Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (  

Components of Participating Organizations
Fogarty International Center (FIC), (
National Human Genome Research Institute (NHGRI), (
National Institute of Dental and Craniofacial Research (NIDCR), (
National Institute of Environmental Health Sciences (NIEHS), (
National Institute of Neurological Disorders and Stroke (NINDS), (

Title: International Research Ethics Education And Curriculum Development Award (R25)

Announcement Type
This is a modification of RFA-TW-04-001, which was previously released August 5, 2003.   

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

Request For Applications (RFA) Number:  RFA-TW-06-003

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.172, 93.121, 93.894, 93.853

Key Dates
Release Date: October 27, 2005
Letters of Intent Receipt Date(s): December 12, 2005
Application Receipt Dates(s): January 13, 2006
Peer Review Date(s): June/July 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 2006
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: January 14, 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. Training 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
  2. Peer Review Contact
  3. Financial/ Grants Management Contact

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Education Objectives

Few developing country institutions provide formal education in research ethics, and few developed country programs for advanced research ethics education/training focus in depth on the internationally relevant aspects of research ethics.  Therefore, few developing country scientists and health professionals conducting clinical or public health research have received extensive education and training in the principles of research ethics, international codes and legal aspects of ethical research, informed consent, elements of study design that affect the ethical conduct of research and the ethical framework for provision of care and risk/benefit analysis for study participants.

To address this need, the Fogarty International Center (FIC) invites applications for International Research Ethics Education and Curriculum Development Awards to develop graduate level curricula and provide educational  opportunities for developing country academics, researchers and health professionals in international ethics related to performing research involving human subjects.  Descriptions of research ethics education/training programs currently supported by the Fogarty International Center can be found at  This RFA reflects the results of a review of the current program conducted in 2005 (  New applications focusing on research ethics education for Mexico, Central America, China, Brazil, Thailand, Vietnam, Nigeria, Russia and the countries of the former Soviet Union are especially encouraged due to the amount of NIH-supported research currently conducted in these countries.  U.S. and foreign applicant institutions can request up to two years of support for program planning and curriculum development in preparation to apply for comprehensive education/training program support in the future.  The goal of this initiative is to increase the cadre of developing country scientists, health professionals and relevant academics with in-depth knowledge of the ethical considerations, concepts and applications in clinical and public health research.  It is expected that such advanced education/training will enhance the career development of individuals from developing countries as well as strengthen expertise to support ethical clinical and public health research at their home institutions.

Proposed degree or non-degree comprehensive education/training programs should equip academics, health professionals and researchers from developing countries with the critical skills that are needed to subsequently provide research ethics education, ethical review leaderships and expert consultation to their institutions, national governments and international bodies and, potentially, to pursue studies of ethical practice in clinical and public health research in developing countries.  Proposed comprehensive education/training plans should address the Curriculum Development Objective to support the development, revision or expansion of advanced courses and practicum experiences to impart skills for the ethical review of research as well as teaching and research bioethics in developing countries.

Proposed curricula should provide a core set of advanced study courses that primarily focus on the internationally relevant aspects of ethical, legal and moral principles guiding the responsible conduct of research in developing countries.  Applicants may wish to refer to the bioethics resources available on the NIH website at  Appropriate educational activities may include advanced degree and non-degree associated course work and practicum experiences, such as participation in ethic review committees, development of research ethics education/training courses for researchers or ethical review committee members at their home institutions, analysis of ethical review guidelines or processes and research on ethical practices in biomedical or behavioral research in the scholars’ countries.  Education can also be provided in areas such as research design methodology, technical manuscript and grant writing, statistical methods, informatics and English as a second language, if needed.  Curriculum developed in new comprehensive programs must be offered to scholars after a maximum of one year of the award and should be ongoing in previously supported programs. 

Applicants are encouraged to develop innovative research ethics education/training related to the specific research interests of the participating NIH Institutes and Centers listed above.

The Educational  Objective is to support appropriate advanced education and training for a cadre of developing country academics, researchers and health professionals who can immediately assume expert roles and leadership responsibilities related to the ethical design and review of clinical and public health research in their countries.

Planning grant proposals should describe in detail how specific curriculum components and educational related processes for a comprehensive program will be designed during the two-year award.

