Instructions for Disseminating and Implementing Evidence-based Computer-Tailored Cancer Control Interventions

• Eligibility Requirements
• Research Objective
• Funds Available
• Application Procedure
• Submission of Administrative Supplement Request Letter
• Review Considerations
• Review Criteria
• Award Criteria
• Required Federal Citations
• Authority and Regulations
• Inquiries

Supplement Title: Disseminating and Implementing Evidence-based Computer-Tailored Cancer Control Interventions
Available Funds: $600,000
Request Letter Receipt Deadline: January 15, 2010
First Possible Award Date: May 31, 2010

Eligibility Requirements

Applicants may request supplement funding for the qualifying R01, P01, P20, P50, U01, U19, or U54 intervention research awards provided the following conditions are met:

1. The proposed intervention dissemination must be relevant to the focus of the qualifying “parent” grant;
2. The proposed dissemination effort must be beyond the original scope of the parent grant;
3. The parent grant must remain active during the entire funding period of this supplement;
4. Computer-tailored interventions proposed for dissemination must have already been tested for their efficacy; and
5. The proposed dissemination effort must be completed within the period of supplemental funding (1 year).

Only the Principal Investigator of the parent grant may request the supplement.

Intervention research activities that are eligible for these supplements may span diverse areas of cancer control and include projects in areas such as:

• Prevention and cessation of tobacco use;
• Promotion of appropriate changes in diet and physical activity;
• Reduction of sun exposure and ultraviolet (UV) radiation exposure;
• Facilitation of informed decisions about genetic testing for cancer susceptibility;
• Enhancement of screening programs for breast, cervix, and colorectal cancers;
• Development and dissemination of improvements in coping skills and quality-of-life for cancer survivors and their families.

All modes of delivering computer-tailored interventions (print, web-based, mobile devices, etc.) are appropriate for these administrative supplements.

Foreign institutions are not eligible under this supplemental funding initiative.

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Research Objective

The purpose of these administrative supplements is to fund the dissemination of evidence-based computer tailored interventions and products.

The so-called “parent” grants that can be supplemented under this opportunity include only R01, P01, P20, P50, U01, U19, and U54 grants for which statistical significance and potential health/clinical significance suggest the merits of dissemination to a broader population than that from which the intervention study sample was originally drawn. These administrative supplements are designed to provide 1 year (maximum) of additional funding to eligible cancer control investigators who are Principal Investigators on eligible “parent” grants.

Applicants should pay attention to improvements in the intervention approach in light of any recent developments in behavioral science, health informatics, and related fields, including potential integration with existing cyberinfrastructure when warranted, such as the cancer Biomedical Informatics Grid (caBIG®) and/or the Nationwide Health Information Network(NHIN). Strong evidence that the target populations and the organizations serving those populations support adoption should be presented in the application. Applicants are encouraged to consider projects that demonstrate cost-effective interventions in addition to public health efficacy in changing or supporting behavior. Study designs other than the traditional randomized controlled trial may be appropriate to capture key process measures of adaptation, implementation, adoption, and sustainability. Study outcomes should not be limited to individual level behavior change, but should also include measures at the group and organizational levels regarding program adoption and use. In their applications, applicants may also address modification of existing interventions to fit practical needs for implementation among larger segments of target populations or larger numbers of organizational structures. Applicants may propose qualitative and/or quantitative studies regarding the adaptation and suitability of interventions. Regardless of study focus, proposed projects should have clear specific aims and strong evaluation components. Intervention research across the cancer control continuum that may be eligible for these supplements includes: prevention and cessation of tobacco use; promotion of appropriate changes in diet and physical activity; reduction of sun exposure and ultraviolet (UV) radiation exposure; facilitation of informed decisions about genetic testing for cancer susceptibility; increases in the uptake of screening for breast, cervix, and colorectal cancers; improving the quality of care; and improvements in coping skills and quality of life for cancer survivors and their families. While standard categories of scientific review will be used to evaluate each request, applicants should pay particular attention to the specific review criteria in each of these standard categories, as described below.

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Funds Available

The NCI intends to commit approximately $600,000 in FY 2010 to fund from three to four administrative supplements in response to this initiative. An applicant may request a project period of 1 year and a budget for total costs of up to $150,000 per year. Although the financial plans of the NCI provide support for this program, administrative supplement awards pursuant to this initiative are contingent upon the availability of funds and the receipt of a sufficient number of meritorious requests.

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Application Procedure

Grantees must identify the individual project for which they are seeking supplemental funds if the parent grant has multiple projects utilizing computer-tailored interventions. Multiple requests from grantees are acceptable if the parent grant has multiple projects. However, separate supplement request letters must be submitted for individual components of the parent grant.

All requests must include the following:

1. Cover letter:
   Request the supplement and identify this program.
   • If applicable, state intent to submit a request for a no-cost extension; and
   • Include the following statement: "Per supplement instructions, a detailed budget request is enclosed."
2. Cover page:
   • Item 1: The request letter must have the same title as the parent grant. Please include the number of the parent grant;
   • Item 2: Identify as "Administrative Supplement;"
   • Item 3: The request letter must have the same PI as the parent grant; and
   • Item 4: Request a single year of support. There must be an active parent grant during the entire funding period.
3. Detailed Budget of Initial Budget Period.
   • All applicants can request up to $150,000 in total costs per year and must provide a detailed budget.
4. Research Plan
   Provide a description of the proposed dissemination and evaluation plan and how it relates to the computer tailored intervention tested in the parent grant. This description 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 was completed), 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, U19, or U54 cooperative agreement award, explain how the project will fit within the cooperative agreement terms and conditions of award.

