IRB Members
IRBs play an important role in the protection of human subjects. The federal regulations define the IRB’s role, authority, and composition requirements. All members must complete the Confidentiality and Non-Disclosure Agreement.
Training
IRB members must complete the online CITI program courses. During CITI registration, you will be prompted to add courses. Select the courses required for IRB members. After you select the courses, the next screen will prompt you to select ‘Basic’ or ‘Refresher’. Choose ‘Basic’ if this is your first time taking a course under Drexel. Choose ‘Refresher’ if you have already been certified in a basic course under Drexel. On the next page, select the group called ‘IRB/Research Administration’. Note: please be sure to set your CITI preferred email address to your Drexel email. (For any CITI account previously registered with a non-Drexel email address, please take the steps outlined in the ORI CITI Update Email SOP to update your preferred address to your Drexel email.)
Required Training:
- Human Subjects Research
- Health Information Privacy & Security (HIPS)
- Good Clinical Practice (GCP)
- Conflicts of Interest
Serving as an IRB Committee member is a generous contribution to Drexel and its community. The Committee’s focus is to protect the safety and well-being of research subjects. This work requires that IRB members receive regular training in addition to maintaining current CITI certifications. The HRPP provides opportunities for education and discussion on a regular basis. IRB members are required to participate whenever possible.
Tools and Templates
- HRP-001 POLICY - Definitions [PDF]
- HRP-002 POLICY - Abbreviations [PDF]
- HRP-003 POLICY - Designations [PDF]
- HRP-010 POLICY - Human Research Protection Program [PDF]
- HRP-020 POLICY - IRB Member Review Expectations [PDF]
- HRP-021 POLICY - Legally Authorized Representatives Children and Guardians [PDF]
- HRP-022 POLICY - End Approval Dates [PDF]
- HRP-023 POLICY - IRB Records [PDF]
- HRP-024 POLICY - IRB Roster [PDF]
- HRP-050 POLICY - States and Transitions [PDF]
- HRP-070 POLICY - Investigator Obligations [DOC]
- HRP-071 POLICY - Prompt Reporting Requirements [DOC]
- HRP-072 POLICY - Designated Reviewer [DOC]
- HRP-200 FORM - Initial Review [DOC]
- HRP-201 FORM - Contact Information [DOC]
- HRP-202 FORM - Continuing Review [DOC]
- HRP-203 FORM – Modification [DOC]
- HRP-204 FORM - Request for Drexel to Cede Review [DOC]
- HRP-205 FORM - Request for Drexel as the Single IRB [DOC]
- HRP-206 FORM - Local Context Survey [DOC]
- HRP-207 FORM - Change of Principal Investigator [DOC]
- HRP-208 FORM - IRB Member Information [DOC]
- HRP-210 FORM - Regulatory Review [PDF]
- HRP-211 FORM - Non-Committee Review [PDF]
- HRP-214 FORM - Reportable New Information [DOC]
- HRP-215 FORM - Report of Emergency Use of a Test Article [DOC]
- HRP-300 CHECKLIST - Waiver of Consent [PDF]
- HRP-303 CHECKLIST - Waiver of Documentation of Consent [PDF]
- HRP-305 CHECKLIST - Pregnant Women [PDF]
- HRP-306 CHECKLIST - Neonates of Uncertain Viability [PDF]
- HRP-307 CHECKLIST - Nonviable Neonates [PDF]
- HRP-308 CHECKLIST - Prisoners [PDF]
- HRP-309 CHECKLIST - Unexpected Incarceration [PDF]
- HRP-310 CHECKLIST - Children [PDF]
- HRP-326 CHECKLIST - Devices [PDF]
- HRP-400 WORKSHEET - Criteria for Approval [PDF]
- HRP-405 WORKSHEET - Additional Criteria DOD [PDF]
- HRP-406 WORKSHEET - Additional Criteria DOJ [PDF]
- HRP-407 WORKSHEET - Additional Criteria ED [PDF]
- HRP-408 WORKSHEET - Additional Criteria EPA [PDF]
- HRP-409 WORKSHEET - Additional Criteria DOE [PDF]
- HRP-410 WORKSHEET - Additional Criteria International [PDF]
