You’ve got questions? We’ve got answers
IRB launching new column
In this issue of IRB Advisor, we are starting a new column designed to answer reader questions. If you have questions regarding IRB responsibilities, federal regulations, adverse event reporting, day- to-day functions, anything related to clarifying the duties and responsibilities of your IRB, we’d like to know. Please forward questions to [email protected], and each issue we’ll ask an expert in the field to provide an answer.
Question: What is the role of a local IRB when a trial is conducted in several locations (i.e., is part of a multicenter trial)?
Answer: John Isidor, JD, CEO, Schulman Associates IRB, Cincinnati — I believe the intent of the question is to distinguish between the role of a local IRB in a multicenter trial and in a trial being conducted only at its institution.
The role of an IRB in reviewing biomedical research is defined by the applicable Code of Federal Regulations, 21 CFR 56 (for FDA regulated research), and 45 CFR 46 (for federally funded research), as well as the standard operating procedures of the IRB. Nothing in the federal regulations distinguishes between obligations of an IRB in a single site study vs. a multicenter trial. The same should be true for IRB standard operating procedures, unless the local IRB has agreed to transfer its obligations to a central IRB.
Accordingly, the local IRB must review a multicenter trial with the same level of responsibility and oversight as it would a trial being conducted only at its institution. The local IRB should establish a period for approval of the research, consistent with the degree of risk, not to exceed one year.
Additionally, the local IRB must have in place procedures for reviewing safety information it receives during a trial. In multicenter trials, a local IRB will receive both adverse event reports and IND safety reports. The local IRB will receive only investigator-generated adverse event reports about events that occur at its institution. If the multicenter trial is being conducted under an IND, the local IRB could receive sponsor-generated IND safety reports about adverse events that occur at other sites.
The local IRB should have a process for reviewing both adverse event reports and IND safety reports that arise from the trial. Additionally, if the study has a data safety monitoring board (DSMB) in place, I would recommend that the local IRB find out when the DSMB meets and request copies of any reports that the DSMB issues.
A final issue is the dilemma of a local IRB requesting changes to the protocol in a multicenter study. The local IRB must decide whether the protocol is approvable based on a risk benefit evaluation and whether it is appropriate to be conducted at its institution. This charge cannot be modified based on whether the research is being conducted at one institution or 400 institutions. If the local IRB decides that the protocol needs modification to be approvable, it must notify its investigator who in turn will notify the sponsor. The sponsor has one of three possible responses to such a request: it could agree to modify the protocol for all sites; it could agree to a site-specific modification, or it could refuse to amend the protocol. If the sponsor will not agree to what the IRB considers to be a modification necessary to make the benefits of the study outweighs the risks, the local IRB should not approve the research.
In this issue of IRB Advisor, we are starting a new column designed to answer reader questions. If you have questions regarding IRB responsibilities, federal regulations, adverse event reporting, day- to-day functions, anything related to clarifying the duties and responsibilities of your IRB, wed like to know.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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