Title: Research Supplements to Promote Diversity in Health-Related ResearchAnnouncement Type
Update: The following update relating to this announcement has been issued:
The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) hereby notify Principal Investigators holding specific types of NIH research grants, listed in the full Funding Opportunity Announcement (FOA) that funds are available for administrative supplements to improve the diversity of the research workforce by supporting and recruiting students, postdoctorates, and eligible investigators from groups that have been shown to be underrepresented. Although the administrative supplements supported under this program provide funding for less than one percent of all individuals involved in NIH supported research, the NIH has found these awards to be an effective means of encouraging institutions to recruit from currently underrepresented groups. Administrative supplements must support work within the scope of the original project.
All NIH Institutes and Centers (ICs), the NIH Common Fund, and the National Institute for Occupational Safety (NIOSH, CDC) participate in this program. Candidates eligible for support under this supplement program include individuals at various career levels who come from groups that have been shown to be underrepresented in science. Such candidates include individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds. Detailed eligibility criteria are described in the full announcement.
Table of Contents
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
3. Other - Special Eligibility Criteria
Section IV. Application and Submission
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
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 and Information
Section V. Application Review Information
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
3. Award Criteria
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
1. Research Objectives
The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) hereby notify all Principal Investigators holding any of the NIH research grants (listed below) that funds are available for administrative supplements to support and recruit students, postdoctorates, and eligible investigators. Administrative supplements must support work within the scope of the original project.
Although the NIH currently provides multiple opportunities to develop research careers and improve participation for individuals from groups with low representation in the biomedical and behavioral sciences, reports from the National Science Foundation (NSF), (see http://www.nsf.gov/statistics/wmpd/) and others provide strong evidence that diversity remains an important problem that the entire research enterprise must actively address.
There is abundant evidence that the biomedical and educational enterprise will directly benefit from broader inclusion. Recent studies have supported the argument that diversity enhances the quality of education in multiple settings. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings. There is limited evidence that individuals who have participated in the NIH administrative supplement program preferentially conduct research in areas related to health disparities or minority health. There is no question that the need for a diverse workforce permeates all aspects of the nation's health-related research effort.
Although the administrative supplements supported under this program provide funding for less than one percent of all individuals involved in NIH supported research, the NIH has found these programs to be an effective means of encouraging institutions to recruit from currently underrepresented groups. Data on prior NIH administrative supplement programs are available at http://grants.nih.gov/training/outcomes.htm. All NIH awarding components participate in this program. This program is designed to provide support for research experiences for individuals from the identified groups throughout the continuum from high school to the faculty level. Continuation of this program in the future will be dependent on frequent evaluation of the career outcomes of the individuals who receive support as well as continuing assessments of the diversity of the scientific workforce as reported by the NSF and others.
Recruitment and Retention to Enhance Diversity
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.
Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.
The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:
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 data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americas, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the US Pacific Islands. In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be included in the recruitment and retention plan.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates (a) have qualified for Federal disadvantaged assistance; or (b) have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program; or have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.
1. Mechanism(s) of Support
Principal Investigators at domestic institutions who hold an active R00, R01 (or RL1), R10, R18, R22, R24, R35, R37, R43, R44, R41, R42, DP1, DP2, P01 (or PL1), P20, P30, P40, P41, P50, P51, P60, U01 (or UL1), U10, U19, U41, U42, U54 grant may be eligible to submit a request for an administrative supplement to the awarding component of the parent grant. Because policies may vary among awarding components regarding eligibility of Small Grant Awards (R03), Academic Research Enhancement Awards (R15), Support of Continuous Research Excellence (SC1, SC2, SC3), or Exploratory/Developmental Grants (R21) for supplements under this program, grantees holding those awards must check with the appropriate awarding component before submitting an application for a supplement (http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm). Supplements to the R15, R03 and the R21 may provide support above the established dollar limits for the parent grant award. The P20, P30, and P60 award mechanisms are eligible for supplements only if they contain research components. The Support of Continuous Research Excellence (SC1, SC2, SC3) award mechanisms are only eligible for supplements to support postdoctoral fellows and faculty. In all cases, the mechanism of support under this program is the supplemental award.
At the time of a supplemental award, the parent grant must have support remaining for a reasonable period (usually two years or more). Applications may be submitted to support high school students, undergraduate students, post-baccalaureate students, post-master's degree students, graduate students, individuals in postdoctoral training, or faculty members who will participate in the ongoing research project. Specific eligibility requirements relative to each level of award are set forth in the description of the individual supplement programs (shown in Section III.2, below). This program also will provide additional support for established NIH investigators and project leaders on components of program projects and center grants who become disabled.
