Full Text HD-94-016

COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK

NIH GUIDE, Volume 23, Number 12, March 25, 1994

RFA:  HD-94-016

P.T.


Keywords: 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  May 1, 1994
Application Receipt Date:  July 19, 1994

PURPOSE

The National Institute of Child Health and Human Development (NICHD)
invites applications from investigators willing to participate, with
the assistance of NICHD under cooperative agreements, in an ongoing
multicenter cooperative program designed to conduct clinical studies
investigating problems in adult reproductive medicine, including
infertility, reproductive endocrinology, gynecology, and andrology.
The objective of this program is to facilitate resolution of these
problems by maintaining a network of sites that, by vigorous patient
evaluation using common protocols, can study large numbers of
patients and can provide answers more rapidly than individual sites
acting alone.  The benefit of this activity will be to the public:
the infertile couples, the individuals with reproductive diseases and
disorders, and their health-care providers.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Cooperative Multicenter Reproductive Medicine
Network, is related to the priority area of family planning.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private.  Minority individuals, persons
with disabilities, and women are encouraged to apply.  The need for
continuous and active communication among sites dictates that only
institutions in the United States will be eligible to apply.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program
will be a cooperative agreement (U10), an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
scientific and/or programmatic involvement with the awardee is
anticipated during performance of the activity.  Under the
cooperative agreement, the NIH purpose is to support and stimulate
the recipients' activity by involvement in the activity and otherwise
working jointly with the award recipients in a partner role, but it
is not to assume direction, prime responsibility, or a dominant role
in the activity.  Details of the responsibilities, relationships and
governance of the study to be funded under cooperative agreements are
discussed later in this document under the section "Terms and
Conditions."

The total project period for applications submitted in response to
the present RFA may not exceed five years.  The anticipated award
date is April 1, 1995.  Because the nature and scope of the research
proposed in response to this RFA may vary, it is anticipated that the
sizes of awards will vary also.

Awards and level of support depend on receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the NICHD, awards pursuant to
this RFA are contingent upon the availability of funds for this
purpose.

At this time, the NICHD has not determined whether or how this
solicitation will be continued beyond the present RFA.

FUNDS AVAILABLE

It is anticipated that one award for the Data Coordinating Center and
eight awards for Clinical Sites will be made, with an estimated total
of $1,800,000 (including direct and indirect costs) for the entire
program in the first year.  Up to five competing continuation awards
and at least four new awards are expected.

RESEARCH OBJECTIVES

Background

Within the mission of the NICHD, a preeminent goal is assuring the
birth of wanted babies through studies on human fertility and
infertility.  To this end, the Reproductive Sciences Branch supports
research on human fertility and infertility and diseases and
disorders of the human reproductive system.

Particularly in the field of infertility, but in other aspects of
reproductive medicine as well, uncontrolled, trial-and-error methods
have led to undeserved claims of effectiveness and resulted in
significant costs, both human and financial.  Even for "male factor,"
the female partner usually undergoes treatment.  Little is available
for diagnosis or treatment of clinically normal men with a sperm
defect.

There are gynecologic conditions that result in significant
morbidity, particularly in women of reproductive age.  Conditions
such as endometriosis, leiomyomata uteri, abnormal uterine bleeding,
and others can cause pain, disruption of function in the workplace
and the home, and other problems beyond or beside effects on
fertility.  Many of these conditions can lead to hysterectomy or
other major surgery.  In some cases, alternative management
strategies might have been effective, but were not understood,
accessible, or affordable.

Following a 1988 concept clearance review by a group of independent
experts, an RFA was issued in 1989 to initiate the Cooperative
Reproductive Medicine Network.  Its overall goal has been to address
the need for rigorous controlled evaluation of diagnostic and
therapeutic practices in the area of reproductive health care.  Since
its inception in 1990, a protocol study comparing intrauterine and
intracervical insemination, with or without ovulation induction by
exogenous gonadotropin, has been developed and is being conducted by
the Network.

Despite this and other examples of careful, modern research, there is
yet much to be done.  Only recently has the basic science base of
knowledge about the pathophysiology of common, distressing conditions
begun to approach the point at which clinical studies can use this
new knowledge as a practical foundation.

