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Bogalusa Heart Study Project Policy NEW PROJECT PROPOSAL POLICY I. General Policy To enhance the value of the Bogalusa Heart Study, the Steering Committee welcomes proposals from individual investigators to carry out new studies. Such study proposals must be reviewed and approved by the Steering Committee before their inception or the submission of a proposal for external funding consideration. II. Overview Project proposals for new studies are based on information from Bogalusa Heart Study participants in an investigation or analysis which is relevant to, yet not described in already existing and/or funded Bogalusa Heart Study protocols, and will derive support from new external funding. It is anticipated that a typical new project will propose the collection of additional data not collected or analyzed as part of the other existing Bogalusa Heart Study datasets or protocols. Proposals may be submitted by investigators within the Bogalusa Heart Study or by investigators without a prior relationship to BHS. New project proposals require a plan for external funding. Examples include studies funded by investigator-initiated NIH research awards (R01s), grants from academic institutions or private sources (e.g. private foundations, pharmaceutical companies). Any new project must have sufficient funding to cover the costs for laboratory (e.g. to process or ship samples) and data coordinating activities (for tasks such as sample selection, preparing and documenting analysis files, participating in statistical analysis, integrating new project data back into the Unified Participant Tracking Database [UPaT-D]) and other related BHS databases), and cover field operations costs. III. Requirements and Procedures for Approval of New Project Proposal IIIa. Overview Participation in, and approval of a new project proposal is subject to review and formal approval by the Bogalusa Heart Study Program Steering Committee. Approval by the Steering Committee will be defined by 3 of 5 votes in favor of the proposal. Dissenting voters must provide the explicit reasons for their dissent. Any issues of concern to dissenting voters will be shared with the applicant and opportunities for clarification provided. A new project proposal must receive approval before a grant application intended to support it is submitted. Investigators are encouraged to discuss potential proposals with the Chair of the Steering Committee prior to submitting a project proposal. All new project proposals must include at least one current BHS investigator as a coinvestigator. Willingness to include additional BHS investigators as co-investigators of the new study is mandatory. New project proposal submissions for external funding are required to include a letter of support from the BHS Steering Committee Chair. 1 of 6 V2.0 20151201 Bogalusa Heart Study Project Policy IIIb. Requests for New Project Proposals as Part of Training or Career Awards The Bogalusa Heart Study investigators and the NIH anticipate that the Bogalusa Heart Study will be an important resource for career development and training among members of the academic community. Special consideration, therefore, will need to be given to requests for new studies to be funded through training grants or career development awards through the NIH or other funding sources. As these funding mechanisms typically provide funding only for investigator effort, not additional data collection, such proposals will generally propose research questions and analyses that could be considered part of the core Bogalusa Heart Study. In these cases, evaluation should consider the scientific gain to the Bogalusa Heart Study from the addition of the proposed new project analyses as well as the training and career development opportunities afforded to the applicant by the proposed new study. Evaluation in the case of proposals to be funded through training grants will be limited to trainees of BHS investigators, as the quality of the analyses will be greatly dependent on the mentor identified in the training grant. In the case of faculty career awards, evaluation of new study applications will need to consider the anticipated scientific contribution of the applicant, including their ability to perform data analyses that may not be able to be performed without additional funding. Further, willingness to adhere to the requirements of the Bogalusa Heart Study Program Publications and Presentation Policy with respect to authorship will be particularly important. The review process will have two steps. The first step is review of the proposal concept and acceptability by the Steering Committee. The proposal concept should be summarized in 2-4 pages. IIIc. Considerations for Approval A. The proposed study must meet requirements of the highest scientific merit. B. Participant burden – 1. The proposed study must be acceptable to the participants (e.g. time, discomfort, privacy). 2. The proposed study must not interfere with participation in any other components of already-funded BHS protocols. 