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 Child Health and Human Development (NICHD/NIH), (http://www.nichd.nih.gov)

Title: International Extramural Associates Research Development Award (IEARDA) (G11)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-HD-06-018

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date:  June 28, 2006
Letters of Intent Receipt Date(s): July 28, 2006
Application Submission Date(s): August 29, 2006
Peer Review Date(s): February/March 2007
Council Review Date(s): January 2007
Earliest Anticipated Start Date(s): July 1, 2007
Additional Information to Be Available Date (Url Activation Date): Not applicable
Expiration Date: August 30, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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

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

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background

Funding in developing countries from the National Institutes of Health (NIH) has increased dramatically since 1997, leading to greater need for accountability and adequate reporting of research activities in these regions. Many institutions have no or limited experience with funding from the NIH or other international agencies and have thus not established the administrative infrastructure to address the fiscal and scientific reporting requirements needed by funding bodies.  The NIH is establishing the IEARDA to promote research capacity through the development and strengthening of administrative infrastructures in private/public institutions with NIH funding in developing countries.  The IEARDA is providing a framework for trained administrators who will be able to facilitate the enhancement of an appropriate infrastructure in their home institutions as well as serve as regional resources.  

Overall, the IEARDA accomplishes this mission by providing institutions in developing countries with the opportunity to identify an individual who will serve as key research administrator and oversee the institution’s Office of Research Development (ORD).  The ORD serves as the primary focus of administrative oversight for grants and contracts and will provide resources for faculty and staff in the application for and oversight of awards. This individual will come to the NIH in Bethesda, Maryland with the goal of gaining the necessary understanding of the processes utilized by the NIH and other Federal agencies in funding biomedical and behavioral research and research training. The function of the research administrator is to act as the agent of the home institution to facilitate research opportunities and funding, and assure that all research activities adhere to scientific, legal, and fiscal requirements of the funding agency. 

The IEARDA consists of an initial flexible orientation, including distance learning training and an on-site visit to assist in the implementation of an Institutional Plan and to maximize the research administrator’s time during the 12-week summer residency at NIH.  The IEARDA is fashioned for institutional representatives who wish to strengthen an Office of Research Development for the purpose of enhancing biomedical and behavioral research activities at their institution.  A successful applicant institution receives an IEARDA to support the Office of Research Development, to implement the Institutional Plan, and to utilize the knowledge and skills obtained by the research administrator.  The individual from the awardee institution who participates in the residency is known as the International Extramural Associate (IEA).

Scope

Candidates for IEARDA must be full-time academic science administrators at the applicant institution. The award will entail:

Successful applicants will be required to spend a 12-week residency at the NIH. The program has the flexibility necessary to allow each IEA to participate in activities that are consistent with the awardee institution's concerns and interests in health-related research. Upon entering the program, IEAs are assigned a preceptor to oversee their residency and participate in the domestic EA Program curriculum.  Information on the domestic EA program curriculum can be found at http://grants1.nih.gov/grants/guide/pa-files/PAR-05-053.html.  

The IEA's preceptor, a senior NIH or Public Health Service (PHS) official, is available for guidance with respect to working assignments and related activities to assure consistency with the Institutional Plan.  The Institutional Plan must map out the reinforcement of the Office of Research Development in the awardee institution.  This plan, coupled with the on-site visit, will allow the IEA’s preceptor to assist in the design of each IEA’s residency at the NIH.  

IEAs attend an initial series of orientation sessions and in-depth seminars that prepare them to use their time effectively at the NIH.  Working assignments are intended to provide in-depth exposure to the administration of NIH and other Federal extramural research programs.  IEAs have the opportunity to learn about the Federal legislative and budgetary processes, to study administrative procedures, and to observe staff and peer review meetings. During the course of the 12-week residency program, they visit other Federal agencies and a nearby university's Office of Research Development to learn different organizational and administrative structures related to biomedical and behavioral research. Opportunities may also be provided to observe NIH site-visits to grantee institutions. It is also envisioned that the IEAs will share, collaborate and learn from the other IEAs in the program as well as their domestic counterparts while in-residence at the NIH.

Upon return to the home institution, the IEA will be responsible for the implementation of the Institutional Plan, ensuring adherence to the agreed-upon goals 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.

Program Objectives

The objective of the IEARDA is to enhance research capacity and infrastructure of NIH-supported institutions by providing the following resources:

The IEAs will participate in this residency with the domestic Extramural Associates (EA).  Information about the domestic EA program can be found at http://grants1.nih.gov/grants/guide/pa-files/PAR-05-053.htmll.

