and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov)
Title: Cancer Education (R25E) Grants Program
Announcement Type
This is a reissue of PAR-03-093, which was previously released April 3, 2003
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-05-065
Catalog of Federal Domestic Assistance Number
93.398
Key Dates
Release Date: March 8, 2005
Letters of Intent Receipt Date(s.) Not applicable.
Application Receipt Dates(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information to be available. Not applicable
Expiration Date: August 30, 2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of AnnouncementProgram scope and aims: The Cancer Education Grant Program employs the R25 grant mechanism to provide funding for the development of innovative cancer education and research dissemination projects. R25 education grants may focus on education for a variety of target audiences: science or health care students with an interest in cancer research careers; established cancer scientists seeking short term educational updates in emerging cancer science areas such as genetics and molecular drug discovery; and health care providers in need of information on the latest developments in cancer prevention and control.
Grants targeting academic audiences should provide a rationale for the program in terms of clinical and scientific manpower needs. Grants targeting community professional or lay audiences should address NCI public health priority areas such as smoking prevention/cessation, cancer screening, nutrition and energy balance, health disparities, public health interventions, supportive care, quality of life for cancer survivors and palliative care. (More information about the NCI public health and science priorities is available at http://plan.cancer.gov/)
R25 cancer education grants may use a variety of formats depending on target audiences and aims. Grants aimed at educating students, cancer scientists, cancer care, clinicians or community health providers may develop and use primarily curriculum- based short term educational experiences, delivered in traditional settings as well as web-based and virtual approaches. Curriculum content may range from cancer biology and genetics to cancer prevention and control and palliative care. The R25 grant does not support long term research training and should not be used in place of National Research Service Award training mechanisms.
R25 applicants proposing to work with community organizations or community health care providers are encouraged to provide preliminary assessments of community, public health and/or professional need for the program and preliminary information on likely utilization by target groups. Preliminary evidence of program effectiveness in educating target audiences and/or in increasing demand for and implementation of evidence-based cancer prevention and control interventions is also highly desirable. These proposals should also include careful consideration of how their approach will reach ethnically and linguistically diverse communities.
All R25 grants supported by this PAR are required to include plans for evaluation and dissemination of the stated programs. (For a more detailed description of these requirements, see Section III.) All R25 grants involving educational interventions are strongly encouraged to provide explicit program evaluation models.
Research dissemination grants provide support for projects with a specific focus on the development and evaluation of educational approaches targeting public health workers, community organization partners, and clinicians in need of knowledge and tools to implement and disseminate cancer prevention and control programs and findings into patient and lay community populations.
R25 research dissemination grants have additional specific requirements. Research dissemination grants should link proposed education and dissemination activities to knowledge transfer approaches such as research-practice partnership models (e.g., community-based or clinic-based participatory research (CBPR), Push-Pull-Infrastructure models, diffusion of innovation models, expanding intervention reach models (e.g., RE-AIM), and virtual approaches to research dissemination (e.g., Cancer Control PLANET) http://cancercontrolplanet.cancer.gov. Additional Reference material on these and other dissemination and diffusion approaches can be found at http://cancercontrol.cancer.gov/d4d.
Program eligibility for the R25: The R25 program is primarily intended to support the development of innovative educational and research dissemination approaches that can be completed within five years. In addition, there are restrictions on eligibility for initial R25 funding. Programs that have had prior multi-year support for development and/or dissemination are not eligible for R25 funding. The R25 research dissemination grant does not provide implementation or maintenance support for established programs, including those proposing minor tailoring of the program to a new target population.
The R25 mechanism targeting community health care providers or community settings is intended to provide information needed to facilitate the diffusion of evidence-based findings within a relatively short time. The R25 grant is generally not appropriate for formative (e.g., pilot) research to develop new educational/research dissemination interventions or to develop new programs for which pilot information is not available on design or content.
The implementation of evidence-based cancer prevention and control interventions will require additional community-based resources. However, the R25 grant does not support training workshops or other efforts to teach community based individuals fund raising or grant application writing skills. All research dissemination grants must be theory- and research-based proposals to develop and test innovative approaches to diffusion and dissemination.
