Institutional Review Board (IRB) Overview
The AdventHealth Institutional Review Board (IRB) reviews all research conducted by AdventHealth team members and agents for ethical standards, scientific merit and regulatory compliance.
The purpose of the IRB is to protect the rights and welfare of people who volunteer to participate in human subject research. The IRB is guided by the ethical principles outlined in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report, called the Belmont Report.
The IRB functions independently but in coordination with other AdventHealth committees and departments. AdventHealth IRB members include women and men of diverse backgrounds, including physicians and PhDs of various disciplines and professions, as well as pharmacists, nurses, clergy, community members and hospital team members. The IRB staff is available to provide guidance and facilitate review.
Institutional Review Board
800 North Magnolia Avenue, Suite 500
Orlando, FL 32803
Meet Our Team
Fouad M. Hajjar, MD
Janice Turchin, CIP
Documents and Resources
- Policies and Procedures
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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, email [email protected] or call 407-200-2677.
- Investigator Guidance
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- Research Participants
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Visit our information for research 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 [email protected].
Our office is open from 7 am to 5 pm Monday through Thursday and 8 am to 5 pm on Friday. After business hours, we will respond to your call or email the next business day.
You may address questions, suggestions, concerns or complaints about the IRB or human research protection program; allegations of undue influence, claims of noncompliance or findings of noncompliance orally or in writing to:
Institutional Review Board
800 N Magnolia Avenue, Suite 500
Orlando, FL 32803OR
AdventHealth Orlando Compliance Hotline: 888-92-GUIDE (48433).
- Submission Process
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Step 1: Register on IRBnet.org and affiliate with AdventHealth
The Orlando AdventHealth IRB 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 protect 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
- 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 into CITI
- Once you have verified this email, your account will be linked, and your CITI certificates will automatically be imported into IRBNet within 24 hours of completion of the course
- Refresher courses must be completed every three years to maintain your education credentials with the AdventHealth IRB
- Should you have questions, please get in touch with the AdventHealth IRB Orlando at 407-200-2677 or [email protected]
- If AdventHealth is the study sponsor and an IND/IDE holder of a clinical trial, you must contact the ORI office as early as possible before the grant or IRB submission to ask about our involvement in this process. For assistance with this, don't hesitate to contact ORI at [email protected].
- REQUIRED: "Basic Biomedical" or "Basic Social/Behavioral," depending on the type of research that you will be conducting
Step 3: Complete Conflict of Interest (COI) Disclosure and Training
- Follow this link for required Conflict of Interest Disclosures
- Conflict of Interest Disclosure
- 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 [email protected]
- The CFD Research Conflict of Interest Training will be assigned to your ALN account
Step 4: Complete the Florence Training and Attestation Form
- To complete Florence training, please go to our SharePoint page: Research Credentialing Process (sharepoint.com). If you do not have an OPID, you will not be able to access this page. Please contact [email protected] for assistance.
Step 5: Regulatory Team will submit the IRB application and supporting documents once steps 1 through 4 are completed
- Contact [email protected] 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-side banner bar, select "Forms and Templates”
- On the Forms and Templates page, choose the library to 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
- If you need to find forms:
- Should you have questions, please contact the AdventHealth IRB at 407-200-2677 or [email protected]
- Checklists and Worksheets
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Below are 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.
The AdventHealth Research Institute recommends using Adobe Acrobat Reader DC to view and complete the checklists and worksheets. If your Adobe Acrobat Reader is not up to date, you can download the latest version here.
- Additional Resources
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Federal Regulations and Guidelines for Protection of Research Subjects
- Code of Federal Regulations for Human Subject Protection (45 CFR 46)
- Protection of Human Subjects (21 CFR 50)
- Institutional Review Boards (21 CFR 56)
- Investigational New Drug Application (21 CFR 312)
- Investigational Device Exemptions (21 CFR 812)
- Humanitarian Use Devices
- Expanded Access to Drugs
- Expanded Access for Medical Devices
- The Belmont Report
- HIPAA Privacy Rule in Research
Federal Agencies
- Office of Human Research Protections
- Food and Drug Administration
- National Institutes of Health
- National Cancer Institute
- Office for Civil Rights (HHS)
Videos
Other Resources
- Registries for Evaluating Patient Outcomes: A User's Guide
- IRB Position Statement Third Party Recruitment Services
- NIH Certificates of Confidentiality
- Community-Based Participatory Research
- International Compilation of Human Research Standards
- International Committee of Medical Journal Editors
- 2023 IRB Meeting Dates and Deadlines