and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components
of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD), (http://www.nichd.nih.gov)
Title: Predoctoral
and Postdoctoral Training Program in Reproductive, Obstetric, Perinatal and Pediatric
Epidemiology and Pharmacoepidemiology (T32)
Announcement Type
This is a reissue of PAR-08-271.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-10-194
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
be Reader is required for download. For assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport
Catalog of Federal Domestic
Assistance Number(s)
93.865
Key Dates
Release Date: May 12, 2010
Opening Date: June 13, 2010 (Earliest date an application may be
submitted to Grants.gov)
Letters
of Intent Submission Dates: June 14, 2010,
April 25, 2011, April 25, 2012
Application Submission Dates: July 13, 2010, May 25, 2011, May 25,
2012
Peer Review Date: October/ November 2010, 2011, and 2012
Council
Review Dates: January 2011, January 2012,
January 2013
Earliest
Anticipated Start Dates: April 2011, 2012 and
2013
Additional Information to Be Available Date
(URL Activation Date): Not applicable
Expiration Date: May 26, 2012
Due Dates for E.O. 12372
Not Applicable.
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview
Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Training Objectives
Section II. Award
Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of
Intent
B. Submitting an Application Electronically to the
NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal
Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Training Objectives
Purpose:
The purpose of the NRSA research training program is to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the Nation’s biomedical and behavioral research agenda. The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. Research training programs are designed to allow the Training Program Director/Principal Investigator (PD/PI) to select the trainees and develop a curriculum of study and research experiences necessary to provide high quality research training. The grant offsets the cost of stipends, tuition and fees, and training related expenses including health insurance for the appointed trainees in accordance with the approved NIH support levels (see Section II, Allowable Costs). More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.
The goals of this program are:
It is expected that such investigators will:
Background:
There is currently a dearth of National Institutes of Health (NIH)-sponsored graduate (i.e. predoctoral and postdoctoral) level training opportunities in reproductive, perinatal, obstetric and pediatric epidemiology and /or pharmacoepidemiology research despite the increasing demands for investigators with these skills. Targeted training grants in these disciplines are needed. Barriers to recruiting and training students include lack of stipends, external funding, dedicated faculty, protected research time, and administrative support.
The NIH will award National Research Service Award (NRSA) Institutional Training Grants (T32) to eligible institutions to develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers in reproductive, obstetric, perinatal, and pediatric epidemiology or pharmacoepidemiology research. Applications submitted in response to this announcement may include predoctoral training, postdoctoral training or both.
Scope:
The institutional research training grants described in this announcement provide support for predoctoral and postdoctoral research training programs at domestic institutions of higher education. Institutional NRSA training grants are designed to allow the director of the program to select the trainees and to develop a curriculum of study and research experiences necessary to provide high quality research training. The NRSA program will provide each trainee with up to five years of full-time predoctoral or three years of postdoctoral support.
Predoctoral research training must lead to the Ph.D. degree or a comparable research doctoral degree. Students enrolled in health-professional training programs who wish to postpone their professional studies in order to engage in full-time research training may also be appointed to an Institutional Research Training Grant. Predoctoral research training must emphasize fundamental training in areas of biomedical and behavioral sciences. Trainees are expected to be participants in a formal curriculum in epidemiology or pharmacoepidemiology. The anticipated curriculum should include courses in epidemiological and/or pharmacoepidemiologic methods and biostatistics, reproductive, obstetric, perinatal and/or pediatric epidemiology and/or pharmacoepidemiology, research ethics, and related areas.
Postdoctoral research training must provide coursework, mentoring, and guided research as needed to assure knowledge and competence in epidemiology or pharmacoepidemiology, as well as opportunities to acquire substantive knowledge of reproductive, obstetric, perinatal, and pediatric health issues.
Specific skills and research areas to be developed include, but are not limited to: fertility, measurement of periconceptual, prenatal and childhood exposures (including occupational and pharmacologic), determinants of pregnancy outcomes, neonatal treatment, issues regarding conduct of clinical trials in pregnant women and children, as well as concentrations on specific health care questions such as pediatric asthma, disaster consequences (natural or man-made), pediatric obesity, and management of pediatric psychiatric conditions.
Special Program Objectives and Considerations:
Within the framework of the NRSA program’s longstanding commitment to excellence and projected need for investigators in particular areas of research, attention must be given to recruiting trainees from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences, individuals with disabilities, and individuals from disadvantaged backgrounds (see Section IV).
Another consideration relates to the duration of training and the transition of trainees to individual support mechanisms. The Training PD/PI should limit appointments to individuals who are committed to a career in research and who plan to remain on the training grant or in a non-NRSA research experience for a cumulative minimum of 2 years. The PD/PI should also encourage and provide training in the skills necessary for trainees to apply for subsequent support through an individual fellowship, mentored career development award (K) programs, or independent research project grants.
Past studies have shown that health professional trainees who train in combined programs with postdoctoral researchers with an intensive research background are more likely to apply for and receive research grant support. Programs located in clinical departments that focus on research training for individuals with the M.D. or other health-professional degrees should consider developing ties to basic science departments or modifying their program to include individuals with research doctorates when this approach is consistent with the goals of the program. Applications should describe the basic science department’s contribution to the research training experience and also indicate whether both health professional trainees and trainees with research doctorates will be included in the program.
