Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
This RFA is developed as an NIH Roadmap Initiative. All Institutes and Centers participate in Roadmap Initiatives. The RFA will be administered by NICHD on behalf of the NIH.

Title: Predoctoral Clinical Research Training Programs

Announcement Type
New

Request For Applications (RFA) Number: RFA-RM-05-015

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: December 17, 2004
Letters of Intent Receipt Date(s): February 25, 2005
Application Receipt Dates(s): March 25, 2005
Peer Review Date(s): July 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: September 2005
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: March 26, 2005

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 Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application 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
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Reporting

  Section VII. Agency Contact(s)
    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 Objectives

Purpose

The National Institutes of Health (NIH) invite applications for developing and implementing novel, flexible institutional Predoctoral Clinical Research Training Programs (called Programs below) that will promote clinical research training among predoctoral medical, dental, nursing, and other allied health students and provide efficient entry of interested students into clinical research careers. The goal is to increase the number of well-trained clinical researchers who will assume leadership roles in the design and oversight of future clinical investigations critical to the overall mission of the NIH. This Program will provide early exposure and appropriate training in clinical research for predoctoral students enrolled in medical and dental schools, and nursing and allied health students enrolled in doctoral programs. Programs are given the flexibility to provide interested students access to a level of clinical research training that is appropriate to their career stage and level of interest, and to accommodate their changing training needs as they progress through their predoctoral training. The program is primarily for predoctoral medical, dental and nursing students; however, it may include other health personnel such as pharmacy, statistics, or psychology graduate students, or individuals working towards doctorates in chiropractic (DC) or naturopathic medicine (ND), who seek additional predoctoral training in clinical research (see Targeted Disciplines section). This program will have a particular emphasis on patient-oriented research, because of a growing need for more researchers with the skills and knowledge to conduct clinical, patient-oriented research.

The Programs will train individuals known as NIH Clinical Research Trainees (CR Trainees), to become the next generation of clinical researchers performing clinical investigations in multi-disciplinary, collaborative clinical research settings. The Programs are expected to be student-based, and provide a range of experiences. Programs must include core didactic components, summer or short research experiences, an intensive clinical research training program, a faculty core, and an administrative core. The intensive training core will support the equivalent of 10-12 full-time trainees enrolled in MS (with a concurrent doctoral degree) or PhD programs in clinical research, or a year-long non-degree training program with practical training in various aspects of the design, conduct, and analysis of clinical research.

These Programs will function as a national program by sharing courses, ideas, and best practices among each other and nationally via web sites and web training courses. The Programs also will work in concert with the Roadmap Multi-disciplinary Clinical Research Career Development Programs funded under separate RFAs (RFA-RM-04-006, RFA-RM-05-016).

Background

The National Institutes of Health (NIH), in keeping with its mission, is engaged in a series of initiatives collectively known as the “NIH Roadmap” (http://nihroadmap.nih.gov/). The goal of the NIH Roadmap is to accelerate both the pace of discovery of new knowledge in the prevention, detection, diagnosis and treatment of disease and the translation of these discoveries into applications that will improve the health of the nation. The objective of this initiative is to increase and enhance the training of predoctoral students in clinical research who will eventually take leadership roles in the design and oversight of future clinical investigation. The overarching goal is to support the development of the clinical research manpower and training infrastructure, which will advance NIH's mission to improve health and prevent disease.

Recent scientific advances have the potential to better discern the etiology and mechanisms of progression of human disease, and promote the rapid transition from the research bench to applied preventive, diagnostic, and therapeutic modalities. Clinical research plays an important bedside to bench to bedside role in discovering the complexities of human disease, and bringing laboratory observations into the clinical setting. This new research paradigm requires an inter- and multi-disciplinary team approach, with well-trained clinical researchers as integral team members and leaders.

A shortage of clinical investigators spans all health professions. The growing chasm between research opportunities and numbers of trained clinical researchers has been recognized and documented through numerous reports, providing a framework for the NIH to stimulate clinical research training and career development opportunities for clinical researchers. These existing training opportunities include individual Career Development Awards (K23, K24), the Clinical Research Curriculum Development Award (K30), created to assist academic health centers in developing a core curriculum and mentoring for training clinical investigators, and Clinical Research Career Development Programs (K12) sponsored by institutes or the NIH Roadmap. While these programs provide sound training for post-doctoral fellows and young faculty, they do not address pipeline issues of stimulating interest in and providing initial clinical research training to predoctoral students of medicine, dentistry, nursing, or other critical allied health clinical research disciplines.

