Psychosocial Needs of Children Affected by AIDS in Low-Resource Countries

RFA Number: RFA-MH-05-008

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 Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute of Nursing Research (NINR), (http://ninr.nih.gov)

Announcement Type
New

Catalog of Federal Domestic Assistance Number(s)
93.242, 93.361

Key Dates

Release Date: November 29, 2004
Letters Of Intent Receipt Date(s): March 22, 2005
Application Receipt Dates(s): April 22, 2005
Peer Review Date(s): June/July 2005
Council Review Date(s) : September, 2005
Earliest Anticipated Start Date: September 30, 2005
Expiration Date: April 23, 2005

Due Dates for E.O. 12372
Not Applicable

Executive Summary

The NIMH and NINR invite research grant applications to address critical gaps in research on the mental health and psychosocial needs of children in low-resource countries facing the loss of parents or caretakers due to HIV/AIDS. For the purpose of this RFA, children affected by HIV/AIDS are those who: (a) are age 21 years or younger, (b) may be infected or uninfected, (c) have lost or will lose one or both parents (or other caregivers) to HIV-associated mortality, and (d) reside in low-resource countries facing high adult HIV prevalence or an expanding HIV epidemic. Psychosocial problems common to affected youth – which may initiate or exacerbate mental disorders, substance abuse, or HIV-risk behavior – are classified in the following ways: primary support group (e.g., death of family members), social environment (e.g., HIV-associated stigma), educational (e.g., illiteracy), occupational (e.g., child labor), housing (e.g., child-headed households), economic status (e.g., extreme poverty), access to health care, legal/criminal involvement or victimhood, and other psychosocial and environmental problems (e.g., disasters, wars, etc.). Low-resource countries are defined here as those meeting the World Bank's (2002) criterion for “developing country” status (i.e., those with estimated gross national incomes per capita (GNI) of less than US$2935). The participating ICs intend to commit approximately $1.2 million in total costs in FY05 to support 2 – 6 new competing grants submitted in response to this RFA. This RFA will use the R01 and R21 award mechanisms. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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. There is no limit to the number of applications an applicant may submit in response to this RFA. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://www.grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

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
    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
      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
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Award Criteria
    4. 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

According to “Children on the Brink 2004”, an estimated 16 million children age 18 or younger have lost one or both parents to HIV; by 2010, this number is expected to increase to over 25 million worldwide. By contrast, an estimated cumulative total of 100,000 – 225,000 U.S. children and adolescents have been maternally-orphaned as a result of HIV through 2000 (Caldwell, Fleming, & Oxtoby, 1992; Lee & Fleming, 2003; Michaels & Levine, 1992). Reflecting broader trends, the vast majority of children affected by HIV/AIDS today are concentrated in Africa: 70% of these youth live in 12 Sub-Saharan Africa, with an additional 10% in other areas on the continent (UNICEF, 2003). The number of children in Sub-Saharan Africa orphaned by HIV will increase disproportionately compared to those orphaned by other causes and will decline only years after the epidemic crests in adults, given the latency between peaks in adult AIDS prevalence and AIDS-associated orphaning (UNICEF, 2003). Similar crises are building in Asia, Eastern Europe, Latin America, and the Caribbean. In Asia, HIV sero-prevalence rates are lower than in Sub-Saharan Africa but the combination of large populations and rising incidence of HIV infections suggest that it will be affected severely as well.

Wars, famines, natural disasters, mass migration, and diseases have long threatened health and well-being in low-resource countries. Yet the impact of parental HIV-infection on children, families, and communities is unique. For children, living with infected parents is associated with elevated psychological distress and diminished emotional support prior to and following parental death. Affected children face multiple losses when parents, siblings, and caregivers become infected or families are dispersed. Relative to unaffected youth, children whose parents become infected face higher rates of psychosocial problems, including: school dropout to become wage-earners and care-providers; loss of access to economic resources and inheritance assets; diminished access to basic needs, including nutrition, shelter, health care, clothing; and increased vulnerability to exploitation, violence, abandonment, and abuse – particularly for girls in societies with inadequate social, legal, and cultural protections. In addition, affected youth from communities unwilling or unable to provide adequate psychosocial support face additional problems, including inadequate housing or homelessness, financial hardship, substance abuse, HIV risk-taking, and initiation or exacerbation of mental health and behavioral disorders.