   The following materials should also accompany the request letter:

   1. Efficacy study publications and/or manuscripts;
   2. Individual biosketches for all key personnel (including updated bioscketches for those already on the parent grant); and
   3. Relevant letters of support from key partner organizations, which may plan to adopt the intervention.

Request letters should contain sufficient detail (similar to a standard research application) to allow assessment of the scientific merit of the proposed dissemination plans and the appropriateness of the request for supplemental funding.

All requests must include an itemized budget. Budget requests must not exceed $150,000 in total costs for a project period of up to 12 months.

Requests for supplements under this program must comply with NIH policies for inclusion of women, minorities, and children in research involving human subjects. All Institutional Review Board (IRB) documentation and site assurances must be submitted to the NCI in the supplement request.

(See later section for information regarding current policies.)

Applications must be signed by the Authorized Organizational Representative (AOR) at the grantee institution.

The earliest anticipated award date for this program will be May 31, 2010. 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 ENCOURAGED to discuss the efficacy data (e.g., effect sizes, consistency with prior research, relevance to target populations) supporting their administrative supplement request from the original project with their respective NCI research project Program Director prior to submission.

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Submission of Administrative Supplement Request Letter

Applicants are strongly encouraged to submit requests electronically as an e-mail attachment in pdf format; however, the signature of the AOR must be clearly visible. The e-mail address for electronic submission is: cvinson@mail.nih.gov.

Applicants may also submit applications on paper (original and four copies) to:

Cynthia Vinson, MPA
Dissemination and Diffusion Coordinator
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 6140
Bethesda, MD 20892-7338 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-594-5906
E-mail: cvinson@mail.nih.gov

Do not send supplement requests to the NIH Center for Scientific Review.

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Review Considerations

Upon receipt, request letters will be reviewed for completeness and for responsiveness by the NCI. Incomplete and/or non-responsive request letters will not be considered.

Request letters will be evaluated by NCI program staff (and appropriate consultants) who have expertise in the cancer control intervention area and/or in dissemination and diffusion research. Supplements will be awarded based on scientific merit, program relevance, and dissemination potential of the proposed interventions as well as on the availability of funds.

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Review Criteria

The goal of NCI-supported dissemination (administrative) supplements is to advance our understanding of effective strategies to encourage dissemination and adoption of evidence-based cancer control computer tailored interventions. The purpose is to improve the control and prevention of cancer and enhance health. The staff and consultants will evaluate the following aspects of the administrative supplement requests 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, weighting them as appropriate for each request. The administrative supplement request does not need to be strong in all categories in order for it to receive a favorable evaluation. 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 administrative supplement requests are listed below.

1. Significance. Do the intervention efficacy data justify dissemination? Does the dissemination of the proposed computer tailored 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?
2. 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, particularly as they apply to technology-based interventions? 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 for the computer tailored intervention once the supplemental funding period has ended?
3. Innovation. Does the proposed computer tailored intervention/dissemination process employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the intervention that is proposed for dissemination challenge existing paradigms, develop new methodologies or technologies, and take into account potential integration with cyberinfrastructure when warranted, such the cancer Biomedical Informatics Grid (caBIG®) and/or the Nationwide Health Information Network?
4. Investigator. Is the investigator appropriately trained and qualified to carry out this work? Does the investigator team include specific dissemination and health informatics expertise when relevant? Relevant letters of support from key partner organizations, which may plan to adopt the computer tailored intervention, are required.
5. 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?

To assess the potential for sustainable adoption of the computer tailored intervention and its use by the target population, the evaluation will examine the request letters for demonstration of the following items: the appropriateness of proposed project budget and duration; and the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the goals of the dissemination plans. Finally, the provisions for the protection of human subjects and the safety of the intervention environment will be examined.

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Award Criteria

Request letters for administrative supplements submitted to the Division of Cancer Control and Population Sciences, NCI, will be considered for award based upon the following considerations: (a) scientific and technical merit; (b) program relevance; (c) dissemination potential; (d) balance of cancer control topics; and (e) availability of funds. Special consideration will be given to requests that involve plans plan to disseminate interventions tested in low income and ethnically diverse populations.

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Required Federal Citations

ALL REQUIRED FEDERAL CITATIONS for PHS grants apply to this administrative supplement including the following:

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.html).

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.

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.

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 2010/2020:
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.

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Authority and Regulations:

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.

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Inquiries

Inquiries related to this notice should be addressed to the NCI Program Director for the particular R01, P01, P50, U01, or U19 grant for which the supplement is being requested. Before submitting an application, each applicant (i.e., Principal Investigator) is 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.

Direct inquiries concerning the programmatic and review matters to:

Cynthia Vinson, MPA
Dissemination and Diffusion Coordinator
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 6140
Bethesda, MD 20892-7338 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-594-5906
E-mail: cvinson@mail.nih.gov

Direct inquiries regarding administrative and financial aspects should be made to:

Crystal Wolfrey
Office of Grants Administration
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8634
E-mail: crystal.wolfrey@nih.gov

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