Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD), (
National Institute on Drug Abuse (NIDA), (
National Institute on Aging (NIA), (
National Institute of Mental Health (NIMH), (

Title:  Research on Pathways Linking Environments, Behaviors and HIV/AIDS (R01)

Announcement Type

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

Program Announcement (PA) Number: PAR-06-114

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.866, 93.279, 93.282

Key Dates
Release Date: December 27, 2005
Letters of Intent Receipt Date(s): Not applicable
AIDS Application Submission Date(s):  September 1, 2006, 2007 and 2008
Peer Review Date:
Council Review Date: January 2007, 2008, 2009
Earliest Anticipated Start Date:  March 2007, 2008, 2009
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: September 2, 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. Submission, 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


Concern about the current and potential future impact of the HIV/AIDS epidemic around the globe has increased dramatically in recent years. According to the U.S. Census Bureau’s report “The AIDS Pandemic in the 21st Century” (issued March 2004), HIV/AIDS is having its greatest impact in the developing world, and the emerging downward trends in life expectancy and population growth, the distortions in age structures and the breakdowns in support systems are already being seen in some sub-Saharan African countries. The U.S. Congressional Research Service, in its 2005 publication “AIDS in Africa” [order code 1B 10050, updated May 12, 2005] notes that “AIDS’ severe social and economic consequences are depriving Africa of skilled workers and teachers while reducing life expectancy by decades in some countries…[AIDS] is regarded as a major contributor to hunger and famine.”  At the same time, many in the scientific community have recognized that the AIDS epidemic is driven not only by individual behaviors, but also by environmental factors that influence behavior and the spread of disease.  The International Monetary Fund’s report “The Macroeconomics of HIV/AIDS” (November 2004) discusses the ways in which HIV/AIDS affects society and the economy through its microeconomic impacts and also how the social and economic impact, combined with the increase in mortality rates, affects the welfare of individuals and households. The 2006 USDHHS/NIH/Office of AIDS Research Prevention Research plan included as a priority “Examine the ways in which social, economic, cultural, and environmental conditions, including stigma and discrimination, contribute to, or create, sources of HIV-related risk; and develop interventions based on this understanding.” A similar theme was sounded in the November 2004 issue of the Journal of International Development special issue, in an article titled “Why don’t HIV/AIDS policies work?” Studies that illuminate the environmental, behavioral, and epidemiological dynamics of HIV and AIDS have great potential to inform policy makers and planners as they formulate economic, social, legal and health-related responses to the epidemic.

A comprehensive understanding of this epidemic requires an examination of the various interacting pathways that contribute to its dynamics. These pathways involve the interrelationships among three components.  Specifically, these pathways and linked components include:

1. Demographic, social, economic, cultural, and institutional factors that affect risk and preventive behaviors, including the population age structure, economic systems, poverty, economic and educational opportunities, the Internet, health care services, gender, family systems and marriage, norms and values regarding HIV-risk behaviors (e.g., unsafe sex, injecting and non-injecting drug abuse), religious organizations and the role of religion in society, and the nature and behavior of political institutions;

2. The prevalence and patterning of individual behaviors related to HIV risk and prevention, including injection drug use, sexual practices, numbers and concurrency of partners, use of condoms and other protective methods, being tested for HIV and other sexually transmitted diseases (STDs), and seeking and initiating treatment for HIV/STDs as well as treatment for substance abuse; and

3. The incidence, prevalence, geographic patterning and spread of HIV infection in a population, and the consequent AIDS morbidity and mortality.

Although research has addressed these and other elements, a better understanding of the dynamic pathways that link them and lead to their differential outcomes and effects on the HIV epidemic is needed to guide responsive and effective public health strategies. 

The first, and most thoroughly explored, set of pathways links environmental factors to individual behaviors. For example, research has explored the effects on sexual behavior and drug abuse of poverty, job markets, family structures, peer network structures, and public policies. Other research has examined links between normative influences and sexual behavior, drug abuse, or other HIV-relevant behaviors.  Examples include research on the effects of gender norms on decisions around sexual behavior (a path that has been studied most often with respect to women’s behavior), and the effects of stigma and norms concerning breastfeeding on HIV+ women’s decisions to wean a newborn or to bottle feed the child. Much work remains to be done regarding these pathways and translation of insights from this research into interventions has lagged behind the basic research. 

A second critical area is research on how individual behavior patterns within a population affect (in combination with current HIV prevalence) the future nature and course of the epidemic. Modeling, based on surveillance data, has been a primary tool for assessing the size and future of the epidemic itself.  However, substantial work remains to be done in modeling how behavior and behavioral change can influence the dynamics of the epidemic.  Some work of this type is underway, demonstrating, for example, the effects of different patterns of sexual concurrency and injecting and non-injecting drug abuse on the spread of the disease under different background levels of disease prevalence.  Tying such studies to population data on behavior and behavior change can greatly enhance their potential to address the epidemic in specific populations.  Research of this type also informs intervention strategies and predictions of intervention outcomes on the course and magnitude of the epidemic in a given location. 

The third area of research examines how the course of an epidemic within a population feeds back to influence demographic, social/structural, economic and cultural conditions (and through these, individual behaviors).  For example, increases in HIV prevalence may influence norms regarding polygamy, large families, and the use of birth control and condoms, as well as policies on community outreach, syringe access and exchange programs, as well as treatment interventions. AIDS-related mortality may erode kinship structures and erode family stability, which may lead to unsafe behaviors in survivors. Deaths of young parents may leave the already economically vulnerable elderly population caring for numbers of grandchildren. The gaps that AIDS-related mortality creates in the economically active population, for example, among teachers and medical workers, weaken systems - such as education or health care - that should act as resources to stem the epidemic. 

