OVERWEIGHT AND OBESITY CONTROL AT WORKSITES RELEASE DATE: October 07, 2003 RFA Number: RFA-HL-04-006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.837, 93.233 LETTER OF INTENT RECEIPT DATE: February 15, 2004 APPLICATION RECEIPT DATE: March 12, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer-Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The National, Heart, Lung and Blood Institute (NHLBI) invites applications for research project (R01) grants to test interventions that are innovative and emphasize environmental approaches or a combination of environmental and individual approaches at worksites to prevent or treat obesity in adults. The purpose is to support studies designed to determine whether worksite interventions that include environmental strategies are successful in preventing or controlling obesity. Environmental strategies include programs, policies or organizational practices to influence health behaviors by, for example, increasing the availability of, and providing access to, healthful food choices and facilities for physical activity and creating a socially supportive climate. RESEARCH OBJECTIVES The objective of this research program is to support multiple controlled trials to test innovative multi-component interventions that have sufficient duration (about 2 years) and intensity to be efficacious. The interventions must be delivered at worksites and must emphasize environmental approaches or a combination of environmental and individual approaches for the prevention or control of overweight or obesity in adults. Background Obesity is increasing in the United States at an alarming rate. An estimated 97 million U.S. adults are overweight or obese, with higher prevalence in racial/ethnic minorities. Overweight and obesity increase the risk of hypertension, dyslipidemia, diabetes, sleep-disordered breathing and cardiovascular mortality. The economic costs of obesity and overweight in the United States approach $117 billion per year. There is a need to address the obesity problem from multiple fronts, including environmental and community approaches. This need was highlighted by the Surgeon General's Call to Action, by the National Nutrition Summit, and in the Healthy People 2010 Objectives for the Nation. Traditional obesity control strategies, which have focused on educating individuals to change diet and physical activity behaviors, often do not reach large numbers of people, and only a small proportion of adults are able to sustain weight loss on a long-term basis. Altering environmental influences on behaviors is a promising additional strategy that may be more generalizable, cost-effective, and sustainable. Environmental approaches use policies, programs, or organizational practices to influence behaviors by, for example, increasing the availability of, and providing access to, healthful food choices and facilities for physical activity and by creating a socially supportive environment. More than 20 published research studies have altered the environment to promote healthful behaviors (e.g., facilities for physical activity, nonsmoking policies at worksites, lower-fat food availability in vending machines or cafeterias at worksites and schools). These studies indicate that this approach could be used with some success, but further research is needed. The worksite is a feasible and potentially effective setting for implementing environmental approaches to promote behavior change. Worksite interventions can reach large numbers of adults and are viable venues for reaching the working population. Characteristics of worksites that may be conducive to environmental approaches include physical (e.g., availability of exercise rooms and cafeteria), social (e.g., social support from coworkers, a well-established communication system for support), and community environments that provide opportunities for healthful diet and physical activity. Low turnover rates in the organization may also be needed for successful interventions of this type. The worksite is an important setting for establishing environmental and policy changes leading to increased physical activity among employees (e.g., policies related to sleep and fitness, flextime, or fitness-center discounts) and improved dietary intakes of employees (e.g., through offering healthful food choices, lowering portion sizes and reducing prices of healthful lower calorie foods in cafeterias and vending machines, or providing nutrient and calorie information on foods at the point-of- purchase). Worksite interventions may also enhance social support from fellow workers to facilitate positive dietary and physical activity behaviors. Work schedules such as early start times, shift work, long hours and schedules that result in shortened sleep patterns, as well as worksite environmental factors such as lighting and temperature, may contribute to unhealthful eating habits as well as physical inactivity. Support from worksite administration and management, as well as from employees is an important consideration for successful implementation of worksite interventions. Therefore, applicants should consider these factors and the organizational and environmental attributes of the workplace that can be used to promote behavior change and to motivate, facilitate, and sustain efforts of workers to prevent weight gain, lose weight, and/or promote weight control. Many published studies on worksite interventions for weight control reveal that the interventions tested have largely not used the worksite environment and its social aspect. Interventions have been primarily individual behavioral approaches of minimal intensity and short-term duration - 6 months or less- and intervention effects have been modest with variable weight loss (a range of about -12.1 lb to +7.9 lb over 6 months in controlled studies). None addressed environmental influences on weight control behaviors or the psychosocial work environment and its role in employee weight control. Only a few were randomized controlled trials, which limit the validity of the results. In addition, because most of the studies were conducted in large worksites (> 500 employees) and lacked information on racial and ethnic minority distributions, their generalizability is uncertain. Requirements Applicants must test interventions that emphasize environmental approaches to behavior change but are encouraged to emphasize and justify areas they believe are most important. Environmental interventions are interventions designed for the entire worksite and may affect policies, programs, facilities or organizational practices to influence health behaviors. Such interventions may be combined with individual approaches. Applicants are encouraged to use behavioral theories