Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH)(http://www.nih.gov)
The Bernard Osher Foundation (http://www.osherfoundation.org/)

Components of Participating Organizations
National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov)

Title: The Bernard Osher Foundation/NCCAM CAM Practitioner Research Career Development Award (K01)

Announcement Type
New

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

• January 7, 2009 - This PA has been reissued as (PAR-09-072).
• August 22, 2008 - See Notice (NOT-AT-08-005) NCCAM announces expanded eligibility.
• October 25, 2007 - See Notice (NOT-AT-08-002) Notice of Additional Receipt dates.

Program Announcement (PA) Number: PAR-07-003

Catalog of Federal Domestic Assistance Number(s)
93.213

Key Dates
Release Date: October 5, 2006
Letters of Intent Receipt Date(s): A letter of Intent is not required
Application Receipt/Submission Date(s) for New Applications: February 1, 2007; October 1, 2008; October 1, 2009
Revised Application Receipt/Submission Date(s): March 1, 2007; November 1, 2008 and November 1, 2009
AIDS Application Receipt Date(s): May 1, 2007; January 2, 2009 and January 2, 2010
Peer Review Date(s): June-July 2007, February-March 2009; February-March 2010
Council Review Date(s): October 2007; May 2009; May 2010
Earliest Anticipated Start Date(s): December 2007; July 2009; July 2010
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: New Date January 8, 2009 (per issuance of PAR-09-072) (Original Expiration Date: January 3, 2010, changed to September 8, 2010 per NOT-AT-08-002)

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• The goals of the NIH-supported career development programs are to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. For this specific announcement the research area of interest is complementary and alternative medicine (CAM).
• The specific purpose of this research career development Award (K01) is to provide research training support for CAM Practitioners with clinical doctorates, who have had limited opportunities for research training, but a strong desire to pursue a career in CAM research. The long term goal is to encourage more CAM practitioners to enter research careers, thus enriching CAM research through their experience and knowledge of CAM practice. This award will provide support and protected time (three, four, or five years) for intensive, supervised career development research experience in the biomedical, behavioral, or clinical sciences related to complementary and alternative medicine (CAM). Awards are not renewable, nor are they transferable from one principal investigator to another.
• Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the numbers, quality, duration, and costs of the applications received.
• The K01 career development award mechanism will be used.
• The K01 application may be submitted on behalf of the candidate (principal investigator) by any domestic for-profit or non-profit institution/organization, or public or private institutions, such as universities, colleges, hospitals and laboratories. Foreign institutions are not eligible to apply.
• Eligible principal investigators include U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence, who hold a CAM health-professional doctoral degree and can commit a minimum of 75% of full-time professional effort conducting research and relevant career development activities specified in the application. A CAM health-professional doctoral degree (CAM clinical doctorate) includes, but is not limited to, Doctor of Chiropractic (D.C.), Doctor of Naturopathic Medicine (N.D.), and Doctor of Acupuncture and Oriental Medicine (D.A.O.M). Candidates who have clinical doctoral degrees from osteopathic medical institutions that teach manual manipulation as part of the core curriculum required for all students are also eligible. Individuals who have a research doctorate, such as a Ph.D., or a conventional clinical doctorate, such as an M.D., in addition to the CAM clinical doctorate, are not eligible for this award. Receipt of prior NIH support may impact on eligibility.
• The candidate must demonstrate and justify the need for a three, four, or five-year period of supervised research experience. Planning, direction, and execution of the proposed career development program and research project will be the responsibility of the candidate and his/her mentor.
• The proposed career development experience must be in a research area new to the applicant and/or one in which an additional supervised research experience will substantially augment the research capabilities of the applicant.
• The applicant should provide a plan and proposed timeline for achieving independent research support by the end of the award period.
• The candidate for this K01 award may not concurrently apply for or have an award pending for another NIH career development award. Up to two revisions of the application are accepted.
• See SectionIV for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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 Career Objectives

