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The Human Research Protection Programs (IRBs) at both Georgetown University (GU) and MedStar Health (MedStar) use an 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.
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
Individuals who do not have a MedStar ID or Huron login must request one to obtain access to the system. Not all study personnel who needed Huron IDs were automatically provided with a Huron Login, creating delays in submission and access. While approximately 1,000 MedStar individuals were automatically provisioned with access to the Huron system, it was not enough. The ORI and IS worked with HR and the GME Office to obtain coordinator and resident lists. Regulatory coordinators and residents were uploaded into the system by January 15, 2019.
For those who are non MedStar employees and do not have a MedStar ID and are unable to access the Huron eiRB system, all studies will be assigned to a scientific center. The Scientific Center Administrator assigned to that center will be asked to assist the researcher who needs access. The SCA or designee will reach out to the study team and obtain the necessary information.
All individuals to be listed on a study submission in Huron must have a valid Huron ID.
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.
Protocols not yet approved and or those with items actively being reviewed by the MHRI IRB will have those reviews completed in InfoEd and then migrated to the new system in February 2019.
Investigative sites generally have a 12 month grace period to upload documents and update the record. Investigative sites should upload the most current version of the protocol, consent(s), and other study documents at the time of continuing review or modification to the study, whichever comes first.
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 that protocol documents are uploaded. Continuing reviews submitted without a modification will be returned to the investigative site as they do not allow for the upload of existing or new documents.
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.