More specifically, the mental health impact is considerable on children whose families and communities face devastation from AIDS. Research conducted in the U.S. has suggested that children of HIV-infected parents – particularly those with symptomatic illness – experience higher rates of grief, depression, dysphoria, anxiety, post-traumatic stress disorder, irritability, social withdrawal and impaired cognitive performance than others (Forehand et al., 1998; BW Forsyth et al., 1996). Parental coping with HIV infection and disease, which may include feelings of guilt, depression, anxiety, has a direct effect on child adjustment (Hough et al., 2003). Other research has shown that children's adjustment may be worsened by aspects of the social environment, including HIV-associated stigma, social ostracism, and availability of resources and support (see Klunkin & Harrigan, 2002). These adverse effects may be preventable. Intervention research conducted in the U.S. has demonstrated that improvements in mental health and behavioral outcomes may be derived from psychosocial interventions for bereavement due to AIDS (Rotheram-Borus et al., 2003), suicide (Pfeffer et al., 2002), and other causes of mortality (Sandler et al., 2003; Williams et al., 1998).

Although scarce, research in developing countries shows similar mental health and psychosocial problems in children from families and communities affected by HIV/AIDS. For example, Congolese children of infected parents show high rates of depression, anxiety, irritability, hyperactivity, and antisocial behavior (Makaya et al., 2002). A study of Tanzanian children orphaned by AIDS found higher rates of suicidal ideation and internalizing disorders among 10 – 14 year olds compared to demographically matched non-orphans (Makame et al., 2002). Other studies show that bereavement and trauma are associated with witnessing declines in parental health (Sengendo & Nambi, 1997). To date, very little research has been conducted in high prevalence, low-resource countries to develop, implement, and evaluate theoretically-based interventions to minimize adverse mental health and psychosocial outcomes in children from hard hit communities.

The need to bolster preventive interventions for communities in low-resource countries is becoming increasingly clear, as parental illness and premature death due to HIV infection worsens economic hardship and may result in loss of succession, social isolation, discrimination, and stigmatization. In addition to straining extended families' capacities to serve as safety nets for affected youth, AIDS and related stigma may exacerbate the effects of war, famine, disasters, and poverty that together may threaten mental health and functioning of future generations, weaken the social fabric that stabilizes communities, prolong cycles of poverty, and imperil long-term economic development of low-resource countries.

A number of new, groundbreaking initiatives have been funded to provide relief to low-resource countries facing expanded HIV epidemics. For example, U.S. President's Emergency Plan for AIDS Relief (PEPFAR) commits critically needed resources to 14 African & Caribbean nations in order to provide treatment, prevention, and care to persons affected by HIV – including orphans and vulnerable children. This and other aid initiatives strive to meet the psychosocial support needs of affected children but are proceeding largely without the benefit of empirically-supported models or best practice guidelines. One common intervention identified for massive scale-up in Africa is the use of memory books, which are collections of family memorabilia (e.g., photos, letters, stories) believed to strengthen families' capacities to cope with grief, plan for the future, and disclose HIV-positive serostatus. Yet, little evidence exists to show for what age groups, under what circumstances, and to what extent such interventions reduce adverse short- and long-term mental health and psychosocial problems. Unintended effects of these interventions may be more pronounced among children of different age groups or youth exposed to the graphic physical, emotional, and mental deterioration of dying parents (Saldinger et al., 2003).

Aid agencies and nongovernmental organizations are generally better equipped to meet the economic, nutritional, basic services, and HIV prevention and treatment needs of affected families than to provide more challenging, locally-appropriate, empirically-based, psychosocial intervention (Daniel, 2003; Foster, 2002; Fox, 2001). This observation highlights a unique opportunity to augment aid programs for affected youth with empirically-supported interventions that address the mental health and psychosocial needs of these children (Stein, 2003). There are insufficient rigorously designed studies to provide definitive answers to questions about the circumstances in which parental loss to AIDS predisposes children to adverse short- or long-term mental health and psychosocial problems (see Wild, 2001). Similarly, there are insufficient data to guide the provision of effective interventions to bereaved children (Curtis & Newman, 2001).

