and Human Services (HHS)
EXPIRED
Department of
Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
Title: Cooperative Research
Partnerships to Promote Workforce Diversity in the Reproductive Sciences (U01)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-HD-09-008
Catalog of
Federal Domestic Assistance Number(s)
93.865
Key Dates
Release/Posted
Date: July 31, 2009
Letters
of Intent Receipt Date: October
19, 2009
Application Due Date: November 17, 2009
Peer Review
Date(s): March/April 2010
Council Review Date: May
2010
Earliest Anticipated Start Date(s): August
1, 2010
Additional
Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: November 18, 2009
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 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, Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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) is committed to promoting diversity in the biomedical workforce. To address this need, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), is soliciting applications that propose research partnerships between faculty at minority-serving institutions (MSIs) and faculty at academic institutions with established reproductive science research programs to form the new Cooperative Research Partnerships to Promote Workforce Diversity in the Reproductive Sciences (CPDR). Partnering investigators will also be responsible for providing CPDR-related research experiences to a diverse cadre of undergraduate students (see Section III.3).
Objectives
The CPDR is being developed to facilitate equal partnerships between full-time faculty at MSIs and faculty at institutions with established basic, clinical, or translational reproductive science research programs. The objectives of this program are to: 1) foster the development of competitive reproductive science research programs at MSIs; 2) support newly developed collaborations among faculty at MSIs and faculty at institutions with established reproductive science research programs; and 3) provide opportunities for a diverse cadre of undergraduate students to participate in research, with the intent of stimulating their interest in pursuing careers in the reproductive sciences.
The NICHD anticipates that this new program will mutually benefit each Principal Investigator (PI). Specifically, each lead investigator will be recognized as the PI of a separate, but linked, U01 award. Partnering investigators will also benefit from sharing research facilities, scientific knowledge, and by recruiting and mentoring a cadre of undergraduate students from diverse backgrounds, who may eventually pursue graduate degrees and fellowships in the reproductive sciences.
Background
The NIH recognizes that the complexity of biomedical research may, in some cases, be more effectively addressed by a team science approach. Along those lines, the NIH recently implemented the multi-PI option for investigators. The multi-PI option offers full recognition of each Principal Investigator's role in the design and implementation of a research proposal. The NIH is also committed to enhancing its efforts to diversify the biomedical workforce to meet the research and medical challenges of the 21st Century. Efforts to diversify the workforce are expected to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.
The Reproductive Sciences Branch (RSB) of NICHD developed the CPDR to facilitate partnerships between full-time faculty at one of the following institutions: Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions and faculty at institutions with established reproductive science research programs. Partnerships developed under this funding opportunity announcement (FOA) will: 1) serve as a resource for establishing or expanding competitive reproductive research endeavors at MSIs; 2) provide partnering institutions with an opportunity to benefit from a broader range resources and technical expertise; and 3) promote NIH's goal of diversifying the biomedical research workforce.
Scope
The RSB supports basic, clinical and translational research studies that are designed to enhance our understanding of normal reproduction and reproductive pathophysiology, as well as enable the development of more effective strategies for the diagnosis, management and prevention of conditions that compromise reproductive health, with the ultimate goal of promoting a better quality of life for all individuals. Examples of areas of research that may be proposed in response to the CPDR FOA are outlined below:
The NICHD anticipates that the CPDR will result in scientific advances in reproductive science and medicine, long-term research and training collaborations between partnering investigators, which will be sustained by successfully competing for subsequent grant funding. Furthermore, the NICHD anticipates that this program will encourage a diverse group of undergraduate students to pursue graduate degrees in reproductive science and medicine.
See Section VIII, Other Information - Required
Federal Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity will use the NIH Cooperative Research Project (U01) award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
NICHD has not determined at this time whether this FOA will be reissued in the future.
2. Funds Available
The Eunice Kennedy Shriver National Institute of Child health and Human Development intends to commit approximately $1.2 million in total costs in fiscal year 2010 to fund up to two partnerships (four awards) with total direct costs not to exceed $400,000 per year for each partnership. Future year amounts will depend on annual appropriations.
