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 Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)

Title:  Institutional Patient-Oriented Career Development Programs in the Environmental Health Sciences (K12)

Announcement Type
New

Request for Applications (RFA) Number: RFA-ES-06-005

Catalog of Federal Domestic Assistance Number(s)
93.894

Key Dates
Release Date: April 14, 2006
Letters of Intent Receipt Date(s): September 23, 2006
Application Receipt Date(s): October 23, 2006
Peer Review Date(s):  February-March, 2007
Council Review Date(s):  May 2007
Earliest Anticipated Start Date: July 1, 2007
Additional Information To Be Available Date (Url Activation Date:  N/A
Expiration Date:  October 24, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The purpose of this RFA is to support the early career development of patient oriented researchers in the environmental health sciences.  Respondents should propose a multidisciplinary Career Development Program centered on a specific aspect of disease etiology, pathogenesis, progression, and/or epidemiology which will prepare physicians and other doctorally trained scientists to pursue a research career in patient oriented research which has a focus on an environmental exposure relevant to the mission of the NIEHS.  Programs must include both a didactic and research career development experience to be guided by a mentoring team.

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 Objectives

Nature of the research opportunity

The National Institute of Environmental Health Sciences is committed to the support and early career promotion of new researchers who will serve in leadership roles to promote the understanding of the impact of environmental exposures on human health.   The need for additional researchers is particularly acute in the integration of the environmental health sciences with research in human disease.  This RFA is intended to support the early career development of doctoral level scientists who can make substantial contributions to the understanding of human health and disease by using environmental sciences to study the etiology, pathogenesis, progression, and epidemiology of human disease. 

Background:

Concerns about the declining role of physician scientists in the research workforce began to emerge over 20 years ago, and since 1994, Institute of Medicine and National Research Council reports have recommended that the National Institutes of Health increase its commitment to the development of scientists who are prepared to engage in clinical research and who are conceptually prepared to engage in research designed to shorten the time to clinical application of important basic research.  Emphasis has been placed on increasing the ranks of clinical researchers, and in particular, individuals who are engaged in patient oriented research.

In 1995, NIH convened a committee to review the status of recruitment and training of future clinical researchers.  The report of this panel, issued in 1997, recommended the support of clinical research programs aimed at medical students, such as combined degree programs (MD/PhD) programs for clinical researchers; ensuring that postdoctoral training grants include formal course work or degree programs in clinical research; development of new support mechanisms for young and mid-career clinical investigators; and taking steps to reduce clinical researchers’ educational debts. 

In response to these reports, in 1999, the NIH introduced three new types of career development awards:  The Mentored Patient Oriented Career Development Award (K23); the Mid Career Patient Oriented Research Career Development Award (K24); and the Clinical Research Curriculum Award (K30) to provide institutions with the funds to develop or expand formal course work in areas related to clinical research.

The Clinical Research Curriculum Award (K30) is designed to support the development or improvement of core courses which provide in-depth instruction in the fundamental skills, methodology, theories, and conceptualizations necessary for the well-trained, clinical researcher.  This includes formal course work in the design of clinical research projects, hypothesis development, biostatistics, epidemiology, and the legal, ethical, and regulatory issues related to clinical research.  The program is complementary to the Mentored Clinical Investigator (K08, K23) programs since the funding is provided for curriculum development and not for the support of the participants in the program. 

More recently, the importance of the cultivation and training of a sufficiently large clinical research workforce to facilitate bench to bedside research and to work in the interdisciplinary, team-oriented environments that characterize current research programs has been further emphasized and promoted by a number of activities within the NIH Roadmap to accelerate medical discoveries to improve health.  Under the Re-engineering the Clinical Research Enterprise, the Multidisciplinary Clinical Research Career Development Programs Request for Applications was first announced in 2003 to support the early career development of clinical researchers from a variety of disciplines engaged in all types of clinical research.  The basis of training is a core curriculum, such as those developed in the Clinical Research Curriculum Award. 

