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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nihcd.nih.gov/)

Title:  Extramural Associates Research Development Award (EARDA) (G11)

Announcement Type
This program announcement (PA) is a modification of PAR-05-053 which was released on February 14, 2005.

Update: The following updatea relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-08-096

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.865  

Key Dates
Release/Posted Date: February 29, 2008
Opening Date:  February 29, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): March 25, 2008, January 24, 2009, January 24, 2010
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s): April 25, 2008; February 24, 2009; February 24, 2010
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): June 2008; June 2009 June 2010
Council Review Date(s): October 2008; October 2009; October 2010
Earliest Anticipated Start Date(s): January 2009; January 2010; January 2011
Additional Information to Be Available Date (Activation Date): Not applicable
Expiration Date: October 22, 2009 (per NOT-HD-10-003) - Originally February 25, 2010

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 of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1.   Research Objectives

Background

The National Institutes of Health (NIH) established the Extramural Associates Program (EAP) in 1978 to produce a cadre of academic research administrators who could promote the participation of domestic women’s colleges and institutions with a traditionally significant to high ethnic minority student enrollment in rigorous biomedical and behavioral research programs.  The EAP accomplishes its mission primarily through the Extramural Associates Research Development Award (EARDA) Program which was designed to facilitate the development of institutional capacity to provide support for the technical development of research grant proposals, provide thorough oversight and administrative management of grant awards, and facilitate the ongoing research activities at the institution.  Through distance learning and training in residence, Extramural Associates (EAs) are provided opportunities to gain an understanding of the processes utilized by the NIH and other Federal agencies to support biomedical and behavioral research and research training and the role of academic research administrators in research development.  Through the support of research infrastructure developmental activities, the EAP aims to facilitate the development of a sustainable capacity in research administration in institutions with limited resources for implementing rigorous research programs in the biomedical and behavioral sciences.  The program is administered within the Division of Special Populations of the National Institute of Child Health and Human Development (NICHD).

Research administration goes beyond research program and project oversight, data management, fiscal accountability, and compliance and scientific reporting related to the NIH and other research funding agencies.   Academic research administrators are change agents at their institutions—strengthening the institutional research culture, which includes but is not limited to:  strengthening administrative and faculty buy-in to research, providing opportunities for training in  research policies and procedures, promoting the development of reward systems for faculty engaged in research, providing opportunities for faculty training in compliance and regulatory policies, research project management, and serving as a networking resource.  For example, the successful research administrator knows who has the latest information about research program priorities, review panel composition, reasonable budget size, subcontract negotiations, and compliance requirements.  Internally, academic research administrators/Extramural Associates also seek to foster the culture of research at their institutions by bridging science and administration, catalyzing the development of seed funding resources, providing resources for students, and influencing crucial institutional research policies. Most importantly, the knowledge gained by the EA through training must be translated into institutional capacity in research administration. Capacity is defined as the ability of individuals and organizations to perform effectively, efficiently, and in a sustainable manner. (Evaluating Capacity Development http://www.idrc.ca/openebooks/111-6/).

Program Objectives

The overall aim of the EARDA program is to develop and/or strengthen the research administration infrastructure (i.e., Office of Sponsored Projects, Offices of Research Development, etc.) at women’s colleges and institutions with a traditionally significant to high ethnic minority student enrollment, thereby enhancing the capacity of these institutions for establishing rigorous research programs in the biomedical and behavioral sciences.  The EARDA Program objectives are:

Through the EAP, institutions with limited resources can become more knowledgeable about how to develop or strengthen capacity in research administration which may include, but is not limited to, acquisition of the appropriate operational resources (i.e., well trained staff, infrastructure, technology, financial resources, etc.) and management (i.e., strategic leadership, program and process management, and networking linkages, etc.);

Evaluating institutional capacity development is of critical importance to ensuring that EARDA supported activities actually lead to improved performance in research administration.