Each of the three areas of research described above explores pathways linking two sets of factors:  environments and behavior; behavior and epidemic dynamics; and epidemic dynamics and environments.  HIV, like all organisms, exists in highly complex, interacting systems and pathways affecting its spread may be considerably more complex than suggested above.  One aspect of the social environment may moderate the effects of other aspects on behavior; feedbacks may operate between behavior and social norms and institutions, and some of these effects may operate differently depending on the stage of the epidemic.  Some cultural, economic, or social structural effects may be mediated or moderated through changes in the age structure, migration patterns, or the geographical distribution of the disease within a population.  The effects of behavior on the spread of disease may depend strongly on institutional and economic characteristics of the social environment, for example, the availability of anti-retroviral therapies, family planning, condoms, drug treatment programs, and syringe access and exchange programs. 

These complexities pose substantial challenges for science, but understanding them, and their interactions, can improve the capacity to design effective intervention and prevention strategies. Despite the progress over the last two decades to address this epidemic, much work remains to be done. Factors slowing this process have included, among others, data and methodological challenges, and the enormous complexity and interdisciplinary and technical requirements of the work.

Research Scope

This announcement invites research on the interrelationships among and pathways linking social, economic, cultural, and institutional environments; prevalence and patterning of individual behaviors related to HIV risk and prevention; and the prevalence, patterning, and spread of HIV infection in a population.  This announcement seeks to stimulate innovative approaches to understanding the complex mechanisms involved in the spread of HIV and its consequences in a variety of populations across the globe. This includes the search for, production of and testing of improved models to account for changes in both behavior and biology under different levels of disease prevalence.

Applications in response to this announcement should be grounded in a theoretical model that illuminates the pathways, interactions and mechanisms under study.  Applicants may wish to consider a range of potential approaches, including observational studies, experimental designs, and simulation modeling. 

Innovative use of extant data is highly encouraged. This includes, but is not limited to, local and national censuses, surveys, and administrative records.  New data collection is also encouraged when extant data are not adequate to meet the aims of the proposed study.  Studies are sought from all parts of the globe where the HIV epidemic is having an increasing or substantial impact. International and cross-disciplinary work is encouraged

For simplicity, examples of research topics responsive to this announcement are grouped below into three sections, corresponding to the three types of pathways described under Background. The examples illustrate possible points of entry into relevant research, although many other entry points are conceivable.

Examples of research on the relationships between demographic, social, economic, cultural, and institutional environments and the prevalence and patterning of individual behaviors related to HIV risk and prevention include:

Examples of research on relationships between the prevalence and patterning of individual behaviors related to HIV risk and prevention and the prevalence, patterning, and spread of HIV infection in a population include:

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 Research Project Grant (R01) award mechanism.  As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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 or matching is not required.

The most current Grants Policy Statement can be found at:

3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided they are scientifically distinct.

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.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date: not applicable
AIDS Application Submission Date(s):  September 1, 2006, 2007 and 2008
Peer Review Date:
Council Review Date: January 2007, 2008, 2009
Earliest Anticipated Start Date: March 2007, 2008, 2009
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five 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

3.C. Application Processing
Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at

Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources
Not applicable

Section V. Application Review Information

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

2. Review and Selection Process

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

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by the Center for Scientific Review (CSR) in accordance with the review criteria stated below.

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

 The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, 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?

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?

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)?

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?

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).

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.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy.

3. Anticipated Announcement and Award Dates
Not Applicable

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 NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (

3. Reporting

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.

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:

Susan Newcomer, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07G, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or non-USPS)
Telephone: (301) 435-6981

Yonette Thomas, Ph.D.
Chief, Epidemiology Research Branch
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5146, MSC 9589
Bethesda, MD 20892-9589
(Rockville, MD 20852 for courier or non-USPS)
Telephone: (301) 402-1910

Angie Chon-Lee
National Institute on Aging/BSR
7201 Wisconsin Avenue, Room 533, MSC 2292
Bethesda MD 20892-2292
(Bethesda, MD 20814 for courier or non-USPS)
Telephone: (301)-496-3131

Andrew D. Forsyth, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6201, MSC 9619
Bethesda, MD 20892-9619
(Rockville, MD 20852 for courier or non-USPS)
Telephone: (301) 443-8403
FAX:  (301) 443-9719

2. Peer Review Contact:

Robert Weller, Ph.D.
NIH Center for Scientific Review
6701 Rockledge Boulevard, Room 3160, MSC 7770
Bethesda MD 20892-7770
(Bethesda, MD 20817 for courier or non-USPS)
Telephone: (301) 435-0694

3. Financial or Grants Management Contacts:

Christy Leake
Grants Management Specialist
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17O, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or non-USPS)
Telephone: (301) 496-1305
FAX: (301) 451-5510

Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse
6101 Executive Boulevard, Room 270, MSC 3119
Bethesda, MD 20892-3119
(Rockville, MD 20852 for courier or non-USPS) 
Telephone: (301) 443-6710
FAX: (301) 594-6849

Janis Peterson
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892-9205
(Bethesda, MD 20814 for courier or non-USPS)
Telephone: (301) 496-1472
FAX: (301) 402-3672

Rita V. Sisco
Supervisory Grants Management Specialist
National Institute of Mental Health
6001 Executive Boulevard, Room 6120, MSC 9537
Bethesda, MD 20892-9537
(Rockville, MD 20852 for courier or non-USPS)
Telephone:  (301) 443-2805
FAX: (301) 443-6885

Section VIII. Other Information

Required Federal Citations

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 (

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,

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 (

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 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 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 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 (; 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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( 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 ( 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 and view the Policy or other Resources and Tools including the Authors' Manual (

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 ( 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

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:

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