EXPIRED
CANCER COMMUNICATION AND INTERACTIVE MEDIA TECHNOLOGY Release Date: September 21, 2000 PA NUMBER: PAR-00-137 National Cancer Institute Letter of Intent Receipt Date: October 24, 2000 Application Receipt Date: November 28, 2000 This Program Announcement (PA) replaces PA-99-141, which was published in NIH Guide on August 16, 1999. PURPOSE Communication is central to effective, high quality cancer care, from primary prevention to survivorship. The continuing evolution of media technology offers multiple opportunities to inform health professionals and the public about cancer prevention and care in better ways. Program Announcement (PA) is designed to promote and support collaborations between non-profit organizations and for-profit small businesses on research projects that address 1) translation of cancer research into interactive applications designed for specific population groups, 2) development of organizational infrastructures within health care settings or training programs that promote the use of media technologies to enhance communication between primary care professionals, oncologists and their patients, 3) development of intervention strategies, tailoring models and tools to better inform the public about cancer prevention and control, or 4) development of traditional or distance- learning core competencies, training modules, evaluation modules and tools needed to develop or expand a master"s degree program in health communication and media technology. This PA utilizes the R25 and Fast-Track (both the Phase I SBIR and Phase II SBIR included in the Fast-Track applications) grant mechanisms in tandem to expedite the transition of successful technology research and development into practical applications. This PA expires on November 29, 2000, unless reissued. RESEARCH OBJECTIVES Effective communication and its impact on health have been the focus of scientists and communicators for more than 25 years. In 1971, the National Cancer Act charged NCI with the dissemination and interpretation of scientific and other information regarding the causes, prevention, detection and treatment of cancer for practitioners, other health professionals, scientists, and the general public. Within the past decade, NCI has utilized a wide array of technologies to expand cancer communications to ensure that all Americans have access to the cancer information they need. Despite these efforts, there is still a need to expand the use of these technologies by the public, patients, high-risk persons, advocates, survivors and health professionals regardless of race, ethnicity, health status, education, income, age, gender, or geographic region to receive communication about recent cancer research. There is evidence that communication technologies are altering health care practices, patient-physician relationships and the way consumers and patients acquire and use information. Effective health communications have influenced American adults to increase their daily consumption of fruits and vegetables, to get screened for breast and cervical cancers, and to stop or limit their use of tobacco products. Today"s technology users are often as informed or more informed than their physicians because of new opportunities for acquiring health information from the World Wide Web, individually-tailored print, multimedia products such as cancer-specific CD-ROMs, interactive computer games, interactive kiosks, and wireless communication products, among others. The current communications revolution offers health professionals better ways to utilize technology to reach people with cancer information, and simultaneously improve health outcomes, decrease health care cost, and enhance consumer satisfaction. However, before we can train health professional to effectively communicate about cancer or develop effective interactive health communication products and interventions, we need to learn more about how people seek, process and use health information. Proactive communication strategies are needed to rapidly accelerate a reduction in the cancer burden across the life span. In order to be successful, these strategies would have to cover a broad cross-section of the U.S. population and reach the most vulnerable population groups. Communications research is needed among diverse population groups (children, ethnic minorities, recent immigrants, low income groups, low literacy groups, rural populations, older adults and people at high-risk because of previous diseases, behaviors, exposures, genetic susceptibility or some other factor, patients, survivors, and health providers) to increase access to and comprehension of cancer information. Cancer communications research should be science-based, developed in collaboration with consumers, industry and academia, and result in high- quality products that have been evaluated for utilization, efficacy, and impact on target audiences. Anticipated results should include, but are not limited to: 1) culturally appropriate interventions, 2) tools to increase familiarity, ease of use, appeal and vividness, 3) removal of cost barriers to use, 4) comprehensive and relevant messages, 5) a flexible and adaptable menu of communication choices to reach the public, patients, under-served populations, survivors, and health providers in a variety of settings, 6) development of organizational infrastructures, in health care and community settings, needed to facilitate rapid advances in knowledge about cancer communications, testing of strategies, models