To ensure the integration and sustainability of activities supported by the EARDA, the EAP emphasizes strong leadership in research administration and the coordination of EARDA supported activities within the existing research infrastructure at the applicant institutions. 

Scope

(1)  An orientation for the EA, implemented through a distance learning component.  The EA, appointed by the institution, will complete the distance learning component of his/her training at the home institution prior to residency training at the NIH.  Distance learning modules will include such topics as introduction to the NIH, NIH terminology and funding mechanisms, role of NIH officials, receipt and referral of grant applications, peer review process, program funding cycle, grants management basics, use of animals in research, use of human subjects in research, best practices of Offices of Research and Sponsored Projects, etc.

(2)  A two part, two-week residency training program for the EA at NIH. The residency component provides core training on NIH processes and procedures and the knowledge and skills needed to administer NIH and other awards.  Residency training also includes broad participation by the NICHD, other NIH Institutes and Centers and components of the U.S. Public Health Service, as well as the involvement of selected public and private sector organizations.  

Residency Training, Part 1, in which all new EAs participate, focuses on seven core areas in Year 1:

(3)  Post-Residency Award.  Following Part 1 of residency training and upon return to his or her home institution, the EA will be responsible for implementing the research administration infrastructure development plan and ensuring adherence to the agreed-upon goals, objectives, and timelines.  The institution will be equally responsible for approving and carrying out the plan and providing sustainable support for it as an ongoing institutional component.  The EA will use the EARDA funds to improve the institution’s research administration infrastructure (through the Office of Research or Office of Sponsored Projects) as outlined in the final, approved version of the infrastructure development plan. The NICHD will also provide information regarding relevant workshops, meetings and training opportunities to assist EAs in leveraging newly gained knowledge, insights, and networks. 

(4)  An on-site, post-award, assessment.  The NICHD will conduct an on-site visit to the awardee’s institution and assist with the resolution of any identifiable infrastructure and research capacity issues.  The recommendations generated by the assessment are envisioned to help guide the institution and appointed EA in the establishment of a more robust research infrastructure that has the capacity to implement a more rigorous research program

(5)  An evaluation plan to assess program outcomes.  The EA is expected to develop an evaluation plan with performance measure targets and baseline data for each stated EARDA objective.  The EA is also expected to collect the relevant data and report progress to the NIH EA Program according to the annual reporting requirements for federal grants. 

(6)   Individual faculty pilot research project EARDA awards. In Years 4 and 5 of the award, the PI may add up to $40,000 to the base budget of $70,000 (direct costs) to support two or more pilot research projects within the mission areas of any of the NIH Institutes and Centers. The maximum amount of a pilot research project award is $20,000 per year for up to two years.  All pilot research proposals will be administratively reviewed by NIH and approved prior to the release of funds designated for pilot research projects.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the National Institutes of Health (NIH) Extramural Associates Research Development Award (G11) award mechanism. The G11 mechanism is used by NICHD to support institutional resources to improve the research infrastructure (including part-time professional and administrative staff, equipment, etc.). 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 (see SF424 (R&R) Application Guide). It also uses the non-modular budget formats.  Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.

2. Funds Available

Applicants may request up to $70,000 (direct costs) annually to support activities that strengthen and/or expand the institution’s research administration infrastructure.  In years 1 and 3, first time applicants may request up to $5,000 to support travel and living allowances during NIH Residency Training, Part 1 and during NIH Residency Training, Part 2 respectively for a maximum amount of up to $75,000 (direct costs).  In addition, in Years 4 and 5, the applicant may request up to $40,000 to support two or more pilot research projects for a maximum amount of up to $110,000 (direct costs).  Included in each pilot award are provisions for one trip to a scientific meeting or symposium for the PI and for student participation.  However, in both of these instances the amounts budgeted should be minimal.  Pilot project funds are restricted, pending the administrative review of projects and written approval by NICHD.