The report language accompanying both House and Senate appropriations
bills for fiscal 1994 emphasizes infertility, and the Senate report
also highlights endometriosis and uterine fibroids as examples of
needed gynecology research.

Use of the cooperative mechanism has many advantages.  The NIH staff
participant will contribute scientifically to consensus
decision-making and maintaining balance among the participants.  In
this way, the group can identify issues with a high degree of
objectivity, develop well-designed protocols, provide to participants
expert statistical consultation in experimental design and analysis,
and provide a large patient base, so that tests and treatments could
be evaluated more rapidly and with greater statistical validity than
otherwise.  The anticipated efficiency of communication among
investigators and dissemination of information to practitioners and
the public would lead to more effective patient care and more
economical use of resources.

Objectives and Scope

There are a number of controversies in Reproductive Medicine that
would lend themselves to cooperative study.  The following should by
no means be viewed as exclusive, and are intended only as examples:

o  In vitro fertilization: Patient selection, comparison of treatment
protocols to optimize live birth rates.

o  Endometriosis: Controlled trials of diagnostic methods and
treatments, examining post-treatment fertility and/or symptom
reduction.

o  Polycystic ovarian syndrome: Definition, subgroups, response to
therapies.

o  Leiomyomata: Controlled trials of diagnostic methods and
treatments, examining post-treatment fertility and/or symptom
reduction.

o  Varicocele: Effect on fertility, benefits of surgery.

o  Male infertility: Diagnosis and treatment directed at the male.

The Network will include approximately eight clinical sites or
"Reproductive Medicine Units" (RMUs) and a Data Coordinating Center
(DCC).  There will be two domains within the Network:
Infertility/Andrology and Gynecology.  "Infertility" is intended to
encompass male factor, female factor, and unknown cause.  It is
anticipated that initial Network activity would encompass one
protocol from each domain, with one RMU acting as lead unit for each
protocol.  The RMUs will recruit, evaluate and treat the participants
in either or both of the clinical studies.  The Data Coordinating
Center will have primary responsibility for data collection and
management for each trial.

A member of NICHD program staff, serving as Research Coordinator,
will cooperate with the funded principal investigators in identifying
research topics of high priority and in designing protocols
appropriate to the evaluation of optimum management in these areas.

Guidance and Management Structures

The Steering Committee will consist of the principal investigators
from each RMU, the principal investigator of the DCC, and the NICHD
staff Research Coordinator; a nongovernment chairperson will be
designated by the Steering Committee.  A member of the NICHD grants
management staff will serve as advisor to the Committee.  The
Steering Committee will develop by consensus the protocols to be
carried out under these cooperative agreements, and supervise the
conduct of the studies.

A Data Safety and Monitoring Committee (DSMC) convened by the NICHD
will have responsibility for reviewing proposed clinical protocols,
and for making a recommendation to the NICHD whether to accept,
modify, or decline such proposed studies.  The DSMC will enlist
additional ad hoc scientific and/or clinical experts as needed to
conduct each review.  Because implementation of a new protocol would
constitute a major change in scope, approval by the Director, NICHD,
will be required before such implementation.

The DSMC will monitor data collection and analysis by the DCC,
including any reports of adverse effects.  When appropriate, the DSMC
will conduct an interim evaluation of the data with respect to the
need to terminate studies, either because the data suffice to answer
the problems posed, data collection provides support for an
alternative study initiative, or because experience has proven the
research not to be feasible.

Time Sequence

It is anticipated that the program will conduct its activities
according to this general outline:

Initially, the Steering Committee will review and identify issues of
importance in reproductive medicine.  It will consider items proposed
for study by the Network from those listed above in "Objectives and
Scope" and others suggested by participating units.  Within each of
the Infertility/ Andrology and Gynecology domains, the Steering
Committee will rank by priority a series of issues that are
substantive, lie within the scope of existing technical capability,
lend themselves to multicenter evaluation, involve sufficient numbers
of patients to be of consequence in terms of morbidity, and comprise
significant public health need.  In this and subsequent activities,
the Steering Committee will attempt to use electronic and
telecommunications whenever possible.