and tools, dissemination of results to researchers, clinicians, patients, practitioners, advocacy groups and other partners and the public, 7) the development or expansion of health communication and media technology curricula, training, and evaluation components to prepare health professionals to better inform and communicate with the public about cancer prevention and control. Objectives and Scope Interested applicants are encouraged to develop, implement and evaluate systems, interventions, programs and/or products that: 1) improve transmission of cancer information, 2) promote cancer-related behavior change, 3) reduce cancer risk among youth and adults, 4) improve health outcomes and quality of life, 5) improve decision making and adherence to cancer prevention, detection and treatment, 6) improve survivorship, or 7) prepare health professionals to better inform and communicate with the public about cancer prevention and control. Technology tools include, but are not limited to, computer software, advanced telephone technologies, videotext, cable or broadcast television, radio, virtual reality, palm pilots, smart cards, or the World Wide Web. Applications in any of the following research categories are considered to be appropriate and applicants may address one or more areas: 1) behaviors associated with cancer risks (smoking, poor nutrition, AIDS/HIV), 2) counseling models for cancer genetics, 3) communication techniques tailored to specific populations including the physically challenged, 4) complementary medicine approaches to enhance cancer-related decision making, 5) innovative alternative teaching methods, 6) quality of life issues and psychosocial interventions for cancer survivors, 7) educational, training, or tracking systems for primary care professionals or the public, or 8) traditional or distance-learning core competencies, training modules, evaluation modules and tools needed to develop or expand a master"s degree program in health communication and media technology. Summary The anticipated increase in scientific knowledge to be achieved through research encouraged by the PA is described in the research objectives section above. The following examples are not all inclusive but indicate the type of knowledge to be achieved through this PA. It is important for applicants to indicate the ultimate value of their research and how it will increase knowledge about cancer communications. COMMUNICATION TOOLS ---- Develop evidence-based strategies for involving children and adults in vulnerable, high-risk populations in activities to prevent or stop tobacco use, improve dietary practices and increase physical activity, participate in cancer screening or treatment, prolong survivorship, and other areas noted above. ---- Develop new strategies, products and methods to enhance information dissemination and to improve the penetration, efficacy and effectiveness of cancer communications based on knowledge of how people search for and use cancer information. Develop optimal formats for communicating cancer risks to culturally diverse audiences. ---- Develop guidelines for users to determine the quality of health information on the Web or viewed through other interactive health communication technologies. ---- Develop strategies for teaching people how to make informed choices. ---- Develop practical decision aids to improve patient-provider communication and to help people make better cancer-related decisions. ---- Develop health communication technology tools to assist physicians in maximizing communication about cancer and integrating cancer communications into all aspects of care. ---- Develop tailored strategies to enhance cancer communications and address barriers that prevent major segments of the population from seeking and/or using cancer information. ---- Develop products that present balanced information about complementary cancer therapies. SYSTEMS ---- Develop systems for using interactive health communication technologies in settings such as hospitals, clinics, HMOs, schools, or worksites that resolve barriers to use. ---- Develop long-term cancer communication tracking systems that monitor outcome measures. ---- Develop integrated systems of cancer information, from prevention through treatment to survivorship and end-of-life issues, including palliative care and pain management, that are consistent with the current recommendations from the Institute of Medicine (http://www.iom.edu/ under reports). ---- Develop integrated systems of cancer care and best practices information on how to communicate uncertainty about risks, and reduce disparities in demand for, access to, and use of cancer communications for primary care professionals. ---- Develop information systems for the public or health care providers that give people the information they want, the way they want it, when and where they want it. TRAINING ---- Develop CME or training modules in cancer prevention and control for doctors, nurses or other primary care professionals. ---- Develop training modules for reporters and journalists who cover scientific or medical meetings and present the information in writing or through different forms of media technology. ---- Develop or expand traditional or distance-learning core competencies, training modules, evaluation modules and tools needed in a master"s degree program in health communication and media technology to prepare students to integrate technology into communication about cancer and other chronic disease prevention and