At the same time the NIH was recognizing the need to encourage the support of greater numbers of clinical researchers, the NIEHS was seeking to define and enlarge the role of clinical research in its programs.  A series of meetings was held in 1999 to try to define the issues and develop strategies for future directions.  In addition to the issues addressed by the NIH as a whole, particular impediments to the development of the field of clinical environmental health sciences research were noted.  First is the lack of a discrete population base from which to attract talented physician and other patient oriented research trained scientists.  Meeting attendees recognized that the environmental health sciences  need to become closely intertwined with the stream of clinical training in a variety of departments and to be made attractive to physicians and other clinical researchers with a wide set of backgrounds.  Second, it must be recognized that the research collaborations of a patient oriented research scientist may not naturally coincide with the clinical “home” department.  Third, the importance of strong mentorship implies that the development of junior scientists engaged in patient oriented research cannot proceed in the absence of strong environmental medicine and environmental health science role models and research funding to support clinical projects for research training.  Lastly, an impediment to attracting physicians and other patient oriented research scientists to the environmental health sciences  has been that in many cases research has focused on mechanism based effects of environmental exposures so that the contribution of an environmental exposure to what is seen  clinically is not well delineated.  Therefore, more research into the etiology, pathophysiological progression, epidemiology, or human biological link between an environmental exposure and a clinical decrement in function is needed as a basis for the development of environmental medicine.

Specific Objectives:

The objective of this Institutional Patient-Oriented Career Development Program in the Environmental Health Sciences is to establish strong, multidisciplinary Institution based programs that promote the career development and career transition of doctoral level scientists in multidisciplinary team settings to design and direct projects in patient oriented environmental health sciences research. 

This specific K12 initiative supports an institutional patient-oriented career development program in the environmental health sciences and  is intended to build upon training and career development programs initiated by the NIH Roadmap activities in Re-engineering the Clinical Research Enterprise, and to complement the refocusing of the research efforts of the training and research programs of the NIEHS to include a greater emphasis on integration of basic and clinical research with a focus on environmental exposures and unique scientific opportunities relevant to the mission of NIEHS.

Programs supported by this initiative will be expected to be characterized by:  1) a core of formal didactic core experiences in research methodology for conducting hypothesis based integrative research and specific courses in environmental health sciences;  2) a base of high quality research in environmental health sciences focusing on a particular aspect of disease etiology, pathogenesis, progression, or epidemiology; 3)  a pool of talented early career patient oriented research scholars from a variety of disciplines who plan to pursue careers in the clinical environmental health sciences; and 4) a unifying seminar series or topics course, along with grand round presentations and journal club, which will instill in the clinical scholars an appreciation for integrative research and research approaches to problems of environmental exposures and human biology, human pathophysiology, and human disease.

The Institutional Patient Oriented Research Career Development Program in the Environmental Health Sciences should be fully integrated with the clinical research infrastructure of the Institutional setting.  A medical school and an accredited graduate school must be co-primary participants in the application.  Other clinically related institutions, such as Schools of Public Health, Pharmacy, Nursing, etc., are encouraged to participate.  Programs are expected to incorporate a multidisciplinary approach to the development of the program and cover a spectrum of scientific disciplines critical to innovative patient oriented research in the environmental health sciences.  This includes physicians trained in numerous clinical specialties and subspecialties, and individuals with doctoral degrees in disciplines such as human genetics, pharmacology, nursing, statistics, epidemiology, psychology, veterinary medicine and engineering.  Programs should be sufficiently flexible to allow either physicians to be trained in basic environmental sciences or those with a PhD in basic science to become proficient and redirect their careers to patient oriented research problems in the environmental health sciences.

Applications responsive to this RFA will also be expected to integrate and build on other NIEHS supported resources at the institutional setting, such at training grants (T32) (http://www.niehs.nih.gov/dert/training/t32.htm) , research grants, NIEHS Core Centers (P30) (http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-05-008.html),  NIEHS DISCOVER Centers (http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-06-001.html), Children’s Centers (http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-05-004.html), etc.