2. Funds Available
The NIH expects to make more than 1,000 administrative supplements under this program at a total cost exceeding $60 million. Direct costs for individual administrative supplements vary from less than $5,000 to more than $75,000 depending on the career level of the candidate (see Section III.3). Requests for administrative supplements can be submitted to the NIH Program Official listed in the contacts section at any time (http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm). Administrative supplements end with the competitive cycle of the parent grant.
1. Eligible Applicants
Only institutions currently receiving eligible NIH grant awards may submit an application for Diversity supplements.
The following organizations/institutions are eligible to apply:
For the purpose of this announcement, institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The strength of an institution's description and justification for the appointment of an identified candidate will be judged along with all other aspects of the proposed experience (see review criteria in Section V.1).
Awards under this program are limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of an Alien Registration Receipt Card or some other legal evidence of admission for permanent residence at the time of application).
Before submitting an application for a research supplement, applicants are strongly encouraged to contact their program administrator to discuss the program (http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm).
The NIH believes that by providing research opportunities for qualified individuals at various career levels, the number entering and remaining in health-related research careers will increase. Accordingly, Principal Investigators are encouraged to consider administrative supplements under this program for candidates at the following career levels:
Special Considerations related to each career level are discussed in Section III, 3.
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
In all cases, the proposed research experience must be an integral part of the approved, ongoing research of the parent grant and it must have the potential to contribute significantly to the research career development of the candidate. Applications for supplements must include a plan for the candidate to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge regarding the selected area of biomedical science. It must also provide evidence of a focus on the enhancement of the research capability of the underrepresented or disadvantaged student or faculty member and that the research experience is intended to provide opportunities for development as a productive researcher. In addition, it must demonstrate that the Principal Investigator is willing to provide appropriate mentorship.
Usually, a parent grant may support only one individual on a supplement. However, investigators are encouraged to recruit more than one high school or undergraduate student for support by a supplemental award. Appointment of more than one individual to a single grant above the high school or undergraduate level depends on the nature of the parent grant, the circumstances of the request, and the program balance of the NIH awarding component. Candidates may receive support from only one supplement program at a time, but may be supported by more than one supplement during the development of their research careers. Support under the supplement program is not transferable to another individual or transportable to another institution.
These programs have been designed to attract individuals from underrepresented groups into research careers and are not intended to provide an alternative or additional means of supporting individuals who already receive support from an NIH research grant, an NIH National Research Service Award (NRSA), or any other DHHS funding mechanism. Graduate students or individuals in postdoctoral training who are supported by an Institutional NRSA may not be transferred to supplemental support prior to the completion of their appointed period of training. Individuals may not be transferred to a supplement to increase the availability of funds to the parent grant for other uses.
Applicants are strongly encouraged to contact the NIH institute staff prior to submission to obtain specific information about eligibility and preparing and submitting an application (http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm).
In addition to eligibility provisions discussed in the general procedures, there are special considerations associated with different career levels. The following describes special requirements for High School Students; Undergraduate Students; Post-Master's and Post-Baccalaureate Degree Students; Graduate Students; Postdoctoral Researchers; Faculty Level Researchers, and Individuals who Become Disabled.
High School Students: The purpose of this program is to provide high school students with an opportunity to obtain a meaningful experience in various aspects of health-related research to stimulate their interest in careers in biomedical, behavioral, clinical or social sciences. Any eligible high school student who is currently enrolled and in good standing at her or his high school and is interested in biomedical, behavioral, clinical or social research is encouraged to participate in this program.
Undergraduate Students: This supplement program provides an opportunity for undergraduate students interested in health-related research to participate in a research project during the summer months and/or during the academic school year. This experience is separate from any requirement of the regular academic program. The student may be affiliated with either the applicant institution or another academic institution. Any eligible undergraduate student interested in health-related research is encouraged to participate in this program.
Post-Baccalaureate And Post-Master's Degree Students: This supplement will provide opportunities for recent baccalaureate or master's degree graduates who wish to spend up to two years engaged in health-related research while applying for admission to graduate or medical school. The duration of the program is normally one year, but the research experience can be extended for an additional year if evidence is provided to show that the candidate is actively pursuing entry into a graduate or a health professions school. This program may not be used to provide technical support to NIH-supported investigators. Recent graduates who have earned either a bachelor's or master's degree in a health-related science are eligible for consideration. Students who plan to attend medical, dental or other professional schools are encouraged to use this program to gain research experience.
