and Human Services (HHS)
EXPIRED
Research on the Economics of Diet, Activity, and Energy Balance
PA Number: PA-05-009
Department of Health and Human Services (DHHS) Participating Organizations Components of Participating Organizations
National Cancer Institute (NCI/NIH), (http://www.nci.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases, (NIDDK) (http://www.niddk.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov/)
Announcement Type
New
Updates: The following updates relating to this announcement have been issued:
Catalog of Federal Domestic Assistance Number(s)
93.393, 93.399 (NCI); 93.847, 93.848 (NIDDK); 93.286 (NIBIB); 93.866 (NIA)
Due Dates for E.O. 12372
Not Applicable
Executive Summary
Obesity has become a major focus of public health efforts at the national, State, and local levels. The major focus of the Program Announcement (PA) is to solicit projects that enhance the state-of-the-science on the causes of obesity and to inform federal decision making on effective public health interventions for reducing the rate of obesity in the United States. Research strategies that nest economic analysis within a broader interdisciplinary context of other social and behavioral sciences as well as the epidemiological, bio-statistical, medical, and biological disciplines relevant to public health policy are especially encouraged.
This PA will use the NIH exploratory/development (R21) award mechanism and the NIH investigator-initiated research project grants (R01) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applicants without extensive preliminary data or who wish to develop research methodology or instruments to address a specific question are urged to submit applications for this PA using the exploratory/developmental grant (R21) mechanism. Investigators are encouraged to seek continued support after completing an exploratory/developmental grant project through a research project grant (R01). For the R21 award mechanism, the applicant may request a project period of up to 2 years with a combined budget for direct costs of up $275,000 for the 2-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. For the R01 award mechanism, the applicant may request a project period of up to 5 years. (Please note that facilities and administrative [F&A] costs requested by any consortium participants are excluded from the direct cost limit per NIH Guide Notice NOT-OD-04-040.) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html)
You may submit (an) application(s) if your institution has any of the following characteristics: for-profit or non-profit; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State and local governments; eligible agencies of the Federal government; domestic or foreign institutions/organizations; and faith-based or community-based organizations.
Individuals eligible to become principal investigators: 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.
Telecommunications for the hearing impaired: TTY 301-451-5936
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
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
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
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
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilites
4. Arbitration Process
3. Award Criteria
4. 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 Announcement
Obesity has become a major focus of public health efforts at the national, State, and local levels. The major focus of the Program Announcement (PA) is to solicit projects that enhance the state-of-the-science on the causes of obesity and to inform federal decision making on effective public health interventions for reducing the rate of obesity in the United States. Research strategies that nest economic analysis within a broader interdisciplinary context of other social and behavioral sciences as well as the epidemiological, bio-statistical, medical, and biological disciplines relevant to public health policy are especially encouraged.
1. Research Objectives
Nature of the research problem:
This PA is intended to make funding opportunities in the area of energy balance (i.e., the relationship between diet, physical activity, and obesity) known to researchers with expertise and experience in health economics and health services research who might otherwise not be aware of the opportunity to apply these disciplines to this area. This PA also aims to foster collaborative activities between researchers from these disciplines and more traditional researchers of cancer and other chronic diseases. Research areas supported by this PA include: consumer economics, industrial organization, community structure, policy, cost-effectiveness/cost benefit studies. A multidisciplinary research approach that integrates economics research in one or more of these areas with knowledge and methodologies from other social and behavioral sciences, and/or with epidemiological and clinical research is strongly encouraged (Hill 2004).
Pertinent background information:
Approximately 35 percent of U.S. adults 20 or older are overweight (i.e., have a body mass index [BMI] of 25 to 29.9), and an additional 30 percent are obese (i.e., have a BMI that is greater than or equal to 30) (Hedley 2004). Among children, an estimated 16 percent of children ages 6-11 are overweight, over twice as much as two decades ago. Among adolescents ages 12-19, the percentage of obesity has more than tripled from 5 to 16 percent (Hedley 2004).