Because of these concerns, the Roadmap Trans-NIH Clinical Research Workforce Committee held a workshop called “Clinical Research Training at Medical and Dental Schools” on May 11-12, 2004. A report of that workshop is available (http://nihroadmap.nih.gov/clinicalresearch/WorkshopReport-CRTraining-0504.pdf). Participants articulated a need for better ways to introduce professional students to clinical research, especially patient-oriented clinical research, and for student-centered training programs that were appropriate for an individual student's level of interest, previous training, and career objectives.

Specific Objectives

The overall goal is to promote training of clinical investigators who will have a significant impact on improving health and preventing disease. The second goal is to expose medical, dental, and nursing students to clinical research, so if they choose to go into practice, they will take part in clinical research activities throughout their professional career by joining large scale clinical research projects, perhaps including the proposed NIH Roadmap National Clinical Research Associates (NCRA) Program. The NCRA will be comprised of clinicians at the front lines of care who enroll their patients into nationwide clinical research studies. The specific objectives of this Program are to increase the awareness of clinical research, support multiple training opportunities in clinical research for predoctoral students, and provide flexible practical experiences to students interested in clinical research, especially patient-oriented clinical research.

Definition of Clinical Research

Clinical research refers to all aspects and kinds of clinical research that meet the NIH definition [Instructions for the PHS 398 research grant application, Section III A., Definitions. NIH defines human clinical research as:

(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.

(2) Epidemiologic and behavioral studies.

(3) Outcomes research and health services research.

Targeted Training Disciplines

Clinical research is a complex endeavor that is ideally performed by a multi-disciplinary team using an integrated team approach. This Program will support clinical research training to enhance knowledge and develop skills in the discipline of clinical research. The primary targeted group is predoctoral students enrolled in medical, dental, and nursing schools (hereafter referred to as the “primary targeted disciplines”). Training programs should be designed to provide a flexible and efficient entrance into clinical research for these students. A secondary targeted group (hereafter referred to as the “secondary targeted disciplines”) consists of allied health personnel [e.g. statistics, pharmacy, and psychology graduate students enrolled in doctoral-level programs, or individuals working towards doctorates in chiropractic (DC) or naturopathic medicine (ND)] or others as appropriate. Training programs may offer an entry into clinical research for these research doctoral students. See “Eligible Trainees” for more information.

Mandatory Components and Core Requirements

Training programs are required to have specific key components that introduce students to clinical research, and to provide a graded series of experiences to expose students to clinical research and clinical research principles. All components are open to students in the primary targeted training disciplines. Where appropriate, the components are also open to predoctoral students in the secondary targeted training disciplines. The short-term practical research experience core may be omitted with suitable justification (for example, impossible to fit into the institution's academic schedule); however, all the other components are mandatory.

1. A curriculum core consisting of lectures, courses, seminar series, etc. that are offered to predoctoral medical, dental, and nursing students at the institution. This may include lectures or courses that are part of the regular curriculum taken by all students that will introduce the concepts of clinical research, and how these concepts provide the foundation for evidence based clinical practice. The courses may use innovative approaches, such as allowing the students to be research subjects in an active clinical research protocol. The curriculum also may consist of more specialized short courses or seminar series that allow more motivated students to explore clinical research topics (methods, design, ethics, etc) in more depth. Courses that introduce PhD students or basic science faculty to clinical research (such as the NIH Demystifying Medicine course, http://www1.od.nih.gov/oir/demystifyingMed/) also are encouraged. Programs will need a letter from the appropriate institutional official(s) indicating how these new courses will be incorporated into the existing curriculum.

2. A short-term practical research experience core. This core will offer approximately 12 students a 2-3 month full-time practical experience in clinical research through summer or elective rotations each year. The curricula of the rotations, which may be offered through ongoing clinical research programs or the General Clinical Research Center (GCRC), should have clearly outlined goals. Ideally, a student should have an independent research project that can be completed within the timeframe of the rotation, and be exposed to many phases of clinical research (design, implementation, data analysis, etc.)

