Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), (http://www3.niaid.nih.gov/)

Title: Biomedical Prevention of HIV Research Education (R25)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request for Applications (RFA) Number: RFA-AI-10-027

Notice:  Applications submitted in response to the 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.

A compatible version of Adobe Reader is required for download.  For assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport.

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856

Key Dates
Release/Posted Date:  July 29, 2010
Opening Date:  September 9, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 9, 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: November 9, 2010 
Peer Review Date: March, 2011
Council Review Date May, 2011
Earliest Anticipated Start Date: July, 2011
Additional Information To Be Available Date (Activation Date): Not Applicable.
Expiration Date: November 10, 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 Education 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
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Education Objectives

Background

NIAID continues to place priority on developing new biomedical approaches for preventing HIV infection.  Approaches currently under investigation include vaccines, microbicides that can be delivered topically at the site of sexual transmission, pre-exposure prophylaxis with antiretroviral drugs administered to HIV- uninfected people at high risk for infection, and strategies to decrease viral exposure within a community by identifying and treating more HIV-infected people in that community (e.g. “test and treat”). 

To assess safety and efficacy of these approaches, HIV-uninfected volunteers are needed to participate in clinical studies.  It is essential that study participants reflect the demographics of the epidemic in HIV prevention studies, particularly efficacy studies of biomedical prevention interventions.  Experience has shown that achieving this representation can be a particular challenge in the United States, partly due to mistrust of clinical research and the lack of accurate information about biomedical HIV prevention research among highly HIV-affected communities.  While progress has been made in recent years, it has become clear that a long-term effort is needed to achieve representation proportional to the epidemic and to sustain ongoing engagement of these communities.  Some of these efforts are appropriately conducted in local communities by researchers conducting the studies.  This FOA aims to complement the local, often trial- or network-specific education, outreach, and recruitment efforts with a national program to raise biomedical HIV prevention research literacy among highly HIV-affected U.S. populations and to foster ongoing interactions between thought leaders of these populations and HIV biomedical prevention researchers.

NIAID has worked since 2000 to educate U.S. populations about HIV vaccine research, first through the HIV Vaccine Communication Campaign, and beginning in 2006 through the NIAID HIV Vaccine Research Education Initiative (NHVREI).  This FOA is to establish the successor to NHVREI and to expand the scope to include education about all types of biomedical HIV prevention clinical research rather than focusing solely on HIV vaccine research.   The goal of the Biomedical Prevention of HIV Research Education (B-PHRE, pronounced “be free”) is to create an enabling environment for biomedical HIV clinical prevention research, including vaccine research, particularly among those U.S. populations most affected by HIV/AIDS.

Research continues to indicate that myths and misinformation about HIV and HIV prevention research persist among populations affected by HIV and AIDS in the United States, particularly among African Americans and Latinos.  For example:

B-PHRE will work to dispel common myths and misconceptions, provide accurate information, foster communication channels and establish trust between researchers and highly HIV-affected communities.

Purpose of FOA

The purpose of B-PHRE is to:

Objectives and Scope

B-PHRE, a domestic (U.S. only) initiative, will seek to increase knowledge, understanding, and informed attitudes towards participation in clinical research on biomedical HIV prevention approaches, among highly HIV-affected populations such as African Americans, Latinos, and gay and bisexual men and transgendered women of all races and ethnicities.  Outreach can be targeted directly to the highly affected populations, or indirectly to individuals, organizations, and media that influence the populations, or can employ a combination of direct and indirect approaches.

Applicants are expected to create innovative, comprehensive, evidence-based programs with a national reach among the target populations (but not the general population).  The specific suite of activities to achieve the goals of B-PHRE should be based on state-of-the-art approaches and theory in the fields of education, social change, and community-based participatory research.  Some activities may need to be adjusted from year to year based on environmental changes, lessons learned, or new evidence-based outreach approaches that become available. 

Activities conducted under this program must complement outreach efforts of HIV prevention clinical researchers.  Any local activities supported by B-PHRE should be conducted in cities where HIV biomedical prevention research is ongoing or planned, and must be closely coordinated with local clinical researchers, but must not engage in or substitute for education and recruitment activities that are the responsibility of the research sites.

