Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Environmental Health Sciences (NIEHS) |
|
Funding Opportunity Title |
Transition to Independent Environmental Health Research (TIEHR) Career Development Award (K22) |
Activity Code |
K22 Career Transition Award |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PA-12-188 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.113 |
FOA Purpose |
The Transitions to Independent Environmental Health Research (TIEHR) Career Development Award is a 3-year bridge scholar development program for newly independent faculty who intend to pursue careers focused on environmental health sciences research. At the conclusion of the career development period the candidates are expected to demonstrate they can successfully compete for research funding in the environmental health sciences.. |
Posted Date |
May 16, 2012 |
Open Date (Earliest Submission Date) |
September 12, 2012 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
Standard dates apply , by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
|
Earliest Start Date(s) |
Standard dates apply |
Expiration Date |
New Date May 23, 2016 per issuance of NOT-ES-16-009. (Original Expiration Date: May 08, 2017) |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
The Transitions to Independent Environmental Health Research (TIEHR) Career Development Award is a 3-year bridge scholar development program for newly independent faculty. This award is intended to provide junior faculty the pilot funding and salary support during this critical period of career development so that he/she can further develop his/her independent research program and, subsequently, successfully compete for research funding in the environmental health sciences at the completion of the award.
This award is for newly independent investigators (within 3 years of their first independent faculty appointment) who have independent research space and resources at their institution. Although this is not a mentored award, the candidates must name a sponsor (either at their own or another Institution) who has active NIEHS grant support or a substantial history of NIEHS funded research grant support, and who will agree to: (1) assist in the establishment of an advisory committee with appropriate research expertise for the candidate; (2) attend at least two meetings of the advisory committee, including one to provide feedback on an R01 draft of a grant submission; (3) sponsor the candidate at meetings largely attended by other NIEHS grantees. Advisory Committee members may be established faculty at either the candidate’s institution or at another institution. Members should be chosen for their expertise in the research project proposed by the candidate. Proposed committee members do not need to be named in the application, but the candidate and the proposed sponsor should describe the research expertise to be sought in the Advisory Committee. If the committee members are external to the applicant organization, funds for travel and consultation may be included in the budget for this purpose.
A letter from the Department Chair outlining the institutional commitment to the candidate, including 1) information about the start-up package which was provided to the candidate at the start of the faculty appointment,, and 2) specifically any commitment to the candidate at the completion of the 3-year award is also required.
The award is intended to promote the faculty development of scientists who intend to make a long term commitment to research in the environmental health sciences.
Career Development and research plan applications submitted in response to this FOA will be expected to be responsive to both the mission of the NIH and, specifically, to the mission of the NIEHS. The mission of the NIH is defined as science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability. The mission of the NIEHS is distinguished from that of other Institutes by its focus on research programs seeking to link the effects of environmental exposures to the cause, mechanisms, moderation, or prevention of a human disease or disorder or relevant pathophysiologic process. For purposes of this announcement, all applications should demonstrate, as a rationale for the study, a direct and significant endpoint associated with a specific human disease, dysfunction, pathophysiologic condition, or relevant human biologic process; and propose to focus on the human health effect of a toxicant exposure relevant to the mission of the NIEHS. Examples of relevant toxicants include, but are not limited to, industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, and bacterial or biologically derived toxins. Agents considered non-responsive to this announcement include, but are not limited to, alcohol, chemotherapeutic agents, radiation which is not a result of an ambient environmental exposure, smoking, except when considered as a secondary smoke exposure as a component in the indoor environment (particularly in children), drugs of abuse, pharmaceuticals, dietary nutrients, and infectious or parasitic agents, except when these are disease co-factors to an environmental toxicant exposure to produce the biological effect. Applications which propose to study only model compounds must provide a clear, reasonable and specific description as to how research on the model compound will lead to a better understanding of the mechanisms involved in responses to specific environmental agents which are included in the mission responsibility of the NIEHS. The peer review committee will assess whether or not the applicant has made sufficient justification to study the model compound. Ecologic and environmental monitoring studies, bioaccumulation, environmental engineering or ecologic degradation studies are not considered to be within the mission interest of the NIEHS unless a significant human exposure biology component is included in the proposed research plan.
