Part I Overview Information


Department of Health and Human Services

Participating Organizations

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

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD), (http://wwww.nichd.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)

Title: Global Partnerships for Social Science AIDS Research (R24)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-HD-06-007

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.866, 93.242

Key Dates
Release Date: April 13, 2006
Letters of Intent Receipt Date(s): November 13, 2006
Application Submission Date(s):  December 13, 2006   
Peer Review Date(s): March/April 2007
Council Review Date(s):  May 2007
Earliest Anticipated Start Date(s): July 2007
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: December 14, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. 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


Background

HIV/AIDS affects entire populations, societies, and countries with enormous and tragic consequences at the national, community, family, and individual level.  According to the December 2005 UNAIDS report, http://www.unaids.org/epi/2005/doc/report_pdf.asp, at the end of 2005, more than 40 million adults and children were living with HIV/AIDS, most of them in places where access to prevention, treatment, and care is severely limited.  Approximately 2.3 million were children under the age of 15 years. 

An estimated 5 million people (adults and children) acquired HIV in 2005.  Over 90 percent of these infections occurred in Sub-Saharan Africa or South, South-East, and East Asia.  The global AIDS epidemic killed more than 3.1 million people in 2004, including almost 600,000 children younger than 15.  Between 2003 and 2005, the number of people living with HIV/AIDS has increased in every region except in the Caribbean. According to the US Census Bureau’s report “The AIDS Pandemic in the 21st Century” (http://www.census.gov/prod/2004pubs/wp02-2.pdf), the impact of HIV/AIDS is already being felt in some countries in terms of downward trends in life expectancy and population growth, distortions in age structures, and breakdowns in support systems.

Sub-Saharan Africa remains the most affected region in the world with an estimated 25.8 million people living with HIV/AIDS and approximately 3.2 million adults and children newly infected in 2005.  In this part of the world, where the mode of transmission is overwhelmingly heterosexual, 57 percent of adults (15-49) living with HIV are women, with many of them at risk of transmitting the virus to their infants.  The cumulative impact of HIV/AIDS-related illness and death has radically diminished the expected life spans of the African population and continues to create unprecedented challenges in coping with the effects of the epidemic for the survivors and their communities and countries.

As the epidemic spreads globally, dramatic increases in HIV infection are now occurring in Eastern Europe, Asia, and Latin America.  Even though the HIV infection levels in Asia are low compared with Africa and some other continents, the populations of many Asian nations are so large that even low national HIV prevalence means that large numbers of people are now living with HIV.  In 2005, 8.3 million people in Asia, including 2 million women, were living with HIV. In India, where an estimated 5.1 million Indians were living with HIV in 2003, the overall HIV prevalence continues to rise. Even minor increases in HIV transmission could result in huge numbers of people being infected in certain densely populated areas.   Several of the epidemics in Asia and Oceania are increasing, especially in China, Papua New Guinea, and Vietnam.  Pakistan and Indonesia are also on the verge of a serious epidemic.   

The epidemics in Eastern Europe and Central Asia continue to grow, with an estimated 1.6 million people living with HIV in this region in 2005.  Three-fourths of these individuals are less than 30 years old.   Most of the people living with HIV in this region come from the Russian Federation and Ukraine.  As in Asia, these epidemics are fueled by a combination of injecting drug use and commercial sex. If uninterrupted, the epidemics will spread to the partners and children of drug users as well.

The number of people living with HIV in Latin America is currently estimated at 1.8 million. The biggest epidemics in the region are in Argentina, Brazil and Argentina.  The highest HIV prevalence is found in the smaller countries of Belize, Guatemala and Honduras.   In the Caribbean, an extremely poor region of high unemployment and gender inequalities, a total of 300,000 people (50 percent of whom are women and girls, 15-49) are living with HIV. 