Applicants applying for competitive renewals may request a project period of up to three years and a budget for up to $70,000 (direct costs) per year for research administration related activities and up to $40,000 per year for pilot research projects.  However, the number of years requested for continuing support is governed by the length of the grant already awarded.  An institution may receive EARDA support for a total of no more than eight years.

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.

Facilities and Administrative (F&A) 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 types of institutions that also meet at least one of the program priorities noted below are eligible to apply:

Program priorities:

Note that program regulations define ethnic minorities as including but not limited to such groups as Black Americans, Hispanic Americans, Asian/Pacific Islanders, and American Indians/Native Alaskans (Native Americans). They also provide that public/state controlled/private institutions located in Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the successor States of the Trust Territory of the Pacific Islands (the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau) are eligible to apply for programs such as the EARDA. Therefore, Foreign Institutions are not eligible to apply.

Grantees with 8 years of EARDA support and institutions that have well developed research infrastructure and faculty that routinely receive support from R01s or equivalent awards from NIH or other funding agencies are not eligible to apply. 

Eligible institutions where faculty members have never participated in the EA Program are strongly encouraged to apply; however, an institution may submit only one application to this solicitation.  Recipients of the National Center for Research Resources’ Research Centers in Minority Institutions (RCMI) award, if successful in applying for this award, may have their budgets reduced in areas where there is significant overlap in capacity development for research administration.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed project as the Project Director/Principal Investigator is invited to work with his/her institution to develop an EARDA application.

The EARDA program is extending the multiple PI option to encourage the team approach to accomplishing the research administration capacity development activities identified within the offices of sponsored projects or research development. The purpose is to encourage the development of a leadership team, consisting of the Extramural Associate and a high ranking official with decision-making authority in research administration, to carry out the institution’s Implementation Plan for building capacity in research administration. Additional information on the policies and procedures to formally allow more than one PI is available at http://grants.nih.gov/grants/multi_pi. All 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).

The appointed EA will serve as the contact PIs. The EA/PI is responsible for the implementation and management of the overall institutional program and will serve as a liaison between the applicant institution and the NIH.  He/she must have an earned degree in the life sciences or in the physical sciences (chemistry, computer science, mathematics, engineering or physics) and be able to contribute significant effort (from 25 to 50 percent) in the role of academic science administrator, which may include the oversight of programs involving teaching, research, or academically-based public service.  Mid- and senior-level faculty are  preferable, provided such an individual has the flexibility to carry out the expectations outlined in this solicitation. The EA/PI should have the terminal degree or top degree in his/her field (i.e., Ph.D., M.D. or an equivalent degree) and have the knowledge and skills to direct the EARDA program.  

The partnering PI is must be a high level official (i.e., Provost, dean, Vice President for Research, director of the Office of Sponsored Programs, etc.) at an eligible institution, have decision-making authority in regard to the research administration infrastructure and contribute up to 3 percent effort to EARDA supported activities. The Ph.D. or an equivalent degree is preferable but not required.  The second PI is responsible for program oversight, for ensuring that the EA/PI has the appropriate level of authority to execute the institutional plan, and for ensuring the integration of EARDA supported activities into any existing research infrastructure.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and 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 electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering the multiple PD/PI option, 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

Not applicable

3. Other-Special Eligibility Criteria


Resubmissions: An institution may submit up to two resubmission applications, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).

Renewals: An institution may receive support for up to eight years. The number of years of continuation support is governed by the length of the grant already awarded. It is expected that applications will stay within the following budgetary guidelines: total direct costs of $70,000 for sustaining research infrastructure related activities and up to $40,000 in additional support for pilot research projects.

An institution may submit only one application to this solicitation. G11 awards may not be transferred to another institution; and an institution may submit and/or hold only one EARDA institutional award at a time.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant SBC can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered  

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Research & Related Budget (See Section IV.6., “Special Instructions,” regarding appropriate required budget component.)  