control. MECHANISM OF SUPPORT Support for this PA is through the NIH Cancer Education and Career Development Grant (R25), and the Fast-Track Small Business Innovation Research (SBIR) Grant). The Fast-Track mechanism is described in the SBIR OMNIBUS SOLICITATION (http://grants.nih.gov/grants/funding/sbirsttr1/index.htm) and includes both a Phase I and Phase II application. This is a one-time PA, which may be reissued. The R25/Fast-Track is a newly established NIH funding mechanism that provides a second phase of support for innovative cancer communication and technology research initiated under the R25 mechanism. Conversion of the R25 to the Fast- Track will be based on the successful completion of negotiated milestones that will result in expediting research into practical commercial applications. This alternative funding mechanism: 1) encourages the R25 principal investigator (PI) from a non-profit organization to collaborate with a small business and allows the R25 PI to personally benefit from the commercialization of the product developed in the phase II, 2) receives one review for three separate applications (R25, Phase I and Phase II SBIR applications in Fast Track), and 3) minimizes the funding gap between the R25 and the Fast-Track. Applications for R25 support alone will not be accepted for this PA. The R25/Fast-Track application has three sections which must be submitted at the same time each with its own face page: the R25, and Phases I and II of the SBIR Fast Track. The total project period for this PA may not exceed four years: R25: 12 months, Fast-Track - Phase I: 6-12 months, Phase II: 2 years. The total funding for the one-year R25 may not exceed $100,000 total costs, which includes direct costs and facilities and administrative costs. The F&A costs for R25 grants is 8%. The Phase I funding includes up to $100,000 direct costs. Applicants requesting in excess of $500,000 dollars direct costs in either year of the Phase II must have approval from NCI Program staff prior to submission. It is strongly recommended that applicants contact NCI staff at an early stage of application development to convey critical information, such as potentially large budget requests or to discuss programmatic responsiveness of the proposed project. Early contact with NCI staff is critical to this PA since it utilizes a new funding mechanism. Refer to the LETTER OF INTENT and INQUIRIES sections of this announcement for NCI staff contacts. The planning, direction, and execution of the proposed project is the sole responsibility of the applicant. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement, NIH Publication No 99-8, October 1998. ELIGIBILITY REQUIREMENTS For this PA, R25 applications may be submitted by domestic public or private non-profit organizations such as universities, colleges, hospitals, foundations, or state and local governments. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for this announcement. A Fast-Track application must be submitted by a Small Business Concern. A small business concern is one that, at the time of award of Phase I and Phase II meets the following criteria: o Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has its principal place of business located in the United States, and is organized for profit, o Is at least 51% owned, or in the case of a publicly owned business, at least 51% of its voting stock is owned by United States citizens or lawfully admitted permanent aliens, o The business can not employ more than 500 employees and meets the other regulatory requirements found in 13 CFR Part 121. (Source: SBIR OMNIBUS SOLICITATION: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm). It is important that the R25 applicant collaborate with a for-profit small business prior to submitting an application. It is extremely important that the R25 applicant include the Fast-Track small business applicant in all stages of the R25 development to insure a smooth transition to the Fast-Track phase. For this PA, the R25 PI must be retained by the small business as the lead consultant to conduct the research necessary for product development. The actual product must be developed by the small business. It is important to note that the R25 PI is paid independently of his/her institution as the primary consultant during the two phases of the Fast-Track project. This arrangement may need to be negotiated with the R25 PI"s non-profit organization. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Connie Dresser, RDPH, LN Division of Cancer Control and Population Sciences National Cancer Institute Executive Plaza North, Room 232 Bethesda, MD 20892-7365 Phone: 301/435-2846 Fax: 301/480-2087 Email: [email protected] Direct inquiries regarding fiscal matters to: Ms. Kathleen Shino Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-8635 FAX: 301/496-8601 Email: [email protected] Direct inquiries regarding review issues to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Telephone (301) 496-3428 Fax: (301) 402-0275 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit, by October 24, 2000, a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone number, and email address of the applicant, the identities of other key personnel and participating institutions, and the number and title of the PA in response to which the application may be submitted. 