From the list of important issues for each domain, the Steering
Committee will generate diagnostic or treatment protocols and agree
on lead units for the two domains.  Each protocol is to be acceptable
by all the participants, adequate for appraisal of the research
issues defined, and amenable to data collection in a single format
acceptable to all units.  Satisfactory controls will be incorporated,
and attention will be given to maximize the number of studies
possible with minimum data collection.  Protocol subcommittees may be
constituted to develop protocols more efficiently.

Participating reproductive medicine units will incorporate the
protocols into the clinical management of patients selected for
study.  The units will supervise the collection of data with adequate
attention to the fidelity of records and transcription and provide
information in uniform data format for analysis.  The mode of data
transmission and analysis will be determined by the Steering
Committee in conjunction with the recommendations of the Data
Coordinating Center.  Data summaries will be provided to the Data
Safety and Monitoring Committee on a semi-annual basis, or as
indicated by study development.  Format and content of final reports
and the dissemination of information to the scientific community will
be determined by the Steering Committee.

Beginning approximately six months after the start of data
collection, the Data Safety and Monitoring Committee will examine the
aggregated data and make recommendations to NICHD on the need to
modify or terminate studies, as described above.  As studies are
terminated, the Steering Committee may reinitiate identification of
new issues and the institution of new protocols.

SPECIAL REQUIREMENTS

Scientific Content

The NICHD invites applications both from current members of the
Network (competing renewal applications) and from prospective members
(new applications).  Minimum requirements for applicants are as
follows (see also Review Criteria and Procedures, below):

o  Requirements for Clinical Site (RMU) Applicants

1.  Participants must be based in departments providing both
inpatient and outpatient reproductive health care.

2.  The unit must have a history of previous successful clinical
research, and expertise in research design, biostatistics, and the
use of clinical protocols.  Ability to enroll sufficient numbers of
patients for meaningful studies should be documented.

3.  The unit must be able to demonstrate past and existing
excellence in collecting and maintaining clinical data on its
patients.  Applications should state the numbers of patients seen
annually for infertility overall and for the other reproductive
health diagnoses listed as examples in II, above.

4.  The principal investigator should be able to make a substantive,
long-term commitment of effort to Network responsibilities.  The unit
should have physician staff representing several areas of expertise,
either based in the participating department or available as
collaborators.  At a minimum, these would include Obstetrics and
Gynecology, Reproductive Endocrinology (either in OB-Gyn or Internal
Medicine), and Andrology (either in Internal Medicine or Urology).

5.  An experienced research nurse must be among the key personnel,
and additional research nursing staff should be available.

6.  Laboratory facilities must be available for appropriate testing
of patients and subjects, such as hematology, blood chemistry,
endocrinology, microbiology, radioimmunoassay, and semen analysis.

7.  Appropriate imaging services must be available, including
ultrasound, contrast studies, and other radiological and related
techniques that may be required to diagnose and follow the conditions
under study.

8.  The unit must be prepared to participate in a cooperative manner
with other clinical centers and the Data Coordinating Center in the
delineation of research protocols, statistical methods, uniform data
formats, and data transfer.

9.  There must be firm institutional and departmental commitments to
support this cooperative study and a strong staff dedication to
adhere to programs jointly defined and generate data of high fidelity
to ensure success.

10. Because the protocols for investigation will not be written until
after awards are made, it is not possible for RMU applicants to
propose the exact work that they would actually carry out if funded.
Therefore, to provide peer reviewers and NICHD an idea of the
capabilities of the investigators, applicants for RMUs must submit a
"concept" protocol for a new study that that site might expect to
conduct as a participant in the Network.  Applicants should note
carefully that the "concept" study proposed may or may not actually
be performed by the Network as one of its protocols, but is requested
to serve as an indicator of the applicant's ability to participate in
the development and design of protocols for cooperative clinical
investigations.  It is anticipated that the Steering Committee will
include the "concept" protocols submitted by the funded RMU sites in
its consideration of topics for actual protocols.

For purposes of this RFA only, it is suggested that the "concept"
protocol address one of the following topics:

1.  Ovulation induction procedures for improved outcome in human in
vitro fertilization
2.  Fertility-sparing management of endometriosis, uterine myoma, or
abnormal uterine bleeding
3.  Improved management of ectopic gestation
4.  Role of evaluation of the luteal phase in management of
infertility
5.  Role of immunologic evaluation and intervention in management of
infertility
6.  Effects of varicocele and the treatment thereof on fertility

The choice of a "concept" topic from one domain will not necessarily
limit the participation of an RMU in the other domain in the event
that it is funded. The protocol should be written specifically for
this Network, and will be a key factor in evaluation of the
application.