See Section VIII, Other
Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This funding opportunity will use the Ruth L. Kirschstein National Research
Service Award (NRSA) T32 award mechanism. Awards may be made for periods
up to 5 years and are renewable.
The PD/PI will be solely responsible for planning, directing, and executing the
proposed research training program.
This funding opportunity announcement (FOA) uses the non-modular budget
format. A detailed categorical budget for the "Initial Budget
Period" and the "Entire Proposed Period of Support" is to be
submitted with the application, following the Instructions for preparing an
NRSA institutional research training (T32) application described in Section IV, including the PHS 398 Training Budget pages, the PHS 398 Subaward
Budget Attachment(s) Form (when applicable) and the PHS Research Training
Program Plan. Detailed instructions for completion of the application and
Research Training related forms are in the SF424 (R&R)
Application Guide for NIH and Other PHS Agencies, Section 8.
2.
Funds Available
Because the nature and scope of the proposed research training programs will
vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the ICs
provide support for this program, the total amount awarded and the number of
awards will depend upon the number, quality, duration, and costs of the
applications received. Applicants are strongly urged to contact appropriate IC
scientific staff listed under Section VII for guidance prior to preparing
the application.
Grantees are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines (NIH Grants Policy Statement - Institutional Research Training Grants). Funds may be used only for those expenses that are directly related to and necessary for the research training not otherwise available and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement, and the NRSA regulations, policies, guidelines, and conditions set forth in this document.
2.A. Allowable Costs
Stipends: Stipends are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience and are based on a 12-month appointment period. The stipend is not provided as a condition of employment with either the Federal Government or the grantee institution nor is it to be considered a payment for services performed. Stipends will be based on the annual NIH stipend levels at the time of award. Stipends may be adjusted only at the time of appointment or reappointment and may not be changed in the middle of an appointment period. For appointments of less than a full year, the stipend will be based on a monthly or daily pro-ration of the annual amount. No departure from the established stipend schedule may be negotiated by the institution with the trainee. For the most recent stipend levels see the Ruth L. Kirschstein National Research Service Award (NRSA) website.
Tuition and Fees: Applicants should request full needs for tuition and fees. The NIH IC will apply the appropriate formula by offsetting the combined costs of requested tuition and fees at the rate in place at the time of the award. The rate currently provides 60% of the level requested by the applicant institution, up to $16,000 per year per predoctoral trainee. If the program supports formally combined dual-degree training (e.g., M.D.-Ph.D., D.D.S.-Ph.D.), the amount provided per trainee will be 60% of the level requested up to $21,000 per year. For postdoctoral trainees, an amount equal to 60% of the level requested by the applicant institution, up to $4,500 per year, will be provided. If the program supports postdoctoral individuals in formal degree-granting training, the amount provided per trainee enrolled in a degree-granting program will be 60% of the level requested up to $16,000 per year. Costs associated with this category are allowable only if they are required as part of the approved research training program and are applied consistently to all persons in a similar research training status at the institution regardless of the source of support. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved training program which should be identified in the application. For a full description of the NIH tuition policy, see NOT-OD-10-073.
Trainee Travel: Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual s research training experience is an allowable trainee expense. Funds may not be expended to cover the costs of travel between the trainee’s place of residence and the training institution, except that the grantee organization may authorize a one-way travel allowance in an individual case of extreme hardship. Amounts for trainee travel are not uniform throughout the NIH. Trainees must be appointed to this training program at the time of actual travel for this to be an allowable cost. Applicants are strongly urged to contact appropriate IC scientific staff listed under Section VII for guidance prior to preparing the application.
Additionally, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent organization must be justified considering the type of opportunities available for training, and how the opportunities differ from and complement those offered at the parent institution, and the relationship of the proposed training experience to the trainee’s career stage and goals. This type of travel and research training requires prior approval from the NIH awarding component, and, if not known at the time of application, may be submitted at any time during the award period.
Training Related Expenses, including Health Insurance (TRE): The applicant institution may request the NIH standard NRSA Training Related Expenses (FY 2009: $4,200 annually for each predoctoral trainee and $7,850 annually for each postdoctoral trainee) to help defray other research training expenses, such as health insurance (self-only or family, as applicable), staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. Health insurance is an allowable expense that may be charged to the Training Related Expenses budget category but only to the extent that the same health insurance fees are charged to non-Federally-supported students and postdoctoral individuals (see NOT-OD-10-047 for additional information). Funds are provided as a lump sum on the basis of the predetermined amount per predoctoral and postdoctoral trainee approved for support.
Under exceptional circumstances, which can include accommodating the disabilities of a trainee, it is possible to request training related expenses above the standard level. Requests for additional costs must be explained in detail and justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised (see Section VII).
When predoctoral and/or postdoctoral level short-term training is included in the research training program, the applicant institution may request the proportion of the NIH standard annual NRSA Training Related Expenses to help defray other costs of the short-term training experience.
Facilities and Administrative (F&A) Allowance: Grantees other than State, local, or Indian tribal governments will receive F&A costs at 8 percent of modified total direct costs (exclusive of tuition and fees, consortiums in excess of $25,000, and expenditures for equipment) rather than on the basis of a negotiated rate agreement. State, local, and Indian tribal government agencies are eligible for full F&A cost reimbursement. For this policy, State universities or hospitals are not considered governmental agencies.
