In a warning letter dated September 24, 2012, FDA says the Texas Applied Biomedical Services Research Review Committee (TABS RRC) “significantly violated…21 CFR Part 56”. The agency is withholding approval of all new trials reviewed by TABS RRC, and the IRB was directed to suspend enrollment in all ongoing trials subject to 21 CFR 56.
These actions stem from an inspection in April 2012, coincident with FDA’s inspection of a company that had contracted with TABS for clinical research consulting services as well as IRB review. The agency requested prompt corrective action to address the following:
1. The IRB failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest. [21 CFR § 56.107(e)].
Two committee members were involved in the development of protocols and consent forms they later reviewed in their capacity as IRB members. Although the letter notes there was a difference of opinion between TABS and FDA, this seems like a clear-cut case. “Conflicting loyalties, whether conscious or not, may influence the IRB’s deliberations.”
2. The IRB failed to prepare, maintain and follow its written procedures for conducting its initial and continuing review of research. [21 CFR §§ 56.108(a) and 56.115(a)(6)].
The IRB did not have written procedures for the review of research involving children.
3. The IRB failed to fulfill membership requirements. [21 CFR § 56.107].
TABS RRC does not have any physicians among its regular voting members and was unable to provide documentation that a physician was consulted when appropriate. The regulations don’t specifically require that an IRB include a physician; they do require that the IRB “possess the professional competence necessary to provide complete and adequate review”.
4. The IRB failed to determine that a pediatric study is in compliance with Part 50 Subpart D. [21 CFR §§ 56.109(h) and 56.111(c)].
The minutes of a meeting that included a pediatric study did not document TAB RRC’s review of the additional criteria for research involving children or its determinations regarding child assent.
5. The IRB failed to prepare and maintain adequate documentation of IRB activities. [21 CFR § 56.115].
TABS RRC was unable to produce any meeting minutes for 2011, blaming a failure of its computer system that caused “all minutes and data for that time frame to be lost”.
The inspection also found repeat violations for insufficiently detailed meeting minutes (previously identified during inspections in 2007 and 2000) and the omission of basic information from membership rosters (for which TABS RRC was cited in 2000).
TABS RRC was given 15 days to respond.