Application Instructions for Administrative Supplements to Study Economic Impact of Interventions Targeting Cancer Survivors and/or their Families
FY2008 Guidelines and Information for Applicants
- Eligibility Requirements
- Background/Research Objective
- Funds Available
- Application Procedure
- Submission of Administrative Supplement Request
- Review Considerations
- Award Criteria
- Required Federal Citations
- Authority and Regulations
Supplement Title: Administrative Supplements for Economic Impact Studies of Interventions for Cancer Survivors and/or their Families
Available Funds: $1,000,000
Request Receipt Deadline: June 9, 2008
First Possible Award Date: September 1, 2008
The Office of Cancer Survivorship (OCS) of the National Cancer Institute (NCI) announces for the Federal fiscal year of 2008 the opportunity for grantees to seek administrative supplemental funding for existing NCI funded behavioral and/or psychosocial interventions among cancer survivors and/or their family members. This initiative, known as the Economic Impact Studies of Interventions for Cancer Survivors and/or their Families, should be within the scope of the active original grant. Current NCI awardees of R01, P01, P50, U01, and U19 grants pertinent to cancer survivorship intervention research may apply for an administrative supplement provided the following conditions are met:
- The original cancer control grant or cooperative agreement involves a psychosocial or behavioral intervention that is delivered to cancer survivors or their family members during or after cancer treatment and designed to improve post-treatment health or well-being;
- Costs for the proposed economic or health services outcome component cannot have been included in the original award;
- The original award must have a minimum of two years remaining on the grant to be eligible for funding under this supplement; and
- The Principal Investigator (PI) for the supplement must be the PI of the original award.
Foreign institutions and organizations are not eligible under this supplemental funding initiative. Contracts are not eligible for supplements under this mechanism.
The following links may be helpful:
- Active Cancer Control Research Grants:
Office of Extramural Research (for forms)
The purpose of these administrative supplements is to fund the addition or inclusion in the design of the planned psychosocial and/or behavioral intervention study of information on the economic or health services impact of the intervention being delivered.
A number of different behavioral, supportive and educational interventions may be helpful in improving the quality of life and functioning of patients during and after cancer treatment. However, studies rarely assess the associated economic impact of these interventions. Understudied aspects include: (i) relative cost of intervention delivery (versus usual care); (ii) potential impact of such interventions on the associated medical care costs; (iii) healthcare utilization of study participants; and (iv) intervention impact on other societal cost indicators (such as employment and out-of-pocket expenses). Such data are needed to provide a clear direction for policy and practice changes to improve cost efficacy of healthcare delivery.
Optimizing the cost of delivering quality cancer care is a specific goal of the NCI’s Strategic Plan. This goal is important, given increasing cancer burden related to an aging population and constrained financial resources for healthcare. Cost-benefit studies are essential to identify the most cost-effective current and new cancer control interventions. This knowledge can facilitate rational and optimal decisions and resource allocation aimed at maximizing benefits while minimizing costs.
Projects proposed for supplemental funding should examine how information regarding the healthcare utilization and/or cost-impact analysis would be used to inform survivors and/or their families about the role of the intervention in improving their health-related outcomes. Applicants should also indicate how the availability and use of this information is expected to impact planning and/or policy decisions at the level of healthcare providers and/or other organizational levels (e.g., practice groups, clinics, and treatment centers). Specific outcomes of interest could include, but are not limited to:
- Cost of administering the intervention (e.g., personnel effort, materials);
- Cost-effectiveness analysis of interventions (e.g., studies that describe the cost-effectiveness of an intervention using data on both costs and intervention outcomes that are "internal" to the original study);
- Impact of the intervention on participants’ healthcare utilization;
- Impact of the intervention on the adherence to medical treatment(s);
- Data on out of pocket expenses associated with participation in the intervention;
- Impact of the participation in an intervention on the survivors’ employment status (or the employment status of their primary caregivers); and
- Changes in the need for medications associated with intervention status.
Investigators applying for these supplements are strongly encouraged to establish appropriate collaborations to secure unique expertise related to the impact of cost considerations in the implementation of standards for quality cancer care. These collaborations may involve, for example, experts in economic analysis or health services research and/or researchers/practitioners. It is also recommended that applicants requesting supplemental funding have a plan for sharing their findings with the behavioral researchers/practitioners as well as cancer clinical community.
Note: Funding priority will be given to projects that assess the effects of interventions conducted among low income and ethnically diverse populations. Such studies may involve the assessment of either economic impact or health services utilization.
The NCI intends to commit approximately $1,000,000 in FY 2008 to fund 5-7 administrative supplements in response to this initiative. An applicant must request a project period of one year. The budget for total costs is limited to $200,000. 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.
Applicants are encouraged to discuss their administrative supplement request with their respective NCI research project Program Official of the original award prior to submission.
Use the PHS 398 Form Pages (http://grants.nih.gov/grants/funding/phs398/phs398.html). Follow standard PHS 398 instructions for font size.
P01 and U19 grantees must identify the individual project for which they are seeking supplemental funds. Multiple requests from P01 and U19 grantees are acceptable. However, separate supplemental requests must be submitted for individual components of the original P01 or U19 grant.