Renewal eligibility: Because of the R25 program's focus on innovation, there are restrictions on eligibility for renewal funding. Academic curriculum development and professional education curriculum development grants are not eligible for renewal. Other research-based education programs focused on the education of community members or community health care providers are not eligible for renewal. Short term or summer programs sponsored and taught by academic faculty and designed to motivate college or graduate students to pursue cancer related careers and programs to provide short term cancer education to research scientists are eligible for renewal. In order to qualify for renewal, these programs should demonstrate evidence of a successful training track record, evidence of innovation and/or scientific updating of curriculum and/or training experiences and techniques. All applicants considering submitting a competing renewal are strongly encouraged to consult with NCI program staff prior to submission.
The R25 grant is not the only mechanism available for cancer education and research dissemination activities. Following a period of NCI R25 support, effective research- tested intervention programs may be selected for inclusion on the Cancer PLANET (http://cancercontrol.cancer.gov/rtips/), an NCI web portal providing evidence based tools to cancer control planners and interventionists. Investigators with effective programs falling within the NCI strategic priority areas may also work with the NCI Office of Education and Special Initiatives (OESI) on dissemination and tailoring efforts (http://www.cancer.gov/aboutnci/oesi) or with the NCI Translating Research into Improved Outcomes (TRIO) program. (http://cancercontrol.cancer.gov/d4d/)
Supplemental and other research funding is available for education/dissemination research, preventive intervention development and studies to identify risk factors such as those needed to tailor interventions to special populations through the Division of Cancer Control and Population Sciences (http://cancercontrol.cancer.gov) and the Division of Cancer Prevention (http://www3.cancer.gov/prevention).
Examples of projects that may be funded through the R25 are provided below. These examples are meant to be illustrative, but not all inclusive, of possible topic areas.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism of Support
This funding opportunity will use the R25 award mechanism. New applicants may request up to five years of support in a single grant period in order to develop an evidence based education program. The maximum support in direct costs per year for new applications is $300,000. Renewal applications may request up to 10 percent above their last year's level of funding. Applicants will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity is not subject to "Just-in-time" application procedures but it is subject to the Streamlined Non-competing Application Process (SNAP). Independently from the amount requested, this funding opportunity uses a non-modular budget format described in the PHS 398 application instructions. (See http://grants.nih.gov/grants/funding/phs398/phs398.html.) A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
2. Funds Available
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
Eligibility to apply for a grant is limited to domestic institutions.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
Principal investigators on R25 grants typically have significant research experience and are leaders in educational activities in the area of the proposed grant.
2. Cost Sharing or Matching
Cost sharing is not required.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
The NCI requires that R 25 grant applications submitted in response to this announcement contain two special sections, an Evaluation Plan and a Dissemination Plan. Applications submitted without evaluation and dissemination plans will not receive further consideration.
Evaluation Plan: In the "Evaluation Plan," the application should clearly describe how the proposed education program/intervention and/or research dissemination program will be evaluated for success or failure based on its purposes and objectives.
Dissemination Plan: In the Dissemination Plan, the application should describe the extent of portability of the proposed program to other educational institutions, geographic areas and/or different populations. The dissemination plan should also indicate how the applicant will communicate and make available the results of the project (e.g., publications, presentations, web postings) to potential user communities (e.g., cancer centers, universities and other educational institutions, professional societies, communities etc.).
As noted in Section I.1 the R25 program is primarily intended to support the development of innovative educational and research dissemination approaches that can be completed within five years. Therefore these applications are generally not eligible for renewal. (See Section I.1 for details on renewal eligibility.) T here is also the expectation that programs, whose effectiveness is established during initial R25 funding, will be readily adoptable by the targeted community or professional groups. Therefore, the dissemination plan for these applications should clearly describe institutional and/or community support and resources anticipated to be available to the program.
Evaluation from NCI: In carrying out its stewardship of human resource related programs, the NCI may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified, that they may be contacted after the completion of this award for periodic updates on various aspects of the educational program including, but not limited to, achievement obtained through the program, trainee accomplishments, publications, dissemination, honors and awards, professional activities and other information helpful in evaluating the impact of the program.
