Manfred, the "informed consent" FIRST was a MUST as per the Institutional Review Boards (USA) and Ethical committes or any similar name in Europe, and FDA/EU regulators mandate, there is no way around that. The researchers design the study with that in mind. IT IS A LOGISTICAL NIGHTMARE.
I have participated as a clinician in at least a dozen studies, some need IRBs, some not, and even almost completely seemingly none harmful studies like my last one on breastfeeding practices, the IRB was consulted and they REQUIRED informed consent JUST FOR PHONE CALLS.
I am right now recruting patients for a large institution, for hypothermia treatment of perinatal asphyxia, the first few hours are critical, last subject took 5 hours to get to study site (in the same city) and qualified for just one hour, obviously the result is not the same if done in the first hour. The condition is operant for placebo too. No way it will be try without full informed consent.
Maybe Europe is different, not much, since about 75% of patients in this study were from the UK.
Commercial reasons, a desperate company cut the study short, The DSMB (data safety monitoring board) suggested 4 times to continue the study, xoma stopped cause they did not have more MONEY.
This is part of the reason many in this thread cry FDA did it.
Well, it is reality.
Your solution will never happened. |