3. An intensive training core. This core will consist of approximately 10-12 full-time (or equivalent) slots that include stipend, partial tuition payments, trainee travel, and training-related expenses. The programs must consist of at least one of the following programs:

3a. A clinical research Master's degree (e.g., MS, Master's in Clinical Investigation, or MPH) obtained during predoctoral training, especially for those disciplines that currently have a shortage of trained clinical researchers. Students must be enrolled in a concurrent MD, DDS/DMD, or PhD Program, and are ineligible if they are only enrolled in a Master's degree program (for example, Master's degree obtained after award of a MD degree). For institutions with existing programs that sponsor clinical research Master's degrees (such as K30 or K12 programs, for example), the applicant must address issues of potential overlap of curriculum development, how it will be determined which program is most advantageous for individual students, and how it will be ensured that students do not obtain overlapping funding. Furthermore, the application should include a letter from the Training or Program Directors and responsible Dean indicating how this new program will integrate with, yet differ from, the existing programs.

3b. A year-long non-degree training program [similar to the NIH Clinical Research Training Program (CRTP; http://www.training.nih.gov/crtp, with individualized practical experiences and training in various aspects of the design, conduct, and analysis of clinical research.

3c. A research doctoral (PhD) program for the primary targeted training disciplines that emphasizes training in patient-oriented clinical research. The research doctoral program may be modeled after a MSTP (MD/PhD) or DSTP (DDS/DMD-PhD) dual degree program. Patient-oriented research, as defined above, specifically excludes research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Programs that desire this option must describe potential overlaps, how the programs will jointly function, and have a letter from the current MSTP/DSTP Program Director(s) (if applicable) and Responsible Dean indicating how the CR Trainee students will be fully integrated into the existing MSTP/DSTP programs, and what changes will be made in the existing MSTP/DSTP programs to enhance the training of clinical researchers throughout the existing program.

4. A faculty core. The faculty core will provide mentor support and training of mentors. The core will also recruit, select, and monitor mentors.

5. An administrative core. The administrative core will assist the Program Director in recruiting, selecting, placing, monitoring, evaluating, and tracking of trainees. The core will also be responsible for oversight and overall evaluation of the program.

The rationale, structure, recruitment, and selection plans must be clearly articulated for those Programs that choose to include the secondary targeted training disciplines.

The Program is expected to be student-centered, with flexible programs that adjust to the needs and experience of the student. While some students may elect to participate in only one of the elements, for those that participate in several elements, the credits must be transferable among the various aspects of the Program. Additional training slots funded using institutional funds (including private support) may be incorporated into the structure of this program.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the T32 NIH Ruth L. Kirschstein National Research Service Institutional Training award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NIH Roadmap intends to commit approximately $ 6.5 million in total costs [Direct plus Facilities and Administrative (F&A) costs] in FY 2005 to fund 9-10 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $642,000 per year. Facilities and administrative costs requested by subcontracts are not included in the direct cost limitation (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html).

Because the nature and scope of the proposed research 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

This is a one time solicitation with an anticipated award date of September 2005. However, there will be subsequent re-issuance and re-competition of a similar program in FY 2006.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Only domestic, non-profit, private or public institutions may apply for grants to support research training programs. Foreign institutions are not eligible to apply. An eligible institution (e.g., university) may submit only a single application in response to this RFA. Multiple applications from different divisions, faculties, centers, schools, etc. at the same university will be returned without further consideration by the NIH. Applicant institutions must demonstrate capability and capacity for clinical research training and patient-oriented clinical research training through a strong clinical research faculty; sufficient ongoing clinical research projects to serve as the platform for mentorship and training; extensive clinical research facilities; and a track record of successfully competing for clinical research support to meet the purposes of this program, namely, to provide exposure to clinical research and clinical research training that promotes health and prevents disease. Collaborating institutions should be included to complement training activities in needed areas.

Institutions that have obtained or are applying for Roadmap K12 Multi-disciplinary Clinical Research Career Development Programs (for example, RFA-RM-04-006, http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-006.html) are encouraged to apply for this RFA. Such institutions must demonstrate integration of curricula, resources, and mentors with the career development program, and indicate how trainees may become eligible for subsequent participation in the K12 program.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

The Program Director will be responsible for planning, directing, and executing the proposed Program for the institution. Program Directors should have a strong and active track record in clinical research, clinical research training, and administration that demonstrates the skills, knowledge, and experience necessary to develop and manage the proposed Predoctoral Clinical Research Training Program. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching
Not applicable.