Programs must include didactic and practical training in the design, conduct and analysis of patient oriented  research along with an emphasis on methods and problems in clinical environmental health sciences research.  Programs must propose to use a didactic core curriculum which is presented to all Clinical Research Scholars, such as those developed by the K30 program or the NIH Roadmap Multidisciplinary Clinical Research Career Development Program as well as  courses in environmental sciences (toxicology, environmental medicine, environmental physiology, etc)

Examples of the multidisciplinary core curriculum include:

This standard clinical research curriculum should be augmented with courses and other didactic experiences which are specifically designed to give the scholar a firm grounding in the environmental health sciences and a research focus on environmental exposures and the particular aspect of the disease etiology, pathogenesis, progression or epidemiology which is central to the theme of the program.

The first and second year of the Clinical Scholar’s program should be equally divided between the core curriculum and a specific research project that uses environmental sciences to understand human disease.  The third through the fifth year of the program should primarily focus the scholar’s time on their research project.

NIH defines human clinical research (http://grants1.nih.gov/grants/policy/hs/glossary.htm) as:  (1) Patient-oriented research; (2) Epidemiologic and behavioral studies; and (3) Outcomes research and health services research.  Studies falling under Exemption 4 for human subjects research are not considered clinical by the NIH definition.   Patient oriented research is further defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.  Patient oriented research includes: (a) mechanisms of human disease; (b) therapeutic interventions; (c) clinical trials; or (d) development of new technologies.  Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. 

In order to be responsive to this announcement, all of the clinical scholars supported by the program must be engaged in patient oriented research.  Programs which propose research training in only epidemiologic research, behavioral studies, and outcomes or intervention research will not be considered responsive to this announcement and will not be considered for review or funding.

In order to provide a cohesive focus for the program and the scholars supported, the application must describe a plan to impart an understanding of current research in the environmental health sciences, particularly the clinical and integrative aspects and emphasizing the relative roles of environmental exposures, genetics and other co-factors in the etiology of human diseases.  This may include currently available coursework, plus a seminar series, a topics course, journal clubs, discussions of case studies, grand round presentations, etc, which are specifically developed for the participants in the program. 

In addition, Programs should propose a unifying core of career development opportunities specifically for Environmental Health Patient Oriented Research Scholars which facilitate the interactions and exchange among scholars, mentors and the Program Directors, and collaboration among scholars.

Research Projects of the Scholars supported by this program are expected to have a defined impact on the environmental health sciences and be responsive to the mission of the NIEHS, which is distinguished from that of other Institutes by its focus on research programs seeking to use environmental sciences to understand the cause, mechanisms, moderation or prevention of a human disease or disorder, or relevant pathophysiologic process.  Scholars who are supported by this K12 Institutional Patient-Oriented Career Development Program in the Environmental Health Sciences will also be expected to pursue research projects involving the study of an NIEHS mission relevant environmental exposure, and to pursue projects which can evolve in Clinical Career Development Award applications (K08, K23, K01, K99/R00, or research grant applications (R01, R03, R21) within the defined mission area of the NIEHS.  Examples of environmental agents relevant to the NIEHS mission include industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, bacterial or biologically derived toxins.  Agents considered to be outside the mission of the NIEHS which would not be appropriate research areas for scholars supported by this program include, but are not limited to:  alcohol, chemotherapeutic agents, ionizing radiation, smoking (except for second hand smoke in children), drugs of abuse, pharmaceuticals, and infectious or parasitic agents, except when these are disease co-factors to an environmental toxicant exposure to produce the biological effect.  Studies using model compounds are only responsive when proposals to extend the research to a relevant compound are included in the protocols.

As part of the research career development experience, scholars should understand the relevance of the exposure paradigm to human exposure, and the biological and clinical rationale for the link between the exposure and the relevant human disease.  Research projects of scholars should emphasize the translational and integrative aspects of the environmental health sciences.

