Research on Social Work Practice and Concepts in Health (R03 Small Grant Mechanism)

Research on Social Work Practice and Concepts in Health (R03 Small Grant Mechanism) is sponsored by National Institutes of Health (NIH). This R03 small grant mechanism is designed for discrete, clearly defined projects that can be completed within a 1- to 2-year period with limited funding.

Expired PA-06-082: Research on Social Work Practice and Concepts in Health (R03) This notice has expired. Check the NIH Guide for active opportunities and notices. 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 Cancer Institute (NCI), ( http://www. nci.

nih. gov ) National Heart, Lung, Blood Institute (NHLBI), ( http://www. nhlbi.

nih. gov ) National Institute on Aging (NIA), ( http://www. nia.

nih. gov ) National Institute on Alcohol Abuse and Alcoholism (NIAAA), ( http://www. niaaa.

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

nih. gov ) National Institute on Drug Abuse (NIDA), ( http://www. nida.

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

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

nih. gov ) Office of Behavioral and Social Sciences Research (OBSSR), ( http://obssr. od.

nih. gov ) Office of Disease Prevention (ODP), ( http://odp. od.

nih. gov/ ) Office of Research on Women’s Health (ORWH), ( http://www4. od.

nih. gov/orwh/ ) Title: Research on Social Work Practice and Concepts in Health (R03) Update: The following update relating to this announcement has been issued: March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants. gov using the electronic SF424 (R&R) application.

This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date. The non-AIDS portion of this funding opportunity expires on the date indicated below. A replacement R03 ( PA-06-233 ) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates thereafter.

Looking Ahead: As part of the Department of Health and Human Services implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants. gov and the use of the SF 424 Research and Related (R&R) forms.

Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants. gov.. For more information and an initial timeline, see http://era.

nih. gov/ElectronicReceipt/ . NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts ( http://grants.

nih. gov/grants/guide/index. html ).

Specific funding opportunity announcements will also clearly indicate if Grants. gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site ( http://grants.

nih. gov/grants/forms. htm ) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PA-06-082 Catalog of Federal Domestic Assistance Number(s) 93. 279, 93. 242, 93.

273, 93. 399, 93. 866, 93.

361, 93. 865, 93. 856, 93.

937 Release Date: December 1, 2005 Letter of Intent Receipt Date: Not Applicable Application Submission Date(s): http://grants. nih. gov/grants/funding/submissionschedule.

htm AIDS Application Receipt Dates(s): See http://grants. nih. gov/grants/funding/submissionschedule.

htm#AIDS Peer Review Date: http://grants. nih. gov/grants/funding/submissionschedule.

htm Council Review Date: http://grants. nih. gov/grants/funding/submissionschedule.

htm Earliest Anticipated Start Date: http://grants. nih. gov/grants/funding/submissionschedule.

htm Expiration Date for Non-AIDS Applications : March 2, 2006 Expiration Date for AIDS and AIDS-Related Applications : May 2, 2006 Additional Overview Content The ultimate goal of this program announcement is to encourage the development of empirical research on social work practice, concepts and theory as these relate to the NIH public health goal of improving health outcomes for persons with medical and behavioral disorders and conditions.

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. The total amount awarded and the number of awards will depend upon the number, scientific merit, overall quality, duration, and costs of the applications received, as well as on the funds available at the participating NIH Institutes/Centers.

This PA will use the NIH Small Grant (R03) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

Eligible organizations include for-profit and not-for-profit, public or private organizations, units of state and local governments, eligible agencies of the Federal Government, domestic or foreign institutions/organizations, faith-based or community-based organizations, units of State Tribal government , and units of Local Tribal government.

Eligible principal investigators are any individuals with the skills, knowledge, and resources necessary to carry out the proposed research. Applicants may submit more than one application, provided they are scientifically distinct. 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) 710-0267, E-mail: [email protected] . Telecommunications for the hearing impaired is available at: TTY 301-451-5936 Part I Overview Information Part II Full Text of Announcement Section I. Funding Opportunity Description Section II.

