The principal function of the IRCM IRB is to conduct monthly reviews of proposed human studies by medical doctors or researchersCONNECTING PHYSICIANS, RESEARCHERS, SCIENTISTS AND ACADEMICS REVIEW PROCESS
There are three types of IRB review: Regular Full Board Review, Expedited Review, and Exemption Review.
Regular Full Board Review
For its regular Full Board Review the IRCM IRB meets on the third Wednesday of each month. Applications and fees must be submitted a week in advance of the scheduled date of review. The principal investigator (or a representative sponsor, medical adviser, or study coordinator) must address the board with a clear summary of the study, its protocol and its purpose, as well as answer any questions about the study, its protocol or its informed consent. The IRCM IRB will report the conclusion of the board (approval, conditional approval, or denial) to the investigator within 48 hours, and will forward approval documentation within a week.
For its Expedited Review, the IRCM IRB can accommodate an urgent request for review of a low-risk protocol. An Expedited Review requires a valid quorum of board members, typically its executive committee, and can be set up in a matter of days following the IRB submission. An additional fee is charged to expedite the process; both approval and approval documentation are processed within 48 hours.
An Exemption Review is for a human research study that is exempt from IRB approval as per categories listed under 21 CFR 56.104(d). Any research project involving human subjects, even if considered to be exempt, must be submitted to an IRB to confirm that exempt status.
The periodicity of reviews is based on the nature of the study, and how risky it is considered. Low-risk studies are reviewed annually. Moderate-risk studies are reviewed at either six-month or three-month intervals, at the discretion of the board, based on perceived level of risk. The IRCM IRB approves no high-risk studies except in the case of compassionate use of experimental drugs.
The IRCM IRB prides itself on the individual attention that it gives to clients during the application process. This is especially important for independent physicians, who do not have the research administration staff of hospital or university institutions.
Physicians who submit research proposals to the IRCM IRB will be guided through the application process so that review time can be streamlined. Prior the review itself, the IRCM IRB can answer all questions regarding IRB policies, IRB requests, and application requirements that could otherwise create unanticipated problems or slow down the approval process.
Clients of IRCM are able to interact with its IRB through a Client Portal. This portal enables clients to download forms, file applications, and view their stored documents. Through their individual portals, clients can monitor the progress of their applications and projects, as well as communicate with the admin staff of the IRCM IRB.
For clients who submit complex studies involving different protocols, or sub-protocols, the IRCM IRB offers a Protocol Vault service, in which simpler SOP procedures are approved, recorded and electronically stored. These approved sub-protocols, proprietary to individual investigators, can then be referred to in future studies without having to include detailed descriptions that would require new reviews and approvals.
As part of its ongoing mission to validate the science and practice of regenerative medicine, the IRCM IRB encourages individual investigators to join larger databases. Through its relationships with clinics, researchers, hospitals and universities nationwide, the IRCM IRB can connect clients to databases, so that the results of their studies can be combine with the results of other, similar studies.
Allocation of Charitable Donations
The IRCM accepts and channels charitable donations to fund specific translational research, expediting the process of bringing treatments to patients. A detailed discussion of these options is available on request.