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: NIDA
Research Education Grants in Drug Abuse and Addiction
(R25)
Announcement Type
This is a reissuance of PAR-06-550 which was
previously released September 18, 2006.
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-07-221
Key Dates
Release/Posted Date: February 16, 2007
Opening Date: February 16, 2007(Earliest date an application may be
submitted to Grants.gov)
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://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL
Activation Date): Not Applicable
Expiration Date: May 2, 2010 (now May 8, 2010 per NOT-OD-07-093)
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 clinically-focused, curriculum and/or research-program building mechanism designed to foster the development of clinical and health services researchers. Although participants may receive a salary/subsistence allowance, this mechanism of support is not to be used for long-term support of participants, and is thus distinct from training mechanisms such as the Ruth L. Kirschstein National Research Service Award (NRSA) and career development awards. Any duration of funding of an individual participant that is longer than two years may be considered long-term support. Therefore, applicants should obtain prior approval in writing from NIDA if an extension of support beyond the two-year period is required.
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. Eligible Individuals
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 developing
curricula to provide educational and/or research
experiences to clinically focused scientists at all
levels of professional career development (e.g.,
independent scientists, postdoctoral fellows, clinical residents, medical
students and/or graduate students). Educational/research
activities and experiences must be designed to enhance the participation and
commitment of clinical researchers to careers in
addiction research.
Clinical research is defined in this FOA as: patient-oriented clinical research conducted with human subjects, or research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.
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 clinical researchers, 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 those affected by drug abuse, including underserved populations of children and adolescents, women, elderly, and racial and ethnic minorities. 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.
This mechanism may be used to provide drug addiction research education to those in clinical training, translational research training, or in a clinical research track within a clinical training program. This mechanism may not be used for support of non-research clinical training. Formats for the research education programs may vary to include either a series of short courses, seminars, workshops, or structured short-term or long-term research experiences; or curriculum development, design, implementation and evaluation and tracking.
NIDA expects applicant institutions to propose their own research education programs. Examples of potential programs include, but are not limited to, the following:
The requisite investigators/faculty and the commitment of sufficient investigators/faculty time are critical factors for this educational program. Graduates of the program should have some fundamental knowledge of at least the following areas, as they relate to drug abuse and addiction, with in-depth knowledge of some of them:
This FOA further encourages collaborative programs involving academic clinical research and basic science departments, clinical or community treatment settings and primary care organizations, multiple academic or research institutions such as schools of public health and departments of preventive and community medicine, 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. If multiple sites are involved in the research education program, the applicant institution must be one of the sites.”
Applicants should describe planned processes for: (a) conducting and monitoring recruitment and selection of participants, (b) planning research activities and selecting mentors for participants, (c) evaluating student progress, (d) coordinating among existing training or research activities available at the site and (e) 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.
Interdisciplinary educational programs are likely to involve active collaborations or special arrangements between institutions and/or departments with drug abuse research programs, 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.
The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.
Special Considerations
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 and counseling education. 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 by following the Funding hyperlink to NACDA Guidelines, or may be obtained by calling (301) 443-2755.
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 Research Education Grant
(R25) award mechanism. 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. 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 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 award may vary with the scope of the research education program proposed, applications must adhere to the following budgetary guidelines: direct costs are limited to $350,000 annually. Applications that do not follow these guidelines will be returned without review.
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
Foreign institutions are not eligible to apply in response to this FOA.
It is anticipated that a substantial number of program investigators/faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. Furthermore, the proposed research education program must complement these other ongoing research training and career development awards, and explicit details about how these programs complement each other must be provided. Moreover, the R25 mechanism is not intended to support long-term training of individuals and may not be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms. Any duration of funding for a specific participant that is longer than two years may be considered long-term support. Therefore, applicants should obtain prior approval in writing from NIDA if an extension of support for a specific participant beyond the two-year period is required.
If multiple sites are involved in the research education program, the applicant institution must be one of these sites for the program. The need for and use of multiple sites must be justified.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research education program as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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. The PD/PI will be expected to monitor and assess the program, submitting annual reports as required. (See Section VI.3., “Reporting.”)
The PD/PI should be an established investigator in the scientific area of the application and must demonstrate capability of providing both administrative and scientific leadership for the development and implementation of the proposed research education program.
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
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: Participants are those individuals who benefit from the proposed research education program. 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 contain an evaluation and tracking plan. Applications submitted without these sections will not be reviewed.
Applicants may submit more than one application, provided each application is scientifically distinct.
