and Human Services (HHS)
EXPIRED
Decision Making in Health: Behavior Maintenance
Program Announcement (PA) Number: PA-05-016
Part I - Overview InformationDepartment of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Catalog of Federal Domestic Assistance Number(s)
93.399, 93.279, 93.273
Key Dates
Release Date: November 22, 2004
Letter of Intent Receipt Date(s): 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 Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date for R21 Non-AIDS Applications: March 2, 2006
Expiration Date for R21 AIDS and AIDS-Related Applications: May 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Not Applicable
Executive Summary
The purpose of this initiative is to invite applications for research projects that will expand our knowledge of basic decision-making processes underlying initiation and long-term maintenance of healthy lifestyle behaviors that may reduce one's risk of cancer and other chronic diseases, such as cardiovascular disease, diabetes, and addiction. The NCI, NIDA, and NIAAA encourage collaborations between basic judgment and decision-making researchers, and applied cancer control or addiction researchers that will elucidate the basic cognitive and affective processes involved in decisions that are made repeatedly over time, such as adhering to weight-loss programs or smoking cessation programs. This PA uses the NIH exploratory/developmental (R21) award mechanism and the NIH investigator-initiated research project grants (R01) award mechanism. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. Application materials and instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.
You may submit an application(s) if your institution has any of the following characteristics:
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 is available at: TTY 301-451-5936
Table of Contents
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing
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 Responsibilities
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 Announcement1. Research Objectives
Purpose
The purpose of this Program Announcement is to invite applications for research projects that will expand our knowledge of basic decision-making processes underlying initiation and long-term maintenance of healthy lifestyle behaviors that may reduce one's risk of cancer and other chronic diseases, such as cardiovascular disease and diabetes, or prevent drug abuse relapse and its related health consequences. Specifically, this Program Announcement seeks to elucidate the basic cognitive and affective processes involved in decisions that are made repeatedly over time, such as adhering to weight-loss programs, exercise programs, alcohol treatment programs, smoking cessation and other substance abuse treatment programs, or medical treatment regimens. Excluded from this initiative are studies that examine single-event decisions, which are discrete decisions made at specific points in time.
Collaborations between basic judgment and decision-making researchers, and applied health behavior researchers are particularly encouraged under this solicitation.
Research Objectives
Despite evidence that prevention and early detection efforts could substantially reduce the morbidity and mortality associated with cancer, cardiovascular disease, and diabetes, these diseases continue to exact an enormous medical and economic toll (Eyre et al., 2004). It is well recognized that tobacco, chemical dependence, obesity, unhealthy diet, sedentary lifestyle, and failure to adhere to recommended health screening guidelines contribute to the human suffering and economic burden imposed by these conditions. The importance of maintaining a healthy lifestyle is underscored in Healthy People 2010 (US DHHS, 2000), the prevention agenda for the United States. The ten Leading Health Indicators identified in Healthy People 2010 reflect the major public health concerns of the Nation. Five of these health indicators physical inactivity, overweight and obesity, tobacco use, substance abuse, and responsible sexual behavior are recognized modifiable risk factors for cancer and other chronic diseases, and, as such, have significant implications for reducing morbidity and mortality (Stein & Colditz, 2004).
The 2003 National Cancer Policy Board report, Fulfilling the Potential of Cancer Prevention and Early Detection (National Cancer Policy Board, 2003), proposed that in order to save the most lives from cancer, health care resources should be concentrated on helping people stop smoking, maintain a healthy weight and diet, exercise regularly, keep alcohol consumption at low to moderate levels, and get screened for breast, cervical, and colorectal cancer.
Tobacco use: Tobacco use is the leading preventable cause of disease and premature death in the United States (Eyre et al., 2004; US DHHS, 1990; CDC, 2003). Approximately 30 percent of cancer deaths and 20 percent of cardiovascular deaths are attributable to tobacco use (Eyre et al., 2004; Doll & Peto, 1981). Cigarettes and other forms of tobacco are linked to over a dozen types of cancer, and cigarette smoking is estimated to cause 90 percent of lung cancer deaths (Eyre et al., 2004).
Obesity: Overweight and obesity are significant risk factors for cancer and numerous other diseases. Obesity has been associated with an increased risk of cancer at several sites, including the colon, endometrium, kidney, pancreas, gallbladder, and breast (among postmenopausal women) (US DHHS, 2001; Bianchini et al., 2002; Michaud et al., 2001; Murphy et al., 2000; Chow et al., 2000; Eyre et al., 2004; Carmichael & Bates, 2004).