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.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.
This FOA requires the involvement of multiple-PIs from two institutions, one of whom must have a full-time faculty appointment at one of the following: Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCU), Tribally Controlled Colleges and Universities (TCCU), or Alaska Native and Native Hawaiian Serving Institutions. The partnering PD/PI must hold a full-time faculty position at an institution with an established program in reproductive science or medicine. Multiple-PIs may also be selected within each partnering institution. However, only one PD/PI from each institution should be designated as the contact PI.
Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility
Criteria
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmission: Resubmission applications are not permitted in response to this FOA.
Renewal: Renewal applications are not permitted in response to this FOA.
Undergraduate Students Eligible for CPDR Research Experiences: Undergraduate students selected to participate in reproductive science research training within in the CPDR must include individuals from one of the following groups:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, Native Americans, Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be included in the recruitment and retention plan.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates (a) have qualified for Federal disadvantaged assistance; or (b) have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program; or have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.
Undergraduate research training under the CPDR is limited to citizens or non-citizen nationals of the United States (U.S.) or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of an Alien Registration Receipt Card or some other legal evidence of admission for permanent residence). Undergraduate participants selected for research training must be enrolled as full-time students at accredited U.S. academic institution information here. Grantee institutions will be responsible for determining eligibility and for selecting undergraduate students to receive CPDR research experiences.
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 in item (box) 2 only of the face page of
the application form and the YES box must be checked.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
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: October 19, 2009
Application Due Date: November 17, 2009
Peer Review
Date(s): March/April 2010
Council Review Date: May
2010
Earliest Anticipated Start Date: August
1, 2010
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.
The letter of
intent is to be sent by the date listed in Section IV.3.A.
The letter of
intent should be sent to:
Charisee
Lamar, PhD, MPH, RRT
Program Director
Reproductive
Sciences Branch
Center for Population Research
Eunice
Kennedy Shriver National Institute of Child Health and Human Development
6100
Executive Blvd, Suite 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone:
(301) 435-6977
Fax: (301)
496-0962:
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications
must be prepared using the 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:
Robert
Stretch, Ph.D.
Director, Division of
Scientific Review
Eunice Kennedy Shriver 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
FAX: (301) 402-4104
Email: [email protected]
3.C. Application
Processing
Applications must be received
on or before the application receipt date described above (Section
IV.3.A.). If
an application is received after that date, the application may be delayed in
the review process or not reviewed. Upon receipt, applications will be
evaluated for completeness by the CSR and for responsiveness by the reviewing
Institute Incomplete and/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.
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 NIH Grants Policy
Statement.
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 award if such costs: 1)
are necessary to conduct the project, and 2) would be allowable under the
grant, if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new 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
Special Instructions for Collaborative U01 Applications
This FOA provides funding for research partnerships between (1) faculty at minority-serving institutions (MSIs) and (2) faculty at academic institutions with established reproductive science research programs to form the new Cooperative Research Partnerships to Promote Workforce Diversity in the Reproductive Sciences (CPDR). These partnerships are formalized and implemented through linked applications; each of the collaborating partner sites must submit a separate application, following the instructions and/or requirements in the subheadings below.
PHS398 Cover Letter: A cover letter is required for each application CPDR. The cover letter must include an identical list of all the collaborative applications including for each the name of the PD/PIs, the unique Title, and the Applicant Institution. The lead (1/2) application should be designated as such.
Application Title: This FOA requires submission of separate, but linked applications. To allow NIH to identify a group of applications as a related set of CPDR applications, the titles should be identical and unique to each partnership (do not repeat the title of the FOA). Each U01 of a partnership must have the following format: a 1/N indicator + identical title (e.g., 1/2-Multisite Comparison of Drug A vs. Drug B for Treatment of Disorder X , where the 1/2 means this is site 1 of 2 sites in the set. The other site will be labeled 2/2.) Titles may not exceed 80 characters in length, including the tag, e.g., 1/2, at the beginning of the title.
