Full Text NOT-97-008
 
NIH ERA AND REINVENTION STATUS REPORT
 
NIH GUIDE, Volume 26, Number 17, May 23, 1997
 
P.T. 34

Keywords: 
  Grants Administration/Policy+ 

 
National Institutes of Health
 
INTRODUCTION
 
This is the fifth 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; and Vol.
25, No. 23, July 12, 1996.
 
The status report provides an update on ERA efforts and the NIH
priority reinvention initiatives for fiscal year (FY) 97.
Initiatives that have been fully implemented and described in
previous status reports are not included, nor are other initiatives
that are under preliminary discussion and not yet at the pilot
testing stage.  Some NIH institutes, centers or divisions (ICDs) may
be conducting their own reinvention initiatives or small-scale
pilots.  Information about these activities may be available on that
ICD's homepage, and questions may be directed to staff of the
particular ICD.
As NIH continues to undertake reinvention activities and new
initiatives, we recognize the need to establish a framework that will
provide the necessary structure for optimal interactions and be
complementary to the various reinvention activities.  The framework
delineates four major goals for reinvention: (1) maximize scientific
opportunities through optimal use of resources; (2) enhance NIH
interactions with the scientific community; (3) clarify and
streamline decision-making processes; and (4) focus internal
operations on outcomes and results.  Each of these goals is further
developed into specific reinvention objectives, and the plan is to
use these goals and objectives as guide-posts as the NIH moves
forward with reinvention projects.
 
The NIH extramural programs are designated as a reinvention
laboratory under Vice President Gore's National Performance Review
effort to "create a government that works better and costs less."  A
crucial component of this effort is feedback both internally from NIH
staff and externally from researchers and research administrators.
Comments or suggestions on the implemented changes and pilot
experiments are welcome and may be sent to the following email
address: DDER@nih.gov.
 
I.  ELECTRONIC RESEARCH ADMINISTRATION
 
Improving stewardship is a prime ongoing objective at the NIH in the
administration of grants and contacts awarded to support research at
universities and other research facilities around the Nation.
Improving the efficiency of various administrative business processes
and introducing more efficient ways to communicate relevant
information between the NIH and 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 phenomenal advances and almost constant changes in Information
Technology are being exploited at the NIH to improve stewardship of
awards.  NIH is currently devoting substantial resources in the
design, development and deployment of an electronic research
administration 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.
 
The ERA system will eventually place the entire grants administration
life cycle of business processes within a client-server common file
database.  Using this database technology will permit the NIH to
maintain timely, fully electronic communication with extramural
grantee "business partners."  The system will be made fully secure
using state-of-the-art encryption methodology.  Access will be
limited to authorized applicants, awardees and NIH staff, who could
each review and add information as required.  Proposed components of
the system include submission and review of competitive grant
applications; maintenance of contact information for all NIH grantee
organizations and investigators; a status system by which authorized
users can determine the status of pending application-related
activities (including review dates, scores, and application
critiques); electronic notification to the grantee organization of
grant award; and a full function search interface to review awarded
research project abstracts.  Other post-award reporting features will
include financial, research progress, research trainee appointments,
inventions, and women and minorities in clinical research.
 
NIH is taking a well-documented, methodical approach to designing the
portions of the ERA system that will support these varied business
processes.  The components of the ERA system that have been built and
are either undergoing pilot testing, or have been fully deployed as
summarized below.  For the majority of the ERA functions described
below, FY 97 is a pilot year (pilot testing with ten institutions, as
described below); FY 98 is a transition year (expanded pilot testing
with Federal Demonstration Partnership institutions); and FY 99 is
the goal for full production implementation.
 
Electronic Submission of Competing Grant Applications
 
A.  Electronic Data Interchange (EDI).  Under a Department of Energy
(DOE) Cooperative Agreement, the NIH and several Department of
Defense (DoD) agencies are participating in a pilot study to test a
new system for the submission of grant application information.
These agencies and ten research institutions will test the 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, will be submitted
directly into NIH's database, without intervening paper copies or
manual re-keying of data.  This pilot implementation will continue
through Spring 1997 and will be expanded in 1998 to include more
aspects of the applications and more grantee organizations.
 