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The faculty member appointed as the EA should be designated as the Contact PI. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the EA who is also designated as the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership 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” [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. The EARDA program is extending the multiple PD/PI option to encourage a team approach to accomplishing the research administration capacity building objectives identified by the applicant institution. The governance and organizational structure of the leadership team for the research administration capacity building project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the program should be delineated for the PDs/PIs. 

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 (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Each EARDA application should involve only a single applicant institution; and accordingly the PDs/PIs should follow the instructions contained in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date:  February 29, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): March 25, 2008, January 24, 2009, January 24, 2010
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s): April 25, 2008; February 24, 2009; February 24, 2010
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): June 2008; June 2009 June 2010
Council Review Date(s): October 2008; October 2009; October 2010
Earliest Anticipated Start Date(s): January 2009; January 2010; January 2011

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:

Regina Smith James, M.D.
Director, Extramural Associates Program, Division of Special Populations
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 5E03A, MSC 7510
Bethesda, Maryland  20892-7510
Telephone: 301-435-2692
Fax: 301-480-0393
Email: rjames@mail.nih.gov 

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Allowable costs

Applicants may request up to $70,000 in direct costs per year (plus 8 percent administrative costs) for up to five years to support the research administration capacity development activities of the institution.  The EA who is also the designated contact PI may request from 25 up to 50 percent salary support; and the second PI may request up to 3 percent salary support for oversight responsibilities.  The second PI is responsible for program oversight, which includes ensuring that the EA/PI has the appropriate level of authority to execute the institutional plan and for ensuring the integration of EARDA supported activities into any existing research infrastructure. 

Activities and other purposes for which research administration capacity development funds may be used include, but are not limited to: 

Research administration capacity development funds may not be used for:

In Years 1 and 3, first time applicants may also request up to $5,000 to support travel and living allowance during NIH Residency Training, Part 1 and during NIH Residency Training, Part 2 respectively.  Allowable costs include a direct economy, roundtrip flight between the home institution and Bethesda, Maryland, U.S.A. and living allowance to cover the cost of lodging, meals, local transportation and other incidentals during the residency program.  

In Years 4 and 5, applicants may request additional funds--up to $40,000--to support pilot research projects that focus on the NIH mission areas, which includes basic biomedical and behavioral research, bioinformatics and other research of public health relevance.  The maximum amount that can be allocated for a single pilot project is $20,000.  Because the nature and scope of pilot research projects will vary, the amount allocated per pilot projects will vary.  Pilot research project funds will be restricted, pending review and written approval by NIH.

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 renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements and Information

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files.  This approach will enable applicants to better monitor formatting requirements such as page limits. Items 2-5 of the Research Plan component are limited to 15 pages.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Special Instructions for Extramural Associates Research Development Award

The five components described below are required; and it is imperative that applicants fully address each component described in the outline below in the Research Plan because each is reflected in the review criteria.

1.  Introduction (for Resubmissions or Revisions only) 

The Introduction, where applicable, must address the previous review critique (Summary Statement) and be limited to one page.

2. The Principal Investigators

The EARDA Program is extending the multiple principal investigator PI option to encourage a team approach to accomplishing the research administration capacity building objectives identified by the institution.

2A. Nominee for Extramural Associate (EA)/Principal Investigator

Provide a brief description of the nominee’s professional background, training, work experience, personal qualifications, knowledge and skills, particularly as they relate to his or her ability to fulfill the requirements and responsibilities of the EARDA.  Also include in the description:

Also provide three letters of reference from colleagues (scanned for electronic submission) supporting the potential effectiveness of the nominee to function as a research administrator with responsibility for the institutions research office. Each letter should contain the following: names, title, institutional affiliation, address, telephone and fax numbers, and e-mail addresses.  Reference letters must be included in the letters of support attachment. In order to comply with this requirement, it is recommended that all reference letters be obtained from the referring individuals as far in advance of the application deadline as possible.