The epidemic is driven primarily by behaviors: unprotected heterosexual intercourse is the predominant mode of transmission in most countries, which is linked to the transmission of the virus from infected mother to child. Intravenous drug use is important in China and Eastern Europe, Russia and Eurasia.  Prevention efforts are of critical importance for slowing the epidemic yet in many places have been unsuccessful in curbing its spread.  Prevention efforts face significant challenges in all countries.  In many countries, implementation of effective prevention strategies by individuals, institutions, and governments remains low. Unsafe sexual practices, gender-based violence, and injecting drug use continue to place many individuals at risk for HIV acquisition. In some places, desires for children conflict with strategies to protect individuals from sexually transmitted diseases, including HIV.  Family systems, social norms, and lack of autonomy often reduce a woman’s ability to introduce protective measures or to refuse sex with a possibly infected partner. Children are orphaned and left with no sources of economic, social or psychological support. In many countries, women and girls engage in high-risk sexual activities for economic reasons. For older persons the impact of HIV/AIDS is often seen in the social, psychological, financial, and health consequences of being a parent or relative of a younger person who dies of AIDS. This includes but is not limited to social and economic caregiving responsibilities; fostering grandchildren; experiencing the loss of the child; and handling the negative reactions of others in the community toward them. School and community-based sex education and HIV prevention programs are often inadequate and sometimes are developed without strong scientific underpinnings.

Research to inform and guide the development of realistic and sustainable local solutions to HIV challenges is needed. Behavioral and social sciences research is essential to developing an understanding of the behavior patterns underlying the epidemic and to designing, implementing, and evaluating prevention efforts based on that understanding. These sciences also contribute to knowledge of the local social, cultural, and behavioral milieus within which an HIV epidemic is occurring - knowledge essential to the design and implementation of effective prevention, care and treatment strategies.  Furthermore, research infrastructure development and capacity-strengthening activities in the behavioral and social sciences are needed to support such research efforts. Finally, research is needed on the ways in which HIV/AIDS affects society and the economy through its microeconomic impacts and on how the social and economic impact, combined with the increase in mortality rates, affects the welfare of individuals and households. 

In 2002 NIH issued RFA HD-02-003, designed to increase the capacity and capability of the African scientific community to conduct rigorous HIV/AIDS-related behavioral and social science research.  Ten grants were funded, supporting research and institution-building in eight sub-Saharan countries. This re-issuance expands the geographic scope of the RFA to all countries of the world where HIV is a large or growing problem. Although the epidemic continues to intensify in Africa, other areas of the world also need improved research capacity in the social and behavioral aspects of HIV risk.  For example, as the epidemic spreads in India and China as well as in Russia and countries in Eastern Europe and Southwest Asia, the social science research infrastructures in these countries are struggling to produce data to inform prevention efforts. 

Research Objectives

This RFA calls for the formation of partnerships between U.S. (or other developed country)  and non-U.S. scientists that will support the strengthening of the behavioral and social science research capability and capacity of investigator(s), research team(s), and/or institution(s) in developing countries affected by the HIV epidemic.  Applications will be accepted for work in any resource-poor country that reports HIV prevalence higher than 1 percent of the adult population (aged 15-49) or can demonstrate that HIV prevalence over the past 5 years in specific populations has increased in the past five years.

Applicants should propose projects designed to:  (1) study social and behavioral science questions related to HIV/AIDS prevention, care, and treatment in their local environments; (2)  develop research infrastructure and strengthen the capacity of institutions and investigators to conduct such HIV/AIDS social and behavioral science research; and (3) establish and/or enhance linkages among local in-country investigators, public health officials, community institutions, and health care providers, including traditional health practitioners.  It is anticipated that the research projects undertaken will contribute to the field as well as enhance the ability of these investigators to compete successfully for HIV/AIDS-related funding under other research grant mechanisms.

Investigators undertaking research in response to this RFA should be mindful of the efforts in their country to develop and implement strategic plans on the national and community levels to address the local HIV/AIDS-related challenges and problems.  Research efforts should support the achievement of objectives included in these plans, to the greatest degree possible.  It is understood that research priorities and goals will differ depending on the country, region, and population groups that are the focus of the research proposed.

Research Infrastructure Development and Capacity-Strengthening

Applications are to request funds to strengthen the research infrastructure of institutions to enhance the capability of local investigators to undertake rigorous behavioral and social science research in relation to HIV/AIDS prevention, care, and treatment problems and issues in local populations.  These funds are to provide capacity-strengthening support that will enhance the competitiveness of institutions, organizations, and scientists in future efforts to obtain research support.  As a result of this program, it is anticipated that the investigators involved in these grants will emerge as recognized leaders in the fields of behavioral and social sciences research related to HIV/AIDS.  All infrastructure development and capacity-strengthening requests must relate to the general goals of the research program.