or prior empirical evidence to develop their interventions. For the individual-level component, behavioral theories may be used separately or in combination to plan the intervention. Examples of such theories are those of planned behavior, social cognition and reasoned action, and the trans-theoretical model (stages of change) as well as mediators such as self-efficacy and social networks. For planning the environmental component of the intervention, socio-ecological, social cognitive and organizational-change theories, and communication processes such as participatory involvement by workers and decision- makers, and/or the diffusion of innovation model may be used. Applicants are encouraged to apply other behavioral theories or frameworks and are not limited to the examples above. Project Phases Applications in response to this RFA will have two phases. Phase 1 is for formative research and recruitment, estimated to last about one year. Phase 2 is to test a two- year intervention followed by data analysis and dissemination. The total duration of the study should not exceed four years. Phase 1 This planning phase consists of formative research to refine the intervention and may include focus groups, in-depth interviews, surveys of worksite administrators and employees, and/or an assessment of the worksite and surrounding community environments to determine attributes of the environments that are conducive to environmental interventions. Such needs assessment approaches should be used to identify barriers to implementing the intervention as well as factors that could enhance participation of employees in the intervention. Phase 1 could be optional for some applicants who already have Phase 1 information, which can be presented in the application in support of the need for the Phase 2 study. Phase 2 Applicants must specify the intervention, which must be innovative, feasible, and attractive to worksite administrators and to employees of varying socioeconomic status and work schedules, have sufficient duration and intensity to be efficacious, and must include environmental approaches. Environmental interventions affect worksite programs and policies, which would result in, for example, increased physical activity and decreased sedentary behaviors both during and after work hours and schedules, changes in cafeteria or vending machine offerings to healthier lower-calorie foods, and/or community outreach or collaboration. The interventions could include family members or participants from employees' social networks outside of the worksite. Applicants must describe the proposed intervention in their application; some refinements may be anticipated based upon the formative research in Phase 1. The process for using formative research from Phase 1 to refine the intervention for Phase 2 should be described. Applicants should present available background material and pilot data that are relevant to the proposed intervention, and describe and justify the innovative aspects of their intervention. Environmental interventions are intended to influence everyone in the target environment, and thus evaluation of their effects should consider the entire exposed population. Some interventions could target overweight and obese individuals at the worksite in addition to using environmental strategies for the entire worksite. Studies must be designed such that the intensity and frequency of the intervention are sufficient to effect change in outcome measures. Examples of research objectives for interventions that could be conducted in the worksite settings include the following: (These examples are illustrative, and do not comprise an exhaustive list.) o Intervention studies that compare environment-focused interventions with individual behavioral approaches to prevent and/or control obesity. o Intervention studies that examine the feasibility of establishing or reinforcing policies for environments supportive of physically active/and or healthful dietary lifestyles. o Studies of environmental interventions that are culturally appropriate and are conducted at the worksite in collaboration with community-based organizations to enhance physical activity and improve dietary practices. o Intervention studies that use social support networks at the worksite and/or family members' support in collaboration with community agencies and/or businesses such as restaurants or food outlets to improve diet and physical activity of workers. o Studies that test the efficacy of environmental interventions or a combination of environmental and individual-focused interventions to prevent obesity in worksites of predominantly underserved populations, including racial and ethnic minority populations and rural men and women. o Intervention studies that examine the efficacy of establishing or reinforcing policies for environments that reduce worksite fatigue and sleepiness as a means of improving the diet and physical activity of workers. A combination of worksite environmental activities and strategies could be used. Some examples of these include: o Offering smaller, healthier portion sizes of foods at lower prices, in worksite cafeteria and/or vending machines, or in surrounding restaurants most frequently used by workers. o Providing flextime for physical activity or fitness breaks during work hours, and/or fitness-center discounts for physical activity before and after work hours. o Establishing walk-to-work or bicycle-to-work days at the worksite. o Providing pedometers for employees to enhance their motivation for physical activity. o Making stairways more accessible and attractive, through lighting, signage, and open access, while discouraging use of elevators. o Mitigating the adverse effects of excessive workplace sleepiness on motivation for physical activity through education and changes in routine, lighting and work schedules. Applicants should design the interventions to be practical, cost effective and sustainable without undue cost after the study. Design and outcome measures Each successful applicant will conduct a separate study. Applicants should have a total of at least four worksites (two intervention and two control) allocated equally to intervention and control groups. Studies could be designed so that worksites would be the unit of randomization and analysis. Alternately, individual employees could be used as the unit of analysis if justified. The primary outcome measure should be a continuous measure of the degree of overweight/obesity such as body weight, body mass index, or percent body fat, or a measure of the proportion of overweight or obese in the population. Secondary outcome measures could include the following: measures at the environmental level to determine the impact of