Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov)
Participating Organizations
National Institutes of Health (NIH),
(http://www.nih.gov)
Components of Participating Organizations
National Institute on Aging (NIA),
(http://www.nia.nih.gov)
Title: Promoting Aging
Research Careers In Health Disparities (K01)
Announcement Type
New
Request For Applications (RFA) Number: RFA-AG-06-008
Catalog of Federal Domestic Assistance Number(s)
93.866
Key Dates
Release Date: August 3, 2006
Letters of Intent Receipt Date(s): October 23, 2006
Application Receipt Date(s): November 22, 2006
Peer Review Date(s): February-May
2007
Council Review Date(s): May
2007
Earliest Anticipated Start Date(s): July
2007
Additional Information To Be Available Date (Url Activation
Date): Not applicable
Expiration Date: November
24, 2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview
Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Date and Time
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
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
The most severe health problems in the United States are concentrated among
minority groups and elders from disadvantaged backgrounds bear a substantial
burden. Research is critically needed to develop basic knowledge,
innovative treatments, techniques and programs focused on challenges of reaching
racial, ethnic, economic and educationally disadvantaged groups, and on understanding
diseases that disproportionately affect the elderly members of these groups
and providing appropriate care and treatment.
Disparities in the burden of illness, disease and death experienced by older African Americans, Hispanic Americans, Asian Americans/Pacific Islanders, American Indians/Alaska Natives, and other health disparity population groups as compared to the U.S. population as a whole, can be improved. NIA recognizes that each group is unique and disparities vary within and between groups such that not all experience excess deaths or high prevalence of the same diseases. Additionally, the NIA recognizes the importance of a diverse research workforce committed to research aimed at redressing health disparities where they exist and assisting in the breakdown of racial, cultural and ethnic stereotypes.
Examples of research that might be appropriate include but are not limited to differential diagnosis of dementia, basic biology (including studies on animal models) of age-related diseases that disproportionately affect racial or minority groups, measurement of cognition, Hispanic paradox, effects of early life quality and quantity of education on late life quality of life, illness conditions and SES position, physical function and disabilities, sleep disorders, prostate cancer, burden and cost of illness, end of life care, cardiovascular risk with aging, family caregiving, medication use and self-management of health, as well as aging-related diseases and conditions that disproportionately affect racial or ethnic minority groups, such as diabetes, hypertension, kidney disease and metabolic syndrome.
Although the NIH currently provides many opportunities
to develop research careers for individuals that are underrepresented in aging
sciences, the National Academies of Science publication Assessment of NIH
Minority Research Training Programs: Phase 3, (2005), http://fermat.nap.edu/catalog/11329.html#toc
provides strong support that diversity in the science workforce remains
a critically important area for advancing the biomedical and behavioral research
enterprise and reducing health disparities.
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 NIH K01 award mechanism. As an applicant,
the candidate and his/her mentor(s) are jointly responsible for planning,
directing, and executing the proposed project and career development activities
with emphasis on aging and health disparities.
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, providing only the total direct costs for each year and the entire proposed period of support and budget justification information.
Awards are for three-five years and are not renewable.
2. Funds Available
NIA expects to award $500,000 dollars through this announcement;
An applicant may request a project
period of up to 3-5 years
and a budget for direct costs up to $150,000. dollars per year.
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 NIA 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:
The following costs are allowed within the overall amounts described above:
Salary: NIA 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 award 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 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 the percent of effort, are provided in addition to the salary.
The sponsoring institution may supplement the NIA salary contribution up to a level that is consistent with the institution's 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: Examples of these expenses include: (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.
Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs.
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.
1. B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research and career development activities in health disparities
research related to aging is invited to work with his/her mentor and sponsoring
institution to develop an application for support. Nationally, health
disparity population groups include but are not limited to African Americans,
Hispanic Americans, American Indians/Alaska Natives, Native Hawaiians, Pacific
Islanders, medically underserved, low socioeconomic populations and rural
populations.
Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. However, for this NIH K01 RFA the following additional eligibility requirements apply to individuals who seek support as principal investigators:
Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-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 for this award must have a health-professional doctoral degree or its equivalent. Such degrees include but are not limited to the M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice.
Candidates contributing to the diversity of the research workforce on aging and are committed to conduct research on health disparities and aging are encouraged to apply and include:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that underrepresentation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the applicant institution are eligible for support under this program.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who were raised in a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary of Health and Human Services for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or that they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
Candidates must identify a mentor with research experience in aging and sufficient independent research funding to support the proposed research project in excess of the allowable costs of this award .
Candidates must be able to commit a minimum of 75 percent of full-time professional effort conducting research career development and research activities associated with this award. The remaining 25 percent effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the goals of the K01 Award, i.e., the candidate's development into an independent investigator in aging and health disparities research. 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 toward satisfying the “full time” requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the NIA prior to preparing an application to discuss their eligibility, see http://grants.nih.gov/grants/guide/contacts/pa-05-143_contacts.htm.
