  Pilot projects of streamlined procedures for the
exchange of information between the NIH and applicant organizations
and within the NIH have begun.

A key feature of the reengineering effort is the idea of maintaining
the information required for various NIH processes within a client-
server "common file" database.  This "common file" is envisioned as
the electronic interface between the NIH and the awardee community
and the repository for information generated during the life cycle of
each award.  The database would be accessible to authorized awardees
and NIH staff, who could each review and add information as required.
Proposed components of the system include the application shell,
institutional profile, status system (including review dates, scores,
and summary statements), notice of grant award, invention reporting,
and other required reporting (e.g., women and minorities in clinical
research, trainee appointments, and financial reporting).  Of these,
three are currently in pilot mode:  the application shell, invention
reporting ("EDISON"), and trainee appointments.  (updated 11/95)

ELECTRONIC SUBMISSION OF GRANT APPLICATION MATERIALS - THE
APPLICATION SHELL:  (pilot study under way) -- Under a Department of
Energy (DOE) Cooperative Agreement, the NIH and several Department of
Defense agencies are participating in a pilot study to test a new
system for the submission of grant application information.  These
agencies and eight research institutions will test the Electronic
Data Interchange (EDI) standards developed collaboratively by the
Federal agencies.  Key administrative information in R01 grant
applications, such as face page information, scientific abstract,
certain budget items, and personal data for the Principal
Investigator (but not including the project description), will be
submitted directly into NIH's database, without intervening paper
copies or manual rekeying of data.  The rest of the application will
be submitted on paper.  The "institutional profile" will contain
administrative information specific to each grantee organization that
can be electronically linked to grant applications through the use of
unique, organizational, identifying numbers.  The institutional
profile database will eliminate the need to provide the same
information for each application submitted by an organization.  By
using EDI standards, commercial software vendors will be able to
develop software for that can create data streams for transmission to
the NIH without the need for compatible processing systems.  (updated
11/95)

ELECTRONIC INVENTION REPORTING:  (expanded pilot project under way) -
- EDISON, the invention reporting system designed to receive, store,
track, sort, and report, became operational in January 1995 with four
grantee organizations.  Thirty organizations are now using EDISON for
reporting inventions and patents that have resulted from research
funded by the NIH.  The EDISON is a Netscape interface to a client-
server through which a common database can be accessed by authorized
grantee organizations and NIH staff.  Data can be viewed or modified
in a real-time, interactive setting.  The eventual use of EDI is
planned to enable organizations to transfer data to the database
directly, without manual keying.  The user-friendly nature of the
EDISON prototype system has proven so attractive, both within NIH and
the research community, that several Institutes and Centers and other
Federal agencies are planning to adapt the intervention reporting
prototype concept for other reporting and communication needs.
(updated 11/95)

ELECTRONIC REPORTING OF TRAINEE APPOINTMENTS: (pilot project under
way) -- The Division of Research Grants (DRG) has developed an
interface for the collection of trainee appointment information.
Like EDISON, the trainee appointment system is an interface on the
world-wide-web (WWW) through which information about trainees
appointed to a National Research Service Act (NRSA) Institutional
Research Training Grant may be entered.  This system will replace the
printed Form NIH 2271.  Currently, seven of the eight DOE Cooperative
Agreement demonstration centers are participating in the pilot
project.  (added 11/95)

INCREASED ELECTRONIC AVAILABILITY OF INFORMATION ABOUT EXTRAMURAL
RESEARCH PROGRAMS:  (various stages of development) -- Access to the
NIH GUIDE, the NIH telephone directory, and the CRISP database, which
lists all NIH awards for grants and contracts, is available on the
NIH GOPHER.  The NIH Home Page (http://www.nih.gov) is the central
gateway to electronic information resources, including the NIH GOPHER
and servers and bulletin boards managed by the various components of
the NIH.  Communication technologies will be used to facilitate
discussion with the research community about NIH issues.  (updated
11/95)

B.  CONTRACTS

REENGINEERED REQUEST FOR PROPOSALS (RFP) ON THE NIH GOPHER SERVER:
(pilot project under way) -- Since December 1994, the National
Institute of Allergy and Infectious Diseases (NIAID) has posted nine
RFPs and the National Institute of Environmental Health Sciences
(NIEHS) has posted three RFPs on the NIH Gopher server.  Electronic
distribution of the RFPs has substantially reduced the cost of staff
time and cost of mailing and copying.  In the new format for RFPs,
information is provided in a sequence that is more efficient and
effective for potential offerors.  For example, the information
generally used by potential offerors to determine their interest in
responding to a requirement (the Statement of Work,
Delivery/Reporting Requirements, and Evaluation Criteria) is now in
the first section of the RFP.  Instructions for Proposal Preparation
and Other Documents (the contract format, clauses, and required
forms) are in separate sections.  (updated 11/95)

