NIH REINVENTION ACTIVITIES:  STATUS REPORT
NIH GUIDE, Volume 24, Number 14, April 14, 1995

P.T.


Keywords:

National Institutes of Health

A full report of the status of the reinvention of NIH extramural
research program administration is available in the full text,
electronic editions of the NIH Guide.  Activities pertain to the peer
review and processing of applications for research grants and
proposals for research and development contracts, post award
administration, and the internal NIH administrative procedures.

INQUIRIES

Electronic and printed copies of the Status Report may be obtained
from:

Dr. Eve Barak
Office of Extramural Research
Building 1, Room 144
9000 Wisconsin Avenue
Bethesda, MD  20892
Telephone:  (301) 496-0979
FAX:  (301) 402-3469
Email:  dder@od1tm1.od.nih.gov

________________________________________________________________________________

Full Text N5

NIH REINVENTION ACTIVITIES:  STATUS REPORT

NIH GUIDE, Volume 24, Number 14, April 14, 1995

P.T.


Keywords: 


National Institutes of Health

Vice President Gore's National Performance Review (NPR) outlined a
plan to reinvent the Federal government to work better and cost less.
In response to this directive, the NIH extramural programs have been
designated one of several Executive Branch "Reinvention
Laboratories," to lead the process of change for a range of
extramural functions in the Public Health Service (PHS).  The
imprimatur of this status has facilitated the efforts of the Office
of Extramural Research (OER) to reevaluate NIH policies and
procedures.  As a consequence, both the momentum to make changes and
the opportunity to effect them have increased.    Many initiatives
are underway at NIH.  Some are new and directly responsive to the
mandate to reinvent; others are a continuation of ongoing efforts to
improve the way NIH does business.  The initiatives are based on
ideas contributed by the extramural research community and NIH staff.

The reinvention activities outlined below are organized into three
sections: those that directly impact on the submission of competing
applications and contract proposals and the peer review process;
those that deal with post-award issues; and those designed to improve
the efficiency and cost-effectiveness of internal NIH processes.  The
reinvention activities discussed below range from those that are
fully developed to those that are still in the conceptual phase.
They represent the present state of an evolving operation, which will
continue to rely on the valued input of all interested parties.  This
report is one of a series in which the current state of reinvention
activities will be regularly updated.

PEER REVIEW AND PROCESSING OF RESEARCH GRANT APPLICATIONS:

 Streamlined Review Process - (implemented February 1995) - Beginning
with the February 1995 round of review (i.e., review of applications
submitted October/November 1994), all Division of Research Grant
(DRG)  study sections have employed a streamlined review process for
R01 and R29 research grant applications. Initial Review Groups (IRGs)
within Institutes and Centers (ICs) may use the same streamlined
process at their option.  This represents an extension of a process
that has been used successfully for a number of years by many ICs for
the review of applications received in response to Requests for
Applications (RFAs).

In the streamlined review process, peer reviewers are asked to
prepare written critiques of each application assigned to them and to
identify before the study section meeting those pending applications
(approximately half) that represent the better applications reviewed
by that study section.  These are fully discussed and scored at the
meeting.  The other applications are not discussed and are not given
numerical scores.  However, if even one member of the study section
wishes to discuss an application, that application is discussed and
if, after discussion, it is judged to be among the better
applications reviewed by the review group, it is scored.  This
streamlined process ensures that ample discussion time is available
at the study section meeting for the better applications.

A multi-phased pilot study was conducted prior to full implementation
of the streamlined process.  The first phase of the pilot study,
performed during the February 1994 review round, included four study
sections within the DRG.  Participating review groups designated 50
to 70 percent of the applications for discussion.  In post-meeting
evaluation, reviewers consistently indicated that there was more time
for discussion of the applications that were scored, and that
meetings ended earlier than usual.  Each principal investigators
received a summary statement of the review of their application.

Expanded pilot studies were conducted in the June and October 1994
rounds of review.  Although streamlined review can now be considered
to be fully implemented at DRG, the process will continue to evolve,
with adjustments and modifications if necessary.

Modified Summary Statement - (fully implemented February 1995) -
Initially, a streamlined format for the expedited production of
summary statements was limited to those applications that were
unscored, that is, applications judged to be in the lower half of
those applications seen by the review group.  These summary
statements consisted of essentially unedited comments from the
reviewers.  Feedback from applicants involved in this initial study
(and others) indicated that, in general, receiving essentially
unedited review comments is preferable to receiving a synthesis of
the critiques prepared by NIH staff. In February 1995, the pilot
study was expanded so that all summary statements for DRG-reviewed
R01 and R29 applications consisted of essentially unedited reviewers'
critiques.  For the scored applications, the summary statement also
included a "Resume and Summary of Discussion" section in addition to
the critiques.  The purpose of the "Resume" is to convey highlights
of the discussion at the review meeting leading to the final rating,
and, when indicated, to detail budgetary recommendations.

