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Part I Overview Information

Department of Health and Human Services

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

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: NIDA Research Education Grants in Drug Abuse and Addiction (R25)

Announcement Type

This is a modification of PAR-04-054 which was previously released February 2, 2004.

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-06-550

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release/Posted Date: September 18, 2006
Opening Date: September 18, 2006
Letters of Intent Receipt Date(s): 30 days prior to the application submission date
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: January 31, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The National Institute on Drug Abuse (NIDA) Research Education grant is a flexible and specialized mechanism designed to foster the development of drug addiction researchers through creative and innovative educational programs. Programs that focus on preparing researchers in cross-disciplinary integration and/or translational research of neuroscience, basic behavioral, prevention, clinical, treatment, and services research are particularly encouraged. Of particular interest are educational experiences that will attract, train, and further the career development of physician scientists and other clinical professionals, underrepresented minority scientists, and adolescent, pediatric and geriatric researchers interested in pursuing research relevant to the mission of NIDA. NIDA invites grant applications to support innovative educational programs that focus on preparing researchers in clinical research careers relevant to drug abuse and addiction.

This mechanism of support is not to be used to substitute the Ruth L. Kirschstein National Research Service Award training and fellowship mechanisms and policies supported by the NIH.

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 of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Individuals Eligible to Become Principal Investigators
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

This FOA invites applications using the R25 mechanism that will focus on providing creative and innovative education research experiences at all levels of professional career development (e.g., independent scientists, postdoctoral fellows, clinical residents, medical students and/or graduate students). This educational training experience must hold the promise of fostering new research approaches that advance the current drug abuse and addiction field.

It is expected that these institutional research sites will develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers as researchers, as clinicians, or, optimally, as a combination of the two. Educational partnerships between institutions such as, research institutions, drug abuse treatment organizations, primary care organizations--are highly encouraged in order to broaden research training and educational opportunities and, as a result, increase the number of well-trained clinical and health services researchers in the drug abuse and addiction field at large.

Education Program Objectives

There is a serious shortage of well-qualified individuals prepared to conduct needed clinical, prevention, health services, and treatment research with drug abusers and underserved populations of children and adolescents, women, elderly, and racial and ethnic minorities affected by drug abuse. At present, few academic institutions have a coordinated curriculum and other essential elements relevant to preparing individuals for a career in clinical research with drug abusers and related populations. A related need is for increased numbers of service providers who are sufficiently sophisticated consumers of research to evaluate and apply research-based findings.

Drug Abuse and Addiction Research Education Grants support only educational activities focused on basic, clinical, prevention, and health services and treatment research, and may not be used for support of non-research clinical training. This mechanism may be used, however, to provide drug addiction research education to those in clinical training or in a clinical research track within a clinical training program. Formats for the research education programs may vary to include a series of short courses, seminars, workshops, or structured short-term or long-term research experiences; or curriculum development, design, implementation and evaluation.

NIDA expects applicant institutions to propose their own creative and innovative research education programs. Examples of potential programs include, but are not limited to, the following:

1. Educational/research activities and experiences that enhance the participation and commitment of clinical researchers to careers in addiction research.

Examples include educational programs that have as the primary focus to:

o Provide mentored clinical research opportunities designed specifically for students enrolled in medical or graduate school degree programs and clinical residents.

o Encourage clinical doctoral-level or equivalent (e.g., MD, PhD, MD/PhD, DO, DSW, DSN, DDS) students and/or postdoctoral fellows/residents to embark on research projects directly applicable to clinical practice.

o Develop or enhance the research curricula and mentoring provided during residency training and/or create research training tracks within residency programs.

o Improve the quality of mentoring in drug abuse and addiction research areas, particularly improvements in the retention and advancement of physician scientists as well as adolescent, pediatric, and geriatric researchers.

o Provide educational experiences relevant to the conduct of drug abuse related clinical, prevention, treatment and services research.

o Provide clinical research career enhancement opportunities for new clinical doctoral-level or equivalent students at the intersection of basic, clinical, treatment and services research.

2. Cross-disciplinary educational and research experiences that prepare drug abuse and addiction researchers to conduct interdisciplinary research (e.g., behavioral, neuroscience, genetic, epidemiological, clinical, etc.) or to translate approaches from basic behavioral, social science, cognitive neuroscience, and biomedical fields to clinical, prevention, treatment and services research. Examples of cross-disciplinary and translational approaches include:

o The use of cognitive, affective, and social neuroscience in the development and evaluation of behavioral and pharmacological treatment interventions for drug abuse and addiction.

o Interdisciplinary approaches to the development, adaptation, and modification of treatment and preventive interventions to enhance and facilitate the rapid advancement of research from bench to clinical research settings and then to community treatment programs and services settings.