• This research career development award, which is being co-funded by The Bernard Osher Foundation, will provide support for a sustained period of protected time for intensive research career development under the guidance of an experienced mentor (also called sponsor) in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that through this sustained period of research career development and training, awardees will launch independent research careers in CAM research and become competitive for exploratory/developmental grant (R21) or research project grant (R01) funding.
• CAM is broadly defined in the NCCAM Strategic Plan (2005-2009) as medical practices that are unproven by science and not presently considered an integral part of conventional medicine (also referred to as biomedicine, or mainstream or allopathic medicine). These medical practices can be divided into four domains: mind-body medicine; biological based-practices; manipulative and body-based practices; and energy medicine. NCCAM is also interested in research on whole medical systems outside of mainstream medicine in the United States such as Indian Ayurvedic medicine, traditional Chinese medicine, and homeopathy. These whole medical practices may encompass one or more of the above domains. For more detailed information on NCCAM’s research mission see the NCCAM Strategic Plan 2005-2009 entitled Expanding Horizons in Health Care (http://nccam.nih.gov/about/plans/2005/index.htm). For current research areas of special interest to NCCAM see: http://nccam.nih.gov/research/priorities/index.htm#5. The research proposed as part of this K01 award may be in any of the CAM domains.
• The candidate must devote a minimum of 75% of full-time professional effort to the goals of this award. The remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award. Both the didactic and research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate.
• All career development programs must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the plan for the career development program. Applicants must justify the need for this award and provide a convincing case that the proposed period of support will substantially enhance their careers as independent research investigators in their chosen field of CAM research. The sponsoring institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator in CAM research.

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 K01 award mechanism.

As an applicant, you and your mentor will be jointly responsible for planning, directing, and executing the proposed project and career development activities.

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. The applicant should follow the instructions for budget information described in the PHS 398, Section III (Career Development Awards CDA section), providing only the total direct costs for each year and the entire proposed period of support and budget justification information.

2. Funds Available

• NCCAM, with co-funding from The Bernard Osher Foundation, anticipate awarding three awards per year for each of the three years that the program announcement is active.
• Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the participating organizations provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Allowable Costs: This award will provide salary and fringe benefits for the career award recipient. The total salary requested must be based on a full time, 12 month staff appointment. The awards requires the candidate to devote a minimum of 75% of full-time professional effort to conducting the research career development plan described in the application, the remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award. For information regarding NIH policy in determining full-time professional effort for career awards, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

The candidate s salary must be consistent both with the established salary structure at the institution and salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12 month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Confirmation of salary is required prior to the issuance of an award. Fringe benefits, based on the sponsoring institution’s rate and percent effort, are provided in addition to the salary.

The award will provide salary support up to $75,000 annually to help offset the full-time salary requirements of the candidate. The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institutions salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation must not require extra duties or responsibilities that would interfere with the purpose of the K01 award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution’s salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-023.html.

Effective for all new competing research project grant applications, mentored career award recipients in the last two years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a Principal Investigator or Subproject Director. This new policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Research Development Support: The award will provide support of up to $25,000 per year for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) travel to research meetings, or training; (d) statistical services including personnel and computer time.

Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed on this K01 award.

Primary mentors of successful K01 candidates will subsequently receive support from The Bernard Osher Foundation in a separate award providing $40,000 in salary support for the primary mentor. However, this salary support is not part of this K01 award and therefore should not be included in the K01 budget.

Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic Institutions

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

The primary goal of this announcement is to provide CAM practitioners, who have had limited opportunities for research training support, an opportunity to gain sufficient research training experience to prepare them to pursue successful independent careers in CAM research. As such, eligible individuals are limited to those with clinical doctoral degrees from CAM institutions. For the purpose of this announcement, a CAM institution is defined as a nationally or regionally accredited academic, health care, or research institution with a primary goal of educating students to be CAM medical practitioners. Candidates for this award must hold a clinical doctoral degree from such an institution in a designated CAM practice that is licensed or certified at the state level. Such institutions may include, but are not limited to, colleges/schools of naturopathy, chiropractic, and acupuncture and Oriental medicine. Candidates who have clinical doctoral degrees from osteopathic medical institutions that teach manual manipulation as part of the core curriculum required for all students are also eligible.

