NICHD INSTITUTIONAL TRAINING IN EPIDEMIOLOGY AND CLINICAL TRIALS FOR
OBSTETRICIANS AND GYNECOLOGISTS
Release Date: May 12, 2000
RFA: HD-00-014
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov)
Letter of Intent Receipt Date: June 12, 2000
Application Receipt Date: July 24, 2000
PURPOSE
The National Institute of Child Health and Human Development (NICHD) invites
applications for National Research Service Award (NRSA) Institutional Training
Grants to establish programs of postdoctoral research training in epidemiology
and clinical trial methodology for obstetricians and gynecologists with a
research interest in contraception and reproductive health. The purpose of
this Request for Applications (RFA) is to develop a cadre of academic
obstetricians and gynecologists trained in epidemiologic and clinical research
in contraception and other areas of reproductive health.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of Healthy People 2010, a PHS-led national
activity for setting priority areas. This RFA is related to one or more of
the priority areas. Potential applicants may obtain Healthy People 2010 at
http://www.health.gov/healthypeople.
APPLICANT ELIGIBILITY REQUIREMENTS
Only domestic, non-profit, private or public institutions may apply for grants
to support research training programs. Applications will be accepted only
from schools of medicine or osteopathy, and schools of public health. The
applicant institution must have a strong research program in the area(s)
proposed for research training and must have the requisite staff and
facilities to carry out the proposed program. The research training program
director at the institution will be responsible for the selection and
appointment of trainees to receive NRSA support and for the overall direction
of the program.
The applicant must have access to a training environment with ongoing clinical
trials, preferably including multi-institutional trials of new contraceptives.
Ideally, the applicant organization serves as a coordinating center that
provides these clinical trials with ongoing biostatistical, epidemiologic, and
research design expertise.
TRAINEE ELIGIBILITY REQUIREMENTS
Positions on NRSA Institutional Training Grants may not be used for study
leading to the M.D., D.D.S., or other clinical, health-professional degrees,
except when those studies are a part of a formal combined research degree
program, such as the M.D./Ph.D. Similarly, trainees may not accept NRSA
support for studies that are part of residency training leading to
certification in a medical or dental specialty or subspecialty, except when
the residency program credits a period of full-time, postdoctoral research
training toward board certification and the trainee intends to pursue a
research career.
Trainees are required to pursue their research training on a full-time basis,
devoting at least 40 hours per week to the program. Within the 40 hours per
week training period, research trainees in clinical areas must devote their
time to the proposed research training and must confine clinical duties to
those that are an integral part of the research training experience.
The trainees appointed under this training program must hold, as of the
beginning date of the NRSA appointment, an M.D. or D.O. degree from an
accredited domestic or foreign institution and have completed, or be within
one year of completing, postgraduate clinical training in obstetrics and
gynecology in an ACGME-approved residency program.
Citizenship: To be appointed to a training position supported by an NRSA
research training grant, an individual must be a citizen or non-citizen
national of the United States, or have been lawfully admitted for permanent
residence (i.e., in possession of a currently valid Alien Registration Receipt
Card I-551, or be in possession of other legal verification of such status).
Non-citizen nationals are generally persons born in outlying possessions of
the United States (e.g., American Samoa). Individuals on temporary or student
visas are not eligible.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) Institutional
National Research Service Award (NRSA) Institutional Training Grant mechanism
(T32). The provisions of this mechanism are detailed in the NIH announcement
for NRSA Institutional Research Training Grants, published in the NIH Guide
for Grants and Contracts, May 16, 1997, and available at:
http://grants.nih.gov/grants/guide/notice-files/not97-007.html.
All provisions of the T32 award described in the announcement apply to grants
made under this initiative, except as noted in this RFA. Only postdoctoral
level training is supported under this RFA.
Institutional NRSA research training grants may be made for periods up to five
years and are renewable. Awards within an approved competitive segment
normally are made in 12-month increments, with support for additional years
based on satisfactory progress and the continued availability of funds.
Trainee appointments are normally made in 12-month increments. No trainee may
be appointed for less than nine months during the initial period of
appointment, except with the prior approval of the NICHD or when
health-professional students are appointed to approved, short-term research
training positions.
No individual trainee may receive more than three years of aggregate NRSA
support at the postdoctoral level, including any combination of support from
institutional training grants and individual fellowship awards. Any extension
of the total duration of trainee support requires approval by the Director of
the NICHD. Requests for extension must be made in writing by the trainee,
endorsed by the director of the training program and the appropriate
institutional official, and addressed to the Director, NICHD. The request
must include a sound justification for an extension of the statutory limits on
the period of support.