This FOA further encourages collaborative programs involving academic clinical research departments and basic science departments, as well as clinical or community treatment settings and multiple academic or research institutions such as schools of public health, departments of preventive and community medicine, primary care organizations or other entities with appropriate expertise for the development and establishment of educational training programs in drug abuse clinical, prevention, health services, and treatment research and practice.

Applicants should describe planned processes for: (a) conducting and monitoring recruitment and selection of students, (b) planning research activities and selecting mentors for students, (c) evaluating student progress, and (d) assessing the quality and effectiveness of the overall training program. Schools, departments, and clinical sites participating in the joint applications should be involved in the planning, implementation, and assessment processes listed above.

These cross-disciplinary educational programs are likely to involve active collaborations or special arrangements between institutions and/or departments such as those with drug abuse research center support grants, schools of public health, departments of community and preventive medicine, and other departments and institutions that have the necessary expertise and resources to fulfill the objectives of this FOA. Any of these entities may act as the applicant organization, as long as the qualifications of the participants and the focus of the program are on the training of clinical researchers to work with drug abusing and related populations.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Education Research Program Grant (R25) award mechanism. Awards will be limited to a maximum of $350,000 in total direct costs per year. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the non-modular budget format. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA.

Research education grant support is renewable. It is recommended that applicants contact the scientific/research contact listed in Section VII concerning the submission of a competing renewal (formerly competing continuation ) application. Up to two resubmissions (formerly revisions/amendments ) of a previously reviewed research education grant application may be submitted. See NOT-OD-03-041, May 7, 2003.

2. Funds Available

Because the nature and scope of the proposed research education program 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 NIDA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Although the size of the award may vary with the scope of the proposed research education program, it is expected that applications will stay within the following budgetary guidelines: total direct costs are limited to $350,000 annually. In addition, NIDA limits personnel costs to no more than 25% of the total direct costs in any year of the proposed project period (see Section IV.2. for details).

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this funding opportunity announcement.

Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, are not included in the direct cost limitation. See NOT-OD-05-004.

All awards are subject to the availability of funds.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions are not eligible to apply in response to this FOA.

It is anticipated that in most cases these programs will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty would have active research projects in which students can gain relevant experiences. If multiple sites are to be used, the applicant institution must be one of those sites and a strong justification must be included. Institutions with existing Institutional National Research Training Grants (T32) or other federally funded training programs may apply for an education research grant provided the proposed educational experiences are distinct from those training programs receiving NIH support. The R25 mechanism is not intended to support long-term training by NRSA-eligible individuals and may not be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms. This FOA will support the research education of United States citizens only.

1.B. Individuals Eligible to Become Principal Investigators

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 support.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

An active research base that includes funded drug abuse research projects should be available for the education of candidates enrolled in the program.

The requisite faculty and the commitment of sufficient faculty time are critical factors for this educational program. Graduates of the program should have some fundamental knowledge of at least the following areas, with in-depth knowledge of some of them:

o Neurobiology, cognitive, affective, and social neuroscience

o Genetic and environmental vulnerability

o Principles of pharmacology, including the pharmacokinetics and pharmacodynamics of major drugs of abuse.

o Clinical aspects of drug abuse, including knowledge of screening, assessment, and diagnostic methods, direct and indirect effects of drug abuse, major prevention and treatment (e.g., behavioral, pharmacological) modalities, consequences of drug use (e.g., medical, psychiatric, social), treatment of drug abusers with comorbid medical and/or psychiatric disorders and development of modes of integrated care.

o Research methodologies such as epidemiology, biostatistics, structural equation modeling, multilevel analysis, IRT, Rasch, qualitative and quantitative measurement models applied to research design and analysis, drug abuse surveillance, and data use.

o Health service delivery, including prevention, referral, screening, assessment, and treatment; organizational dynamics, culture, and climate; quality management; provider career development; patient satisfaction, financing; cost-effectiveness; and dissemination of research to practice.

o Prevention science and health education; developmentally appropriate intervention design and strategies.

o Racial/minority, health disparity, cultural, and gender issues.

o Protection of human subjects and related ethical issues in the conduct of research.

Sponsoring Institution: The sponsoring institution must assure support for the proposed research education project. Appropriate institutional commitment to the project includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education project.

Participants: Describe who the intended participants are, and what eligibility and/or specific educational background characteristics are essential for participation in the proposed program. This FOA will support the research education of United States citizens only.

Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).

Applications must also contain an evaluation plan and a dissemination plan. Applications submitted without these sections may be delayed in the review process or not reviewed.