In keeping with the goal of targeting this award to CAM practitioners who have limited research experience, individuals who have a conventional research doctorate degree, such as a Ph.D., or a conventional clinical doctorate, such as an M.D. in addition to their CAM degree are not eligible. Furthermore, individuals who have successfully competed for a National Research Service Award (NRSA) Individual Fellowship or have been selected as trainees on NRSA institutional training grants AND have more than one year of research training on the NRSA award at the time of application are also not eligible. Individuals who have had minimal research training (one year or less) as an NRSA trainee or fellow at the time he/she submits an application for this K01 award and who meet the other eligibility criteria are eligible to apply.

Individuals interested in CAM research training who are ineligible for this K01 award are encouraged to consider other NCCAM research fellowship and career awards that are described on the NCCAM training website at www.nccam.nih.gov/training/opportunities. They may also contact the Scientific/Research contact listed in the Agency Contact section of this announcement for additional information and guidance.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who possess an Alien Registration Receipt Card (1-151 or 1-551), or some other verification of legal admission as a permanent resident prior to the time of award are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Candidates must identify a mentor or mentors with extensive and appropriate research experience for the proposed research career development plan.

Candidates must be able to commit a minimum of 75% effort of full-time professional effort conducting research career development and research activities associated with this award. The remaining 25% effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the goals of this K01 award, i.e., the candidate’s development into an independent research investigator. The candidate must have a full time appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort towards satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person at NCCAM listed in the Agency Contact Section under Grants Management and Financial Contact prior to preparing an application to discuss their eligibility.

2. Cost Sharing or Matching

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

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

A candidate for this K01 award may not simultaneously submit or have an application pending for any other PHS career award (e.g. K07, K08, K22, K23) or any PHS award that duplicates any of the provisions of this K01 award. Current or former principal investigators on NIH career awards or research grants are not eligible. In addition, individuals with more than one year of training on an institutional or individual NRSA award, at the time of submission of this K01 award, are not eligible for this award.

Special Requirements

Each career development program must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the plan for the career development program. The sponsoring institution must demonstrate a commitment to provide the environment and resources needed for the candidate to perform the activities included in the career development program. K01 awardees are encouraged to apply for independent funding during the latter period of this award, and that sponsoring institutions will provide the resources required for them to do so.

Key elements for the award, in addition to information about the applicant /candidate, include:

Environment: The applicant institution must have a well-established record of funded research and research career development activities and qualified research faculty to serve as mentors. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and be willing to allow the protected time needed by the applicant. The candidate, mentor, and institution must describe a career development program that maximizes the use of relevant research and educational resources, and propose qualified faculty as mentors in the specific research area. While it is not necessary for the institution to have a CAM research program, the institution and mentor must provide the appropriate research and research training resources needed for the candidate to develop an independent career in CAM research.

Career Development Program: The award provides three, four, or five consecutive 12-month budget periods. At least 75 percent of the recipient's full-time professional effort must be devoted to the program, although 100% effort may be requested. The remainder of the applicant's time should be devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. The candidate is expected to further develop knowledge in the biomedical, behavioral or clinical sciences and enhance research skills relevant to his/her career goals as a CAM researcher. The candidate is encouraged to include relevant courses and didactic experiences in consultation with his/her mentor.

Mentor(s): The candidate must name a primary sponsor/mentor, who together with the applicant is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models. While the primary mentor’s research program need not focus on CAM per se, the mentor must have an appreciation of CAM and work with the candidate to develop a research training program that will provide the candidate with the necessary skills and experience to develop an independent career in CAM research. If necessary, the candidate and the primary mentor may name and involve secondary mentors to enrich the candidate’s research training and prepare him/her for a career as an independent investigator in CAM research.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