Although overweight and obesity occur in all population groups, their prevalence varies by age, gender, race and ethnicity, and socioeconomic status. For example, the prevalence of overweight and obesity increases with advancing age in both men and women, but starts to decline after the sixth decade. Overweight and obesity are more prevalent among minority women than among non-Hispanic white women, but Mexican-American men are more likely to be overweight or obese than non-Hispanic whites or non-Hispanic blacks. Racial and ethnic disparities in overweight also occur among children and adolescents. Socioeconomic status also impacts the prevalence of overweight and obesity. Women of lower socioeconomic status (income less than or equal to 130 percent of poverty threshold) are approximately 50 percent more likely to be obese than women with incomes greater than 130 percent of poverty threshold. However, the likelihood that men will be overweight or obese is approximately equal regardless of socioeconomic group. (Surgeon General's Call to Action, 2001). The association between socioeconomic status and prevalence of overweight/obesity is weaker among girls less than or equal to 19 years old than among women, and family income is not reliably associated with overweight prevalence among Mexican American and non-Hispanic black children and adolescents, although low-income non-Hispanic white adolescents are more likely to be overweight than those from higher-income families (Troiano 1998).
Existing research indicates that weight, physical activity, and nutrition alter cancer risk and carcinogenesis for many cancers, and evidence is accumulating on the effect of these health factors on cancer prognosis and quality of life among cancer survivors. A recent study of a very large prospective cohort of 900,000 U.S. adults estimated that overweight and obesity in the US could account for 14 percent of all deaths from cancer in men and 20 percent of those in women (Calle, 2003). An International Agency Research on Cancer (IARC) review, Weight Control and Physical Activity , summarized the evidence across basic and population research and estimated that between one-quarter and one-third of the cases of many common cancers may be attributable to the combined effect of increased body weight and inadequate physical activity (IARC, 2002).
Research to date on economic factors related to diet, activity, and energy balance has been mainly limited to how individuals respond to broad changes in technology, price, and income conditions, although there has been limited consideration of broader policy and social-structural factors. The evidence base for this research has mainly been restricted to aggregated statistical associations that make it difficult to identify and evaluate specific causal mechanisms and to design effective public health interventions. For example, several economic studies have found associations between obesity and such factors as the decreasing monetary and time costs of food, the increased availability of restaurants, especially fast-food restaurants, the increasing value time associated with increased labor force participation, and the decreasing physical activity associated with work (Philipson 1999, 2001; Chou 2002, Cutler 2003). While these observations are suggestive of the importance of trends in technology, market structure, relative prices, and availability of food, these associations do not, in themselves, explain the specific food consumption and physical activity patterns that lead to obesity and why these patterns differ across individuals and, systematically, across socioeconomic groups. These observations also fail to provide information on the cost-effectiveness of individual, community or policy-level interventions designed to address the problem of obesity.
Examples of the types of research topics and approaches that would be relevant areas of investigation for the development of R01 and R21 grant applications under this PA include, but are not limited to:
Consumer Economics
Industrial Organization
Community Structure
Policy
Cost-effectiveness / Cost-Benefit studies
This PA will use the NIH exploratory/development (R21) award mechanism and the NIH investigator-initiated research project grants (R01) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applicants without extensive preliminary data or who wish to develop research methodology or instruments to address a specific question are urged to submit applications for this PA using the exploratory/developmental grant (R21) mechanism. Investigators are encouraged to seek continued support after completing an exploratory/developmental grant project through a research project grant (R01).
For the R21 award mechanism, the applicant may request a project period of up to 2 years with a combined budget for direct costs of up $275,000 for the 2-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. See the link at http://grants.nih.gov/grants/funding/r21.htm. For the R01 award mechanism, the applicant may request a project period of up to 5 years. (Please note that facilities and administrative [F&A] costs requested by any consortium participants are excluded from the direct cost limit per NIH Guide Notice NOT-OD-04-040 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html.)
This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise, follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.
2. Funds Available
No set-aside funds are available for this PA. The awards are $275,000 direct cost for the 2-year period for R21 grants. R01 grants are expected to be in the range of $200,000 - $500,000 direct cost per year for 3 years.