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Allowable Costs

Allowable costs must be consistent with NIH policy and be reasonable, allowable, and well-documented and justified for the research education program. Grant funds may not be used to supplant funds otherwise available at the applicant institution.

Personnel: Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the percent of time devoted to the program. Normally, all personnel costs (including administrative and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 25% of the total direct cost. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students are considered a regular part of an individual's academic duties, then mentoring and other interactions with students are non-reimbursable from grant funds.)

Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Consultation costs, equipment, supplies, necessary travel, and other program-related expenses must be justified as specifically required by the program proposed and not duplicate items generally available for educational programs at the host institution.

Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget.

Participant Costs: Participants are those individuals who benefit from the proposed research education program. Participant costs must be justified as specifically required for the proposed research education program. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.

Participants in the education program may receive subsistence allowance, which includes partial costs of meals and lodging (unless furnished as part of the fee for registration). They may also receive partial tuition, other education-related and travel expenses, including foreign travel, if strongly justified. Note that effort and how the dollar amount is determined must be included when describing the participant support and also be listed in the budget justification area.

Individuals supported by NIH training and career development mechanisms (K, T or F Grants) may not receive stipend or salary support from the Research Education Grant in Drug Abuse and Addiction. However, if funds are not available from other sources, limited support to defray participation costs (e.g., travel, meals, lodging) may be provided only when in accordance with grantee institutional policy and with sufficient budget justification, distinguishing the differences in the costs in this program and the NRSA funds being provided.

Partial costs for off-site rental space will be considered if it is short-term and shown to be necessary for the implementation and execution of the educational program (seminar, workshop, etc.). Matching funds from applicant institutions or other organizations for such off-site costs are strongly encouraged.

Facilities and Administrative (F&A) Costs, formerly known as "indirect costs," may be allowed for the applicant organization and any approved subcontract based on 8% of total direct costs exclusive of tuition and fees and expenditures for equipment.

Funds will not be provided for fringe benefits or health insurance for participants involved in this education program.

Note that all costs associated with consortium/contractual arrangements, both direct and F&A costs are considered direct costs and are included in the $350,000 direct costs ceiling limitation for this program. Normally, funds for the research education evaluation plan are not expected to exceed 5% of the total direct costs.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: September 18, 2006
Letters of Intent Receipt Date: 30 days before the submission date
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date: See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Director
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. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit 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 an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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.

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 renewal 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 renewal 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 the NIH Grants Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:

Videos, CDs, and/or DVDs specifically related to the research education program. Applicants should contact the SRA for submission instructions after application assignment.

Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Supplementary Research Education Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form. Applications that do not conform to the specific instructions detailed below will be returned.

1. SF 424 Title Page: You must include the FOA number and the title, Research Education Grants in Drug Abuse and Addiction (R25).

2. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate, with a description of plans for collaborating with other institutions for purposes of exchange and sharing of resources, including faculty, equipment, and facilities. If multiple sites are to be used, the applicant institution must be one of those sites and for other sites a strong justification must be included.

3. SF 424 Research & Related Other Project Information, Item 9 (Facilities & Other Resources): Describe arrangements for administration of the program; provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to drug abuse and addiction, and can organize and administer the education program, as well as evidence of institutional and community commitment and support for the proposed program.

3. SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI as well as any other key persons (such as those involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program.

4. Research & Related Budget: Complete for each budget period requested.

A. Senior/Key Person: complete for all senior/key persons associated with the research education program. The PD/PI must be included here.

B. Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program. Note that the total funds requested in Sections A + B may not exceed 25% of the total direct costs in any year of the project period.

C. Equipment: self-explanatory.

D. Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the research education program.

E. Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program. If categories in addition to those listed in this section of the 424R&R form are needed, describe in the section titled, Other. State the number of Participants/Trainees to be supported by the proposed research education program. Refer to Section IV.2. for allowable participant support costs.

F. Other Direct Costs: itemize as appropriate and allowed for the research education program.

K. Budget Justification: provide a detailed justification for each category for which funds are requested. For Section E, itemize each category of support costs per participant and justify.

5. PHS 398 Research Plan Attachments:

Part 4 of this section (Preliminary Studies/Progress Report) should contain information on steps that have led to the proposed research education program. A Progress Report must be included in renewal applications.

Part 5 of this section (Research Design and Methods) should be re-titled "Research Education Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.

Program Direction: Describe arrangements for administration of the program; provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to drug abuse and addiction, and can organize and administer the research education program, as well as evidence of institutional and community commitment and support for the proposed program.