The following are highly desirable:

1.  The cooperating institution should have a computer facility
linked to a network such as BITNET or Internet, and the unit should
include an authorized user knowledgeable in computer data storage and
retrieval.

2.  The site should have previous experience in multicenter clinical
trials.

3.  If the specialty of the principal investigator is in disorders of
one sex, the designation of a co-principal investigator with
expertise in disorders of the opposite sex will be viewed as a
strength.

o  Requirements for Data Coordinating Center (DCC) Applicants

1.  The applicant must have demonstrated prior experience as a
Coordinating Center in multi-center studies.

2.  The Principal Investigator, with other staff, must have
appropriate biostatistical, data management, and coordination
expertise.

3.  The applicant must have ability to assist in designing protocols
and the data collection system.

4.  Experience in developing and monitoring quality control shall be
demonstrated.

5.  The Data Coordinating Center will report to the Data Safety and
Monitoring Committee at least every six months regarding accumulating
data and the RMUs' performance.  The application should document
ability to meet such reporting deadlines as well as the overall
timetable.

6.  The applicant must be prepared to cooperate with the RMUs and
NICHD staff in all design, collection, and analysis functions.

7.  The application must include a plan detailing methods of data
receipt, analysis, quality control, and reporting, including
communications with administrative and clinical personnel.

8.  If an institution applies for both RMU and DCC, the DCC
application must address the issue of how the DCC would maintain
operational independence if both were funded.

For the DCC as for the RMUs, access to and familiarity with a network
such as BITNET or Internet is desirable.

Budget Preparation

The instructions for budget estimates provided with the Research
Grant application form (PHS 398) should be followed.  Indirect costs
will be awarded in the same manner as for research project grants
(R01).  Budgets will be reviewed on the basis of appropriateness for
the work proposed.  Allowable costs and policies governing the
research grants programs of the NIH will prevail.  In planning the
budget section of the application each applicant should submit budget
estimates for all years including estimates of staffing needs.

Since the details of study requirements will not be known at the time
of application, however, it is understood that requested budgets will
be estimates.  Therefore, funding levels will be subject to
negotiation between the grantee institutions and the NICHD prior to
awarding funds.

In the first year, support should be requested for the principal
investigators to travel to meetings required for initial activities:
joint identification of topics, the development of protocols, and the
design of data gathering instruments.

The first year budget should also request partial year support for
new protocol start-up costs, to begin after the initial tasks, above,
have been completed, as well as completion of studies that may have
been approved during 1994 or 1995.  A composite for all these
activities might include the following:  a full-time research
nurse/study coordinator, fractional-time senior investigator,
fractional-time data clerk, fractional-time technician, clinical
testing expenses, travel expenses covering four meetings in Bethesda,
Maryland for the principal investigator, one trip each for nurse
coordinator and technician training, and justifiable supplies and
"other" expenses.

The budget proposal for future years, should, at this time, present
estimated costs of participating in a study such as the proposed
"concept" protocol, including personnel costs similar to the first
year, plus recruitment costs and travel for the principal
investigator to three Steering Committee meetings per year in
Bethesda.

Terms and Conditions of Award

The following terms and conditions of the award, and details of
arbitration procedures pertaining to the scope and nature of the
interaction between NICHD and the participating RMUs and Data
Coordinating Center, will be incorporated into the Notice of Grant
Award and provided to the Principal Investigator as well as the
institutional official at the time of award.  These procedures will
be in addition to the customary programmatic and financial
negotiations which occur in the administration of grants.

1.  The purpose of these Agreements is to facilitate resolution of
problems in adult reproductive medicine by establishing a network of
units (Reproductive Medicine Units and a Data Coordinating Center)
able to study large numbers of patients and provide conclusions more
rapidly than institutions acting alone.

