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AgVetLink, October 2004

DAS – conflict of interest

The August 2004 AgVetLink article on FAQs on the Data Assessment Service (DAS) did not clarify the issue of conflict of interest although the ACVM Group has commented on this aspect at DAS workshops.

We wish to remind applicants of their responsibilities in this area and the importance of avoiding conflict of interest. The ACVM Group has stated that applicants may undertake their own chemistry DAS reports on the basis that:

a) the person who does the report is not the same person who undertakes the regulatory function of dealing with the ACVM Group; and

b) the chemistry DAS report in the main is a summary of data rather than a hazard or risk assessment.

However, the above does not apply to other DAS reports such as residue and efficacy. It is important that persons undertaking these reports are independent of the applicants; otherwise, there is the concern that applicants are marking their own homework. Persons undertaking a data assessment also should not have been involved in any consultancy role in that area for the applicant, or be involved in the design of or running of the trial(s).

Applicants should be careful in their choice of DAS assessors to ensure they can be demonstrated to be independent. If the ACVM Group has any concerns over the independence of a DAS assessor, then it will use one of its own assessors to check and verify the advice in the DAS report.