and Human Services (HHS)
EXPIRED
REVIEW AND ANALYSIS OF TOBACCO INDUSTRY DOCUMENTS Release Date: March 7, 2001 PA NUMBER: PAR-01-063 National Cancer Institute Letter of Intent Date: June 13, 2001, January 8, 2002 Application Receipt Date: July 18, 2001, February 12, 2002 THIS PROGRAM ANNOUNCEMENT (PAR) REPLACES PAR-99-114, WHICH WAS PUBLISHED IN NIH GUIDE ON JUNE 17, 1999. THIS PAR USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PAR. PURPOSE This Program Announcement (PAR) is intended to stimulate research on a wide variety of scientific, technical, marketing and tactical undertakings by the tobacco industry, which were documented in papers, memos, and other records. The systematic, comprehensive analysis and evaluation of these documents will enhance understanding of the tobacco industry’s knowledge, strategies and tactics, provide a greater understanding of the determinants of tobacco use and addiction and help researchers and public health practitioners identify effective strategies to prevent and reduce tobacco use. This PAR will expire on February 13, 2002, unless reissued. NIH Grants policies apply to these awards. RESEARCH OBJECTIVES Background Tobacco use, responsible for nearly one in five deaths, is the nation’s leading cause of death. Cigarettes cause more than 420,000 deaths in the U.S. each year, including 120,000 deaths from lung cancer and more than 31,000 deaths from other cancers. At least 3,000 lung cancer deaths occur annually in nonsmokers exposed to environmental tobacco smoke (ETS) carcinogens. In 1993, the direct medical costs of tobacco use were $50 billion. Despite the enormous health hazards of tobacco use, 24.1% of adult Americans (47.2 million) are current smokers. Approximately 3,000 youth under age 18 become regular smokers every day. Landmark tobacco litigation brought by the State Attorneys General and others, Congressional inquiries, and the Food and Drug Administration’s historic investigation have resulted in the release of millions of previously inaccessible tobacco industry internal documents. Among other things, the documents contain important information about the health consequences of tobacco use, cigarette design, tobacco marketing to particular demographic groups (including youth, women and racial/ethnic minorities), the determinants of tobacco use, and how the tobacco industry has worked to block and undermine public health efforts that effectively reduce tobacco use. The most comprehensive collection of tobacco industry documents is in Minneapolis, Minnesota, at the State of Minnesota’s document depository. This was established as part of the settlement reached in May 1998 to resolve the lawsuit brought by the Minnesota Attorney General and Blue Cross and Blue Shield of Minnesota against the tobacco companies. The depository contains an estimated 26 million pages of documents acquired through discovery in the Minnesota litigation and will, as a condition of the Minnesota settlement, incorporate documents released in any other smoking and health litigation in this country. Another 7 million pages of documents acquired through the litigation are stored in Guildford, England. A rapidly increasing portion of the documents in the depository, as well as other documents, are now available through the Internet, at the following sites: the House of Representatives Commerce Committee site (http://www.house.gov/commerce/TobaccoDocs/documents.html), Tobacco Documents Online site (http://www.tobaccodocuments.org), the University of California Library site (http://galen.library.ucsf.edu/tobacco), the Tobacco Resolution (tobacco industry) site (http://www.tobaccoresolution.com), and the Tobacco Control Resource Center website (http://www.tobacco.neu.edu). It is expected that additional sites will also become available. These newly released documents present a unique opportunity to make vast amounts of previously inaccessible scientific information available to the public, in the fields of nicotine addiction, tobacco marketing, and tobacco product engineering, among others. The research findings contained in the tobacco industry documents will only be useful if they undergo systematic analysis, and these analyses are published in the scientific literature. Several analyses have already been published: five from Brown and Williamson documents concerning nicotine addiction, environmental tobacco smoke, and lawyer manipulation of both internal and external scientific research (see reference numbers 1-5), and one from Minnesota tobacco trial documents concerning nicotine addiction, low tar/low nicotine cigarettes, cigarette design, and nicotine manipulation in cigarette manufacture, (see reference number 6). Through the analysis of these documents, new information will be obtained about tobacco industry research, programs and other activities. Investigators may review the industry documents in order to assess the scientific validity and the application of the industry’s findings. Information found in these documents can be analyzed in conjunction with the analysis of other data sets. This new information will help scientists understand tobacco use behavior and will guide scientists and public health practitioners in the development of new research and programs to prevent and reduce tobacco use. Applications to analyze the tobacco industry documents in areas including, but not limited to the following, are encouraged: - nicotine pharmacology - nicotine addiction - health consequences of tobacco use - tobacco product additives - tobacco product design and manufacturing - advertising and promotion - youth initiation - tobacco use cessation - disruption of scientific research and public health programs - policy research Investigators face unique challenges in obtaining and analyzing these documents because of their large volume and limited organization. Investigators may choose to assess methods for retrieving and analyzing documents through electronic and other means. All investigators funded under this program announcement will be asked to make the tobacco industry documents and indices they use available to scientists and lay audiences through the Internet. Other means of disseminating documents and research results are encouraged and expected. Investigators will be convened twice annually to discuss research methods and results of common interest. SPECIAL REQUIREMENTS Applications responding to the PAR should include costs for two round trips for two-day meetings to Bethesda, MD in the overall budget request for each year. MECHANISM OF SUPPORT This PAR will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PAR may not exceed four years. The earliest anticipated award date is April 1, 2002. Applications requesting $250,000 or less in direct costs per year must be in modular format. Applications that request more than $250,000 direct costs per year must follow the traditional PHS 398 application instructions. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michele Bloch, MD, PhD Division of Cancer Control and Population Sciences National Cancer Institute Executive Plaza North, Room 4032, MSC 7337 Bethesda, MD 20892-7337 Telephone: (301) 496-8584 FAX: (301) 496-8675 Email: [email protected] Direct inquiries regarding fiscal matters to: Brian Albertini Grants Administration Branch National Cancer Institute 6120 Executive Blvd Suite 243, MSC, 7150 Bethesda, MD 20892 Telephone: (301) 496-7239 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 June 13, 2001 and January 8, 2002, a Letter of Intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the PAR 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 IC staff to estimate the potential review workload and plan the review. The Letter of Intent is to be sent to the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this PA. APPLICATION PROCEDURES Applications requesting $250,000 or less in direct costs per year must be in modular format. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. 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 301/710-0267, email: [email protected]. The title and number of the PAR must be typed on line 2 of the face page of the application form and the YES box must be marked. For those applicants with internet access, the 398 kit may be found at: http://grants.nih.gov/grants/funding/phs398/phs398.html Applicants planning to submit a grant application requesting $500,000 or more in direct costs for any year are required to discuss their eligibility with the NCI program staff contact listed under INQUIRIES before submitting the application. Furthermore, the applicant must obtain agreement from the program staff that NCI will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the NCI program staff member who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html Applicants are strongly encouraged to call the program contacts listed in INQUIRIES with any questions regarding the adherence to the guidelines of their proposed project to the goals of this PAR. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages). At the top of the page, enter the total direct costs requested for each year. This is not a form page. o Under personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. o For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is domestic or foreign. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. o Provide an additional narrative budget justification if there is a change in the number of modules requested from year to year. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page,- List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this PAR and will be returned without further review. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, 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) At the time of submission, two additional copies of the application 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 July 18, 2001, February 12, 2002. 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 in response to this PAR 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Center for Scientific Review and for adherence to the guidelines to this PAR by the National Cancer Institute. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and adhere to the guidelines of this PAR will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the Division of Extramural Activities, National Cancer Institute in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique, and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. 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. 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 analyzes 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? The initial review group will also examine: 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. 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 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 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 is 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 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 these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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. 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 PAR, Review and Analysis of Tobacco Industry Documents, is related to the priority areas of cancer and tobacco, alcohol and other drugs. 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 Cancer Cause and Prevention Research. 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. REFERENCES 1. Glantz SA, Barnes DE, Bero LA, Hanauer P, Slade J. Looking through a keyhole at the tobacco industry: the Brown and Williamson documents. JAMA. 1995, 274: 219-224. 2. Slade J, Bero LA, Hanauer P, Barnes ED, Glantz SA. Nicotine and addiction: the Brown and Williamson documents. JAMA. 1995, 274: 225-233. 3. Hanauer P, Slade J, Barnes ED, Bero LA, Glantz SA. Lawyer control of internal scientific research to protect against product liability lawsuits: the Brown and Williamson documents. JAMA. 1995, 274: 234-240. 4. Bero LA, Barnes ED, Hanauer P, Slade J, Glantz SA. Lawyer control of internal scientific research: the Brown and Williamson documents. JAMA. 1995, 274: 241-247. 5. Barnes Ed, Hanauer P, Slade J, Bero LA, Glantz SA. Environmental tobacco smoke: the Brown and Williamson documents. JAMA. 1995, 274: 248-253. 6. Hurt RD, Channing RR. Prying open the door to the cigarette industry’s secrets about nicotine. JAMA. 1998, 280: 1173-1181.
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