Activities may include, but are not limited to, the following types:

This FOA will not support:

Program Organization and Coordination

Awardees will collaborate closely with the NIAID Division of AIDS (DAIDS) clinical trial networks (currently the HIV Vaccine Trials Network, HIV Prevention Trials Network, Microbicide Trials Network) and other major NIAID-supported HIV prevention clinical trials in the U.S.  The description of the program must contain, but is not limited to, the following elements:

The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and women.

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 NIH Research Education Grant (R25) award mechanism. The Project Director/Principal Investigator (PD/PI) (or multiple PD(s)/PI(s) if multiple PD/PI option is used) will be solely responsible for planning, directing, and executing the proposed research education program.

This FOA uses just-in-time concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA. 

Research education grant support is for new projects only; renewal (formerly “competing continuation”) applications will not be accepted.   

2. Funds Available

Because the nature and scope of the proposed research education program 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 NIAID provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Although the size of award may vary with the scope of the research education program proposed, it is expected that applications will stay within the following budgetary guidelines: total costs are limited to $1.8M annually.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

Allowable Costs: Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution, nor can they be used to circumvent or supplement funds provided to individuals supported by Ruth L. Kirschstein National Research Service Award (NRSA) programs.

Personnel: These requested expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget.  Individuals (PD/PIs)  designing, directing, and implementing  the research education program may request salary and fringe benefits appropriate for the person months devoted to the program.  Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds).

Other Program-Related Expenses: These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget.  Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution.

Participant Costs: Participants are those individuals who benefit from the proposed research education program.   In some instances, participants may be paid if specifically required for the proposed research education program and sufficiently justified.  Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs (exclusive of tuition, fees, and equipment).

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:

Foreign institutions are not eligible to apply in response to this FOA.

If multiple sites are involved in the research education program, the applicant institution must be one of these sites for the program.  The need for and use of multiple sites must be justified.   

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research education program as the PD/PI is invited to work with his/her organization 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.

The PD/PI should have experience in HIV/AIDS education or in educating vulnerable and underserved U.S. populations about clinical research.  The PD/PI or a senior member of the team should have established relationships, credibility, and channels of communication with key leaders in the response to HIV/AIDS in the U.S., including leaders in the non-governmental organization NGO community.  The PD/PI should be capable of providing both administrative and programmatic leadership to the development and implementation of the proposed research education program.

The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required (See Section VI.3. “Reporting.”)

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://grants.nih.gov/grants/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. 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 research education program, 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

Sponsoring Institution: The sponsoring institution must assure support for the proposed research education program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. The application must have a strong research program in the area(s) proposed for research education and should include a letter explaining the institutional commitment to the proposed research education program.

Participants: Describe who the intended participants are, and the eligibility and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels essential for participation in the planned program.  For the purpose of this FOA, participants are scientists and educators, media experts, community leaders, and members of stakeholder organizations engaged in biomedical HIV prevention research among highly HIV-affected communities in the United States.  These individuals must be members or influencers of highly affected communities and those involving HIV-impacted populations in the U.S. as indicated by surveillance data from the U.S. Centers for Disease Control and Prevention (see http://www.cdc.gov/hiv/topics/surveillance/index.htm for more information).

Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions: Resubmission applications are not permitted in response to this FOA. 

Renewals: Renewal applications are not allowed for this research education program.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, go to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an applicationSeveral of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

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

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

Several additional separate actions are required before an applicant institution/organization 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 PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

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

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

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, 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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

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

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

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SF 424 Research & Related Budget

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 contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

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

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan, entitled “Multiple PD/PI Leadership Plan”, 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 Plan 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 program 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.

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.

Applications Involving Multiple Institutions: If multiple sites are involved in the research education program, the applicant institution must be one of these sites for the program.  The need for and use of multiple sites must be justified.   