Each Institutional Patient-Oriented Career Development Program in the Environmental Health Sciences application should include a Governance Committee composed of scientists from the sponsoring Institution who have clinical and environmental health science research expertise, and including the Program Director and Co-Director(s).   The Committee may use institutional or outside consultants if needed.  The Governance Committee is responsible for making recommendations regarding the appointment of scholars to the program, monitoring scholar progress and making recommendations to the Program Director regarding their continuation, evaluating ongoing research activities for merit and relevance to the program’s theme, and making recommendations for the addition or deletion of mentors from the program.  The Governance Committee is a formal part of the structure of the program.  It should meet regularly, and keep written minutes, which will be reviewed as part of a competing or non-competing application.  In addition, an annual evaluation is recommended.

Each Environmental Health Clinical Scholar appointed to the K12 award must be supervised by a mentoring team of at least two mentors from two different disciplines.  One should have research expertise in the environmental exposure proposed in the research project and one should provide expertise in the clinical and patient oriented research.  Either through interactions with the mentoring team, or other career development activities, the mentoring team should insure the clinical scholar has appropriate scientific training in the basic and mechanistic scientific foundation for the clinical research problem under investigation.

The purpose of the K12 is to provide systematic support for the transition of clinical scientists from trainee to new mentored faculty.  Therefore, how this transition is to be accomplished and the progress of the scholars monitored should be addressed in the application.  Benchmarks for progress of the scholars should be outlined in the application.

Within the application, applicants must present a recruitment plan.  The application should describe the potential pool of scholars, including the types of prior clinical and research training.  The criteria to be used for candidate evaluation and selection should be described.  In addition a plan for recruiting scholars with economically, socially, or culturally disadvantaged backgrounds, individuals with disabilities or from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences should be included in the recruitment plan described in the application.

Applicants should also describe a comprehensive evaluation and tracking component that will review the effectiveness of all aspects of the program (including scholars, courses, mentors, Co-directors, mentoring effectiveness and institutional characteristics, and a system for tracking graduates throughout their career to determine the success rate of applying for and obtaining research support, and publications.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Mentored Clinical Scientist Development Program (K12) institutional award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed program.

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 detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application
PHS 398 application instructions

2. Funds Available

Applications may request support for two scholars during the first year, three scholars during the second year, and four scholars in years three through five of the award. 

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 IC(s) 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.

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

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

Foreign Institutions are not eligible to apply

An eligible institution (e.g., university) may submit only a single application in response to this RFA.  Multiple applications from different divisions, faculties, centers, schools, etc. at the same university will be returned without further consideration by the NIEHS.

Applicant institutions must have a strong base of research and faculty in the clinical environmental health sciences and in environmental medicine representing a variety of clinical disciplines, specialties and subspecialties as well as a spectrum of relevant environmental agents and exposures.  Participating faculty must demonstrate an appropriate base of funded research grant support in the mission area of NIEHS, which is elaborated in Section IV.6 “Other Submission Requirements.”

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed institutional career development program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Principal Investigator/Program Director

The Program Director (Principal Investigator) will be responsible for planning, directing and executing the proposed Institutional Patient-Oriented Career Development Program in Environmental Health Sciences.   Program Directors must be a senior faculty member, or director of a research center or multidisciplinary program who possesses scientific expertise in environmental medicine and supervising patient oriented research in the environmental health sciences, and the leadership and administrative capabilities required to coordinate and supervise an interdisciplinary research and career development program.

The application should also name a co-director or deputy director whose responsibilities will include the development, management and continued improvement of the core didactic experiences in the clinical environmental health sciences.

The Director and Co-Director are each expected to devote a minimum of 10% effort to this program.

It is expected that collectively, the Program Director and the co-director will have a strong record of research, administrative, and training achievements in the environmental health sciences, including funding from the NIEHS.