Human Subjects Research: If human subjects (including identifiable specimens or data) are involved in the proposed research project, all linked applications within the project must check the yes box.
Vertebrate Animals: If vertebrate animals are to be used in the project, all linked applications within the project must check the yes box.
Description, Performance Sites, and Key Personnel: Partnership applications must include an identical description. All performance sites should be listed on each application. The key personnel section should also be identical for each application. The contact PD/PIs for each institution should be listed first followed by other PD/PIs listed in alphabetical order. Other key personnel and their organizations should follow.
Budget: The first application (1/2) must include a summary budget for the entire project as well as an individual budget for the work proposed at both institutions. The linked application should only include a budget request for CPDR activities to be carried out at the second (2/2) institution. Follow the instructions in PHS 398 for completing the budget materials. The percent effort should be provided for each PD/PI. Modular budgets should be submitted for projects involving direct costs of $250,000 or less. Otherwise, non-modular budgets should be submitted. The combined total direct costs for linked applications may not exceed $400,000 per year.
Biosketches: All biographical information for PD/PIs and other key personnel should be included only in the each application.
Overview and Research Plan: The application from each partnering site must contain an identical overview that is no longer than 2 pages. This is in addition to the 25 page research plan. The overview should provide a description of the role of each site; the approach to project management and training; and elements unique to any of the sites. The application from each site must contain an identical Research Plan (Sections 2 5). The research plan must describe those aspects of the project that are common to all sites of the collaboration. Investigators should use this section to describe the research procedures or protocol, the study population from which samples are drawn, resources, data analyses, and any other characteristics that support each site’s importance to the overall research and training activities. All variations in the research plan between sites, must be highlighted in a subsection of Section 5.5, item 5 with the heading "ELEMENTS UNIQUE TO SITE ONE or TWO (institution name should be provided)."
Applications must describe a feasible mechanism for scientific integration of research procedures, overall managerial and administrative responsibilities, and cross-site comparability of training to assure reliability and quality control. Plans for ensuring access to data by all sites, analytic resources, publication and authorship rights, the possibility of public use research materials and data, or other means of distributing research materials to the wider scientific community, and a means of arbitrating disagreements on publication and other issues should be included in the application.
Any site that contracts out any portion of the CPDR should include this information under "ELEMENTS UNIQUE TO SITE ONE or TWO," and provide a full description of the nature, purpose and oversight of this contractual arrangement.
Partnership Structure: Partnering institutions must submit separate, but linked U01 applications: one from the MSI and one from an institution with an established research program in reproductive science or medicine. It is expected that one PD/PI from each partnering institution will be designated as the contact PD/PI. However, each partnering institution may also designate more than one Principal Investigator. The contact PD/PI from each institution will be responsible for all communications between the PIs and the NIH, for assembling the application materials, and for coordinating progress reports for the project.
Participating institutions should ideally be located within 100 miles of each other to enhance the likelihood of accomplishing the research and training goals of this initiative. If partnering institutions are geographically distant, a detailed plan for overcoming any potential challenges in accomplishing the research and training goals of the partnership must be provided.
An institution may submit no more than two CPDR applications. While existing collaborators are eligible to submit applications in response to this FOA, the research projects must represent a new line of investigation that is relevant to the RSB's mission.
Undergraduate Research Experience: The PD/PIs have the responsibility for the development, implementation, selection, and evaluation of the reproductive research activities for undergraduate students. Research experience and training must be directly related to the awarded U01 CPDR award. At a minimum, trainees must be given the opportunity to participate in research during the summer months and must have an opportunity to be mentored and trained at each partnering academic institution. Programs may also provide training during the academic school year. NICHD anticipates that undergraduate students will be recruited from within the CPDR institutions, as well as from outside of the partnering institutions.