Expedited Release of Summary Statements to Applicants - (to be
implemented within the next few months) - Currently, summary
statements prepared by Scientific Review Administrators (SRAs) are
routed to Program staff at the ICs, who review and then release them
to the applicants.  This introduces a time lag, sometimes
substantial, between preparation of the document and receipt by the
applicant.  There are plans to release summary statements for
unscored applications directly from DRG to applicants.  This would
provide considerably faster feedback to investigators whose
applications were unscored.  Longer-term plans include making summary
statements available to applicants electronically.

Retrospective versus Prospective Review - (concept under discussion)
- The NIH peer review process is primarily prospective in that it
focuses on a detailed description of the specific research for which
the applicant is seeking support.  However, some contend that a
retrospective review, focussing primarily on the investigator's
recent accomplishments, would be advantageous.  Researchers would be
relieved of the burden of writing detailed plans that are likely to
change in the course of conducting their investigations, and could
instead spend the saved time on research.  Evaluation of past
scientific record allows the wisdom of hindsight and is believed by
some to be the best predictor of continued creativity and
accomplishment.  Success could be less dependent on grantsmanship
skills.  On the other hand, there are concerns that investigators
just beginning their careers or at career turning-points may not be
well served by retrospective review.

There is discussion about the circumstances in which a
retrospective-based review might be appropriate.  Historical data on
funding patterns and information derived from examination of
precedents for retrospective peer review at NIH and other Federal
agencies are being considered in these discussions.  Further
deliberations, involving both NIH staff and extramural researchers,
are clearly needed.

Identification of High Risk/High Impact (HR/HI) Research Applications
- (implemented June 1994) - Since June/July, 1994, reviewers serving
on DRG study sections have been asked to identify those applications
that involve high risk research and have 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 IRG.  The goal is to determine if IRGs can
identify HR/HI applications better when specifically asked to, and if
the information they provide aids program staff and the National
Advisory Councils to better identify special research opportunities
for consideration.

Restructuring DRG Review Groups - (under discussion) - Ideas about
how to use the new Initial Review Group-based organization of DRG to
broaden the range of expertise represented on individual study
sections without sacrificing focus are being considered.  In
addition, possible mechanisms for periodic review of the composition
of IRGs and their constituent study sections, to ensure that they
evolve in pace with scientific advances, are being considered.

"Just in Time" - (pilot experiments under way) - "Just-in-Time"
postpones the collection of a fairly substantial amount of the
information, such as "other support" and complete budget detail, that
currently must be provided at the time of submission for all
competitive applications.  Applicants would be required to provide
only information related to research background and experience in the
biographical sketch and, at the option of the applicant, the
sponsored support relevant to the proposed research.  This would
reduce the administrative burden associated with the preparation of
NIH grant applications without compromising the initial review group
determination of scientific merit or the reasonableness of the
proposed budget.  Detailed information relevant to an award would be
submitted, upon request, "just in time" prior to award.  This would
reduce the administrative burden for the approximately 75% of
applicants who will not receive an award.  For "Just-in-Time" to be
effective, applicant institutions must be prepared to provide the
detailed information quickly if a decision is made to fund an
application.  "Just-in-Time" pilot tests are being conducted through
a number of RFAs from a few ICs.

Amended Applications - (under discussion) - Currently, there is no
limit to the number of times an application can be resubmitted in an
amended version.  Relatively strong applications for which reviewers
may have raised a few minor criticisms that can be addressed easily
are obliged to resubmit revised applications in the hope of achieving
a fundable score.  For these applications, the process is clearly
inefficient, since minor issues could very likely be addressed by a
short response and an expedited review process rather than require a
full-fledged application, which must wait for the next regular review
cycle.  In contrast, intrinsically weak applications may be revised
to address reviewers' comments cycle after cycle, with the
expectation that this will eventually result in a fundable score.  In
such cases the likelihood of success is low and the burden relative
to benefit for the applicant and the review process is considerable.
Discussions are now focused on whether and how to limit the number of
amendments of an application that may be submitted and on ways in
which the review of those promising applications that require only
minor revisions might be expedited.