Scholar Candidates

Scholar candidates must have a doctorate and be considered in an early career stage of development in patient-oriented research.  The program covers a spectrum of scientific disciplines critical to innovative patient-oriented research in the environmental health sciences.  This includes physicians trained in numerous clinical specialties and subspecialties, and individuals with doctoral degrees in disciplines such as human genetics, pharmacology, nursing, statistics, epidemiology, psychology, veterinary medicine, and engineering.

2. Cost Sharing or Matching

Cost sharing is not required.

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 medical school and an accredited graduate school must be co-primary participants in the application.  Consortia including Schools of Public Health, Pharmacy, Nursing, and other professional and graduate programs are encouraged.  Only one application per institution will be accepted.

Clinical Capability and Infrastructure

The applicant should provide evidence of existing shared clinical research support facilities that aid the patient-oriented research scholars in developing and managing their research projects.  There should be evidence of an active clinical research faculty, statistical and epidemiological support, and basic science support for appropriate clinical research questions.  In particular, the availability of appropriate clinical faculty, clinical resources and human subject resources for the study of exposures relevant to the mission of the NIEHS must be demonstrated.    

Institutional Commitment to the program

Applicant Institutions should show commitment to the Program’s goals and to the future of patient oriented research in the environmental health sciences.  There should be assurances provided that the Program will be an integral part of its research endeavor and that research and training opportunities in the clinical environmental health sciences will be a critical part of the infrastructure. Letters should be included from high ranking institutional officials describing how the proposed program will form an integral component of the institution’s broader vision with respect to clinical research; outlining how institutional barriers for clinical research and clinical researchers will be or are being addressed; and providing a guarantee of 75% protected time for the patient oriented research scholars.

Governance Committee

The committee members must be scientists who have clinical and environmental health science research expertise, and includes the Program Director and Co-Directors).  While it is expected that the member will be from the sponsoring institution, outside consults may be included if needed.

Mentors (two required for each scholar)

Mentors are considered to be in a mentoring team with at least two mentors from two different disciplines.  One should have research expertise in the environmental exposure proposed in the scholar’s research project, and the other  should provide expertise in the clinical and patient oriented research. 

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

Applications must be prepared using the  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.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): September 23, 2006
Application Receipt Date(s): October 23, 2006
Peer Review Date(s):  February-March, 2007
Council Review Date(s):  May 2007
Earliest Anticipated Start Date: July 1, 2007

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:

Sally E. Eckert-Tilotta, Ph.D.
Scientific Review Branch
NIEHS
79 T.W. Alexander Drive
Building 4401, Room 3173
Research Triangle Park, NC  27709
Telephone: (919) 541-1446
FAX: (919) 541-2503
Email: eckertt1@niehs.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications 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)

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

Sally E. Eckert-Tilotta, Ph.D.
Scientific Review Branch
NIEHS
79 T.W. Alexander Drive
Building 4401, Room 3173
Research Triangle Park, NC  27709
Telephone: (919) 541-1446
FAX: (919) 541-2503
Email: eckertt1@niehs.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIEHS. Incomplete and non-responsive 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 review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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

Allowable costs

Salary Support:  The NIEHS will provide salary and fringe benefits for each scholar for 75% of their effort for a minimum of two years and a maximum of five years.  The total 12-month salary from this grant may be up to the NIH legislated cap, although the institution may supplement from non-federal sources.  The total salary requested must be based on a full time, 12 month staff appointment.  It must be consistent with both the 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.  If full-time, 12 month salaries are currently not paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 

Personnel costs for Program Directors and Mentors:  The Program Director and Deputy Director may each request reimbursement for up to 10% salary and fringe benefits to organize, direct, and monitor the program.  Mentors may not receive salaries or fringe benefits from the K12 award, but may receive up to $5,000 for laboratory costs directly related to the scholar’s research project.  Salary and fringe benefits for an administrative assistant may be requested for up to 0.25 FTE per year only for duties and effort specifically associated with the conduct of K12 program.