3. The proposed study must not hamper continued participation in the BHS. 4. The proposed study must place minimal demand on scarce BHS resources such as blood samples, urine specimens, VHS echo recordings etc. C. The proposed study must require the unique characteristics of the BHS cohort to accomplish its goals. D. The investigators must have adequate resources to effectively complete the project, including: 1. Sufficient budget for staff and personnel 2. Personnel having the requisite expertise to meet the objectives of the project 2 of 6 V2.0 20151201 Bogalusa Heart Study Project Policy E. Investigators must agree to central coordination of research operations and participant visits at the 712 Willis Ave clinic currently in use for BHS data collection operations. F. The proposed study must not interfere with the completion of the main objectives of already funded BHS protocols. G. The proposed study must not adversely affect participant cooperation or compliance with BHS. H. The proposed study must not create a serious diversion of study resources (personnel, equipment or study samples) or investigator/staff time, either at Tulane University or in Bogalusa. I. The proposed study must not jeopardize the public image of the Bogalusa Heart Study. J. Documented involvement of BHS investigators as part of the research team. K. Shared support for BHS staff and personnel. IIId. Instructions for Preparation of Requests for Approval of a New Project Proposal All proposed new projects must be submitted to the BHS Steering Committee in time for circulation and subsequent review before submission to a funding agency. Studies submitted for review less than 6 weeks before a funding application deadline may not receive approval. The following are the elements to be included in a new project proposal. IIIe. Proposal Format A written request for approval of a new project should be submitted as a two to three page summary to the Steering Committee containing the following information: A. Identifiers: 1. Initiating investigators, collaborators, BHS co-investigator and project roles 2. Planned starting date and project timeline 3. Funding plans and estimated cost B. Design and Methods 1. Brief background and rationale 2. Study questions or hypotheses – specific aims 3. Specific data collection methodology, including questionnaires and coding forms, if available. C. Specific answers to the following questions 1. What is the expected burden to participants? What are the time burdens, discomfort, and expected participation rates? 2. What BHS data and/or analyses are needed for this study? 3. Is blood or other biologic sample (either fresh or from the BHS repository of stored samples) required? What will be the quantity of specimens needed? 4. What collaboration with BHS investigators is planned? With whom? Have the collaborating investigators approved the proposal? 3 of 6 V2.0 20151201 Bogalusa Heart Study Project Policy 5. What, if any, follow-up is needed? Specify length of time and events to be ascertained. 6. How many participants are required? 7. When will data be collected? 8. How will the project be funded? Would additional work or personnel time be expected of BHS staff? How will the new study budget cover demands on BHS personnel time and resources? 9. Where will the data analyses be conducted? 10. How will the confidentiality and other aspects of protection of human subjects be maintained? 11. What is the time frames and plan for merging data to the main BHS data repository as required? D. Data or Specimen Requirements 1. Historical data needed from BHS analysis files 2. Specimens needed from BHS repositories, specifying type and amount E. Handling of BHS Data and Specimens 1. Disposition of stored samples from main study and those processed by new study 2. Disposition of new study data at the conclusion of the new study IV. Changes to Proposed Study Once a new project proposal is approved, if a change occurs in the structure or concept of the study, such changes should be disclosed to the Steering Committee for review and approval. V. Proposal Budget The investigator applying for a new project must supply all additional funds needed to successfully complete the study. Because the BHS field office is owned by Tulane University, on campus indirect costs will be charged by Tulane University. The Steering Committee will be concerned with both the obvious and the hidden costs to the Bogalusa Heart Study entailed by a new project. Provision of funds for these expenses is essential – a new project cannot begin without such fiscal support. The need for such support must be stressed in research grant applications since this is a mandatory element. Such costs include, but are not limited to: a. Field operation costs. b. Statistical and data management staff for coordinating the additional data management and analyses, and biweekly data merging required. c. BHS expenses involved in altering key identifying data so that subjects’ confidentiality will be protected. d. Costs for notification of alert values. e. If work is to occur on site, appropriate clinic, lab, and office costs. f. If subject recruitment outside of main exams is anticipated, support for current staff and nurse coordinator to arrange subject appointments. 