Award Information 1. Mechanism(s) of Support Section III. Eligibility Information 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 and Review and Anticipated Start Dates B. Sending an Application to the NIH C. Application Processing 4.

Intergovernmental Review 6. Other Submission Requirements Section V. Application Review Information 2.

Review and Selection Process A. Additional Review Criteria B. Additional Review Considerations D.

Sharing Research Resources 3. Anticipated Announcement and Award Dates Section VI. Award Administration Information 2.

Administrative and National Policy Requirements 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 The Office of Behavioral and Social Sciences Research (OBSSR), via this program announcement (PA) encourages innovative, theory-driven empirical research on social work practice, concepts and theory as these relate to the NIH public health goal of improving health outcomes for persons with medical and behavioral disorders and conditions.

Areas of interest include studies that characterize the usual and/or best practices of social workers and how these relate to health outcomes, studies establishing the efficacy and effectiveness of health-related interventions and services delivered by social workers, aspects of health-related social work services that are unique to specialty health care settings (e.g., clinics, hospitals, nursing homes, hospices, etc) and non-specialty health care settings (e.g., social service agencies, schools, jails and prisons, etc.), the nature and impact of routine prevention or clinical practice, and factors related to successful dissemination and implementation of social work services and interventions with proven effectiveness.

The award mechanism is designed to provide flexibility to meet unique needs of both applicant institutions and supporting NIH institutes. This PA is consistent with the recent NIH plan for social work research ( http://obssr. od.

nih. gov/Documents/Publications/SWR_Report. pdf ), building upon efforts of NIMH, NIDA, NIAAA, NCI, and NIA), following recommendations of the Institute of Medicine/National Academy of Sciences found in their reports - Bridging the Gap Between Practice and Research: Forging Partnerships with Community-Based Drug and Alcohol Treatment, and Health Services (1998).

The goals of this program are three-fold: (1) to encourage submissions of research studies relevant to both social work practice and to the missions of individual NIH institutes, (2) to develop an empirical knowledge base on an important but often neglected component of the real world health care system, and (3) to increase the participation of social work researchers in interdisciplinary public health research.

These goals are viewed as critical to improving the quality and outcomes of health care in this country.

As one of the largest allied health professions in the U.S., social work is a primary provider of psychosocial interventions and services intended to facilitate treatment of medical conditions, improve disease management and prevention, and address related social, psychological or emotional problems in order to improve health and functioning.

The underlying theoretical perspective of social work is the biopsychosocial model, derived from systems theory, which posits that physical, psychological, and social environmental conditions influence one another and must be taken into account in order to optimize health outcomes and functioning. In fact, studies (1, 2) have suggested that medical interventions may be enhanced with behavioral and social intervention.

In delivering such interventions, social work practice often involves intervening in the context of complex interactions that may include not only patients and their families, but other service and treatment providers, service organizations and systems, and communities and community organizations.

The profession has, therefore, developed significant clinical expertise in working within and across systems of care and services on a variety of levels, in the context of interdisciplinary teams, and in direct practice with diverse and/or multi-problem populations.

An empirical approach to understanding the mechanisms of action in social work practice, to improving the efficacy and effectiveness of social work interventions, and to disseminating and implementing exemplary practice approaches and methods can add a significant but understudied component to the portfolios of various NIH institutes and make a unique and important contribution to improving public health. 1) McLellan, A. , Arndt, I.

, Metzger, D. , Woody, G. and O'Brien, C.

(1993). The effects of psychosocial services in substance abuse treatment. Journal of the American Medical Association 269 (15), 1953-9.

2) O'Malley, S. S. , Jaffe, A.

J. , Chang, G. , Rode, S.

Schottenfeld, R. , Meyer, R. E.

and Rounsaville, B. (1996). Six-month follow-up of naltrexone and psychotherapy for alcohol dependence.

Archives of General Psychiatry 53:217-224 Applications should be relevant to the objectives of the PA and to the research interests of at least one of the participating institutes. Prior to preparing an application, researchers are strongly encouraged to both review the research interests of the participating institutes, and to contact relevant program staff to discuss the intended study.

