Hyderabad: Patients opting for clinical trials must give their consent to undergo the trials before an audio-visual camera, which will ensure that all the questions from the consent form are read out and understood.
As the consent form runs into four pages, the boxes are currently checked and evaluation is done by para-medical staff or junior doctors. However, in case of camera recordings, all the questions have to be understood and accepted.
In case of a dispute, the reasons need to be specific and patients must be allowed to voice their concern.
Ravinder Sharma of the Forum for Better Health said, “This order makes it important to record not only the consent but also the complete clinical trial.
The researchers have to tell the patient what drugs are being given to them. After that, the effect of the drug, agony of the patient and also the various tests conducted from time-to-time must be before the camera.
The patient must ask for it as it safeguards his rights and ensures that if anything goes wrong he can use the recordings to show his reaction to the drug or the misery he suffered.”
Patients need to know that it is not only the consent part that is being recorded but also the complete proceedings.
Sharma explained that it is not only the agony of the patient but also the observation of the doctors and evaluation that is important in the trial. Hence it is very important that there is clarity at every stage for both the parties.
At present, patients suffer in silence in their homes and approach doctors only when things are not in their control, but this order demands that field trials or trials at home are also recorded so that the exact effect of the drug is known.
Researchers feel that this will increase their costs as they will have to place cameras and record the effect of the drug on the patient.
They are thus demanding clarity on the order of the Union ministry.
A researcher of Mahaveer Hospital and Research Centre said, “The guidelines state that all clinical research must be done under camera.
The one at hospital level can be monitored, but what about the ones at the home or field level? It is logistically not possible for us to observe and keep records of so many patients.
It is very important that the stakeholders make all the points clear to patients for they have the right to take them to court.