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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.
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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
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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?
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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.
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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
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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.
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