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
CW AHC Policies
- CW AHC 101 POLICY Research Oversight
- CW AHC 102 Abbreviations in Research
- CW AHC 103 POLICY Designations in Research
- CW AHC 104 POLICY Financial Conflict of interest in Research Individual
- CW AHC 105 POLICY Research Misconduct
- CW AHC 106 POLICY Billing compliance in Clinical Research Policy
- CW AHC 107 POLICY Definitions in Human Research
- CW AHC 108 Human Research Protection Program
- CW AHC 109 POLICY IRB Member Review Expectations
- CW AHC 110 POLICY Legally Authorized Representatives, Children, and Guardians in Research
- CW AHC 111 POLICY Prompt Reporting Requirements in Research
- CW AHC 112 POLICY Investigator Obligations in Research
- 405.001 Intellectual Property Policy
- 400.721 POLICY F and A Cost Recovery on Grants, Contracts, Funded and Sponsored Projects
- 400.725 POLICY Time and Effort Certification
Standard Operating Procedures
- HRP-120 Management of Financial Interests
- HRP-135 Designated Exempt Review Conduct
- CW AHC 201 SOP Regulatory Review
- CW AHC 202 SOP Designated Reviewers
- CW AHC 203 SOP Non-Committee Review Preparation
- CW AHC 204 SOP Non-Committee Review Conduct
- CW AHC 205 SOP Committee Review Preparation
- CW AHC 206 SOP Committee Review Conduct
- CW AHC 207 SOP Committee Review Monitoring
- CW AHC 208 SOP Minutes
- CW AHC 209 SOP Not Otherwise Approvable Research
- CW AHC 210 SOP Consultation
- CW AHC 211 SOP Post Review
- CW AHC 212 SOP New Information
- CW AHC 213 SOP Unexpected Incarceration
- CW AHC 214 SOP Suspension and Termination by the Organization
- CW AHC 215 SOP Continuing Review Not Required
- CW AHC 216 SOP Informed Consent Process and Written Documentation of Informed Consent
- CW AHC 217 SOP Organizational Financial Interests
- CW AHC 218 SOP Undue Influence of the HRPP
- CW AHC 219 SOP IRB Records
- CW AHC 220 SOP IRB End Approval Dates
- CW AHC 221 SOP IRB Roster
- CW AHC 222 SOP IRB Formation
- CW AHC 223 SOP IRB Deactivation
- CW AHC 224 SOP IRB Member Addition
- CW AHC 225 SOP IRB Member Removal
- CW AHC 226 SOP Designated Exempt Reviewers
- CW AHC 227 SOP IRB Records Retention
- CW AHC 228 SOP Annual Tasks
- CW AHC 229 SOP Monthly Tasks
- CW AHC 230 SOP Daily Tasks
- CW AHC 231 Meeting Scheduling
- CW AHC 232 SOP External IRB Screening
- CW AHC 233 SOP IRB Review of Emergency and Compassionate Uses
- SOP CW AHC 236 Humanitarian Use Device (HUD)
- CW AHC 237 SOP Process and Required Elements of Consent for Exempt Research
- CW AHC 240 SOP Utilization of External IRBs
- CW AHC 241 SOP AHRI Personnel Financial Interests
- CW AHC 242 SOP Observation of the Informed Consent/Assent Process in Research
- CW AHC 246 Adverse Event Review Documentation for Research
- CW AHC 249 Remote and Electronic Methods for Conducting Informed Consent in Non-Exempt Research
- CW AHC 250 Research Participants Remuneration
- CW AHC 251 Greenphire ClinCard Payment
- CW AHC 252 Research Personnel
- CW AHC 254 Release of Research Notes
- CW AHC 255 External Site Reliance
- CW AHC 256 PI Oversight
- CW AHC 257 SOP Research Billing Compliance
- SOP 851.020 Investigational New Drug (IND) Safety Reports
Files
- HRP-509 TEMPLATE - Informed Consent Process Checklist
- HRP-804 INVESTIGATOR GUIDANCE - Short-From Consent Process in Research
- HRP - 810 IVESTIGATOR 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-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-830 INVESTIGATOR GUIDANCE - Self-assessments_0
- HRP - 831 INVESTIGATOR GUIDANCE - Certificate of Confidentiality FAQs
- HRP - 832 INVESTIGATOR GUIDANCE - Incidental Findings
- HRP-835 INVESTIGATOR GUIDANCE - Submission of HUDs to IRB
- HRP-840 Interpreter Services Guide for Researchers
- HRP-910 - Investigator Manual
- Quick Guidance - IC Process for Non-English Speaking Subjects in Research_1
- Quick Guidance - Short Form Consent Use in Research_1
- HRP-820 INVESTIGATOR GUIDANCE - Quality Improvement and Quality Assessment (QIQA)
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).