Comprehensive training program applications should propose programs for up to two years and no less than 12 months of advanced research ethics education for developing country scholars at the grantee, consortium or home country institutions.  Educational activities should be initiated in comprehensive programs during the first year of support, if feasible.  Educational  support can be provided for educating and training developing country academics such as ethicists or philosophers, researchers and health professionals working at institutions conducting clinical or public health research.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH R25 award mechanism.  The applicant organization’s administration must provide the necessary management for the transfer of funds and materials to the collaborators and any subcontracts. 

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

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see  A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The Fogarty International Center intends to commit approximately $1.5 million in FY 2007 to fund five to six new and/or competing continuation grants and two to three planning and curriculum development awards in response to this RFA.  Under this RFA:

R25 education  awards limit facilities and administrative (F & A) costs to eight percent of applicable direct costs

Because the nature and scope of the proposed research education and curriculum development programs will vary from application to application, it is anticipated that the size and duration of each award will also vary.  Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization has any of the following characteristics:

Only developing country applicants may apply for a two-year program planning and curriculum development grant.  Eligible developing foreign countries include those that have a Gross National Income per capita (GNI per capita) below $9,000, according to the World Bank classification system at (refer only to the GNI per capita ranking in the left column labeled “Atlas Methodology”). 

Collaborations with faculty or consultants from other U.S. or international institutions may be supported to enhance the international research ethics training proposed.   

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to develop and carry out the proposed research education and curriculum development program is invited to work with their institution to develop an application for support.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at:

3. Other-Special Eligibility Criteria

An institution may submit only one application and only one new or existing program will be supported at an institution.  Consequently, institutions with existing awards are not eligible to apply.  Descriptions of existing programs can be found on the Fogarty International Center website ( 

An Advisory Committee must be established for comprehensive research educational  programs and planning awards that includes a majority of members not affiliated with the program.  It is highly recommended that the committee include representatives of potential scholar countries or regions.  The committee’s responsibilities in a comprehensive educational program may include scholar selection, evaluating scholar progress and monitoring and evaluation of the overall effectiveness of the program.  Applicants should provide a detailed description of the committee’s composition and functions, as well as how the committee fits into the organizational structure of the program.

A detailed plan must be provided for the evaluation of the curriculum developed and education/training provided in comprehensive educational programs.  Evaluation plans should specify clear linkages between the stated research ethics education and training needs of the developing countries from which scholars will be recruited, academic and career needs of the scholars, the objectives of the proposed courses and curriculum topics and measures of outcome. 

Competitive renewal applications should contain detailed information about previous FIC-supported research education and training efforts including:  a comprehensive list of all scholars; scholar status before involvement in the program —including position, country of residence and institution; type and length of training provided, and the participant’s current position and responsibilities in providing research ethics training, review or consultation.  Applicants for competitive renewal awards should provide a list of scholar publications in peer-reviewed journals and descriptions of other significant accomplishments related to the research ethics training provided. 

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at in an interactive format.  Applicants must use the currently approved version of the PHS 398.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:

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  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.

All potential applicants who wish to attend a workshop about the program should contact Dr. Barbara Sina (listed under Section VII Agency Contacts) by November 10, 2005.  Support will be available for a limited number of potential developing country applicants to attend the workshop. 

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research education and curriculum development  activities should provide a unique opportunity not available in the U.S. ( 

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

Letter of Intent Receipt Date: December 12, 2005
Application Receipt Date(s): January 13, 2006
Peer Review Date: June/July 2006
Council Review Date: September 2006
Earliest Anticipated Start Date: September 2006

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 at the beginning of this document.

The letter of intent should be sent to:

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 402-9467
FAX: (301) 402-0779

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

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:

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 Fogarty International Center.  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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

Applicants should develop a budget that reflects the resources necessary to implement the activities of the comprehensive educational and curriculum development plan included in their application.  The budgets may include costs to support the various types of education and training proposed (scholar costs) for scholars and faculty, and costs to support the administration of the program and grant.  A detailed budget justification should be provided explaining how requested funds will primarily support developing country scholars.  All expenses related to participation in the program should be itemized on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the appropriate categories.  All expenses related to faculty participation in the program should be itemized on the PHS Form 398 (budget form pages 4 & 5) in the appropriate categories.  The total direct costs of the participation budget should be identified on PHS Form 398 (budget form pages 4 & 5) in the “Other” category.  The combining of the budget figures will allow reviewers and FIC staff to review a composite budget of all costs.