B.  HyperText Markup Language (HTML).  The first pilot implementation
of the competitive application involves transmission of data via
Electronic Data Interchange formatted files.  In an effort to provide
grantee organizations with alternative modes of transmission of the
same data, the NIH is currently prototyping software that will allow
for the receipt of competitive application information via an HTML-
formatted data stream.  HTML is the language used to format data for
use and visualization on the World Wide Web.  Thus, allowing for
receipt of grant application information in this format affords
grantee organizations who are developing research administration
systems centered on Internet and HTML to retain data in this common
format as they prepare to submit information to the NIH.  It is
important to emphasize that both EDI and HTML-formatting datastreams
will be based strictly on the same standard set of data elements.
NIH began demonstration of the HTML prototype software in March 1997,
and future expansion will occur in parallel with receipt of data via
EDI.
 
Electronic Streamlined Noncompeting Award Process (e-SNAP)
 
In FY 95, NIH instituted a simplified noncompeting award process
(SNAP) for the majority of noncompeting continuation awards.  Under
SNAP, which applies to awards under the Expanded Authorities and
Federal Demonstration Partnership, certain components of the
noncompeting application are not required if there are no significant
changes.  (For more information on SNAP, see the NIH Guide for Grants
and Contracts, October 27, 1995 and July 5, 1996.)  An ERA version of
the SNAP process is now being pilot tested.  "E-SNAP" is an
interactive World Wide Web-based site for electronic submission of
the SNAP information.  Using the interface authorized grantees will
submit electronically all required information, and then through a
separate site grantee organization administrative official(s) will
approve the submission to initiate the noncompeting award process.
Upon receipt of the e-SNAP submission, NIH staff will evaluate the
electronic application and if approved generate an electronic Notice
of Grant Award back to the grantee and grantee organization
administrative official(s).  The pilot implementation of e-SNAP began
in December 1996 with ten grantee organizations.  Plans call for full
implementation of e-SNAP for all Expanded Authorities awards in FY
98.  Eventually, all NIH awards will be eligible to provide the
noncompeting continuation information via the Web-based system.
 
Electronic Reporting Of Trainee Appointments
 
Organizations that receive National Research Service Act (NRSA)
Institutional research training grants must report on the appointment
of trainee(s) supported under the grant.  An ERA system interface is
now being piloted that provides for the electronic submission of
trainee appointment information.  Like e-SNAP, the trainee
appointment system takes advantage of the user-friendly benefits of
the World Wide Web.  In this case, the grant Training Program
Director will submit required information through the secure Web
interface.  The pilot deployment of this portion of the ERA system
started at the beginning of FY 96 with test data.  "Live" data was
received from eight grantee organizations in mid-FY 96, with NIH
staff issuing electronic approvals.  Expansion to an additional 40
institutions is anticipated by the end of FY 97.
 
Application Status System
 
One of the obvious benefits of electronic communication is the
ability to exchange time-sensitive information in a timely manner.
Once critical administrative decisions or updates in information
occur, the results of these actions can be communicated rapidly.
This type of functionality for NIH extramural grants administration
will be provided through the ERA "Status" interface.  In the first
phase of the pilot test of Status, which began in March 1997,
authorized users log onto a secure Web site where they can review
pre-award status, including application arrival at NIH, assignment
for review, dates of review, review score, critique, Advisory Council
meeting dates, and, if successful, likely award date.  Grantee
organization officials will be able to view pending actions for all
applications originating from their organization.  This will offer
improved administration within the grantee organization.
 
