The Human Research Protection Programs (IRBs) at both Georgetown University (GU) and MedStar Health (MedStar) use the same electronic system to manage their respective Human Research Protection Programs and the IRB review process. On November 29, 2018, the joint system went live for research at both institutions, replacing existing IRB systems (eRIC and InfoEd).
All submissions for IRB review, including new projects, requests for reliance on external IRBs or single IRBs, as well as modifications and continuing review of active projects must be submitted through the new eIRB platform at gumedstarirb.georgetown.edu/IRB.
Click here to view FAQs on the eIRB system.
As of November 16, 2018, InfoEd was closed to submissions. Protocol records and critical documents have been maintained in archived form. If you require continued access to protocol records or documents please contact the Office of Research Integrity at [email protected].
Templates and Forms
- Research Protocol Template
- Exempt Chart Review Protocol Template
- Informed Consent Form Template
- External Team Member List Template
- External Site Questionnaire
- HIPAA Waiver
General IRB Guidance
- General Guidance for External or Single IRB (sIRB) Review at MedStar Health
- MHRI IRB Quick Guidance For Humanitarian Use Device (HUD)
- Quick Reference Guide for Research Involving Deception or Incomplete Disclosure
Guidance for using the eIRB system can be found on the MHRI website here.
IRB policies and procedures are being updated as part of the new system. All policies currently in place are available on StarPort, on the Policies page under Research Integrity. Please refer to these policies for the procedures of record.
Case Managers for IRB Submissions
ORI Administrators are assigned to assist specific departments. In addition, MHRI has a dedicated coordinator for IRB reliance agreements (use of external IRBs).
If you have a question/issue regarding a protocol or require pre-submission assistance, please contact the appropriate ORI administrator or coordinator listed below. If you are unsure of who to contact, please email the Office of Research Integrity at [email protected].
Case Report Forms
MedStar Health Institutional Review Board has determined that a case report of less than three (3) patients does not meet the DHHS definition of research (45 CFR 46.102(d)(pre-2018)/45 CFR 46.102(l)(1/19/2017)) or the FDA definition of clinical investigation (21 CFR 46.102(c)) and therefore are not subject to IRB review requirements and do not require IRB approval.
Case reports for publication may be considered a disclosure of protected health information (PHI) and therefore must be prepared in accordance with HIPAA. Please review the guidance below to determine if a patient’s authorization is required. Frequently Asked Questions on Case Reports are available below as well.
Questions related to this determination can be directed to MHRI ORI at [email protected]. Questions related to HIPAA requirements should be directed to [email protected] or the corporate Privacy Director at [email protected].