Physical activity: Physical inactivity is another well recognized risk factor for cancer and other diseases. Epidemiological data suggest that physical activity may be associated with a reduced risk for developing certain cancers (McTiernan et al., 1998). A consistent inverse relationship between level of physical activity and risk of colon cancer has been documented in numerous epidemiological studies (McTiernan et al., 1998; Friedenreich, 2001; Lee, 2003; Willer, 2003), and most of the epidemiological studies of physical activity and breast cancer have documented a reduced risk among physically active women (Gammon et al., 1998; McTiernan et al., 1998; Friedenreich, 2001; Lee, 2003; Willer, 2003; Lagerros et al., 2004; John et al., 2003). The findings from studies of physical activity and risk of prostate cancer have been mixed (McTiernan et al., 1998; Friedenreich, 2001; Torti & Matheson, 2004). A few studies have suggested a possible association between physical activity and lung cancer (McTiernan et al., 1998; Friedenreich, 2001; Mao et al., 2003), and physical activity and endometrial cancer (McTiernan et al., 1998; Friedenreich, 2001; Moradi et al., 2000).
Alcohol consumption: Alcohol, a known carcinogen, is associated with cancers of the mouth, pharynx, esophagus, and liver (Report on Carcinogens, 2002; Longnecker & Enger, 1996; Thun et al., 1997), and possibly associated with breast and colon cancer (Longnecker & Enger, 1996).
Sexual behavior: Responsible sexual behavior has important implications for cancer control since there is considerable evidence linking sexually transmitted viral infections to cancer (Stein & Colditz, 2004; Morrison et al., 1997). The association of human papilloma virus infection with cervical cancer (Bosch et al., 2002), and hepatitis B virus and hepatitis C virus with hepatocellular carcinoma (Morrison et al., 1997) are well established.
Despite having well developed and widely tested theoretical models that provide elegant conceptual frameworks for interventions targeting risk behaviors, and despite having demonstrated that these interventions can yield positive behavior change that is maintained for brief periods of time, we know relatively little about the decision-making processes involved in sustaining behavior change over the long term. The 2001 Institute of Medicine report, Health and Behavior: The Interplay of Biological, Behavioral, and Societal Influences (Institute of Medicine, 2001), highlights the fact that most intervention studies though demonstrating the ability to alter behavior, either do not test, or when tested do not demonstrate, sustained behavior change.
What accounts for the failure to develop interventions that yield long-lasting effects? According to the 2001 National Research Council report, New Horizons in Health: An Integrative Approach (Committee on Future Directions for Behavioral and Social Sciences Research at NIH, 2001), lack of success in achieving long-term behavior maintenance may in large part be due to the fact that behavioral interventions have traditionally emphasized acute change rather than enduring behavior change over time. This report emphasizes the need for new models of behavior change that address sustaining effort in the face of forever-changing personal, social, and environmental circumstances. It has also been suggested that lack of attention to long-term maintenance of healthy behaviors may be due to the fact that models of health behavior change have largely focused on the intention and the decision to initiate behavior change, mistakenly equating successful initiation of change with long-term maintenance (Rothman et al., 2004; Rothman, 2000). The high rates of relapse reported for smoking cessation programs (Ockene et al., 2000), weight loss programs (Jeffery et al., 2000), substance abuse programs (Booth et al., 1991; Vaillant et al., 1983; Pettinati et al., 1982), and exercise programs (Robison & Rogers, 1994; Oldridge et al., 1983; Oldridge, 1982) attest to the need for research to improve our understanding of the decisional processes and strategies involved in moving from the point of behavior change initiation through the early stages of behavior change and on to long-term behavior maintenance.
Recent research suggests that the decision-making processes involved in initiating a behavior change are distinct from those involved in maintaining a behavior once the behavior initiation phase is completed (Rothman et al., 2004). It has been proposed that while the decision to initiate a new behavior is based on the expected outcomes of the behavior, the decision to maintain behavior involves an on-going, iterative process of evaluating the behavioral, psychological, and physiological experiences associated with the new behavior, and determining whether the behavior warrants continuing (Rothman et al., 2004).
This program announcement invites research applications that explore the basic judgment and decision-making processes that underlie not only initiating a desired healthy behavior, such as participating in an exercise program, but, as critically, maintaining the behavior over the long term. While the scientific focus of this solicitation is to understand decision-making processes, intervention studies that highlight decisional processes and mediators and moderators of decision making are acceptable. Applicants developing or testing behavioral treatments that highlight judgment and decision-making processes among drug and alcohol abusers are encouraged to refer to the Behavioral Therapies Development Program Announcement (http://grants1.nih.gov/grants/guide/pa-files/PA-03-126.html).
Collaborations between basic judgment and decision-making researchers, and applied behavioral or clinical researchers are particularly encouraged.