Funding Instrument |
Grant |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
|
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. |
Award Budget |
Award budgets are composed of salary and other program-related expenses, as described below. |
Award Project Period |
The total project period may not exceed 3 years. |
Salary |
NIEHS will contribute up to $75,000 plus fringe benefits per year toward the salary of the career award recipient. |
Other Program-Related Expenses |
NIEHS will contribute $50,000 per year toward the research development costs of the award recipient, which must be
justified and consistent with the stage of development of the candidate and
the proportion of time to be spent in research or career development
activities. |
Indirect Costs |
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. |
NIH grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are
not eligible to apply.
Foreign components, as defined in the NIH
Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
- Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
- Grants.gov
- eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI is invited to work with his/her sponsor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Multiple Program Director(s)/Principal Investigator(s)
are not allowed for this FOA.
By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status),
Candidates for this award must have earned a terminal clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD., or equivalent doctoral degree), or a combined clinical and research doctoral degree.
Candidates must be within 2 years of their first independent faculty position at the time of submission of the first application, and within 3 years at the time of submission of any amended application.
Applications from candidates who are in positions which are tenure track or equivalent are encouraged to apply. Candidates whose position is not tenure track must demonstrate institutional commitment and include documentation from the institution that the candidate has independent laboratory and/or other space, and that the position: 1) qualifies the candidate to hire postdoctoral fellows and be the responsible supervisor of graduate students; 2) allows the candidate to attend and participate in faculty meetings; 3) allows the candidate to apply for independent research funding as the principal investigator of an NIH R01 or equivalent research grant; 4) is not contingent on the award of this grant application.
Applications from newly appointed faculty who have received start-up packages from their institution are eligible and encouraged to apply. It is noted that if the institution has provided salary support for research effort consistent with the career development experience outlined in this award, the salary offset may be rebudgeted into "Other Program Expenses."
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed. An individual may not have two or more competing NIH career development applications pending review concurrently.
Candidates may submit research project grant (RPG)
applications concurrently with the K application. However, any concurrent RPG
application may not duplicate the provisions of the career award application. K
award recipients are encouraged to obtain funding from NIH or other Federal
sources either as a PD/PI on a competing research grant award or cooperative agreement
or as project leader on a competing multi-project award as described in NOT-OD-08-065.
Candidates are eligible for a K22 award if they have been, or currently are, the PD/PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the provisions or research goals of an R03 or R21 grant. Individuals are NOT eligible to apply if they have pending an application for any other PHS career development award, another NIH institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals are not eligible to apply if they have been or are currently a PD/PI on an NIH research grant (such as R01, R29, P01) or a subproject leader on a Program Project (P01) or Center Grant (P50), or a non-NIH equivalent to these grants/awards.
At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. The sponsoring institution must demonstrate a commitment to the candidate by providing a minimum of nine person-months (75% full time professional effort) protected research time. 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 relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.
Before submitting the application, the candidate must identify a sponsor who will guide the proposed career development and research experience. The sponsor should be an active investigator in the Environmental Health Sciences (a history of NIEHS R01, P50 or P01 grant support) and be committed to the career development of the candidate. The sponsor may be at the same or different institution than the candidate. The candidate's previous postdoctoral sponsor may not serve as the sponsor for the candidate. The sponsor, or a member of the team of sponsors, should have a successful track record of mentoring. Candidates are encouraged to identify more than one sponsor, i.e., a team of sponsors, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the principal sponsor who will coordinate the candidate’s career development experience. The candidate must work with the sponsor(s) in preparing the TIEHR application and the subsequent R01 application. The sponsor should also sponsor the candidate to present research at meetings largely attended by other NIEHS supported grantees, if the candidate is not a member of the appropriate society.
