Subject Safety Problems – Not An Isolated Incident

Sometimes I wonder if NYU had any idea of how often the safety of their human research subjects was being placed at risk – but how could they not know?

The FDA dinged them on multiple violations for the Pfizer drug trial (Protocol #B0541013), however that study wasn’t the only one in which NYU’s regard for subject safety is questionable. An earlier brain imaging study (S12-01521), a collaborative effort between NYU and Yale, had problems as well.

As I mentioned in my open letter to NYU, one of the incidents that I believe jeopardized my safety was being put on a plane so quickly upon my release from the Yale PET Imaging Center. I had had an arterial line placed, and upon its removal and bandaging I was literally immediately put in a cab and sent to the airport.

Not only does this violate NIH guidelines for post-arterial line care, but also the post-care instructions given to me by the institution that conducted the scans – Yale School of Medicine:

Post-Care
Yale University PET Discharge Instructions

 

  • No bending affected arm or wrist for 4 hours
  • Refrain from strenuous exercise, reaching, or lifting heavy objects (no more than 5 lbs,) for 48 hours

According to my Informed Consent documents given to me by NYU, I was to stay at the PET center for up to an hour to make sure that I did not have any problems or reactions from the radiotracer used in the study. That obviously didn’t happen. And I would have happily abstained from any physical exercise as per instructions in order to prevent complications, but I had a flight to catch. NYU violated its own guidelines.

So why was I on a plane so soon after my line was removed?

As a direct result of NYU’s scheduling, I ended up stranded in an airport mid-mental melt down with a pressure dressing on my arm (that I’m supposed to somehow take care of while travelling) in the middle of the night, fending for myself.

What would have happened had I had a complication mid-flight? I had a line in my artery less than two hours before I was in the air – and that is WITH a flight delay. What if I would have started bleeding at 35,000 feet?

Should that not be a safety issue that needs to be addressed – or is this how all subjects are treated?

So many questions, so few answers, and such little accountability.

NYU Informed Consent Form to Participate and Authorization for Research
NYU Informed Consent Form to Participate and Authorization for Research

 

 

1 Comment

  1. Karen S DeMello

    October 12, 2016 at 3:10 pm

    You are braver than you know and stronger than you feel. You will make this right in time. ❤

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