For the purposes of this RFA, infrastructure development and capacity-strengthening refer to the enhancement of resources (including field support, training, administration, ethical review and oversight, data storage and management, instrument design and data collection, data management and analysis, information exchange and the dissemination of findings) that are needed by investigators to pursue research independently and to compete successfully for research funding.  The behavioral and social sciences include, but are not limited to, anthropology, demography, economics, psychology, sociology and  social work.

Research Projects

Each of these grants must, most importantly, support a small portfolio of relevant and innovative research. The application should propose one to three social or behavioral science projects that will contribute to the knowledge base required to address the HIV/AIDS epidemic in that nation and that address topics considered to be of urgent scientific and public health importance by the domestic scientific and health care communities. Research projects may address basic scientific questions or the application of basic knowledge to intervention. All must address one or more aspects of behavioral, cultural, social, economic, biosocial and/or psychosocial factors in HIV/AIDS prevention, care and/or treatment. Applicants may concentrate their research studies on any combination of topics within this broad area; illustrative examples are provided below. 

The research projects described in the application should be designed to take advantage of the support that the proposed infrastructure development and capacity-building activities will provide. The research program will be integrated with carefully planned and measurable activities that will strengthen research capacity.  For example, infrastructure activities could provide training and other support for the investigative teams. Projects must be conducted with the leadership and involvement of local social and behavioral scientists in partnership with scientists in the U.S. and/or other developed countries. It is envisioned that the research projects funded under this RFA may have the potential to be developed into larger-scale research proposals that might lead to funding under other grant programs through the NIH or other funding sources. 

Illustrative examples of research topics include but are not limited to:

1.  Research that informs interventions through studies of individual, cultural, social, economic, and institutional influences on HIV-related risk behavior, and/or the preliminary development and testing of innovative intervention approaches at the individual, group, and community levels.

2.  Research on the effects of gender on HIV prevention, treatment, and care.  Gender is defined as cultural understandings of appropriate male and female roles and behavior and their embodiment in norms, institutions, and other sociocultural structures.

3.  Studies of the role and impact of religious organizations, traditional health practitioners, and traditional health practices on AIDS prevention, care, stigma, and treatment.

4.  Examination of the Interrelationships between HIV/AIDS prevention, treatment, and care and other aspects of reproductive health and family planning, including other sexually transmitted diseases, desire for children, and use of contraception.

5.  Research addressing Issues of prevention, treatment and care among children infected by HIV, orphaned by AIDS, or in families affected by the epidemic.

6.  Research that informs interventions to mitigate the adverse social, psychological, financial, and health consequences of being a parent or relative, including a child, of someone who dies of AIDS.  For example, interventions to assist older persons in caregiving for adult ill children and to ensure that the health and economic needs of the caregivers are addressed.

7.  Research on the impact of the AIDS epidemic on education, social security, pension, health and welfare systems.

Special Requirements

Each application must include the following components and detailed budgets for each, as well as a timeline: 

(1) A description of one to three research projects that will be conducted [10 pages each] which must cover, in addition to the regular NIH requirements listed below, the following items:

(2) A description, including justification, of the infrastructure development and capacity-strengthening support requested and the activities proposed [25 pages]; which must 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 R24 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

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.A. Eligible Applicants

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

The participating NIH co-sponsors recognize that the applicant institutions may require different types and levels of research infrastructure development and capacity-building support depending on the particular research needs, activities, and initiatives proposed in the application. NIH provides for limited reimbursement of F&A costs to foreign institutions and international organizations to support the costs of compliance with NIH requirements including, but not limited to, protection of human subjects, animal welfare, and research misconduct. This is usually calculated at 8 percent of total direct costs, less equipment. NIH will not support the acquisition of, or provide for depreciation on, any capital expenditures, or support the normal, general operations of foreign and international organizations. Excepted from this policy is the American University of Beirut, and the World Health Organization. Also, domestic organizations that submit applications with a foreign or international consortium, may request eight percent of total direct costs, less equipment, for the consortium.  Information about the allowability of F&A costs for foreign and international organizations is available in the NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html

In general, the costs that are allowable under grants to domestic U.S. organizations are also allowable under foreign grants, except:

Alteration and Renovation (A&R): NIH will not allow its foreign research grants to pay for any building or structural alterations or renovations. This restriction also applies to the foreign components of grants made to U.S. institutions.

