PA-04-034: EXPLORATORY GRANTS FOR BEHAVIORAL RESEARCH IN CANCER CONTROL

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EXPLORATORY GRANTS FOR BEHAVIORAL RESEARCH IN CANCER CONTROL RELEASE DATE: December 11, 2003 PA NUMBER: PA-04-034 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, this funding opportunity expires on the date indicated below. A Replacement R21 (PA-06-351) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.399 This Program Announcement (PA) replaces PA-02-001, which was published in the NIH Guide on October 1, 2001. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The Division of Cancer Control and Population Sciences of the National Cancer Institute (NCI) invites the submission of behavioral research applications in cancer control from investigators from a wide range of behavioral and social science disciplines who wish to focus their research on the behavioral aspects of the cancer control continuum from prevention to end of life care. The Exploratory Grant Program is designed to encourage the growth of a diverse cohort of scientists with a high level of research expertise in behavioral cancer control research. This exploratory grant is a 2-year award designed to encourage exploration of new ideas and new methodologies in the target area and to provide support for the collection of pilot data to be used as the basis for later R01 s. NIH Grants policies apply to these awards. The Behavioral Research Program (BRP) at NCI also issues an R03 program announcement http://dccps.nci.nih.gov/smallgrants/.) The two mechanisms, the R21 and the R03, are both considered small grants but are targeted to two different audiences. The BRP R21 targets new ideas and feasibility studies in areas new to seasoned investigators. The R03 is designed for new investigators. The R21 provides enough funding for a (small) collaborative team. The R03 guidelines until recently mandated a mentor relationship; this is still encouraged. The R21 applications are reviewed in the large pool of CSR study sections where the applications are evaluated by behavioral and/or prevention scientists who may or may not have primary interests in oncology. The R03 applications are reviewed by NCI. Hence, the PI must use different strategies in presenting the research design and other sections of the applicants. The R21 is often used as a vehicle to provide rich pilot data for a later R01, and PI’s are encouraged to think ahead to the next step, should their R21 hypotheses test favorably; there is a lesser emphasis on the continuation into the R01 for the R03 applicant. In summary, seasoned investigators use the R21 mechanism to pursue new avenues of research with new populations; new investigators use the R03 to learn the factors involved in leading an investigation in an area they may have been working in since graduate school or as a post-doc. RESEARCH OBJECTIVES Background The NCI supports behavioral research and other intervention studies related to cancer prevention and control through research project grants. Historically, this research has emphasized evaluation of health behavior interventions or disease outcomes, rather than the fundamental mechanisms of cancer-related behaviors or pre-intervention research. It is expected that these R21 grants will serve as a basis for planning future behavioral and cancer control intervention research project grant applications (R01). This PA, therefore, is intended to stimulate developmental and exploratory approaches to primary and secondary cancer prevention, prevention of cancer-associated morbidity, quality of life, communication and health promotion behavioral research through a program of exploratory investigator-initiated R21 grants. Because this developmental/exploratory grant mechanism is designed to support the collection of pilot data, and to allow an avenue for the exploration of new concepts and new methodologies, preliminary data as evidence of feasibility are not required. The applicant does have the responsibility for developing a sound research plan with a strong theoretical or empirical basis. Feasibility of the proposed research and potential significance for ongoing research are major considerations in the evaluation. This program is designed to encourage investigators from a variety of academic, scientific, and public health disciplines to apply their skills to behavioral research investigations in cancer prevention and control. The research may occur in a variety of settings, such as hospitals, universities, cancer centers, communities, schools, health departments, and worksites. It is appropriate to look at different populations within those settings and their interactions with cancer care health systems. Investigators may choose any of the full range of scientific approaches to conduct their work. Studies may contribute to: the design, implementation, or evaluation of intervention programs; the development and administration of descriptive baseline surveys; the testing, modification and validation of surveys or program materials for use in the proposed population groups, testing of recruitment, intervention or compliance procedures for participants; etc. Applications should include justifications of study designs, methods, and sample sizes. In addition, applicants should identify the theoretical framework used and clearly indicate the significance of the research and where it will lead. Research Goals and Scope The major goal of this initiative is to promote timely and innovative behavioral and culturally appropriate research approaches in cancer prevention and control. Studies may focus on: 1) Assessment (instrumentation methods, measurement development, particularly in new research populations); 2) Intervention (feasibility of new and innovative approaches, appropriateness for use in populations disproportionately burdened with cancer or in populations involving other clinical, organizational, and community settings), 3) Dissemination (applications, sustainability), 4) Surveillance (issues of inclusion of minority populations, data base linkage studies to monitor progress toward cancer prevention and control), and 5) biological and psychological influences on cancer and cancer-related behaviors. This R21exploratory/developmental award mechanism is appropriate for testing timely interventions in pilot studies for feasibility or using rigorous qualitative research methods to assess the potential efficacy of an intervention; it is also appropriate for testing new methodology in various applications. It is also appropriate for the psychometric evaluation of new measures or culturally appropriate ones to be adapted for use in populations for whom measures have not yet been developed or validated. Research Issues The Behavioral Research Program (BRP) and the Office of Cancer Survivorship (OCS) support research on a range of topics, and applications in any of the areas mentioned below or in areas which bridge these topics are appropriate. The list is illustrative rather than comprehensive. It is expected that investigators responding to this announcement will identify additional research topics. 