- HRP-411 WORKSHEET - New Information [DOC]
- HRP-412 WORKSHEET - Financial Interest Management [PDF]
- HRP-413 WORKSHEET - Closure Criteria [PDF]
- HRP-414 WORKSHEET - Adults Lacking Capacity [PDF]
- HRP-420 WORKSHEET - Regulatory Review [PDF]
- HRP-421 WORKSHEET - Human Research [PDF]
- HRP-422 WORKSHEET - Engagement [PDF]
- HRP-423 WORKSHEET - Exemptions [PDF]
- HRP-424 WORKSHEET - Expedited Review [PDF]
- HRP-425 WORKSHEET - Drugs [PDF]
- HRP-428 WORKSHEET - HIPAA Waiver of Authorization [PDF]
- HRP-430 WORKSHEET - IRB Composition [PDF]
- HRP-431 WORKSHEET - Quorum [PDF]
- HRP-432 WORKSHEET - Contracts [PDF]
- HRP-440 WORKSHEET - Additional Criteria New Jersey [PDF]
- HRP-441 WORKSHEET - Additional Criteria California [PDF]
- HRP-450 WORKSHEET - Criteria for Approval HUD [PDF]
- HRP-451 WORKSHEET - Emergency Use Drugs and Biologics [PDF]
- HRP-452 WORKSHEET - Emergency Use Devices [PDF]
- HRP-453 WORKSHEET - Compassionate Use Devices [PDF]
- HRP-454 WORKSHEET - Expanded Access Drugs and Biologics [PDF]
- HRP-470 WORKSHEET - External IRB Screening [PDF]
- HRP-480 WORKSHEET - FERPA [PDF]
- HRP-481 WORKSHEET - PPRA [PDF]
- HRP-500 TEMPLATE - Consent [DOC]
- HRP-501 TEMPLATE - Consent for Minimal Risk Research [DOC]
- HRP-502 TEMPLATE - Consent for Emergency and Compassionate Use [DOC]
- HRP-502 TEMPLATE - Consent for Emergency Use [DOC]
- HRP-504 TEMPLATE - Protocol [DOC]
- HRP-504 TEMPLATE - Protocol for Chart Review [DOC]
- HRP-504 TEMPLATE - Protocol for Minimal Risk Research [DOC]
- HRP-505 FORM - Permission to Use Personal Health Information for Research [DOC]
- HRP-505 FORM Spanish- Permission to Use Personal Health Information for Research [DOC]
- HRP-802 INVESTIGATOR GUIDANCE - Informed Consent [PDF]
- HRP-803 INVESTIGATOR GUIDANCE - Documentation of Informed Consent [PDF]
- HRP-804 INVESTIGATOR GUIDANCE - Reliance Agreements [PDF]
- HRP-810 INVESTIGATOR GUIDANCE - Additional DOD Obligations [PDF]
- HRP-811 INVESTIGATOR GUIDANCE - Additional DOE Obligations [PDF]
- HRP-812 INVESTIGATOR GUIDANCE - Additional DOJ Obligations [PDF]
- HRP-813 INVESTIGATOR GUIDANCE - Additional ED Obligations [PDF]
- HRP-814 INVESTIGATOR GUIDANCE - Additional EPA Obligations [PDF]
- HRP-815 INVESTIGATOR GUIDANCE - Additional FDA Obligations [PDF]
- HRP-816 INVESTIGATOR GUIDANCE - Additional ICH-GCP Obligations [PDF]
- HRP-817 INVESTIGATOR GUIDANCE - Additional ISO 14155 Obligations [PDF]
- HRP-818 INVESTIGATOR GUIDANCE - Additional HHS Obligations [PDF]
IRB Calendars
| IRB Meeting Date | Date Agenda Locks | Submission Deadline to be Considered for Agenda |
|---|---|---|
| 1/15/2025 | 1/8/2025 | 1/1/2025 (NYD Holiday) |
| 2/19/2025 | 2/12/2025 | 2/5/2025 |
| 3/19/2025 | 3/12/2025 | 3/5/2025 |
| 4/16/2025 | 4/9/2025 | 4/2/2025 |
| 5/21/2025 | 5/14/2025 | 5/7/2025 |
| 6/18/2025 | 6/11/2025 | 6/4/2025 |
| 7/16/2025 | 7/9/2025 | 7/2/2025 |
| 8/20/2025 | 8/13/2025 | 8/6/2025 |
| 9/17/2025 | 9/10/2025 | 9/3/2025 |
| 10/15/2025 | 10/8/2025 | 10/1/2025 |
| 11/19/2025 | 11/12/2025 | 11/5/2025 |
| 12/17/2025 | 12/10/2025 | 12/3/2025 |
| IRB Meeting Date | Date Agenda Locks | Submission Deadline to be Considered for Agenda |
|---|---|---|
| 1/27/2025 | 1/17/2025 (due to MLK holiday) | 1/13/2025 |
| 2/24/2025 | 2/17/2025 | 2/10/2025 |
| 3/24/2025 | 3/17/2025 | 3/10/2025 |
| 4/28/2025 | 4/21/2025 | 4/14/2025 |
| 5/26/2025– Memorial Day, no meeting | ||
| 6/23/2025 | 6/16/2025 | 6/9/2025 |
| 7/28/2025 | 7/21/2025 | 7/14/2025 |
| 8/25/2025 | 8/18/2025 | 8/11/2025 |
| 9/22/2025 | 9/15/2025 | 9/8/2025 |
| 10/27/2025 | 10/20/2025 | 10/14/2025 |
| 11/24/2025 | 11/17/2025 | 11/10/2025 |
|
12/22/2025 – Holiday, no meeting |
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