All requests must include the following:
- Cover letter: Request the supplement and refer to the NIH Guide Notice number NOT-CA-08-012. Identify the eligible original grant and indicate the start date of this original award. If appropriate, provide length of time the intervention study has been open to accrual. Include the following statement: "Per supplement instructions, a detailed budget request is enclosed."
- PHS 398 Face page (PHS 398, Form Page 1):
- Item 1: The request must have the same title as the original award. Please include the number of the original award.
- Item 2: Identify as NOT-CA-08-012 "Economic Impact Studies of Interventions for Cancer Survivors and/or their Families"
- Item 3: The request must have the same PI as the original award.
- Item 4: Request a single year of support. There must be an active original award during the entire funding period.
- PHS Biographical Sketch Format Page: For key personnel. Involvement by personnel with expertise in economic, cost-efficacy and/or health services research is highly encouraged.
- PHS Other Support Format Page – Documentation of active research funding (i.e., NIH, other federal, private sources, etc) for all collaborating investigators.
- Detailed Budget for Initial Budget Period (PHS 398, Form page 4)
- All applicants can request up to $200,000 in total costs and must provide an itemized budget and must be signed by the grantee institution's business office.
- Research Plan (Strictly limited to 7 pages total)
- Include the specific aims, projected outcomes and significance (not to exceed 2 pages).
- Study design (not to exceed 5 pages). Design must be presented in adequate detail to allow scientific evaluation of the feasibility.
- Literature Cited
- Relevant letters of support.
Post Award Requirements
Final Report: Within 90 days after the conclusion of the funded activity, the PI must submit to their respective original grant Program Officials a Final Progress Report that includes a description of the activities and outcomes and an assessment of the success in meeting the stated aims and objectives, including identification of problems if encountered.
The earliest anticipated award date for this program will be September 1, 2008. 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.
Requests for these administrative supplements must be submitted to DCCPS (see address below) as described in these program guidelines. This is a one-time announcement and formal requests must be received on or before June 9, 2008. Late applications will not be accepted. Note that the NIH Center for Scientific Review (CSR) IS NOT involved in receipt and processing of these requests. Applicants are strongly encouraged to submit their administrative supplement requests electronically as an e-mail attachment in PDF format; however, the scanned application must include the signature of the AOR.
If sending an electronic PDF copy, the email address is email@example.com. DO NOT submit application via Grants.gov as the NIH Center for Scientific Review (CSR) IS NOT involved in receipt and processing of these request
Submit a signed, typewritten original of the request and five signed, single-sided photocopies, in one package to:
Keith M. Bellizzi, Ph.D., M.P.H.
Office of Cancer Survivorship
Division of Cancer Control and Population Sciences
National Cancer Institute
6116 Executive Boulevard, Suite 404, MSC 8336
Bethesda, MD 20892-8336 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Administrative supplement requests that are complete and responsive to the supplement announcement will be evaluated for scientific and technical merit by NCI program staff (and appropriate outside consultants) who have expertise in behavioral and/or psychosocial intervention research and/or health services research. Applications will be evaluated on the following criteria:
- Significance. Will the planned analyses add to the understanding of the economic and health services impact of the intervention delivered? If the aims of the proposed project are achieved, will decision-making regarding future use of the intervention tested be advanced? Does the proposed work show promise for dissemination or application in other intervention settings?
- Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the assessment proposed? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the applicant demonstrate an understanding of cost utility or health services research techniques? Are the measures being used appropriate to the target outcomes of interest and study population? Is the analytic approach appropriate to the methods proposed?
- Innovation. Does the proposed economic or health services assessment employ novel concepts, approaches, or methods? Are the aims original and innovative? Are the results of this study likely to lead to a new line of research or changes in the way the intervention is delivered?
- Investigator. Is the investigator appropriately trained and qualified to carry out this work? Does the investigator team include specific economic or health services research expertise?
- Environment. Does the environment in which the work will be done contribute to the probability of success? Do the proposed approaches take advantage of unique features of the planned intervention study? Is there evidence of institutional support?
Requests for administrative supplements will be considered for award based upon the following criteria: a) scientific and technical merit of the proposed study; b) the appropriateness of proposed project and duration; c) the adequacy to include both genders, minorities and their subgroups, and children as appropriate for the goals of the outcomes assessment plans; and d) availability of funds.
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); and 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/archive/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.
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.
Direct inquiries concerning the impact on economic and health services research of survivorship interventions and administrative review matters to:
Julia H. Rowland, Ph.D.
Director, Office of Cancer Survivorship
Division of Cancer Control and Population Sciences
National Cancer Institute, NIH/DHHS
6116 Executive Blvd, Suite 404, MSC 8336
Bethesda, MD 20892-8336
Joan L. Warren, Ph.D.
Epidemiologist, Health Services and Economics Branch
Applied Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute, NIH/DHHS
6130 Executive Blvd, MSC 7344
Bethesda, MD 20892-8336
Direct inquiries regarding fiscal matters to:
Ms. Crystal Wolfrey
Office of Grants Administration
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)