Institutional Review Boards Contend with FDA, OHRP

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I have noticed some concern from many IRBs about the GAO & OHRP difference of opinion regarding some aspects of human subject testing. If accreditation is ever fully pulled from an IRB, the reasons will be stated by FDA or OHRP. Through my review of many types of IRBs large and small (central & institutional) I have noted a few trends.

Central IRBs have two fundamental issues to deal with: quality assurance (QA) at the study site, and having a local representative of the community where studies are being conducted present at IRB meetings.

FDA & OHRP are now expecting IRBs to conduct QA audits as is done with most institutional IRBs. If the central IRBs can do a bit more with the funds they receive for service, they will survive this transition. The IRB’s basic functions are to insure patient safety & rights and assure clinical trials are following the CFR (all applicable sections).

In the end, the most basic function of an IRB is patient advocacy & record retention of patient safety discussions (for verification of review). Institutional IRBs in some cases do not scrutinize the in-house clinical trials adequately. In-house clinical trials do not get monitored as frequently due to lack of funds.

The institutional IRB’s should insure the name of the parent company/institution is tied to CFR compliant clinical trials, or the brand may be effected.

But I have a question for IRBs using electronic records: are you ready for the FDA investigator to challenge your 21 CFR Part 11 electronic record compliance? I have observed many large IRB’s staying in the paper records format. Due to cost & physical space issues, electronic is now the obvious way to go.

IRBs are getting more ICH audits and vendor qualifications which help IRBs stay in compliance with ICH guidance and the FDA regulations. FDA needs IRBs in good standing to review the many studies FDA field Investigators will not be able to Inspect. IRB’s play a major part in regulating clinical trials.

When I was with the FDA I always tried to encourage the IRB’s after a 483 was issued to do more for the patients and to effect real change in the amount of studies audited for QA. The FDA cannot get to every study or even thirty percent of the on-going clinical trials combined (biologics, drugs, & devices).

You, IRBs, do the heavy lifting for domestic clinical trial regulatory compliance. Thanks for the hard work.

Patrick Stone is President of TradeStone QA. Follow Patrick on Twitter.




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