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 candidate for an NIH K01 award may not simultaneously
submit or have an application pending for any other NIH career award (e.g.,
K01, K07, K08, K22, K23, K25, K99), a research project grant (R01), or any
PHS award that duplicates any of the provisions of the K01 award. Ineligible
individuals include current and former principal investigators on NIH research
project grants, comparable individual career development awards (e.g., K07,
K08, K01, K25) equivalent non-PHS peer-reviewed research grants that are over
$100,000 direct costs per year, or project leaders on sub-projects of program
project (P01) or center (P50) grants, and the equivalent, such as VA Merit
Awards. Recipients of K12 support may apply provided that they have no more
than three years of K12 support by the time the K01 award is issued.
Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental
Grants (R21) remain eligible.
K01 recipients are encouraged to apply for independent research grant support during the latter period of this award. K01 award recipients that obtain independent support during the K01 award period may hold concurrent research support, and under certain circumstances (see Allowable Costs above) salary support from their career award and a competing NIH research project grant when recognized as a Principal Investigator or subproject Director of the research project grant, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.
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 in aging and health disparity research. The sponsoring institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator. The candidate must identify a mentor with documented aging-related research experience and sufficient independent research funding .
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 research career development activities and qualified research faculty to serve as mentors in the specific area of aging research identified by the candidate. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and allow the protected time needed by the applicant. It must have faculty qualified in aging research to serve as mentors. The candidate, mentor, and institution must describe a career development program that maximizes the use of relevant research, and educational resources, and qualified faculty as mentors.
Career Development Program: The award provides three, four, or five consecutive 12-month budget periods. At least 75% of the recipient's full-time professional effort must be devoted to the program of aging and health disparities research, although up to 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 develop knowledge, skills and expertise relevant to her/his career goals. The candidate may include didactic, laboratory, interdisciplinary and field experiences in their career development plan as needed.
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
in aging. 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. Appropriate mentors include, but are not limited to,
NIH-supported investigators involved in aging 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 301-451-0088.
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, starting on page 44.
Note that new and revised applications responding to this
announcement must include at least three sealed letters of reference 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 returned without review.
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): October 23, 2006
Application Receipt Date(s): November 22, 2006
Peer Review Date(s): February-May 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date: July 2007
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes:
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:
Dr. Mary Nekola, Chief
Scientific Review Office
National Institute on Aging
7201 Wisconsin Ave., #2C212
Bethesda, MD 20892-2292
Telephone: (301) 402-7702
FAX: (301)-402-0066
Email: NekolaM@nia.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 and all copies of the appendix material must be sent to:
Dr. Mary Nekola, Chief
Scientific Review Office
National Institute on Aging
7201 Wisconsin Ave., #2C212
Bethesda, MD 20892-2292
Telephone: (301) 402-7702
FAX: (301)-402-0066
Email: NekolaM@nia.nih.gov
Applicants may, if they wish, submit appendix materials on CD-ROM disks. If appendix materials are submitted as hard (paper) copies they should be comprised of unbound materials with separators between documents.
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 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 National Institute on Aging. 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
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.
Citizenship: Applicants must meet the citizenship requirements as described
in the Eligibility section of this announcement prior to award (Section III).
Concurrent Awards: Applicant 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 minimum 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 allowed for this program must be carefully justified annually and must 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.
Pre-Award Costs: 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 K01 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
In addition to the Supplementary Instructions in the
PHS 398 for Research Career Awards (Instructions, Part III, starting on page
44), the following information must be included in the application.
Candidate:
Describe the candidate's commitment to an academic career in aging and health disparity research. A strong candidate will demonstrate prior experience and productivity in health disparities research. Include a description of all of the candidate's professional responsibilities in the grantee institution and elsewhere and show their relation to the proposed activities on the career award.
Present evidence of the candidate's ability to interact and collaborate with other scientists.
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 experiences in health disparities research.
Provide evidence of the candidate's potential to develop into an independent investigator.
Include a statement that the candidate will commit at least 75% effort to career development activities. The mentor or department chair must agree and provide a statement in the application documenting that this percent of time will be protected.
Letters of reference:
Three sealed letters of reference addressing the candidate's potential for a research career in aging and health disparities research must be included as part of the application. The letters must be from references other than the designated mentor(s).
Statement(s) By Mentor(s)/Consultant(s)/Collaborator(s):
The candidate must name a primary sponsor (or mentor), who, together with the applicant, 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 aging and have a track record of success in training independent investigators.
The mentor should have sufficient independent research funding to support the proposed research project in excess of the allowable costs of this award.
Where feasible, women, individuals from diverse race and ethnic groups, individuals with disabilities and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research should be involved as mentors to serve as role models.