This Advisory Committee should meet fomally six months after
the issuance of the award to asess progress, and 18 months after the award to
provide feedback on the draft of a research project grant submission.
The sponsor and the Department Chair should describe the career development plan
for the candidate (coordinated with the candidate’s research strategy). The
research environment and the availability and quality of needed research
facilities and research resources (e.g., equipment, laboratory space, computer
time, available research support, etc.) must also be described.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate’s Background (Component of Candidate Information)
- Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.
- Provide evidence of the candidate's potential to develop further into a successful independent investigator. Usually, this is evident from publications, prior research interests and experience, and letters of reference.
- Present evidence of the candidate’s success to-date as an independent investigator and his/her potential to make future contributions to research in the environmental health sciences research.
- Explain how the career award will contribute to career goals, and further the candidate’s research career and ultimate impact on science.
- Provide an explanation as to how relief from non-research and non-sponsoring responsibilities will contribute to the development or expansion of the candidate’s research program and increased level of commitment to sponsoring new investigators.
- Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of the NIH.
Career Goals and Objectives (Component of Candidate Information)
- Describe a systematic plan that: (1) shows a logical progression from prior research and training experiences to the research and career development activities that will occur; (2) justifies the need for further career development as an independent investigator; and (3) utilizes the relevant research and educational resources of the institution.
- Describe a systematic plan that shows a logical progression from prior research and training experiences to the research and training experiences that will occur during the K22 award period.
Career Development/Training Activities During Award Period (Component of Candidate Information)
- The candidate, the sponsor, and the Chair of the Department are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The candidate and sponsor should propose an Advisory Committee as described above.
- Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Include a plan to obtain the necessary research experience to further the independent research career.
- Describe the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
Training in the Responsible Conduct of Research (Component of Candidate Information)
Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in Chapter 7 of the SF424 (R&R) Application Guide.
Statements by Sponsor, Co-sponsor(s), Consultants, Contributors (Component of Statements of Support)
- The candidate must name a primary (sponsor), who, together with the candidate, is responsible for the planning, direction, and execution of the program. The candidate may also identify co-sponsors as appropriate to the goals of the program.
- The sponsor(s) should be recognized as an accomplished investigator with expertise relevant to the proposed research area and have a track record of success in training individuals in postdoctoral and early faculty positions who have gone on to become independent investigators.
- The sponsor, Department Chair, and any co-sponsors should provide a statement of his/her areas of expertise and responsibility. Co-sponsors should clearly describe how they will coordinate sponsoring of the candidate. If any of the co-sponsors is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings.
- Signed statements must be provided by each collaborator/consultant 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 collaboration/consultation. Any other opportunities for the candidate’s professional growth should also be documented in these statements.
- The sponsor(s) must agree to provide annual evaluations of the candidate’s progress, as required in the annual progress report.
Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)
- The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
- Describe the sponsoring institution’s scientific environment including the resources and facilities that will be available to the candidate.
Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to 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 the award. The sponsoring institution must provide the candidate with the appropriate facilities and other resources to carry out the proposed Research Plan.
Research Strategy (Component of 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. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
- If the candidate is at the same institution as the former postdoctoral sponsor, the application must also describe the relationship between the former postdoctoral sponsor’s research and the candidate’s proposed research plan. Independence must be demonstrated, and the proposed sponsor must be scientifically independent of the previous postdoctoral sponsor. The application should also describe how the research plan carried out during the 3-year transition phase will be used to develop a research grant submission. It is expected that an R01 research grant submission will be an outcome of the career development plan in the third year.
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted. Applications lacking the appropriate, required reference letters will not be reviewed (more details in the Notice). This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
Applicants are
responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.
Information on the submission process and a definition of on-time submission are
provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
Applications must be submitted electronically following the
instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the
application due date. Section III. Eligibility
Information contains information about registration.