environmental changes such as changes in worksite programs, policies, and food availability as well as other environmental elements of interest; measures at the individual level to determine the effect of the intervention on health behaviors, such as employees' dietary intake, physical activity, and sleep patterns; and mediating variables such as self-efficacy, employee attitudes, and perceived benefits and barriers. Measurements of interest to the worksite, such as worker productivity, absenteeism rates, and intervention costs, are strongly encouraged. Cost- effectiveness analysis is encouraged. Additional secondary outcome measures may include cardiovascular risk factors such as blood pressure, blood lipids, fasting blood glucose, hemoglobin A1c, and insulin. Critical Elements of Applications Each applicant must: o describe the characteristics of their proposed worksites and provide evidence of support from worksite administrators and employees, for example, in the form of a letter of intent to collaborate that should be included in the appendix of the application. o provide information on the size and type of the proposed worksites, as well as employee turnover rates and stability, which could affect power calculations and sample size. o provide adequate representation of minorities and women. o use and describe methods to assure the similarity of intervention and control groups on important characteristics. o describe methods for recruiting and retaining worksites and participants and for maximizing intervention exposure, especially for individuals who are overweight or obese. o describe and justify the intervention in detail and include an environmental component in the intervention plan. Where appropriate, applicants are strongly encouraged to: o provide information on the physical, social and surrounding neighborhood environments that would support an intervention to promote healthful diet and physical activity behaviors. o target worksites that are small to medium size or that require sedentary activities and often have automated work tasks. o describe procedures for employees to continue to pursue healthful dietary and physical activity behaviors outside of the worksite setting (e.g., intervention activities with family members or social networks). o address the economic impact of the interventions on the worksite or employer (e.g., costs and benefits related to the impact of the intervention on absenteeism and sick days). Coordinating functions To facilitate coordination of research activities between awardees, this RFA will also support the costs of performing coordination functions by one of the awardees. These functions include the following: o developing a program website and email system for group communication o arranging meetings and conference calls o coordinating preparation of scientific publications and dissemination of findings from the studies It is anticipated that coordinating functions will include supporting multiple committees that the investigators would want to form in order to collaborate. Applicants should propose to perform coordinating functions in addition to conducting the study. A separate budget should be included for this purpose. The evaluation of these coordinating functions would be separate from the overall review of the scientific merit of the research application. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) R01 award mechanism. The total requested project period for an application submitted in response to this RFA may not exceed four years. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all other investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see https://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 https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NHLBI intends to commit a total of approximately $17 million (including direct and Facilities and Administrative (F&A) costs) over a four-year period to award 4 to 5 applications in response to this RFA. About $3.0 million in total costs (direct and F&A costs) will be awarded in FY 04. It is anticipated that the first year will cost less than subsequent years because it will be for Phase 1 and start-up activities. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Coordinating functions Applicants should also include a section in their application to conduct coordinating functions. NHLBI intends to commit an additional total budget of about $0.5 million (including direct and Facilities and Administrative (F&A) costs) over a four-year period to support one award for coordinating functions. Although the financial plans of the NHLBI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not expected that this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Domestic for-profit or non-profit organizations and worksites o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Faith-based or community-based organizations o Foreign institutions are not eligible to apply Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institutions to develop an application for support. Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are encouraged to apply as Principal Investigators for NIH research programs. SPECIAL REQUIREMENTS Annual meetings Applicants funded under this RFA will be required to attend meetings in which study plans, findings, and issues of common interest and concern will be shared and discussed. Investigators will meet: (1) shortly after the beginning of funding to discuss study plans; (2) annually until the end of the study, to share experiences in the needs assessment, design, recruitment, and implementation of the interventions; (3) after completion of the analyses to share results and materials. Applicants should include in their budgets funds for attending these meetings. For budgeting purposes, applicants should assume that the meetings would be for 2 days in Bethesda, MD, at the National Institutes of Health and require the attendance of the Principal Investigator and up to one other person. Applicants should include the cost of meeting rooms and equipment in the budgets for coordinating functions for these annual meetings. Dissemination plan Applicants must include in their application a plan for dissemination of research results and interventions, which will be implemented if the intervention is successful and appropriate to be used at other worksites. Such a plan should include: o Identification and description of target audience of the dissemination plan. o Description of the methods to be used to reach the audience. o Appropriate benchmarks for success of the dissemination plan. o Discussion of how the intervention may be made translatable and sustainable. o Appropriate additional personnel for developing and implementing