3. Other-Special Eligibility Criteria

An eligible institution (e.g., university) may submit only a single application in response to this RFA. Multiple applications from different divisions, faculties, centers, schools, etc. at the same university will be returned without further consideration by the NIH.

Eligible Trainees

Clinical Research Trainees (CR Trainees) must have received a baccalaureate degree by the beginning of their NRSA appointment. Positions are open to students enrolled in doctoral-level degree programs in the primary targeted training disciplines, and where appropriate, for students in the secondary targeted disciplines. Candidates for support as NSRA Trainees must be US citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-155) or some other verification of legal admission as a permanent resident. Individuals on temporary or student visas are not eligible. Non-citizen nationals are persons born in lands that are not States but are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa).

Clinical Research master's option (intensive training core): This option is open to students from both the primary and secondary target disciplines provided that the students are enrolled in a research or professional doctoral program. Students who obtained a research doctorate prior to entering medical or dental school are also eligible for support under this option.

Research doctoral option (intensive training core): For this option, trainees must be enrolled in a formal, combined program that leads to the award of a MD, DDS, or DMD and a research doctoral degree (typically, MD/PhD or DDS/DMD-PhD), or must have an RN and be enrolled in a research doctoral (typically PhD) program. Trainees must enter the program no later than their third year of professional school. Individuals already enrolled in a joint MD-PhD or DDS/DMD-PhD program are eligible for consideration as trainees. Individuals who obtained a PhD prior to entering medical or dental school and desire to pursue another research doctorate while in medical or dental school are not eligible for support under this option.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Special Program Requirements

The NIH recognizes that individual institutions will be positioned to respond in different ways to the opportunities presented in this RFA. Applicants are strongly encouraged to contact NIH Program Staff well in advance of the letter of intent submission date to discuss their proposed Program. There will be a Program website, FAQ's, Listserve, and a pre-submission National meeting (and videocast) to disseminate information about this Program. Subscribe to the program Listserve (RM-PredocCRTP-L at http://list.nih.gov) to obtain information about these additional resources. Applicants are invited to arrange a pre-application phone consultation with NIH Program Staff. These contacts will assure that the applicants have a thorough understanding of the intent and expectations of this RFA before they engage in the development of an application. These activities are described in the section WHERE TO SEND INQUIRIES.

A. Key components

Successful programs will have addressed the following using the format specified in FORMAT OF THE APPLICATION (Section 6 Other Submission Requirements).

B. Budget and Related Issues

The Program budget should be constructed using the following general guidelines. The full details in constructing the budget are listed under Stipend, Tuition-fees-health insurance, Trainee Travel, and Training related expenses below. It is expected that approximately 8% of the total program direct costs budget may be used for trainee expenses (stipends) for the short-term training experiences, and approximately 62% of the total program direct costs budget may be used for trainee costs (stipends, tuition-fees-health insurance, and trainee travel) in the intensive training core. All of the remaining expenses (curriculum core, faculty core, administrative core) are considered Training related expenses (see below), and are expected to account for approximately 30% of the total program direct costs budget.

Note that the total program direct costs budget may not exceed the maximum allowed $642,000 direct costs. If the short-term training core is not part of the program due to institutional academic scheduling, this portion of the budget may be requested for any of the other core elements except for the administrative core (and only used to increase the faculty core in proportion to additional trainees added to the program). The distribution of funds between the program cores (with the exception of the administrative core) may be altered modestly with careful justification. No other institutional faculty or professional employees can be reimbursed from this award.

Because the Program uses a T32 NIH Ruth L. Kirschstein National Research Service Institutional Training award mechanism, the budget must be constructed in the following fashion:

1. Stipend. The NIH will provide the legislatively mandated stipend level for each short-term trainee position and for each intensive training core trainee position according to pre-doctoral NRSA guidelines. Only pre-doctoral NRSA stipends may be requested. A stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. Stipend levels are adjusted periodically and current stipend levels are available on the NIH website at: http://grants.nih.gov/training/nrsa.htm. The total stipend must be based on a 12-month appointment. Short-term trainees will be funded stipends pro-rated for the 2-3 months they are in the program, based on the 12-month predoctoral stipend level. The institution may supplement the NIH stipend up to a level that is consistent with the institution's scale from non-Federal sources only. It is expected that total stipends must be consistent with the level of effort, with the established stipend structure at the institution, and with stipends actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

2. Tuition, Fees, and Health Insurance. Costs associated with tuition and fees are allowable only for Trainees in the intensive training core. The NIH will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the current rates as published at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc5460018. A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at: http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm.