The application must include a statement from the mentor(s) 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; 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; and 4) an assessment of the candidate’s background in health disparities research, level of commitment to a career, and how this individual’s advancement in research will strengthen diversity in aging and health disparities research.
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).
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.
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, information should be provided that clearly documents expertise in the proposed area(s) 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. The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator 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 of the institution is particularly suited for the development of the candidate's research career 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 developing his/her research program, that the remaining percent effort will be devoted to activities related to the development of his/her 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 their award should include a letter of agreement from either the GCRC program director or the principal investigator as part of the application.
Career Development Plan:
The candidate and the mentor are jointly responsible for the preparation of the career development plan that reflects interest in aging and health disparities. A timeline is often helpful. The sponsor/mentor may form an advisory committee to assist with the development of the program of study or to monitor the candidate's progress through the career development program.
Describe a systematic plan: (1) that shows a logical progression from 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 in aging and health disparities; and (3) that utilizes the relevant research and educational resources of the institution.
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. The candidate must demonstrate they have received training or will participate in courses such as: basic science, gerontology, life course perspectives, minority health and health disparities, data management, epidemiology, study design, hypothesis development, etc., as well as the legal and ethical issues associated with research on human subjects.
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 conducting aging research related to minority health and health disparities.
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.
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. Complementary laboratory research directly related to minority health and health disparity research may be proposed in the application, thereby providing an opportunity for a career development experience in translational research.
Studies that involve clinical trials (biomedical and behavioral intervention studies) must include a description of the plan for data and safety monitoring of the research and adverse event reporting to ensure the safety of subjects (see Federal Citations in Section VIII).
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 instruction 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 regarding 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, and propose plans to receive 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.
Letters of Reference:
Include with the application three sealed letters of reference from well-established scientists addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator in aging and health disparities research. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three recommendations. All sealed letters of reference should be attached to the face page of the application.
Budget for the Entire Proposed Period of Support:
Follow the application instructions, providing only the total direct costs for each year and the entire proposed period of support. 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 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
Only the review criteria described below will be considered
in the review process.
The following will be considered in making funding
decisions:
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 the National Institute on Aging in accordance with the review criteria stated below.
As part of the initial merit review, all applications
will:
Review Criteria
The goals of 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. A major goal of this RFA is to support research career development in aging and health disparities research. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application.
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
Career Development Plan
Likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence, based on:
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. For candidates who require substantial didactic training as part of their program, the research plan may cover less than the full period of the award.
Training in the Responsible Conduct of Research
Statements By Mentor/Co-Mentor(s)
Environment and Institutional Commitment
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 and Minorities in Research: The adequacy of plans to include subjects from both genders
and all racial and ethnic groups (and subgroups) 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.
Contribution to Diversity in Aging and Health Disparity Research: The strength of the descriptions in the supporting letters of the mentor(s) and one other reference letter of how this individual's advancement in research will strengthen diversity in aging and health disparities research.
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
Not Applicable
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (See
the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr
and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making recommendations
about funding applications. Program staff may negotiate modifications of the
resource sharing plans with the awardee before recommending funding of an
application. The final version of the 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 NIH eRA
Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant.
For details, applicants may refer to the NIH Grants Policy Statement Part
II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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 that 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:
Usually, funds budgeted in an NIH supported research 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 3 months. For longer periods, prior written approval of the NIH funding 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 percent. 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 percent 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 percent effort 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
See http://grants.nih.gov/grants/guide/contacts/pa-05-143_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, program 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 a change of institution or termination is being considered, see http://grants.nih.gov/grants/guide/contacts/pa-05-143_contacts.htm.
A change of institution 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, and the qualifications of the proposed new mentor. 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 Principal Investigator is moving to another eligible institution, career award support may be continued provided:
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.
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.
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 in the general PHS Form 2590 instructions, as well as Sections g through j as described in Section IV of the 2590 instructions. Evaluation of the awardee's progress will encompass the following:
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.
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:
Dr. J Taylor Harden
Office of Special Populations
National Institute on Aging
31 Center Drive,
Bethesda, MD 20892-2292
Telephone: (301) 496-0765
FAX: 301-496-0765
Email: Taylor_Harden@nih.gov
2. Peer Review Contacts:
Dr. Mary Nekola, Chief
Scientific Review Office
National Institute on Aging
7201 Wisconsin Ave., #2C212
Bethesda, MD 20892-2292
Telephone: (301) 402-7702
FAX: (301)-402-0066
Email: NekolaM@nia.nih.gov
3. Financial or Grants Management
Contacts:
Linda Whipp, Chief
Grants and Contracts Management Office
National Institute on Aging, NIH
7201 Wisconsin Avenue
Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Fax: (301) 402-3672
Email: WhippL@mail.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.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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