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Institutional Review Board Resources

Institutional Review Board (IRB)

Documents and Resources

If you are not an AdventHealth employee, please note that the links will allow you to download copies of the policies. 

If you need to contact the IRB you may email: ORL.IRB.General@AdventHealth.com or call: 407-200-2677

 

Standard Operating Procedures

Research Volunteers 

Visit our For Participants page for more information about participating in a research study.

If you have a question regarding your rights as a research participant, you may reach us at 407-200-2677 or ORL.IRB.General@AdventHealth.com 

Our office is open from 7:00 a.m. - 5:00 p.m. Monday through Thursday, and 8:00 a.m. - 5 p.m. on Friday. After business hours, we will respond to your call or email promptly the next business day.

You may address questions, suggestions, concerns, or complaints about the IRB or human research protection program; allegations of undue influence, allegations of noncompliance, or findings of noncompliance orally or in writing to:

Institutional Review Board

800 N. Magnolia Avenue Suite 500 Orlando, FL 32803
OR
AdventHealth Orlando Compliance Hotline:  888-92-GUIDE (48433).


About Research Participation

NCI Clinical Trials Programs & Initiatives

Step 1: Register on IRBnet.org and affiliate with AdventHealth

The AdventHealth IRB Orlando uses IRBnet.org for electronic submissions, and all users must be registered in the system. 

  • Go to www.irbnet.org
  • Click “New User Registration”
  • Affiliate with AdventHealth Orlando
  • Complete activation of your account via a link received in an email upon registration

 

Step 2: Complete all IRB education requirements per Policy CW AHC 112 Investigator Obligations in Research

To ensure the protection of human participants, all research investigators and staff must complete and show verification of their CITI training. 

  • CITI TRAINING
    • Register on www.citiprogram.org – make sure your “institutional email” is the one you will check regularly.
    • Select AdventHealth Orlando as your affiliated institution. (NOTE: We cannot accept Certificates of Completion under another institution’s affiliation. Modules completed under another institution’s affiliation will be credited to the required modules for AdventHealth once you affiliate under AdventHealth.)
    • Take courses
      • REQUIRED: “Basic Biomedical” or “Basic Social/Behavioral” depending on the type of research that you will be conducting.
        • Biomedical: Research that involves any drugs/devices, medical record data, physical activity, venipuncture, radiation, or the collection of biological samples, or physiological statistics.
        • Social/Behavioral: Research involving surveys, interviews, observation, focus groups, etc.
        • If the project is both social/behavioral and biomedical in nature, the biomedical course must be completed. 
      • REQUIRED: Health Information Privacy and Security (HIPS).
      • REQUIRED (ONLY for those involved in trials with FDA oversight, aka clinical trials): Good Clinical Practice (GCP).
    • Log into IRBNet and navigate to your User Profile.
    • Click the link to “add an external account” – you’ll need your CITI Member ID number.
    • A verification email will be sent to the institutional email address you entered in CITI.
    • Once you have verified this email, your account will be linked and your CITI certificates will automatically import into IRBNet within 24 hours of completion of the course.
    • Refresher courses must be completed every 3 years to maintain your education credentials with the AdventHealth IRB.
  • Should you have questions, please contact the AdventHealth IRB Orlando at 407-200-2677 or AH.IRB.general@adventhealth.com.
  • If AH is the study sponsor and/or an IND/IDE holder of a clinical trial, you must reach out to the ORI office for our involvement in this process as early as possible, before grant or IRB submission. For assistance with this, please contact ORI at AH.ORI@adventhealth.com.
     

Step 3: Complete Conflict of Interest (COI) Disclosure and Training

  • Follow this link for required Conflict of Interest Disclosures.
    1. Conflict of Interest Disclosure
    2. Significant Financial Disclosure – this form is only needed if you are reporting financial interest as it pertains to your Institutional Responsibilities
  • Once complete, submit your COI documentation to the Office of Research Integrity (ORI) at AH.ORI@adventhealth.com
  • The CFD Research Conflict of Interest Training will be assigned to your ALN account.

Step 4: Complete Florence Training and Attestation Form

  • To complete Florence training please go to our SharePoint page: Research Credentialing Process (sharepoint.com). If you dont have an OPID therefore you will not be able to access this page. Please contact Julie.Pepe@AdventHealth.com for assistance.

Step 5: Regulatory Team will submit IRB application and supporting documents once steps 1-4 are completed

  • Contact CFDS.Research.Regulatory.Services@AdventHealth.com to work on completing the IRB application and all supporting documents.
  • The research regulatory team will upload your submission via IRBNet
    • If you need to find forms:
      • ​​​​​​Go to www.IRBNet.org
      • On the left-sided banner bar, select "Forms and Templates".
      • On the Forms and Templates page, select the library for AdventHealth Institutional Review Board Orlando. 
      • Scroll down to find all the forms and templates needed for your IRB submission.  The Manuals provide useful “how to” information. 
  • Should you have questions, please contact the AdventHealth IRB Orlando at 407-200-2677 or AH.IRB.general@adventhealth.com

Below you will find many of the checklists and worksheets utilized by the IRB members and administrative staff. These are provided for informational purposes only and should not be submitted.

 

AHRI recommends using Adobe Acrobat Reader DC to view and complete the checklists & worksheets. If your Adobe Acrobat Reader is not up to date, you can download the latest version here.