2B. The second Principal Investigator (PD/PI)

Provide a brief description of the second PIs professional background, work experience, personal qualifications, knowledge and skills, particularly as they relate to his or her ability to fulfill the oversight responsibilities of the EARDA, which includes ensuring that the EA/PI has the appropriate level of authority to execute the institutional plan and for ensuring the integration of EARDA supported activities into any existing research infrastructure.  The PD/PI should be a high level official at the applicant institution (i.e., Provost, Dean, Vice President for Research, director of the Office of Sponsored Projects, etc)

2C. Multiple PD/PI Leadership Plan

Please describe your Leadership Plan in Section 14 of the Research Plan Component in the SF424 (R&R) as directed in theSpecial Instructions for Applications with Multiple PDs/PIs.”  Note that the governance and organizational structure of the leadership team for the research administration capacity building project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the program should be delineated for the PDs/PIs. 

3. Current Research Capability of the Institution

3.A. Current Research Administrative Infrastructure

The principal investigator should document the current status of the institution’s research administrative infrastructure and address the following:

3.B. Research Environment            

Describe the research environment, specifically including a description of the science faculty and research capability as indicated by:

3.C. Current funding from the NIH (if applicable)

Please provide information on the institution’s current NIH funding. This should be presented in a separate chart or list and included in the Appendix.  For each project, the chart should include the NIH project number, key personnel from the applicant institution and their designations in the grant (e.g., PI, subproject director, investigator, etc.), grantee institution, title of project, total amount of grant award (or subcontract or subproject award), and project period (start and completion dates).

4. Research Administration Infrastructure Development Plan (IDP)

The applicant should develop a realistic plan that can be achieved within the specified time frame.  The EA should consider carefully what he/she wants to accomplish during each year and over the course of the project period.  The goals, objectives, activities, timelines, and intended outcomes will differ from institution to institution but there may be basic categories of activity that each applicant may want or need to undertake.

The IDP proposed as part of this application can be modified and finalized by the EA during NIH Residency Training, Part 1 to reflect the knowledge and skills gained from the distance learning and residency experiences.   Also note that adherence to the timeline proposed in the Plan should be reported within the annual progress reports mandated by the NIH.

4.A. Short and Long-term Goals, Specific Objectives 

The Research Administration Infrastructure Development Plan must describe key short and long-term goals, specific objectives, and the proposed strategies for enhancing and strengthening the existing research administrative infrastructure within the institution’s Office of Research or Office of Sponsored Projects, as applicable.  The objectives (e.g., increased administrative staffing, establishment of database or tracking systems, enhancement of Internal Review Boards (IRB) for both human and animal subjects, training seminars to address grant preparation or grants management, etc.) should be clear, concise, and measurable; and the planned strategies and activities to help achieve each objective should be described.  The intended outcomes (e.g., support staff hired, computers purchased, training curriculum for faculty and research administration support staff under development, etc.), resources, and key personnel involved during the proposed project period of the EARDA should be noted.  In addition, the Plan should be clear and coherent and provide evidence of adequate coordination among key faculty and administrators in its development. 

4.B. Timeline for Achieving Objectives

A timeline for achieving each objective should be indicated.  It may be helpful to summarize this information for each year of the project period using a chart or table format. Examples of such activities may include but are not limited to the following:

Year 1:  adequately staff and equip the research development office; strengthen office communication and computing capabilities; establish and activate advisory committee; assess faculty and student training needs and resources; establish performance measures and collect baseline data for the evaluation plan.

Year 2:  assess and strengthen accounting and monitoring practices; facilitate direct proposal submissions; develop core training capabilities and materials; conduct workshops; monitor performance of workshops.

Year 3: review and refine sustainability plan for research development office; continue training workshops and seminars; continue monitoring quality of training; conduct mid-course review and refine work plan as needed.

Year 4: continue to develop and implement strategies to develop research capacity through improved grantsmanship; assess regional needs and plan regional activities; establish partnerships and other linkages in support of goals.

