Need Assistance? Call 855-MED-0229

MHRI IRB

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

General IRB Guidance

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]

Amy Harchelroad
ORI Administrator
[email protected]

  • Infectious Disease
  • Cardiology
  • Orthopedics
  • Emergency Medicine
  • Dermatology
  • Endocrinology
  • Hand Center
  • Infection Control
  • OB/GYN
  • Otolaryngology

TJ Rodriguez
ORI Administrator
[email protected]

  • MI2/Health Services Research and Human Factors
  • Neurology
  • National Rehabilitation Network/PM&R
  • Biostatistics
  • Critical Care
  • Family Medicine/Medicine/Internal Medicine
  • Surgery/Burn Center
  • Gastroenterology
  • Imaging
  • Pharmacy
  • Oncology/Hematology
  • Ophthalmology
  • Rheumatology
  • Urology
  • Palliative Care

Yessica Contreras
ORI Coordinator
[email protected]

  • IRB Reliance Agreements
  • Use of External IRBs
  • IRB Meeting Management
  • Human Subject Protection Training

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].

Contact Information

Contact us to obtain more information about our research programs.

Search Principal Investigators

If you would like to learn more about MedStar's researchers and scientists, please visit our Principal Investigator search portal.