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

Title: Drug Abuse Dissertation Research: Epidemiology, Prevention, Treatment, Services, and Women and Sex/Gender Differences

Announcement Type
This is a reissuance of PA-02-055 which was previously released February 5, 2002.

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

Program Announcement (PA) Number: PAR-05-083

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release Date: April 1, 2005
Letters of Intent Receipt Dates: 30 days before the standard receipt dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Application Receipt Dates(s): Standard receipt dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Peer Review Date(s): June-July, October-November, and February-March: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): September, February, and May: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: October, March, and June: http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date):
Expiration Date for Non-AIDS Applications: March 2, 2006
Expiration Date for AIDS and AIDS-Related Applications: May 2, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The purpose of this Program Announcement is to invite applications for support of drug abuse doctoral dissertation research in epidemiology, prevention, treatment, services, and women and sex/gender differences. This Program Announcement provides funding support of dissertation research through the NIH Dissertation Award (R36) mechanism. Grants to support dissertation research will provide no more than $50,000 in direct costs per year, and are awarded for up to two years, with the possibility of extension without additional funds for up to 12 months. Any domestic public or private university or college is eligible to apply, given that it has the staff and facilities available to provide a suitable environment for the candidate to perform high-quality research. The applicant for a dissertation research grant must be enrolled in an accredited doctoral degree program in the behavioral, biomedical, or social sciences and must propose to conduct research in one of the areas specified in this Program Announcement. (These awards do not support study leading to the M.D., D.O., or D.D.S., or similar professional degrees unless they are part of a combined degree program.) The doctoral student must be a citizen or a non-citizen national of the United States or an individual who has been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. Only one application may be submitted by a doctoral candidate in response to this announcement. Application materials are available through the NIH website (http://grants.nih.gov/grants/forms.htm), and technical assistance in preparing applications is available from the contact people listed in this announcement. Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing 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. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
   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
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  3. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

Purpose of this PA

This PA replaces in its entirety PA-02-055, Drug Abuse Treatment and Services Dissertation Research, published in the NIH Guide February 5, 2002 at: http://grants.nih.gov/grants/guide/pa-files/PA-02-055.html.

The National Institute on Drug Abuse (NIDA) announces the availability of NIH Dissertation Award grants (R36) to support drug abuse doctoral dissertation research in epidemiology, prevention, treatment, services, and women and sex/gender differences, areas in which there is a significant need for new investigators. Grant support is designed to encourage doctoral candidates from a variety of academic disciplines and programs to conduct research in these areas of interest to NIDA. It is hoped that this program will ultimately facilitate the entry of promising new investigators into the field of drug abuse research.

Special Program Considerations for Recruiting Minority Researchers

The primary objective of this PA is to prepare qualified individuals for careers that can significantly impact the Nation's drug abuse research agenda. Within the framework of this program's commitment to excellence in research and projected need for investigators in drug abuse research, special attention will be given to recruiting individuals from racial or ethnic groups underrepresented in the biomedical and behavioral sciences. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups.

Research Objectives

NIDA supports more than 85 percent of the world's research on the health aspects of drug abuse and addiction. Research supported by NIDA encompasses basic, behavioral, and applied sciences related to the underlying mechanisms and health effects of drugs of abuse. This grant initiative is to provide students with grant-in-aid to perform drug abuse dissertation research on a topic related to the study of epidemiology, prevention, treatment, services, or women and sex/gender differences, and thereby increase the pool of highly talented drug abuse scientists who conduct research in these areas.

The descriptions below are examples of the research foci of this grant program and are provided to guide potential applicants to determine whether a given scientific topic may be appropriate for this initiative. These descriptions are not intended to be comprehensive. In addition, given the complexity of drug abuse research, it is permitted to conduct the proposed dissertation research in conjunction with an ongoing research study or to use extant data. Research studies focused on HIV/AIDS and Health Disparities are encouraged. Questions on the relevance of a particular research topic to NIDA's scientific mission and other questions about this PA should be addressed to the program contact listed under INQUIRIES. Potential applicants are strongly encouraged to discuss their application with the appropriate program contact.

Epidemiology:

Studies of multiple factors that influence drug use outcomes. That is, studies that examine genetic, neurological, biomedical, familial, environmental, social, cultural, developmental, psychopathological, psychological, their interactions, and mediating characteristics.

