Bioequivalence and Bioavailability Forum

❝ Is it "only" about ECG data or is there more? I didn't follow this case closely.

❝ I remember one CRO in the Ranbaxy case, but is there some kind of overview on notorious CRO for such stuff?

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.