Who Can serve as the sIRB?
Any IRB with a federal-wide assurance (FWA), or registration, filed with the Office for Human Research Protections (OHRP) can serve as the sIRB.
What if I want to be the Lead Principal Investigator and have MIT COUHES as the reviewing IRB?
Responsibilities of the Lead Study Team
As part of the grant preparation process, the lead PI for a multi-site study that will use an sIRB should identify who will take on the role of the Lead Study Team. This may be the lead PI’s own study team or a coordinating center or both, or also a Contract Research Organization (CRO), or program officer.
The Lead Study Team has responsibilities associated with the use of the sIRB. These are described in the Overall Principal Investigator/Lead Study Team Guidance and Checklist.
Responsibilities of the Reviewing IRB (sIRB)
The selected IRB must be willing to serve as the sIRB and all of the participating sites must agree to rely on the sIRB. As the IRB of Record, the sIRB is responsible for ethical review and safety of the research for all relying institutions. Decisions on if COUHES will serve as the reviewing IRB are made on a case-by-case basis. COUHES will consider factors including the number of study sites, study team resources, and risk level of the study.
Please contact COUHES SMART IRB Point of Contacts early in the application process.
Before Beginning Research Activities
Reliance decisions in the SMART IRB Online Reliance System apply only to the determination of IRB reliance and do not reflect IRB approval for the research project itself. If COUHES is the reviewing IRB, the Lead PI will still need to obtain approval from COUHES prior to beginning research at MIT.
Please note: If the reliance request was initiated after COUHES approved the study, the addition of sites and/or collaborators will need to be specifically reviewed and approved, which will require the Lead PI to submit an amendment to COUHES.
What if I want to be a relying site PI and have MIT COUHES be a relying IRB?
Relying Institutional Responsibilities
If there are any local requirements, such as institutional policy on compensation for language, the reviewing IRB must be provided information to meet the local requirements.
If the protocol is ceded to an external IRB, the MIT investigator(s) is/are required to obtain all regulatory information regarding the study, including the approval letter, study protocol and approved consent documents. In addition, the investigator(s) is/are required to remain in compliance with MIT policies as well as those set by the reviewing institution. Any questions and required reporting must be done through the reviewing IRB.
The relying study team is responsible for providing information and documentation to the reviewing IRB regarding its research personnel’s education and training, as needed. The relying study team is also responsible for maintaining its study records, such as consent forms and HIPAA authorizations. In addition, the reviewing IRB must be updated with information about the local study status for its continuing review.
How do I get started?
Investigators engaged in multi-site research with an institution(s) not associated with the SMART IRB should contact the COUHES office.
Lead Principal Investigators engaged in multi-site research with an institution(s) associated with the SMART IRB should initiate a new reliance request through the SMART IRB Online Reliance System. See the list of SMART IRB Participating Institutions.
For research involving collaboration with outside institutions, does the Data Classification and Information Protection requirement apply to the outside institution(s) collaborating with MIT?
This depends on whether COUHES is the reviewing IRB for the outside collaborators.
If COUHES is the reviewing IRB, meaning that the outside institution(s) has signed a reliance agreement for COUHES to be their IRB and to oversee their research activities, then the outside institution(s) are required to follow MIT Data Classification and Information Protection requirement or a comparable standard at the collaborating institution(s).
The MIT PI of the study will need to certify for the outside collaborators if the study is chosen to complete the information protection tasks. If the outside institution(s) cannot follow the MIT information protection tasks, then they will need to provide an alternative plan that is similar and comparable to MIT information protection tasks. The MIT PI is responsible for mapping the outside collaborator’s plan to MIT Information Protection requirement to determine whether it is acceptable and the MIT PI can consult IS&T and MIT Research Compliance if they have any specific questions.
If COUHES is not the reviewing IRB for the outside institution, meaning no IRB reliance agreement is in place between MIT and the outside institution(s), then the outside institution(s) is strongly encouraged to follow MIT information protection tasks or a similar information protection plan.
If COUHES cedes IRB review to an outside IRB via a reliance agreement, then MIT investigators are strongly encouraged to follow MIT standards, in addition to following the requirements of the outside reviewing IRB.