The Bogalusa Heart Study

Research

A paragraph about research, research teams, collaborations, ongoing research. Institutions involved in the research. Goals of research perhaps.

Access to Bogalusa Heart Study Data and Specimens

Tulane University and SPHTM recognize that BHS Resources are a valuable resource for other researchers. In keeping with NIH policies for data and resource sharing, CLER wants to encourage other qualified researchers to utilize final BHS Resources for secondary research once the main findings from the final data set have been accepted for publication. (NIH Grants – Data Sharing and NIH Grants – Policy).

Support Secondary Research Using Existing BHS Resources

The BHS Steering Committee welcomes requests by researchers to use existing BHS Resources for quality secondary research. The BHS Steering Committee will review for approval written proposals for studies using BHS Resources (data, recordings and/or specimens). Applicants must submit proposals on the proposal form, which is available on this website. If a proposal is approved by the BHS Steering Committee, all investigators involved in the approved study must complete and sign a BHS Data Distribution Agreement, which will specify that the investigators will use the BHS Resources only for the approved project as described.

Protect the Integrity of BHS Resources & Privacy of BHS Volunteers

A critical role of the BHS Steering Committee is to safeguard the integrity of BHS Resources to ensure they endure and are available for future secondary research. The BHS Steering Committee will establish procedures for the storage of BHS Resources at SPHTM facilities and access of BHS Resources by researchers of either currently funded Bogalusa Heart Study grants or researchers accessing BHS Resources for secondary research that has been approved by the BHS Steering Committee.

The BHS Steering Committee will develop and implement procedures consistent with the “Guidelines for Responsible Data Management in Scientific Research,” issued by the US Department of Health and Human Services’ Office of Research Integrity (ORI) (available here.) According to ORI’s Guidelines, “In order to protect the integrity of stored data, project data should be protected from physical damage as well as tampering, loss or theft. This is best done by limiting access to it.”

BHS Resources include electronic data, images (e.g., electrocardiograms), and biological specimens. Each of these forms of BHS Resources requires different safeguards. Key aspects of the procedures that will apply to each form of BHS Resources include:

Electronic Data

All electronic data will be password protected and must be access through the BHS portal. Administrator access will be limited as appropriate for the particular study. Only coded, de-identified data will be available for secondary research.

Images

Original images are stored at SPHTM facilities and may not be removed from the storage site. Images may be studied at the storage site or copies made by BHS staff at the facility and provided to the researcher. Researchers are not allowed to remove original images from the storage site or to make copies.

Biological Specimens

Unlike electronic data or images, BHS specimens are finite. They can not be duplicated. As such, they require additional safeguards to ensure their use is limited to high quality research. Priority will be given to federally funded studies that involve research of existing BHS specimens. Proposals for secondary research of BHS specimens submitted to the BHS Steering Committee will need to include a justification for the specimens requested and specific details regarding the volume of specimens required for the study. Only BHS staff will have direct access to original BHS specimens. All preparation of BHS specimens to provide to researchers will be performed by BHS staff.

Policies and Agreements

Bogalusa Heart Study Steering Committee

The BHS Steering Committee has three primary responsibilities: 1) to sustain and grow the Bogalusa Heart Study; 2) to support quality secondary research using existing BHS resources; and 3) to protect the integrity of BHS Resources and the privacy of BHS volunteers who have participated in the Bogalusa Heart Study.

Sustain and Grow the Bogalusa Heart Study

The BHS Steering Committee will provide scientific and operational leadership to the Bogalusa Heart Study in order to continue the success of the study. This includes all NIH funded Bogalusa Heart Studies. These leadership roles include:

  • Set scientific direction and priorities for new Bogalusa Heart Study proposals and grants;
  • Facilitate and coordinate the operations of funded research activities;
  • Provide technical support for access to existing BHS Resources (if needed);
  • Coordinate shared personnel and equipment of funded research projects;
  • Coordinate and facilitate new research grant application submissions;
  • Coordinate and facilitate scientific presentations and publications.