NIH GUIDE, Volume 23, Number 44, December 16, 1994

P.T. 34


  Grants Administration/Policy+ 

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 and the accompanying mandate to reduce

the size of the Federal workforce, the NIH extramural programs have

been designated one of several Executive Branch "Reinvention

Laboratories," to lead the process of change for grants

administration 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.

A large number of initiatives are currently underway at NIH.  Some

are new and directly responsive to the mandate of reinvention; others

are a continuation of ongoing efforts to improve the way NIH does

business.  Some address issues specific to extramural activities,

while others address overarching issues at the NIH, PHS, or HHS level

that potentially have impact on extramural programs.  They emanate

from ideas contributed by individuals and groups, both within and

outside of NIH.  When feasible, pilot studies are being conducted.

The activities are coordinated by the Extramural Reinvention

Committee (ERC), which operates under the auspices of the OER and

ensures sharing of knowledge and prevents duplication of effort.  An

essential feature of this coordination is that it does not serve a

"gatekeeping" function, i.e., it does not serve as a bureaucratic

impediment to the free flow of ideas, activities of working groups,

or development of pilot experiments.

The reinvention activities outlined below are organized into three

sections: those which directly impact on the submission of competing

applications and the peer review process; those which deal with post-

award issues; and those which aim 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 state of reinvention activities will be updated.


Triage - (full implementation beginning February 1995) - Beginning

with the February 1995 round of review (i.e., review of applications

submitted October/November 1994), all DRG study sections will employ

the triage process routinely, and Initial Review Groups (IRGs) within

Institutes and Centers (ICs) may use it at their option.  This

represents an extension across NIH of a triage process that had been

used successfully for a number of years by the ICs for the review of

applications received in response to Requests for Applications

(RFAs).  In triage, peer reviewers are asked to identify the pending

applications (approximately half) that are "unrealistic candidates

for funding in the present budgetary environment" (not to be equated

with "disapproval" or "not recommended for further consideration").

Those applications are not discussed at the study section meeting,

and are not given priority scores.  If even one member of the study

section believes that the application has some chance of being

funded, the application is fully discussed and scored.

A pilot study has been conducted.  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

30 to 50 percent of the applications as not to be discussed, and

reviewers consistently indicated that there was more time for

discussion of the applications that were scored, and that meetings

ended earlier than usual.  Expanded pilot studies were conducted in

the June and October 1994 rounds of review.  While triage can now be

considered to be fully implemented, the process will nonetheless

continue to evolve, with adjustments and modifications if necessary.

Modified Summary Statement - (full implementation beginning February

1995) - The first-phase triage study incorporated a streamlined

format for the expedited production of summary statements.

Applicants whose projects were unscored received a critique that was

essentially unabridged comments from the reviewers, with the intent

that this would allow for a quicker return of the critiques and

provide the applicant more time to amend and resubmit the

application, if desired.  Feedback from applicants involved in the

first-phase study (and others) indicated that, in general, receiving

essentially unedited reviewers' comments is preferable to receiving a

synthesis of the critiques prepared by NIH staff.  In the expanded

triage study, the use of essentially unabridged reviewers' critiques

was extended to all applications.  For the scored applications, a

"Resume and Summary of Discussion" was included to convey the

highlights of the discussion at the study section meeting leading to

the final rating, plus a paragraph detailing budgetary

recommendations as appropriate.  The modified summary statement

format will be used for all applications reviewed by DRG study

sections beginning with the February 1995 round of review (i.e.,

those submitted in October or November 1994).

Expedited Release of Summary Statements to Applicants - (concept

under discussion) - In current practice, 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. Now that

full implementation of triage and the use of modified summary

statements are in place, it has been suggested that summary

statements for unscored applications, which consist of the

essentially unedited reviewers' comments, might be released to

applicants directly from DRG.  This would provide considerably faster

feedback to investigators whose applications were unscored.

Retrospective versus Prospective Review - (concept under

discussion) - The usual NIH peer review process is primarily

prospective in that it typically focuses on a detailed proposal of

the specific research studies 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 could afford

the precision of hindsight and is believed by some to be the best

predictor of continued creativity and accomplishment; and 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.  Ongoing discussion is focused on the question of under what

circumstances 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.

Restructuring DRG Review Groups: - (concept under discussion) - Ideas

are being considered about how the new Initial Review Group-based

organization of DRG can be exploited to broaden the range of

expertise represented on individual study sections without

sacrificing focus.  In addition, discussions are under way to

identify mechanisms for periodic review of the organization and

function of IRGs and their constituent study sections, to ensure that

they evolve in pace with scientific advances.