II.  PEER REVIEW AND COUNCIL REVIEW

A.  GRANTS

STREAMLINED REVIEW PROCESS:  (fully implemented) -- In February 1995,
the review of R01 and R29 grant applications was streamlined.  In
streamlined review, the applications that the reviewers think are in
the better half of the applications are discussed and scored.  The
rationale for this process is based on data indicating that almost
all R01 applications reviewed by the Division of Research Grants
(DRG) and selected for funding by the Institutes or Centers received
scores within the upper half (50th percentile or better) of all
reviewed applications.  The benefits of this process are shorter
review meetings and more time for discussion of the better
applications.  All applications, whether or not they are discussed at
the meeting, receive in-depth review and written critiques by the
assigned reviewers.  The review of all applications for R01 and R29
grants by DRG has been streamlined.  Many of the review panels of the
Institutes and Centers also use a streamlined review process.
(updated 11/95)

MODIFIED SUMMARY STATEMENT:  (fully implemented February 1995) --
Review feedback to applicants also has been streamlined.  In the
past, applicants received summary statements that were prepared by
NIH Scientific Review Administrators from the critiques of the
reviewers and the discussion at the meeting.  Now, summary statements
are the unedited critiques of the reviewers and, if the application
was discussed, a Resume and Summary of the Discussion are included.
This process saves staff time and provides more specific information.
(updated 3/95)

EXPEDITED RELEASE OF SUMMARY STATEMENTS TO APPLICANTS:  (partially
implemented June 1995) -- Summary statements for unscored
applications are sent to applicants directly from the DRG, rather
than being routed through the Institute or Center as done previously.
There are plans to send summary statements to applicants
electronically.  (updated 11/95)

IDENTIFICATION OF HIGH RISK/HIGH IMPACT RESEARCH:  (fully implemented
June 1994) -- Reviewers on DRG study sections are asked to identify
the applications that propose high risk research that has the
potential for high scientific impact.  This identification occurs
after the merit review and assignment of priority scores and requires
agreement of at least two members of the Initial Review Group (IRG).
The goal is to determine if review groups can identify such
applications and if the information can assist program staff and the
National Advisory Councils to better identify special research
opportunities for consideration.  (updated 11/95)

RESTRUCTURING DRG REVIEW GROUPS:  (initial implementation January
1994; further activities under discussion) -- In January 1994, the
DRG initiated a major internal reorganization in which the more than
85 study sections were grouped into 19 entities on the basis of broad
but cohesive scientific topics.  These 19 entities were chartered as
Initial Review Groups (IRGs), which are now the basic functional
units of peer review in the DRG.  The operative subcomponents of the
19 IRGs are still referred to as study sections; each IRG consists of
three to seven study sections.  Inherent in this new administrative
structure of the IRG is the ability to form new subcommittees as
needed to ensure coverage of scientific areas and increased
flexibility to use members where their expertise is most needed.
Another advantage is that Scientific Review Administrators working
together will have a broader view of the science covered by their
IRG.  This review committee structure can be more responsive to the
changes in science and the dynamics of the research enterprise, while
remaining anchored to the basic principles of objective peer review
for all applications.  Moreover, applications that do not fit easily
into existing review committee structures can be more appropriately
handled.  (updated 11/95)

FLEXIBLE INITIAL REVIEW GROUPS:  (pilot experiments under way) -- A
pilot study was initiated within the DRG in June 1995 to test the
flexibility and responsiveness of the new IRG format and stimulate
increased communication among the IRGs, NIH staff, and the scientific
community that they serve.  Eight (Behavioral and Social Sciences;
Cell Development and Function; Endocrinology and Reproductive
Sciences; Genetic Sciences; Immunological Sciences; Nutritional and
Metabolic Sciences; Oncological Sciences; and Pathophysiological
Sciences) of the 19 IRGs were selected to participate in the Pilot
Study of Independent IRGs.  These IRGs were removed from the
administrative structure of the Review and Referral Branch and
charged to operate as independent teams of Scientific Review
Administrators.  Thus, the referral of applications was
decentralized, with each team being responsible for the appropriate
grouping of applications for review.