Studies of the underlying physiological and psychosocial mechanisms associated with the transition from lower to higher levels of drug involvement and from higher levels of drug involvement to dependence and addiction.

Development and improvement of techniques for studying drug abuse, including enhancements in measurement, development of improved sampling procedures, and refinement of analytic methods.

Development of innovative approaches to identify both physical (ecological) and social environmental/contextual characteristics of local communities that influence drug use, emerging drug use patterns, and adverse drug-related outcomes.

Delineation of the underlying dynamic causal mechanisms associated with drug use patterns and adverse drug-related outcomes by integrating individual and community level factors.

Studies of emerging trends (e.g., club drugs), including studies that relate these trends to influences such as changes in social attitudes, new drugs of abuse, new patterns of social interaction, new technologies, new drug trafficking patterns, and similar macro-level changes.

Research on drug use and drug-related consequences among ethnic/racial minority groups and other underserved populations. This includes studies that uncover the basis for racial/ethnic disparities in drug use and social, behavioral, and health outcomes related to drug use.

Research to assess the impact of mental health interventions in childhood on subsequent drug abuse.

Studies to assess the nature, scope, and consequences of drug-related crime including violent and nonviolent crime.

Research to assess the impact of drug use on adverse behavioral, social, and health consequences (e.g., violence, educational attainment, HIV) as well as the role of adverse consequences on further drug involvement.

Prevention:

Studies that use findings on cognitive strategies and functioning to improve or develop targeted prevention strategies.

Examination of the interactions between emotional and cognitive responses to prevention messages to construct messages more likely to elicit appropriate responses (e.g., triggering refusal behaviors when confronted with potential drug use situations).

Studies on the efficacy of drug abuse prevention program and strategies that are largely untested but widely used such as: case management, mentoring, job training, and challenge activities.

Developing and testing the efficacy of interventions for specific contexts such as primary care settings, college and/or personnel orientation programs, faith-based settings, and community recreational settings.

Tests for the effectiveness of proven prevention interventions for individuals at-risk for the combined problems of drug abuse, anti-social behavior, high-risk sexual and other health behaviors, and co-morbid psychiatric disorders.

Analyzing longitudinal data to determine the long-term effectiveness of drug abuse prevention programs and potential crossover effects on associated health problem behaviors, including HIV/AIDS and other STIs.

Studies of the initiation, development, and continuity of community coalitions to prevent drug abuse and their impact on selection and implementation of effective drug abuse prevention strategies.

Determination of the cost and cost-effectiveness of short-term drug abuse prevention programs that have been integrated into standard health, mental health and community settings.

The development and assessment of physiological and biochemical measures that may elucidate cognitive and affective factors associated with individual responsiveness to particular prevention interventions.

The development and use of real-time data collection strategies or other methods to strengthen, validate, or corroborate self-reported behaviors.

Treatment:

Behavioral and combined behavioral and pharmacological treatment research at NIDA is guided by a stage model of therapy development. For a detailed description of this model, as well as NIDA's therapy development and testing priorities, please see the Behavioral Therapies Development Program Announcement at: http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html. Examples of behavioral treatment research appropriate for this announcement include, but are not limited to the following:

Research involving secondary analyses of existing behavioral treatment research data sets to identify predictors, moderators, or mediators of treatment outcome, or mechanisms of action of treatment.

Research on instrument development and/or psychometric analysis of tools for the clinical assessment of drug abuse and HIV risk.

Research to develop and test a therapy module to be added to an existing therapy to address targeted issues (e.g., adding an HIV risk reduction module to a family therapy for drug-abusing adolescents).

Research testing a principle of behavior change among drug-abusers in treatment (e.g., by adding more frequent or multi-method assessments to an existing study in order to track behavior change over time).

Services:

Studies to assess the impact of financing and organizational and managerial factors on access to and use, quality, efficiency, costs, and outcomes of prevention and treatment services.

Research to measure the effectiveness, cost-effectiveness, and cost-benefits of drug abuse prevention and treatment services.

Drug abuse service delivery systems and models, such as continuity of care, development of therapeutic rapport, service linkages and integration models.

Studies that advance the adoption and implementation of evidence-based drug abuse prevention and treatment interventions into service delivery systems (e.g., specialty care, primary care, criminal justice, child welfare).

