Instructions for Applying for a Supplement to R01, P01, P50 Grants and U01 and U19 Cooperative Agreements
Supplement Title: Disseminating Evidence-based Intervention Research Products
Available Funds: $1 million (total cost)
Letter of Intent Receipt Date: May 30, 2003
Application Receipt Deadline: June 30, 2003
Award Date: September 2003
Applications may be submitted by National Cancer Institute (NCI)-funded cancer control intervention research RO1, P01, P50, U01 and U19 grantees (domestic only) in one of three ways. First, applicants may apply for a supplement to the parent grant, in which the intervention was being tested and who are in the final two years of their funding period. There must be an active parent grant during the entire funding period of this supplement. If the parent grants ends before 9/30/03 the applicant has the following options:
- Apply for a no-cost extension for the parent grant.
- Investigators that have submitted a competing continuation application (Type 2) of their R01, P01, P50, U01 or U19 intervention research award may submit the supplement application if the Type 2 application does not include funding for the dissemination effort. In this particular case, the Type 2 must be awarded before 9/30/03 and the supplement (if awarded) will be linked to the Type 2 award to disseminate the evidence-based intervention tested in the original R01, P01, P50, U01 or U19 (Type 1) project.
Applicants may apply for a supplement to a related R01, P01, P50, U01 or U19 intervention research award, as long as the focus of this award is similar to the focus of the intervention dissemination supplement that is being proposed, the PI of the related grant is the same as the PI of the parent grant in which the intervention was originally evaluated, and there are no funds in the related award related to the proposed dissemination effort.
Foreign institutions are not eligible under this initiative. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators.
The purpose of these supplements is to fund the dissemination of promising interventions and products that have been developed and tested in the original R01, P01, P50, U01 or U19 (Type 1) project. This includes interventions where statistical significance and potential public health/clinical significance suggest the merits of dissemination to the broader population from which the intervention study sample was originally drawn. Applicants also should pay attention to improvements in the intervention approach in the light of any recent developments in the field. Moreover, there must be strong evidence that the target populations and the organizations serving those populations support adoption. The supplement also may support cost-effectiveness evaluations of interventions, qualitative and quantitative research needed to adapt intervention products for use after formal research evaluation has ended. Intervention research across the cancer control continuum that may be eligible for these supplements includes: tobacco use prevention and cessation, promotion of appropriate changes in diet and physical activity, reduction of sun exposure and UV radiation exposure, facilitating informed decisions about genetic testing for cancer susceptibility, enhancing screening for breast, cervix and colorectal cancers, improving the quality of care, as well as improving coping skills and quality of life for cancer survivors and their families. While standard categories of scientific review will be used to evaluate each application, applicants should pay particular attention to the specific review criteria in each of these standard categories, as described below.
The NCI intends to commit approximately $1,000,000 in FY 2003 to fund 4 to 5 competitive supplemental grants in response to this initiative. An applicant may request a project period of one year and a budget for direct costs of up to $125,000 per year, excluding Facility and Administrative costs on consortium arrangements. If there are extenuating circumstances that require a marginally larger budget, these should be well documented and justified. Although the financial plans of the NCI provide support for this program, awards pursuant to this initiative are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Applicants are to use the research grant application form PHS 398 (rev. 05/2001) to apply for these grants, with the modifications noted below. The 398 kit is available at: http://grants.nih.gov/grants/funding/phs398/phs398.html. P01 and U19 grantees must identify the individual project for which they are seeking supplemental funds. Multiple applications from P01 and U19 grantees are acceptable. However, separate supplement applications forms must be submitted for individual components of the parent P01 or U19 grant.
All sections of the PHS 398 package must be completed. The standard application instructions are modified as follows:
a. Cover letter:
- Request the supplement and identify this program.
- If applicable, state intent to submit a request for a no-cost extension.
- Include the following statement: "Per supplement instructions, a detailed budget request is enclosed"
b. Face page:
- Item 1: Application must have the same title as the parent grant.
- Item 2: Identify as "Supplement"
- Item 3: Application must have the same PI as the parent grant
- Item 6: Request a single year of support. There must an active parent grant during the entire funding period. Therefore, if the parent grant ends before 9/30/04, and the supplement is not attached to a Type 2 competitive renewal of the parent grant or a related grant, upon receipt of notification of award eligibility the grantee must apply for a no-cost extension.
c. Detailed Budget of Initial Budget Period
- Although all of the applicants will be requesting $125,000 in direct costs per year, and would normally use the modular budget mechanism, applicants must nevertheless provide a detailed budget as instructed under Item 4.
d. Research Plan
- Provide a description of the proposed dissemination and evaluation plan and how it relates to the intervention tested in the parent grant. This should include an introduction, intervention efficacy data justifying dissemination, relevance to target populations and settings for dissemination, proposed dissemination theory, strategies and methodology (all of the preceding incorporating new findings in the field since the intervention study commenced), procedures to assess dissemination program effectiveness, and plans to sustain effective dissemination approaches once the supplement funding period has ended (not to exceed 12 pages).
- Dissemination and evaluation plan needs to be informed by dissemination theories and include process measures tracking dissemination plan components.
- If the parent grant is a U01 or U19 cooperative agreement award, explain how the project will fit within the U01/U19 cooperative agreement terms and condition of award.
e. Intervention program descriptions and products (or copies) must be provided and made available for review for the Research-tested Intervention Programs Website (http://rtips.cancer.gov/rtips/index.do). Once the application is received, the PI will be contacted by the National Registry of Effective Programs for submission.
f. Efficacy study publications and/or manuscripts must be provided.
g. Include relevant letters of support from key partner organizations, which may plan to adopt the intervention.