For assistance with your electronic application or for
more information on the electronic submission process, visit Applying
Electronically.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Important Update: See
NOT-OD-16-012 and
NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.
Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.
For this announcement, note the following: This career development funding
opportunity announcement is intended to aid the transition of newly independent
faculty and allow them to successfully compete for research funding sooner than
would be possible without this support. It is meant to foster the research careers
of individuals with a long-term commitment to environmental health science
research in Institutional settings which promote such career development.
Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Candidate
Has the candidate's record to-date
demonstrated the capacity to carry out independent research? Is the
candidate’s academic, clinical (if relevant), and research record of high
quality? Does the candidate have potential to become an outstanding scientist
who will make significant contributions to the field of environmental health
sciences? Is there evidence of past and present research productivity as
evidenced by contributions to the scientific literature, and what is the
candidate's perceived potential success in obtaining independent funding? Has
the candidate demonstrated the ability to conceptualize and organize a
long-term research approach? Is the candidate’s level of training, experience,
and competence commensurate with the purposes of the award?
Career Development Plan/Career Goals & Objectives
What is the likelihood that the
award will contribute substantially to the continued scientific development and
productivity of the candidate? Are the career goals and objectives consistent
with the candidate’s career goals? Are the content, scope, phasing, and
duration of the career development plan appropriate when considered in the
context of prior training/research experience and the stated training and
research objectives? Are there adequate plans for monitoring and evaluating
the candidate’s research and career development progress? Is there evidence
that the award will enable the candidate to devote full time (at least the
required minimum percentage of full-time professional effort) to research and
related duties by release from teaching, administration, clinical work, and
other responsibilities?
Research Plan
Are the proposed research question, design, and methodology of significant scientific and technical merit? Is the research plan of high quality, and does it have potential for advancing the field of study? Does the research proposed have the potential to provide the basis to develop into an independent research application? Is the research plan an appropriate vehicle for developing the prospective mentee’s skills and capabilities? Do the research and career development plans together further the candidate’s research career? Is the research plan relevant to the candidate’s research career objectives?
Sponsor(s), Co-Sponsor(s), Consultant(s), Collaborator(s)
Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration? Have the proposed sponsor(s), consultant(s), and collaborator(s) provided evidence of commitment to the candidate and the candidate’s project? Do the proposed sponsor(s), consultant(s)/collaborator(s) provide the required expertise for successful conduct of the research project?
Environment & Institutional Commitment to the Candidate
Is the level of the applicant institution’s commitment to the scientific development of the candidate appropriate? Are there adequate and appropriate research facilities and educational opportunities, including collaborating faculty? Is there clear commitment of the sponsoring institution to ensure that the required effort of the candidate will be devoted directly to the research training, career development, and research activities described in the proposed career development and research plans? Is there strong institutional commitment to fostering the career development of the candidate? Are there unique features of the scientific environment that benefit the proposed research; e.g., useful collaborative arrangements or subject populations? Is the environment of high quality and relevance for scientific and professional development of the candidate?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: (1) risk to
subjects, (2) adequacy of protection against risks, (3) potential benefits to
the subjects and others, (4) importance of the knowledge to be gained, and (5)
data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: (1) the justification for the exemption, (2) human
subjects involvement and characteristics, and (3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable.
Revisions
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Training in the Responsible Conduct of Research
Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsoror other faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIEHS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
- May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
- Will receive a written critique.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.
Information regarding the disposition of applications is available in the NIH Grants
Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Sponsor’s Report must include an annual evaluation statement of the candidate’s progress.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants 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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Service Desk(Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Carol Shreffler, Ph.D.
Program Officer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1445
E-mail: [email protected]
Linda Bass, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1307
Email: [email protected]
Wanda Boggs
Grants Management Specialist
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316--4638
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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 Part 52 and 45 CFR Parts 74 and 92.