4 of 6 V2.0 20151201 Bogalusa Heart Study Project Policy g. Personnel, equipment and supplies necessary to complete the project. Once a study concept is approved, applicants must develop a budget that adequately provides for these types of expenses at both the data and clinical levels. VI. Human Subjects/Data Confidentiality Confidentiality of BHS participants must be guaranteed. Individually identifiable data may not be released. A signed consent must be obtained from every participant in the new study, if the data collection/request is not covered in the original informed consent process for one of the funded clinical Bogalusa Heart Study protocols. a) Any investigator or personnel having access to BHS subject data should have received an orientation to BHS confidentiality procedures. Key personnel of the new study must be certified in the CITI Program Group 1 Biomedical Researchers and Key Personnel or equivalent training course. b) A copy of the IRB approval letter for the new study is to be sent to the Steering Committee. If a separate consent form is required for the new study, a copy of the signed new study consent form for each study participant must be included in the BHS records. A data file tracking all signed new consent forms must be maintained by the new study and an electronic copy of that file must be delivered to the Bogalusa Heart Study Program Coordinator for our records. The principal investigator of a new project is responsible for presenting the study to the Steering Committee, monitoring the study to assure continuing compatibility with BHS and serving as a liaison to the BHS Steering Committee. The Steering Committee monitors the development of the new studies, receipt of funding, initiation dates, and progress. A written progress report on new studies must be made semi-annually to the Steering Committee. VII. Analysis and Publication of Results of New Studies Unless specifically arranged, all analyses will take place in the TU Department of Epidemiology or Center for Lifespan Epidemiology Research and be conducted under the supervision of its biostatistician-investigators. Under specifically approved circumstances, datasets will be released for analysis by external investigators. Career or training awards may be situations in which release of data for analysis deserves special consideration. Under these circumstances, the investigator of the new study will provide interim reports on analyses to the data coordinating center during data analysis to ensure that all study data used in analysis of new study results are consistent with data in the main study database and to ensure the quality of analytical approaches. Proposals for manuscripts resulting from all new studies must be submitted for review to the Steering Committee and require approval before establishment of a writing committee or a submission for publication or presentation. It is anticipated that principal investigators of approved new studies will lead at least one scientific paper emerging from the new study analyses as specified in the Bogalusa Heart Study Program Publications and Presentations Policy. Each manuscript and abstract would be expected to include a BHS investigator. The phrase "The Bogalusa Heart Study" should be included in the title or abstract in 5 of 6 V2.0 20151201 Bogalusa Heart Study Project Policy all scientific presentations and manuscripts and listed as a key word whenever possible. Manuscripts will also contain an appendix listing BHS investigators deemed appropriate. VIII. Feedback of Results of New Studies to Participants Results of new studies shall be reported to participants and/or their physicians if medically useful. Such reporting should follow standard BHS protocol for notification of participants. IX. Handling of BHS Data and Specimens At the time of distribution of BHS specimens and/or information, the BHS Collaborating Investigator will make explicit arrangements with the new study PI for the security of these study materials, and for their final disposition at the conclusion of the new study. The safety and confidentiality of the BHS data at the collaborating institution is the responsibility of the new study PI, as is the appropriate disposition of these materials after the study has been completed. Leftover DNA and laboratory specimens must be returned, and files of BHS data are returned or deleted, as established at the outset of the collaboration. During sample data collection, the new data and/or materials will be merged on a biweekly basis with available data. An archival copy of the newly collected data and/or laboratory results will be sent to the TU Center for Lifespan Epidemiology Research at the conclusion of the data analysis and publication of the main (new) study hypothesis. This transfer is the responsibility of the new study BHS collaborator(s). Once transferred back to the BHS, these new data will become part of the aggregate BHS data. Subsequent access to these data will be governed by the BHS Steering Committee. Any new funded study which relies on BHS samples or participant records must agree to be part of a system of operations coordinated by the BHS Steering Committee and data collections coordinated at 712 Willis Ave in Bogalusa. Participant contact must be centralized and can only occur via BHS staff employed by Tulane University at 1440 Canal St in New Orleans, LA or located at the field clinic at 712 Willis Ave in Bogalusa, LA. 6 of 6 V2.0 20151201