1. Enhancing Risk Communications, Comprehension, and Informed Decision- Making Under Uncertainty: As new technologies are integrated into mainstream medical care, patients are being challenged to make difficult decisions in the face of uncertain risks and benefits. Valid and reliable methods to evaluate strategies to improve cancer risk communication, enhance comprehension, and facilitate informed decision-making about options for cancer prevention, screening, and treatment are required. Research on communication patterns as a measure of patient- centered treatment, as well as redesign of existing communication process to impact client satisfaction, health status, and quality of life is encouraged. Research is also needed to understand the effects of media coverage and treatment of cancer-related topics on the knowledge, attitudes, and behavior patterns of both individuals and social groups. 2. Enhancing Survivorship of Cancer Patients: Due to advancements in early detection and treatment, people are living longer with cancer, dramatically increasing the number of cancer-affected life-years in our nation. This raises the question of the quality of that extended survival time, including its effect upon productivity, the family functioning, and both medical and psychiatric comorbidity. There are now a number of under-studied cancer sites (e.g., liver, pancreatic, hemolytic cancers) and under-studied minority populations where survivors are of interest. New behavioral and psychosocial interventions targeted to these populations are needed. There has been little work done using the family or the extended family as the unit of analysis, and looking at the long-term effect of the cancer experience on that unit. Research is also needed to enhance functional health status (e.g., return to work), improve coping and adjustment to the effects of cancer and its treatment, improve the delivery of palliative and end of life care, and promote health behaviors that may reduce the risk of second malignancies. Instrument development, observational studies, and innovative approaches for these populations are needed before research can proceed. 3. Promoting a Healthy Diet and Physical Activity: Nutrition and physical activity as keys to an energy balance strategy play an important role in the prevention of the initiation, promotion, and progression of cancer. Only a small proportion of the U.S. population adheres to recommended guidelines for diet or participates in regular physical activity, and obesity is becoming a national disease. Refinement of current theoretical mechanisms of behavior change as well as a focus on developing new models is needed to examine and explain the determinants of changes in unhealthy behaviors. How individuals and groups maintain healthy behaviors is also of interest. Relatively little research has been published on key theoretical measures of constructs such as self-efficacy or perceived barriers when applied to fruit and vegetable consumption. Little is known about measures appropriate for minority, low-literacy, or high-risk populations. Innovative intervention designs must be assessed for feasibility and cultural competence before they can be targeted to populations at high risk for cancer. 4. Studying Prevention, Treatment and Control of Tobacco Use among Children, Teenagers, Young Adults and Adults: Innovative methods are needed to identify determinants of smoking initiation and maintenance in U.S. children and teenagers, including high risk groups. Psychometric validation of new measures may be necessary before these are applied in larger studies. Innovative strategies, with potential for broad public health application, to reduce smoking prevalence among these population groups need to be designed. These methods and strategies must be tested for feasibility and efficacy in different settings. 5. Researching Biological Mechanisms of Psychosocial Effects on Disease: Our appreciation of the complex interplay between psychosocial factors (e.g., stress) and nervous, endocrine, and immune systems has substantially increased. However our understanding and of this knowledge to the study of the development and control of malignant disease is limited. Research that examines how interactions among environmental, psychosocial, immune, neuroendocrine, genetic, and other biological factors influence cancer biology, treatment and side effects, and/or outcome is needed. Research involving interactions among genetic, behavioral, and social factors in the development of cancer or cancer risk behaviors (smoking, physical activity, alcohol intake, nutritional intake, etc.) are of interest. Such behavioral and social factors might include: a) factors related to the social context such as poverty, cultural practices and social support and b) individual behavioral factors such as personality or coping style. The focus of this work must involve examining the complex interplay of these factors related to health. Interdisciplinary research and research that includes integrative conceptual models are encouraged. 6. Issues Involved in Cancer Screening Behaviors: Social and behavioral research to promote the use of effective cancer screening tests, as well as strategies for informed decision-making regarding all cancer screening technologies, in both community and clinical practice is encouraged. Particular areas of interest include the need to identify effective and appropriate messages related to cancer screening among subgroups (e.g., ethnic, gender, and income), and the development of methods for improving patient/provider communication and decision making about screening particularly in the context of new and changing screening technology. Also of interest is research to incorporate risk assessment, genetic susceptibility, genetic risk information, and biological risk into screening programs. Crosscutting Themes Although individual branches within the Behavioral Research Program or the Office of Cancer Survivorship concentrate on tobacco cessation, health promotion, communication, biobehavioral mechanisms, or survivor issues, the following are relevant to all areas of behavioral and social research, and therefore, are strongly encouraged as cross-cutting themes to be considered in applications prepared in response to this Program Announcement. 