2.  Planning and implementation of the study will by done by a
Steering Committee consisting of the principal investigator from each
participating unit, a Program Officer from the Reproductive Sciences
Branch, CPR, NICHD, serving as Research Coordinator; with a
nongovernment chairperson designated by the Steering Committee.  A
member of the NICHD grants management staff will serve as advisor to
the Committee.

3.  Primary authorities and responsibilities of the awardees:

o   Define objectives and approaches;
o   Plan the design and implementation of the protocols;
o   Conduct the studies;
o   Collect and analyze the data;
o   Publish the results, conclusions and interpretations of studies.
o   Modify, delete or add protocols, subject to NICHD approval, when
a new protocol would constitute a major change in scope.

Awardees will retain custody of and primary rights to their data
developed under the award, subject to current Government policies
regarding rights of access.

The awardees agree to accept the coordinating role of the Steering
Committee and the cooperative nature of the group process.

4.  The degree of programmatic involvement by NICHD staff:

o   Assist in and facilitate the development of study protocols;
o   As a member of the Steering Committee, review and comment on each
stage of the program before subsequent stages are started, including
options of modification or termination by mutual consent between the
Network and NICHD;
o   Assist in maximizing cooperation among the units, and help
redirect efforts, if necessary;
o   Retain the option to withhold support of a participating unit, if
technical performance requirements such as compliance with the
protocol, meeting patient enrollment targets, and adherence to
uniform data format are not met.  Support will be contingent upon
meeting these requirements. Alternatively, determine jointly with the
awardees, the need to add clinical sites for the purpose of
increasing patient accrual.
o   Assist, through review, comment, analysis and, where appropriate,
co- authorship, in reporting results to the community of
investigators and health care recipients.

5.  Arbitration

When agreement between an awardee and NICHD staff cannot be reached
on scientific/programmatic issues that may arise after the award, an
arbitration panel will be formed.  The panel will consist of one
person selected by the principal investigators, one person selected
by NICHD staff, and a third person selected by these two members.
The decision of the arbitration panel, by majority vote, will be
binding.  This special arbitration procedure in no way affects the
right of an awardee to appeal an adverse action in accordance with
PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at
45 CFR Part 16.

6.  Cooperative agreements are assistance mechanisms and are subject
to the same administrative requirements as grants.  The above special
Terms of Award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS, PHS, and NIH grant
regulations, policies and procedures, with particular emphasis on HHS
regulations at 45 CFR Part 74 and 92.  Business management aspects of
these awards will be administered by the NICHD Grants Management
section in accordance with HHS, PHS, and NIH grant administration
requirements.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

(NOTE:  When the proposed study or studies in the RFA or PA involves
a gender specific study or a single or limited number of minority
population groups, this should also be stated to inform potential
applicants and reviewers.)

LETTER OF INTENT

Prospective applicants are asked to submit, by May 1, 1994, a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains allows NICHD staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to Dr. Donna L. Vogel at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

All applicants must document their ability to meet or exceed the
minimum requirements as set out in the SPECIAL REQUIREMENTS section
for RMU or DCC applications as detailed above.  This specifically
includes understanding of and commitment to the cooperative nature of
this program.

If an applicant institution elects to submit applications for both an
RMU and the DCC, they must be separate applications, appropriately
labeled, with different personnel, and separate budgets.

Any competing renewal application should include in the progress
report a description of how the site has met the special cooperative
agreement terms and conditions of the award, including its
interaction with other Network sites and the NICHD Research
Coordinator.

Applications from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research, if appropriate.  If so, a letter of agreement
from either the GCRC program director or principal investigator could
be included with the application.

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these awards.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/435-0714.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title, COOPERATIVE MULTICENTER
REPRODUCTIVE MEDICINE NETWORK, and number, RFA HD-94-016, must be
typed on line 2a of the face page of the application form and the YES
box must be marked.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
Building 61E, Room 5E03
Bethesda, MD  20892

Applications must be received by July 19, 1994.  If an application is
received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

Schedule

Letter of Intent Receipt Date:     May 1, 1994
Application Receipt Date:          July 19, 1994
Initial Review Group Peer Review:  October/November 1994
NACHHD Council Review:             January 31, 1995
Earliest Award Date:               April 1, 1995

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness and
responsiveness by NIH staff.  Incomplete applications will be
returned to the applicant without further consideration.  Any
application that does not meet the minimum requirements of this RFA
will be considered unresponsive to the RFA and returned to the
applicant.

