When I met the orthopedic surgeon last Tuesday he mentioned a double-blind research study of an investigational drug, a blood thinner. He added that this drug is, "not approved by the United States Food and Drug Administration." Not yet, at least. It will be compared to a drug that is approved by the FDA for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) after knee replacement surgery.
He gave me a 14 page contract-like legal document -- an Informed Consent Form -- and asked me to read it and decide, by the time of my pre-op interview at the hospital, if I would take part.
I have decided not to participate. The study appears to require a lot of followup and some tests that sound intrusive and stressful.
Am I expected to participate? I feel awkward turning it down, but I really don't want to be part of it. Deciding on having the knee surgery itself was a huge step for me. Now this question comes up. And by the surgeon himself.
I am sure the surgery and recovery will be quite stressful enough without adding any more stress factors.
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