Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

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

Title: NIMH Career Transition Award (K22)

Announcement Type
This is a re-issuance of PAR-01-065, which was previously released March 7, 2001

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

Program Announcement (PA) Number: PAR-05-109

Catalog of Federal Domestic Assistance Number(s)
93.281

Key Dates
Release Date: May 17, 2005
Letters of Intent Receipt Date(s): Thirty days before the application receipt deadline date.
Application Receipt Dates(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: March 2, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

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

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

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

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

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

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

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

Purpose of this PA

The purpose of the NIMH Career Transition Award is to facilitate the transition of outstanding physician-scientists and senior postdoctoral investigators (with at least 2-3 years of postgraduate research experience) from the mentored to the independent stage of their research careers. To achieve this objective the NIMH Career Transition Award will provide investigators with the opportunity to initially train within the NIMH Division of Intramural Research Programs (intramural scholar development phase) and then to transition to a domestic U.S. extramural institution (extramural faculty transition phase) where they can continue to work toward establishing their own independent research program. As such, the program is intended to provide support for highly motivated and qualified candidates to focus on gaining significant research and career development experience in research areas relevant to the mission of NIMH. For a description of areas of research covered by NIMH, see http://www.nimh.nih.gov/researchfunding/reorganization.cfm.

Research Objectives

NIMH Intramural Program

The NIMH Division of Intramural Research Programs provides a unique and rich environment for research training and career development for senior postdoctoral fellows and beginning investigators. The NIMH Career Transition Award is intended to provide an opportunity for the most promising and exceptionally talented new investigators, early in their career, to develop an independent research career, with funds available for both salary and research expenses. Each awardee, along with their intramural mentor, will be responsible for all aspects of their research program, including the design and execution of the research and the management of research funds. In addition to working in his/her mentor's laboratory, the investigator has ample opportunity to interact with and seek guidance from other intramural and extramural scientists during his/her tenure at the NIMH.

The Division of Intramural Research Programs at NIMH conducts a broad array of research activities that range from basic neuroscience and behavioral investigations conducted at the systems, cellular and molecular levels to clinical investigations conducted in the diagnosis, treatment and prevention of mental illness. Major disease entities studied throughout the lifespan include, but are not limited to, mood disorders and anxiety, schizophrenia, obsessive-compulsive disorder, attention deficit hyperactivity disorder, and pediatric autoimmune neuropsychiatric disorders. Detailed information about these and other NIMH Intramural research programs can be obtained at http://intramural.nimh.nih.gov.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIMH Mentored Career Transition (K22) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The entire project period for this award consists of up to three years in an NIMH intramural laboratory, followed by continued research and career development support for up to two years at an extramural institution. The aggregate period of NIMH support under this award cannot exceed five years , and NIMH policy on career awards limits such support to one mentored career award per individual.

Intramural Scholar Development Phase:

Funds for this phase of the award will be derived from the NIMH Division of Intramural Research Programs, and will include a full-time salary (12 month employment), technical support and research expenses (supplies, travel, equipment, and health care). There are no indirect costs associated with this phase, and total costs will not exceed $140,000 per year.

Extramural Faculty Transition Phase:

Allowable Costs: Funds for the extramural faculty transition phase will be provided through the non-competing K22, awarded to the domestic extramural institution to which the awardee is recruited. The NIMH will contribute up to 100 percent of the awardee's annual institutional base salary (based on a full-time, 12-month appointment) up to a maximum of $90,000. Note that these awards require a commitment of a minimum of 75 percent of full-time professional effort. The salary allowance will be commensurate with the actual level of effort directed to research and career development activities up to $90,000, plus applicable fringe benefits. This salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. In addition, NIMH will provide up to $50,000 for research costs including technical personnel, equipment, supplies, travel to research meetings or training, statistical services (including personnel and computer time), and other expenses. Salary for ancillary personnel support (secretarial and/or administrative assistance) is NOT allowed. Facilities and administrative costs (formerly called indirect costs) will be reimbursed at 8 percent of modified total direct costs. The 2 years of extramural support are NOT transferable to another institution. Salary supplementation using Federal funds is NOT allowed, and any institutional salary supplementation using non-Federal funds must NOT require responsibilities that may interfere with the awardee's research and career development activities. For specific policy regarding allowable costs associated with NIMH mentored career development awards, see http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-001.html.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A budget summarizing the total direct costs for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