Stipend Supplementation, Compensation, and Other Income: 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 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 conditions described below are met. 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.
Supplementation: Grantees may supplement stipends from non-Federal funds provided the supplementation is without obligation to the trainee. An organization can determine what amount of stipend supplementation, if any, will be provided according to its own formally established policies governing stipend support. These policies must be consistently applied to all individuals in a similar training status regardless of the source of funds. Federal funds may not be used for stipend supplementation unless specifically authorized under the terms of the program from which funds are derived. An individual may use Federal educational loan funds or VA benefits when permitted by those programs. Under no circumstances may PHS funds be used for supplementation.
Compensation: Funds characterized as compensation may be paid to trainees only when there is an employer-employee relationship, the payments are for services rendered, and the situation otherwise meets all of the conditions and policies in the NIH Grants Policy Statement. Additionally, compensation must be in accordance with organizational policies consistently applied to both federally and non-federally supported activities and must be supported by acceptable accounting records that reflect the employer-employee relationship. An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services performed outside of the responsibilities of the full-time NRSA-supported training 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 a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal full-time research training activities. In addition, compensation may not be paid from a research grant that supports the same research that is part of the trainee’s planned training experience as approved in the institutional training grant application. The Training PD/PI must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved training program.
A full description of the NIH policy regarding NRSA supplementation and compensation can be found in the NIH Grants Policy Statement at: NIH Grants Policy Statement - Part II: Terms and Conditions of NIH Grant Awards.
Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible to apply:
Only domestic, non-profit, private or public institutions
may apply for grants to support National Research Service Award (NRSA)
institutional research training programs. Foreign institutions are not
eligible to apply. The applicant institution must have a strong and high
quality research program in the area(s) proposed for research training and must
have the requisite staff and facilities on site to conduct the proposed
research training program.
1.B.
Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to organize and implement a high-quality research training program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.
The Training PD/PI should be an established basic, behavioral, and/or clinical researcher with the skills, knowledge, a successful past training record, and available resources to conduct the proposed research training program at the sponsoring institution. The PD/PI will be responsible for the selection and appointment of eligible trainees to the NRSA training grant, for the overall direction, management and administration of the research training program, program evaluation, and the submission of all required forms in a timely manner.
Multiple PD/PIs: More than one Training PD/PI (or multiple PD/PIs), may be designated on the application for training programs that require a team approach and therefore clearly do not fit the single PD/PI model, e.g., interdisciplinary or multidisciplinary training. The decision to apply with a single PD/PI or multiple PD/PIs is the responsibility of the investigators and applicant organizations, and should be determined and justified by the goals of the training program. Applications for grants with multiple PD/PIs require additional information. When considering multiple PD/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PI will be factored into the assessment of the overall scientific merit of the application. Multiple PD/PIs on a program share the authority and responsibility for leading and directing the training program, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization for the proper conduct of the program, including the submission of required reports.
Applications with multiple Training PD/PIs must provide a Leadership Plan that emphasizes how leadership by multiple PD/PIs will benefit the research training program and the trainees. A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary. Because training programs are intended to be coherent a single award will be made. NIH will not allocate the budget or training positions between multiple PD/PIs. Multiple PD/PI application should include reasonable numbers of PD/PIs and each should be included for a specific purpose. Multiple PD/PI applications should not include all mentors of the training grant as PD/PIs, except in unusual cases.
Additional instructional information associated with the multiple PD/PI option is located in the application instructions 8.10.10 (Multiple PD/PI Leadership Plan). For background information on the Multiple PD/PI initiative, see: Multiple Principal Investigators.
2. Cost Sharing or Matching
Cost sharing is not required.
3.
Other-Special Eligibility Criteria
Training Program: Trainees appointed to the research training program must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career. Trainees must commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to the program and its related research activities, consonant with NRSA guidelines. Within the full-time training period, research trainees who are also training as clinicians 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.
A Kirschstein-NRSA institutional research training grant must be used to support a program of full-time research training. It may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional degrees except when those studies are part of a formal combined research degree program, such as the M.D./Ph.D. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.
Trainee Appointments: All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIH awarding unit, or when trainees are appointed to approved, short-term training positions.
No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of NRSA support at the postdoctoral level, including any combination of support from institutional training and individual fellowship awards. Any exception to the maximum period of support requires a waiver from the NIH awarding office based on a review of the written justification from the individual trainee, and endorsed by the PD/PI and the sponsoring grantee institution. Trainees seeking additional support are strongly advised to consult with the NIH awarding office.
Trainee Citizenship: The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Noncitizen nationals are people, who, although not citizens of the United States, owe permanent allegiance to the United States. They generally are people born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals who have been lawfully admitted for permanent residence must have a currently valid Permanent Resident Card (USCIS Form I-551) or other legal verification of such status. For example, if an individual has the proper validation on his/her passport, a notarized photocopy of the passport could suffice. Because there is a 6-month limitation on this validation, it is the grantee’s responsibility to follow up and ensure that the individual received the I-551 prior to the 6-month expiration date.
