Correspondence Address:
Dr. Jayaprakash S Appajigol
Department of Medicine, Jawaharlal Nehru Medical College, KLE University of Higher Education and Research, Belagavi, Karnataka
India

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According to Schedule Y of Drug and Cosmetic Act and principles for good clinical research practice by the World health organization, freely given informed consent is one of the vital components in clinical drug trials. Informed consent is an essential ethical requirement for clinical research on human participants. There are many misunderstandings in the public about participating in a clinical trial. There is always a perception that the participant will be exposed to an unknown drug first time; he will be made a test animal and deceived. Contrary to this, the clinical trials are done only after studying the drug on animals (preclinical trials) and after confirming that benefits outweigh the risks. The participant is closely monitored with frequent visits and laboratory investigations. In spite of these precautions and standards of care, any participant is free to decide about his participation and continuation in the clinical trials. It is the duty of the investigator to make the participant understand pros and cons of participating in the clinical research. In recent years, there have been concerns raised by policy makers and general population about the process of informed consent, especially among illiterate and vulnerable population. There are alleged incidents of malpractices and getting informed consent signed without properly informing advantages and disadvantages of participating in trial.

In response to order from Honorable Supreme Court of India, CDSCO vide F. No.GCT/20/SC/Clin./2013 DCGI dated November 19, 2013, wherein it has issued instruction that in all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual (AV) recording of the informed consent process of each trial subject, along with the procedure of disseminating information to the subject and his/her understanding on such consent is required to be done while adhering to the principles of confidentiality. A videotape recording of the consent interview is not new in clinical research. It is already recommended by the United States Food and Drug Administration in case of illiterate participants who can understand and comprehend spoken English but are physically not able to speak or write.

There are many advantages of this type of AV consent process. AV consenting not only safeguards the participants but also investigators and sponsors. It ensures that the actual process has taken place, all the important information is actually explained to the prospective participant and he/she has accepted and signed the informed consent form. There will be irrefutable AV evidence for this entire process. It creates more transparency of the whole consent process. These digital data are less space occupying, durable and enhance trust among the stakeholders.

On the other hand, there are many challenges faced by this type of consenting process. Some trials may have a narrow time window between meeting the inclusion and exclusion criteria and administration of the investigational product. It will be challenging to arrange for AV consenting and meet the narrow time window in such studies. Informed consent is an ongoing process; there is no clarity on whether to include AV recording when the participant comes with queries regarding the investigational product. It has been reported from some parts of India that villagers especially females deny for getting video recorded. Participants suffering from HIV like diseases may deny to discuss illness in front of camera. The provision of appropriate infrastructure, protecting digital material against deletion, copying and tampering is the other challenges.

Every common man in India still believes that only allopathic drugs have adverse effects. It is very difficult to make him understand the real facts about drug trials. Even if he understands and is willing to participate, signing at multiple areas on the consent form that also under the scanner of AV recording puts him in an uncomfortable situation.

The fear and skepticism in the public about participating in clinical trials are expected. The modern efficient electronic and print media propagate the sensational news in a short period. Now, we the investigators have to prove and assure both the community and policymakers that the clinical trials are conducted ethically and informed consent process is transparent.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.