NIH REINVENTION STATUS REPORT

Release Date:  October 21, 1998

P.T.

National Institutes of Health

Introduction

This is the sixth status report on NIH electronic research administration (ERA)
and reinvention activities.  The previous reports were published in the NIH Guide
for Grants and Contracts on the following dates:

Vol. 23, No. 44, December 16, 1994;
Vol. 24, No. 14, April 14, 1995;
Vol. 24, No. 40, November 24, 1995;
Vol. 25, No. 23, July 12, 1996; and
Vol. 26, No. 17, May 23, 1997.

The status report provides an update on ERA efforts and the NIH priority
reinvention initiatives for 1998 that the NIH Office of Extramural Research (OER)
is coordinating in a partnership with the NIH Institutes and Centers (IC).  The
1998 NIH priority reinvention initiatives are being pursued along a continuum of
activity that ranges from concept development to implementation.  Some NIH
institutes and centers also may be conducting their own reinvention initiatives
or small-scale pilots.  Information about these activities may be available on
that IC's homepage, and questions may be directed to staff of the particular IC.

As the NIH continues to undertake reinvention activities and new initiatives, we
recognize the need to establish a framework that guides our efforts.  The
framework NIH currently references was crafted by a cross-section of NIH
officials with input from the extramural community.  It delineates four major
goals for reinvention:  (1) maximize scientific opportunities through optimal use
of resources; (2) enhance NIH interactions with the research community; (3)
clarify and streamline decision-making processes; and (4) focus internal
operations on outcomes and results.  Each of these goals is further classified
into specific reinvention objectives, and the plan is to use these goals and
objectives as guideposts as the NIH moves forward with its reinvention projects.

MILESTONE ACHIEVEMENTS

In 1994, the NIH extramural programs were designated as a Reinvention Laboratory
under Vice President Gore's National Performance Review  (now the National
Partnership for Reinventing Government) to "create a government that works better
and costs less."  Since formalizing its involvement in reinvention four years
ago, the NIH has achieved a number of milestones in its development of electronic
research administration (ERA) and reinvention of its extramural research
administration practices.

o  In Fiscal Year 1995, the NIH implemented SNAP (Simplified Noncompeting Award
Process).  Because noncompeting awards represent the largest percentage of the
grants workload for NIH program and grants management staff, the NIH chose to
streamline the amount of information noncompeting grantees are required to report
to the agency every year.  As a result, noncompeting applicants do not need to
submit certain financial reports so long as there are no significant changes in
their project's budget.  In Fiscal Year 1998, 76 percent of noncompeting awards
were processed under SNAP procedures.  In 1999, NIH plans to increase the
efficiency of SNAP procedures by deploying an electronic version, e-SNAP.

o  In 1995, NIH fully implemented Streamlined Review�a process that all Center
for Scientific Review (CSR) study sections now employ to identify those
applications that are in the "top half." The rationale for this approach was
based on data indicating that almost all investigator-initiated applications
reviewed by CSR and selected for funding by the Institutes received scores within
the upper half (meaning 50th percentile or better) of all reviewed applications.
The use of streamlined review has shortened review meetings and enabled peer
reviewers to focus their professional expertise on those applications most likely
to be selected for funding.

o  In conjunction with streamlined review, NIH also implemented the use of
simplified summary statements.  Applicants now receive the reviewers' raw
critiques as opposed to a document that NIH staff once prepared, summarizing all
of the reviewers' comments.  This practice improves NIH staff efficiency and the
amount of information each applicant receives regarding his or her application.

o  In 1995, the NIH deployed "Edison," a secure, interactive Web site for
reporting, monitoring, and tracking inventions derived from Federally funded
research. Implementation of this system streamlined the invention reporting
process by reducing the average of 15 cycles of paper correspondence for each
invention to only four documents with requisite original signatures.  As of
September 1998, 130 organizations had established accounts to use the Edison
system.  Over 75 inventions are reported to Edison each week.  Further, six other
Federal agencies have adopted Edison for their invention reporting and tracking
purposes. (http://www.iedison.gov)

o  In 1996, the NIH began development of the NIH Commons, a web-based
client/server environment where the NIH and grantee community will conduct their
research administration business electronically by Fiscal Year 2000.  In 1998,
NIH pilot tested the following features of the NIH Commons system:
(http://commons.era.nih.gov/commons/)

o  Deployed the Status interface of the NIH Commons, which allows institutional
officials and principal investigators, with appropriate security, to access the
status of pending applications and awards, for testing with institutions
participating in the Federal Demonstration Partnership (FDP)
(http://TheFDP.org/);

o  Granted FDP institutions access to the e-SNAP interface of the NIH Commons�a
web site designed to facilitate submission of the noncompeting grant applications
(PHS form 2590) and the submission of annual scientific progress reports;

o  Posted an Internet web site where FDP institutions can submit (and NIH can
receive) training statement of appointment forms (form 2271).  Since 1996, the
NIH has received over 2,000 training appointment forms utilizing this technology. 
In December 1998, the current site will be replaced by the more efficient X-Train
Training Appointment System, which will be accessed through the NIH Commons;

o  Finally, in conjunction with members of the FDP, the NIH Commons staff
developed institutional and professional profiles, which will standardize the
information collected about applicant institutions and individuals and minimize
the redundancy of information collected with every grant application.  NIH is
also working with other Federal agencies to develop the Federal Commons, a common
electronic grant system that will promote flexible technological approaches to
accommodate the needs of all Federal grant recipients.  In 1998, the NIH received
$220,000 from the General Services Administration, on behalf of other Federal
agencies, to fund development of the Federal Commons interface.

o  In 1998, the NIH completed development and began deploying a revised version
of its Information for Management, Planning, Analysis, and Coordination (IMPAC)
system.  IMPAC II is a system, used by internal NIH staff, to track and manage
research grants and contracts.  IMPAC II has been developed so its information
can be migrated to the NIH Commons.  Hence, deployment of the IMPAC II system
will enhance the amount of information NIH makes available to the public about
its research grants and contracts.  Through this system, NIH has processed and
mailed approximately 6,000 electronic notice of grant awards to institutions
participating in the Federal Demonstration Partnership.

o  In 1998, NIH posted its Computer Retrieval of Information on Scientific
Projects (CRISP) system on the NIH Commons.  The searchable CRISP database, which
includes information regarding federally funded biomedical research projects
conducted at universities, hospitals, and other research institutions, enables
users to research scientific concepts, emerging trends and techniques, or
identify specific projects and/or investigators.  Since 1992, CRISP has been
located on a Gopher server maintained by the NIH.  By relocating the database on
the Commons, NIH has improved the public's ability to access and search the CRISP
records.  (http://commons.era.nih.gov/commons/)

o  OER hosts numerous Web sites at NIH in an effort to facilitate communications
with the public and NIH staff.  The OER Grants web site
(http://www.nih.gov/grants/oer.htm) provides a service for researchers, research
administrators, research organizations and others interested in NIH programs.
This site provides information to approximately 35,000 users per month and has
become a primary vehicle for dissemination of timely and critical information to
the public.  A new addition to OER is the NIH Research Training Opportunities web
site (http://www.nih.gov/training/), which incorporates information about
intramural and extramural training opportunities of all NIH Institutes and
Centers.  It is expected that this site will play a significant role in providing
the NIH community with important and timely training-related information,
organized in a user-friendly format.

Electronic Research Administration

Improving stewardship is a prime ongoing objective at the NIH in the
administration of grants and contracts to support research at universities and
other research facilities throughout the nation.  Improving the efficiency of
various administrative business processes and introducing more efficient ways to
communicate relevant information to grantee/contractor organizations will
maximally leverage appropriations devoted to research, and thereby contribute
directly to the productivity of the nation's medical research enterprise.

The impressive advances and almost constant changes in Information Technology are
being exploited at the NIH to improve stewardship of Federal funds.  NIH is
currently devoting substantial resources to the design, development, and
deployment of an electronic research administration (ERA) system.  This ERA
system will greatly facilitate preparation of grant applications by research
investigators, processing of applications by NIH staff, and management of awards
by grantee organizations and NIH staff.  Eventually, the ERA system will place
the entire grants administration life cycle of business processes within a
secure, efficient client-server common file database.

For the majority of the ERA functions described below, 1997 is a pilot year; 1998
is a transition year (expanding pilot testing to include 65 Federal Demonstration
Partnership Institutions); 1999 is a further expanded pre-production deployment
year during which approximately 100-150 organizations will be using the software;
and 2000 represents the goal for the full production implementation.

Advances in ERA and reinvention, while inter-related, are developing on separate
tracks.  Therefore, to keep the public apprised of the latest ERA news, NIH has
developed a web site solely devoted to it.  The latest 1998 ERA Status Report can
be accessed on the ERA homepage. (http://era.nih.gov/)

The 1998 NIH Priority Reinvention Initiatives

MODULAR RESEARCH GRANTS AND AWARDS

In 1998, pending the approval of Dr. Varmus and the NIH Institute and Center
directors, NIH is implementing the modular research grant application and award
concept.  Modular application, review and award procedures will apply to most
research project grant mechanisms (totaling no more than $250,000 in direct
costs) for the June 1, 1999, receipt date.

The modular research grant initiative, which has undergone extensive development
and pilot testing since 1994, builds upon previous activities in just-in-time
submission of information and modular budget proposals.  Under just-in-time
procedures, selected information or forms are not required at the time of
application; instead, this information is requested prior to award from just
those applicants with a likelihood of funding.  Under modular budget proposals,
applicants are instructed to prepare the budget request in direct cost "modules"
(multiples) usually up to a maximum direct cost level.  This process eliminates
the need for much of the budget detail, thereby relieving administrative burdens
on both NIH staff and grantee organizations and simplifying cost management by
NIH program staff.  Just-in-time procedures have been applied to several
mechanisms, including selected Career (K), AREA (R15), and SBIR Phase I (R43)
awards.  In the past four years, modular budget procedures have been extensively
pilot tested in over 34 application solicitations, covering a wide variety of
award mechanisms issued by the National Heart, Lung and Blood Institute (NHLBI)
and the National Institute of Allergy and Infectious Disease (NIAID).

The initial goal of the modular research grants initiative has remained constant:
to refocus the application and award process on the proposed science by reducing
unproductive attention to budget details.  Consistent with this goal, a trans-NIH
committee, comprised of grants management, review, and program officials, has
developed a final recommendation for implementing the modular research grant
concept.  The committee's recommendation has been thoroughly reviewed and
commented on by groups inside and outside of the NIH.  Based on public reaction
and input, the final proposal recommends allowing future applicants to request
total direct costs in $25,000 increments up to $250,000.  (Applications
requesting more than $250,000 in any year would be required to follow current
application instructions).  The proposal also envisions applicants submitting
simplified budgets absent of detailed categorical budget information on a
revised, streamlined form.  Additional budget detail would be requested only
under unusual circumstances.  The just-in-time features of the proposed modular
scheme would allow applicants to postpone the submission of other support
information until just prior to award.

If the committee's recommendation for implementing the modular research grant
application and award proposal is approved by NIH Director Harold Varmus and the
NIH Institute and Center Directors, an announcement unveiling the details of the
modular proposal will be published in the NIH Guide for Grants and Contracts.

The first full year of implementation will be a period for comment.  A thorough
evaluation will be conducted in the three years following implementation of the
modular proposal.  Throughout the initial implementation phase, NIH will welcome
input from investigators, reviewers, applicant organizations, and staff and will
consider appropriate modifications.  Inquiries and comments will accepted at:
grantsinfo@nih.gov

EXPEDITED RECEIPT TO AWARD

Since 1996, NIAID, in a partnership with the Center for Scientific Review (CSR)
and the OER, has been pilot testing an initiative designed to shorten the time
from receipt of application to award for the most meritorious applications.  This
initiative has been pilot-tested with all applications that are reviewed by the
CSR Tropical Medicine and Parasitology (TMP) study section and assigned for
potential funding to NIAID.

The pilot test has involved streamlining five features of the application-to-
award process.  (For the full details, see the notice published in the NIH Guide
for Grants and Contracts, January 10, 1997.)  First, the internal NIH process for
assignment of applications for review and potential funding is by-passed, so that
investigators self-assign their applications to the TMP study section and NIAID. 
Second, NIAID has developed a World Wide Web-based electronic review system,
which allows study section members to submit their electronically encrypted
reviews to a password-secured Web server prior to the study section meeting. 
However, the essential components of the peer review system remain unchanged, and
as under current procedures, independent scoring of applications is done by each
reviewer at the meeting.  Third, applicant institutions have the option of
deferring submission of the institutional review board (IRB) human subjects
certification; for fundable applications, this certification will be requested
by NIAID immediately after peer review.  Fourth, selected applicants (those whose
applications exhibit only minor problems) will be invited to submit an
abbreviated application amendment (three to five pages) in response to specific
questions and concerns raised during the initial review; these brief amendments
will be reviewed at the very next meeting of the study section.  Finally, under
the TMP pilot, the second level of peer review, performed by the National
Advisory Council, is expedited for the most meritorious applications (as
determined by peer review) so that it occurs electronically prior to the actual
Council meeting, thus allowing awards to be made sooner.

