Expired PA-06-083: Research on Social Work Practice and Concepts in Health (R21)

Department of Health
and Human Services (HHS)

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EXPIRED

Title: Research on Social Work Practice and Concepts in Health (R21)

Announcement Type
New

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.

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:

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:

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.

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:

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/).

This PA will use the NIH Exploratory/Developmental Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see 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.

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.

1. Eligible Applicants

1.A. Eligible Institutions

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

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

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.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

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

3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the 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.

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/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.

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

2. Review and Selection Process

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

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:

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
Not Applicable

1. Award Notices

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

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.

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 announcement should be directed to:

National Institutes of Health
G. Stephane Philogene, Ph.D.
Assistant Director for Policy and Planning
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
31 Center Drive, Room B1C32
Bethesda, MD 20892-2248
Telephone: 301-402-3902
Fax: 301-480-7555
E-mail: [email protected]

Direct inquiries regarding research interests and topics of Specific Institutes and Centers to:

National Cancer Institute
Suzanne Heurtin-Roberts, Ph.D., M.S.W.
Basic and Biobehavioral Research Branch
Behavioral Research Program,
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., MSC 7326
Executive Plaza North, Room 4054
Bethesda, MD 20892-7326
Phone: 301-594-6655
Fax: 301-435-7547
Email: [email protected]

National Heart, Lung and Blood Institute
Susan Czajkowski, Ph.D.
Behavioral Medicine and Prevention Scientific Research Group
Clinical Applications and Prevention Program
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 8114
Bethesda, MD 20892
Phone: 301-435-0406
Fax: 301-480-4773
Email: [email protected]

National Institute on Aging
Sidney M. Stahl, Ph.D.
Chief, Individual Behavioral Processes Branch
Behavioral and Social Research Program
National Institute on Aging/National Institutes of Health
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Phone: 301-402-4156
Fax: 301-402-0051
Email:[email protected]

National Institute on Alcohol Abuse and Alcoholism
Peggy Murray, M.S.W.
Chief, Health Sciences Education Branch,
Office of Research Translation and Communications, NIAAA
5635 Fishers Lane, Room 3105, MSC 9304
Bethesda, MD 20892-9304
Ph: 301-443-2594
Fax: 301-480-1726
Email: [email protected]

National Institute on Child Health and Human Development
V. Jeffery Evans Ph.D., J.D.
DBSB, CPR, NICHD
Room 8B07 6100 Executive Blvd
Bethesda, MD 20892
Phone: 301-496-1176
FAX: 301-496-0962
E-Mail: [email protected]

National Institute on Drug Abuse
Jerry Flanzer, Ph.D.
Services Research Branch
Division of Epidemiology, Services and Prevention
National Institute of Drug Abuse, Room 5185
6001 Executive Blvd
Bethesda, MD 20892
Telephone: (301) 443-6504
FAX: (301) 443-6815
Email: [email protected]

National Institute of Mental Health
Ms. Denise Juliano-Bult, M.S.W.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7146, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-3364
FAX: (301-443-4045)
Email: [email protected]

National Institute of Mental Health (AIDS)
Andrew D. Forsyth, Ph.D.
Chief, Primary HIV Prevention & Behavior Change Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, RM 6201, MSC 9619
Bethesda, MD USA 20892-9619
Phone: 301/443-8403
Fax: 301/443-9719
E-mail: [email protected]
FedEx: Rockville, MD 20852

National Institute on Nursing Research
Martha L. Hare, Ph.D., R.N
National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD 20892-4870 Courier: 20817
Phone: 301-451-3874
Fax: 301-480-8260
Email: [email protected]

Office of Disease Prevention
Martina Vogel-Taylor
Senior Advisor for Disease Prevention
Office of Disease Prevention
Office of the Director
National Institutes of Health
Office of Disease Prevention, OD, NIH
Phone: 301-496-6614
Email: [email protected]

Office of Research on Women's Health
Eleanor Z. Hanna, Ph.D.
Associate Director for Special Projects and Centers
Office of Research on Women’s Health
Office of the Director
National Institutes of Health
Executive Plaza South 150A
6120 Executive Boulevard
Bethesda, Maryland 20892-7116
Phone: 301-435-1573
Fax: 301-402-0005
E-mail: [email protected]

National Cancer Institute
Crystal Wolfrey
Team Leader, DCCPS Team
Grants Administration Branch
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., Suite 243
Bethesda, MD 20892 (for regular mail)
Rockville, MD 20852 (for hand delivered mail)
Phone:(301) 496-8634
Fax: (301) 496-8601
Email: [email protected]

National Heart, Lung and Blood Institute
Tanya McCoy
Grants Management Specialist
DEA, GOB, ECAGMS
National Heart, Lung, & Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7154
Bethesda, MD 20892
Phone: 301-435-0171
Email: [email protected]

National Institute on Aging
Linda Whipp
Chief, Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Room 2N212
7201 Wisconsin Ave.
Mailstop Code: 2292
Bethesda , MD 20892
Telephone: 301-496-1472
Email: [email protected]

National Institute on Alcohol Abuse and Alcoholism
Judy Fox
Chief, Grants Management Branch, NIAAA
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Phone: 301-443-4704
Fax: 301-443-3891
E-mail: [email protected]

National Institute on Child Health and Human Development
Victoria Connors
GMB, NICHD
Room 8A17P 6100 Executive Blvd
Bethesda, MD 20892
Phone: 301-496-5482
FAX: 301-451-5510
E-Mail: [email protected]

National Institute on Drug Abuse
Gary Fleming, J.D., M.A.
Grants Management Branch
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]

National Institute of Mental Health
Rebecca Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
Email: [email protected]

National Institute on Nursing Research
Brian Albertini
Chief, Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD 20892-4870 Courier: 20817
Phone: 301-594-6869
Fax: 301-402-4502
Email: [email protected]

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).

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, 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 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.

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.

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 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.