Leadership Plan: All Multiple PI projects will be required to include a section within the Research Plan (Item 14) describing the leadership of the project. This section, entitled Multiple PI Leadership Plan, should describe the governance and organizational structure of the research project, including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, and procedures for resolving conflicts. The roles and administrative, technical, and scientific and training responsibilities for the project or program should be delineated for the PD/PIs. The Leadership Plan should also address the responsibilities of the Multi-PI(s) and their institutions for the protection of human subjects as defined by 45 CFR 46 and the Office for Human Research Protections (OHRP) and the PHS Policy on Humane Care and Use of Laboratory Animals as defined by the Office of Laboratory Animal Welfare (OLAW)
Partnership Commitment: Each application must include written "Letters-of-Commitment" from the respective PI(s) at the MSI and the research-intensive institution that demonstrate support for the CPDR multi-PI program. The linked applications must clearly outline the mutual benefits to be gained as a result of the partnership.
Institutional Commitment: Each application must provide documentation of institutional commitment from a senior official (e.g., President or Dean).
Partnership Meetings: Each CPDR should plan regular meetings (no less than monthly) to discuss the progress and direction of its activities and to ensure that the necessary interactions are taking place. These meetings may be in the form of phone teleconferencing, videoconferencing, or web conferencing as well as face-to-face meetings.
CPDR applications should also request funds to attend a one-day annual meeting in Bethesda, Maryland for the purpose of discussing progress, exchanging ideas, and sharing programmatic challenges. Alternatively, annual meetings may rotate between the NIH and partnering institutions. PD/PIs should also anticipate participating in virtual meetings and conference calls as needed.
Checklist: The checklist for the lead application (1/2) should reflect total Indirect Cost calculations for the entire project. The checklist for the other application should reflect their individual estimated Indirect Costs
Cooperative Agreement Terms: Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
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 NICHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
The following criteria will be applied to applications in the determination of scientific merit and the impact/priority score. Although partnering applications will be submitted separately, they will be reviewed and scored as a unit. Linked applications will receive a single score for each of the review criteria below and receive one overall impact/priority score. Likewise, NICHD’s Division of Scientific Review will prepare one summary statement for linked applications.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the proposed undergraduate research experience directly related to the CPDR research objectives? How will implementation of the proposed undergraduate program advance the objectives of this funding opportunity announcement? If the objectives of the program are achieved, will they further the research training and career preparation of underrepresented students participating in the CPDR program? If the training objectives are achieved, will they enhance the number diverse undergraduate students advancing to graduate research programs in reproductive science and medicine?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the role of each collaborative partner site in the overall project clear and well specified? Is there a feasible plan for achieving scientific integration of research procedures, overall managerial and administrative responsibilities, appropriate quality control and reliability assurance, and planning for data management, analysis, and reporting and disseminating results? Is a means for arbitrating disagreements specified? Do the PIs have the expertise to conduct the proposed undergraduate research activities? Does the time commitment of the investigators appear appropriate to conduct the training activities?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Do the investigators incorporate innovative ideas to recruit and provide reproductive science research experiences to a diverse cadre of undergraduate students?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is there a plan to conduct research and provide research experiences for a diverse group of undergraduate students at each of the partnering institutions? Is the approach feasible to achieve the stated undergraduate research training objectives? Is the recruitment plan adequate to ensure a qualified and diverse participant pool? Is there a plan to recruit diverse candidates from within and outside of the CPDR institutions? Does the training proposal provide appropriate measures for assessing the effectiveness (process and outcome) of the program in achieving its objectives? Are the planned activities consistent with the proposed objectives and are they likely to enhance the chances that trainees will matriculate into reproductive science graduate programs?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the environment at the partnering institutions contribute to the probability of successfully recruiting and providing research experiences for a diverse cadre of undergraduate trainees? Is there sufficient evidence of institutional commitment at each institution for the proposed training activities?
Additional Review Criteria.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
3. Anticipated Announcement and Award DatesIf 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.
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.