The second phase, to follow near the end of FY 97, will not only
provide status feedback, but also will enable research investigators
to receive the text of Summary Statement(s) as well as priority
score(s) for any of their reviewed but yet to be awarded
applications, in addition to updating their contact information
(Professional Profile including curriculum vitae).  In a similar way,
authorized Grantee Organization officials will be able to update the
organizational contact information (Organizational Profile including
administrative officials, financial, assurance and certification
information).  These actions will preclude re-keying of such
information for each submitted application, as must now be done with
paper submissions.
 
Electronic Invention Reporting
 
The requirement for reporting of information pursuant to inventions
derived from Federal funds is mandated in the Bayh-Dole Act.  To
support this requirement the NIH has developed an ERA system dubbed
"Edison", designed to receive, store, sort, and provide reports on
invention, patent, licensing and invention utilization.  As the first
secure interactive Web site developed in ERA, it has been deployed in
a full production version since the beginning of FY 96.  The mission
of ERA has been realized and can be documented by the Edison system.
After one year, almost 50 percent of the grantee organizations that
report inventions routinely to the NIH are using Edison.  For each
invention this represents the reduction from typically 15 cycles of
paper correspondence to 3, dramatically shortening reporting time and
effort, as well as making more information available in a usable
format for grants administrators.  In addition to continued
recruitment of grantee organizations to use Edison, the next phase
for this ERA system component will be to include other Federal
research agencies in the deployment.  Seven additional agencies,
including NSF, EPA, FDA, CDC, USDA, NOAA and USAID have made
commitments to use the Edison system to support invention reporting
by their grantees.  "Interagency Edison" will be piloted in the
Spring of 1997.
 
CRISP on the Web
 
The NIH awards database, Computer Retrieval of Information on
Scientific Projects (CRISP), is a collection of information that
spans nearly 25 years.  It is accessible via a "gopher" interface,
which is limited to relatively simple queries.  As part of the ERA
initiative, a Web-based CRISP interface will allow full text
searching of research project abstracts and grantee organization
information.  This will improve the ability to retrieve the most
relevant sources of information to facilitate further research
through inquires by researchers, to provide useful orientation for
the public, and to improve the efficiency of responses to inquires
issued by other agencies and Congress.  The new CRISP Web interface
will be pilot-tested with NIH staff commencing in summer 1997.
Deployment to the public will follow in FY 98.
 
ERA Interagency Efforts
 
NIH continues to work with other Federal agencies through the
Electronic Commerce Committee (ECC).  The ECC will focus attention
this year on development of data requirements associated with the 1)
notice of grant award, 2) investigator biographical information, 3)
progress reports, and 4) organizational profile information.  In
addition, the ECC will update the Electronic Commerce Project Plan.
All efforts, including pilot demonstrations, will be closely
coordinated with the Federal Demonstration Partnership.  The agencies
will continue to use a wide variety of outreach mechanisms to assure
the involvement of and communication with institutions, researchers,
and others affected by electronic commerce in research
administration.
 
Research Contracts -- Electronic Requests for Proposals
 
Four additional NIH institutes (NIEHS, NLM, NICHD, and NIDA) have
joined NIAID, NHLBI, and NCI in posting Requests for Proposals (RFPs)
on the NIH Gopher server.  A substantial savings in the cost of
mailing and copying, and in contract staff effort, will be realized
through electronic distribution of RFPs.  In addition, the electronic
RFP provides information in a more logical sequence, making the
process of reviewing the document much more efficient and effective
for potential contract offerors.
 
Research Contracts -- Paperless Acquisition
 
The NIAID has conducted a pilot to test the feasibility of
"paperless" acquisition of research contract proposals.  This
"paperless" system is expected to reduce the time and expense of all
parties involved in the acquisition process.  Under this pilot, the
issuance of the RFP, the submission of proposals, and the
distribution of proposals to the reviewers were conducted
electronically, via the internet.  The peer review was conducted
through the use of an electronic format, which allowed the reviewers
to interact, and evaluate and score the proposals.  Appropriate
security was maintained through the use of a dedicated server with
access restricted by assigning passwords to approved users.  This
approach has the potential to save the Government the cost of travel
and per diem for reviewers, and to reduce the staff time needed to
process a proposal through to award.  In addition, offerors will be
spared the costs associated with copying and mailing proposals.  A
subsequent effort to eliminate the use of a dedicated server and use
the World Wide Web directly is currently under discussion.
 