FUNDS AVAILABLE
The NICHD intends to commit approximately $600,000 in total costs [direct plus
Facilities and Administrative (F&A) costs] in FY 2001 to fund up to three new
and/or competing continuation institutional training grants in response to
this RFA. Each trainee may receive two years of support with a possibility of
extending for a third year. Although the financial plans of the NICHD provide
support for this program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications. At this time, it is not known if competing continuation
applications will be accepted and/or if this RFA will be reissued.
RESEARCH OBJECTIVES
Background
There is currently a dearth of training opportunities for obstetricians and
gynecologists in epidemiologic research and clinical trials methodology. This
is partly responsible for the insufficient number of investigator-initiated
NIH grants in this area. The U.S. Congress has noted the absence of such
training opportunities and has directed NICHD to address the shortage. In
addition, the Institute of Medicine (IOM), in the publication Strengthening
Research in Academic OB/GYN Departments, outlined the need for NICHD to
target training support to expand the number of research training
opportunities for obstetricians and gynecologists. In another publication,
Careers in Clinical Research, the IOM recommended that NIH support expansion
or replication of model programs that have a proven track record in preparing
successful clinical investigators. Experience gathered from such programs has
informed the development of this RFA. In the area of contraception and
related areas of reproductive health, there are very few clinicians with
significant skills in epidemiologic research and clinical trials methodology.
Many of the most qualified researchers are approaching retirement and there is
a need to develop a new cadre of independent investigators in these fields.
The objective of this program is to produce a well-qualified cadre of academic
obstetricians and gynecologists who are capable of successfully competing for
NIH and foundation research support for epidemiologic and clinical research in
contraception and reproductive health. It is anticipated that many of the
trainees will be encouraged to pursue further training in epidemiologic and
clinical research via individual research career development awards (K-series
mechanisms) and eventually develop the experience and expertise necessary to
direct large, multicenter epidemiologic studies or clinical trials.
Scope of Training
The emphasis of this postdoctoral research training program is on the training
of obstetricians and gynecologists in the basics of epidemiology and
biostatistics, including clinical epidemiology, reproductive epidemiology,
and clinical trials methodology. Master’s level coursework in epidemiology
and clinical trials methodology must be an integral part of the program. At
least one mentored independent research study in the area of contraception or
reproductive health, including the design, conduct and analysis of an
epidemiologic study or clinical trial, must be undertaken by each trainee.
The program must be a cooperative effort between (1) a department of
epidemiology, biostatistics or community medicine (or the equivalent) in a
school of public health or a school of medicine and (2) a department of
obstetrics and gynecology in a school of medicine or osteopathy. The program
director may be in either department, but evidence of significant cooperation
between the two departments must be presented in the application.
The training program will provide each trainee with a minimum of two years of
full-time postdoctoral research training, including didactic instruction,
mentoring, and supervised research experience. Plans must be presented for
each trainee to be guided by qualified mentors experienced in the conduct of
epidemiologic studies and clinical trials. Each trainee should have both an
epidemiologic/methodologic mentor from the department of epidemiology or
biostatistics (or equivalent), and a clinical mentor from the department of
obstetrics and gynecology. The research mentors must have participated as
Principal Investigators in funded, peer-reviewed research programs in the
areas of contraception or reproductive health. Plans must also be presented
for the means by which individual trainee needs and goals will be developed
and addressed. Plans for ongoing program evaluation and mechanisms to improve
course content, mentoring, and supervised research experiences must be
included. The training program may be integrated into the last year of a
residency program in obstetrics and gynecology or integrated into a fellowship
program in reproductive endocrinology and infertility. Because separate
funding exists for research training in maternal/fetal medicine and
gynecologic oncology, this program is confined to trainees in general
obstetrics and gynecology or reproductive endocrinology and infertility.
The training program should include, but not be limited to, instruction in the
following areas: (1) epidemiology, (2) biostatistics, (3) clinical
epidemiology, (4) reproductive epidemiology, (5) clinical trials design and
conduct, (6) data management and analysis, (7) bioethics and the responsible
conduct of research, (8) preparation for individual career development
research grants or independent research grants.