This Program Announcement invites applications to develop research in key areas in which social work practice can serve as a platform for advancing knowledge.

Such areas include, but are not limited to: Studies that establish the impact of social work services and interventions on health outcomes, diseases, health behaviors and treatments, including strategies that: optimize outreach, engagement and referral of patients to services and treatment in order to facilitate access to and utilization of health care and adjunct services; enhance informed decision-making by patients, families and other involved professionals; contribute to adherence to therapeutic or preventative regimens (including prevention of co-morbid illness or decline in functioning); Improve palliative care for patients with advanced illness and their families; enable community living and optimize community integration and social support; foster health promotion and other consumer health-related actions; enable and sustain collaboration, coordination, and/or integration across healthcare and other relevant service systems to optimize health outcomes in specific disease or condition categories; and develop effective methods and new technologies in social work practice research.

Studies to assess or adapt existing or develop new interventions to be delivered by social workers.

For the purpose of this PA, "intervention" includes psychosocial or combination approaches to: screen, assess, and intervene early to prevent health problems and disorders; treat or support the treatment of disorder, (including continuation and maintenance); improve the access, quality and outcomes of treatment, rehabilitation or palliative services and care; facilitate maintenance of health behavior change over time and context, prevent relapse, side effects, or co-morbid symptoms and disorders; reduce residual symptoms, enhance symptom management and individual functioning (rehabilitation); target provider behavior change; or improve care quality, coordination or delivery through changes at the supervisory, systems or organizational level.

Studies of effective strategies to improve health outcomes via social work interventions delivered in nontraditional health care delivery settings (e.g., school, employment- or faith-based settings, welfare or social services agencies, jails or prisons).

Such strategies might also include coordination or integration of services across settings such as specialty health, general health, educational, vocational and housing services to maximize receipt of needed services and improve health outcomes.

Research that examines those features of routine social work prevention practice (e.g., intake, assessment, and referral for treatment or services) that: improve identification of service, functional and rehabilitative needs; enable accurate detection of changing needs across life circumstances and life-span; result in more effective patient-service matching strategies.

Studies of social work’s role in effective program implementation strategies whereby efficacious health interventions are introduced, integrated into and sustained in community settings, including studies of: specific implementation strategies (e.g., training, program fidelity, care setting capacity building) barriers and facilitators to program implementation (e.g., accessibility, provider attitudes, or organizational culture).

aspects of program delivery that improve outcomes, and enhance the likelihood of program adoption. The intended result of the support provided by this PA is the integration of social work research programs and concepts into the mainstream of sound science, including prevention science and into standard public health practice.

Applicants are required to develop collaborative relationships across disciplines and with public sector agencies involved in the exploration of solutions to healing associated with specific diseases of the NIH interests. Innovative projects which cross traditional institute lines are encouraged following the recommendations for science innovation in the NIH Roadmap Initiative ( http://nihroadmap. nih.

gov/researchteams/ ). See Section VIII, Other Information - Required Federal Citations , for policies related to this announcement. Section II.

Award Information 1. Mechanism(s) of Support This PA will use the NIH Small Grant (R03) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The Small Grant (R03) provides 2 years of funding with a maximum of $50,000 direct costs for each year (see http://grants. nih. gov/grants/guide/pa-files/PA-03-108.

html ). 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. Applications received in response to this program announcement will compete for funds in the general funding pool of the participating NIH ICs.

No specific funds have been set aside for this announcement. The number and size of the awards will depend on the number of applications received, their relative scientific merit, and the general availability of funds for investigator-initiated research at the participating ICs.

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 Institutions You may submit (an) application(s) if your organization has any of the following characteristics: Public or private institutions, such as universities, colleges, hospitals, and laboratories Units of State government Units of local government Eligible agencies of the Federal government Faith-based or community-based organizations Units of State Tribal government Units of Local Tribal government Applications from foreign institutions must conform to the NIH’s policy for foreign grants.

See http://grants. nih. gov/grants/policy/nihgps/part_iii_5.

htm . 1. B.

Eligible Individuals Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. 2.

