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.
- HRP-001 POLICY Definitions in Research
- HRP-002 POLICY Abbreviations
- HRP-003 POLICY Designations
- HRP-010 POLICY Human Research Protection Program
- HRP-020 POLICY Member Review Expectations
- HRP-021 POLICY Legally Authorized Children and Guardians in Research
- HRP-069 POLICY Prompt Reporting Requirements in Research
- HRP-070 POLICY Investigator Obligations in Research
- HRP-910 - Investigator Manual
- HRP-802 INVESTIGATOR GUIDANCE - Informed Consent
- HRP-803 INVESTIGATOR GUIDANCE - Documentation of Informed Consent
- HRP-804 INVESTIGATOR GUIDANCE - Short-Form Consent Process in Research
- Quick Guidance - IC Process for Non-English Speaking Subjects in Research
- Quick Guidance - Short Form Consent Use in Research
- Interpreter Services Guide for Researchers
- HRP-810 INVESTIGATOR GUIDANCE - Additional DOD Obligations
- HRP-811 INVESTIGATOR GUIDANCE - Additional DOE Obligations
- HRP-812 INVESTIGATOR GUIDANCE - Additional DOJ Obligations
- HRP-813 INVESTIGATOR GUIDANCE - Additional ED Obligations
- HRP-814 INVESTIGATOR GUIDANCE - Additional EPA Obligations
- HRP-815 INVESTIGATOR GUIDANCE - Additional FDA Obligations
- HRP-816 INVESTIGATOR GUIDANCE - Additional ICH-GCP Obligations
- HRP-820 INVESTIGATOR GUIDANCE - Quality Improvement and Quality Assessment (QIQA)
- HRP-821 INVESTIGATOR GUIDANCE - Radiation Procedure and Risk Language for Consent
- HRP-823 INVESTIGATOR GUIDANCE - Phone Screen Procedure
- HRP-825 INVESTIGATOR GUIDANCE - HIPAA
- HRP-826 INVESTIGATOR GUIDANCE - Emergent & Non-Emergent Use of Test Articles
- HRP-827 INVESTIGATOR GUIDANCE - Humanitarian Use Devices
- HRP-828 INVESTIGATOR GUIDANCE - Common Rule 2019
- HRP-829 INVESTIGATOR GUIDANCE - Template Revisions 2019
- HRP-830 INVESTIGATOR GUIDANCE - Self-assessments
- TEMPLATE - Informed Consent Process Checklist
Standard Operating Procedures
- 400.071 SOP Utilization of External IRBs
- HRP-101 SOP - Regulatory Review
- HRP-102 SOP - Designated Reviewers
- HRP-103 SOP - Non-Committee Review Preparation
- HRP-104 SOP - Non-Committee Review Conduct
- HRP-105 SOP - Committee Review Preparation
- HRP-106 SOP - Committee Review Conduct
- HRP-107 SOP - Committee Review Monitoring
- HRP-108 SOP - Minutes
- HRP-109 SOP - Not Otherwise Approvable Research
- HRP-110 SOP - Consultation
- HRP-111 SOP - Post Review
- HRP-112 SOP - New Information
- HRP-113 SOP - Unexpected Incarceration
- HRP-114 SOP - Suspension and Termination by the Organization
- HRP-120 SOP - Management of Financial Interests
- HRP-121 SOP - Organizational Financial Interests
- HRP-122 SOP - Undue Influence of the HRPP
- HRP-125 SOP - IRB End Approval Dates
- HRP-126 SOP - IRB Roster
- HRP-130 SOP - IRB Formation
- HRP-131 SOP - IRB Deactivation
- HRP-132 SOP - IRB Member Addition
- HRP-133 SOP - IRB Member Removal
- HRP-134 SOP - Designated Exempt Reviewers
- HRP-135 SOP - Designated Exempt Review Conduct
- HRP-140 SOP - IRB Records Retention
- HRP-141 SOP - Annual Tasks
- HRP-142 SOP - Monthly Tasks
- HRP-143 SOP - Daily Tasks
- HRP-144 SOP - Meeting Scheduling
- HRP-170 SOP - External IRB Screening
- HRP-180 SOP - Emergency and Compassionate Uses
Visit our For Participants page for more information about participating in a research study.
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
901 N. Lake Destiny Road, Suite 400
Maitland, FL 32751
AdventHealth Orlando Compliance Hotline: 888-92-GUIDE (48433).
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
To ensure the protection of human participants, all research investigators and staff must complete and show verification of their CITI training. Investigators must complete additional training, described below.
- CITI TRAINING
- Register on www.citiprogram.org – make sure your “institutional email” is the one you will check regularly
- Select AdventHealth as your affiliated institution. (NOTE: We cannot accept Certificates of Completion under another institution’s affiliation. If you have completed modules under another institution’s affiliation, these 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. (NOTE: If you have questions, contact the IRB.)
- REQUIRED: Health Information Privacy and Security (HIPS)
- MAY BE REQUIRED: Good Clinical Practice (GCP) is REQUIRED IF you are conducting FDA-regulated research
- 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
- Alternative method of submitting your CITI training: save your Certificate of Completion for each course as a PDF file. (NOTE: the summary listing dates of completion is not acceptable)
- Upload your Certificates of Completion to your User Profile in www.IRBnet.org
- Refresher courses must be completed every 3 years to maintain your education credentials with the AdventHealth IRB.
- Required for all investigators (PIs and Sub-Is)
- The requirement is met by attending the AdventHealth Research Institute Orlando sponsored event either live, in-person or by viewing a recorded version and completing a post-test.
- For investigators with an AdventHealth user name and password
- From the AdventHealth or AHMG IntraNet, log into ALN (Adventist Learning Network)
- In the search bar at the top right of the page, search for INVESTIGATOR FORUM
- Click “Enroll” on the bottom right of the course description box.
- Another box will pop up confirming your enrollment.
- The next page will be your course page. Click the first “launch” button to view the material (video is approximately 50 minutes).
- Once the video is complete, you will return to the previous screen and the “launch” button should now say “review”
- Click the button for the post-test, and complete as directed.
- The passing score is 80%
- When returned to the course description screen, click the button that says “export certificate” or simply print the certificate.
- Save the certificate as a PDF file and upload into your User Profile in www.IRBnet.org, then take the final step of clicking the submit button in order to submit the document to the IRB.
- For investigators that do not have a AdventHealth opid and password, contact Melissa Pallone for additional information (Melissa.Pallone@adventhealth.com). You will need to have a Google/You Tube account to access the training.
- For investigators with an AdventHealth user name and password
Step 3: Submit IRB application and supporting documents
- 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.
- Complete the IRB application and all supporting documents.
- Upload your submission via IRBnet
Should you have questions, please contact the AdventHealth IRB Orlando at 407-200-2677 or via email at FH.IRB.email@example.com. IRB Administration
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.