Baptist Health South Florida Clinical Research Processes

Human subjects research involving patient data from the Bethesda Hospital (BH) East/West, Boca Raton Regional Hospital (BRRH), or other Baptist Health South Florida (BHSF) facilities must be approved by BHSF. The principal investigator (PI) must be an attending physician on staff at a BHSF hospital (BH or BRRH). The PI must obtain hospital approval and sign off on all submissions. For additional information regarding research services available through BHSF, download the BHSF Research Services presentation .

Prerequisite Requirements

• CITI Program affiliation with Baptist Health South Florida and completion of courses Group 1.Biomedical and Conflicts of Interest. CITI certifications are good for three years.
  
  
  1. Log on to citiprogram.org and affiliate with Baptist Health South Florida. (Note: You can see your institutional Courses and affiliations from the My Courses tab.)
  2. Select Baptist Health South Florida   View Courses tab   Complete the following courses:
     
     • Group 1.Biomedical
     • Conflicts of Interest
• Complete a Clinical Conflict of Interest (CCOI) form – Contact ResearchCompliance@baptisthealth.net to request the form. CCOI is an annual disclosure.

Documents

To create your protocol, complete the following:

1. Access IRBNet.org – Select the Forms and Templates tab (left side of screen). From the Select a Library box, select Baptist Health South Florida IRB. If BHSF IRB is not an option, add this affiliation in the User Profile by selecting “Add an Additional Affiliation” and follow prompts.
2. Scroll through the list of documents and select the appropriate protocol.
3. Download the appropriate protocol and complete the document. Additional documents required (e.g., data collection sheet).

Hospital Approval Process

Bethesda Hospital

Research must be approved by the hospital’s Chief Medical Officer before IRB submission.

1. Upon completion of the appropriate forms, email the documents to hospital’s Chief Medical Officer, Dr. Keith Foster. You may receive requested edits of your documents. Complete all revisions appropriately.
2. Once the protocol is acceptable, Dr. Keith Foster will send an email response indicating project approval
3. Save the approval document (pdf) for later submission to Baptist IRB.

Boca Raton Regional Hospital

Research must be approved by the hospital's Research Committee (RC) before IRB submission.

To optimize the approval processes, you can use the same protocol for BRRH RC approval, and BHSF IRB approval. To create your protocol, complete the following:

1. Upon completion of the appropriate forms, email the documents to the hospital’s Research Committee chairperson, Dr. Louise Morrell. You may receive requested edits of your documents.  Complete all revisions appropriately. (Always use track changes on revisions.)
2. Research Committee (RC) meetings are held on the 3^rd Friday of each month. Protocols (with revisions) need to be completed and emailed to Amanda Vera Weiner by the Wednesday prior to the RC meeting date.  
3. Attend the RC meeting and be prepared to discuss your protocol.
4. Make any required revisions and send to Ileana Vargas for oncology research OR to Amanda Vera-Weiner for non-oncology research.
5. Receive the BRRH RC approval letter.

IRB Approval Process

1. Access IRBNet.org. Select Create New Project tab (left side of screen).
2. Select Baptist Health South Florida, Miami, FL as the Research Institution.
3. Complete the opening form (e.g., Project title, PI, etc.).
4. Complete the initial application by selecting the 'Start a Wizard' button. You may return to this page by clicking on the Designer tab (left side of screen).
5. Upload the protocol and all supporting documents (e.g., data collection sheet) that were approved by the hospital.
6. Upload hospital approval letter.
   
   • Bethesda Hospital: approval letter from the Chief Medical Officer (Dr. Keith Foster).
   • Boca Raton Regional Hospital: approval letter from the hospital research committee.
7. Sign the package as Principal Investigator.
8. Share the project with Gustavo Rodriguez, Brianna Anon, and Jacqueline Grass (read only access, signature required from either Heather, Beatriz, or Jackie to attest investigator training compliance).
9. Share the project with hospital signatory.
   
   • BH: Dr. Keith Foster (read only access, signature required).
   • BRRH: Amanda Vera Weiner (full access, no signature required).
10. Once signatures have been obtained, select Submit this Package (left side of the screen).
11. Revise as required - Receive IRB approval or exempt status.
12. After receiving letter from the IRB, start your study. Study data can now be accessed or received.

Case Report Approval Process

Case reports for 1-3 patients do not require Baptist (BHSF) IRB review. For case reports with 1-3 patients, complete the following:

Boca Raton Regional Hospital

1. Draft a one-page rationale / summary of the case report. (This will most likely be part of your actual case report that will be submitted to a journal).
2. Obtain HIPAA authorization from the patient or patient’s legally authorized representative, or the next of kin if the patient is deceased. The clinical hospital authorization form should be used.  Also, this must be documented in the patient's medical record.  Contact Amanda Vera Weiner to obtain the appropriate form.
3. Email the rationale and consent to BRRH Research Committee (Amanda Vera Weiner).
4. If journal requires a “letter” from the IRB, the case report must be submitted to BHSF IRB for a Request for Determination.  This is not done through IRBNet but is directly communicated to BHSF IRB.  Contact Amanda Vera Weiner to obtain the appropriate form.

Contacts

Baptist Health South Florida

• IRB , 786-527-9280
  
  • Amanda Coltes-Rojas, Office of Research Integrity Director, 786-527-9282
  • Natalie James, IRB Manager, 786-527-9285
• Research Compliance
  • Gustavo Rodriguez
  • Jacqueline Grass
  • Brianna Anon

Bethesda Hospital

• Chief Medical Officer
  • Dr. Keith Foster

Boca Raton Regional Hospital

• Facilitated Review Committee

  • Amanda Vera Weiner, 561-955-4519

• Regulatory Office
  • Oncology Research - Ileana Vargas
  • Non-Oncology Research - Amanda Vera Weiner