3. Trainee Travel. Programs should budget for one trip to Bethesda for a two-day meeting for each trainee in the intensive training core. Trainee travel to scientific meetings that the institution determines to be necessary for the individual's research training is an allowable trainee expense at $800 per trainee per year. In addition, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent institution must be justified considering the type of opportunities for training available, the manner in which these opportunities differ from and complement those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and goals. This type of research training requires prior approval from the NICHD. Letters requesting such training may be submitted to the NICHD at any time during the award period. Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request institutional costs above the standard rate. Requests for additional trainee costs must be explained in detail and carefully justified in the application. Consultation with NICHD program staff in advance of such requests is strongly advised.

4. Training-Related Expenses. Training related expenses should be apportioned into 4 separate budgets, each displayed on a separate page.

a. Curriculum Core Training-related Expenses: It is expected that approximately 10% of the total program direct costs can be used for the development and provision of lectures, courses, seminar series, or a Program web site.

b. Faculty Core Training-related Expenses: Because of the unique nature of this NIH Roadmap initiative, applications submitted in response to this RFA may request specific training-related expenses to help defray mentor laboratory costs directly associated with the training program. Faculty mentors who actively host candidates supported by this training grant in their laboratories may request funds up to $500/each for each of the 12 short-term (often summer) students, and up to $3,000 per year for each of the 10-12 trainees in the intensive training core. It is expected that no more than 6.5% of the total program direct costs would be used to support such expenses.

c. Administrative Core Training-related Expenses: This core contains the personnel costs for the Program Director(s) and administrative staff. Any salary and fringe benefits requested for administrative staff must be in accordance with the applicable cost principles for the grantee institution. It is expected that approximately 11% of the total program direct costs may be used for administrative expenses, including Program Director(s) (5-10% effort) and administrative staff salary and fringes (up to 1 FTE). No other institutional faculty or professional employees can be reimbursed through this award.

d. Other Costs: A budget of up to $15K direct costs may be allowed for other costs (e.g., supplies, equipment, and Program Director(s) or faculty travel to the national meeting).

5. Facilities and administrative costs: A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. See NRSA Policy Guidelines on the NIH Website at: http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm.

C. Related issues

1. Number of trainees. This program will provide funds for up to approximately 12 short-term training slots (2-3 months each), and up to approximately 10-12 intensive year-long training slots.

2. Duration of support. Support will be provided for individual trainees according to their individual track through the Program. In planning all trainee appointments, the Program Directors and the trainees should be aware of the following:

All applications should include a plan for continuation of support for trainees, in particular other potential sources of support for an individual's additional years of study. This is especially important for the MSTP/DSTP component since a MSTP/DSTP trainee's course of study for the combined degrees may take longer than five years.

3. Stipend supplementation, compensation, and other income. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the NICHD. Such additional amounts may be either in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the following conditions 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.

4. Leave. Trainees supported by academic institutions should refer to the NIH NRSA guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html for guidance regarding vacations and requested leave. In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research training experience longer than specified here must seek approval from the NICHD for an unpaid leave of absence. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271).

5. Taxation. Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report as gross income any monies paid on their behalf for stipends, or for any course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. The taxability of stipends, however, in no way alters the relationship between NRSA trainees and institutions. NRSA stipends are not considered salaries. In addition, trainees supported under the NRSA are not considered to be in an employee-employer relationship with the NICHD or the awardee institution. It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. The NICHD takes no position on the status of 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.

D. Special Administrative Requirements

1. Carryover of unobligated balances: The carryover of funds from one budget period to the next requires prior written approval by the NIH funding component.

2. Termination of Award: When a grantee institution plans to terminate an award, the NICHD must be notified in writing by the Program Director and countersigned by the appropriate institutional business official at the earliest possible time.

