Sponsor and IRB: Direct Communication?
I came across an interesting article which talked about sponsor communication with an IRB. In a nutshell, it explained: Sponsor communication with IRBs has long been deemed inappropriate and since the 1980’s, sponsors having direct contact with an IRB has been frowned upon. Per Paul Goebel, president of Paul W. Goebel Consulting, Inc., a clinical research consulting firm, and former chief of CDE’s Institutional Review Branch, “When the regs were first written, some FDA officials said the communications should go through the principal investigator to keep the sponsors from bullying the IRBs and to keep IRBs safe from undue influence by the sponsors.”
So what has changed? According to Good Clinical Practice Q & A: Focus on IRBs, The FDA has encouraged a sponsor to communicate directly with the IRB to avoid an inefficient, error-prone process since 1984. Apparently, however, some Sponsors still are reluctant to go directly to the IRB.
According to the FDA information sheets the FDA does not prohibit direct communication between a sponsor and the IRB. The FDA also acknowledges that direct communication between a sponsor and IRB could result in a more efficient resolution of problems. For instance, a colleague of mine was performing monitoring for a particular study. When she arrived at the site, it was noted that two deaths had occurred. Not only had the deaths not been reported during the visit (much to the dismay of my colleague) but the site proceeded to wait an additional period of time before informing the IRB. When the Continuing Review for the study occurred, the IRB only granted a conditional approval. In the end, a conference call with the IRB, study staff, and the monitor who was representing the sponsor resulted in the study staff being more aware of their reporting guidelines and IRB policies. Had this direct communication not taken place the site may continue to be in non-compliance.
As monitors, we often consider having direct communication with the IRB for instances including:
- No IRB policies available for the monitor to review. We may need to contact the IRB to verify that the site is following the IRB polices;
- Disagreement with the site in the interpretation of policies - contacting the IRB can provide clarification of the intent; and
- IRB correspondence is not properly maintained at the site - the monitor may contact the IRB to verify that appropriate approvals were indeed obtained.
Should direct communication between the IRB and Sponsor be encouraged? According to 21 CFR 812.40, the investigator has a responsibility in ensuring that all correspondence with the IRB is filed, including that the IRB review and approval are obtained and that any significant new information about an investigation is promptly reported. So the monitor (working for the sponsor) needs to ensure this regulation is being followed. At times, the sponsor may need a direct line of communication with the IRB to be sure that reporting is done in an efficient and timely manner according to that IRB’s policies. If this occurs, will the principal investigator who was once the direct link between the sponsor and the IRB be left out of such communication?
Do you encourage this direct communication with the IRB, and think it will ultimately improve accountability of the PI as well as the study staff adhering to reporting guidelines? Let us know what you think.
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