It is yet to be determined what happens to the participants who r

It is yet to be determined what happens to the participants who refuse video recording of their consent discussion, if they are already on study medication for ongoing studies. Will selleck screening library these participants be withdrawn from the study drug only because they refuse to be video recorded and is it ethical to do so, when they were not informed about this requirement at a time when they decided to participate in the study? Recording of a ??process??; not an ??event?? Informed consent is a process and not an event. The investigator may counsel the patient or resolve the patient’s doubts as and when these are asked, which may be through a telephone call, during outpatient departments or through subinvestigator(s). So recording informed consent at one stretch seems to be a difficult task and recording each small consultation on camera may not be practically possible.

However, it is definitely going to take more time for the investigator to obtain consent from each participant with this method. Also before the start of the informed consent process, the participant will have to consent for AV recording. This will significantly increase the volume of the work at the site. In addition, who is responsible for recording the consent process is questionable. Is it the site staff or a third party professional, in case of the latter, subject confidentiality would be at stake. Another option worth considering will be automatic recording with self timer which would engage only the concerned parties.

Willingness to discuss ailment over camera In India, patients may not be comfortable discussing about their disease in front of the camera especially in cases of sexually transmitted diseases, acquired immune deficiency syndrome, and so on patients with depression Carfilzomib and mania may be suspicious and may have to be dealt with carefully. The patient may be worried about social stigma associated with diseases such as leprosy or tuberculosis. The investigator will have to reassure the patient about the confidentiality maintained by the site and sponsors who are end users of the data. This may lead to fewer patients opting for clinical trials and subsequently recruitment delays. Interpretation of behavior on camera It seems to be a big problem how the body language or the facial expressions of the participant or the investigator providing information are interpreted, since it is very subjective.

It may seem that the participant is coerced to take part in the trial based on his/her body language or vice versa. Confidentiality at stake With personally identifiable information being collected, the responsibility of handling this sensitive 17-AAG chemical structure information with utmost care increases multifold. The investigators will have to strengthen the governance at the site to ensure that there is no theft or misuse of the confidential discussion available on record.

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