Expired PAR-07-364: NIBIB Research Supplements to Promote Clinical Resident Research Experiences (Supplements to Currently Active NIBIB P01, P41, P50, U01, U54 Grants)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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
National Institute of Biomedical Imaging and Bioengineering (NIBIB), ( http://www.nibib.nih.gov/)

Title: NIBIB Research Supplements to Promote Clinical Resident Research Experiences (Supplements to Currently Active NIBIB P01, P41, P50, U01, U54 Grants)

Announcement Type
This is a reissue of PAR-06-531 which was previously released on August 22, 2006.

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-07-364

Catalog of Federal Domestic Assistance Number(s)
93.286

Key Dates
Release Date: April 24, 2007
Letters of Intent Receipt Date(s): May 14, 2007; September 17, 2007; January 14, 2008; May 13, 2008; September 15, 2008; January 13, 2009; May 15, 2009
Application Receipt or Submission Date(s): June 13, 2007; October 17, 2007; February 13, 2008; June 13, 2008; October 15, 2008; February 13, 2009; June 15, 2009
Peer Review Date(s): October/November; February/March; June/July
Council Review Date(s): January, May, October
Earliest Anticipated Start Date(s): April, July, December
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: June 16, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The intent of this Program Announcement is to provide a 1-2 year period of research experience for physicians in a residency program through supplements (revisions) to existing NIBIB grant awards.
The program targets applicants who have demonstrated the potential for productive research in an area of interest to the candidate and of relevance to the mission of the NIBIB.
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. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.
This PAR will use the NIH competitive supplement (revision) award mechanism.
Eligible Institutions/Organizations. Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Small Business; For-Profit Organization (Other than Small Business); State Government; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Regional Organization; Other(s):Eligible agencies of the Federal government; Faith-based or community based organizations.
Eligible principal investigators include those holding an active P01, P41, P50, U01, or U54 from the NIBIB.
This supplement (revision) program is also available for NIBIB R01 and R37 grant awardees as outlined in a companion Funding Opportunity PAR-07-363.
Each parent grant may support up to two clinical residents. A separate supplement (revision) application must be prepared and submitted for each resident.
See Section IV.1 for application materials.
Telecommunications for the hearing impaired is available at: TTY 301-451-5936
Special Submission/Receipt Date(s): June 13, 2007; October 17, 2007; February 13, 2008; June 13, 2008; October 15, 2008; February 13, 2009; June 15, 2009
Initial merit review convened by the National Institute of Biomedical Imaging and BioengineeringIniIni

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 or Matching
  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 and Times
    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
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  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 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

The purpose of this Program Announcement is to provide a 1-2 year period of research experience for physicians in a residency program through supplements (revisions) to existing NIBIB grant awards. The program targets applicants who have demonstrated the potential for productive research in an area of interest to the candidate and of relevance to the mission of the NIBIB. This initiative is not intended to support clinical residency training. The NIBIB anticipates that by providing research opportunities for these individuals during their residency, the number entering and remaining in NIBIB-focused research careers will increase. It is expected that individuals selected for this research experience will continue in research and subsequently apply for career development awards and/or research project grants.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) seeks to improve human health by supporting research and training aimed at developing imaging, engineering, and bioinformatics tools with broad medical utility in the diagnosis, treatment, and prevention of disease. To this end, the institute will fund the research and/or training of creative and insightful clinicians to work in interdisciplinary research teams. Furthermore, cognizant of the importance of translating research findings to health benefits, NIBIB considers facilitation of the translation of discoveries from the laboratory to the clinical setting a cornerstone of its mission. This PAR aims specifically to enhance the fundamental knowledge and research skills of clinical residents interested in research careers in areas related to the mission of the NIBIB.

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 NIH competitive supplement (revision) award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). The budget format of the supplemental (revision) application must be the same as that of the parent grant.

2. Funds Available

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.

Up to $100,000 direct costs per year may be requested. Of that amount, residents may request funds for research costs and travel up to $25,000 direct costs per year of support. A maximum of $2000 per year can be allocated for travel. Salary and fringe benefits for the candidate should be consistent with the institution’s salary structure for the residency-training program. No funds may be requested to supplement the salaries of the PI or other personnel, or to purchase equipment

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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:

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
U.S. Territory or Possession
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organization
Hispanic-serving Institution
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Regional Organization
Other(s): Eligible agencies of the Federal government; Faith-based or community based organizations.