Special Program Considerations
The primary objective of the NRSA program is to prepare qualified individuals
for careers that significantly impact the nation"s research agenda. Within
the framework of the program"s longstanding commitment to excellence and
projected need for investigators in particular areas of research, attention
must be given to recruiting individuals from minority groups under-
represented nationally in the biomedical and behavioral sciences. The
following groups have been identified as under-represented in biomedical and
behavioral research nationally: African Americans, Hispanic Americans, Native
Americans, Alaskan Natives, and Pacific Islanders. Use of the term minority
in this announcement will refer to these groups.
Other considerations relate to the duration of training and the transition of
trainees to individual support mechanisms: Studies have shown that the length
of the appointment to a training grant for postdoctoral trainees with
health-professional degrees strongly correlates with subsequent application
for and receipt of independent NIH research support. Program directors,
therefore,
should limit appointments to individuals who are committed to a career in
research and plan to remain on the training grant or in some other type of
research experience for a minimum of two years. It also has been shown that
individuals who have been supported by individual postdoctoral fellowships are
more likely to subsequently apply for and receive NIH research support than
are individuals who have received support only from a research training grant.
Therefore, program directors should encourage trainees to apply for individual
postdoctoral fellowships or mentored research career development awards (K
awards). During the review of training grants applications, for existing
programs, peer reviewers will examine the training record of the program to
determine the average duration of training appointments for
health-professional postdoctoral trainees and whether there is a record of
transition to individual support mechanisms.
Trainee Reporting Requirements
The institution must submit a completed Statement of Appointment (PHS Form
2271) for each trainee appointed or reappointed to the training grant at the
beginning of the appointment period. Additionally, a completed Payback
Agreement (PHS Form 6031) must be submitted for each trainee in their first 12
months of postdoctoral support. Within 30 days of the end of the total
support period for each trainee, the institution must submit a Termination
Notice (PHS Form 416-7). Failure to submit the required forms in a timely
manner may result in an expenditure disallowance or a delay in any
continuation funding for the award.
Leave
In general, trainees may receive stipends during periods of vacation and
holidays observed by individuals in comparable training positions at the
grantee institution. For the purpose of these awards, however, the period
between the spring and fall semesters is considered to be an active time of
research and research training and is not considered to be a vacation or
holiday.
Trainees may receive stipends for up to 15 calendar days of sick leave per
year. Sick leave may be used for the medical conditions related to pregnancy
and childbirth pursuant to the Pregnancy Discrimination Act [42 USC 2000
e(k)]. Trainees also may receive stipends for up to 30 calendar days of
parental leave per year for the adoption or the birth of a child when those in
comparable training positions at the grantee institution have access to paid
leave for this purpose and the use of parental leave is approved by the
program director.
A period of terminal leave is not permitted and payment may not be made from
grant funds for leave not taken. Individuals requiring periods of time away
from their research training experience longer than specified here must seek
approval from the NICHD for an unpaid leave of absence. At the beginning of a
leave of absence, the trainee must submit a Termination Notice (PHS Form
416-7) and upon return from the leave of absence, the trainee must be formally
reappointed to the grant by submitting an updated Statement of Appointment
(PHS Form 2271). Trainees within the first 12 months of postdoctoral support
also must submit a Payback Agreement (PHS Form 6031) upon return from a leave
of absence.
Stipends
National Research Service Awards provide funds, in the form of stipends, to
postdoctoral trainees. A stipend is provided as a subsistence allowance to
help trainees defray living expenses during the research training experience.
It is not provided as a condition of employment with either the Federal
Government or the awardee institution. Stipends must be paid to all trainees
at the levels approved by the Secretary of the Department of Health and Human
Services.
The current annual stipend for postdoctoral trainees is determined by the
number of FULL years of relevant postdoctoral experience at the time of
appointment. Relevant experience may include research experience (including
industrial), teaching, internship, residency, clinical duties, or other time
spent in full-time studies in a health-related field following the date of the
qualifying doctoral degree. Current postdoctoral stipend levels effective for
FY 2000 are as follows:
Years of Relevant Experience Annual Amount
less than 1 $26,916
greater than or equal to 1 but less than 2 28,416
greater than or equal to 2 but less than 3 33,516
greater than or equal to 3 but less than 4 35,232
greater than or equal to 4 but less than 5 36,936
greater than or equal to 5 but less than 6 38,628
greater than or equal to 6 but less than 7 40,332
greater than or equal to 7 42,300
No departure from the established stipend schedule may be negotiated by the
institution with the trainee. The stipend for each additional full year of
stipend support is the next level in the stipend structure and does not change
in the middle of an appointment. The grantee institution is allowed to
provide funds to an individual in addition to the stipends paid by the NIH.