Requests should contain enough detail to allow assessment of the scientific merit of the proposed dissemination plans and the appropriateness of the request for supplemental funding. Budgets should not exceed $125,000 in direct costs for a time period not exceeding 12 months. If there are extenuating circumstances that require a marginally larger budget, these should be well documented and justified. If this initiative is reissued, the grantee may request a second one-year administrative supplement to complete the dissemination work initiated in the first supplement year. Funding of the subsequent administrative supplement will depend on an administrative review of the first year's progress report and availability of funds. All requests require an itemized budget and must be signed by the grantee institution's business office. Requests for supplements under this program must comply with NIH policies for inclusion of women, minorities, and children in research involving human subjects. (See later section for information regarding new policies.)
The earliest anticipated award date for this program will be September 2003. Inquiries related to this notice should be addressed to the NCI Program Director for the particular R01, P01, P50, U01 or U19 for which the supplement is being requested. Applicants are STRONGLY ENCOURAGED to discuss the efficacy data (e.g. effect sizes, consistency with prior research, relevance to target populations) supporting their competing supplement request from the original project with their respective NCI research project Program Director prior to submission.
SUBMISSION OF APPLICATION
Submit a signed, typewritten original of the application, including the checklist, and five signed, exact, single-sided photocopies, in one package to:
Cynthia Vinson, MPA
Dissemination and Diffusion Coordinator
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., Suite 6146
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
Applicants are requested to submit a letter of intent to Jon F. Kerner by May 30, 2003. (See contact information for Jon Kerner located under the "INQUIRIES" section.) Applications must be received by June 30, 2003. If an application is received after that date, it will be returned to the applicant without review. The National Cancer Institute will not accept any supplement application in response to this supplement that is essentially the same as a competitive supplement currently pending initial review, unless the applicant withdraws the pending application. The NCI will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed. Revised applications must include an introduction addressing the previous critique.
Upon receipt, applications will be reviewed for completeness and for responsiveness by the NCI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration.
Applications that are complete and responsive to the supplement will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI Division of Cancer Control and Population Sciences in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique. Only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score.
The goal of NCI-supported dissemination supplements is to advance our understanding of effective strategies to encourage dissemination of evidence-based cancer control interventions. The purpose is to improve the control of disease and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed project will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories in order for it to receive a high priority score. For example, an investigator may propose to carry out important work that, by its nature, is not innovative but is essential to move a field forward.
The five categories of review criteria to be used in the evaluation of these supplemental grant applications are listed below.
- Significance. Do the intervention efficacy data justify dissemination? Does the dissemination of the proposed intervention address an important cancer control problem? If the aims of the proposed project are achieved, how will dissemination and implementation knowledge be advanced? What will be the effect on the concepts or methods that drive this field?
- Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the intervention that is proposed for dissemination? Has the applicant made appropriate changes in the intervention design based on the current state-of-the-art? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the applicant demonstrate an understanding of dissemination principles? Is the dissemination approach appropriate to the problem and population? Are the procedures to assess the dissemination program appropriate? Is the evaluation plan linked to the dissemination plan and does the evaluation incorporate the best available data to track dissemination process and impact (within the limits of temporal and budgetary constraints)? How appropriate are the plans to sustain effective dissemination approaches once the supplemental funding period has ended?
- Innovation. Does the proposed intervention/dissemination employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the intervention that is proposed for dissemination challenge existing paradigms or develop new methodologies or technologies?
- Investigator. Is the investigator appropriately trained and qualified to carry out this work? Does the investigator team include specific dissemination expertise? Relevant letters of support from key partner organizations, which may plan to adopt the intervention are required.
- Environment. Does the environment in which the dissemination work will be done contribute to the probability of success? Do the proposed approaches take advantage of unique features of the intervention delivery environment or employ useful, collaborative arrangements? Is there evidence of institutional support?
- The initial review group also will examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the goals of the dissemination plans, for the sustainable adoption of the intervention and for use by the target population. Finally, the review group will examine provisions for the protection of human subjects, and the safety of the intervention environment.
Applications recommended by the Division of Cancer Control and Population Sciences, NCI will be considered for award based upon (a) scientific and technical merit, (b) program relevance, (c) dissemination potential, and (d) balance of cancer control topics, and (e) availability of funds. Special consideration will be given to proposals that plan to disseminate interventions tested in low income and ethnically diverse populations.
REQUIRED FEDERAL CITATIONS
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.
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
All clinical trials supported or performed by NCI require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff to a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
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 research projects involving human subjects, unless a clear and compelling rationale and 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH-defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.
It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998.
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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply).
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://grants1.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. Reviewers are cautioned 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 letter RFA, Dissemination of Efficacious Cancer Control Interventions Tested in Effective Research Projects, is related to the priority area of cancer prevention and control. 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 No. 93.399 and 93.393. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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.
Direct Inquiries concerning the dissemination supplements and review matters to:
Jon F. Kerner, Ph.D.
Assistant Deputy Director for Research Dissemination and Diffusion
Division of Cancer Control and Population Sciences
6130 Executive Boulevard
Executive Plaza North, Room 6144
Rockville, MD 20852
Direct inquiries regarding fiscal matters to:
Ms. Crystal Wolfrey
Grants Administration Branch
6120 Executive Boulevard
Executive Plaza South, Room 243
Rockville, MD 20852