This study has produced significant results.  Communication between
the IRGs and the program staff has been enhanced and more suggestions
have been made by the scientific community about which scientific
areas may be more appropriately reviewed by the new configuration of
IRGs.  The flexible IRG concept has been adopted for the review of
patient oriented research applications.  It is anticipated that the
momentum of the pilot study will increase with the participation of
other study sections.  (added 11/95)

REVIEW OF FELLOWSHIP APPLICATIONS: (fully implemented April 1995) --
The flexible IRG approach has been used to review F32 fellowship
applications.  Until recently, these applications were reviewed by
study sections that reviewed fellowship applications exclusively.
Reconsideration of this process was stimulated by (1) the realization
that as science had become more sophisticated and complex, the
broadly constituted fellowship study sections had become unable to
review with scientific depth; and (2) NIH accommodating mandated
Federal workforce reductions.  Consequently, F32 fellowship study
sections have been abolished.  Fellowship applications usually are
reviewed now in study sections most appropriate for the research area
proposed.  In some instances, particularly when the number of
fellowship applications is small in a particular area, applications
are organized into scientifically discrete clusters within the IRG to
create a "critical mass" for review.  In either case, the resultant
review of the science can be more thorough and informed than before,
while accommodating reductions in the number of review staff.  (added
11/95)

RATING GRANT APPLICATIONS:  (concept under discussion) -- The
conceptual framework for discussion focuses on assessing the
scientific and technical merit of grant applications as measured by
priority score and percentiles.  The NIH recognizes that priority
scores and percentiles alone cannot address adequately the wide
variety of scientific disciplines and public health priorities.  This
provides impetus to develop a more valid, reliable, and useful rating
system.  One issue under discussion is the revision of review
criteria.  The following three criteria have been proposed:
"significance," "research approach," and "feasibility."  Also under
discussion is scoring applications criterion by criterion.  Data
suggest that reviewers can rate each criterion more reliably than
they can rate overall scientific merit.  Other issues under
discussion include:  the rating scale; individual reviewers'
consistency in the use of scoring procedures; and comparability of
ratings across reviewers and IRGs.  (added 11/95)

PERCENTILE SCORES:  (pilot experiment under way) --  Currently, study
section members assign one of 41 possible scores to an application
using a 1-to-5 rating scale with intervals of 1/10 of one point
(e.g., 1.0, 1.1, 1.2...).  These scores are used to compute
percentile scores, of which there are 1001 different possible values
(the percentile scale is a 0-to-100 scale with intervals of 1/10 of
one point).  The percentile scores and the priority scores from which
they are calculated are expressed at a level of discrimination
greater than actually exists.

The National Institute of General Medical Sciences (NIGMS) is
experimenting with an alternative to priority and percentile scores
using scores that more accurately reflect the level of discrimination
that reviewers have made.  In the existing system, the priority score
for an application is based on the study sections' average rating of
technical merit of that application, expressed to the second decimal
place (e.g., 1.23), then multiplied by 100.  In the pilot experiment,
the average technical merit rating is determined to the first decimal
place, resulting in 41 different possible priority scores (130, 140,
150)--the same number of scores available in the rating of each
application.  Similarly, percentile scores will be rounded off to the
nearest odd integer (for example, the first, third, fifth
percentiles), resulting in 50 different possible percentile scores.
The rounded scores will be used only on applications for the R, P,
and K mechanisms with primary assignments to NIGMS.  No changes will
be made in either the computation or reporting of priority and
percentile scores for applications with primary assignments to other
Institutes and Centers.  (added 11/95)

STREAMLINING NATIONAL ADVISORY COUNCIL REVIEW:  (pilot experiments
under way) -- In the National Institute of Allergy and Infectious
Diseases (NIAID), a pilot study was conducted for the May 1995
National Advisory Council (NAC) cycle to test the feasibility of
obtaining NAC pre-approval for some applications by mail ballot,
about two months prior to the NAC meeting.  The applications in this
category were those with scores within the payline that required no
specific discussion by the NAC.  The rationale was that awards could
be made immediately for these applications, rather than after the NAC
meeting, thereby informing applicants of the pending awards earlier,
awarding competing grants earlier, and distributing staff workload
more evenly throughout the fiscal year.  The National Center for
Research Resources (NCRR) now uses mail ballots to obtain NAC
approval of construction grants.