Funding for the other institutions(s) must be requested via a subcontract to be administered by the primary institution.  When submitting a detailed budget, the primary institution should submit its budget using the Research & Related Budget component.  All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Application Due, Review and Anticipated Start Dates
Opening Date:  September 9, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 9, 2010
Application Due Date(s): November 9, 2010 
Peer Review Date(s): March, 2011
Council Review Date(s) May, 2011
Earliest Anticipated Start Date(s): July, 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:

Peter R. Jackson, PhD
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
MSC 7616, Room 3133
6700-B Rockledge Drive 
Bethesda, MD 20892-7616 (Express Mail/Couriers: 20817-7616)
Telephone: (301) 496-8426
Fax: (301) 480-2310
Email: pj8v@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/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

In order to expedite the review, applicants are requested to notify the NIAID Referral Office by email NIAIDReceiptReferral@niaid.nih.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

3.C.1 Submitting On-Time

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

Please visit http://grants.nih.gov/grants/ElectronicReceipt/support.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive 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 the application status in the Commons.

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.

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.

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 the NIH Grants Policy Statement.

6. Other Submission Requirements

Additional Instructions for the Inclusion of Letters of Collaboration

Applicants should upload the letters of collaboration as line Item 14 (Letters of Support) included in Other Research Plan Sections of the PHS 398 Research Plan within the SF424 application (see http://grants.nih.gov/grants/funding/424/index.htm).

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.”

PHS 398 Research Plan Component Sections

Page limitations must be followed as outlined in the SF424 (R&R) Application Guide. ·          

All application instructions outlined in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm) are to be followed, with the following requirements for R25 applications:

Research Education Program Plan (Item 3): The Research Education Program Plan must be uploaded using the Research Strategy section, and must include the following components:

Proposed Research Education Program (Component of Item 3): Applicants should propose how their education program creates a supportive environment for participation in biomedical HIV research, and how the organizational structure of the program and the recruitment of thought leaders in the HIV field and those in highly affected communities will facilitate the overarching goals of this education program. Applicants need not give the specific requirements for education and career levels of participants in their application, given that the participants are scientists, educators, media experts, community leaders, and members of stakeholder organizations engaged in biomedical HIV prevention research among highly HIV-affected communities in the United States

Institutional Environment and Commitment (Component of Item 3): Describe the institutional environment, including facilities and educational resources that can contribute to the planned Research Education Program.  Evidence of institutional commitment to the research educational program is required.  A letter of institutional commitment must be attached at line item 14 (Letters of Support). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.  Applications that do not include a letter of institutional commitment will be deemed non-responsive and will not be reviewed.

Program Director/Principal Investigator (Component of Item 3): For multiple PD/PI Leadership Plan, see instructions for the Multiple PD/PI Leadership Plan section of the Research Plan. Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research, teaching, or project management in an area related to the mission of the NIAID, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program. The PD/PI should have experience in HIV/AIDS education or in educating vulnerable and underserved U.S. populations about clinical research.  The PD/PI or a senior member of the team should have established relationships, credibility, and channels of communication with key leaders in the response to HIV/AIDS in the U.S., including leaders in the NGO community.

Program Faculty/Staff (Component of Item 3): Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of the NIAID. Applicants should describe their experience and expertise in facilitating and recruiting the scientists and educators, media experts, community leaders, opinion leaders, and members of stakeholder organizations engaged in biomedical HIV prevention research among highly HIV-affected communities in the United States. Applicants should also describe their previous experience in developing education content through team-building. For the purpose of this FOA, “faculty” refers to those who will be developing and delivering messages, materials, and presentations to educate the target populations about biomedical HIV prevention research.  Thus it will be necessary for the team to combine subject matter expertise with expertise in communication of scientific concepts to the general public.  The team will also be expected to demonstrate cultural and language competency in communicating with each of the target populations.

Program Participants (Component of Item 3): Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.  For the purpose of this FOA, participants are scientists and educators, media experts, community leaders, and members of stakeholder organizations engaged in biomedical HIV prevention research among highly HIV-affected communities in the United States.