Research and Career Development Support: Up to $40,000 annually may be provided for research and career development support for each scholar, which can include expenses such as (1) tuition and fees; (2) travel to relevant training or scientific meetings; (3) supplies and equipment; and (4) technical support and statistical or computer services.  Funds within this category must also be budgeted for one trip annually for a programmatic meeting at NIH or NIEHS.  Research and development costs must be specifically documented for each individual scholar and must be specifically related to the scholar’s research activities.  They cannot be pooled and used for other programs unrelated or indirectly related to the research activities of the individual scholars.

Programmatic travel for Program Director and Co-director:  Up to $1000 each for the Program Director and Co-Director is allowed and should be budgeted for a program related trip to NIH or NIEHS. 

Grant support may not be used for salaries, fringe benefits of the mentors, nor the direct support of the mentor’s laboratories; compensation of administrative personnel normally paid from institutional overhead charges, administrative activities such as public relations, health or educational services, travel of the Principal Investigator, Co-Director or mentors to scientific meetings, costs of clinical care, alterations or renovations.  Note that this list may not be all inclusive; any questions about allowable costs for the K12 program should be directed to the NIEHS Grants Management contact listed in Section VII. 3.

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.

6. Other Submission Requirements  

Participating faculty must demonstrate an appropriate base of funded research grant support in the mission area of NIEHS, as described above.  This is to include a base of at least $250,000 of relevant support (in the fiscal year prior to the submission date of the application) for each clinical scholar slot requested.  (Thus for the limit of four scholars, a base of $1 million in direct costs for research grants is required.)  It is expected that the preponderance of the research base will consist of research projects in the patient oriented environmental health sciences funded by the NIH.  All grants cited to qualify for the required research base must be directly responsive to the mission of the NIEHS, as defined above.  The responsiveness of the research base and the research focus on the use of relevant environmental exposures to understand human diseases or disorders will be a prime factor in funding decisions.  Programs proposing collaborative activities with researchers in the basic environmental health sciences or toxicology, particularly those with research grants funded by the NIEHS, are highly encouraged.  Training Grants, fellowships, Core Center grants without direct project support, education grants, and contract support will not count in the tally of the research base, but it is expected that Institutions with these NIEHS funded resources will integrate these programs and core facilities with the Patient Oriented Research Career Development Program in the Environmental Health Sciences.  In particular, it is expected that any seminar series, topics course, etc., developed for this Institutional Clinical Research Career Development Program will be advertised and made available to trainees in the NIEHS and other NIH funded training programs.

The narrative portion of the application (including tabular material) is limited to 50 pages.  No appendices will be accepted.

The instructions in the Form 398 do not fully apply to the special needs of this grant application.  Therefore, follow these modified instructions when preparing an application for an Institutional Patient-Oriented Research Career Development Program in the Environmental Health Sciences (K12).

Face Page:  Use Form Page 1 of the PHS 398. On line 1, include a title which is descriptive of the Patient Oriented Career Development Program.  On line 2, provide the number of this request for applications and the RFA title Patient Oriented Research Career Development Program in the Environmental Health Sciences.  The Program Director will be the Principal Investigator (PI) of the grant application.

Description/Performance Site(s)/Key Personnel (Form Page 2 of PHS 398): Complete as instructed in the PHS 398.  Information provided should include the PI, Governance Committee Members, mentors, and other faculty participating in the Program.  The roles of the participating personnel should be clearly delineated. The detailed budget page for the first year of support and the budget page for the entire proposed period of support that escalates the number of scholars from 2 in the first year to 4 in the third year should be completed.

Biographical Sketches in standard NIH format for Program Director, Deputy Director, Governance   Committee members and External Advisory Committee members (if applicable), Mentors and other faculty.

Other support:  for the Program Director and Deputy Director, Mentors, Governance Committee members, and Other Faculty providing research guidance.