In many cases, it is anticipated that the proposed research education program will complement other ongoing research training occurring at the applicant institution and that a substantial number of program investigators/faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals.
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
301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-0088.
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
Research Education Program
While the proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. Plans for the coordination of the proposed research education program with other training and career development award programs otherwise available to participants must be explicitly detailed.
If multiple sites are involved in the research education program, the applicant institution must be one of these sites for the program. The need for and use of multiple sites must be justified.
The Biographical Sketches of proposed investigators/faculty, including a complete listing of active research grant support, must be provided. In addition, the applicant should specify their roles, if any, in ongoing research training (such as mentorship on research training grants or sponsorship of individual fellowships) at the institution.
Evaluation Plan and Tracking
Research education grants require an evaluation and tracking plan in order to determine the degree of success or failure. A plan must be provided for program evaluation. 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. In addition, the application must describe a system for tracking each participant during the time they are on the R25 award and for a period of 5 years (subject to annual reporting) following each participant’s termination from this R25 award. The evaluation component must include information on the career trajectories of the participants, including positions obtained, publications, and independent research grant submissions/awards. The evaluation and tracking plan should address whether the program is enhancing the participation and commitment of future clinical researchers into careers in drug abuse and addiction research.
Allowable Costs
Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. 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 person months devoted to the program. These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. 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/participants are considered a regular part of an individual's academic duties, then mentoring and other interactions with students/participants 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.
All personnel costs (including administrative and clerical costs, as well as salaries of the PD/PI and other investigators/faculty) associated with directing, coordinating, and administering the program should be justified and reasonable.
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 research education program may receive a salary/subsistence allowance, including costs of meals and lodging unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition, other education-related, and travel expenses. Expenses for foreign travel must be exceptionally well justified. Funds will not be provided for fringe benefits or health insurance for participants in any research education program. Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the R25 mechanism, as participants, but may not receive salary supplementation from a research education program. Note that the R25 mechanism is not intended to support long-term training of participants. Funding for a specific participant that is longer than two years may be considered long-term support. Therefore, applicants should obtain prior approval in writing from NIDA if an extension of support beyond the two-year period for a specific participant is required.
Institutional Commitment: Evidence of institutional commitment to the research educational program is required.
Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified 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: February 16, 2007
(Earliest date an application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): 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 Application Submission Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: Standard dates apply, please see http://grants1.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” (3 pages maximum) 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:
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. Please see the New Limits on Appendix Materials policy (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html) for further information.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
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 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.
If multiple sites are involved in the research education program, the applicant institution must be one of these sites for the program. A justification must be included for sites other than the applicant institution in the program narrative.
2. SF 424 Research & Related Other Project Information, Item 9 (Facilities & Other Resources): Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support. Describe the plan for coordination of the Research Education Program with these related sources of support.
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 the development, 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. Applications must adhere to the following budgetary guidelines: direct costs must adhere to a limitation to $350,000 annually. All personnel costs (including administrative and clerical costs, as well as salaries of the PD/PI and other investigators/faculty) associated with directing, coordinating, and administering the program should be justified and reasonable.
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.
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 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 Director(s): 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, administer, monitor, and evaluate 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 participating investigators/faculty; provide evidence that the participating investigators/faculty and preceptors are actively engaged in research or other scholarly activities related to drug abuse and addiction. NIDA strongly 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 participants, procedures for the selection of research activities and mentors for participants, and evaluation of participant 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, seminars, workshops).
Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program investigators/faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction. Instruction which is tailored to drug abuse and addiction research is particularly encouraged.
If such training is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.
Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.
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 investigators/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 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 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 and Tracking 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. The application should identify the individual responsible for evaluating the program, including that individual’s credentials. Include a system for tracking each participant during the R25 award and for a period of 5 years (subject to annual reporting) following each participant’s termination from this R25 award. The evaluation component must include information on the career trajectories of the participants, including positions obtained, publications, and independent research grant submissions/awards. The evaluation and tracking plan should address whether the program is enhancing the participation and commitment of future clinical researchers to careers in drug abuse and addiction research? Applications submitted without these sections will not be reviewed.
Plan for Sharing Research DataNIH
policy expects that grant 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
dissemination 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 dissemination plan should address,
as appropriate, the following goals:
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. 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 that are complete will be evaluated for
scientific and technical merit by an appropriate review group convened by NIDA in accordance with the review criteria stated below.
