During the review, we identified several compliance issues in both protocols. The concerns consisted of the use of an unlicensed physician to conduct certain diagnostic interviews and to draw blood without disclosing this to the IRB; irregularities in the de-identification of the informed consent documents; unavailability of medical records for some subjects to support pre-existing diagnoses qualifying the subjects for the study; failure to obtain approval from either the IRB or the Office of Research and Development (ORD) for conducting research activities internationally; and the use of a tissue bank not approved by the VA.The blood samples were collected from participants who were interviewed and paid a stipend of $125. They drove a government vehicle across the line and when returning, failed to declare the blood samples with Customs, according to the website VA Watchdog.org. Also noted from the report is the following:
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However, we did find irregularities in the recruitment process, verification of inclusion criteria, informed consent de-identification, and the credentialing and privileging of research personnel involved in the two protocols reviewed. Finally, we note that both protocols involved the banking of tissue specimens from human subjects at an offsite tissue bank not approved by VA for use in these particular protocols. (emphasis mine)The report goes on to outline the failure of government personnel to secure consent forms from all participants, obtain prior medical records to determine health history, and the unsubstantiated claim that used needles were utilized for the blood draws. The exploitation of Mexican citizens was noted due to the currency disparity, with the rate being nearly 10 pesos for every U.S. dollar.