Cost Management: budgeting for total costs rather than direct costs -
(concept under discussion) - Currently, applicants request and
reviewers and program staff recommend grant budgets in terms of
direct costs.  Indirect costs increase total costs by approximately
30 percent on the average.  However, indirect cost amounts may vary
unpredictably during a multi-year grant, because institutional
indirect cost rates may change or direct-cost spending patterns may
vary.  An alternative approach, which is standard practice in several
other Federal agencies, is to consider the requested and recommended
budgets at all stages of the process in terms of total costs.  In
addition to accurately reflecting the total cost of the research and
stabilizing the out-year budget commitments, this might provide cost
management incentives to the grantee institution and investigator.

Modular Grants - (pilot experiments under way) - The concept of the
modular grant is based on the principle of a grant as an assistance
mechanism that does not necessarily provide full-cost reimbursement
for the research project.  In the modular grant model, applications
would be submitted and/or awards would be made with direct (or
possibly total) costs in modules (multiples) of a given amount, e.g.,
$50,000, with work proposed within these incremental categories.
Alternatively, a limited series of capped award levels (e.g.,
$100,000, $200,000) might be used.  The modular grant, as envisioned,
would eliminate the submission or review of detailed budgets.  Fiscal
accountability for individual projects could be shifted to the
recipient organizations.  The NIH would be responsible for oversight
of the organization's monitoring system and would be accountable for
the scientific progress of the project.  A feasibility test of the
modular grant mechanism is being undertaken by the National Heart,
Lung, and Blood Institute (NHLBI) through an RFA.  A second pilot
project is planned by the NHLBI, in conjunction with an RFA for
multi-project awards.

Post-Council Notification - (limited implementation) - NHLBI has
eliminated routine use of post-council letters to all applicants.
Instead, each applicant is informed, in the letter that accompanies
the summary statement, of the status of the pending application and
that the applicant will be notified if the National Advisory Council
makes any recommendation that differs from the information in the
letter.  The use of post-council letters is thus reserved for only
the small group of applicants for whom the National Advisory Council
takes a separate action, such as addressing a rebuttal or
recommending deferral, or to inform the applicant of funding or
possible funding.  Full implementation would eliminate the mailing of
more than 25,000 letters each year.

Electronic Research Administration - (in planning stage; some pilot
experiments under way) - Currently, 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 initiatives represent a commitment
to improve administrative operations through information
technologies.  Recommendations to streamline both the exchange of
information between the NIH and applicant organizations and
procedures within the NIH have been developed.  The electronic
"common file" is envisioned as the electronic interface between the
NIH and the grantee community and would be the repository for all
information generated during the life cycle of each grant.  This data
base would be accessible to authorized grantee 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, 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,
two are currently in pilot mode:  the application shell (Limited
Electronic Submission System, LESS) and invention reporting
(Extramural Invention Information Management System, EIIMS).

The LESS experiment began in October 1994 in cooperation with two
major grantee institutions.  The face page, second (Abstract) page,
certain budget items, and personal data for the Principal
Investigator for R01 applications are submitted electronically, with
the remainder of the application submitted as paper copies.  The
electronically submitted information will be entered directly into
NIH's data base (IMPAC), without intervening paper copies or manual
re-keying of the data.  Soon, each institution will be assigned a
unique number to link the application with administrative information
already contained in IMPAC, e.g., institutional assurances and
certifications and names of institutional officials.  By using these
institutional profiles, the need to provide data repeatedly on a
project-by-project basis would be eliminated.

An experiment in which grant applications were submitted
electronically in their entirety  (Automated Grant Application
System, AGAS), was carried out from February 1993 through July 1994.
Among the problems encountered in this test was the diversity in the
way applicant organizations use automation to create applications and
to capture relevant data for use within their inhouse systems.
Therefore, the NIH is cooperating with other Federal agencies to
design and publish Electronic Data Interchange (EDI) standards.
Independent software vendors can then develop grant application
creation software that can create data streams compatible with NIH
processing systems.  The EIIMS pilot became operational in January
1995, in cooperation with four grantee institutions.  This system is
designed to receive, store, track, sort and report information
regarding inventions and patents that have resulted from NIH
extramural funding.  It employs a MOSAIC interface and a
client/server database architecture in which a common file can be
accessed by authorized grantee organizations and NIH staff.  Data can
be viewed or modified in a real-time interactive setting.  The use of
EDI is planned to allow grantee organizations to transfer data to the
database directly.

Online information about extramural research programs - (enhancement
of current implementation) - Access to the NIH Guide and telephone
directory has been provided on both the NIH Gopher and NIH Grantline;
the PHS Grants Policy Statement and the CRISP database, which lists
all NIH grants and contracts, are available on the NIH Gopher.  The
full text of the NIH Guide and the Table of Contents are available
through separate subscription lists (NIH Guide, Vol. 23, No. 20, May
27, 1994).  Efforts are underway to add several items, such as a
subscription list for information from the Office for Protection from
Research Risks (OPRR); rosters of advisory groups including initial
review groups; the minutes of the public portions of the National
Advisory Council meetings; the NIH Extramural Programs; and
descriptions of ongoing programs such as the First Independent
Research Support and Transition (FIRST) Awards, the National Research
Service Act (NRSA) Awards, and the Minority Supplement Program.

The NIH Mosaic Home Page is being redesigned to serve more
effectively as the central gateway to information resources from the
NIH.  The Home Page will provide researchers, the medical profession,
and the general public with focal access to servers and bulletin
boards managed by various components of the NIH community.
REVIEW AND PROCESSING OF R&D CONTRACT PROPOSALS:

Re-engineered RFP on the NIH Gopher Server -  Since December 1994 the
NIAID has posted two RFPs on the NIH Gopher server.  A substantial
savings in the cost of mailing, copying, and contract staff effort
will be realized through electronic distribution of Requests for
Proposals.  The reengineered RFP provides information in a more
logical sequence, and is more efficient and effective for potential
offerors to peruse.  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.  Potential offerors will thus be able to more easily
determine their further interest in the solicitation.

Just in Time for Contract Proposals - (under discussion) - This
concept, which is currently being pilot tested in grant applications,
postpones the collection of a fairly substantial amount of
information that currently must be provided in all proposals.
Consideration is being given to delaying submission of certain types
of information and requiring it instead as part of the "best and
final offer" (e.g., substantiating cost information, financial
statements, institutional travel policies, compensation plans,
specific certifications).  This would relieve administrative and
paperwork burdens for offerors who are not included in the
competitive range, without compromising the determination of
technical acceptability or the determination of the competitive
range.

Electronic Submission of Business Proposal Information (under
discussion) - A work group will examine the concept of submission of
offerors' business proposals online or on diskette.

Expedited Review of R&D Contract Proposals - The 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 RO1s and R29s.  The ERP is used by a Special Emphasis Panel
if a large number of proposals are received for a relatively small
number of awards.  The process is designed to improve the efficiency
of the Special Emphasis Panel review meeting by reducing the overall
workload of the reviewers and providing reviewers more time for
discussion of the strengths and weaknesses of proposals having the
highest probability of being recommended acceptable.

POST-AWARD MANAGEMENT OF GRANTS:

Notice of Grant Awards (NGA) - (fully implemented, NIH GUIDE,
December 2, 1994) - The awarding Institutes and Centers (ICs) now
mail only one copy of the NGA to the grantee institution;  the
administrative official is asked to distribute copies to the
Principal Investigator and other interested parties.  The longer-term
goal is electronic transmission of NGAs.

Streamlining the Non-Competing Award Process - (implemented October
1994) - To the extent possible, the financial and administrative
information required for the award and administration of a grant will
be obtained at the time of the competing award.  The noncompeting
applications then focus on the scientific progress of the research.
Beginning October 1, 1994, all out-year budgets are provided to NIH
program staff at the time of initial award.  Therefore, instead of
submitting four different financial documents each year (year "x"
budget, estimate of year "x-1" expenses, Financial Status Report, and
quarterly Federal Cash Transaction Reports), only the Financial
Status Report and the Federal Cash Transaction Reports are required.
Annual progress reports are still required, but these should focus on
scientific progress, changes in scientific direction, changes in
other support, and other matters relevant to the programmatic
management of the grant.  This streamlined approach had been tested
for two years under the Federal Demonstration Project.  Elimination
of the annual Financial Status Report is under consideration.

NIH INTERNAL STREAMLINING:

The NIH Extramural Research Reinvention Laboratory has requested
redelegation of authorities related to advisory committee
administration and grants and contracts administration policy and
regulation, to reduce the paperwork, effort, and delay caused by
obtaining clearances at several levels within HHS.  Other internal
reinvention activities at various stages of development include:
streamlining the DRG process for nominating study section members;
expedited referral of applications in DRG for renewals and amended
applications; evaluation of new staffing patterns to identify ways to
accomplish more work with fewer staff; reinventing aspects of
National Advisory Council activities; streamlining procedures to
obtain approval for the use of the cooperative agreement award
mechanism; streamlining internal review of non-competing awards;
reinvention of contracts management procedures, in parallel with
grants management reinvention; and simplification of other
management-related processes.

INQUIRIES

Suggestions may be submitted to:

Dr. Wendy Baldwin
Deputy Director for Extramural Research
Building 1, Room 152
National Institutes of Health
Bethesda, MD 20892
Email:  DDER@OD1TM1.OD.NIH.GOV

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