Graduate Research Assistants: The objective of this program is to reach out to graduate students already in biomedical, behavioral, clinical or social sciences and provide an opportunity to further develop their research capabilities. However, students who are currently supported on research or training grants may not be supported on research supplements. Any eligible graduate student who is enrolled in a master's or a research doctoral degree program in biomedical, behavioral, clinical or social sciences is eligible for consideration. Students in medical school or other professional schools are encouraged to use this program to gain research experience. Students in Ph.D. degree programs who are supported on supplements are encouraged to apply for the Ruth L. Kirschstein National Research Service Award, or similar types of support (e.g. dissertation grants) from the NIH, other federal agencies, or private organization.
Individuals in Postdoctoral Training: These supplements provide research support to permit individuals in the postdoctoral phase of their training to participate in ongoing research projects. This experience must serve as a means of assisting the postdoctoral fellow's development into productive researcher in a health-related science. Postdoctoral fellows who are currently being supported on research or training grants may not be supported on research supplements. Supported candidates should be encouraged to submit applications for fellowships, research grants, and other sources of independent support before the supplement period ends. The individual in postdoctoral training may be affiliated with either the applicant institution or some other institution. Only under extraordinary circumstances, which must be well justified in the application, would it be acceptable for the postdoctoral candidate to work with his/her former predoctoral mentor.
Investigators Developing Independent Research Careers: These supplements provide either short or long-term research support for faculty members to enhance their research skills and establish an independent research career.
Short-term Investigator Research Supplement: This supplement provides short-term support for faculty members to conduct full-time research for three to five months each year during the summer or another portion of the academic year, over a maximum period of four years.
Long-term Investigator Research Supplement: This supplement provides long-term research support for faculty members to conduct research in the biomedical or behavioral sciences. Support is usually provided for up to two years at a minimum of 9 person months (equivalent to 75% effort) during each 12-month period.
In both cases, the investigator may be affiliated with the applicant institution or some other institution. The investigator must have a doctoral degree, be beyond the level of a research trainee, typically employed at the junior faculty level (instructor or assistant professor) with at least one year of postdoctoral or equivalent research experience. The candidate is still eligible if they have previously received support from these programs: the Minority Biomedical Research Support (MBRS) Program, Minority-Research Infrastructure Support Program (M-RISP), the Minority Access to Research Career (MARC) Program, Career Opportunities in Research Education and Training (COR), Small Grants (R03), National Research Service Award (NRSA) predoctoral (F31) and postdoctoral (F32) fellowships, or the Academic Research Enhancement Award (AREA) Program (R15). On the other hand, an individual who has received previous funding from NIH as an independent Principal Investigator on a regular research grant (e.g., R01, R29), or as the project leader on a component of a program project or center grant (e.g., P01, P50, G12), or as Principal Investigator on an individual research career award (e.g., KO1, K02, K07, K08, and K12) is not eligible.
Supplements for Established Investigators Who Become Disabled: Established investigators on NIH research, program project, or center grants who become disabled during the current project period may request funds for reasonable accommodations to permit completion of the currently funded research project. Any currently funded Principal Investigator or Co-Investigator (hereinafter referred to as Established Investigator) on an NIH research project grant, program project grant, or center grant may request support for special equipment, an assistant, or other modifications to facilitate reasonable accommodation to a disabling injury or illness that has occurred during the current project period.
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. 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 PHS 398 research grant application forms. Applications must have a Dun and Bradstreet (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. The D&B number should be entered on the face page of the PHS 398 form.
See Section VI.2 for additional information.
The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.
A request for a supplement may be submitted at any time. In making requests, the grantee institution, on behalf of the Principal Investigator of the parent grant and in cooperation with the candidate must submit the request for supplemental funds directly to the awarding component that supports the parent grant. The request should not be submitted to the NIH Center for Scientific Review. The Principal Investigator must submit one original and two copies of the application to the address listed under the appropriate awarding component under Agency Contacts in Section VII.1 (http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm).
The request for a supplemental award must include the following:
3. Submission Dates
Applications must be mailed directly to the awarding component and may be mailed at any time. However, some ICs have specific application submission dates. See http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm.3.A. Receipt, Review and Anticipated Start Dates
A letter of intent is not required for the funding opportunity.3.B. Sending an Application to the NIH
A request for a supplement may be submitted at any time. In making requests, the grantee institution, on behalf of the Principal Investigator of the parent grant and in cooperation with the candidate must submit the request for supplemental funds directly to the awarding component that supports the parent grant. The request should not be submitted to the NIH Center for Scientific Review. The Principal Investigator must submit one original and two copies of the application to the address listed under the appropriate awarding component in the “Inquiries” section of this document.3.C. Application Processing
Applications are received and evaluated for completeness by NIH staff within the awarding component that supports the parent grant.