Because of the success of the pilot, the NIAID is pursuing two
additional innovations.  The first, piloted in Fall 1995, involved
further streamlining of the mail ballot procedure.  Instead of the
full NAC receiving copies of all summary statements available for
pre-approval, the NAC members receive only the information relevant
to their specific subcommittee and members of the subcommittee make
their recommendations on behalf of the full NAC.  The second
enhancement is scheduled for February 1996 and will involve
eliminating the paper-based system by placing information on an
electronic server accessible to NAC members.

On a trans-NIH level, a request has been made to broaden the
categories of applications that are currently exempt from
statutorily-mandated NAC review.  The request is to extend current
exemptions to other awarding components of the NIH (i.e., the Centers
and the National Library of Medicine), as well as to the Institutes
and to increase from $50,000 to $100,000 per year the dollar amount
for grant and cooperative agreement awards that can be made after
scientific peer review, but without NAC recommendation.  These
proposed changes would have the effect of shortening the time from
review to award for a larger percentage of applications and would
allow the Institutes and Centers to streamline and balance workloads.

The Institutes and Centers have been reconsidering the kinds of
information and documentation the NACs need to review grant
applications.  Many Institutes and Centers provide the NAC members
only those applications with scores in the top third or two-thirds of
the total range, thus reducing the workload for both staff and NAC
members in preparation for the meeting.  Some Institutes and Centers
have streamlined the process by providing the summary statements to
their NAC members electronically prior to the meeting.  (update
11/95)

B.  CONTRACTS

STREAMLINING THE RESEARCH AND DEVELOPMENT (R&D) CONTRACT REVIEW
PROCESS:  (in planning stage) -- In November 1994, a Reinvention
Forum was convened for Scientific Review Administrators responsible
for R&D Contract Review.  Several recommendations for streamlining
R&D contract review were developed.  Further discussions in 1995 by
contract and project officers have concentrated on recommendations
for limiting the number of pages in technical proposals, developing a
common format for the preparation of proposals, and requiring input
from the Scientific Review Administrator regarding the clarity of the
statement of work, adequacy of the evaluation criteria, and the
milestone dates pertaining to the initial peer review.  (added 11/95)

EXPEDITED REVIEW OF R&D CONTRACT PROPOSALS:  (pilot project under
way) -- The National Heart, Lung, and Blood Institute (NHLBI) has
developed an Expedited Review Procedure (ERP) for R&D contract
proposals, which is similar to the streamlined review process
recently introduced in DRG for R01s and R29s.  The process is
designed to improve the efficiency of the Special Emphasis Panel
review meeting by reducing the workload of the reviewers and
providing reviewers more time for discussion of the strengths and
weaknesses of proposals having the highest probability of receiving
an "acceptable" recommendation.  These procedures are similar to the
streamlined review process for grants, but all contract proposals are
discussed by the Special Emphasis Panel, as required by the
regulations for contract review.  The ERP was used when many
proposals were received for a few planned awards.  A working group
consisting of Scientific Review Administrators, Program Officials,
and Contract Specialists has reviewed the procedure.  Other
Institutes and Centers are being encouraged to use the ERP.  (updated
11/95)

III.  APPLICATION PROCESSES AND GRANT MECHANISMS

A.  GRANTS

AMENDED APPLICATIONS:  (concept under discussion)  -- Amended grant
applications have become a major source of work and delay in the
funding of research projects.  Unsuccessful applicants respond to
reviewers' critiques by submitting amended applications in hopes of
improving the scientific and technical merit rating of the grant
application.  The distinction between unsuccessful applications with
relatively minor shortcomings and those with major flaws often is not
made.  Relatively strong applications for which reviewers have raised
a few minor criticisms that can be addressed readily must be revised
and resubmitted for review, usually two review cycles later.  In
contrast, intrinsically weak applications may be revised cycle after
cycle to address reviewers' comments, with the expectation of the
applicant that the application will eventually obtain a fundable
score.  Ways to streamline and improve these procedures for amending
applications are being discussed.  (updated 11/95)

"JUST-IN-TIME":  (pilot experiments under way) -- The first "Just-in-
Time" experiments were completed with Requests for Applications
(RFAs) in several Institutes and Centers.  Institutions were not
required to submit certain kinds of information until an award was
likely to be made.  For example, "other support" information is not
needed in the application package.  Instead, the information is
requested "just-in-time" for an award to be made.  The process is
slightly different for budget information because it is needed for
the initial scientific review.  Therefore, applicants are asked to
submit a simplified budget.

