Ethics? [BE/BA News]
❝ Is it "only" about ECG data or is there more? I didn't follow this case closely.
Yep. I can send you sumfink.
❝ I remember one CRO in the Ranbaxy case, but is there some kind of overview on notorious CRO for such stuff?
Not that I recall. BTW, some European member states started to suspend MAs; the BfArM is one of them (#1, #2).
Ethics? C’mon!*
None of the 50 HVs [Healthy Volunteers] knew anything about the study in which they were participating. It was surprising that even the volunteers who were graduates did not remember any of the details of the trial (the name or purpose of the study). They only remembered that blood would be drawn from them, that they may develop rashes or a headache, and that they should report any other symptoms that crop up. They were quite confident that the doctors and the facilities available would suffice to deal with any health risk they might encounter in the course of the trial. Several HVs said that participating in these studies was like an alternative profession for them.
During the ICF session it was noted that the volunteers were more concerned about the issue of payment than their health. The amount mentioned or agreed upon in the protocol document does not match the amount paid to the volunteers. While the ethics committee laid down that the HVs are paid Rs 2500, the VMT [voluntary mobilisation team] coordinators promised Rs 5000, but the HVs demanded Rs 10,000. It was finally negotiated that the HVs would be paid Rs 8200 for seven days, in addition to allowance for travel, accommodation and food.
- Krisha S, Prasad PN. Ethical issues in recruitment of “healthy volunteers”: study of a clinical research organisation in Hyderabad. Indian J Med Ethics. 2014;11(4):228–32. free resource.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Bioequivalence in prime time TV news Dr_Dan 2014-12-05 08:42
- Bioequivalence in prime time TV news nobody 2014-12-05 08:51
- Bioequivalence in prime time TV news Ohlbe 2014-12-05 14:10
- Bioequivalence in prime time TV news nobody 2014-12-05 16:56
- Bioequivalence in prime time TV news Helmut 2014-12-05 17:24
- Bioequivalence in prime time TV news nobody 2015-01-23 17:08
- Bioequivalence in prime time TV news nobody 2014-12-05 16:56
- Bioequivalence in prime time TV news Ohlbe 2014-12-05 14:10
- If you know German… Helmut 2014-12-05 13:27
- If you know German… nobody 2014-12-05 14:20
- Monitoring CROs Helmut 2014-12-05 17:49
- Monitoring CROs nobody 2014-12-05 18:02
- Ethics?Helmut 2014-12-05 22:54
- Ethics? nobody 2014-12-06 14:23
- Ethics?Helmut 2014-12-05 22:54
- Monitoring CROs ElMaestro 2014-12-06 22:10
- Monitoring CROs Helmut 2014-12-07 14:08
- Monitoring CROs nobody 2014-12-12 10:51
- Inspectors ≠ teachers (rather = examiners) Helmut 2014-12-12 14:41
- Monitoring CROs nobody 2014-12-12 10:51
- Monitoring CROs Helmut 2014-12-07 14:08
- Monitoring CROs nobody 2014-12-05 18:02
- Monitoring CROs Helmut 2014-12-05 17:49
- If you know German… nobody 2014-12-05 14:20
- RCA ElMaestro 2014-12-07 01:06
- Speculations Helmut 2014-12-07 14:41
- Speculations nobody 2014-12-07 17:31
- Speculations ElMaestro 2014-12-07 20:20
- Speculations Helmut 2014-12-07 14:41
- Bioequivalence in prime time TV news nobody 2014-12-05 08:51