How do I handle a deviation in the use of blood specimens collected outside the timeframe?


Our phase I informed consent document (ICF) is very specific in terms of the types of analyses that will be completed from the blood draw specimens that are collected from our subjects. It recently came to our attention that sites were collecting samples for a particular assay on days that were not noted in the ICF. So, the subjects consented to blood draws for "general health" but not for the performance of the assay on those particular days. We have since revised the ICF by adding a statement that the assay will also be performed on those specific days. May we perform the assay and retain the data for those samples we received before we revised the ICF?
- Director, Clinical Compliance, Pharmaceutical Company


The deviation from the approved protocol as described is a minor error with no substantive subject rights or safety issues.  While the reporting requirements for this type of error may vary across IRB, we suggest that as a first step, you make a note to file describing the deviation and the corrective actions. 

If you wish to test the samples collected prior to the approval of the modification to the ICF, you should consider reporting the event to the IRB as a protocol deviation along with a request to use the specimens and data and then retain the IRB communications in your regulatory binder.

About the Author

David Forster, JD, MA, CIP | Chief Compliance Officer

Mr. Forster joined Western IRB (WIRB) in 1996 and is currently the Chief Compliance Officer for the WIRB-Copernicus Group (WCG). A strong advocate for human subject protections, Mr. Forster co-chairs the Secretary’s Advisory Committee on Human Research Protections (SACHRP) Sub-Committee on Harmonization. He previously served a four-year term as a member of SACHRP, and was previously a member of the SACHRP Sub-Committee on Inclusion of Individuals with Impaired Decision-Making in Research. Mr. Forster also served on the Certified IRB Professional (CIP) Council. Mr. Forster has a law degree and a Masters in Medical Ethics from the University of Washington.

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