3. Change of Institution: The Program may not be transferred from one institution to another. Trainees seeking to change institutions must terminate their current appointment at the earliest possible time using termination notice form PHS 416-7 located at http://grants.nih.gov/grants/forms.htm#training and apply directly to the desired program.

4. Change of Program Director: If change of a Program Director is necessary, support of the award is not automatic, but may be continued with NICHD prior approval, provided:

5. Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular Program Director. Changes in any of these parameters require prior approval by NICHD Program Staff. A rationale must be provided for any proposed changes in the aims of the original peer-reviewed program. Programmatic changes will be evaluated by NICHD Program Staff to ensure that the program remains within the scope of the original peer-reviewed application. If the new program does not satisfy this requirement, the award will be terminated.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): February 25, 2005
Application Receipt Dates(s): March 25, 2005
Peer Review Date(s): July 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: September 2005

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 at the beginning of this document.

The letter of intent should be sent to:

Robert Star, M.D.
Senior Scientific Advisor
National Institute of Diabetes and Digestive and Kidney Diseases
Building 31, Room 9A-19C, MSC 2560
31 Center Drive
Bethesda, MD 20892-2560
Telephone: (301) 594-7717
E-mail: robert.star@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
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
E-mail: stretch@nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the Trans-NIH Clinical Research Workforce Committee. Incomplete or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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 http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

The maximum funding level per award is $642,000 direct costs per year. The anticipated size of each award will vary and the actual funding may be less than the levels recommended by the peer review, dependent upon budgetary considerations. Funds for continuation beyond the initial year are determined by the success as described in the annual progress report, the timely submission of all required forms, and the availability of funds.

6. Other Submission Requirements

Inquiries concerning this RFA are encouraged and we welcome the opportunity to answer questions from potential applicants. Applicants are encouraged to sign up for the program Listserve (RM-PostdocCRTP-L at http://list.nih.gov) and contact NIH Program Staff for a pre-application consultation to ensure that they have a thorough understanding of the intent and expectations of this RFA before they engage in the development of an application.

Format of Application

The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, follow the modified instructions below in preparing an application for a Predoctoral Clinical Research Training Program (T32). These instructions have been adapted to accommodate the PHS 398 and the special needs of the T32 grant:

Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Training Program. On Line 2, provide the number of this Request for Applications, RFA-RM-05-015, and the RFA title "Predoctoral Clinical Research Training Programs." The Program Director will be the Principal Investigator (PI) of the grant application.

Description/Performance Site(s)/Key personnel (Form Page 2 of PHS 398): Complete as directed in the PHS 398 instructions. The information provided should include the Program Director, co-directors(s), Core directors, and Advisory Committee members.

Biographical Sketches in the standard 4 page NIH format for all the Key Personnel listed on page 2 of the application.

The body of the application (no more than 40 pages) should be organized as follows. When following this format, applicants should refer regularly to those sections of this announcement that delineate “Special programmatic requirements” and “Review criteria”.

Overall Program Aims

Environment

Major Program Elements

Candidate Pool and Recruitment Plans

Plan for Sharing Research Data
Not applicable.

Sharing Research Resources
Not applicable.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The role of peer review is to assess the extent to which the applicant is likely to develop and run a successful training program.

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the Trans-NIH Clinical Research Workforce Committee. Incomplete and/or non-responsive applications will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD in accordance with the review criteria stated below.

Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

As part of the initial merit review, all applications will:

The goal of this Training Program is to ensure that a diverse pool of highly trained clinical researchers will be available in adequate numbers and in appropriate research areas to enhance the clinical research enterprise for the conduct of clinical investigation. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. 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.

The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Overall Program Aims: The adequacy of the overall Program strategy to satisfy the intent of this initiative to develop and sustain a high quality Predoctoral Clinical Research Training Program. Does the Program provide excellence in training, and in the design and conduct of clinical research? If the aims of the Program are achieved, how do they address the shortage of well-trained clinical investigators? Will the Program prepare CR Trainees to become potential leaders in clinical research? Does the Program take maximum advantage of existing didactic capabilities, clinical infrastructure, and faculty strengths?