Program Faculty/Staff: Describe the characteristics and responsibilities of the Key Personnel who are the faculty; provide evidence that participating faculty and preceptors are actively engaged in research or other scholarly activities related to drug abuse and addiction. NIDA recommends forming a multidisciplinary Clinical Addiction Research Education Committee, which is essential to the overall administration of a Clinical Research Education Program in Drug Abuse and Addiction. A primary responsibility of this committee is the recruitment and selection of students, procedures for the selection of research activities and mentors for students, and evaluation of student progress. The committee should consist of experts representing basic, behavioral, and clinical disciplines concerned with drug abuse and its treatment and prevention. Schools, departments, and clinical sites participating in joint applications should be represented on the committee. Evidence should be provided of the committee’s function, structure, composition, and frequency of meetings.

Proposed Research Education Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula).

Program Participants: Provide details about the pool of proposed participants; include a description of plans for recruiting as participants individuals from underrepresented racial/ethnic groups, women and persons with disabilities. Competing continuation applications must include a detailed account of experiences in recruiting and retaining individuals from underrepresented groups during the previous award period.

Diversity Recruitment and Retention Plan: Provide a detailed diversity recruitment and retention plan for the research education program. Renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period. Include, in a table, the total numbers of individuals who applied, were interviewed, admitted, and participated in the research education program as well as the total number of individuals from the three classes defined below. For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI must explain why this information is not appropriate.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIDA, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives. The inclusion of evaluation instruments is encouraged. Please note that applications that do not have an adequate evaluation plan will be considered non-responsive to this program announcement.

Plan for Sharing Research Data

Not applicable

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_2003/NIHGPS_Part7.htm#_Toc54600131). 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.

Research education programs are not generally expected to generate research resources. However, applications are expected to include a software sharing plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software sharing plan should address, as appropriate, the following goals:

Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.

The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

The initial review group will comment on the appropriateness of the proposed software dissemination plan. Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee. 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). 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 ICs on the basis of established PHS referral guidelines.

Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened by the National Institute on Drug Abuse 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:

o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score

o Receive a written critique

o Receive a second level review by the appropriate National Advisory Council on Drug Abuse

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application.

Grant applications to the Research Education Grants in Drug Abuse and Addiction should be characterized by innovation, scholarship, and responsiveness to the special and/or changing needs of drug abuse and addiction research. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals:

SIGNIFICANCE: Does the proposed research education program address the objectives stated in this program announcement?

APPROACH: Is the proposed specialized curriculum appropriate and adequate to achieve the research education goals outlined? Are the course requirements and sequence, and timetable for completing the planned activities also appropriate? Is there an adequate plan for evaluating the effectiveness of the program in achieving its objectives? Will a multidisciplinary Clinical Addiction Research Education Committee be involved in the overall administration of the grant?

INNOVATION: Does the curriculum include original and unique approaches or methods for addressing the needs put forth in the goals and objectives? Are plans to challenge existing paradigms or develop new approaches or techniques described?

INVESTIGATOR: Does the program leadership demonstrate a record of achievements and are their qualifications appropriate to meeting the proposed goals and implementing the stated plan?

ENVIRONMENT: Is the scientific/education environment described, indicating the unique features and probability of success of the program? Is institutional commitment to the proposed program documented? Is the institute able to attract and recruit appropriate trainees? If multiple sites are to be used, is this adequately justified in terms of the educational experiences provided? Are plans provided for the coordination and communication between multiple sites?

Evaluation Plan: For competing continuation applications, has the program been adequately evaluated and has the level of success been satisfactory? Is the need for further R25 support clear?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score.

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

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 item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF 424 (R&R) will be assessed.

Resubmission Applications (formerly revised/amended applications): In addition to the above criteria, the following criteria will be applied to resubmission applications:

Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research education program will be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIDA, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

2.C. Sharing Research Data

Not applicable.

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_2003/NIHGPS_Part7.htm#_Toc54600131). 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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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), 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 PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

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

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

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 NIDA to the grantee business official.

2. Administrative and National Policy Requirements

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution: The research education program may not be transferred from one institution to another.

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the Specific Aims of the original peer-reviewed research education program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

Awards made in response to this FOA are subject to the streamlined non-competing application process (SNAP).

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report should provide information on the development and implementation of the proposed research education program (including education in the responsible conduct of research), modifications to the research education program as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, award recipients are hereby notified that they may be contacted during and after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: This project was supported by NIH grant number ________. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.

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:

Dorynne Czechowicz, M.D.
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse, NIH/DHHS
6001 Executive Boulevard, Room 3154, MSC 9593
Bethesda, Maryland 20852 ( for express/courier service)
Telephone: 301-443-2237
E-mail: dc97d@nih.gov

2. Peer Review Contacts:

Director
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. Financial or Grants Management Contacts:

Diana Haikalis
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: dhaikali@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 (45 CFR 46) 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).

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

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). Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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.

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

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

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

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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA 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 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 Part 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 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.

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