Although there may be no immediate acknowledgement of the receipt of an application, applicants are generally notified of the decision to fund the supplement within approximately ten weeks after receipt.4. Intergovernmental Review
This initiative is not subject to intergovernmental review.5. Funding Restrictions
All 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 (See also Section VI.3).
Awards are based on the current programmatic needs of the NIH awarding component, therefore investigators must contact their program administrators at the NIH before applying (http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm). The decision to fund a supplement will take approximately ten weeks from receipt of a complete application
In competing renewal applications, funds for continuation of support of the supplemental award will depend on the successful renewal of the parent grant and will be handled as follows:
For students who have not yet completed their research experience, funds for the continuation of support must be requested as a research supplement to ensure continued tracking of the individual supported. The request for continued support should not be included in the competing renewal, but instead, should be prepared as a letter with information on research progress and accomplishments of the candidate. The request must be addressed to the program administrator of the parent grant and must be submitted promptly in anticipation of a renewal award to avoid an interruption of support. Support for individual students by the supplement mechanism will be limited to five years. Additional time may be considered, particularly for students and investigators who have disabilities, but must be well justified.
Funds for the continuation of support for a postdoctoral fellow or an investigator must be requested by name in the parent grant application at the time of renewal and may not be requested as a research supplement. Postdoctoral fellows and investigators are expected to be fully integrated in the research laboratory when considered for continuation of support.
Supplement awards must be consistent with the goal of strengthening the existing research program and with the overall programmatic balance and priorities of the funding component of the NIH. Awards will be made according to the policies and provisions stated in this announcement or as further specified by the NIH component funding the parent grant. The award limits listed in this document for each career level represent the support the NIH will provide. An award does not preclude the institution's use of funds from other sources to supplement the award.
Applicants for summer-only research appointments must submit early enough to ensure that funding is in place by the time the summer experience is scheduled to begin. In most cases, during the first budget period, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on continued funding of the parent grant and cannot extend beyond the current competitive segment of the parent grant and the availability of funds.
Reasonable Accommodations: As part of these awards, funds may be requested to make changes or adjustments in the research setting that will make it possible for qualified individual with a disability to perform the essential functions associated with his/her role on the project. The accommodations requested under this program must be DIRECTLY related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under these awards include: specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations requested from the supplement must be reasonable in relationship to the direct costs of the parent grant and the nature of the supplement award.
High School Students: The salary for a high school student, whether full- or part-time, should be consistent with the institutional salary policies. Institutional salary rates for high school students which exceed the hourly minimum wage must be justified. Equipment may not be purchased with these funds. Students are expected to devote sufficient effort to the research project and related activities during the period of support to gain insight into the process of scientific discovery. Support for at least three months is encouraged during any one year. This may include a mixture of full-time summer experience and part-time experience during the school year. Principal Investigators are encouraged to seek high school students who will devote at least two years to this program (i.e., equivalent to two three-month, full-time periods). Exceptions to the latter will be considered, depending on the circumstances of the applicant, the parent grant, and the specific request.
Undergraduate Students: The salary for an undergraduate student should be consistent with the institutional salary policies. Institutional rates for undergraduate salary that exceeds $10 per hour must be justified. An additional amount of $200 per month for supplies and travel may also be requested. Equipment may not be purchased using these funds. Students are expected to devote the equivalent of at least three months of full-time effort to the research project and related activities in any one year and, in most cases, the period of support for any individual should last at least two years. Exceptions to these requirements will be considered, depending on the circumstances of the applicant, the parent grant, and the specific request.
Post-Baccalaureate And Post-Master's Degree Students: The salary for students at the post-baccalaureate and post-master's degree levels should be reasonable and consistent with the institutional salary policies and can not exceed the amount allowed for graduate students. Additional funds up to $3,000 per year may be requested for supplies and travel. Funds may not be used to purchase equipment.
Graduate Research Assistants: The NIH will provide salary support in addition to other necessary expenses, such as supplies and travel, to enable the individual to participate as a graduate research assistant in funded research project. The NIH will provide compensation that (1) conforms to the established, consistently applied salary and wage policies of the institution and (2) reflects the percentage of time devoted to the PHS-funded project. For graduate students this compensation may include tuition remission paid as, or in lieu of, wages provided that the student is in a bona fide employer-employee relationship with the institution for the work performed, and payment is made explicitly for performance of necessary work. The total amount requested for salary, tuition and fringe benefits can not exceed the amount allowable for a first year postdoctoral fellow (i.e., level zero) at the same institution performing comparable work (see NIH Guide announcement, http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html. Additional funds up to $4,000 per year may be requested for supplies and travel. Funds may not be used to purchase equipment.