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 NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Connie Dresser at the address listed under INQUIRIES by October 24, 2000. APPLICATION PROCEDURES R25/Fast-Track Contents The R25/Fast-Track is submitted as one application and consists of three sections, each with its own face page: 1) the R25 (form PHS 398-rev. 4/98), 2) the Fast-Track Phase I (PHS 6246-1), and 3) the Phase II (PHS 6246-2). The three-part R25/Fast-Track application must be received by November 28, 2000. The R25/Fast-Track application will be assigned one (1) priority score that applies to all three sections. However, the initial review panel has the option of scoring only the R25 or only the R25 and the Phase I. An unscored Phase II will reflect upon the judgement of the applicant. For these reasons, inclusion of clear and complete goals and feasibility milestones for each section of the R25/Fast-Track application are critical. R25 Application and Preparation The R25 is to be submitted on form PHS 398 (rev. 4/98) and prepared according to the instructions provided unless specified otherwise within this section. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, E-mail: [email protected]. For those applicants with internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm The PA number and title must be typed on line 2 of the face page of the application and the YES box must be marked. Unlike the traditional R25, the R25 part of this application is a "paper product" that describes the overall justification and objectives of the entire R25/Fast-Track project and a research plan describing who will conduct the research and how it will be conducted. Focus groups of experts and end-users must be convened to critique and assist with the refinement of the final "paper" product that is to be developed, implemented, and evaluated in Phases I and II. For example, if a training module is to be developed, the R25 application should include the proposed content, course schedule, evaluation components, focus group participants and feed-back topics, and an outline of proposed work to be conducted in the Phase I and Phase II. Following the "Research Plan", a "Milestones" section must describe the research aims and measures of feasibility that justify transition to the Phase I. The milestones must be quantifiable and scientifically justified and relevant to R25 progress and the successful completion of the Phase I. Applications lacking this information, as determined by the NCI program staff, will be returned to the applicant without review. It is highly recommended that R25 applicant 1) specify how the project will reduce health disparity or alter behavior of the public or health professionals, 2) chose a small business with the appropriate experience to develop, implement, and evaluate the R25 concept in the Fast-Track Phases, 3) address privacy issues for the entire project, 4) conduct a literature search prior to submission, and 6) include appropriate hypotheses and study demographics. In the R25 budget justification section, a time line and a dollar level for all three phases (R25, Fast-Track Phase I and Phase II) must be included. This should be in chart format and include direct costs, F&A and fee, if applicable, for each of the three phases separately and as an aggregate. The release of funds for the Phases I and II will be based on topics discussed in the REVIEW CONSIDERATIONS section. Fast-Track Application and Preparation The Fast-Track section of this applicant consists of the Phase I (PHS 6246-1) and Phase II (PHS 6246-2) of the SBIR. Electronic application forms and instructions for their preparation may be accessed at the Web site: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm (Source: SBIR OMNIBUS SOLICITATION) As described in OMNIBUS SOLICITATION, both Phases I and II must be completed, each with its own face page and all other required components, including Research Plan. All of the instructions within the OMNIBUS SOLICITATION apply with the following exceptions: ---- Special receipt date ---- Initial review convened by the NCI Division of Extramural Activities ---- More flexible time and budget specifications ---- Inclusion of a Product Development Plan Appendix in the Phase II In the Phase I, the applicant is responsible for testing the feasibility of translating the "paper" product, developed in the R25, into a form of media technology with a focus group of experts and end-users. In the Phase II, the applicant is expected to develop the technology transfer medium, and implement and test the efficacy and effectiveness of the product with a specific population. A detailed product development plan and a business plan for distribution must be included in the Phase II. Phase I must include a "Research Plan" citing specific aims and a section labeled "Feasibility Milestones," that would justify transition from the Phase I to the Phase II. The milestones should be well described, quantifiable, scientifically justified and relevant to the progress of the Phase I for the successful completion of the Phase II. Applications lacking this information, as determined by the NCI program staff, will be returned to the applicant without review. It is highly recommended that Fast-Track applicants: 1) collaborate with the R25 investigator from the beginning of the R25, 2) provide a cohesive follow through from the R25 concept to the development, implement, and evaluation stages of the Fast-Track, 3) provide the necessary Human Subjects information or the justification for excluding information about gender, minority groups, or children, 4) include precise milestones in both phases of the