Patient Oriented Career Development Program in the Environmental Health Sciences (maximum 50 pages total, including the tabular material).  Applicants are discouraged from giving programmatic URL’s in their applications, and reviewers are not obligated to view applicant’s web sites to review public information.  The application should be arranged as follows:

1) Overall aims:

2)  Major program elements:

3)  Candidate Pool and Recruitment Plans, including plan for recruitment from underrepresented groups

4)  Evaluation/Tracking

5)  Human Subjects

6)  Vertebrate Animals

7)  Responsible Conduct of Research

8)  Checklist

Tables:  Suggested tabular formats to supplement, not replace the narrative section.  These tables will help reviewers to assess ongoing clinical and patient oriented research infrastructure relevant to the proposed program.  Include tables in the body of the grant application.  No appendices are allowed and if submitted, will not be forwarded to reviewers.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

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

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/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 data and resource sharing plans 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

The following will be considered in making funding decisions:

Applications will be reviewed by the NIEHS staff to determine responsiveness to the RFA.  Applications deemed non-responsive will not be considered for review or funding..  To be considered responsive, an application must have a medical school and a graduate school as collaborating organizations.  In addition, applicant(s) must demonstrate a research funding base of $250,000 of relevant grant support for each scholar slot requested (see Section IV.6. Other Submission Requirements).  One application per institution will be accepted; applications in excess of one per institution will be returned.

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIEHS in accordance with the review criteria stated below.

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

The purpose of this program is to support the early career development of patient oriented researchers in the environmental health sciences or environmental health researchers in focusing on a particular aspect of disease etiology, pathogenesis, progression, or epidemiology.  In their written comments, the reviewers will be asked to discuss the following aspects of the application to judge the likelihood that the proposed program will have a substantial impact on the pursuit of these goals.

Significance: Is the overall program strategy adequate to satisfy the intent of this initiative to develop and sustain a high-quality Career Development Program?  Does the program take maximum advantage of didactic capabilities, clinical infrastructure, available schools, departments, and disciplines to address the multidisciplinary nature of the program envisioned in this RFA?  Will the proposed program serve to increase the number of researchers with skills and understanding in both environmental health sciences and patient oriented research needs?

Approach: Evaluate the approach for development and implementation of the program.  Specific components to be evaluated under the Approach are as follows:

1)  Didactic Core Curriculum.  Are the didactic requirements sufficient to train scholars to lead, design, and conduct hypothesis-based integrative research and work effectively in collaborative teams?  Are the disciplines encompassing basic sciences in environmental health sciences incorporated in the core curriculum as well as clinically focused core classes?  What unifying method (i.e., seminar series, topics course, grand round presentation series, or journal club) will be used to instill an appreciation of the multiple disciplines and integrative research approaches?  Is it appropriate and well thought out?

2)  Integrative Research Program.   Is a high-quality integrative research program designed?  Is flexibility maximized to allow basic scientists to become proficient in clinical research problems and to allow clinicians to receive appropriate training in environmental health sciences research?  Are the research projects appropriate to the mission of NIEHS, i.e., focused on exposures to environmentally relevant toxicants?  Do the projects emphasize translation and integrative aspects of the environmental health sciences?

3)  Career Development Core.  Have appropriate career development classes and/or other activities been incorporated to facilitate interactions and exchanges among scholars, mentors, and program leadership?  Has the program adequately addressed the need to assist scholars in their transition from trainee to junior faculty?  Are the plans appropriate and likely to be successful?

4)  Mentoring Teams.  Are appropriate plans provided for obtaining and designing mentoring teams for the scholars?  Are the identified mentors clearly delineated and do they have the experience, skills, track record in mentoring necessary to provide scholars with high-quality multidisciplinary, team-oriented research training? 

5)  Recruitment and Retention.  Does the application demonstrate an adequate pool of potential scholars, well-defined recruitment and retention strategies, potential sources and numbers of high-quality candidates, and an equitable scholar selection process?  Are these processes adequate to achieve and retain a high-quality pool of scholars representative of a broad range of disciplines appropriate for environmental health sciences?

6)  Evaluation and Tracking.  Are adequate plans and procedures proposed to evaluate the performance of the program as a whole (e.g., quality of the didactic curriculum, performance of the mentors, faculty participation) and to make changes that improve performance and outcomes?  Are plans to track career outcomes of the scholars adequately developed and described, including positions held, papers published, grants and awards submitted/obtained, and other relevant information?