Such additional amounts may be either in the form of augmented stipends
(supplementation) or in the form of compensation, such as salary or tuition
remission for services such as teaching or serving as a laboratory assistant,
provided the following conditions are met:
Stipend Supplementation. Supplementation or additional support to offset the
cost of living may be provided by the grantee institution. Supplementation
does not require any additional effort from the trainee. Federal funds may
not be used for supplementation unless specifically authorized under the terms
of both the program from which such supplemental funds are to be received and
the program whose funds are to be supplemented. Under no circumstances may
PHS funds be used for supplementation.
Compensation. An institution may provide additional funds to a trainee in the
form of compensation (as salary and/or tuition remission) for services such as
teaching or serving as a research assistant. A trainee may receive
compensation for services as a research assistant or in some other position on
a Federal research grant, including an NIH research grant. However,
compensated services should occur on a limited, part-time basis apart from the
normal research training activities, which require a minimum of 40 hours per
week. In addition, compensation may not be paid from a research grant
supporting research that is part of the research training experience.
Under no circumstances may the conditions of stipend supplementation or the
services provided for compensation interfere with, detract from, or prolong
the trainee’s approved NRSA training program. Refer to the NRSA Guidelines
(http://grants.nih.gov/grants/guide/notice-files/not97-007.html)
for additional information on compensation.
Educational Loans or GI Bill. An individual may make use of Federal
educational loan funds and assistance under the Veterans Readjustment Benefits
Act (GI Bill). Such funds are not considered supplementation or compensation.
Concurrent Awards. Support from an NRSA may not be held concurrently with
another federally sponsored fellowship or similar Federal award that provides
a stipend or otherwise duplicates provisions of the NRSA.
Tuition, Fees, and Health Insurance
Tuition, for purposes of the NRSA, is defined as the cumulative amount of
tuition, all fees, and self-only or family medical insurance, and are
allowable trainee costs only if such charges are required of all individuals
in a similar training status at the institution, regardless of their source of
support. Tuition at the postdoctoral level is limited to that required for
specific courses in support of the approved research training program. On an
annual basis, for each trainee, the training grant will cover 100 percent of
the first $3,000 of the combined cost of tuition, fees, and health insurance
and 60 percent of any amount above $3,000. Institutions are instructed to
request the full amount of these costs in competing applications.
Noncompeting awards will reimburse tuition, fees, and health insurance costs
in the amount paid in the previous award year, unless there is a change in the
scope of the award or the number of trainees to be supported.
Other Trainee Costs
Trainee travel, including attendance at scientific meetings that the
institution determines to be necessary to the individual"s research training,
is an allowable trainee expense. In addition, support for travel to a
research training experience away from the institution may be permitted.
Research training experiences away from the parent institution must be
justified considering the type of opportunities for training available, how
these opportunities differ from those offered at the parent institution, and
the relationship of the proposed experience to the trainee’s career stage and
goals. This type of research training requires prior approval from the NICHD.
Letters requesting such training may be submitted to the NICHD at any time
during the award period.
Institutional costs of up to $2,500 a year per postdoctoral trainee may be
requested to defray the costs of other research training related expenses such
as staff salaries, consultant costs, equipment, research supplies, and staff
travel.
Under exceptional circumstances, which can include providing accommodations
for a trainee with disabilities, it is possible to request institutional costs
above the standard rate. Requests for additional costs must be explained in
detail and carefully justified in the application. Consultation with the
NICHD program staff contact listed under INQUIRIES, below, in advance of such
requests is strongly advised.
A facilities and administrative (F & A) allowance (indirect costs) based on
eight percent of total allowable direct costs (excluding amounts for tuition,
fees, health insurance, and equipment) may be requested. Applications from
State and local government agencies may request full F & A cost reimbursement
(see NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps/).
Payback Provisions
Payback provisions, specified in the NIH Revitalization Act of 1993, state
that NRSA recipients incur a service payback obligation only during their
first 12 months of postdoctoral support. Additionally, the NIH Revitalization
Act of 1993 specifies that the second and subsequent years of postdoctoral
NRSA training will serve to pay back a postdoctoral service payback
obligation.
Consult the NRSA Guidelines
(http://grants.nih.gov/grants/guide/notice-files/not97-007.html)
for complete information on payback provisions.