Requested Salary Support:  The salary for the Principal Investigator, other training faculty and administrative staff must be commensurate with the salary structure and benefits at the institution where they are employed.  The program director may receive salary and fringe benefits compensation for up to 25% professional effort (salary must not exceed the annual salary cap level from federal sources, as described at

Scholar Costs:  In comprehensive education programs, scholars may be compensated at a rate comparable to their professional experience in accordance with grantee institutional policies while involved in long-term training at the grantee institution. 

Re-entry Support:  Support of up to $10,000 per developing country scholar in comprehensive training programs may be requested in the “Other Expenses” category for research ethics practicum projects of up to one year upon return to their countries after didactic training.

Network Meetings:  Funds to support the attendance of the Principal Investigator and one or two faculty at the annual network meeting for the program in the U.S. may be requested. 

6. Other Submission Requirements

Applicants should use the NRSA substitute page for the Table of Contents form.  Although this RFA makes reference to the use of some NRSA forms, this RFA is not a NRSA grant opportunity.  In place of the research plan requested in the PHS 398 application instructions, applicants should follow the instructions regarding training plans for NRSA applications.  In addition, the following information should be included:

FIC strongly encourages grantees to include plans to disseminate the educational tools and curricula developed on a publicly accessible website or by other means.

Section V. Application Review Information

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

For foreign applications, the proposed education and curriculum development program  should provide a unique opportunity not available in the U.S. ( 

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 Center for Scientific Review in accordance with the review criteria stated below.

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research education and curriculum development program  will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

-  Appropriate courses and curriculum topics that provides balance and breadth in all critical areas of international research ethics;
-  Education that addresses the gaps in ethical review of research and needs for research ethics education and training at the developing country institutions where scholars will be recruited;
- Provision of practicum experiences to build scholar skills in ethical review of research, teaching research ethics and designing ethical research;
-  A recruiting, application and selection process that captures the most qualified individuals who could most benefit from the education and training proposed and immediately provide research ethics expertise and leadership to their institutions after completing the program;
-  Evaluation of the proposed program;
-  Recruitment of an adequate representation of women and ethnic minorities in the home countries of the developing country scholars;
Support for scholars to develop sustainable research ethics efforts at their home institutions; and
Role of the Advisory Committee.

The clarity and feasibility of plans to design curriculum and educational components and related processes for a comprehensive  program

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

Innovation in the international research ethics curriculum designed for developing country researcher and health professional scholars; and
Innovation in education and training developing country academics, researchers and health professionals in research ethics.

Innovation in plans to design curriculum and education components and  related processes for a comprehensive  program. 

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Qualifications of the program director to lead, and other faculty and Advisory Committee members to participate in the proposed program.

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  The adequacy of the teaching facilities and educational resources including the availability of research ethics practicum opportunities and the overall educational  environment at the applicant institution(s).

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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

2.B. Additional Review Considerations

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

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

Competing Renewal Applications:  Progress in meeting the education and curriculum development program objectives. 

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates

Applicants can expect to learn the outcome of their applications, whether successful or unsuccessful, in September 2006.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant.  For details, applicants may refer to the NIH Grants Policy Statement Part II:  Terms and Conditions of NIH Grant Awards, Subpart A: General (

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 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 Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually ( and financial statements as required in the NIH Grants Policy Statement.

Awardees will also be required to submit annual scholar tracking data to a Fogarty International Center database.  Instructions on scholar data submission will be provided at the time of award.

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:

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
Bethesda, MD  20892-2220
Telephone: (301) 402-9467
FAX: (301) 402-0779

2. Peer Review Contacts:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD  20892 (For express mail, use ZIP 20817 and remove “MSC 7840”)
Telephone: (301) 435-1021
FAX: (301) 480-3567

3. Financial or Grants Management Contacts:

Mr. Bruce Butrum
Grants Management Officer
Fogarty International Center
Building 31, Room B2C29
Bethesda, MD  20892-2220
Telephone: (301) 496-1670
FAX: (301) 594-1211

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 ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( 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 (

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 (; a complete copy of the updated Guidelines is available at 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 (

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at 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

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:

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
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