The principal function of the IRCM IRB is to conduct monthly reviews of proposed human studies by medical doctors or researchers
CONNECTING PHYSICIANS, RESEARCHERS, SCIENTISTS AND ACADEMICS REVIEW PROCESS
IRB Reviews
The principal function of the IRCM IRB is to conduct monthly reviews of proposed human studies by medical doctors or researchers (here after referred to as “investigators”). The IRCM IRB determines whether the experimental protocols proposed in the study are ethically conducted, reasonably safe, and comply with federal regulations that protect human subjects. Ultimately, the IRB decides if the risks are sufficiently minimized, and the potential benefits sufficiently maximized. As part of this core function, the IRCM IRB also ensures that the human subjects who volunteer for the study have been provided with sufficient information to make a legally effective informed consent to participate.
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 second and fourth 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.
Expedited Review
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.
Exemption Review
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.
Ongoing Renewals
Investigators who are approved by the IRCM IRB are required to periodically report to the board for an ongoing review of their research. These reviews are typically conducted live with the investigator by conference call, but can also be done via documents, especially when there is little to report in a low-risk experiment.
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.
Physician Guidance
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.
Client Portal
Clients of IRCM will be 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. Client portal coming soon.
Protocol Vault
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.
Investigator Database
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.
The Institute of Regenerative and Cellular Medicine
100 Wilshire Blvd. Suite 700
Santa Monica, CA 90401
Phone: (888) 664-8893