Drug abuse treatment and prevention services for HIV seropositive patients and for those at risk of HIV infection and other diseases that are a consequence of drug abuse.

Studies focusing on management strategies (e.g., work team models, quality management) aimed at improving the quality, effectiveness, and efficiency of drug abuse treatment and prevention services.

Research focusing on the development or improvement of research methods---including but not limited to study design, measurement, data collection, and analytic procedures---for studying the societal impact of drug abuse and/or the delivery, quality, outcomes, and economics of drug abuse prevention or treatment services.

Women and Sex/Gender Differences:

Through this dissertation award program, NIDA seeks to foster research on females and sex/gender differences in all areas of drug abuse research. From basic cellular and genetics research to epidemiology, prevention, treatment, and services research, investigators are encouraged to explore the possible importance of sex/gender differences in their chosen area of study and to explore drug abuse issues specific to females. Examples of research areas include, but are not limited to the following:

Sex/Gender differences in the basic behavioral, biological, and genetic mechanisms underlying drug abuse and addiction; and laboratory (both human and animal), clinical, and epidemiological studies of sex/gender differences in the determinants of initiation, progression, and maintenance of drug use and addiction.

Laboratory (both human and animal), field, and clinical research aimed at: (1) identifying sex/gender differences in the consequences of drug use, abuse, and addiction following acute use, chronic use, as well as residual effects following prolonged abstinence, and (2) examining drug-related consequences that are unique to females.

The application of sex/gender-specific theories and empirical research on the origins, pathways, and risk and protective factors related to drug use, progression/transition, and maintenance, to the design, development, and testing of gender-sensitive prevention strategies and interventions to determine effectiveness and efficacy.

The development and testing of theoretically-based drug treatment approaches (including behavioral treatment and pharmacotherapies) that address sex/gender-specific issues and the examination of sex/gender-specific issues related to the effective and efficient delivery of drug abuse treatment services.

The development and evaluation of sex/gender-specific interventions directed at preventing HIV infection and treating HIV/AIDS among drug using populations.

For additional background and research areas of interest dealing with women and sex/gender differences, see http://grants.nih.gov/grants/guide/pa-files/PA-03-139.html.

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 National Institutes of Health (NIH) Dissertation Award (R36) mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PA may not exceed two years. Grants to support dissertation research will provide no more than $50,000 in direct costs per year; they are awarded for up to two years and may be extended without additional funds for up to 12 months.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

The National Institute on Drug Abuse will consider funding NIH Dissertation projects throughout the life of this Program Announcement, depending upon the scientific merit of the applications, availability of funds, and programmatic priorities.

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. However, grants to support dissertation research will provide no more than $50,000 in direct costs per year, and are awarded for up to two years, with the possibility of extension without additional funds for up to 12 months.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Allowable Costs

Expenses usually allowed under PHS research grants will be covered by the NIDA dissertation research grant, but may not exceed $50,000 per year in direct costs. An application that requests more than $50,000 per year in direct costs will be returned to the applicant. Allowable costs include the investigator's salary (not to exceed NIH's current salary for predoctoral fellows for 12 months full-time effort). In developing the modular budget, applicants may also include costs for research assistants' salaries, and direct

research project expenses, such as data processing, payments to subjects, supplies, consultants, and dissertation costs (e.g., printing and binding of the dissertation). No tuition, alteration/renovations, contracting costs, faculty salary, or space rental are allowed on dissertation research grants. Indirect costs are limited to eight percent of requested direct costs, less equipment.

Level of Effort

Any level of effort by the investigator that is less than full time (40 hours per week) must be fully justified, and the investigator's salary must be prorated accordingly.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Eligible applicant institutions are those that are domestic public or private non-profit universities, colleges, or professional schools with accredited doctoral degree granting programs. Institutions must have staff and facilities available on site to provide a suitable environment for performing high-quality research.

1.B. Eligible Individuals

The applicant for a dissertation research grant must be enrolled in an accredited doctoral degree program in the behavioral, biomedical, or social sciences and must propose to conduct research in one of the areas specified in this Program Announcement. The applicant must be a registered doctoral student in good standing. Information on the student's academic standing as well as a commitment from the school to implement the study as proposed must be included in the application. The student's advisor must submit with the grant application a letter of recommendation in support of the candidate and the proposed research dissertation.