A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving Kirschstein-NRSA support. Individuals on temporary or student visas are not eligible for Kirschstein-NRSA support.
Predoctoral Trainees: Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, must be training at the post-baccalaureate level, and be enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program. Health-professional students, graduate students in the quantitative sciences, or individuals in postgraduate clinical training who wish to interrupt their studies for a year or more to engage in full-time research training before competing their formal training programs are also eligible.
Postdoctoral Trainees: Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., Psy.D, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Research training at the postdoctoral level must emphasize specialized training to meet national research priorities in the biomedical, behavioral, or clinical sciences that are within the scientific purview of the NICHD in the research training program.
Short-Term Health-Professional Trainees: Research training programs solely for short-term research training should not apply to this announcement, but rather the separate T35 NRSA (see PA-10-037). A Kirschstein NRSA-Institutional Research training application may include a request for short-term predoctoral and postdoctoral positions reserved specifically to provide full-time health-related research training experiences during the summer or other off-quarter period. Such positions are limited to medical students, dental students, students in other health-professional programs, and graduate students in the physical or quantitative sciences. Short-term appointments under T32 research training programs are intended to provide such students with opportunities to participate in biomedical or behavioral research in an effort to attract these individuals into research careers. To be eligible for short-term predoctoral research training positions, students must be enrolled and in good standing and must have completed at least one quarter or semester in a program leading to a clinical doctorate, or a doctorate in a quantitative science such as physics, mathematics, or engineering. Individuals already matriculated in a formal research degree program in the health sciences, or those holding a research doctorate or master’s degree or a combined health-professional/research doctorate normally are not eligible for short-term training positions. Within schools of pharmacy only individuals who are candidates for the Pharm.D. degree are eligible for short-term research training positions.
Short-term training is not intended, and may not be used, to support activities that would ordinarily be part of a research degree program, nor for any undergraduate level training. Positions on NRSA short-term institutional training grants may not be used for courses and study leading to an M.D., D.D.S. D.O., D.V.M., or other clinical, health professional degree, nor do they support residency training. Research elective credit may be granted for students who complete a short-term research training experience supported by the T32. The decision to award elective credit will be at the discretion of the sponsoring institution and must be consistent with the policies of the institution. Any additional costs associated with the decision to allow research elective credit may not be charged to the T32.
Short -term positions can support predoctoral and/or postdoctoral level individuals for a period at least 8, but no more than 12 weeks in a grant year, and must involve full-time research training, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.
Funding for short-term training is prorated, based on the allowed annual amounts for stipends and training related expenses. Individuals currently supported by other Federal funds are not eligible for concurrent trainee support from this program.
Applicants considering requesting short-term research training positions as part of the T32 application are urged to contact the appropriate NIH IC since some ICs do not support short-term positions under the T32 or support them on a limited basis only.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).
A one-time registration is required for institutions/organizations at both:
The PD/PI should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered http://www.grants.gov/applicants/get_registered.jsp
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PDs/PIs and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.
For
further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2.
Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm)..
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required
Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance
Site Locations
Research & Related Other Project
Information
Research & Related Senior/Key Person
Profile (Expanded)
PHS 398
Training Budget Pages
PHS 398
Research Training Program Plan
PHS398 Cover
Letter
PHS398 Checklist
Optional
Components:
Training Subaward Budget Attachment(s) Form (when applicable)
SF424 (R&R) Detailed Budget (when applicable)
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan, entitled Multiple PD/PI Leadership Plan [Section 8.10 of the Research Training Program Plan], must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
3. Submission Dates and Times
See Section IV.3A for details.
3.A. Submission, Review and
Anticipated Start Dates
Opening Date: June 13, 2010 (Earliest date an application may be
submitted to Grants.gov)
Letters
of Intent Submission Dates: June 14, 2010,
April 25, 2011, April 25, 2012
Application Submission Dates: July 13, 2010, May 25, 2011, May 25,
2012
Peer Review Date: October/ November 2010, 2011, and 2012
Council
Review Dates: January 2011, January 2012,
January 2013
Earliest
Anticipated Start Dates: April 2011, 2012 and
2013
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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 IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section
IV.3.A. to:
Zhaoxia Ren, M.D., Ph.D.
Obstetric
and Pediatric Pharmacology Branch
Center
for Research for Mothers and Children
Eunice
Kennedy Shriver National Institute
of
Child Health and Human Development, NIH
6100
Executive Blvd Room 4B15 MSC 7510
Bethesda, MD 20892-7510
Phone:
301-402-9340
Fax:
301-480-2897
Email: [email protected]
3.B. Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
3.C.1 Submitting On-Time
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the CSR. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at Grants Policy and
Guidance.
The National Research Service Award (NRSA) policies apply to this program. Awards are contingent upon availability of funds. Furthermore, the duration of the award and the number of funded training positions may be less than the levels recommended by the peer review group, based on programmatic and budgetary considerations.
Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.
Pre-Award Costs: Pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants since these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. However, the policies governing the pre-award cost authority for the expenditure of the other funds provided as training-related expense in a training grant are those permitted as follows:
A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: (1) are necessary to conduct the project, and (2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.
Concurrent Awards: An NRSA appointment may not be held concurrently with another federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.