Training Curriculum

Distance Learning Component:

Distance learning training 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, etc.  IEAs will complete part of their training while at the home institution, prior to their residency training at NIH.

Please note:  By submitting an application in response to this RFA, the Institution agrees and indicates understanding that the time devoted to this portion of the training is required and must be completed before the IEA arrival at NIH.  It is NICHD’s expectation that the IEAs will not be overloaded with other institutional duties that would detract from the IEA’s concentration on the details of this phase of training. 

Site Visit:

At approximately the time of the distance learning component, the awardee institution will have a site visit by NIH staff.  The goal of this visit is to conduct an assessment of research capacity and specific issues to address during residency at the NIH.  The knowledge and skills learned from these components (distance learning, residency and the on-site visit) are expected to inform and be integrated into the Institutional Plan.

Residency:

The purpose of the 12-week NIH residency is to provide the IEA with the skills needed to improve or enhance the research infrastructure of the grantee institution.  Toward this end, the curriculum will focus on nine core areas:

The NICHD and the Fogarty International Center will collaborate in the training of IEA’s and will work closely to ensure that assigned mentors/preceptors will provide individualized training specific to needs of the IEAs and or their home institutions.

Upon completion of the residency, the IEAs will have:

Post-Residency Award

Following residency training, IEARDA grant funds will be used to improve the research infrastructure at the awardee institution.  These funds are provided to support the reinforcement of the research infrastructure (through the Office of Research Development) at the awardee institution as outlined in the Institutional Plan, including the integration of the on-site visit recommendations and development of a timeline for both short- and long-term goals. 

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the NIH Extramural Associates Research Development Award (G11) mechanism.  As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

2. Funds Available

The NICHD intends to commit approximately $325,000 in total costs (Direct plus Administrative costs) in FY 2007 to support up to three to six new awards in response to this RFA.  An applicant may request a project period of up to five years and a budget of up to up to $35,000 in Direct Costs per year to support building the research administrative infrastructure for the Institution.  In addition, applicants may request up to $15,000 in the first year that can be used for travel and living allowance for the International Extramural Associate for participation in the residency program at NIH. 

Funds for up to 8 percent administrative costs (excluding equipment) may be requested (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html).

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Only private or public institutions in India and sub-Saharan Africa that are currently receiving research grant support from NIH, either through a direct grant or as a subproject to a U.S. domestic award, are eligible to apply for these grants.  The institution must be the recipient of at least three NIH awards (e.g., R01, R03, R21, U01, etc.) and must have an Office of Research Development in place.  In addition, the institution must have the electronic connectivity and Internet access necessary for NIH electronic grants administration.  The institution should be undertaking significant research in the area of global health disparities in the biomedical or behavioral sciences.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed work is invited to work with their institution to develop an application for support.  

The Principal Investigator must be nominated by an institution meeting the eligibility criteria above.  This individual will serve as the International Extramural Associate (IEA) for the program.  Full-time academic administrators are eligible to become Principal Investigators.  The Ph.D., M.B.A. or equivalent is preferred but not necessary.  The Principal Investigator must have the commitment of the Institution to oversee the Office of Research Development and administer the institution’s grant portfolio upon their completion of residency training at NIH. This individual should have the authority and decision-making ability within the awardee institution needed to execute the Institutional Plan.  In addition, this individual must have flexibility in terms of academic responsibilities and workload to carry out the expectations outlined in this solicitation.  The ideal candidate should have experience in management of a business office and some familiarity with management of scientific research, as well as familiarity with the research scope of their home institution.  Applicants must be available to participate in the 12-week summer residency program at the NIH in Bethesda, Maryland, U.S.A.

3. Other-Special Eligibility Criteria

Institutional Commitment

Institutions may nominate only one Principal Investigator per cycle for participation in the program, and may have only one G11 grant at a time.  In nominating the IEA candidate, the sponsoring institution must demonstrate commitment by providing the release time needed for IEA training and to formulate and implement an Institutional Plan, which will build upon the IEAs residency training experience.   The Institution’s commitment must include:

The IEA and the institution must be fully committed to the IEA residency training. Specifically, because of the time and effort expended in scheduling and conducting the training, only in extreme cases will the IEA be excused from any part of the training to engage in institutional responsibilities incurred prior to or during the residency training.

