I feel like I was dragged almost to the point of needing to be in a psychiatric hospital myself, while my colleagues who just used the bipolar screening test — without making the mistake of trying to check if it works — continue to do so without anybody questioning them or giving them the slightest bit of aggravation. When we got patients, I would give them the bipolar screening exam and record the results. But aside from the EpiPen itself, only one competitor has ever made it past the FDA and onto the pharmacy shelf — a system called Adrenaclick. See Regulation 45 CFR I may have mis-remembered some things or gotten them in the wrong order. No amount of hassle is going to prevent the Pfizer-Merck-Novartis Corporation from doing whatever study will raise their bottom line.
We asked the hospital administration for a one-time exemption, to let our patients have pens just long enough to sign the consent form. But we said our patients would sign in pencil. Newbie was good to go. But aside from the EpiPen itself, only one competitor has ever made it past the FDA and onto the pharmacy shelf — a system called Adrenaclick. He cheerfully agreed this made no sense, but said we had to do it or else our study would fail an audit and get shut down. The first problem was that nobody wanted to give us a locked room that nobody except us had access to. I swear I am not making this up. Should IRBs human subjects research approval committees be dismantled? I thought it was unwise to publish it while I worked for the hospital in question. They needed an attending high-ranking doctor to sign on as Principal Investigator before the IRB would deign to hear their case. I started working really late. Surely trained doctors would be able to ask simple questions from a screening exam on their own without supervision, I thought. Pieced together from memory years after the event. After enough knocking, a lady finally opened the door and motioned for me to sit down at a paperwork-filled desk. We are never going to live this one down. Consent forms traditionally included the name of the study in big letters where the patient could see it before signing. I have it in front of me now. Thanks to constant bureaucratic hurdles, plus patients being less cooperative than I expected, I had about twenty-five. A section on possible safety risks. When I was done, I went back to the corner office and submitted everything to the Institutional Review Board. We were to gather all our records, submit them to the auditor, and hope for the best. We should figure out some risks, then write a paragraph explaining how those were definitely the risks and we took them very seriously. It was locked, as always. Wal-Mart is going to keep selling groceries no matter how much paperwork and inspections it takes; the poor immigrant family with the backyard vegetable garden might not. IRB overreach is a small part of the problem. Having an adequate monitoring plan is a federal requirement for the approval of a study.
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