Evaluation Plan (Component of Item 3): Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine their effectiveness. A program evaluation plan must be provided. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report short or long-term outcome measures that would determine the success of the research education program in achieving its objectives.  Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program improvements.  If a dissemination plan is required, a specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sample curricula, web postings, presentations at scientific meetings, workshops, etc. The awardee will be required to collaborate with and provide evaluation data to an independent evaluation contractor selected by NIAID.

Resource Sharing Plan(s) (Item 15):  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: Investigators seeking $500,000 or more in direct costs in any year 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: Not applicable.

(c) Genome-Wide Association Studies (GWAS): Not applicable.

d) Research education programs: These programs are not generally expected to generate research resources. However, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.  There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

The initial review group will comment on the appropriateness of the proposed software dissemination plan.  Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award.  Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee.  The adequacy of the resources sharing plan and any related data sharing plans (if applicable) will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

(e) Educational materials:  Applications are expected to include a plan for sharing educational materials if support for development and production of materials is requested in the application.  Educational materials include print materials, videos, radio spots, and standard (not one-time only) presentation slides.  The materials sharing plan should address, as appropriate, the following goals:

The initial review group will comment on the appropriateness and adequacy of the proposed materials and software sharing and dissemination plan(s).  This consideration will be reflected in the technical merit of the application.

·         Appendix (Item 16): 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. An application that does not comply with the required page limitations may be delayed in the review process.

SF 424 Research & Related Other Project Information

Item 9 (Facilities & Other Resources): Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program.  List all thematically related sources of support for research training and education following the format for Current and Pending Support.

SF 424 Research & Related Senior/Key Person Profile

Key Personnel must include the PD/PI (or multiple PDs/PIs) as well as any other key persons (such as those involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program.

Research & Related Budget

Complete for each budget period requested.

A.   Senior/Key Person: complete for all senior/key persons associated with the research education program.  The PD/PI (or multiple PDs/PIs) must be included here.

B.   Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.

C.    Equipment: self-explanatory.

D.   Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the research education program.

E.    Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program.  If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participants/Trainees to be supported by the proposed research education program. 

F.    Other Direct Costs: itemize as appropriate and allowed for the research education program.

K.   Budget Justification: provide a detailed justification for each category for which funds are requested.  For Section E, itemize each category of support costs per participant and justify.

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

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.

Review Process

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

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

The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of individuals is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs.  The goals of NIH-supported science education programs across the nation are to provide public education and outreach on NIH-supported clinical and basic science research.

Research education program grant applications submitted in response to this funding opportunity announcement should be characterized by innovation, scholarship and responsiveness to the priorities and/or changing needs of the NIAID in meeting its objectives.  Applicants are strongly encouraged to contact NIAID program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the research education program to exert a sustained, powerful influence on the activities involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the proposed program).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific 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 proposed research education program address an important problem or critical question in research education or other critical issues as outlined in this funding opportunity announcement (FOA)?  How will implementation of the proposed program advance the objectives of this FOA?  If the aims of the education program are achieved, will they achieve the intended purpose of this FOA?  Will the proposed materials and/or software sharing plan support or facilitate a nationwide effort to develop a supportive climate in the United States for participation in biomedical HIV prevention trials?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program?  If Early Stage Investigator or New Investigator, or in the early stages of independent careers, does the PD/PI have appropriate experience to lead the program?  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 there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives? Does the PD/PI (or Multiple PDs/PIs if a multiple PD/PI application) have experience in HIV/AIDS education or in educating vulnerable and underserved U.S. populations about clinical research?  Does the PD/PI (or Multiple PDs/PIs if a multiple PD/PI application) or a senior member of the team have established relationships, credibility, and channels of communication with key leaders in the response to HIV/AIDS in the U.S., including leaders in the NGO community? Does the team include adequate expertise in biomedical HIV prevention research, communication of science to laypeople, and cultural and language competency in communicating with each of the highly HIV-affected populations? How well-suited is the PD/PI (or Multiple PDs/PIs if a multiple PD/PI application) to providing those teams with the leadership and resources to accomplish the goals of the application?

Innovation. Is the proposed research education program characterized by innovation and scholarship?  Does the proposed program challenge and seek to shift current research education paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area?  Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere?  Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.   