As part of the initial merit review, all
applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs. 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 education program 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. These criteria are not listed in any order of priority.
Research education program grant applications submitted in response to this funding opportunity announcement should be characterized by scholarship and responsiveness to the priorities and/or changing needs of drug abuse and addiction research and NIDA in meeting its objectives. Applicants are strongly encouraged to contact NIDA program staff for current information about targeted priorities and policies before preparing an application (see Section VII).
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?
Does the proposed research education program address scientific/education areas and/or topics important to the mission of NIDA? How will implementation of the proposed program advance the objectives of this funding opportunity announcement as well as the mission of NIDA? Is the proposed education program likely to prepare researchers in clinical research careers relevant to drug abuse and addiction? Is the program likely to increase the number and/or quality of clinician scientists in the drug abuse field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Is there evidence that the program is based on sound clinical research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? If curricula are proposed, are course requirements, sequence, and timetable for completing planned activities appropriate? lf a multidisciplinary Clinical Addiction Research Education Committee is proposed, is it appropriate and adequate for meeting the overall needs for the administration of the grant? If a multidisciplinary Clinical Addiction Research Education Committee is not proposed, are there adequate plans for meeting the overall needs for the administration of the grant? Are there adequate plans to ensure coordination among other training or career development mechanisms while ensuring that the proposed program is distinct from other extant programs? Is the evaluation and tracking plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives? Are benchmarks, plans, and procedures to capture, analyze and report program outcome measures adequately specified and described? If evaluation instruments are used, are they adequately described and justified?
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?
Innovation is encouraged. If this is a new application, have innovative aspects of the program been appropriately identified? Are innovative elements well organized and logically developed? If the application is a renewal, have aspects of the program been identified for change and new innovative elements introduced?
While innovation is encouraged, not all aspects of a program of research training and career development need be innovative. Since the focus of these programs is to foster the development of clinical and health services researchers via a clinically-focused curriculum and/or research-program building mechanism, whether or not the research supported is innovative and/or potentially high risk is of less importance than it would be in a research application. Does the program provide for the development or maintenance of strong, stable clinical research education opportunities? If the application is a renewal and some elements are maintained, is the value of the maintained aspects adequately demonstrated?
Investigators/Faculty: Are the PD/PI(s)and other key personnel appropriately trained and well suited to carry out this work? Is the proposed program appropriate to the experience level of the PD/PI and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the program (if applicable)? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?
Is the percent effort allocated to personnel costs associated with directing, coordinating, and administering the program justified and reasonable?
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? Is the institutional commitment to the proposed program appropriate?
Is there evidence of appropriate collaboration among participating programs, departments, and institutions? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?
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 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.
Biohazards: If materials or
procedures are proposed that are potentially hazardous to research personnel
and/or the environment, the adequacy of the proposed protection will be
assessed.
Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
For renewal applications only: Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the program's evaluation? Have an adequate number of clinician scientists progressed through the program? Has the research education program successfully achieved its stated objectives during the prior project period? New applicants are asked to be aware of these requirements as they prepare this application in view of future potential renewal applications.
Plans to Evaluate Progress: Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives?
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 investigators/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 investigators/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 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 expects
that grant 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 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), length of time individuals are supported for research training (two years or less without previous NIDA permission), 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 and Tracking: 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 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.
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 Contact:
Debra
Grossman, M.A.
Behavioral
and Integrative Treatment Branch
Division
of Clinical Neuroscience and Behavioral Research
National
Institute on Drug Abuse/NIH/DHHS
6001
Executive Boulevard, Rm. 3153 MSC 9551
Bethesda, Maryland 20892-9551
Phone:
(301) 443-0107
Fax:
(301) 443-6814
E-mail: mailto:dg79a@nih.gov
Mimi M. Ghim, Ph.D.
Office of Science Policy and Communications
National Institute on Drug
Abuse/NIH/DHHS
Suite 5230, MSC
9591
6001 Executive Boulevard
Bethesda, MD 20892-9591
Telephone: (301) 443-6071
FAX: (301) 443-6277
Email: ghimm@mail.nih.gov
2. Peer Review
Contact:
Teresa Levitin, Ph.D.
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 Contact:
Catherine Mills
Grants Management Branch
Office of Planning and Resource
Management
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Phone: 301-443-6710
FAX: 301-594-6849
Email: cmills@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).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
Access to Research Data through
the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent statements
and other human subjects procedures given the potential for wider use of data
collected under this award.
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.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Office of Extramural Research (OER) |
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