Applications meeting the minimum requirements will be reviewed as a
group on a competitive basis with each other and in accordance with
the usual NIH peer review procedures for research grants.

Applications may receive a preliminary scientific peer review
(triage) by an NICHD peer review group to determine their relative
competitiveness.  The NIH will withdraw from further competition
those applications judged to be noncompetitive for award and notify
the applicant Principal Investigator and institutional official.
Those applications that are complete and responsive, and judged to be
competitive in triage (if used), will undergo further scientific
merit review in accordance with the criteria stated below for
scientific/technical merit by an appropriate peer review group
convened specifically for this purpose by the Division of Scientific
Review, NICHD. The second level of review will be provided by the
National Advisory Child Health and Human Development Council.

1.  Criteria for Review of Clinical RMU Applications:

a.  Qualifications, Experience, and Commitment of Key Personnel

o  Scientific, clinical, and administrative abilities of the
principal investigator and other team members;
o  Knowledge and experience in areas relevant to the conduct of
potential studies utilizing clinical and laboratory evaluation of
patients with reproductive disorders;
o  Commitment of staff time for the satisfactory conduct of the
study;
o  Experience and qualifications of team members who would be
responsible for internal coordination of data management.

b.  Protocols and Procedures

o  Responsiveness of the application to the objectives of the study
as outlined in this RFA;
o  Willingness to work and cooperate with other RMUs and the NICHD in
the manner summarized in this RFA;
o  Quality of the proposed "concept" protocol designed to be
undertaken by the Network, including ethical issues relating to human
subjects, and separately, appropriate inclusion of women and
minorities as subjects.

c.  Facilities and Management

o  Adequacy of administrative, clinical, and data organizational
management facilities as described in the minimum requirements.
o  Institutional assurance to provide support to the study in such
areas as fiscal administration, personnel management, space
allocation, procurement, planning and budgeting.

2.  Criteria for Review of Data Coordinating Center

a.  Qualifications, Experience, and Commitment of Key Personnel

o  Scientific and administrative abilities of the principal
investigator and other team members.
o  Experience of the principal investigator and other key personnel
in statistical, data management, quality control, study coordination,
and administrative aspects of multicenter clinical studies.
o  Commitment of staff time for satisfactory conduct of the study.
o  Understanding of the scientific objectives and design of the
program, as evidenced by discussion of design, recruitment and
implementation issues.

b.  Protocols and Procedures

o  Proposed data collection and monitoring system.
o  Discussion of ability to meet proposed timetable.
o  Willingness to work cooperatively with the RMUs and the NICHD, in
the manner summarized in this RFA.

c.  Facilities and Management

o  Satisfactory facilities and supporting environment, including
space and equipment for the work proposed (any new equipment
requested under this award must be strongly justified).
o  Evidence of institutional support for participation in a long-term
collaborative program.

AWARD CRITERIA

The anticipated date of award is April 1, 1995.  Applications
recommended by the NACHHD Council will be considered for award based
on scientific and technical merit; program balance, including in this
instance, sufficient compatibility of features to make a successful
collaborative program a reasonable likelihood; and availability of
funds.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues and address the letter
of intent to:

Donna L. Vogel, M.D., Ph.D.
Reproductive Sciences Branch
National Institute of Child Health and Human Development
Building 61E, Room 8B01
Bethesda, MD  20892
Telephone:  (301) 496-6515
FAX:  (301) 496-0962

Direct inquiries regarding fiscal matters to:

Ms. Melinda Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
Building 61E, Room 8B17
Bethesda, MD  20892
Telephone:  (301) 496-5481
FAX:  (301) 402-0915

AUTHORITY AND REGULATIONS

This Program is described in the Catalog of Federal Domestic
Assistance number 13.864, Population Research.  Awards will be made
under the authority of the Public Health Service Act, Title X,
Section 1004 (Public Law 92-572, as amended; 42 USC 241) and Title
III, Section 301 (Public Law 78-410, as amended; 42 USC 241).  These
special Terms of Award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Part 74, and other HHS, PHS, and
NIH grant administration policies.  This program is not subject to
the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the american people.

.

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