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

SUPPLEMENTARY INSTRUCTIONS for Career Development awards are located in the PHS 398, Section III (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Note that new and revised applications responding to this announcement must include at least three sealed letters of reference following the instructions and using the CDA Reference Guidelines Format Page; these letters must be attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be retuned without review.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): A letter of intent is not required.
Application Receipt/Submission Date(s) for New Applications: February 1, 2007; October 1, 2008; October 1, 2009
Revised Application Receipt/Submission Date(s): March 1, 2007; November 1, 2008 and November 1, 2009
AIDS Application Receipt Date(s): May 1, 2007; January 2, 2009 and January 2, 2010
Peer Review Date(s): June-July 2007; February-March 2009; February-March 2010
Council Review Date(s): October 2007; May 2009; May 2010
Earliest Anticipated Start Date(s): December 2007; July 2009; July 2010

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. 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)

Two photocopies of the original application and all copies of the appendix materials should be sent to:

Martin Goldrosen, Ph.D.
Chief, Office of Scientific Review
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594 2014
Fax: (301) 480 2419
Email: [email protected]

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

3.C. Application Processing

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

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

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

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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 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 award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

Citizenship: Applicants must meet the citizenship requirements as described in the Eligibility section of this announcement prior to award (Section III).

Concurrent awards: Applicants must be aware of the NIH policies associated with other federally sponsored support.

Salary Support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department. The candidate is required to devote a mimimum of 75% of full time effort to this program, and confirmation of the actual salary is required prior to the issuance of an award.

An NIH policy change (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html) now allows NIH mentored career development award recipients in the final two years of their award, to receive salary support from both their K award and an NIH research grant or subproject. The K-award recipient must be the named Principal Investigator on a competing NIH research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.).

Research Development Support: The research development support costs must be justified and be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Salary for ancillary personnel support, such as mentors, secretarial and administrative assistants is not allowed.

6. Other Submission Requirements

Using the Supplementary Instructions in the PHS 398 for Research Career Awards (http://grants.nih.gov/grants/funding/phs398/phs398.html),the following information must be included in the application.

Candidate

Describe the candidate's commitment to a health-related career in CAM research. Include a description of all the candidate's professional responsibilities in the grantee institution and elsewhere and show their relation to the proposed activities on the career award.

• Discuss prior training and how it relates to the objectives and long-term career plans of the candidate
• Discuss the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experience.
• Provide evidence of the candidate's potential to develop into an independent investigator in CAM.
• Include a statement that the candidate will commit at least 75% effort to the career development program and related career development activities.

Career Development Plan

• Describe a systematic plan: (1) that shows a logical progression from the candidate's prior research and training experiences to the training and research experiences that will occur during the K01 award period and then to independent investigator status; (2) that justifies the need for further career development to become an independent investigator; and (3) that utilizes the relevant research and educational resources of the institution.
• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The sponsor/mentor may form an advisory committee to assist with the development of a program of study or to monitor the candidate's progress through the career development program.
• The didactic and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals in CAM.
• Describe the professional responsibilities/activities including other research projects, beyond the minimum required 75% effort commitment to the K01 award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.

Research Plan

A sound research project that is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided. In addition, it must be relevant to the candidate’s goal to develop an independent career in CAM research.

Organize the research plan as indicated in the Form PHS 398, following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Research Design and Methods. The candidate should consult with mentor(s) regarding the development of this section.

Training in the Responsible Conduct of Research

Applications must include a description of a program to receive 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.

Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component.

Statement(s) by Mentors(s)/Consultant(s)/Collaborator(s)

• The candidate must name a primary sponsor (also called mentor), who, together with the applicant and other mentors, is responsible for the planning, direction, and execution of the program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators.
• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• The application must include a statement from the mentor providing: 1) information on their research qualifications and previous experience as a research supervisor; 2) a mentoring plan describing the nature of the supervision and mentoring that will occur during the proposed award period and how it will relate to the goals of the candidate to become an independent researcher in CAM, and 3) a plan for transitioning the candidate from the mentored phase of their careers to the independent investigator phase during the project period of the award.
• Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate.
• The mentor and department chair must agree and provide a statement in the application documenting that this amount of the candidate's time will be protected.
• The mentor must agree to provide annual evaluations of the candidate's progress for the duration of the award as required in the annual progress report, PHS 2590 (see Section VI.3 Reporting).

Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, if a biographical sketch is not provided, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.