Cost Sharing or Matching The most current Grants Policy Statement can be found at: http://grants. nih. gov/grants/policy/nihgps_2003/nihgps_Part2.

htm#matching_or_cost_sharing . 3. Other-Special Eligibility Criteria 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) 710-0267, Email: [email protected] . 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. Several special provisions apply to applications submitted by foreign organizations: Charge back of customs and import fees is not allowed. Format: every effort should be made to comply with the format specifications, which are based upon a standard US paper size of 8.

5" x 11." Funds for up to 8% administrative costs (excluding equipment) can now be requested ( http://grants. nih.

gov/grants/guide/notice-files/NOT-OD-01-028. html ) Organizations must comply with federal/NIH policies on human subjects, animals, and biohazards. Organizations must comply with federal/NIH biosafety and biosecurity regulations.

See Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

Proposed research should provide a unique research opportunity not available in the U.S. 3. Submission Dates and Times See Section IV. 3.

A for details. 3. A.

Submission, Review and Anticipated Start Dates Letter of Intent Receipt Date: Not Applicable Application Submission Date(s): http://grants. nih. gov/grants/funding/submissionschedule.

htm AIDS Application Receipt Dates(s): See http://grants. nih. gov/grants/funding/submissionschedule.

htm#AIDS Peer Review Date: http://grants. nih. gov/grants/funding/submissionschedule.

htm Council Review Date: http://grants. nih. gov/grants/funding/submissionschedule.

htm Earliest Anticipated Start Date: http://grants. nih. gov/grants/funding/submissionschedule.

htm A letter of intent is not required for the funding opportunity. 3. B.

Sending an Application to the NIH Applications must be prepared using the PHS 398 research grant application instructions and forms as described above.

Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail) Bethesda, MD 20817 (for express/courier service; non-USPS service) Personal deliveries of applications are no longer permitted (see http://grants.

nih. gov/grants/guide/notice-files/NOT-OD-03-040. html ).

3. C. Application Processing Applications must be submitted on or before the application receipt dates described above ( Section IV.

3. A. ) and at http://grants.

nih. gov/grants/dates. htm .

Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed. The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application.

The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks. 4. Intergovernmental Review This initiative is not subject to intergovernmental review .

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/grants/policy/nihgps_2003/NIHGPS_Part6. htm . 6.

Other Submission Requirements Specific Instructions for Modular Grant applications. Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail.

Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants. nih.

gov/grants/funding/phs398/phs398. html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398.

Additional information on modular budgets is available at 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. 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/grants/policy/nihgps_2003/index. htm and http://grants. nih.

gov/grants/policy/nihgps_2003/NIHGPS_Part7. 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 resources sharing plan and any related data sharing plans 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, http://grants. nih.

gov/grants/funding/2590/2590. htm ). See Section VI.

3. Reporting . Section V.

Application Review Information Only the review criteria described below will be considered in the review process. 2. Review and Selection Process Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures ( http://www. csr. nih.

gov/refrev. htm ) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.

Receive a written critique Receive a second level of review by the appropriate national advisory council or board. The following will be considered in making funding decisions: Scientific merit of the proposed project as determined by peer review Relevance of program priorities The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health.

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Significance .

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

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

Innovation . Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?

Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Investigators . Are the investigators appropriately trained and well suited to carry out this work?

Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Environment .

Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2. A.

Additional Review Criteria: In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score: Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398). 2.

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

2. C. Sharing Research Data Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers.

However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.

nih. gov/grants/policy/data_sharing . 2.

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 (See the NIH Grants Policy Statement http://grants. nih.

gov/grants/policy/nihgps/part_ii_5. htm#availofrr 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 awardee 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. Reporting .

3. Anticipated Announcement and Award Dates Section VI. Award Administration Information 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/grants/policy/nihgps_2003/NIHGPS_part4.

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. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk.

These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV. 5.

Funding Restrictions . 2. Administrative and National Policy Requirements All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of 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/grants/policy/nihgps_2003/NIHGPS_Part4.

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/grants/policy/nihgps_2003/NIHGPS_part9.

htm ). 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: General Inquiries regarding the scope and content of this program