Reliance on an IRB other than the MHRI IRB and IRB authorization agreements
When collaborating with other institutions, sometimes a single or joint IRB review may be preferred over separate reviews at each institution. The institution will enter into an IRB authorization agreement with other institutions, a Central IRB, and/or Independent IRB with whom the institution and employees collaborate on single or multiple projects.
When collaborating with other institutions, an IRB authorization agreement must be drafted. The IRB Authorization Agreement establishes a written understanding defining the scope of responsibility of the respective institutions for the research study in which both institutions are involved in the review, approval, and continuing oversight performed by the approving institutions IRB and the requirements of the HHS regulations for the protection of human subjects at 45CFR46 as well as the requirements of the federal, state, and local laws.
For research involving FDA-regulated products, the approving institution’s IRB must be in compliance with requirements defined in 21 CFR Pats 50,56, 312, and 812.
MedStar Health will comply with the determinations of the reviewing IRB, follow reporting and conflict of interest disclosure requirements as specified in the authorization agreement, conduct monitoring, identify an appropriate contact person, ensure researchers have appropriate qualifications, and provide local context information (and any updates) to the reviewing IRB.
When this institution provides IRB review for other institutions, this HRPP will follow established policies and procedures to ensure that the composition of the IRB is appropriate to review the research and will comply with applicable laws of the relying site. This includes ensuring the IRB is appropriately constituted, members are appropriately qualified, members will not participate in the review of research in which they have a conflict of interest; and that the IRB separates business functions from ethical review.
All requests for reliance on a commercial or single IRB need to be processed through the eIRB system. You can find instructions for that process here: submitting a study to be reviewed by an external IRB
Please contact the ORI at mhri-orihelpdesk@medstar.net if you wish to rely on a commercial or single IRB for which an institutional profile has not yet been established.
Institutional animal care and use committee (IACUC)
The MedStar Health Research Institute established the IACUC under the guidelines of the Association for Accreditation and Assessment of Laboratory Animal Care International (AAALAC) to oversee the humane conduct of animal studies. The IACUC is responsible for the initial and continuing reviewing of all research studies involving animals done at any MedStar Institution. Federal regulations require that any research protocol involving the use of animals be reviewed and approved by the IACUC. The IACUC consists of members with varying backgrounds who are knowledgeable in animal regulations, humane treatment of animals, law, and research.
Guidance On Humane Animal Use Categories
Note: For additional guidance on the humane conduct of animal studies, MedStar Health associates and investigators should visit StarPort.
GHUCCTS IRB
Georgetown Howard Universities Center for Clinical and Translational Science Institutional Review Board is the IRB for the GHUCCTS consortium; its purpose is to review consortium research studies. GHUCCTS IRB members are appointed by each participating institution
What studies will the GHUCCTS IRB review?
The GHUCCTS IRB will review all studies funded by GHUCCTS, such as:
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GHUCCTS funded pilot research studies
The following additional studies are eligible for review by GHUCCTS IRB:
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research studies that will utilize GHUCCTS facilities
Whom do I contact for questions related to GHUCCTS IRB?
Please contact Kristen Katopol at krk63@georgetown.edu
How do I submit a study to the GHUCCTS IRB?
Investigators will submit research studies using the Georgetown MedStar IRB System web-based application. For more information on the IRB system, please click here or contact Kristen Katopol at krk63@georgetown.edu
Frequently asked questions
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I am using an external IRB (commercial, independent, or other institution); do I need to submit my proposal through the eIRB system if I am not using the MHRI or GU IRB Committees to conduct the review?
Yes, you need to submit through the eIRB system. An outline of the process can be found here: Submitting a Study to be Reviewed by an External IRB.
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What is the purpose of submitting in the new eIRB system if I am not using the MHRI or GU IRB Committees to conduct the review?
The submission of the information in the eIRB system provides a mechanism for MHRI to conduct the administrative review necessary to meet institutional responsibilities which are required regardless of IRB utilized. No IRB review is performed, however much of the same information is needed, for example, to determine if a conflict exists or if the investigative site and investigators have the required training, expertise, or resources to conduct the research. The Human Subject Protections Regulations, as well as other federal regulations such as those on COI and Human Subject Protection training, outline responsibilities and requirements for Institutions as well as IRBs. You may find the following Clinical Trials Transformation Initiative Considerations documents helpful in understanding the differences between IRB and Institutional responsibilities: Considerations documents helpful in understanding the differences between IRB and Institutional responsibilities: Considerations to support communication between institutions and outside IRBs.
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What information needs to be uploaded to the eIRB system?
Each project is different and the smart forms in the eIRB system will guide you to ensure the correct information is included. At a minimum, study-related documents such as the proposed protocol and consent (if applicable) will need to be provided.
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I have a study that was previously authorized to be reviewed by an external IRB and was either not in InfoEd or was not migrated to the new eIRB system from InfoEd. Will it be migrated?
Generally, no, studies that were reviewed by an external IRB and remain ongoing without modification to study personnel or an unanticipated problem to subjects or others will not be migrated to the new eIRB system. However, studies may need to be entered into the system by an investigative site at the time of modification. See below for more details.
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I have a study that was previously authorized to be reviewed by an external IRB and was either not previously in an electronic IRB system at MHRI or was not migrated to the new eIRB system from InfoEd. I am now modifying or updating the study to include reportable new information, changes in study personnel or an additional site and the sponsor is requiring approval for the change from MHRI as an institution, even though the MHRI IRB is not the reviewing IRB. Do I need to submit this information to MHRI and if so, what system do I use?
Yes, when adding study personnel, this information needs to be submitted to the institution so that MHRI can ensure we are meeting institutional responsibilities. Since this protocol information was not previously collected in an electronic system at MHRI or was not migrated from InfoEd to the new eIRB system, there is no protocol record to "update". Instead, the project should be submitted as a new submission in the eIRB system, following the process for submitting a study for review by an external IRB. Please be sure to append a comment that the study was previously authorized to utilize an external IRB and that the submission being made now is to update protocol records with new information. A power point presentation outlining the process is available at the following link: submitting a study to be reviewed by an external IRB. The ORI office will then review the request and notify you when the review is complete.
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