Examples of appropriate research topics and approaches include, but are not limited to, the following suggestions:
Research that addresses methodology and measurement issues in studying decision-making processes (e.g., studies of methods to assess changing cognitive and affective states that may influence decisional processes; studies that test the validity of ecological momentary assessment measures as they relate to decision-making processes);
Research that examines ongoing cognitive, affective, and physiological processes that underlie decision making related to initiating and maintaining a healthy behavior;
Research that examines mediators and moderators of the decision-making processes involved in sustaining behavior change over time. Such variables might include psychological factors, associative learning and memory processes, and social, cultural, and structural factors (e.g., access to medical care, access to health care information, health insurance status) that mediate or moderate decision-making processes;
Research that examines and compares cognitive and affective processes involved in decision making in the early maintenance phase of behavior change and the mature maintenance phase of behavior change;
Studies that examine and compare decision-making processes in the context of a structured behavior change program (e.g., a medically monitored weight-loss program) and decision-making processes in the context of self-initiated behavior change;
Studies that examine and compare decision-making processes related to maintaining a behavior during a structured behavior change program and decision-making processes related to sustaining the behavior change following completion of a structured program;
Research that examines decision-making processes involved in initiating and sustaining multiple health behavior change (e.g., beginning a smoking cessation and exercise program at the same time) compared to decision-making processes involved in initiating and sustaining a single health behavior change;
Research that examines how biological factors and processes may influence decision-making processes related to sustaining behavior change (examples of potentially relevant biological factors include: stress reactivity; drug dependence or withdrawal; health states such as fatigue, cachexia, or depression; temperament; personality; gender; and age);
Studies that examine the role of time preferences related to decision-making and behavior maintenance. Such research might explore trade-offs between immediate and delayed benefits, or the extent to which delayed outcomes are discounted relative to immediate outcomes; and
See Section VIII. Other Information Required Federal Citations for policies relation to this announcement.
Section II. Award Information1. Mechanisms of Support
This funding opportunity will use the NIH investigator-initiated research project grant (R01) and the NIH exploratory/developmental grant (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. For the R21 mechanism, applicants may request a project period of up to 2 years with a combined budget for direct costs of up to $275,000 for the 2-year period. Normally, no more than $200,000 may be requested in any single year. The R21 grant is not renewable. (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-05-004, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html .)
This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget 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 described in the PHS 398 application instructions. Otherwise, follow the instructions for non-modular research grant applications.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Facilities and administrative costs are not included in the direct cost limitation; see NOT-OD-05-004.
Section III. Eligibility Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
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.
3. Other-Special Eligibility Criteria
Not applicable
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. 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; 9/2004 version after May 10). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
All instructions for the PHS 398 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.
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 must be mailed on or before the receipt date described below (Section IV.3.A).
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): 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.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
3.C. Application Processing
Applications must be sent 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 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
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 web site, 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. The funding organization will be responsible for monitoring the data sharing policy, http://grants.nih.gov/grants/policy/data_sharing.
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 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_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 resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Award Criteria.
Section V. Application Review Information1. Criteria
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the ICs 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
Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.
The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools or technologies that have the potential to significantly advance our knowledge or the status of health related research. Because the research plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications.
The goals of NIH-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 continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk : The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subject 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 Subject 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 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, http://grants.nih.gov/grants/policy/data_sharing.
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/part_ii_5.htm#availofrr 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 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 awardee 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 Section VI.3. Award Criteria.
Section VI. Award Administration Information1. Award Notices
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 (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 (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
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.
Section VII. Agency ContactsWe encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Wendy Nelson, Ph.D.
Basic Biobehavioral Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN Rm. 4064
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-4590
FAX: (301) 435-7547
Email: [email protected]
Minda R. Lynch, Ph.D.
Behavioral and Cognitive Sciences Research Branch
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd., Room 4282
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-1322
FAX: (301) 594-6043
Email: [email protected]
Robert Freeman, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2073
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-8820
FAX: (301) 443-8614
Email: [email protected]
2. Peer Review Contacts:
Not applicable
3. Financial or Grants Management Contacts:
Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd., EPS Rm. 243
Bethesda, MD 20892
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: [email protected]
Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Blvd., Room 270
Bethesda, MD 20892
Rockville, MD 20852-1705 (for express/courier service
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Judy S. Fox
Chief, Grants Management Branch
Chief Grants Management Officer
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3021, MSC 9304
Bethesda, MD 20892-9304
Rockville, MD 20852-1705 (for express/courier service)
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: [email protected]
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm) and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); 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 (see the NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://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 at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR web site (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, see: http://www.lrp.nih.gov.
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