URLs IN NIH GRANT APPLICATIONS AND APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed training program, the name, address, and
telephone number of the Program Director, the identities of other key
personnel and participating institutions, and the number and title of this
RFA. Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information that it
contains allows NICHD staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by June 12, 2000 to Dr. H. Trent MacKay at
the address listed under INQUIRIES, below.
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. It contains special instructions for Institutional
National Research Service Awards (T32). These forms are available at most
institutional offices of sponsored research, on the Internet at
http://grants.nih.gov/grants/forms.htm, and from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267,
E-mail: GrantsInfo@nih.gov.
Applicants must observe the 25-page limit on the narrative section.
Applicants may request up to five years of support through the T32 mechanism.
The applicant should justify the number of full-time postdoctoral training
positions requested. Predoctoral and short-term research training positions
may not be requested in responses to this RFA.
The RFA label available in the PHS 398 (rev. 4/98) application form must be
stapled to the bottom of the face page of the application and must display the
RFA number HD-00-014. A sample RFA label is available at
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is
in the pdf format. 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 and number must be typed on
line 2 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:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application should be
sent to:
L. R. Stanford, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-9254
Applications must be received by July 24, 2000. If an application is received
after that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) 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
CSR 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.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
for responsiveness by NICHD. Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration.
Applications that are complete and responsive to this RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NICHD in accordance with the review criteria stated below. As
part of the initial merit review, all applications will receive a written
critique and may undergo a process in which only those applications deemed to
have the highest scientific merit will be discussed, assigned a priority
score, and receive a second level review by the National Advisory Child Health
and Human Development Council.
Review Criteria
o Past research training record of both the program and the designated
preceptors as determined by the success of former trainees in seeking further
career development and in establishing productive scientific careers.
Evidence of further career development can include receipt of fellowships,
career awards, further training appointments, and similar accomplishments.
Evidence of a productive scientific career can include a record of successful
competition for research grants in the design and conduct of epidemiologic
studies or clinical trials, receipt of special honors, a record of
publications, receipt of patents, promotion to scientific positions, and any
other measure of success consistent with the nature and duration of the
training received.
o Objectives, design, and direction of the research training program.
o Caliber of preceptors as researchers with expertise in contraception,
reproductive health, biostatistics, epidemiology, and clinical trials,
including successful competition for research support.
o The institutional training environment, including the level of
institutional commitment, quality of the facilities, availability of
appropriate courses, and availability of research support, including access to
a variety of clinical trials and epidemiologic studies in the areas of
contraception and/or reproductive health.
o Recruitment and selection plans for trainees and the availability of high
quality candidates.
o Record of the research training program in retaining health-professional
postdoctoral trainees for at least two years in research training or other
research activities.
o When appropriate, the concomitant research training of health-professional
postdoctorates (i.e., individuals with the M.D., D.O., D.D.S., etc.) with
basic science postdoctorates (i.e.,
individuals with a Ph.D., etc.) or linkages with basic science departments.
o Commitment to the objectives, design, and direction of a research training
program responsive to this RFA.
Additional Review Considerations
Minority Recruitment Plan: The NIH remains committed to increasing the
participation of individuals from under-represented minority groups in
biomedical and behavioral research. As first announced in 1989, all competing
applications for institutional NRSA research training grants must include a
specific plan to recruit and retain under-represented minorities in the
training program. In addition, all competing continuation applications also
must include a report on the recruitment and retention of under-represented
minorities during the previous award period. If an application is received
without a plan, or without a report on the previous award period, the
application will be considered incomplete and will be returned to the
applicant without review. Additional information on this requirement was
published in the NIH Guide for Grants and Contracts, Volume 22, Number 25,
July 16, 1993 (http://grants.nih.gov/grants/guide/notice-files/not93-188.html).
As indicated above, competing continuation applications must include a
detailed account of experiences in recruiting individuals from under-
represented groups during the previous award period. Information must be
included on successful and unsuccessful recruitment strategies. The report
should provide information on the racial/ethnic distribution of:
o students or postdoctorates who applied for admission or positions within
the department(s) relative to the training grant,
o students or postdoctorates who were offered admission to or a position
within the department(s),
o students actually enrolled in the academic program relevant to the training
grant,
o students or postdoctorates who were appointed to the research training
grant.
For those trainees who were appointed to the grant, the report should include
information about the duration of research training and whether those trainees
have finished their training in good standing.