the dissemination activities. o An appropriate budget for the proposed dissemination activities for the last year of requested funding. o A statement that the investigators agree to discuss and finalize the dissemination plan with Institute staff prior to its implementation. Applications that do not include a dissemination plan will be considered non- responsive and not eligible for review. Final Report At the completion of the project, the Principal Investigator (PI) of each research project grant must provide a report to the NHLBI Project Office with: (1) detailed recommendations concerning the intervention(s) evaluated, based on the study's findings; (2) a complete description of the intervention(s) used in the study, including a description of the rationale for the intervention(s), the intervention procedures used (e.g., manual of procedures), and any intervention materials used; (3) training, certification, and quality control procedures for ensuring effective implementation of the intervention(s); and (4) description of how the interventions could be tailored for other worksites. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: Direct questions about scientific/research issues to: Charlotte Pratt, PhD, RD National Heart, Lung, and Blood Institute Division of Epidemiology and Clinical Applications Prevention Scientific Research Group 6701 Rockledge Drive MSC 7936, Room 8134 Bethesda, MD 20892 (20817 for Express or Courier Service) Tel.: (301) 435-0382 Fax: (301) 480-1669 Email: prattc@nhlbi.nih.gov Direct your questions about peer review issues to: Anne Clark, PhD Chief, Review Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7924, Room 7214 Bethesda, MD 20892 (20817 for Express or Courier Service) Telephone: (301) 435-0270 Fax: (301) 480-0730 Email: clarka@nhlbi.nih.gov Direct your questions about financial or grants management matters to: Mr. Kieran Kelley Senior Grants Management Specialist National Heart, Lung, and Blood Institute/NIH 6701 Rockledge Drive, Rockledge 2, Room 7170 Bethesda, Maryland 20892-7926 Tel.:(301)-435-0154 Fax: (301)-480-3310 email: kelleyk@nhlbi.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows Institute staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to Anne Clark at the address listed under Where to Send Inquiries. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). 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 DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant 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 https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. The following are requirements: o The page limit for sections a-d is 25 pages, including tables and figures. o Additional three pages are allowed for coordinating functions. SPECIFIC INSTRUCTIONS FOR COORDINATING FUNCTIONS: Applicants must provide descriptions of how they plan to perform coordinating functions and must address the critical elements for coordinating functions specified in this RFA. Up to three additional pages will be allowed to describe these functions and the budget for coordinating functions should be provided separately. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies plus all five collated sets of appendix material must be sent to Anne Clark at the address listed under Where to Send Inquiries. APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second-level review by the National Heart, Lung, and Blood Institute National Advisory Council. Principal investigators should not send supplementary material without first contacting the Scientific Review Administrator (SRA). The SRA will be identified in the letter sent to you indicating that your application has been received. If you have not received such a letter within three weeks after submitting the application, contact Dr. Anne Clark at the address listed under Where to Send Inquiries. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The 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. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the intervention address obesity prevention and/or control at the worksite? Are environmental strategies major components of the proposed intervention? Applicants must include environmental strategies, which have the ability to influence an entire workforce, in their application. INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator 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 (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 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 criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). 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 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html for guidance. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. COORDINATING FUNCTIONS: Reviewers will consider the plan for facilitating the coordination of research activities between awardees, but will not factor the plan into the determination of the scientific merit or the primary priority score. Each plan will receive a secondary priority score which is separate from the primary priority score of the parent application. The following review criteria will be used. SIGNIFICANCE: Does the applicant address the importance of performing coordinating functions in order to enhance the value of the research program? APPROACH: Are the proposed activities appropriate for facilitating coordination among awardees? Are state-of-the-art coordinating strategies proposed? INVESTIGATOR: Is the applicant well suited to or experienced in carrying out coordinating functions? ENVIRONMENT: Is there evidence of institutional support? Does the applicant have prior experience in performing coordinating functions? DATA SHARING: The coordinating plan will be evaluated on the adequacy of the proposed plan to share data. For more information on data sharing, please see the following websites: https://grants.nih.gov/grants/policy/data_sharing/. https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 15, 2004 Application Receipt Date: March 12, 2004 Peer Review Date: June/July 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. 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). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $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. https://grants.nih.gov/grants/policy/data_sharing 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. 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 responding to the RFA should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://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 RFA 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 https://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.
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |