Baptist Health Institutional Review Board (IRB)

The Baptist Health Institutional Review Board (IRB) is responsible for protecting the rights and welfare of human research participants. The IRB reviews research activities to ensure compliance with federal regulations, ethical principles, and Baptist Health policies.

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

Contact Information

For questions regarding IRB submissions or policies, please email Baptist.IRB@bmcjax.com

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

Submissions

All IRB submissions must be completed through the Baptist Health IRB Electronic Submission System (E-System). Investigators and study staff must log in to submit new studies, amendments, continuing reviews, reportable events, and closures.

The following submission types are available through the E-System:

  • New Study Submission
  • Amendment / Modification
  • Continuing Review
  • Reportable New Information (RNI)
  • Study Closure

Reach out to the IRB office for the link at Baptist.IRB@bmcjax.com.

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.

Is it Research, Evidence-Based Practice or Quality Improvement?

Determine if your project is research, evidence-based practice or quality improvement using these research guidelines.

Complete the Clinical Research Project Application and return to Amanda.Brown@bmcjax.com.

Publications and/or Presentations
Publications and/or presentations must be reviewed for content by the Clinical Scientific Review Committee. Please use the Clinical Research Project Application and include a copy of your article or presentation on the email submission.

Evidence-Based Practice
Evidence-based practice (EBP) is a term that means providing care based on what science and research have shown works best for patients.

Clinical Research / Trials at Baptist Health

If you have a school project proposal or research protocol, please attach it along with the application. The project application will be reviewed by the Clinical Scientific Review Committee. Please allow two months for the application review process.

IRB Policies and Procedures

The IRB operates in accordance with applicable federal regulations, state laws, and institutional policies. All investigators are responsible for reviewing and complying with the policies listed below prior to submitting research for IRB review.

Investigator Resources

Resources are available to assist investigators and study teams throughout the research lifecycle. These can be found in the E-system under the library tab.

Good Clinical Practice Training

All research staff are required to complete good clinical practice 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, "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.