Baptist Health Institutional Review Board (IRB)

Baptist Health Institutional Review Board (IRB) is responsible for protecting the rights and welfare of all research participants in clinical trials and other human subject's research conducted at Baptist Health.

Baptist Health Institutional Review Board (IRB) Main Content

The Role of the IRB

The federal government has established rather complex but important requirements for the protection of human subjects involved in research. To meet those requirements, many institutions have established Institutional Review Boards or Committees. This is a group of people responsible for protecting the rights, and well-being of study subjects. The purpose of the Board is to review, in detail, research protocols and insure compliance with FDA and OHRP (Office of Human Research Protection) regulations.

Baptist Health IRB

Baptist Health IRB operates in compliance with the U.S. Department of Health and Human Services regulations 45 CFR Part 46, the U.S. Food and Drug Administration regulations as described in 21 CFR Parts 50 and 56 and complies with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines as adopted by the U.S. Food and Drug Administration.

The IRB at Baptist Health is headed by a volunteer IRB chair and a board of volunteer members who meet the HHS requirements of IRB membership, per 45 CRF 46.107. The Full Board meets once monthly to review research-related matters. Investigators are notified in writing of the actions taken by the IRB.

Baptist Health IRB Registrations:

  • Federalwide Assurance: FWA00001001
  • IRB registration number: IRB00001666
  • IRB organization number: IORG0001248

Baptist Health Institutional Review Board (IRB) Additional Content Section 1

Active Protocols at Baptist Health

If you are interested in enrolling a patient in a study being conducted at Baptist Health, please click on the link(s) below for additional contact information:

Cinical Research

The Baptist Health Clinical Scientific Review Committee is a sub-committee of the Baptist Health Institutional Review Board. The Clinical Scientific Review Committee exists to review including quality improvement, case reviews, and evidence-based practice implementation projects. It also serves as a privacy and risk review for chart reviews.

Obtaining Approval to do Research at Baptist Health

Prior to submission to the IRB, any research studies that involve any hospital departments must receive approval by the Baptist Health Research Committee (BHRC), a division of Baptist Health Research Institute. This group reviews the operational impact of a potential research protocol and determines which hospital resources will be required to conduct the research.

Any sponsored research to be performed at any of the Baptist Health campuses must be approved by or granted a waiver of review by the IRB after its review by the BHRC.

For questions regarding the Baptist Health Research Committee process or submission to the BHRC: BHRCsubmissions@bmcjax.com

Human Subjects Protection Training

All research staff are required to complete human subject's protection training before beginning any study related activities. Each research staff member is responsible for ensuring they maintain up to date training.

Baptist Health offers complementary access to the courses necessary to complete this requirement via CITI Program.

To access this training:

  1. Visit CITIprogram.org
  2. Log in with existing credentials or create a new registration (new users)
  3. Choose "Baptist Health - Jax" affiliation.
  4. For Clinical Research, complete the "Biomedical Research" course and "GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)" course.
  5. For Socio-Behavioral and other non-human subjects research, complete "Social & Behavioral Research" course.
  6. Each research staff member's training completion certificate(s) must be submitted with the IRB submission.

Financial Conflict of Interest Training

In accordance with Investigator Disclosure of Potential Financial Conflict of Interest, all investigators and research staff must complete Conflict of Interest training, at least every four (4) years.

To access the NIH Financial Conflict of Interest Training:

  1. Visit https://grants.nih.gov/grants/policy/coi/index.htm
  2. On the right-hand side, click the small window showing "FCOI Training"
  3. Submit completion certificate with IRB submission

Data Collection for Review Preparatory to Research

If an investigator wishes to review protected health information (PHI) to determine the feasibility of a research project, he/she may do so by notifying the IRB of a planned "Review Preparatory to Research" (45 CFR 164.512(i)(1)(ii)). By this notification the investigator declares that he/she will use the PHI solely as needed to prepare a research protocol or for similar purposes preparatory to research, that the PHI will not be reused or re-disclosed for another purpose or leave the investigator's institution (covered entity), and that the PHI is necessary in order to develop the protocol.

For submission of requests for permission to conduct a review preparatory to research, complete the Application for Review Preparatory to Research Submission Form and submit it to IRBSubmission@bmcjax.com.

Is it Research?

Not all projects fit easily into the definition of research. However, all relevant federal regulations make it clear that the ultimate decision about whether a given project constitutes research rests with the Institutional Review Board (IRB).

To receive a formal determination letter from the IRB office confirming that your project is not research, use the Checklist for Determining Research Status to determine if your project must be submitted for IRB review, and submit with a summary of your project to IRBSubmission@bmcjax.com

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