Special Requirements

Activating the Extramural Faculty Transition Phase

The candidate must receive approval in writing from NIMH and must be accepted by an extramural institution in a tenure-track or equivalent position in order to activate the extramural support phase. The extramural institution will submit an application on behalf of the candidate for the extramural phase of support, using Form PHS 398 (http://grants.nih.gov/grants/funding/phs398/phs398.html), and http://grants.nih.gov/grants/funding/phs398/cdafp3.doc). Required information to be included the PHS 398 document can be found in NIMH Policy on Change of Institutions (sections I and II) of (http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-001.html). The application should include a letter from the department or division chairman describing the institution's commitment to the candidate and plans for career development. The application submitted by the awardee and the extramural institution will be evaluated by the mentor, the NIMH Intramural Training Director, and extramural program staff for completeness and responsiveness to the program.

Transition from the intramural scholar development phase of support to the extramural faculty transition phase is NOT automatic and is subject to review of the success of the awardee's research accomplishments and the evaluation of a research plan to be carried out at the extramural institution. The review will take place during the last (normally the third) year of the intramural scholar development phase, and will be conducted by the awardees mentor, the NIMH Intramural Training Director, and appropriate NIMH extramural program staff. Individuals approved for the extramural faculty transition phase will receive continued support through the NIMH K22 award mechanism. The extramural institution must be a domestic U.S. institution that demonstrates a commitment to the candidate by providing protected research time (minimum of 75% effort), space and other support needed to perform the proposed research. The extramural institution must describe the candidate's academic appointment, bearing in mind that it must be tenure-track or equivalent, and that the appointment must not be contingent on the transfer of the award to the institution. K22 awardees are expected to apply for an investigator-initiated research grant (R01, R03, and/or R21), in a research area relevant to the mission of the NIMH, during their tenure as a K22 awardee. It is expected that such an application will be submitted early in the extramural phase of the K22 award in order to ensure continued support and a smooth transition to independence. During the last two years of mentored K support, NIH policy permits award recipients to reduce the level of effort required for their career development award to no less than 50% and replace that effort with effort on their own NIH research grant or subproject provided that they remain in a mentored situation. This NIH policy will permit those mentored K award recipients who are ready to compete for NIH research grants to continue to benefit from the period of protected time offered by the career development award. For specific details regarding the policy on concurrent support from a mentored career development award and a research grant, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Annual Evaluation

Intramural Scholar Development Phase

Each awardee will be evaluated for progress on an annual basis by the mentor, and the NIMH Intramural Training Director. The second annual scientific review will also constitute the formal review to determine suitability for transition to the extramural phase of the award.

Extramural Faculty Transition Phase

The awardee will be required to submit a Form PHS 2590 non-competing continuation application for the final years of extramural support http://grants.nih.gov/grants/funding/2590/2590.htm. The application should provide a description of the research and career progress of the awardee, including: 1) publications in press or submitted; 2) current investigator-initiated research grant support; and 3) all applications submitted for investigator-initiated research grant support. It should also include a description of the extramural institution's commitment to development of the awardee's career.

Important Note: Acceptance into the NIMH Career Award for Transition to Independence Program does not imply a commitment on the part of the Institute to consider the awardee for a tenure-track position at the NIMH Division of Intramural Research Programs. The primary intent of this program is to develop outstanding mental health researchers who will pursue extramural research careers. However, awardees may wish to apply for available tenure-track positions at the NIMH or another NIH Institute. The K22 award will be terminated if the candidate is offered and accepts such a position.

2. Funds Available

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

During the Intramural Scholar development Phase applications may only be submitted for research within the NIMH intramural program at the National Institutes of Health.

During the Extramural Phase you may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. At the time of the award, candidates must be U.S. citizens, non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent U.S. resident.