7)  Governance.  Are roles and responsibilities of the Governance Committee and the External Advisory Committee (if included) clearly described and appropriate for the proposed program?  Do the individual members have the appropriate expertise, experience, and training to fulfill their roles? 

Innovation:  Is the program original and innovative?  Does the program challenge existing training or career approaches, or address a critical barrier to progress in the field?  Does the program develop or employ novel concepts, approaches, methodologies, tools, or technologies for research education that will lead to the development of the essential skill sets needed to lead integrative research teams? 

Investigators:  Do the Program Director and Deputy/Co-Director have the necessary research background, experience, and training and administrative qualifications, to provide scientific leadership, management, and coordination of an integrative research career development program such as that described in the application?   Have they committed sufficient time to devote to the program?  Will the Program Director have sufficient authority and position in the institution to work across institutional boundaries?

Environment: Does the scientific environment in which the training and research will be done contribute to the probability of success?  Is the existing infrastructure (e.g., biostatistical and/or informatics support, access to patients, research facilities, instrumentation, research nurses, etc.) in the participating institution(s) adequate to support training and research in basic environmental health sciences as well as in patient-oriented studies?  Is there an established track record of research and training?  Are adequate space and facilities committed for the program?  Are the plans for supporting research or clinical support cores adequately justified?  Is the institutional leadership committed to this program and its goals?  Are institutional assurances provided that indicate the program will be an integral part of the overall institutional research and training endeavor and in appropriate departments across the institution?  Have institutional barriers for clinical research and researchers been adequately addressed? 

Responsible Conduct of Research:  Is the applicant’s plan for training in the responsible conduct of research appropriate in terms of topics, format, amount and nature of faculty participation and the frequency and duration of instruction?

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. The priority score should not be affected by the evaluation of the budget.

Minority Recruitment and Retention Plan:  Peer reviewers will separately evaluate the minority recruitment plan after the overall score has been determined.   The review panel’s evaluation will be included in an administrative note in the summary statement.  If the plan for minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received.  NIEHS staff, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable. 

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

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://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.

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

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

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).

3. Reporting

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

This program is not subject to the Streamlined Noncompeting Application Process (SNAP).  In general, this means that all reporting of budgetary information and program information are provided in greater detail the annual progress reports.

Progress Reports:  An Annual Progress Report is required.  The report should provide information about changes in the Program, a summary report of the evaluation of the Governance Committee, and a description of the career progress of each scholar.  These annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the program.   The PHS Non-competing Grant Progress Report Form 2590 should be adapted to contain the following information:

Final Reports –  A final progress report, invention statement, and Financial Status Report are required upon termination of an award or relinquishment of an award.

Evaluation –  In carrying out its stewardship of human resource related programs, the NIEHS may request 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 scholar’s employment history, publications

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:

Carol Shreffler, Ph.D.
Division of Extramural Research
National Institute of Environmental health Sciences, EC-23
Building 4401, Room 3411
P.O. Box 12233
Research Triangle Park, NC  27709
Telephone: (919) 541-1445
FAX: (919-541-5064
Email:  shreffl1@niehs.nih.gov

2. Peer Review Contacts:
Sally E. Eckert-Tilotta, Ph.D.
Scientific Review Branch
National Institute of Environmental Health Sciences
Building 4401, Room 3173
79 T.W. Alexander Drive
Research Triangle Park, NC  27709

Telephone: (919) 541-1446
FAX: (919) 541-2503
Email: eckertt1@niehs.nih.gov

3. Financial or Grants Management Contacts:

Mr. Donald Ellis
Grants Management Branch
National Institute of Environmental Health Sciences
Building4401, Room 3444B
79 T.W. Alexander Drive
Research Triangle park, NC  27709
Telephone: (919) 541-1874
FAX: (919) 541-2860
Email: donaldellis@niehs.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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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