The institutional commitment to the Office of Research Development should include office space; significant salary support for the academic administrator; office equipment and any other in-kind activities to illustrate the long-range commitment to the Office past the duration of this program/grant.   The application should address the institutional support in these areas with as much specificity as possible.

The NIH will conduct a needs assessment at the pre-award stage to assist the awardee institution in identifying its current infrastructure and research administration capacity issues.  The recommendations generated by the assessment are envisioned to help guide the institution in developing its Institutional Plan and in individualizing the residency training of the IEA to reflect the home institution’s particular needs and concerns.

The awardee institution and Principal Investigator must submit progress reports (as mandated by federal funding requirements) that document activities during the report period that track efforts to meet the targeted outcomes as detailed in the Institutional Plan. 

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): July 28, 2006
Application Submission Date (s): August 29, 2006
Peer Review Date(s): February/March 2007
Council Review Date(s): January 2007
Earliest Anticipated Start Date: July 1, 2007

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 NICHD staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Julia B. Anderson, Ph.D.
Special Assistant to the Deputy Director
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03A, MSC 7510
Bethesda, Maryland  20892-7510
Telephone: 301-435-2712
FAX: 301-480-0393
Email:  Andersju@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

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

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

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

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone:  301-496-1485
FAX: 301-402-4104
Email:  stretchr@mail.nih.gov  

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

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

Up to $15,000 may be requested to support travel and living allowance during the NIH residency training period. These can include a direct economy flight from the home institution to Bethesda and a maximum monthly allowance of $4000.

Up to $35,000 (plus 8 percent indirect costs) may be requested to support the activities of the IEA upon returning to the home institution. Such activities may include equipping and staffing an office, support of small pilot research studies, conduct of student/teacher seminars and workshops to enhance research infrastructure, provide ethics training and research management and the establishment of consortium research arrangements. Other purposes for which funds may be used include, but are not limited to, the following:

Funds may not be used for the following:

Pre-Award Costs are allowable.  A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

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

6. Other Submission Requirements

Special Instructions for Research Infrastructure Development Plan

For section I.C.9, Specific Instructions - Research Plan, use Continuation Pages to provide information on the three parts described below. The total length for these three parts combined should not exceed 15 pages.

The Research Plan for the IEARDA application consists of three parts. These parts are required and it is imperative that applicants fully address each point described in the outline below because they are reflected in the review criteria.

Part I:  The Nominee

This part pertains to the nominee's background and potential as an IEA. It should be prepared by the nominee and must include:

Part II: The Institution

This part pertains to the institution's mission and commitment to the goals of the IEA Program.   This section must include the following:

 In addition to this letter, this part of the application should include:

Part III:  Institutional Plan

The IEA selected to participate in the IEARDA must submit a preliminary plan that describes the enhancement of the institution's Office of Research Development. This plan should describe an approach for strengthening the research capabilities of the institution using the skills to be gained by the nominee. The Institutional plan must address the following items:

At least one advisory committee must be described and established. The purpose, function, and expectation of the committee should be described in the application, but specific members should not be appointed until after an award is made. This committee could serve as advisory to the IEA 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.

The plan can be modified after residency and the on-site visit to reflect the knowledge gained from both of these activities which may be integrated into the Institutional Plan.

The plan must also provide a clear description of outcomes or goals (both long- and short-term goals) for the Office of Research Development.  This should include a timeline for completion of these goals/outcomes during the funding cycle and a detailed description of monitoring the completion of these goals.  Adherence to the timeline should be reported within the annual progress reports mandated by the NIH. The goals and/or outcomes developed for the IEAP application can be modified based on recommendations by the initial on-site visit/assessment done at the pre-award stage and with consultation with the IEARDA core scientists and administrators.

More specifically, the institutional plan should include a brief description of the research management activities that have been implemented and steps to be taken under the IEAP to strengthen the Institution’s capacity for research oversight.  These steps should include:

Special Instructions for Appendix

The Appendix to the application should include the following items:

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

I. The Nominee

II. The Institution

In the context of the institution's history and stage of development:

Added Per Notice NOT-HD-06-011

III. The Institutional Plan

2.A. Additional Review Criteria

Not Applicable

2.B. Additional Review Considerations

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

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

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

3. Reporting

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

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:

Julia B. Anderson, Ph.D.
Special Assistant to the Deputy Director
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:  Andersju@mail.nih.gov

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone:  301-496-1485
FAX:  301-402-4104
Email:  stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Stuart Tate
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone:  301-496-5001
FAX:  301-451-5510
Email:  tatestua@mail.nih.gov 

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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