Institutional Commitment: Is the institutional leadership committed to this program and its goals? Does the institution provide assurances that the institution intends the Program to be an integral part of its research endeavor; that courses in clinical research will be added to the standard medical/dental school curriculum; and that clinical research facilities and training opportunities will be a critical part of the environment? Have institutional barriers for clinical research and clinical researchers been adequately addressed? Adequacy of cooperative arrangements between consortium institutions, if applicable, that will ensure that the Program performs effectively as one activity across institutional boundaries. Is there adequate commitment of the institution(s) from the institutional leadership to Department Chairs to support the career and tenure process for clinical researchers at the institution?

Clinical Research and Training Environment: Does the training environment contribute to the probability of success? The adequacy of the overall clinical research and training environment and track record of the institution(s) in conducting interactive, multi-disciplinary, collaborative, peer-reviewed clinical research involving a broad range of clinical disciplines and diseases. Is the Program well integrated with existing clinical research infrastructure such as GCRC(s) or a K30 program? Does the Program benefit from unique features of the training environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? What is the past research training record of the program, the designated teachers and mentors, as determined by the success of former trainees in seeking further career development and in establishing productive careers in clinical research?

Approach: Are the training conceptual framework, design, methods, and curricula adequately developed, well integrated, and appropriate to the aims of the training program? Are the curriculum and research experience elements adequately developed and implemented to stimulate interest in clinical research careers, and provide trainees with the stage-appropriate and multi-disciplinary training in the discipline of clinical research? Does the training plan encourage interaction among trainees in the short-term and intensive training cores, and include team building training? Is the structural organization and multi-disciplinary leadership team adequate to carry out the mission of the Program. Are potential problem areas acknowledged and are alternative tactics considered? What will be the effect of the proposed training program on studies, concepts, or methods that drive clinical research training? Has the application addressed integration of the short-term and intensive trainees with other program trainees and the appropriateness of the number of short-term and intensive positions? Do institutional policies permit the appointment of short-term and intensive trainees?

Research Doctoral (PhD) Component (if applicable): Does the planned PhD component have the institutional commitment and ability to provide opportunities for an integrated training program, including didactic and clinical research components; the relationships among clinical, basic, behavioral and other science, dental/medical/nursing departments and the graduate school in the design and conduct of research programs; the organization and quality of multi- and inter-disciplinary research training; degree requirements; the availability of prescribed and optional courses or seminars; the manner in which the trainee's guided research activities will be selected; procedures for monitoring trainee's progress; the unique and innovative aspects of the program; and the plans to provide support for trainees in the event that a competitive renewal application is unsuccessful.

Applications from institutions with existing MSTP/DSTP programs will be assessed further using the following criteria: Success of processes developed over past five years to deal with recruitment of trainees in clinical research, admissions, retention, progress, monitoring procedures, and post-doctoral activities of trainees; integration of clinical and research curriculum. Adequacy of plans by the MSTP/DSPT Program director(s) to integrate CR Trainee students fully into the existing MSTP/DSTP programs, and plans to enhance the training of MSTP/DSTP students as clinical researchers.

Innovation: Is the Program original and innovative? For example: Does the Program challenge existing training or career approaches, or address a critical barrier to progress in the field? Does the Program develop or employ novel concepts, approaches, methodologies, tools, or technologies for clinical research education that will lead to the recruitment and training of clinical researchers? Does the program provide strong evidence that the addition of the T32 Program will provide clinical research training that would not otherwise be possible?

Program Leadership: Does the Program Director have the necessary recent clinical research background, training expertise, administrative qualifications and experience to provide leadership, management, and coordination of a Program of this size and complexity? Have the Program Director and co-Director committed sufficient time to devote to this Program? Will the Program Director have sufficient authority and credibility in the Institution to work across institutional boundaries (if applicable)?

Program Management/Administration: Are advisory committee members sufficiently experienced and representative to oversee this Program? Have the advisory committee members committed sufficient time to meet the needs of the Program? Will the advisory committee procedures and processes adequately select, monitor, and evaluate the CR Trainees, teachers, mentors, and the overall Program? Are there adequate procedures described for selecting and replacing advisory committee members?

Program Teachers/Mentors: Are the teachers and mentors who will participate in this Program clearly delineated, do they have the experience, skills, and track record at mentoring necessary to provide CR Trainees with high quality clinical research training, and do they broadly represent the disciplines, specialties, and subspecialties necessary to make this Program work effectively? Will the mentors commit sufficient time to ensure the success of the Program?

