SUMMER INSTITUTE FOR TRAINING IN BIOSTATISTICS (SIBS) RELEASE DATE: January 2, 2003 RFA: HL-03-010 (Requesting competing renewal application, see NOT-HL-05-118) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) LETTER OF INTENT RECEIPT DATE: February 25, 2003 APPLICATION RECEIPT DATE: March 25, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Heart, Lung and Blood Institute (NHLBI) invites applications for a grant to develop, conduct, and evaluate a summer course in the basic principles and methods of biostatistics as employed in biomedical research. The course would introduce advanced undergraduate students to the field of biostatistics for the purpose of attracting new students into the field as a response to the dwindling national pool of trained bio-statisticians. The course will attract students from the entire USA and will cover the fundamental concepts of probability, statistical reasoning and inferential methods motivated, in part, by examples that include data collected in studies of heart, lung, blood, and sleep disorders. The course will be developed during the first year and taught during the summers of 2004, 2005, 2006, with appropriate modifications or refinements following each of the first two summer sessions. RESEARCH OBJECTIVES AND SCOPE Background Biostatistics is a fundamental scientific component of biomedical and public health research. Traditional and emerging methodologies are used in clinical trials, observational or epidemiologic studies, medical imaging, and genomics. The current demand for biostatisticians far exceeds the supply and the gap is expected to continue to widen. This under supply results from a combination of burgeoning need and a relatively flat rate of graduating doctoral- and masters-level biostatisticians. A large proportion of the currently senior biostatisticians were trained in the late 1960's and early 1970's and were supported during the early stages of their careers by National Institutes of Health (NIH) training initiatives. With this cohort approaching retirement over the next decade and the tremendous needs and opportunities, now is the time for the government and private sector to re- invest in the training of the next generation of biostatisticians. Objectives and Scope The goal of this announcement is to stimulate applications for a Summer Institute for Training in Biostatistics (SIBS) to increase interest in the field of biostatistics among advanced undergraduate students majoring in mathematics or another quantitatively oriented area of study. This program is definitely not intended to provide an in-depth basic course in the subject nor is it intended to be a standard introductory course in statistics. SIBS would, instead, comprise an innovative introduction to some basics of probability and elementary statistical methods motivated by a series of examples illustrating the use of probability and statistical reasoning applied to the design and analysis of data from studies including those of the heart, lung, blood, and sleep disorders. There is a wealth of data from observational cohort studies and numerous clinical trials (http://www.nhlbi.nih.gov/resources/deca/default.htm) that can be used to demonstrate the essential role biostatistics plays in medical research. An essential aspect of the course will be the use of a personal computer by each student. The PC will be an indispensable learning tool for understanding and using some of the fundamental elements of data analysis. For this reason, instruction in the use of a basic programming language, such as S-plus, would comprise part of the early classroom instruction. Applicants are encouraged to be as creative as possible, since the primary goal of the course is to attract the interest of potential biostatistics students. Depending on the level and interest of the students, the following are examples of the concepts to be covered and the approach to be used in their assignments. o Descriptive statistics (measures of central tendency and dispersion, histograms) are formally presented followed by a PC-based demonstration using real data. Student assignments would repeat these calculations on individually chosen samples from real data sets. o Students learn to draw random samples from data sets and compute measures of central tendency and sample proportions. With this skill they explore the nature of the distributions of these quantities in the context of repeated sampling from a large data set. This sets the stage for introducing the normal, Student's t, and binomial probability distributions. o Using an epidemiology cohort study data set, possibly from one of those funded by NHLBI, instructors demonstrate the concept of adjusted (for age, race, gender, etc.) rates of disease incidence and mortality. Students learn how to compute and compare these rates in different subsets of the cohort. o A classroom exposition of some of the details underlying the results of an actual epidemiologic cohort study reported in the media. o The principles underlying the randomized clinical trial are introduced using data from one of the clinical trials related to disorders of the heart, lung, blood, or sleep. Students learn some of the subtleties of the conduct and interpretation of data using, for example, the Cardiac Arrhythmia Suppression Trial as a case study. o A review of several published studies where flawed analyses have produced misleading results. o Guest lectures by one or more investigators who have recently completed studies that have attracted media attention. The course will take a creative approach to engaging students' interest, perhaps through data associated with topics pertaining to their own particular interest. They should be expected to spend time outside of class on individual assignments involving projects that address questions related to selected data sets. Assuming a summer schedule of classes with perhaps four hours of class and laboratory each day over a five to six week period, the course may reasonably qualify as a one year credit course in basic statistics that many undergraduate curricula require. Proposals for SIBS should indicate criteria for student selection and the number of students expected per class, and should include specific plans for evaluating the effectiveness of the course in terms of students' perceptions of the material and conduct of the course. In addition, there must be plans in place to assess the longer-term impact, as measured by students' subsequent choice of vocation and field of graduate study. MECHANISM OF SUPPORT This RFA will use the NIH Continuing Education Training Grant award mechanism (T15). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2003. This RFA uses just-in-time concepts. It also uses the non-modular budgeting format. FUNDS AVAILABLE The NHLBI intends to commit approximately $250,000 in FY 2003 to fund one new grant in response to this RFA. An applicant may request a project period of up to 4 years and a budget for total costs of up to $250,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. It is anticipated that the award for the second budget period may be issued as early as July 1, 2004, to assure sufficient support for the first course offering in the summer of 2004. Although the financial plans of the NHLBI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution is a domesticc organization and 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 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. SPECIFIC REQUIREMENTS The proposed program must include and the applicant must address the following issues in the application: o The program structure enables awarding course certification and/or course credit towards an undergraduate degree. o Databases from published reports of clinical trials and epidemiologic studies related to disorders of the heart, lung, blood, and sleep, including those with a genetic focus or from the National Health and Nutrition Examination Survey (NHANES) funded studies are the source of examples for student exercises. Selected data bases, suitably modified to insure subjects' anonymity, can be accessed through The Division of Epidemiology and Clinical Applications of NHLBI. o The course approach is based on the use of personal computers, with individual data-oriented projects depending on the students' level. o Proposed distribution of the course announcement will be wide, in order to attract students from the entire US. o Student qualifications and the criteria for their selection are specified. o All available faculty and facilities, including student housing, personal computers, software, and classroom facilities are described. o A formal evaluation is conducted at the end of first and second summer courses to improve overall quality of the program. o A dissemination plan is included. It describes the applicant's willingness and plans for disseminating, via an Internet website, SIBS course materials, including syllabi, manuals or handbooks, references, data sets and assignments, and recommendations for best practices in teaching biostatistics. The website will be available for use by other institutions after the grant period. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. James E. Norman Division of Epidemiology and Clinical Applications National Heart, Lung and Blood Institute Rockledge 2, Room 8110 Bethesda, MD 20892 Telephone: (301) 435-1298 FAX: (301) 480-1862 E-mail: jn3@nih.gov o Direct your questions about peer review issues to: Anne Clark, Ph.D. Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Dr., Room 7214 (MSC 7924) Bethesda, MD 20892-7924 (20817 for express/courier service) Telephone: (301) 435-0270 FAX: (301) 480-0730 Email: clarka@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Marsha Mathis National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7158, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0170 FAX: (301) 480-3310 Email: MathisM@nhlbi.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Applicants should employ the forms and format for Institutional National Research Service Award, described in section V of Form PHS 398, which can be found at https://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing _NRSA_app.htm. However, because section V provides instructions for submitting a traditional training grant (T32) and the present T15 mechanism is considerably different, applicants are encouraged to modify the format appropriately. In addition, applicants should use form pages 4 and 5 for preparing the budget information for this application. Forms suitable for use in a word processor can be found at https://grants.nih.gov/grants/funding/phs398/fp4.rtf and https://grants.nih.gov/grants/funding/phs398/fp5.rtf, respectively. Allowable Costs Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and justified for SIBS. Grant funds may not be used to supplant funds or resources otherwise available at the applicant institution. Personnel Costs - individuals participating in the design and implementation of the SIBS program may request salary and fringe benefits appropriate for the percent of time devoted to the program. Normally, all personnel costs (including administrative and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 25% of the total direct cost. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the Congressionally mandated maximum ($166,700 in fiscal year 2002). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Consultation costs, equipment, supplies, necessary travel, and other program related expenses must be justified as specifically required by the program proposed and not duplicate items generally available for programs at the host institution. Except for housing and meals expenses, undergraduate students may not receive support for participating in the SIBS program. Funds will not be provided for fringe benefits or health insurance for students involved in the SIBS program. Partial costs for off-site rental space will be considered if it is short term and shown to be necessary for the implementation and execution of the SIBS program ( computer lab, etc.). Matching funds from applicant institutions or other organizations for such off-site costs are strongly encouraged. Facilities and Administrative (F&A) Costs, formerly known as "indirect costs," will be reimbursed at a rate of 8% of modified total direct costs for the applicant organization and any approved subcontract. Normally, funds for the evaluation plan are not expected to exceed 5% of the total direct cost. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all five collated sets of Appendix material must be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the (IC). Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the (IC) in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Heart, Lung and Blood Advisory Council. REVIEW CRITERIA The proposed Summer Institute in Biostatistics program is intended to attract students into the field of biostatistics. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed training program will have a substantial impact on the realization of this goal: Training Program o The potential effectiveness of the proposed course in training researchers in biostatistics. o Quality of the course content and adequacy of the syllabus. o Criteria for selecting trainees and for awarding scholarships, for publicizing the availability of the course to the target audience of active researchers, and plans to reach students of both genders and all racial and ethnic groups. Program Leadership o Training, experience, and competence of the faculty in biostatistics issues applicable to this program. Evaluation and Dissemination Plans o Plans for conducting a formal evaluation of the course at the end of first and second summer courses and to use the evaluation results to improve overall quality of the program at its next offering. o Plans for evaluating the effectiveness of the course including longer-term impact, as measured by attendees' subsequent activities or responsibilities in their institutions in the area of biostatistics. o Plans for disseminating course materials and recommendations Institutional Commitment and Resources o Adequacy and availability of any necessary institutional facilities, such as the classroom and computer resources. The scientific review group will address and consider each of these criteria in assigning your application=s overall score, weighting them as appropriate for each application. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 25, 2003 Application Receipt Date: March 25, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS 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 AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. 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 https://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: (if applicable) NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.837, 93.838, 93.839 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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