Scope

This RFA solicits applications to support the development, implementation, evaluation, and dissemination of theoretically-based, locally-appropriate, basic or intervention research to minimize the adverse mental health and psychosocial problems – including substance abuse and HIV risk behavior -- associated with loss of parents and other attachment figures (e.g., siblings, school teachers, community leaders) to AIDS. This solicitation is also intended to encourage new collaborations between U.S.- and foreign-based principal investigators that effectively augment existing HIV treatment, care, and support programs with empirically-supported, sustainable interventions.

Applicants are encouraged to consider the following examples of basic mental health and behavioral research that may be supported by this RFA. This list is not intended to be exhaustive:

The following areas of intervention research are illustrative and are not intended to be exhaustive:

Applicants are encouraged to consult program staff in advance of application submittal, (See Section VII). In addition, applicants are encouraged to be familiar with the review criteria described below. (See Section V)

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Research Project (R01) and the Exploratory/Development (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). 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

The participating ICs intend to commit approximately $1.2 million dollars in FY2005 to fund 2 - 6 new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs up to $500,000 dollars per year. The $500,000 applies to R01s only. 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 RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. The anticipated start date for new awards are September 30, 2005.

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
Cost sharing is not required.

3. Other-Special Eligibility Criteria
There are no additional eligibility criteria.

Section IV. Application Submission Instructions

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. 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 PHS 398 research grant application instructions and forms. Applications must have a Dun and Bradstreet (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. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Section VI.2 Administrative Requirements for additional information.

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.

3. Submission Dates

Applications must be mailed on or before the receipt date described at http://grants.nih.gov/grants/funding/submissionschedule.htm.

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date(s): March 22, 2005
Application Receipt Dates(s): April 22, 2005
Peer Review Date(s): June/July 2005
Council Review Date(s) : September, 2005
Earliest Anticipated Start Date: September 30, 2005

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:

Andrew D. Forsyth, Ph.D.
Division of Mental Disorders, Behavioral Research, & AIDS (DMDBA)
National Institute of Mental Health
6001 Executive Boulevard, Room 6201, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-8403
FAX: (301) 443-9719
Email: aforsyth@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

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

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6147, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@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 listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review. Applications will be evaluated for completeness by CSR. Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the participating ICs. 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 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 http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria)

6. Other Submission Requirements
None

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 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

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. http://grants.nih.gov/grants/policy/data_sharing

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

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the data sharing plan and the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section V. Application Review Information

1. Criteria

Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review.

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

The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 an RFA, it is to be prepared as a NEW application. That is, the application for the RFA 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.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the participating ICs . Incomplete applications will not be reviewed.

If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

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 NIMH in accordance with the review criteria stated below.

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

3. Merit Review Criteria

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.

1. 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?

2. 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?

3. 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?

4. 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)?

5. 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?

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will 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).

3.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.

Community input: Adequacy of plans to incorporate input from affected communities at all levels, from project conceptualization to interpretation of outcomes, as doing so may increase the likelihood that proposed studies meet local needs and benefit from guidance from community-advisory panels comprised of members of targeted communities, including affected youth.

Intervention feasibility & sustainability: Proposals should emphasize feasibility and sustainability of interventions that are developed, implemented, and tested will be considered with sponsorship from this RFA.

Integration into existing programs of community-based, aid implementing, or non-governmental organizations (NGO): Adequacy of plans to build on existing capacity through collaborations with community-based or non-governmental organizations with demonstrated expertise in the target country and population.

3.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, http://grants.nih.gov/grants/policy/data_sharing.

3.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a summary statement.

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 will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The notice of grant award will be sent via email to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398.

2. Administrative Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Award Criteria

The following will be considered in making funding decisions:

4. 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:

Andrew D. Forsyth, Ph.D.
Division of Mental Disorders, Behavioral Research, & AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6201, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-8403
FAX: (301) 443-9719
Email: aforsyth@mail.nih.gov

Martha L. Hare, Ph.D., R.N
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD  20892-4870
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 451-3874
FAX: (301) 480-8260
Email: martha.hare@nih.gov

2. Peer Review Contacts:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6147, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@mail.nih.gov

3. Financial or Grants Management Contacts:

Stephen L. Daniels
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6132, MSC 9605
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-0322
FAX: (301) 443-6885
Email: danielss@mail.nih.gov

Teresa Farris Marquette
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 594-2177
FAX: (301) 402-4502
Email: tm275a@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, June 12, 1998: 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, 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.

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://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). 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 that is available at 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 (see 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.

Public 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 public 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 PA 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.

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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