Taxability of Stipends: Section 117 of the Internal Revenue Code applies to the tax treatment of scholarships and fellowships. Degree candidates may exclude from gross income (for tax purposes) any amount used for course tuition and related expenses, such as fees, books, supplies, and equipment, required for courses of instruction at a qualified educational organization. Nondegree candidates are required to report as gross income any monies paid on their behalf for stipends or any course tuition and fees required for attendance.
The taxability of stipends in no way alters the relationship between Kirschstein-NRSA trainees and grantee organizations. Kirschstein-NRSA stipends are not considered salaries. In addition, trainees supported under Kirschstein-NRSA institutional research training grants are not considered to be in an employee-employer relationship with NIH or the grantee organization solely as a result of the Kirschstein-NRSA support. Interpretation and implementation of the tax laws are the domain of the IRS and the courts. NIH takes no position on what the status may be for a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations.
Service Payback: As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Additionally, the Act specifies that the second year of postdoctoral Kirschstein-NRSA training support will serve to pay back a postdoctoral service payback obligation (see Section VI.2, Administrative and National Policy Requirements for further details).
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Specific Instructions for Applications Requesting
$500,000 (direct costs) or More per Year:
Applicants requesting $500,000 or more in direct costs for any year must carry
out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,
3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2 renewal), competing supplement (type 3 revision), or any amended or revised (resubmission) version of these grant application types. For additional information on this policy, see: NOT-OD-02-004.
6.A. Special Program Requirements
Application Research Training Plan Component Sections
All application instructions outlined in the SF424 (R&R) application, Section 8 are to be followed with the following requirements for T32 applications:
Background
Provide rationale for the proposed research training program, relevant background history, and the need for the research training proposed. Indicate how the proposed program relates to current training activities at the applicant institution. See SF424, Section 8.7. Research Training Program Plan Components, Item 2, Background.
Program Plan
a. Program Administration Training Program Director/Principal Investigator (PD/PI): The Training PD/PI must possess the scientific background and leadership and administrative capabilities required to coordinate, supervise, and direct the proposed research training program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI must provide potential trainees information associated with NRSA programs and submit all required trainee forms in a timely manner. See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.
If multiple PDs/PIs are involved in the research training program, applicants must describe how the research training program and trainees will benefit from this arrangement. A Leadership Plan is required. See Section III.1.B in this FOA, NIH multiple PD/PI instructions: Multiple Principal Investigators, and information in Section 8.7, Item 10 of the PHS 398 Research Training Program Plan Component Instructions.
b. Program Faculty Preceptors/Mentors: The application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise to the level of trainees proposed in the application. The preceptors/mentors should have strong records as researchers, including successful competition for research support in the area of the proposed research training program. This section should also describe the past research training record of the program faculty, including the success of former trainees of the designated preceptors/mentors in establishing productive scientific careers. Evidence can include successful completion of programs and further career advancement of former trainees such as 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, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other accepted measures of success. See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.
c. Proposed Training: The program should plan to provide didactic training as well as laboratory or clinical research experience. This should include a plan for determining trainee experience and needs and monitoring progress to accomplish desired goals. The program should develop trainee skills in understanding research, applying their critical abilities to conduct research, identifying problems in the process of conducting research, raising questions and proposing solutions to resolving problems. Trainees should be prepared to utilize their research findings as they pursue future research. Programs should provide all NRSA trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support. All postdoctoral NRSA trainees should also be provided with instruction in laboratory and project management. See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.
d. Training Program Evaluation: The application must describe an evaluation plan to review and determine the quality and effectiveness of the training program. This should include plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvements, as well as plans for assessing trainees career development and progression, including degree completion, publications, and post-training positions. Evaluation results should be included in future competing continuation (renewal) applications and as part of the Final Progress Report. See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.
e. Trainee Candidates: The application must describe the recruitment plans, including the sources and availability of trainees; the qualifications of prospective trainees; and the criteria and procedures by which trainees will be selected. This section should include information about trainee admissions and completion records, qualifications of applicants, and current trainee qualifications. See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.
f. Institutional Environment, Commitment, and Resources: The administration of the applicant institution as well as all participating units and departments should include information in the application that documents institutional support and commitment to the goals of the research training program. The application should include a description of support (financial and otherwise) to be provided to the proposed program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD/PI and/or participating faculty, support for additional trainees in the program, or any other creative ways to improve the climate for the establishment and growth of the research training program. Note: See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.
Recruitment and Retention Plan to Enhance Diversity
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation s capacity to address and eliminate health disparities.
Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/nsf07308/content.cfm?pub_id=3633&id=3) In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.
Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:
For those trainees who were enrolled in the training program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.
This Program Announcement requires all applicants to submit a recruitment and retention plan to enhance diversity (see SF424, Section 8.7. Research Training Program Plan Components, Item 4, Recruitment and Retention to Enhance Diversity). Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).
Applications without a diversity recruitment and retention plan will be considered incomplete and will not be reviewed.
Training in the Responsible Conduct of Research
Every trainee supported by this training grant must receive instruction in the responsible conduct of research. All Applications must include a plan to provide such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction as detailed in NOT-OD-10-019. Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan. All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. See SF424, Section 8.7. Research Training Program Plan Components, Item 5, Plan for Instruction in the Responsible Conduct of Research.
