Georgetown – MedStar IRB System Update
The new Georgetown-MedStar IRB system was installed on November 29, 2018 for both Georgetown University (GU) and MedStar Health and has been the only active system in use since then, with hundreds of protocols now submitted and managed through this electronic platform. Nonetheless, we continue to make additional improvements and progress on migrating studies over to the new electronic system and identifying continued areas of concern.
All new submissions for IRB review, including modifications and continuing review of active projects must be submitted through the new eIRB platform at gumedstarirb.georgetown.edu/IRB.
All individuals to be listed on a study submission in Huron must have a valid Huron ID.
Individuals who do not have a MedStar ID or Huron login must request one to obtain access to the system. Submissions for new accounts can be made in MedStar’s ASAP request system. These requests can be entered by your department head or manager. ASAP can be accessed here or through StarPort following this path: Select Departments > Information Services > ASAP – System Access Requests.
The PI Proxy can perform IRB submission responsibilities such as submitting studies, modifications, continuing reviews, and reportable new information. The principal investigator is responsible for ensuring these procedures are carried out, and that submissions are complete and accurate. The PI Proxy must be a study team member with engagement in the study conduct. A PI can designate a PI proxy at the time of study submission and must be assigned protocol by protocol. Designation of a PI Proxy does not defer PI responsibility in the conduct of research as defined in regulations, policies, and the Investigator Manual (HRP-103).
The PI proxy must provide a substantial contribution to the conception or design of the work; the implementation of the work; provides regulatory support to the work; or the acquisition, analysis, or interpretation of data for the work.
Protocol migration is nearing completion with over 98% of studies migrated from InfoEd to the new IRB platform. Reminder: Closed projects, those that were determined to be exempt, or those that were reviewed by an external IRB were not migrated.
In addition, limited administrative information was migrated from InfoEd to Huron to create a “protocol shell”. This protocol shell will need to be updated at the time of continuing review or modification, whichever comes first. This needs to be completed through the submission of a combined continuing review/modification request.
When submitting a continuing review for the first time in the new system if a modification was not previously submitted, the continuing review must be submitted as a combined continuing review/modification so protocol documents can be uploaded to the study. Investigative sites generally have a 12 month grace period to upload documents and update the record. When submitting the combined continuing review/modification request investigative sites should upload the most current version of the protocol, consent(s), and other study documents.
Continuing reviews submitted without modification will be returned to the investigative site as they do not allow for the upload of existing or new documents.
Please contact the Office of Research Integrity at [email protected] if you have any questions.
If you’d like to stay informed and have access to detailed information on training schedules, access to the system, links to policies, forms and templates as well as quick reference guides, training materials, and frequently asked questions, please visit here.