II.  NIH FY 97 PRIORITY REINVENTION INITIATIVES
 
Modular Applications and Awards
 
This reinvention initiative builds on 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 "just-in-time" for award from just those applicants with a
likelihood of funding.  Under modular budget proposals, applicants
are instructed to prepare the budget request in direct costs modules"
(multiples) (e.g., $25,000), 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.
 
To date, just-in-time procedures have been applied to FIRST (R29),
selected Career (K), AREA (R15) and SBIR Phase I (R43) awards, and
modular budget procedures have only been used in a small number of
requests for applications (RFAs).  The Modular Applications and
Awards initiative would extend these prior experiments to other types
of NIH research grants.  The goal is to refocus the application and
award process on the proposed science by reducing unproductive
attention to budget details.  A proposal is being developed regarding
the procedures, budget formats, and amounts/modules by which
applications for most NIH research grant mechanisms would request
their total direct costs, and how these newly-formatted applications
will be handled by peer review and by NIH grants management and
program staff.
 
Experience with both the review and award of modular grants, with the
handling of abbreviated budgets, and with just-in-time procedures has
been gained over the past few years through RFAs issued by several
Institutes and through the official changes in the application
requirements for FIRST, Career, AREA, and SBIR Phase I grants.  This
experience will serve as background for the modular assistance
reinvention initiative.
 
The next steps involve discussing the proposal and receiving feedback
on it with diverse parties, including high-level NIH officials, the
various NIH functional committees, initial review group members, the
extramural community (both individually and through professional
associations), and HHS and other agency officials.  This discussion
period would proceed through approximately June/July 1997, with a
decision by the NIH Director by September/October 1997.  If approved,
the change and specific instructions would be announced in the NIH
Guide for Grants and Contracts in November/December 1997.
 
Progress Reporting and Scientific Coding
 
NIH has undertaken an in-depth review and analysis of issues related
to progress reporting (the annual reports submitted by grantees) and
scientific coding (the key terms for each project that appear in the
NIH database on funded research).  The primary objectives are to
ensure that NIH staff receive necessary and useful information
related to progress in a timely manner, and to improve the process of
capturing scientific coding information about projects, so as to
ensure that NIH systems accurately reflect the research being
supported by NIH.
 
As NIH prepares to receive progress reports electronically for the
majority of noncompeting applications (e-SNAP, described above), the
time is ripe to reconsider the purpose, timing, content, and format
of the annual progress information.  For scientific coding, NIH must
consider who uses the information and for what purposes; who is
responsible for the accuracy and quality; and what portion could be
provided electronically from applicants/grantees and who reviews or
"adds value" to that information.
 
Possible changes to progress reporting and scientific coding will be
pilot tested over the next year.  For example, NIAID is developing a
progress reporting pilot in which a subset of grantees would submit
electronic updates on the funded research that would include a
general description that is accessible to the public, and a
confidential section for use only by NIH staff.  Investigators will
be asked to update the information in May of each year.  However,
they may update more frequently, particularly when there are new
publications or significant changes in the research progress.  For
scientific coding, an experiment is planned that would evaluate the
degree of concordance between scientific review administrators,
referral officers, program staff, NIH coding staff, and the principal
investigators, in coding a group of grant applications after an award
has been made.  The pilot is designed to address whether coding at a
gross level can be done by the investigators, followed by assignments
of more detailed terms by NIH coding staff.  The objective is to
improve consistency and reliability of the CRISP database in order to
reflect accurately the NIH award portfolio.
 