The candidate must have a doctoral degree such as Ph.D., M.D., or equivalent, and at least two, but no more than five years of postdoctoral training (exclusive of clinical training) at the time of application. Individuals who have been principal investigators on NIH research project grants, program projects and center grants, or career development (K) awards are NOT eligible. Former principal investigators of an NIMH Small Grant (R03), Academic Research Enhancement Awards (AREA) (R15), or Exploratory/Developmental Grants (R21) remain eligible. A candidate for the NIMH Career Award Transition Award may neither concurrently apply for any other PHS award that duplicates the provisions of this award, nor have another application pending award by the PHS. Fellows who meet these requirements and are currently working at the NIMH Division of Intramural Research Programs are eligible to apply, provided that the research experience proposed promotes new areas of professional growth and development. Individuals supported by an NIMH Institutional NRSA training grant (T32) or an NIMH Individual NRSA postdoctoral fellowship (F32) are encouraged to apply; however, applicants should request start dates that allow for the completion of the NRSA training experience.

2. Cost Sharing or Matching

Not applicable

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

3. Other-Special Eligibility Criteria
Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact Grants Info, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

For the extramural phase of this award the extramural institution will submit an application on behalf of the candidate for the extramural phase of using the most current PHS 398 grant applications instructions and forms, and which must include a D&B Data Universal Numbering System (DUNS) number as the universal identifier. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date: Thirty days before the application receipt date
Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm

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 at the beginning of this document.

The letter of intent should be sent to:

Barry Kaplan, Ph.D.
Division of Intramural Research
National Institute of Mental Health
Building 10, Room 4N-222, MSC 1381
Bethesda, MD 20892
Telephone: (301) 496-4183
FAX: (301) 480-8438
Email: barrykaplan@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission of the application, two additional copies of the application should be sent to:

Jean G. Noronha, Ph.D.
NIMH Referral Officer
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3367
E-Mail: jnoronha@mail.nih.gov

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Intramural Scholar Development Phase

Prospective applicants should contact Barry B. Kaplan, Ph.D. (see Section VII.1) in order to initiate the process of identifying a mentor (if one has not already been selected), with whom the candidate can consult in preparing and submitting an application for the intramural phase of the award. Candidates from academic institutions or other NIH Institutes may obtain information about the NIMH Intramural Research Programs from the following Website: http://intramural.nimh.nih.gov. Fellows working at an NIMH laboratory may work with their current mentor, or with another intramural investigator, provided the research experience proposed in this application is in a fundamentally new area of research that will enhance the candidate's scientific career. In any case, both the candidate and intramural mentor must collaborate closely in preparing the application and follow the appropriate instructions for current NIMH fellows.

Application Contents

Candidate

Career Development Plan

Research Plan

Training in the Responsible Conduct of Research

Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. 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, policies regard the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

For submission of progress reports for the extramural phase of the award, see Section VI.

Plan for Sharing Research Data
A plan for sharing research data is not required.

Sharing Research Resources

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

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).

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 NIMH.

Appropriate scientific review groups convened by the NIMH in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the applicant will assume an independent extramural mental health research career.

Candidate

Career Development Plan

Research Plan

Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the depth and breadth of that submitted by a more experienced investigator. Nevertheless, a fundamentally sound research plan must be provided.

Mentor

Environment

2.A. Additional Review Criteria:

Responsible Conduct of Research: Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. 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, policies regard the use of human and animal subjects, and data management. Applicants must follow the application instructions and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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

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

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data
A data sharing plan is not required.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

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

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

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Extramural phase awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Barry Kaplan, Ph.D.
Division of Intramural Research
National Institute of Mental Health
Building 10, Room 4N-222, MSC 1381
Bethesda, MD 20892
Telephone: (301) 496-4183
FAX: (301) 480-8438
Email: barrykaplan@nih.gov

2. Peer Review Contacts:

Chief, Extramural Review Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892
Telephone: (301) 443-3367
FAX: (301) 443-4720

3. Financial or Grants Management Contacts:

Rebecca Claycamp
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892
Telephone: (301) 443-2811
FAX: (301) 443-6885
Email: rc253d@nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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

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

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

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

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

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

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


H H S Department of Health
and Human Services

 
  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892