Section IV. Application and Submission Information1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants should use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
Cancer Education Grant applications are expected to follow the instructions and Table of Contents provided in the PHS-398 application kit.
3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: Not applicable
Application Receipt Dates(s): http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1 Letter of Intent Receipt Date:
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional copies of the application and all five copies of the appendix material must be sent to:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496 3428
FAX: (301) 402-0275
Email: [email protected]
Appendices should be comprised of unbound materials with separators between documents.
3.C. Application Processing
Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by CSR and responsiveness by the NCI.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
In general, allowable costs on R25 grants must be consistent with NIH policy and the recommendations of peer reviewers. These costs include but are not limited to the following: personnel costs, supplies, support to defray student participation expenses, student compensation (when appropriate), student subsistence allowance (e.g., partial costs for meals and lodging and other travel expenses, when appropriate), other student costs (e.g.; tuition ) consultant costs, equipment, travel, sub-contractual costs and other expenses. It is recommended that potential applicants consult NCI staff if there are any questions regarding allowable costs. The R25 remains under "Expanded Authorities."
Facilities and administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-04-040. F&A costs for grantee institutions and third party institutions will be budgeted and reimbursed at a rate of 8 percent of modified total direct costs, exclusive of tuition and fees, expenditures for equipment, and sub-grants and contracts in excess of $25,000. State and local governmental agencies, except State universities or hospitals, and Indian tribal governments may receive full F&A cost reimbursement.
6. Other Submission Requirements
Plan for Sharing Research Data
Not applicable
Sharing Research Resources
NIH policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Section V. Application Review Information1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to NCI on the basis of established PHS referral guidelines.
Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. Incomplete and/or non-responsive applications will not be reviewed.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighing them as appropriate for each application.
1. Significance. Does this project address an important problem in cancer prevention or control; or does it address a significant educational goal related to manpower and training? If the aims of the application are achieved, how will educational practice and/or dissemination knowledge be advanced? What will be the effect of the project outcomes on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?
2. Approach. Are the conceptual or educational framework, design, methods, analyses and other methods and plans as mentioned in 2.A below (evaluation , dissemination) adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative approaches?
3. Innovation. Is the project original and innovative? For example: Does the project challenge existing dissemination paradigms or educational practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does the project provide for the application of new educational technologies or methods to significant cancer prevention and control problems or training needs?
4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria:
In addition to the above criteria, for the R25 Cancer Education Grant, NCI requires the following criteria to be addressed.
Evaluation plan. Does the project adequately describe how the success of the program will be evaluated in terms of achieving its objectives? Is the program evaluation linked to an adequately developed model? Curriculum based programs are expected to state educational goals and objectives and methods for measuring their attainment. Research dissemination programs are expected to link outcomes to their theoretical model.
The evaluation plan should also include consideration of resources available and measures to facilitate adoption of the program by targeted professional or community groups after a period of Federal support.
Dissemination plan. A dissemination plan to communicate and make available the results of the project through such means as publications in professional journals, presentations at national and international meetings, and internet websites is required.
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Not applicable
2.D. Sharing Research Resources
NIH policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
3. Anticipated Announcement and Award Dates
Not applicable
1. Award Notices
After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.
A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
Principal Investigators whose proposals have been selected for award will be notified either by electronic mail or by postal mail.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
2.A Cooperative Agreement Terms and Conditions
Not applicable
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency ContactsWe 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:
Mary C. Blehar PhD
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, suite 7019
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service )
Telephone: (301) 496-8580
FAX: (301) 402-4472
Email: [email protected]
2. Peer Review Contacts:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496 3428
FAX: (301) 402-0275
Email: [email protected]
3. Financial or Grants Management Contacts:
Ms. Catherine E. Blount
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard MSC 7150
Bethesda, MD 20892-7150
Rockville, MD 20852-7150 (for express/courier service)
Telephone: (301) 496-3179
Email: [email protected]
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.
Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public 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 PA 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.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
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NIH Funding Opportunities and Notices
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