1.B. Eligible Individuals

An 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 support.

Principal Investigators (PIs) holding an active P01, P41, P50, U01, or U54 from the NIBIB may apply for this program.

Any individual who meets the criteria described below is invited to work with his/her institution and an identified mentor (PI holding an active P01, P41, P50, U01, or U54 from the NIBIB) 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 support.

Candidate Eligibility: A candidate must have a health professional degree (M.D. or the equivalent) and be enrolled in an accredited clinical residency-training program in the United States. Candidates need not be citizens or permanent residents of the U.S. Individuals who received medical degrees at foreign sites, but are currently enrolled in an accredited U.S. residency-training program are eligible. The NIBIB will also accept applications from clinicians who are continuing their training as clinical fellows. However, the duration of this award may not exceed the fellowship years.

2. Cost Sharing or Matching

Cost sharing or matching is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

The candidate must work with a mentor for the research experience who is the PI on an active NIBIB grant. Co-mentoring is encouraged for interdisciplinary projects.

The duration of the supplement (revision) should be at least one year to provide the candidate with a meaningful research experience, and to prepare him/her for further research experiences.

Supplements (revisions) can be requested only for active NIBIB grants that have a minimum of one year of support remaining. Submit a supplemental (revision) application only for a period within the current period of support. A supplement (revision) may not extend beyond the parent award period. A maximum of two clinical residents (i.e., two supplements (revisions)) will be allowed on any given parent grant award. Supplement (revision) applications for more than one clinical resident must be prepared and submitted as separate supplement (revision) applications.

Ideally, candidates may take time off from residency training to participate in this program on a full-time basis. However, candidates must be willing and able to dedicate at least 75% of their professional time to the research project.

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) 710-0267, Email: [email protected].

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.

The request for a supplemental (revision) award must include the following:

1. The supplemental (revision) application must have the same Principal Investigator/Program Director as the currently funded (parent) grant.

2. Supplements (revisions) can be requested only for active NIBIB grants that have a minimum of one year of support remaining. Submit a supplemental (revision) application only for a period within the current period of support. (A supplement (revision) may not extend beyond the parent award period.)

3. A proposed budget related to the percent effort (where appropriate) for the research experience of the candidate during the first and future years. The budget format (modular or non-modular) must be the same as that of the parent grant.

4. Completed biographical sketch pages (for the candidate and updated for the mentor(s)), resources page (updated), and checklist page (updated). The biographical sketch of the candidate should include evidence of scientific achievement and/or interest.

5. Research and Career Plans:

The description of the research and career plans (items (a) (d) below) must not exceed 10 pages. This section must be prepared by the candidate and the PI of the parent grant and must include:

(a) Career Goals, Timeline, and Training in the Responsible Conduct of Research: A statement by the candidate outlining his/her overall career plans and a timeline for the research and career development experiences proposed in this supplement (revision), Applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. 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, policies regard the use of human and animal subjects, and data management. Applicants may refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance. Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component.

(b) Eligibility and Mentoring Plan: A statement by the PI of the parent grant (i.e., the mentor) addressing the eligibility of the candidate for support under this program, detailing any current or previous PHS research grant support the candidate has received, and outlining how mentoring will be provided to help expand and foster the research capabilities of the candidate.

(c) Parent Grant Description: A description of the specific aims of the original project, and how the research proposed under this supplement (revision) relates to the specific research goals and objectives of the parent grant. The review committee will not receive a copy of the parent grant.

(d) Research Design & Methods: A description of the candidate’s proposed research project including research design and methods section.

If the candidate’s proposed project uses vertebrate animals and/or human subjects, the application must address the points of Section E (human subjects research, including inclusion of women, minorities, and children in the study population) and/or Section F (vertebrate animals) of the PHS 398 application instructions.

6. A letter of support from the director of the residency program or department chair specifically stating that the candidate will be able to devote time at the requested effort (at least 75%) to his/her research experience.

7. If any of the research is to be conducted at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must be submitted. The request must be signed by the candidate, the PI, and the appropriate institutional business official.

8. Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html .