These awards support research activities related to preparation of a dissertation and do not support study leading to the M.D., D.O., or D.D.S., or similar professional degrees unless they are part of a combined degree program (see: Individual Pre-doctoral National Research Award for M.D./Ph.D. Fellowships - PA-99-089, which may be obtained from: http://grants.nih.gov/grants/guide/pa-files/PA-99-089.html.

The doctoral student must be a citizen or a non-citizen national of the United States or an individual who has been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application.

An applicant who receives support for dissertation research under a grant from NIDA may not hold concurrently another federally sponsored fellowship or similar Federal award, such as a National Research Service Award (NRSA) that provides a stipend or otherwise duplicates provisions of this grant program. A NIDA dissertation grant recipient may, however, accept concurrent educational remuneration from the Department of Veterans Affairs (VA) and loans from Federal funds. Receipt of non-Federal funds during the grant period is also allowable if it is in accordance with the sponsoring institution's policy and does not detract from or prolong the approved doctoral training program.

2. Cost Sharing or Matching

There is no requirement for cost-sharing, matching, or participation for applications submitted in response to this announcement.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Special Requirements

A doctoral candidate may submit only one application in response to this announcement. Projects funded through the NIH Dissertation Award mechanism must support research activities related to preparation of a dissertation.

Letter of Certification

A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted prior to grant award as requested by NIDA's Grants Management Branch. The letter must: (a) fully identify the members of the dissertation committee and certify their approval of the dissertation proposal; (b) certify that all requirements for the doctoral degree, except the dissertation and, if necessary, the clinical internship, are completed or will be completed by the time the grant award starts; (c) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or without NIDA support; and (d) briefly describe the facilities and resources for the project and certify that they are adequate to conduct the proposed research.

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.

Official Transcript

A copy of an official transcript of the applicant's graduate school record should be included with the application.

Statement of Career Goals

Applicants must provide a statement of career goals, including reference to their interest in the specific areas of research designated in this program announcement and a description of their intended career trajectory. This information will be used by NIDA program staff to determine how the proposed study addresses program priorities.

Biographical Sketch of the Mentor

A biographical sketch of the mentor, normally the dissertation director, should be sent. This should be on the biographical sketch form found in the form PHS 398. The applicant should also include material on the mentor's previous, and active related research support.

Narrative of the Proposed Research Plan

The applicant must provide a narrative project description (not to exceed 10 pages in sections a-d of the Research Plan) that contains a detailed scientific and technical discussion of the following specific points:

a. A description of the research project and what it is intended to be accomplished.

b. A summary of related published research that addresses the identified problem(s).

c. The questions to be answered or the hypotheses to be tested by the project.

d. The methodological procedures to be followed and, whenever applicable, information on such matters as sampling procedures, including the size and composition of the population to be studied and the size and composition of the sample and control groups, as well as a description of the types and sources of data to be gathered, methodological problems to be encountered, specific statistical analyses to be used, and steps that will be taken to protect human subjects.

e. The management of the project including a schedule of the main steps of the proposed investigation.

3. Submission Dates and Times
Applications must be mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Dates: 30 days before the standard receipt dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Application Receipt Dates(s): Standard receipt dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details. Peer Review Date(s): June-July, October-November, and February-March: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): September, February, and May: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: October, March, and June: http://grants.nih.gov/grants/funding/submissionschedule.htm

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 NIDA 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:

Director- R36
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and 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)

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.

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 (see also Section VI.3. Reporting).

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

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.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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

Sharing Research Resources

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

The adequacy of the 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

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 NIDA on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened by NIDA 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 following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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

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

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

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

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).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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 will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

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/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Where applicable, 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

Section VI. Award Administration Information

1. Award Notices

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

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

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

If the grantee organization has the capability to receive e-mailed awards from NIH, the award will be e-mailed to the authorized business official of the grantee institution. If the organization is not e-mail enabled, one copy of the Notice of Award will be mailed to the authorized business official. The business official's office is responsible for sending a copy of the award to the Principal Investigator.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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/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:

Melissa W. Racioppo. Ph.D.
Division of Clinical Neuroscience, Development, and Behavioral Treatment
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4230, MSC 9593
Bethesda, MD 20892-9593
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2261
FAX: (301) 443-6814
Email: mraciopp@nida.nih.gov

2. Peer Review Contacts:
Not applicable

3. Financial or Grants Management Contacts:

Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gfleming@nida.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

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

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755.

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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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