After the overall educational and technical merit of an application has been
assessed, peer reviewers will examine and evaluate the minority recruitment
plan and any record of recruitment and retention. For competing continuation
applications, the reviewers will examine and evaluate the record of the
program in recruiting and retaining under-represented minority trainees during
the previous award period. The panel also will consider whether the
experience in recruitment during the previous award period has been
incorporated into the formulation of the recruitment plan for the next award
period.
The findings of the review group will be included in an administrative note in
the summary statement. If the minority recruitment plan or the record of
recruitment and retention of minorities is judged to be unacceptable, funding
will be withheld until a revised plan that
addresses the deficiencies is received. Staff within the NICHD, with guidance
from the National Advisory Child Health and Human Development Council, will
determine whether amended plans and reports submitted after the initial review
are acceptable.
Training in the Responsible Conduct of Research: Every NRSA trainee supported
by an institutional research training grant must receive instruction in the
responsible conduct of research. For more information on this provision, see
the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27,
1992 (http://grants.nih.gov/grants/guide/notice-files/not92-236.html).
Applications must include a description of a program to provide formal or
informal instruction in scientific integrity or the responsible conduct of
research. Applications without plans for instruction in the responsible
conduct of research will be considered incomplete and may be returned to the
applicant without review.
o Although the NIH does not establish specific curricula or formal
requirements, all programs are encouraged strongly to consider instruction in
the following areas: conflict of interest, responsible authorship, policies
for handling misconduct, policies regarding the use of human and animal
subjects, and data management. Within the context of training in scientific
integrity, it is also beneficial to discuss the mutual responsibilities of the
institution and the postdoctorates appointed to the program.
o Plans must address the subject matter of the instruction, the format of the
instruction, the degree of faculty participation, trainee attendance, and the
frequency of instruction.
o The rationale for the proposed plan of instruction must be provided.
o Program reports on the type of instruction provided, topics covered, and
other relevant information, such as attendance by trainees and faculty
participation, must be included in future competing continuation and non-
competing applications.
The NIH encourages institutions to provide instruction in the responsible
conduct of research to all graduate students and postdoctorates in a training
program or department, regardless of the source of support.
The NICHD scientific review group will assess the applicant’s plans on the
basis of the appropriateness of topics, format, amount and nature of faculty
participation, and the frequency and duration of instruction. The plan will
be discussed after the overall determination of merit,
so that the quality of the plan will not be a factor in the determination of
the priority score. Plans will be judged as acceptable or unacceptable. The
acceptability of the plan will be described in an administrative note in the
summary statement. Regardless of the priority score, applications with
unacceptable plans will not be funded until a revised, acceptable plan is
provided by the applicant. The acceptability of the revised plan will be
judged by NICHD staff.
Following initial review, applications are reviewed by the National Advisory
Child Health and Human Development Council. The council will consider, in
addition to the assessment of the scientific and educational merit of the
research training grant application, the scientific review group"s comments on
the recruitment of individuals from under-represented minority groups into the
research training program and the plan for instruction in the responsible
conduct of research.
SCHEDULE
Letter of Intent Receipt Date: June 12, 2000
Application Receipt Date: July 24, 2000
Peer Review Date: November 2000
Council Review: January 2001
Earliest Anticipated Start Date: May 1, 2001
AWARD CRITERIA
Applications for this program will compete for available funds with other T32
applications received and reviewed by the NICHD. The following will be
considered when making funding decisions:
o Responsiveness to the purpose of this announcement,
o Quality of the proposed training program, as determined by peer review,
o Availability of funds.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome. Consultation with
NICHD staff is strongly encouraged, especially during the planning phase of
the application process.
Direct inquiries regarding programmatic issues to:
H. Trent MacKay, M.D., M.P.H.
Contraception and Reproductive Health Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 8B13, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6988
FAX: (301) 480-1972
E-mail: mackayt@mail.nih.gov
Direct inquiries regarding fiscal matters to:
Michael Loewe
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-7008
FAX: (301) 402-0915
E-mail: ml70m@nih.gov
AUTHORITY AND REGULATIONS
NRSA Institutional Research Training Grants are made under the authority of
Section 487 of the Public Health Service Act as amended (42 USC 288). Title
42 of the Code of Federal Regulations, Part 66, is applicable to this program.
This program also is described under the following numbers in the Catalog of
Federal Domestic Assistance: 93.121, 93.172, 93.173, 93.272, 93.278, 93.282,
93.306, 93.361, 93.398, 93.821, 93.837-93.839, 93.846-93.849, 93.853-93.856,
93.859, 93.862-93.868, 93.871, 93.880, 93.894, and 93.929.
PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the nonuse of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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