1. Consideration of Ethnicity, Social Class, and Culture: The development and testing of interventions with valid and reliable measurement tools that are practical and culturally competent are needed. Since little is known about the relative importance of sociocultural, economic, educational and other behavioral factors to the differential burden of cancer in the United States, special efforts are required to identify and reduce the risk, incidence and mortality of cancer among population subgroups and underserved populations. This includes racial/ethnic minorities, rural, elderly, immigrant, and under-insured populations. In addition, we need to examine both system-wide as well as individual and group barriers to screening, medical treatment and adherence, and end of life care. The medical system and its cultural components as they impact on cancer disparities are also of interest. 2. Methods and Measurement: Innovative methods as well as measurement and analysis techniques are a critical need within many domains of the behavioral and social sciences. We encourage research that focuses on understanding the theoretical mechanisms of behavior change, and on developing new models as well as refining current theories. We need to develop instrumentation methods and measurement that can be used to evaluate the impact of environmental and policy interventions and develop sociocultural/ecological perspectives as the context for behavior change. Qualitative research methods based on sound theoretical models have potential value for understanding the complexity of health behaviors. 3. Levels of Analysis: We encourage increased attention to group as well as individual behaviors. Study designs, including intervention approaches and statistical analyses must extend from individual analysis to an emphasis on multiple population levels: communities, clinics, neighborhoods, etc. Understanding the success or failure of interventions will also depend on the ability to study the mechanisms of intervention impact and dissemination. 4. Research Settings: Behavioral and social research initiatives may focus on any or all phases of the cancer control continuum, from prevention, detection, diagnosis, and treatment, through survivorship, and end of life issues. Research activities may take place in a variety of settings as noted above. Exploratory studies of novel approaches targeted at specific research settings are encouraged. Summary Research funded through this R21 mechanism is expected to increase scientific knowledge about health behaviors and health care practitioners' behaviors in a number of areas. These areas include but are not limited to: tobacco cessation, sun exposure, cancer screening behaviors, diet, weight, and physical activity factors relevant to in cancer risk reduction and treatment, communication patterns and technologies between health care practitioners and patients, cancer survivorship issues, socio-cultural factors in health behaviors and in health care practitioner behaviors, and basic bio-behavioral factors. We also encourage inquiries into areas such as risk communication, communication inequality, and the impact of mass media on cancer-related risk behaviors. MECHANISM OF SUPPORT This PA will use the NIH exploratory/development (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project The applicant may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. These grants are non-renewable and continuation of projects developed under this PA will be through the traditional unsolicited investigator initiated grant program. This PA uses just-in-time concepts. It also uses the modular budgeting format. (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. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations 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 Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research, and financial or grants management issues: o Direct your questions about scientific/research issues to: Sabra F. Woolley, Ph.D. Health Promotion Research Branch Division of Cancer Control and Population Sciences National Cancer Institute 6130Executive Blvd., EPN Room 4078, MSC 7335 Bethesda, MD 20892-7335 Rockville, MD 20852 (for express/courier service) Telephone: (301) 435-4589 FAX: (301) 480-2087 Email: sw215x@nih.gov o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Blvd., EPS Room 243 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-7800 FAX: (301) 496-8601 Email: wolfreyc@mail.nih.gov 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 http://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. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SUPPLEMENTARY INSTRUCTIONS: All instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions: o Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if it is available. Please note that a Progress Report is not needed; competing continuation applications for an exploratory/developmental grant will not be accepted. Appendix. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included. 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 http://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 http://grants.nih.gov/grants/funding/modular/modular.htm. For the NIH Exploratory/Developmental Grant (R21), applicants may request direct costs in $25,000 modules, up to a total direct cost of $275,000 for the combined two year award period. SENDING AN APPLICATION TO THE NIH: 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 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR 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 CSR 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. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group 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: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Those that receive a priority score will receive a second level review by an appropriate national advisory council or board. 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 evaluate 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 the following 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? 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 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 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 BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program 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: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/ 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 - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 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 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 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 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is available online at: http://cme.nci.nih.gov/ 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). 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 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.

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