A preliminary evaluation of the NIAID expedited receipt-to-award pilot has
demonstrated that the combination of electronically-assisted peer review and the
NIAID expedited council review process cuts the time from application receipt to
award from nine months to five or six months.  Given these promising results, the
NIH has expanded pilot testing to four additional institutes (NHLBI, National
Institute on Aging (NIA), National Institute of Child Health and Human
Development, and National Institute of Neurological Disorders and Stroke
(NINDS)).  In 1998, these institutes, acting as "model institutes," are
instituting policies and procedures to initiate implementation of certain
components of the NIAID experiment, including expedited council review and the
use of just-in-time procedures.  These model institutes are also planning to
pilot test pre-award, pre-council grants management review procedures.  These
procedures authorize grants management staff to calculate total costs and conduct
business reviews of the most meritorious applications (those with scores within
a predetermined payline) prior to, as opposed to after, the Advisory Council
meeting.  At NHLBI, NINDS, and NIA, where this initiative has been pilot-tested,
pre-award, pre-council grants management review has helped cut more time from the
overall receipt-to-award process.  The model institutes are also being encouraged
to develop and experiment with their own procedures for expediting the receipt-
to-award process.

Over the next year, the NIH will be tracking the progress of this initiative and
evaluating its effectiveness.  If the results are encouraging, the NIH plans to
further expand implementation of the expedited receipt-to-award initiative.

PROGRESS REPORTING

In 1998, the NIH will continue its in-depth review and analysis of issues related
to the annual scientific progress reports submitted by grantees.  The primary
objective of this initiative is to ensure that NIH staff receive necessary and
useful information related to scientific research progress in a timely manner. 
As NIH prepares to receive progress reports electronically for the majority of
noncompeting applications (See March 1998 ERA Status Report regarding e-SNAP
initiative), the time is ripe to reconsider the purpose, timing, content, and
format of the annual progress information.  Further, given the progress that has
been made towards building the "Federal Commons" (an interagency electronic
interface where grantees will be able to conduct electronic research
administration transactions), the time is ideal for NIH to coordinate its
electronic progress reporting initiatives with other research agencies.

In this spirit of interagency coordination, the NIH has met with other Federal
research agencies to exchange information about their respective progress
reporting procedures and to identify common data elements in their progress
reporting formats.  The goal for 1998 is for the NIH, working with other Federal
research agencies, to develop a pilot that will enable a subset of NIH grantees
to submit their progress reports electronically�ideally, through the Federal
Commons interface.

SCIENTIFIC CODING

The NIH is continuing to review and analyze issues related to its scientific
coding process.  Scientific codes are those key terms assigned to each project
that appears in the NIH database of funded research.  NIH has been working to
improve the accuracy, quality, and assignment process of its scientific codes to
ensure that NIH systems accurately reflect the NIH-supported research.  The NIH
Office of Extramural Research (OER) is sponsoring a variety of experiments aimed
at improving the NIH scientific coding process.  Specifically, this year, OER is
testing the feasibility of using alternative source documents, such as an
application's abstract and/or specific aims to expedite and enhance the indexing
process.  OER is also experimenting with automated indexing software to compare
the quality of machine-indexed versus human-indexed abstracts and the retrieval
of machine versus human-indexed projects.  Finally, OER is working with the NICHD
to synchronize the NICHD project coding system with the NIH CRISP database that
the public accesses to retrieve scientific project data.  If OER and NICHD are
able to develop a common coding system, this effort will be expanded to include
other NIH Institutes and Centers.

COMMENTS

Input from NIH staff and the extramural research community is essential to the
success of the NIH reinvention effort.  Therefore, comments or suggestions on the
implemented changes and pilot experiments discussed in this report are welcome
and may be sent to the following email address: DDER@nih.gov

INQUIRIES

Dr. Wendy Baldwin
Deputy Director for Extramural Research
National Institutes of Health
Building 1, Room 144
Bethesda, MD  20892-0162
Email:  DDER@nih.gov


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