Meritorious CPDR applications will be administratively linked by a special Term and Condition that will be included in the Notice of Grant Award (NoA). Each partnering U01 application will receive a separate NoA that will reflect the full F&A rate reimbursement based upon the negotiated rate in effect at the time of award. The budgetary recommendations of the scientific review group and programmatic considerations will be taken into account in developing a funding plan for successful applicants.
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 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).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement
Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and
funding instrument used for this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the NIH as defined below.
2. A.1. Principal
Investigator Rights and Responsibilities
The PD(s)/PI(s) will have the primary responsibility for: coordinating program activities scientifically and administratively at the awardee institution and accepting the terms and conditions of conducting research and training activities in a cooperative manner. Specifically, the partnering PD/PIs will:
2. A.2. NIH Responsibilities
NICHD Responsibilities
The NICHD Program Coordinator will be an Extramural Official of the Reproductive Sciences Branch. The Program Coordinator’s involvement in the CPDR is expected to be above and beyond that normally exercised in the administration of a traditional R01 research grant. The expanded programmatic involvement will provide support, coordination, and momentum to help accomplish the goal of creating effective reproductive science research and training partnerships and will include:
The NICHD will also appoint a staff member to serve as a Project Officer who will:
The NICHD reserves the right to withhold, suspend, or terminate grant support for any aspect of the Diversity Partnership award for lack of scientific progress, failure of one or more of the PD/PIs to participate in a collaborative manner, failure of the partnerships to develop and execute an effective diversity training program, or failure of the partnerships to evolve within the intent and purpose of this initiative.
2.A.3. Collaborative Responsibilities
Overall guidance and
management of the CPDR will be provided by a Steering Committee consisting of
each Principal Investigator and one staff member of the Reproductive Sciences
Branch, NICHD. One Principal Investigator will be selected to serve the
Chairperson for Steering Committee meetings. The Steering Committee will
oversee and coordinate interactions among the projects, and will mediate
interactions between the projects and the NIH. The Steering Committee will
discuss scientific and training goals and progress, and will make
recommendations for awarded partnership programs.
Each full member will
have one vote. Awardee members of the Steering Committee will be required to
accept and implement policies approved by the Steering Committee.
2.A.4.
Dispute Resolution
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. A Dispute
Resolution Panel composed of three members will be convened. It will have three
members: a designee of the Steering Committee chosen without NIH staff voting,
one NIH designee, and a third designee with expertise in the relevant area who
is chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special arbitration
procedure does not alter the awardee's rights in accordance with PHS
regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
The CPDR progress report should also in the following:
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Charisee
Lamar, PhD, MPH, RRT
Reproductive
Sciences Branch
Center for Population Research
Eunice
Kennedy Shriver National Institute of Child Health and Human Development
6100
Executive Blvd, Suite 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone:
(301) 435-6977
Fax: (301)
496-0962:
Email: [email protected]
2. Peer Review
Contacts:
Robert
Stretch, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver 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
FAX: (301) 402-4104
Email: [email protected]
3. Financial or Grants Management
Contacts:
Bryan
Clark, M.B.A.
Chief
Grants Management Officer
Grants
Management Branch
Eunice
Kennedy Shriver National Institute of Child Health
and Human Development
6100
Executive Boulevard, Room 8A01, MSC 7510
Bethesda,
MD 20892-7510
(Rockville, MD 20852 for courier or non-USPS service)
Telephone:
(301) 435-6975
Fax:
(301) 402-0915
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.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088. For additional information,
see http://grants.nih.gov/grants/gwas/.
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.
NIH Public Access
Policy Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be
made publicly available no later than 12 months after publication. As of May
27, 2008, investigators must include the PubMed Central reference number when
citing an article in NIH applications, proposals, and progress reports that
fall under the policy, and was authored or co-authored by the investigator or
arose from the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
Standards
for Privacy of Individually Identifiable Health Information:
The Department
of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides information on the
Privacy Rule, including a complete Regulation Text and a set of decision tools
on "Am I a covered entity?" Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH
Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. 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 FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations: This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. Awards are made under the authorization of 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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