Section III. Eligibility Information
1. A. Eligible 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.
2. Cost Sharing
This program does not require cost sharing as defined in the current NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility CriteriaSection IV. Application and Submission Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. 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 PHS 398 research grant application instructions and forms (rev. 5/2001). 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 DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form.
All instructions for the PHS 398 (rev. 5/2001) must be followed. Please see the link for the NIH Exploratory/Developmental Research Grant Award Program at http://grants.nih.gov/grants/funding/r21.htm for specific instructions on submitting R21 applications.
See also Subsection VI.2., Administrative Requirements, for additional information.
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.
3. Submission Dates
Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit.
3. A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Dates: not applicable
Application Receipt Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
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, type written original of the application, including the checklist, and five 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
Bethesda, MD 20817 (for express/courier service)
3. C. Application Processing
Applications must be received on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Applications will be evaluated for completeness by CSR.
The NIH will not accept any application in response to this PA 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
5. Funding Restrictions
All 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. Award Criteria)
6. Other Submission Requirements
Grantees should plan to attend annual meetings of investigators funded under this PA for the purpose of reporting on research progress and sharing information with other investigators on data resources, methodology, analytical tools and preliminary results. Applicants should include the cost of attending this meeting in their proposed research budgets.
Attendance at meeting here
Specific Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,
3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application http://grants.nih.gov/grants/policy/data_sharing. The funding organization will be responsible for monitoring the data sharing policy.
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy requires that grant awardees make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at 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 data sharing plan and the resources sharing plan 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) (see also Section VI.3. Award Criteria).
Section V. Application Review Information
This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.
Not applicable.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
3. Merit Review Criteria
The goals of NIH's supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve 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.
1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
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?
3.A. Additional Review Criteria:
In addition to the above criteria, the following items will 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.
3. 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.
3. C. Sharing Research Data
1. Data Sharing Plan: The reasonableness of the data sharing plan (http://grants.nih.gov/grants/policy/data_sharing) or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy.
3. D. Sharing Research Resources
NIH policy requires that grant awardee 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 at http://grants.nih.gov/grants/policy/nihgps and at http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan that addressies addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590) (see also Section VI.3. Award Criteria).
Section VI. Award Administration Information
After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a summary statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm.
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.
The NGA will be sent via email to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398.
2. Administrative 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 at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable.
3. Award Criteria
The following will be considered in making funding decisions:
4. Reporting
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. (Add any IC specific reporting requirements not in the GPS or 2590.)
We encourage your inquiries concerning this PA 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
Martin L. Brown, Ph.D.
Applied Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN Room 4005, MSC 7344
Bethesda, MD 20892-7344
Telephone: 301-496-5716
Fax: 301-435-3710
Email: [email protected]
James Everhart, M.D., M.P.H.
Chief, Epidemiology and Clinical Trials Branch
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 655, MSC 5450
Bethesda, MD 20892-5450
Telephone: (301) 594-8878
Fax: (301) 480-8300
Email: [email protected]
Peter Moy, Ph.D.
Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Room 200, MSC 5469
Bethesda, MD 20892-5469
Telephone: 301-451-4778
Fax: 301-480-1614
Email: [email protected]
John W. R. Phillips, Ph.D.
Behavioral and Social Research Program
The National Institute on Aging
7201 Wisconsin Avenue
Gateway Building, Room 533, MSC 9205
Bethesda, MD 20892-9205
Telphone: (301) 496-3138
Fax: (301) 402-0051
Email: [email protected]
Deborah H. Olster, Ph.D.
Office of Behavior and Social Science Research (OBSSR)
National Institutes of Health
One Center Drive Building 1, Room 256, MSC 0183
Bethesda, MD 20892-0183
Telephone: (301) 451-4286
Fax: (301) 402-1150
Email: [email protected]
2. Peer Review Contacts:
Not applicable.
3. Financial/Grants Management Contact
Crystal WolfreySection VIII. Other Information
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. See 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. (See the NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998, at 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 (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible.
Investigators should seek guidance from their institutions, on issues related to institutional policies, 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://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). 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 that is available at 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 (see 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.