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).
- REQUIRED: “Basic Biomedical” or “Basic Social/Behavioral” depending on the type of research that you will be conducting.
- 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.
- 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 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.
- If you need to find forms:
- Should you have questions, please contact the AdventHealth IRB Orlando at 407-200-2677 or AH.IRB.general@adventhealth.com.
IRBNet Researcher User Guides
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.
Checklists
- HRP-303 CHECKLIST - Waiver of Documentation of Consent
- HRP-305 CHECKLIST - Pregnant Women
- HRP-306 CHECKLIST - Neonates of Uncertain Viability
- HRP-307 CHECKLIST - Nonviable Neonates
- HRP-308 CHECKLIST - Prisoners
- HRP-309 CHECKLIST - Unexpected Incarceration
- HRP-310 CHECKLIST - Children
- HRP-313 CHECKLIST - Non-Significant Risk Device
- HRP-326 CHECKLIST - Devices
- HRP-311 CHECKLIST - Wards
- HRP-300 CHECKLIST - Waiver of Consent HHS
Worksheets
- HRP-400 WORKSHEET - Criteria for Approval
- HRP-401 WORKSHEET - Scientific and Scholarly Review
- HRP-402 WORKSHEET - Advertisements
- HRP-403 WORKSHEET - Payments
- HRP-404 WORKSHEET - Short Form
- HRP-405 WORKSHEET - Additional Criteria DOD
- HRP-406 WORKSHEET - Additional Criteria DOJ
- HRP-407 WORKSHEET - Additional Criteria ED2
- HRP-408 WORKSHEET - Additional Criteria EPA
- HRP-409 WORKSHEET - Additional Criteria DOE
- HRP-410 WORKSHEET - Additional Criteria International
- HRP-411 WORKSHEET - New Information
- HRP-412 WORKSHEET - Financial Interest Management
- HRP-413 WORKSHEET - Closure Criteria
- HRP-414 WORKSHEET - Adults Lacking Capacity
- HRP - 420 Regulatory Review
- HRP-421 WORKSHEET - Human Research
- HRP-422 WORKSHEET - Engagement
- HRP-423 WORKSHEET - Exemptions
- HRP-424 WORKSHEET - Expedited Review
- HRP-425 WORKSHEET - Drugs
- HRP-426 WORKSHEET - Devices
- HRP-427 WORKSHEET - HIPAA Authorization
- HRP-428 WORKSHEET - HIPAA Waiver of Authorization
- HRP-430 WORKSHEET - IRB Composition
- HRP-431 WORKSHEET - Quorum
- HRP-432 WORKSHEET - Contracts
- HRP-450 WORKSHEET - Criteria for Approval HUD
- HRP-451 WORKSHEET - Emergency Use Drugs and Biologics
- HRP-452 WORKSHEET - Emergency Use Devices
- HRP-453 WORKSHEET - Compassionate Use Devices
- HRP - 470 WORKSHEET - External IRB Screening
- HRP-471 FORM - Protocol Suitability
- HRP-480 WORKSHEET - FERPA
- HRP-481 WORKSHEET - PPRA
Federal Regulations & 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 for Drugs
- Expanded Access for Medical Devices
- The Belmont Report
- HIPAA Privacy Rule in Research
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
- 2025 IRB Meeting Dates & Deadlines