"Just in Time" - (pilot experiments currently under way) - "Just-in-

Time" postpones the collection of a fairly substantial amount of

information that currently must be provided for all competitive

applications.  Data on other support and complete budget detail would

not be requested at the time of application, and the biographical

sketch would instruct applicants to provide only information related

to research background and experience, including, at the option of

the applicant, the sponsored support relevant to the proposed

research.  This approach would simplify and reduce the administrative

burden associated with the NIH grant application without compromising

the initial review group determination of scientific merit or the

reasonableness of the proposed budget.  Detailed information relevant

to the award of the project would be exchanged "just in time" prior

to award.  This delayed request and receipt of information should

relieve administrative and paperwork burdens for the approximately

70-75  percent of applicants who will not receive an award.  In order

for "Just-in-Time" to be effective, it is essential that applicants

and their institutions be prepared to provide the detailed

information quickly, if a decision were made to fund an application.

"Just-in-Time" pilot tests are being conducted through a number of

RFAs and Program Announcements from several ICs.  This provides an

opportunity to explain the requirements to a defined set of

applicants and to evaluate the results.

Identification of High Risk/High Impact (HR/HI) Research Applications

- (implementation in place since June 1994) - Since June/July, 1994,

reviewers serving on DRG study sections have been asked to identify

those applications that both 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 will

require agreement of at least two members of the IRG.  The goal is to

determine whether IRGs can better identify HR/HI applications when

specifically asked to, and if the information they provide will aid

program staff and the National Advisory Councils to better identify

special research opportunities for consideration.

Amended Applications - (concept under discussion) - Currently, there

is no limit to the number of times an unsuccessful application can be

resubmitted in an amended version.  This impacts on review burden,

and can result in inefficiency, particularly in cases where the

original application is either fairly weak overall or for the most

part quite strong.  Applicants with intrinsically weak proposals have

been known to incorporate reviewers' specific suggestions into

amended versions, cycle after cycle after cycle, with the expectation

that eventually this will suffice to merit a fundable score.  On the

other hand, applications that are very strong overall, but for which

reviewers have raised a few relatively minor questions or criticisms

(the sort that could easily be dealt with by a one or two page

response from the applicant), are frequently voted scores that put

them beyond the nominal payline for funding.  Those applicants must

then resubmit an amended version, which is then subjected to the

lengthy review process all over again.  This introduces delays in the

initiation of worthwhile research activities.  Such delays can be

deleterious to the careers of beginning investigators, and can result

in serious inefficiencies of both cost and time when the delay

results in a funding discontinuity for a renewal project.

Discussions are focusing on a proposal to limit the maximum number of

amended versions permitted to two (i.e., no more than three

submissions of the same project), and on ways in which time-consuming

resubmission of promising applications might be avoided (e.g., by

increased use of deferral and request for additional information by

study sections and/or by Program staff for presentation to National

Advisory Councils).

Cost Management:  budgeting for total costs rather than direct

costs - (concept under discussion) - The usual current practice is

for applicants to request, and for reviewers and program staff to

recommend, grant budgets in terms of direct costs.  Indirect costs

usually increase total costs by approximately 30 percent.  However,

indirect cost amounts may vary unpredictably over the duration of a

multi-year grant, as institutional indirect cost rates change as a

result of negotiations or as direct-cost spending patterns vary

(e.g., if funds originally budgeted for equipment are instead used

for supplies, or vice-versa).  Thus, it is difficult to estimate true

out-year funding commitments for budget projection purposes.  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 provides cost

management incentives to the grantee institution and investigator.

Modular Grants - (pilot experiments under way) - The concept of the

modular grant is based on a return to the underlying 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 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 is

envisioned as eliminating the need for submission or review of

detailed budgets.  Fiscal accountability for individual projects

could largely be shifted to the recipient organizations, with NIH

retaining responsibility for oversight of the organizations'

monitoring systems and remaining accountable for the scientific

progress of the projects it supports.  A feasibility test of the

modular grant mechanism is being undertaken by the National Heart,

Blood, and Lung Institute (NHLBI) through a Request for Applications

(RFA) for R01 applications that was issued in the Fall of 1994, with

applications due in January 1995.  A second pilot is planned, also at

NHLBI, in conjunction with an RFA for multi-project applications.

This concept could be extended to address total costs.