Fast-Track, 5) address privacy issues in both Phases of the Fast-Track, 6) include a detailed evaluation plan in Phase II, 7) provide examples of the intended interactive media, if appropriate, 8) compare how the proposed end-product is better than what already exists, and 9) locate potential backers for the commercialization of the final product prior to submitting the R25/Fast-Track. The release of Phase I funds is contingent upon the successful completion of the milestones described in the R25. Likewise, the release of Phase II funds is contingent upon the successful completion of the milestones described in the Phase I. The funding of both Phase I and II are also subject to the availability of funds. If your Phase II includes clinical trails, please adhere to the following: All clinical trials supported or performed by NCI require some form of monitoring. 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 to 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 NCI Policy details about Data Safety Monitoring of Clinical Trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm Applicants should submit a signed, typewritten original of the three-part R25/Fast-Track application (R25, SBIR Phase I and Phase II), including the checklist, and one signed, exact, single-sided legible photocopy, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express service) To expedite the review process, at the time of submission, send one additional copy of the application package must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Applications must be received by November 28, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness to the guidelines of this PA by the NCI. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and adhere to the guidelines of this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the National Cancer Institute in accordance with the review criteria stated below and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of this PA. As part of the initial merit review, all applications will receive a written critique and 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 assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Reviewers reserve the right to score the entire R25/Fast-Track application, only the R25, or the R25 and the Phase I. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques 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 by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a 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. The reviewers will use the following criteria to evaluate each of the three sections (R25, Fast-Track Phase I and Phase II) in this PA. Following the review, a single score will be assigned to the entire R25/Fast-Track application. 1. 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? To what degree does the technology support the needs of the targeted research community? 2. 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? Is the time frame appropriate for completing the description of the content, design, and operation of the proposed health communication application? How easy will it be to use the proposed health communication application? 3. 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? 4. Milestones. How appropriate are the proposed R25 and Phase I milestones against which to evaluate the demonstration of feasibility for transition to the phases? It is critical that the R25 and the Phase I clearly specify measurable goals (milestones) that should be achieved prior to initiating the Phase II. A MILESTONES section must be included in both the R25 and the Phase I. 5. 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)? 6. 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? The following SBIR criteria (Source: OMNIBUS SOLICITATIONS) complement the criteria cited above: 1. The soundness and technical merit of the proposed approach. 2. The qualifications of the proposed principal investigator, supporting staff, and consultants. 3. The scientific and technological innovation of the proposed research. 4. The potential of the proposed research for commercial application. 5. The appropriateness of the budget requested. 6. The adequacy and suitability of the facilities and research environment. 7. Adequate assurances detailing the proposed means for safeguarding human subjects 8. Innovative aspects of the approaches used in delivering cancer communication. The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders and minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. SCHEDULE Letter of Intent Receipt Date: October 24, 2000 Application Receipt Date: November 28, 2000 National Cancer Advisory Board Review: May 2001 Earliest Anticipated Award Date: July 2001 INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH 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 clear and compelling 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. As part of the scientific and technical merit evaluation of the research plan, reviewers will be instructed to address the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. 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. Reviewers are cautioned 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 Program Announcement (PA), Cancer Communication and Interactive Media Technology, is related to cancer and health communication 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 No. 93.399. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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