McGuff Company News Room
Enrollment Stopped in Trial to Access Chelation Therapy
November 20, 2008
Lead investigator Doctor Gervasio Lamas (Mount Sinai Medical Center-Miami Heart Institute, Miami Beach, FL) along with the National Institute for Health (NIH) optioned to temporarily stop enrolling new patients in response to a complaint received by the Office for Human Research Protections. Doctor Lamas is the lead investigator for the Trial to Access Chelation Therapy (TACT). It is alleged in the compliant that the consent form and general process of patient enrollment does not adequately identify patient risk. Further, the complaint addresses alleged safety concerns.
The complaint was received by the Office for Human Research Protections from an “outside party”. The name of the outside party has not been released.
The moratorium on patient enrollment will be reexamined upon completion of the parent Investigational Review Board’s (IRB) examination of the complaint and review of the study design. The parent IRB is the University of Miami. Patient safety and enrollment procedures will be the primary areas of focus by the parent IRB.
The American College for Advancement in Medicine (ACAM) has announced its support for the NIH decision to suspend patient accrual of the TACT trial until allegation of impropriety can be proven false.
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