Environment and Institutional Commitment to the Candidate

The sponsoring institution must define and document a strong, well-established research and training program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate. While the institution does not need to have a research training program specifically focused on CAM research, it must be clear how the proposed training will further the candidate’s career in CAM research. The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator in CAM and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K01 award.

• Describe the resources and facilities that will be available to the candidate.
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career in CAM and the pursuit of the proposed research plan.
• In a clear statement, provide assurances that the candidate will be able to devote a minimum of 75 % of his/her effort in developing his/her research program, that the remaining percent effort being devoted to activities related to the development of their research career, and that the candidate will be released from normal clinical, teaching or administrative duties. Candidates who will use the resources within a General Clinical Research Center (GCRC) during the course of the award should include a letter of agreement from either the GCRC program director or the principal investigator with the application.

Letters of Reference

Include with the application three sealed letters of reference from individuals addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator in CAM research. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. All sealed letters of reference should be attached to the face page of the application.

Special NCCAM Requirements on Research Using Biologically Active Agents

Applicants who use biologically derived substances must follow the NCCAM policy and applicant guidance for studies of biologically active agents as stated on the NCCAM website, http://nccam.nih.gov/research/policies/index.htm. Instructions are provided on the type of information that should be included in the application, as well as the type of information that NCCAM may request after review but before grant award.

Questions regarding Investigational New Drug (IND) applications should be addressed to the Food and Drug Administration (FDA). If IND is required, it is the sole responsibility of the applicant to obtain all necessary clearances from the FDA. The applicant should present a plan for IND submission, evidence that an IND application is in process or that the FDA has allowed an exemption.

NCCAM Policy on Terms of Award for Clinical Trials

In addition to the required Federal Citations listed below related to clinical research, applicants submitting applications in response to this announcement should also follow the NCCAM Policy on Terms of Award for Clinical Trials http://nccam.nih.gov/research/policies/terms-of-awards.htm, where applicable.

Budget for Entire Proposed Period of Support

Allowable costs for the CAM Practitioner Research Career Development Award (K01) program include salary, fringe benefits, and a research development fund as described in the above Section on Funds Available under the heading Allowable Costs. Follow the application instructions, providing only the total direct costs for each year and the entire proposed period of support. Within the direct costs limitation for research development support, provide a detailed description, with justification, for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

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/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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 NCCAM in accordance with the review criteria stated below.

As part of the initial merit review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique
• Receive a second level of review by the NCCAM National Advisory Council.
  
  The following will be considered in making funding decisions:
• Scientific merit of the proposed project as determined by peer review
• Relevance of the proposed career development program and commitment of the applicant to becoming an independent investigator in CAM research
• Availability of funds
• Relevance of program priorities

Review Criteria

The goal of this research career development award (K01) is to provide research training support for CAM Practitioners with clinical doctorates, who have had limited opportunities for research training, but a strong desire to pursue a career in CAM research. The long term goal is to encourage more CAM practitioners to enter research careers, thus enriching CAM research through their experience and knowledge of CAM. The scientific review group will address and consider each of the criteria below in assigning the application's overall score, weighting them as appropriate for each application.

• Candidate
• Career Development Plan
• Research Plan
• Training in the Responsible Conduct of Research
• Appropriateness of and statements by former Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s)
• Environment and Institutional Commitment to the Candidate

The application does not need to be strong in all categories to receive a high priority score. These criteria are listed in logical order and not in order of priority.

Candidate

• Potential to develop as an independent and productive investigator in CAM research.
• Quality of the candidate's research, academic and/or clinical record;
• Commitment to meeting the program objectives to become an independent researcher;
• Quality of the letters of reference from three individuals who can evaluate the candidate's potential to pursue an independent health-related research scientist career in CAM;
• Letters of reference submitted by mentor(s)/ co-mentor(s) will be considered independent of and in addition to of the three required reference letters.

Career Development Plan

Likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence, based on:

• Appropriateness of the content, scope, phasing, and duration of the career development plan when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence as a CAM investigator;
• Plans for monitoring and evaluating the candidate's research and career development progress.

Research Plan

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

• Scientific and technical merit of the research question, design and methodology;
• Relevance of the proposed research to the candidate's career objectives;
• Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills described in the career development plan and leading to an independent research career in CAM.