Individuals In Postdoctoral Training: The NIH will provide support for salary in addition to other necessary expenses, such as travel and supplies, to enable the candidate to participate as a postdoctoral research assistant or associate on the funded research project. The requested salary and fringe benefits must be in accordance with the salary structure of the grantee institution, consistent with the level of effort, and may not exceed $50,000 per year. However, exceptions to this rule may be made. Applicants must check with their program administrators at the NIH before submitting an application. The supplement budget may include up to $6,000 for supplies and travel for the candidate. These funds may not be used to purchase equipment.
Investigators Developing Independent Research Careers: The requested salary and fringe benefits for an investigator should be consistent with the level of support provided by NIH Career Development Awards. When that is not appropriate, the requested salary and fringe benefits can be up to $85,000 total direct cost. This includes the candidate's salary of up to $75,000 per year plus fringe benefits, in accordance with the salary structure of the grantee institution, and must be consistent with the level of effort. Additional funds of up to $10,000 may be requested for supplies and travel. Equipment may not be purchased except in unusual circumstances and not without prior approval of the NIH awarding component. The maximum period of support for any investigator is usually two years. Applicants must contact the NIH staff listed under Inquiries prior to submission to obtain specific information about preparing and submitting an application (http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm).
Supplements for Established Investigators Who Become Disabled: Support will be limited to items that will permit the investigator to complete the remaining years of a currently funded research project. This might include: salary support for an individual who can assist the Established Investigator in meeting the goals of the research project, specialized equipment such as computers, or modifications of the working environment. In all cases, the requested support must be consistent with the type of disability and the nature of the approved research. The total amount of support requested under this supplement must be reasonable in relationship to the direct costs of the parent award and the Established Investigator's role and effort on the project. In future competing applications, funds for continuation of the accommodations provided under this supplement must be requested in the parent grant application and may NOT be requested as a research supplement.6. Other Submission Requirements and Information
Resource Sharing Plan(s)
The staff of the NIH awarding component will review requests for a supplement to determine its overall merit. The following general criteria will be used:
Applications submitted for this funding opportunity will be assigned to the awarding component for the parent grant and will be reviewed using the criteria shown above.3. Merit Review Criteria
Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications using the criteria shown in Section V.1.3.A. Additional Review Criteria:
In addition to the above criteria, the following items will be applied only when it has not been previously reviewed as part of the parent grant:
3.C. Resource Sharing Plan(s)
The following resource sharing policies do not apply to this FOA:
Approximately ten weeks after receipt of the application, applicants will be notified of the intent to award. Staff at the awarding component will describe the award process at that time.2. Administrative Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA.3. Award Criteria
Awards are based on the current programmatic needs of the NIH awarding component, therefore investigators must contact their program administrators at the NIH before applying (http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm). The decision to fund a supplement will take approximately ten weeks from receipt of a complete application.4. Reporting
In non-competing continuation applications, the progress report and budget for the supplement must be clearly delineated from the progress report and budget for the parent grant. The progress report must include information about the research and career development activities supported by the supplement even if support for future years is not requested. Continuation of support for the candidate in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent grant and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the PHS Non-Competing Grant Progress Report, Form 2590, which can be found at http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement. In the future, identifying information on candidates supported by supplements will be collected at the beginning of the supplement period and at the beginning of each award year in order to evaluate the impact of this program on the candidate’s career development.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:
For general information about the diversity supplements, candidates and Principal Investigators should contact the program official of the parent grant at the appropriate awarding IC. Candidates who have not yet made contact with a Principal Investigator are encouraged to contact the program official whose IC is specific to the research interest (http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm).2. Peer Review Contacts:
Not Applicable.3. Financial or Grants Management Contacts:
Applicants should refer to the NIH Web site (http://grants.nih.gov/grants/guide/contacts/pa-08-190_contacts.htm) for information regarding each IC's grants management contact for this program.Section VIII. Other Information
Choose all citations that are appropriate to the funding opportunity announcement.
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, June 12, 1998: 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, 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.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see
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://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). 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.
Access to Research Data through the Freedom of
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.
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 that is available at http://grants.nih.gov/grants/funding/children/children.htm.
Required Education on the Protection of Human Subject
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 (see http://escr.nih.gov/) It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.
Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at .
Standards for Privacy of Individually Identifiable Health
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 web site (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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance 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, 510, 515, and 504 of the Public Health Service Act. Federal regulations at 42 CFR Part 52, "Grants for Research Projects" and 45 CFR part 74, "Administration of Grants," are applicable to these awards. Grants must be administered in accordance with the NIH Grants Policy Statement (10/98).. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
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