Year 5: implement and assess regional activities; continue training activities; finalize plan for sustainability of research development office; implement (process and outcome) evaluation of program.   

4.C. Other Components of the IDP

The infrastructure development plan should include a section on an advisory committee and an plan for evaluating the proposed capacity development activities.  The IDP should also pay particular attention to outreach  (i.e., outreach related to capacity development in research administration) as well as to sustainability and the integration of EARDA supported activities within any existing research administration infrastructure at the institution).

Advisory Committee: The infrastructure development plan should include a proposal for establishment of an Advisory Committee to review and monitor ongoing infrastructure development activities.  The purpose, function, and expectation, as well as prospective members of the committee should be described in the application, but specific members should not be appointed until after an award is made.  This committee is intended to be advisory to the EA in the enhancement and maintenance of ongoing research development activities. All other planned committees should be included in this section with a justification for the particular committee structure and function proposed and a description of the proposed membership.

Evaluation Plan. The evaluation strategy should be linked to the statement of goals and objectives and should include benchmarks and a timeline for measuring progress or outcomes; and include a role for the Advisory committee as well.  This information can be presented in a chart or table.  The Plan should also address how the results from the evaluation will be used to improve the research infrastructure and capabilities of the institution. Implementation of any evaluation or assessment activities should include input from the proposed advisory committee.

Outreach.  The plan should briefly describe any proposed outreach regionally to help strengthen research capacity and research administration capabilities; and other plans to initiate or expand local or regional cooperation/collaboration in research activities, including partnering with foundations and other organizations, including businesses and industry.

Integration. The infrastructure development plan should also indicate how this plan relates to and is integrated within the existing research administrative infrastructure and overall strategic plan of the Institution.

Sustainability. The infrastructure development plan should describe briefly how the Institution intends to sustain the acquired research administration related programs and activities once NIH support through the EARDA expires.  The plan for sustainability should include long-range goals and objectives for the research office and indicate commitment of funding from the Institution or availability of other sources of support to ensure continuation of research office activities at the enhanced level.

5.     Institutional Commitment

Support for the EA and the proposed capacity development in research administration should be evidenced by providing the release time needed to participate in EA training and to formulate and implement an infrastructure development plan, which will build upon the EA’s distance learning and residency training experience. The Institution’s commitment must also include:

1.     Approves the nominee’s EARDA training periods at home through the distance learning component and at the NIH residency, and provides the release time for these periods and any financial support needed for training;

2.     Is committed to working cooperatively with the designated research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects) in the home institution for the benefit of the particular administrative unit;

3.     Confirms the institution’s commitment and support to the sustainability of the designated research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects). Institutional provision of resources such as office space, administrator salary, office equipment and other in-kind activities should be addressed both in the proposal and this support letter.  The letter should also explicitly explain how the Institution plans to support and sustain the research office after the EARDA program/grant has been completed.

4.     Confirms the institution’s commitment to biomedical and behavioral research including a statement of plans (as detailed as possible) to improve the health-related research capabilities of the institution.

The letter from the President or equivalent official head must be included in the letters of support attachment.

Appendix Materials 

For this FOA, the Appendix  should include the current funding from the NIH (if applicable) in tabular format.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

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.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files.  This approach will enable applicants to monitor better formatting requirements such as page limits.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Resource Sharing Plan(s)  

The following resource sharing policies do not apply to this FOA:

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

A pplications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by (NICHD) and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

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:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious 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.

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? 

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

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 or methodologies, tools, or technologies for this area? 

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

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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? 

Specific Review Criteria for this FOA

What follows are general review criteria for the EARDA application. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research administration capacity development activities will have a substantial impact in strengthening or expanding the Office of Research Development or Office of Sponsored Projects at the applicant institution

1. Significance: , Do the proposed capacity development activities significantly enhance the research administration infrastructure at the applicant institution?  What is the likelihood that the proposed program will facilitate and/or enhance the development of a culture of research at the institution?