Select Agent Research
If participating faculty proposed in the training program are conducting or plan to conduct research involving select agents in which trainees may participate, follow the instructions in SF424, Section 5.5, and include information in PHS398 Research Training Program Plan, Item 9, Select Agent Research.
6.B. Resource Sharing Plans
Not Applicable.
6.C. Data Tables
Applications should include the data requested in the SF424 using the instructions for submission of Data Tables 1-12 (See Data Table Instructions), unless those instructions are further modified by information given in the funding component contacts section of this announcement (Table of Institute and Center Contacts). The information in the data tables will be used by reviewers during peer review and NIH staff in reaching funding decisions.
NOTE: It is no longer required for applicants to provide pre-enrollment data for individuals with disabilities or individuals from disadvantaged backgrounds on Data Tables 7A and 7B (see: NOT-OD-09-135).
NOTE: Renewal applications: Reporting of information on completion rate and time to degree for graduate students in doctoral degree programs that have been supported by NIH training awards must be documented in the Program Statistics section of Table 12A (see NOT-OD-09-141). Information must include:
Note: See SF424, Section 8.7. Research Training Program Plan Components, Item 13, Data Tables.
6.D. Appendix Materials
Do not use the appendix to circumvent the page limitations of the Training Plan. The specifically required Data Tables 1-12 described in the SF424 are exempted from the application page limits. Check with the appropriate PHS awarding component contacts listed in the FOA (e.g., Table of Institute and Center Contacts) for the types of appendix materials that are allowed and typically included or are not allowed in applications reviewed for that specific awarding component.
A summary listing all of the items included in the appendix is required, and should be the first PDF file. Applications that do not follow the appendix requirements may be delayed in the review process. All appendix material must be submitted as PDF attachments.
Research publications of trainees and mentors are not normally included as part of the Training Grant applications, but are allowed. Other types of publications reflecting on the activities of the program as a whole may also be included. When publications are allowed, appendix materials should be limited to those which are not publicly available, such as:
Do not include unpublished theses or abstracts/manuscripts submitted, but not yet accepted, for publication.
Publications that are publicly accessible must not be included in the appendix. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References Cited/Progress Report Publication List section of the Research Plan, and/or in the Biographical Sketch.
Some materials other than publications that are unique to training grant applications (but not typically included in research grant applications) may be included as appendices. The appendix may be used to provide samples of materials that are referred to in the body of the application, but are too cumbersome to include in the Training Program Plan without disrupting the narrative flow. Examples include:
i. Additional tables not requested in the SF424 instructions designate these by letter, rather than number, to avoid confusion with the numbered required tables;
ii. Syllabi for key courses, core courses and electives, including courses in Responsible Conduct of Research, Survival Skills for Research, etc.;
iii. Retreat, seminar series, and other program activity agendas, rosters, and schedules;
iv. Examples of forms used to document trainee progress and monitoring by the program;
v. Examples of materials used in recruitment and particularly recruitment and retention to enhance diversity of the student pool.;
vi. Lists of meetings attended by students and their presentations;
vii. Student biosketches; and
viii. Letters of support, collaboration, and commitment of institutional resources.
For materials that cannot be submitted as a PDF attachment, applicants should contact the Scientific Review Officer for instructions following notification of assignment of the application to a study section. Applicants are encouraged to be as concise as possible and submit only information essential for the review of the application.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Review Process
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the initial merit review, all applications:
The goals of NIH-supported research training are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. Reviewers will first determine the quality of the proposed research training program, including information presented in the data tables and appendix, and then consider whether the requested number of trainee positions is appropriate for the program.
Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the research training program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the research training program proposed).
Scored Review Criteria: Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Although individual Institutes and Centers may have specialized review criteria appropriate for their special initiatives and mission, most research training applications are evaluated using the following criteria:
Training Program and Environment:
Training Program Director/Principal Investigator (PD/PI):
Preceptors/Mentors:
Trainees:
Training Record:
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children: When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals: The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. . For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
Biohazards: Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications: When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Recruitment and Retention Plan to Enhance Diversity: Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from all three underrepresented groups (A, B, and C). For renewal applications, peer reviewers will evaluate whether the experience in recruitment during the previous award period has been incorporated into the formulation of the plan for the next award period. The review panel s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.
Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address five Instructional Components (Format, Subject Matter, Faculty Participation, Duration and Frequency), taking into account the characteristics of institutional programs or the unique circumstances for short-term training programs, detailed in NOT-OD-10-019. The review of this consideration will be guided by the principles set forth in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.
Applications from Foreign Organizations. Foreign applications are not allowed for this FOA.
Select Agents Research: When applicable, reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Not applicable for this FOA.
Budget and Period of Support: The reasonableness of the proposed budget and the requested period of support will be assessed in relation to the proposed research training program and the number of proposed trainees at the requested levels. The impact/priority score should not be affected by the evaluation of the budget.
Selection Process
The following will be considered in making funding decisions:
3. Anticipated Announcement and
Award Dates
Not applicable.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the Training PD/PI will
be able to access the written critique called a Summary Statement via the eRA Commons.
If the application is under consideration for funding, NIH may request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General (NIH Grants Policy
Statement - Part4.htm).