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): May 14, 2007; September 17, 2007; January 14, 2008; May 13, 2008; September 15, 2008; January 13, 2009; May 15, 2009
Application Submission/Receipt Date(s): June 13, 2007; October 17, 2007; February 13, 2008; June 13, 2008; October 15, 2008; February 13, 2009; June 15, 2009
Peer Review Date(s): October/November; February/March; June/July
Council Review Date(s): January, May, October
Earliest Anticipated Start Date(s): April, July, December

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

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:

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
6707 Democracy Boulevard, Suite 920, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Voice: (301) 496-8633
Fax: (301) 480-0675
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
6707 Democracy Boulevard, Suite 920, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Voice: (301) 496-8633
Fax: (301) 480-0675
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt/submission 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 CSR. Incomplete 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 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. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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.

Pre-award costs are allowable. 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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

The budget format of the supplemental (revision) application must be the same as that of the parent grant. If the parent application requested up to $250,000 per year in direct costs, the budget for the supplement (revision) must be submitted in a modular budget grant format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

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

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

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the National Advisory Council of the National Institute of Biomedical Imaging and Bioengineering.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review.
Availability of funds.
Relevance of program priorities.

The goal of this PAR is to provide research experiences for physicians in a residency program through supplements (revisions) to existing NIBIB grant awards. The NIBIB seeks to enhance the research experiences of creative and insightful clinicians in order to help facilitate the translation of research findings to health benefits. This PAR aims specifically to enhance the fundamental knowledge and research skills of clinical residents interested in research careers in areas related to the mission of the NIBIB. In the written comments, reviewers will be asked to evaluate the application 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 the following criteria in assigning the application’s overall score, weighting them as appropriate for each application.

Significance
Approach
Innovation
Investigator
Environment

Note that an application does not need to be strong in all categories to be judged likely to have major impact on the career of the clinical resident 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 and provide an important research experience for the clinical resident.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Will the proposed research experience have a significant impact on candidate’s future career as a researcher?
Will the proposed research experience enhance the candidate’s ability to apply for future career development awards and/or research project grants?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Candidate

Is the candidate's proposed research appropriate for their career goals?
Is the candidate’s career development plan appropriate?

Research Plan

Are the research question, design and/or methodologies of scientific and technical merit?
Is the proposed research relevant to the parent grant?
Will the candidate receive appropriate training in the responsible conduct of reserach?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Candidate

What is the quality of the candidate’s academic and clinical record?
Does the candidate have the potential to develop as an independent researcher?
Does the candidate have a commitment to a research career?

Mentor/Co-Mentor

Is the quality and extent of the mentor(s) proposed role in providing guidance and advice to the candidate appropriate?
Do(es) the mentor(s) have experience in fostering the development of researchers?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Environment and Institutional Commitment

Does the applicant’s institution demonstrate a commitment to an appropriate balance of research and clinical responsibilities including the level of effort proposed by the candidate? (A minimum of 75% effort is required.)

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.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

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.

2.C. Sharing Research Data

Not Applicable

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://ott.od.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

N/A

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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 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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the 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 (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).

3. Reporting

In non-competing continuation applications, the progress report and budget for the supplement (revision) must be clearly delineated from the progress report and budget for the parent grant. The progress report must include information about the research and career development activities supported by the supplement (revision) even if support for future years is not requested. Continuation of support for the candidate in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent grant and the supplement (revision) project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort.

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.

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:

Richard Baird, Ph.D.
Director, Division of Interdisciplinary Training
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institutes of Health/Dept. of Health and Human Services
6707 Democracy Boulevard, Democracy II, Suite 200, MSC 5477
Bethesda, MD 20892
Telephone: (301) 496-7671
FAX: (301) 480-1614
Email: [email protected]

2. Peer Review Contacts:

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
6707 Democracy Boulevard, Suite 920, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Voice: (301) 496-8633
Fax: (301) 480-0675
Email: [email protected]

3. Financial or Grants Management Contacts:

Florence Turska
Grants Management Specialist
Grants Management Branch
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
6707 Democracy Blvd., Suite 900, MSC 5469
Bethesda, MD 20892
Telephone: (301) 496-9314
FAX: (301) 480-4974
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 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.

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.

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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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/.