Evaluation/Tracking: Is the proposed evaluation plan sufficiently detailed? Are the plans to evaluate the performance of the Program as a whole (e.g., quality of the cores, adequacy of the performance of mentors, adequacy of faculty participation), and to make changes that improve performance and outcomes adequate? What about the adequacy of the plans to track career outcomes of CR Trainees, including subsequent training, positions held, papers published, grants and awards submitted/obtained, and other relevant information?

Interactions: Commitment of the applicant to work with other Programs and the NIH as reflected by their proposed ideas to improve performance and outcomes, commitment to share best practices, and to participate in the NIH Roadmap program (http://nihroadmap.nih.gov/) to improve the National Clinical Research Enterprise.

Candidate Pool and Recruitment Plans: Does the application demonstrate well-defined recruitment procedures, potential sources, and number of high-quality candidates, CR Trainee selection criteria, and retention strategies? Are these processes adequate to achieve a high-quality pool of CR Trainees? Does the Program seek to recruit CR Trainees from outside the institution? Are there adequate plans to recruit women and members of underrepresented racial/ethnic minorities?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Minority Recruitment and Retention Plan: Peer reviewers will separately evaluate the minority recruitment plan after the overall score has been determined. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan for minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan 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.

Competing continuation (if applicable) 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. Recruitment plans and reports should address all efforts to increase the diversity of the trainee pool including those that address: the underrepresentation of individuals from specific racial and ethnic groups that have been shown to be underrepresented nationally; the underrepresentation of individuals with disabilities; or the underrepresentation of individuals who have recently participated in federal programs for individuals from disadvantaged backgrounds. The report should provide information on all efforts to increase the diversity by describing recruitment efforts and successes at the following stages:

For those trainees who were enrolled in the academic program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.

Training in the Responsible Conduct of Research: Every predoctoral NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, available at http://grants.nih.gov/grants/guide/notice-files/not92-236.html.) Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review.

Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the predoctoral students appointed to the program.

NIH initial review groups will assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Staff within the NIH awarding component will judge the acceptability of the revised plan.

Following initial review, the NICHD Advisory Council will also review the applications. The advisory group will consider the assessment of the scientific and educational merit of the research training grant application as well as the initial review group's comments on the recruitment of individuals from underrepresented groups and the plan for instruction in the responsible conduct of research.

2.C. Sharing Research Data
Not applicable.

2.D. Sharing Research Resources
Not applicable.

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 Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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.

Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via e-mail notification from the awarding component to the grantee business official (designated in Item 14 on the Application Face Page). If a grantee is not e-mail enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

The T32 award is not subject to the streamlined non-competing application process (SNAP).

1. Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant at the beginning of the appointment period. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure to submit the required forms in a timely manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

2. Progress Reports: An Annual Progress Report is required. This report should provide information about changes in the program, a summary report by the Advisory Committee, and a description of the research and career progress of each trainee. These Annual Progress Reports will be closely monitored by NICHD staff to ensure that the grant is achieving the goals of the overall Program.

Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. Expand the application for continuation to contain the following information:

3. Final Reports: A final progress report and Financial Status Report are required within 90 days after the end of the grant project period or upon relinquishment of an award.

4. Evaluation: In carrying out its stewardship of human resource-related programs, the NICHD may request information essential to an assessment of the effectiveness of this Program. Accordingly, recipients are hereby notified that they may be contacted during and after the completion of this award 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 Program.

Section VII. Agency Contacts

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:

Robert Star, M.D.
Senior Scientific Advisor
National Institute of Diabetes and Digestive and Kidney Diseases
Building 31, Room 9A-19C, MSC 2560
31 Center Drive
Bethesda, MD 20892-2560
Telephone: (301) 594-7717
E-mail: Robert.Star@nih.gov

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
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
E-mail: stretch@nih.gov

3. Financial or Grants Management Contacts:

John “ Chris” Robey
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non USPS service)
Telephone: (301) 435-6996
FAX: (301) 480-478 3
E-mail: robeyj@mail.nih.gov

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 IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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.

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 new PHS Form 398; 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-02-005.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. Applications that do not provide this information will be returned without review.

Public 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 public 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 PA 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.

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 PA 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 or Health Systems Agency review. NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. 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, ple ase see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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