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization. The NoA signed by the grants management officer
is the authorizing document. Once all administrative and programmatic issues
have been resolved, the NoA will be generated via email notification from the
awarding component to the grantee business official.
Selection of an application for award is not an authorization to begin
performance. Any costs incurred before receipt of the NoA are at the
recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Also Section IV.5. Funding
Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (NIH Grants Policy
Statement)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (NIH Grants Policy
Statement).
Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy statement at NIH Grants Policy Statement - Institutional Research Training Grants, and any terms and conditions specified in the NoA.
Special Administrative Requirements Associated with NRSA Programs:
Leave Policies: In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring 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. Trainees may also receive stipends for up to 60 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 this level of paid leave for this purpose and the use of parental leave is approved by the Training PD/PI (see NOT-OD-08-064). A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines at: NIH Grants Policy Statement for further guidance regarding vacations and requested leave.
Part-time Training: While NRSA trainees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, under pressing personal circumstances, a Training PD/PI may submit a written request to the awarding component to change a trainee appointment to less than full-time. Such requests will be considered on a case-by-case basis and must be approved by the awarding Institute in advance for each budget period. The nature of the circumstances requiring part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the trainee’s position at the institution. In each case, the PD/PI must submit a written request countersigned by the trainee and an appropriate institutional business official that includes documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the trainee intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the research training program. In no case will it be permissible for the trainee to be engaged in NRSA supported research training for less than 50% effort. Individuals who must reduce their commitment to less than 50% effort must take a leave of absence from NRSA training grant support. The stipend will be pro-rated in the grant award during the period of any approved part-time training. Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral trainees.
Carryover of Unobligated Balances: Most of the NIH funding components require prior written approval for carryover of funds from one budget period to the next. When required, such requests must include compelling justification including the status of trainee appointments to the program. If not stated on the Notice of Award, the Training PD/PI should contact the applicable IC’s Grants Management contact to determine the funding IC’s carryover policy.
Termination of Award: NIH may terminate a Kirschstein-NRSA institutional research training grant before its normal expiration date if it determines that the grantee has materially failed to comply with the terms and conditions of the award or to carry out the purpose for which the award was made. If an award is terminated for cause, NIH will notify the grantee organization in writing of this determination, the reasons for the determination, the effective date, and the right to appeal the decision. NIH also may terminate an award at the request of the grantee.
An organization that wants to terminate a training grant before the scheduled termination date must notify the NIH awarding office immediately. In such cases, NIH will issue a revised NGA to specify the changed period of support and to show prorated trainee stipends, depending on the amount of time spent in training.
Change of Institution: Kirschstein-NRSA institutional research training grants may not be transferred from one domestic organization to another except under the most unusual circumstances. Such a change generally will be approved by the NIH awarding office only if all of the major benefits attributable to the original grant can be transferred and there is no negative impact on trainees active in the program.
Change of Training Program Director/Principal Investigator (PD/PI): If change of a Training PD/PI or multiple PD/PIs is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI(s) or the grantee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to program and grants management staff at the NIH funding component describing the reasons for the change, and include a new leadership plan (for changes in multiple PD/PIs). The Biographical Sketch of the proposed PD, including a complete listing of active research grant support, must be provided. The information in the request must establish that the specific aims of the original peer-reviewed program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research training and administrative expertise to lead the training program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.
Change of Program: A rationale must be provided for any proposed changes in the original, peer-reviewed research training program objectives. Any change requires prior approval by program staff of the NIH funding component. If the new program does not satisfy this requirement, the award will be terminated.
Service Payback Provisions: As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Additionally, the Act specifies that the second year of postdoctoral Kirschstein-NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply:
Postdoctoral trainees in the first 12 months of postdoctoral Kirschstein-NRSA support must sign the Payback Agreement Form (PHS 6031) before initiating an appointment. Postdoctoral trainees in their first 12 months of support will incur a period of service payback obligation equal to the period of support.
Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payment agreement form and will not incur a service payback obligation for this period of support. In addition, the 13th and subsequent months of postdoctoral Kirschstein-NRSA support are considered acceptable payback service for prior postdoctoral support. For example, postdoctoral trainees who continue under that award for two years have fulfilled the obligation incurred during the first 12 months of support by the end of the second year.
Service payback obligations can also be paid back after termination of Kirschstein-NRSA support by conducting health-related research or teaching averaging at least 20 hours per week of a full work year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment in the United States or in a foreign country. Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research. Recipients with service obligations must begin to provide acceptable payback service on a continuous basis within two years of termination of Kirschstein-NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the NIH specifying the need for additional time and the length of the required extension.
Recipients of Kirschstein-NRSA support are responsible for informing the NIH of changes in status or address.
For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the total amount of Kirschstein-NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary, DHHS (or those delegated this authority), may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, may waive or suspend the payback obligation of an individual. Detailed information on the accrual and repayment of the Kirschstein-NRSA service payback obligation and waivers is available at: NIH Grants Policy Statement - Payback Reporting Requirements.
Officials at the grantee institution have the responsibility of explaining the terms of the payback requirements to all prospective trainees before appointment to the training grant. Additionally, all trainees recruited into the training program must be provided with information related to the career options that might be available when they complete the program. The suitability of such career options as methods to satisfy the NRSA service payback obligation must be discussed.