The use of the "Just-in-Time" concept for all NIH-initiated research
grants, i.e., requests for applications, is being considered.  In
addition, investigator-initiated applications for select types of
grants, e.g., R03, R13, R15, R29, and K mechanisms, are being
considered for "Just-in-Time" procedures.  This group of mechanisms
has direct cost caps and other restrictions.  The basic principle of
"Just-in-Time" is to simplify and reduce the administrative and
paperwork burdens of preparing an NIH grant application without
compromising the initial review group determination of scientific
merit or reasonableness of the proposed budget.  The plan being
considered for these unsolicited applications would require
applicants to submit a budget for total direct costs only, with
simplified procedures for the budget narrative or categorical
breakdown of costs.  The project description section would include a
brief biographical sketch of the personnel listed on the budget page.
Information regarding other support would be submitted, upon request,
"just in time" prior to award.  It is important to note that for
"Just-in-Time" to be effective, applicant organizations must be
prepared to provide the additional information quickly if requested.
(updated 11/95)

MODULAR GRANT:  (pilot under way) -- Applications are submitted
and/or awards made with direct (or possibly total) costs in modules
(multiples) of a given amount, e.g., $25,000, with work proposed
within these incremental categories.  Alternatively, a series of
capped award levels (e.g., $100,000, $200,000) might be used.  The
model involves using pre-established funding levels for awards and
acknowledging that grantees can and do rebudget post-award.  This
process eliminates the need for many budget details, thereby
relieving administrative burdens on both NIH staff and grantee
organizations and simplifying cost management by NIH program staff.
The NHLBI has tested this model in an RFA and plans to expand these
procedures to other NHLBI-initiated research efforts.  (updated
11/95)

CONSOLIDATION OF GRANT MECHANISMS:  CAREER AWARDS - (fully
implemented April 1995) -- Redundant grant mechanisms that have
proliferated over time are being consolidated.  A Program
Announcement was issued in April 1995 (NIH Guide, Vol. 24, No. 15,
April 28, 1995), announcing six new K-series (research career) awards
that replace the previous K awards.  The new K mechanisms are
organized on the basis of career level and previous training of the
principal investigator and whether or not a mentor is required.
(updated 11/95)

CONSOLIDATION OF GRANT MECHANISMS:  OTHER AWARDS - (concept under
discussion) -- As a result of the success of the K-series
consolidation, other award series (R, P, U) are being examined.  For
example, a committee of senior program staff has recommended that the
First Independent Research Support and Transition (FIRST) (R29) award
mechanism (a five-year award for supporting research of newly
independent investigators) remain a distinct mechanism.  Ongoing
discussions are focusing on how to strengthen the R29 to meet better
the needs of new investigators.  (updated 11/95)

STREAMLINING THE NON-COMPETING AWARD PROCESS:  (fully implemented
October 1994) -- The submission of information prior to the issuance
of a non-competing award for most research and career award
mechanisms has been streamlined.  Instead of submitting annual
continuation budget requests, the application proposes budgets for
all years of the project, which are analyzed by NIH staff when the
competitive award is negotiated.  Annual requirements for financial
documentation have been streamlined accordingly, and the annual
progress report is used to monitor scientific progress, changes in
level of effort, other support, rebudgeting, and unobligated
balances.  Presently, two financial reports, the Federal Cash
Transaction Report and the Financial Status Report, are required each
year.  NIH staff are studying the possibility of eliminating the
latter.  (updated 3/95)

B.  CONTRACTS

"JUST-IN-TIME":  (in planning stage) -- The concept of "Just-in-Time"
has been applied to R&D contract proposals.  Specifically,
substantiation of cost information, financial statements,
institutional travel policies, compensation plans, and subcontracting
plans will no longer be required for initial proposals, but will be
required in the best and final offer.  This will relieve
administrative and paperwork burdens for offerors who are not
included in the competitive range, without compromising the
determination of technical acceptability or competitive range.  The
National Cancer Institute is in the process of revising the R&D
Request for Proposal (RFP) work form to include procedures for
implementing "Just-in-Time."  It is envisioned that this procedure
will be broadly implemented. (updated 11/95)

INQUIRIES

Dr. Wendy Baldwin
Deputy Director for Extramural Research
National Institutes of Health
Building 1, Room 144
Bethesda, MD  20892
Email:  DDER@nih.gov

.

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