Post-Council Notification - (limited implementation in place) -

Several ICDs have eliminated routine use of post-council letters.

Instead, all applicants are informed of the status of their pending

applications in the letters that accompany the summary statements and

that they will be notified if the National Advisory Council makes any

recommendation that differs from or alters the recommendation of the

IRG.  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 (NHLBI only).  Full implementation of this

reinvention would eliminate the mailing of more than 25,000 letters

from the NIH each year.

Electronic Research Administration - (in planning stage; some pilot

experiments under way) - Electronic research administration

initiatives are based on the concept that electronic files would be

created to serve as the repository for all information generated

during the life cycle of each grant.  This data base would be

accessible to authorized institutional and NIH staff, who could each

review and add information as required.  When fully implemented, this

should streamline the administration of research grants and

cooperative agreements.  One major initiative involves the electronic

submission of grant applications.  A feasibility experiment in which

R01 applications were submitted electronically in their entirety,

using software provided by NIH (Automated Grant Application System,

AGAS), was carried out for five review cycles (February 1993 through

July 1994) in cooperation with seven major grantee institutions.

Analysis of the results of the experiment have not yet been

completed.  However, the experiment was limited by the fact that

internal NIH procedures for the post-receipt handling of applications

are not yet electronic and therefore require the use of paper

documents.  These trials illuminated the diversity in the way

applicant organizations use automation to create applications and to

capture relevant data for use within their inhouse systems.

Therefore, NIH has adjusted its plan to emphasize the publication of

transmission stream specifications.  This will open up opportunities

for independent software vendors to develop grant application

creation software, which can create data streams compatible with NIH

processing systems.

Another experiment (Limited Electronic Submission System, LESS) was

begun in October 1994 in cooperation with two major grantee

institutions, in which 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 aim is to feed the

electronically-submitted information directly into NIH's internal

data base (IMPAC), without the need for intervening paper copies or

manual re-keying of the data.  In the near future, this process will

be further simplified through an initiative to provide each

institution with a unique, assigned number that would be used to link

the application with administrative information already contained in

IMPAC, e.g., institutional assurances and certifications, names of

institutional officials.  By using these institutional profiles, the

need to provide data repeatedly on a project-by-project basis would

be eliminated.

Increased electronic availability of information about extramural

research programs - (planned 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 will soon be available on the NIH Gopher; and the CRISP

database, which lists all NIH grant and contract awards, is available

on the NIH Gopher.  The full text of the NIH Guide and the Table of

Contents is available through separate LISTSERV 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.


Notice of Grant Awards (NGA) - (full implementation announced in NIH

GUIDE, Vol. 23, No. 42, December 2, 1994) - The awarding Institutes

and Centers (ICs) have recently implemented a new procedure whereby

only a single copy of the NGA is mailed to the grantee institution's

administrative official, with the instruction that the institution

distribute copies to the Principal Investigator and other interested

parties.  This eliminates the mailing of copies to several offices

from NIH, and will serve as a phase-in to the longer-term goal of

electronic transmission of NGAs.

Streamlining the Non-Competing Award Process - (implementation begun

October 1994) - The goal is to create a process that is more

efficient and less burdensome for all parties involved.  One guiding

principle is that, to the extent possible, the financial and

administrative information required for the responsible award and

administration of a grant should be obtained at the time of the

competing award; the noncompeting applications could then focus on

the scientific progress of the research.  Toward this end, beginning

October 1, 1994, financial reporting for Type 5 applications has been

streamlined.  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 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.  Further streamlining is under consideration,

notably the possibility of eliminating the annual Financial Status



A number of experiments and other activities are underway to improve

the efficiency and cost-effectiveness of internal NIH processes.  For

example, the NIH Extramural Research Reinvention Laboratory has

requested redelegation of authorities related to advisory committee

administration and grants administration policy and regulation, with

the goal of reducing paperwork, effort, and delay related to

obtaining clearances at several levels within the DHHS.  Other

internal reinvention activities at various stages of development

include: streamlining the DRG process for nominating study section

members; expedited assignment 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 internal clearance

and approval of cooperative agreement RFAs; streamlining internal

review for non-competing awards; reinvention of contracts management

procedures; and simplification of other grants management-related


(Suggestions may be submitted to Dr. Wendy Baldwin, Deputy Director

for Extramural Research, National Institutes of Health, Building 1,

Room 152, Bethesda, MD 20892, or via e-mail:  DDER@NIHOD1.BITNET  or


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