3.
Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, PHS Form 2590, annually and annual financial
statements as required in the NIH Grants Policy Statement. The NRSA
program is not subject to SNAP.
The NRSA instructions for the Non-Competing Grant Progress Report for an institutional research training grant in, PHS Form 2590) must be followed. Note that a substitute budget page and a summary of trainee page are to be included in the request for continuation support. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program. Information on each trainee should also be included in the narrative portion of the Progress Report as described in the PHS Form 2590 instructions. Additional information that should be included in the annual progress report in concert with the PHS Form 2590 instructions:
3.A. Additional Reporting Requirements
Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and accepted.
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. This form must be submitted to the awarding IC at or before the start of each participant’s appointment or reappointment. Grantees will be required to submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at https://commons.era.gov/commons/. An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year. Additionally, a completed Payback Agreement Form (PHS 6031) must be submitted for each postdoctoral trainee in his or her first 12 months of support. No funds may be provided until such documents are submitted. A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving Kirschstein-NRSA support.
Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) to the NIH. Grantees will be required to submit the PHS 416-7 data electronically using the xTrain system. More information on xTrain is available at https://commons.era.gov/commons/.
Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.
Graduate Student Reporting: For renewal applications, the grantee institution must report the following information for graduate students in doctoral degree programs that have been supported by NIH training awards:
Information on completion rates and time to degree should be reported in the Program Statistics section of Table 12A (Predoctoral Trainees Supported by this Training Grant) when submitting a renewal application (SF424) or a non-competing continuation progress report (PHS 2590).
Publication and Sharing of Research Results: NIH supports the practical application and sharing of outcomes of funded research. Therefore, trainees should make the results and accomplishments of their Kirschstein-NRSA research training activities available to the research community and to the public at large. The grantee organization should assist trainees in these activities, including the further development of discoveries and inventions for furthering research and benefiting the public. No restrictions should be placed on the publication of results in a timely manner.
Trainees are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from a trainee s research, NIH support should be acknowledged by a footnote in language similar to the following: This investigation was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. In addition, federal funding must be acknowledged as provided in Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.
Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this Program. Accordingly, NRSA participants should be notified that they may be contacted after the completion of their appointment for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program.
Inventions: Traineeships made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required for institutional training grants.
Copyrights: Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.
Final Reports: A Final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award. Evaluation results should be included as part of the Final Progress Report.
We encourage your inquiries concerning this
funding opportunity and welcome the opportunity to answer questions from
potential applicants. Inquiries may fall into three areas: scientific/research,
peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Zhaoxia
Ren, M.D., Ph.D.
Obstetric
and Pediatric Pharmacology Branch
Center
for Research for Mothers and Children
Eunice
Kennedy Shriver National Institute
of
Child Health and Human Development, NIH
6100
Executive Blvd Room 4B15 MSC 7510
Bethesda, MD 20892-7510
Phone:
301-402-9340
Fax:
301-480-2897
Email: [email protected]
2. Peer Review Contacts:
Director,
Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
3. Financial or Grants Management Contacts:
Bryan Clark
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 8A01A, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6975
FAX: (301) 451-5510
Email: [email protected].
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research: Recipients of PHS support for activities involving live, vertebrate
animals must comply with PHS Policy on Humane Care and Use of Laboratory
Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan: Data and safety monitoring is required
for all types of clinical trials, including physiologic toxicity and
dose-finding studies (phase I); efficacy studies (Phase II); efficacy,
effectiveness and comparative trials (Phase III). Monitoring should be
commensurate with risk. The establishment of data and safety monitoring boards (DSMBs)
is required for multi-site clinical trials involving interventions that entail
potential risks to the participants (NIH Policy for Data and Safety Monitoring,
NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data: Investigators submitting an NIH application
seeking $500,000 or more in direct costs in any single year are expected to
include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local institutional review board (IRB) rules, as
well as local, State and Federal laws and regulations, including the Privacy
Rule.
Policy for Genome-Wide Association Studies (GWAS): NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/
Sharing of Model Organisms: NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Access to Research Data through the Freedom of Information Act: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Inclusion of
Women And Minorities in Clinical Research: It is
the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of
clinical research; updated racial and ethnic categories in compliance with the
new OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the SF424 (R&R)application; and updated
roles and responsibilities of NIH staff and the extramural community. The
policy continues to require for all NIH-defined Phase III clinical trials that:
a) all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research: The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC): Criteria for federal funding of
research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116 .html. Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project
description and elsewhere in the application as appropriate, the official NIH
identifier(s) for the hESC line(s) to be used in the proposed research.
NIH Public Access Policy Requirement: In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for
Privacy of Individually Identifiable Health Information: The Department of Health and Human Services (DHHS) issued final
modification to the "Standards for Privacy of Individually Identifiable
Health Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete
Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or 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.
Furthermore, we caution reviewers that their anonymity may be compromised when
they directly access an Internet site.
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 FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372.
Awards are made under the authorization of Section 487 of the Public Health
Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR
66. All awards are subject to the terms and conditions, cost principles,
and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use 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.
Loan Repayment Programs: NIH encourages applications for educational
loan repayment from qualified health professionals who have made a commitment
to pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP recipient
with the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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