References:
Allison DB, Fontaine KR, Manson JE, Stevens J, Van Itallie TB. Annual deaths attributable to obesity in the United States. JAMA 1999;282:1530-1538.
Anderson PM, Butcher KF, Levine PB. Maternal employment and overweight children NBER Working Paper #8770, National Bureau of Economic Research. Cambridge, MA, 2002.
Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, Obesity, and Mortality from Cancer in a Prospectively Studied Cohort of U.S. Adults . N Engl J Med 2003;348(17):1625-1638.
Chou S, Grossman M, Saffer H. An Economic Analysis of Adult Obesity: Results from the Behavioral Risk Factor Surveillance System NBER Working Paper #9247, National Bureau of Economic Research. Cambridge, MA, 2002.
Connoly, C. Public Policy Targeting Obesity. The Washington Post. Sunday, August 10, 2003; Page A01. Available at http://www.washingtonpost.com/ac2/wp-dyn/A39239-2003Aug9?language=printer.
Cutler D, Glaeser E, Shapiro J. Why have Americans become more obese? Journal of Economic Perspectives. 2003;17(3):93-118.
Department of Health and Human Services Press Release, March 9, 2004. Citing Dangerous Increase in Deaths, HHS Launches New Strategies Against Overweight Epidemic. www.hhs.gov/news/press/2004pres/20040309.html .
Finkelstein EA, Fiebelkorn IC, Wang G. National Medical Spending Attributable To Overweight and Obesity: How Much, And Who's Paying? Health Affairs, 2003 (May 14): W3-219 W3-226.
Healthy People 2010, Chapter 19, Nutrition and Overweight. Available at http://www.healthypeople.gov/document/HTML/Volume2/19Nutrition.htm.
Hill JO, Sallis JF, Peters JC. Economic analysis of eating and physical activity. A next step for research and policy change. Am J Prev Med 2004;27(3S):111-116.
IARC WORKING GROUP. Vanio H, Bianchini F (eds). IARC Working Group on the Evaluation of Cancer-Preventive Strategies. IARC Handbooks of Cancer Prevention, vol. 6. Weight control and physical activity. 1-315. 2002. Lyon, France, IARC Press.
Lakdawalla D, Philipson T. The Growth of Obesity and Technological Change: A Theoretical and Empirical Examination. NBER Working Paper #8946, National Bureau of Economic Research. Cambridge, MA, 2002.
Mokdad AH, Ford ES, Bowman BA, Dietz WH et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA 2003;289:76-79.
NCHS, CDC. Prevalence of overweight and obesity among adults: United States, 1999 [Internet]. [Hyattsville (MD)]: NCHS [cited 2004 March 25]. Available from: www.cdc.gov/nchs/products/pubs/pubd/hestats/obese/obse99.htm.
NCHS, CDC. Prevalence of overweight among children and adolescents: United States, 1999 [Internet]. [Hyattsville (MD)]: NCHS [cited 2004 March 25]. Available from: www.cdc.gov/nchs/products/pubs/pubd/hestats/over99fig1.htm.
National Council on State Legislatures Health Promotion Database, available at http://www.ncsl.org/programs/health/phdatabase.htm.
NIH Obesity Research Task Force Draft Strategic Plan for NIH Obesity Research, February 2004. Available from: http://obesityresearch.nih.gov/.
Philipson TJ, Posner RA. The Long-Run Growth in Obesity as a Function of Technological Change. NBER Working Paper #7423, National Bureau of Economic Research. Cambridge, MA, 1999.
Philipson T. The world-wide growth in obesity: an economic research agenda. Health Economics 2001;10:1-7.
Surgeon General's Call to Action To Prevent and Decrease Overweight and Obesity, 2001. Available from: http://www.surgeongeneral.gov/topics/obesity/calltoaction/CalltoAction.pdf.
Troiano RP, Flegal KM. Overweight children and adolescents: Description, epidemiology, and demographics. Pediatrics 1998 Mar;101(3):497-504.
Wolf, A.M., and Colditz, G.A. Current estimates of the economic cost of obesity in the United States. Obesity Research 6(2):97-106, 1998. PubMed; PMID 9545015
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