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  Is the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program?  Is there evidence that the program is based on sound research concepts and educational principles?  Is the approach feasible and appropriate to achieve the stated research education goals?  If the proposed program will recruit research education participants or partners, are the recruitment, retention, and follow-up activities adequate to ensure an appropriate and diverse education participant or partner pool?   If the program 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?  Are proposed activities appropriately tailored for and targeted to each of the different highly HIV-affected populations in the U.S.?  Does the applicant propose a management structure that facilitates strategic adjustments to the program in response to ongoing program evaluation and changes in the environment?

Environment.  Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success?  Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed?  Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Is there evidence of appropriate collaboration among participating programs, departments, and institutions?  If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication among multiple sites (if appropriate)? Does the plan for coordination and collaboration include all the appropriate organizations and a reasonable coordination structure?  

Additional Review Criteria

As applicable for the program proposed, reviewers will consider the following additional items in the determination of scientific merit, but will not give separate scores for these items.

Protections for Human Subjects: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities and Children: When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals:  Vertebrate animals are not applicable to this FOA.

Biohazards:  Biohazards are not applicable to this FOA.

Resubmission Applications: Resubmission applications are not applicable to this FOA.

Renewal Applications: Renewal applications are not applicable to this FOA.

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.

Applications from Foreign Organizations: Applications from foreign organizations are not applicable to this FOA.

Select Agents Research:  Select agents research is not applicable to this FOA.

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 (Not Applicable); 3) Genome Wide Association Studies (GWAS) (Not Applicable); and 4) Research education programs: If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the appropriateness of the proposed software dissemination plan.

Budget and Period of Support: Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research education program and the number of proposed participants.

Selection Process

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:

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 Institute to the grantee business official. 

Selection of an application for award is not an authorization to begin performance. Any allowable costs incurred 90 days before the beginning (or start) date of the NoA (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

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution: The research education program may not be transferred from one institution to another, unless strongly justified.

Consultation with the Institute program staff is strongly encouraged when a change of institution is being considered.  In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in the original objectives, and the facilities and resources at the new organization will allow for successful performance of the project or activity. If these conditions or other programmatic or administrative requirements are not met, the Institute may require peer review or may disapprove the request and, if appropriate, terminate the award.

The applicant must provide the following information to the NIAID for review:

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI.  A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component.  A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program.  If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met.  The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change.  The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided.  The information in the request must establish that the Specific Aims of the original peer-reviewed research education program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program.  This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review. 

 In addition to NIH policy requirements, NIAID has the following special terms and conditions of this award:

NIAID will facilitate collaboration and coordination with other stakeholders at NIH, the DAIDS trial networks, the Centers for Disease Control and Prevention, other biomedical HIV prevention research funders, and other U.S. government stakeholders.

3. Reporting

Awards made in response to this FOA are not subject to SNAP.

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report should provide information on the development and implementation of the proposed research education program, modifications to the research education program as originally proposed, updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program. To facilitate and standardize reporting, programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the PHS 2590 additional instructions for preparing a Progress Report for an institutional training grant. The progress report should also describe how findings from the program evaluation inform the program plans for the following year.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program.  Accordingly, award participants are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Education Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice.  For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________.  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”  

Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated. Evaluation results should be included as part of the Final Progress Report.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Katharine Kripke, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
MSC-7628, Room 5144   
6700B Rockledge Drive
Bethesda, MD 20892-7628
Telephone: (301) 402-0846
Fax: (301) 402-3684
Email: kripkek@niaid.nih.gov  

2. Peer Review Contacts:

Peter R. Jackson, PhD
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
MSC 7616, Room 3133
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (Express Mail/Couriers: 20817-7616)
Telephone: (301) 496-8426
Fax: (301) 480-2310
Email: pj8v@nih.gov

3. Financial or Grants Management Contacts:

Jane Paull
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
MSC 7614, Room 2119
6700 B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 594-1544
Fax: (301) 493-0597
Email:paullj@niaid.nih.gov

Section VIII. Other Information


Required Federal Citations

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).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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.

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. 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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