2. Approach: Given the size and characteristics of the applicant institution, are the design and methods adequately developed, well reasoned and appropriate to the aims of the infrastructure program?  Does the applicant acknowledge potential problem areas and consider alternative approaches?  How well are the proposed activities integrated into the existing research administration infrastructure at the applicant institution?

Specifically in regard to the IDP: Is the IDP coherent and does it provide adequate coordination among key faculty and administrators in its development? Does the plan include an evaluative component for monitoring progress in implementing and accomplishing the capacity development goals and objectives in research administration? Does the evaluative component confirm a role for the Advisory Committee in reviewing and monitoring research development activities?  Does the plan address outreach to other regional academic/scientific institutions? Does the plan include long range goals and objectives for sustainability?

3. Innovation: Will the proposed capacity development activities facilitate the efforts by faculty to develop and submit strong applications for research support especially considering the time restraints of faculty at primarily undergraduate institutions in regard to participating in the research enterprise?  For example, do the proposed activities address a critical barrier to research at undergraduate institutions?

4. Investigators: Does the leadership plan reflect a true team approach to strengthening the research administration infrastructure at the applicant institution?  In regard to the EA Nomine/PI and the PD/PI respectively:

Are the strengths of the EA Nominee/PI’s personal qualifications as indicated by training, work experience, knowledge and skills?  Does the applicant provide evidence of commitment to and experience in research administration?  Is there evidence that the applicant has rapport with faculty and students that would enable him/her to successfully engage these individuals in biomedical and behavioral research activities?  Does the application demonstrate the nominee’s ability to commit himself or herself to function as the EA for the duration of the grant?

Are the strengths of the PD/PI’s (with oversight responsibilities) personal qualifications as indicated by training, work experience, knowledge and skills? Is there evidence that the PI will delegate the appropriate authority to the EA/PI to implement the proposed IDP for strengthening its research administration infrastructure? Is there evidence that the PI will ensure integration of EARDA supported activities into the existing research administration infrastructure?

5. Environment: Taking into account the institutional context, including the quality of faculty and students in health-related science departments, how do the proposed activities contribute to the strengthening and/or development of a culture of research at the applicant institution? Do the proposed activities benefit from or employ useful collaborative or consultative arrangements? Is there evidence of strong institutional commitment to implementing the IDP? Is there evidence of long range institutional commitment to strengthening behavioral and biomedical research capacity?

2.A. Additional Review Criteria

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

Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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 “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

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 “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).
 
2.B. Additional Review Considerations

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

2.C. Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See 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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

When multiple years are involved, 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.

NICHD will evaluate this program. Each awardee will be required to define a set of concrete and quantifiable project-specific milestones, which will became a component of the approved Research Administration Development Plan. Each awardee will be required to update these milestones annually in the annual progress reports. These milestones will become a condition of the award, including appropriate language to recognize that the project includes capacity development activities, outcomes of which are unpredictable. In addition, each awardee is expected to provide additional information as required to assist the program evaluation. 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.

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Jean L. Flagg-Newton, Ph.D.
Extramural Associates Program, Division of Special Populations
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03A, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-2722
Fax: 301-480-3093
Email: flaggnej@mail.nih.gov  

Carl V. Hill, Ph.D., MPH
Extramural Associates Program, Division of Special Populations
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03A, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-2712
Fax: 301-480-0393
Email:  hillcv@mail.nih.gov 

2. Peer Review Contact(s):

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
Fax: 301-402-4104
Email: stretchr@mail.nih.gov 

3. Financial/Grants Management Contact(s):

Victoria Bishton
Grants Management Specialist
National Institute of Child Health & Human Development
6100 Executive Blvd., Room 8A01B
Bethesda, MD 20892
Telephone: (301) 451-5857
Fax: (301) 451-5510
Email: bishtonv@mail.nih.gov 

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) 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).

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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 Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 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 Part 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 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/.


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