Receipt and Referral Process
 
The "Receipt and Referral" process is the process by which NIH
receives grant applications and refers each to a scientific review
group for initial review and to an NIH institute or center for
potential funding.  The main goal of the Receipt and Referral
reinvention initiative is to shorten the time from application to
award by streamlining the process and, at the same time, to consider
changes to the process that will be required in the future when NIH
receives applications in electronic format.  Each year, approximately
40,000 applications are received by NIH and appropriately assigned
for peer review and funding; it is extremely rare that an application
is lost.  However, this process absorbs up to two months of time
after applications are received by NIH.  The most time-consuming and
costly components of the process are the re-keying of data from each
application and the printing and duplication of each application (up
to 50 copies each) for use by the review group and funding institute.
This initiative is currently underway and will result in a report
that analyzes the current process and provides recommendations on
near-term and longer-term improvements to the process.  Many of the
longer-term recommendations are related to receipt of electronic
applications; these will be pilot tested over the next year and
evaluated against benchmark data from the current process prior to
deciding on a final design.
 
Expedited Review and Award
 
NIAID, in partnership with the Division of Research Grants and the
Office of Extramural Research, is leading this pilot initiative that
is designed to shorten the time from receipt of application to award
for the most meritorious applications.  This initiative is being
pilot-tested with all applications that are reviewed by the DRG
Tropical Medicine and Parasitology (TMP) study section and assigned
for potential funding to NIAID.
 
The pilot test will experiment with 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 is being tested in this pilot.  The
system allows study section members to submit their
electronically-encrypted reviews to a password-secured Web server
prior to the Study Section meeting.  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 until requested by NIAID for fundable applicants
immediately after peer review.  Fourth, selected applicants (those
with minor problems) will be invited to submit an abbreviated
application amendment (three to five pages) directly related to
questions and concerns raised during the initial review, for review
at the very next meeting of the study section.  Finally, 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 prior to the Council meeting, thus
allowing awards to be made sooner.
 
This initiative was begun in October 1996 and will continue through
February 1998; three rounds of pilot tests will be conducted during
this period, with ongoing evaluation and refinements incorporated as
the initiative proceeds.  The combination of electronically assisted
peer review and NIAID's expedited council review have cut the time
from receipt of application to award from 9 months to approximately 5
months.  Although the initial pilot tests are limited to a single
initial review group and awarding institute, the eventual results
will likely streamline aspects of the receipt, referral, review, and
award processes for all NIH applicants.  For more information about
this and additional NIAID electronic review experiments being done in
collaboration with other ICDs, see the NIAID website at
http://www.niaid.nih.gov/ncn/news.htm
 
Accelerated Amendment Review
 
As explained above, NIAID is pilot testing an expedited process for
the submission of amended applications.  National Cancer Institute
(NCI) has fully implemented a similar process called Accelerated
Executive Review (AER), in which original, unamended Type 1 (new) or
Type 2 (competing continuation) R01 applications that are within four
percentile points of the NCI payline for basic research or 10
percentile points for patient-oriented research are eligible for an
expedited administrative review.  Notification is sent to eligible
applicants along with their Summary Statements.  These applicants
have the option of submitting a three to five page response to the
critiques in the Summary Statement.  These responses are reviewed by
Institute program staff and forwarded to the NCI Executive Committee,
composed of the Institute Director, senior NCI staff, and extramural
researchers on detail to NCI.  The Executive Committee assesses the
response to determine whether the additional information would enable
the application to move up in rank to within the payline.  The
Committee has several options: to pay or reject the application after
AER, to hold an application with high program relevance that has not
improved and consider it later for funding as a straight exception
beyond the payline, or to consider it immediately for funding as a
Shannon Award.  Competing continuation applications also may be
recommended to receive a reduced level of interim funding for an
additional 3 to 6 months while a full amendment is submitted to DRG,
or no action might be taken except to recommend submission of a
revised application under the normal procedures.
The major benefit of AER is the elimination of eight months from the
amendment process for successful applicants.  It is also designed to
encourage submission and funding of clinical projects and time-
sensitive collaborations.  The AER process is described in more
detail on the NCI home page at
http://www.nci.nih.gov/extra/deaweb/doc/aer.htm
 
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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