Customs and Import Duties: For its foreign research grants or foreign components within U.S. grants, NIH will also not pay for any customs or import-related expenses. This includes consular fees, customs surtax, value-added taxes, and other related charges.

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. Non-U.S. scientists and researchers from resource-poor countries are strongly encouraged to apply as the Principal Investigators and/or to assume other leadership roles in the proposed studies. Grants may be awarded to Principal Investigators from the United States, other developed countries, or from other countries that have been affected by the HIV epidemic.

Partnerships among institutions are a key component of each application.  Please note that applications submitted by foreign investigators and institutions without developed country partners are eligible for consideration.

2. Cost Sharing or Matching

Not Required

3. Other-Special Eligibility Criteria

Currently funded applicants from RFA HD02-003 will have an additional 3 pages to address their success during the initial funding period.  In addition, in order to encourage south-to-south collaboration, these applicants may propose to work with a second country in addition to the one in the parent grant.

The proposed Principal Investigator, who may either be at a U.S. institution or at the foreign institution, must commit to spending at least 25 percent effort annually on the award over the entire period of support, with a significant effort expended in-country engaged in project implementation and oversight of the appropriate use of resources on the project. 

Areas considered as infrastructure development and capacity-strengthening support include those listed above under purpose: recruitment, training and retention of staff, statistical and other relevant consultations, data management, and collaborations with other institutions.  In this regard, funds may be requested for the following:

Areas for which research-related support may be requested include, but are not limited to, the following:

For the purpose of this RFA, “key personnel” is defined as follows: “All personnel involved in each application, regardless of whether salary support is requested.”  Names of all personnel should be included in the application with their specific responsibilities in support of the infrastructure development, capacity-strengthening, and research effort outlined and with their percent time and effort specified.  Alphabetized biographical sketches for all personnel should follow the budget justifications.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date(s0: November 13, 2006
Application Submission Date(s): December 13, 2006
Peer Review Date(s): March/April 2007
Council Review Date(s): May/June 2007
Earliest Anticipated Start Date(s): July 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows 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:

Susan F 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/express service or non-USPS delivery).
Telephone: (301) 435-6981
FAX: (301) 435-6981
Email: newcomes@mail.nih.gov

3.B. Sending an Application to the NIH

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

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

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

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

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

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

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

Not applicable

Plan for Sharing Research Data

Although data sharing is not generally required for grants requesting less than $500,000 per year in direct costs, applicants are encouraged to consider sharing 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. 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

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

·         Receive a second level of review by an appropriate national advisory council or board

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?  Do the proposed studies take advantage of unique features of the scientific environment or employ useful collaborative arrangements?  Is there evidence of prior successful scientific collaboration involving the U.S. (or other developed country) investigators and the involved local researchers?  Is there evidence of foreign and U.S. (or other developed country) institutional support, e.g., letters of support and other documentation of commitment? 

Progress: This evaluation criteria will be used for applications from currently funded studies under the first issuance of this RFA as evidence of progress toward achieving stated research goals and objectives.


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

2.D. Sharing Research Resources

Not applicable

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

3. Reporting

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

For NICHD:

Susan F 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/express service or non-USPS delivery)

Telephone: (301) 435-6981
FAX: (301) 435-6981
Email: newcomes@mail.nih.gov

For NIA:

Georgeanne E. Patmios
Behavioral and Social Research Program
National Institute on Aging
Gateway Building 7201
Wisconsin Avenue, Suite 533
Bethesda, MD  20892
Telephone: (301) 496-3138
FAX: (301) 402-0051
Email: patmiosg@mail.nih.gov   

For NIMH:

Willo Pequegnat, Ph.D.
International Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6205, MSC 9619
Bethesda MD 20892-9619
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 443-1187
FAX: (301) 443-9791
Email: wpequegn@mail.nih.gov

2. Peer Review Contacts:

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

For NICHD:

Cecelia E. Bruce
Grants Management Specialist
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1304
Fax: (301) 496-4782
Email: brucec@mail.nih.gov

For NIA:

Linda Whipp
Grants Management Officer
National Institute on Aging
Gateway Building, Suite 2N212
Bethesda, MD 20892-2292
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: whippL@mail.nih.gov

For NIMH:

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 express/courier service; non-USPS service)
Telephone:  (301) 443-2805
FAX: (301) 443-6885
Email: rr46w@nih.gov

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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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