Training in the Responsible Conduct of Research

• Quality and appropriateness of the proposed training in the responsible conduct of research.

Statements by Mentor/Co-Mentor(s), Consultant(s), and Collaborator(s)

• Appropriateness of the mentor's research qualifications in the area of the proposed research;
• Quality and extent of the mentor's proposed role in providing guidance and advice to the candidate and preparing the candidate for an independent career in CAM research;
• Previous experience in fostering the development of independent investigators;
• History of research productivity and peer-reviewed support;
• Adequacy of active/pending support for the proposed research project; and
• Strength of the mentor's statement.

Environment and Institutional Commitment to the Candidate

• Clear commitment of the institution to ensure that a minimum of 75% of the candidate's effort will be devoted directly to research, with the remaining percent effort being devoted to activities related to the successful development of a research career including clinical responsibilities;
• Strength of the institutional commitment to the career development of the candidate;
• Adequacy of research facilities and training opportunities, including faculty capable of productive collaboration with the candidate; and
• Quality and relevance of the environment for the scientific and professional development of the candidate, and
• Assurance that the institution intends for the candidate to be an integral part of its research program.

2.A. Additional Review Criteria:

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

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

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

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

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 career development plan. 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/grants/policy/nihgps/part_ii_5.htm#availofrr and http://ott.od.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 PD/PI will be able to access his or her Summary Statement (written critique) via the 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA 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 NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following related administrative policies apply to NIH Research Career Award ( K ) programs:

A. Evaluation:

In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

B. Other Income:

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

• The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
• The funds may be used for health-related research purposes.
• The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment.

Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

C. Special Leave:

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIH awarding institute or center is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.)

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the K01 award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75%. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50% effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75% as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Changes in Research or Career Development Program:

http://grants.nih.gov/grants/guide/contacts/pa-06-001_contacts.htm

Individual awards are made for career development at a specific institution in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH institute. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by staff of the awarding NIH component institute to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

E. Change of Institution or Termination

Consultation with the applicable NIH program staff is strongly encouraged when either termination or a change of institution is being considered. See (http://grants.nih.gov/grants/guide/contacts/pa-06-001_contacts.htm).

A change of grantee request normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the grantee is moving to another eligible institution, career award support may be continued provided:

• A relinquishing statement is submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by the NIH awarding institute.
• The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new sponsor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program.
• All conditions of the award are met at the new institution.
• The period of support requested is no more than the time remaining within the existing award

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision period.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually: Note that the instructions for Research Career Development applications must be followed for this program http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the2590 instructions. Evaluation of the awardee's progress will encompass the following:

• A demonstration of scientific progress toward the aims of the research as described in a brief summary of the studies and results obtained during the prior funding period;
• A description of career development and research-related activities undertaken during the prior funding period.
• A list of accomplishments such as publications, scientific presentation, new collaborations, inventions, or project- generated resources made during the prior funding period;
• A brief explanation of plans to address the specific aims during the next year of support;
• A description of proposed career development and research-related activities for the next year of support with a clear indication of percent effort devoted to research/research training and other activities.
• An annual evaluation statement of the candidate's progress, as required in the PHS 2590 continuation application instructions (item J. Sponsor's Report).

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Partap Khalsa, D.C., Ph.D., D.A.B.C.O.
Program Officer
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594-3462
FAX: (301) 401-1587
Email: [email protected]

2. Peer Review Contacts:

Martin Goldrosen, Ph.D.
National Center for Complementary and Alternative Medicine
National Institutes of Health
Democracy II, Suite 401
6707 Democracy Blvd.
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594 2014
FAX: (301) 480 2419
Email: [email protected]

3. Financial or Grants Management Contacts:

George Tucker, M.B.A.
National Center for Complementary and Alternative Medicine
National Institutes of Health
Democracy II, Suite 401
6707 Democracy Blvd.
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594 9102
FAX: (301) 480 2419
Email: [email protected]

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.

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 http://grants.nih.gov/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.

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 (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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 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/.

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NIH Funding Opportunities and Notices

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