Ethics Committee approval is required for all real-world studies

Wednesday, August 4, 2021, 08:00 Hrs  [IST]

Is using advertisement and infographics to inform patients regarding clinical trials and share it using social media platforms and recruitment portal, allowed in India as per regulations?
Ashish Chawda

The regulations do not cover digital recruitment specifically. Digital information would be considered advertisement. EC approval is a must before use of such digital advertisements or social media recruitment methods.  

Can we use digital technology along with audio-visual consent to remotely consent patient for trial participation in India?
Ashish Chawda

Electronic consent is covered in ICMR 2020 ethical guidelines for Ethics Committees reviewing Covid-19 pandemic.

Electronic consent
In light of Covid-19 infection control measures, the alternative procedures to avoid direct interaction with the patient in isolation must be explored.
Technology should be utilized to prepare interactive formats and using electronic tools such as text, graphics, audio, video, podcasts, interactive website, platforms to explain information related to a study and to electronically document informed assent/consent the same.
Electronic methods (e.g., digital signature) must be reviewed and approved by the EC a priority.
Process can be documented through audio or video recording (if required).
However, ICMR guideline is not clinical trial regulation. You need to check with CDSCO whether they will permit e-consent with audio or video recording.

We plan to conduct a real-world study of a drug using retrospective data. Do we require regulatory and ethics approvals?
Shubhangi Bhatia

Retrospective observational real-world study of a drug may require regulatory if it is a new drug. As per New Drugs and Clinical Trials Rules 20119:

Post marketing surveillance study or observational or non-interventional study for active surveillance - such studies are conducted with a new drug under approved conditions of its use under a protocol approved by Central Licencing Authority with scientific objective. Inclusion or exclusion of subject are decided as per the recommended use as per prescribing information or approved package insert.

In such studies the study drugs are the part of treatment of patient in the wisdom of the prescriber included in the protocol. The regulatory provisions and guidelines applicable for clinical trial of a new drug are not applicable in such cases as drugs are already approved for marketing.

Ethics committee approval is required for all real-world studies as EC must consider (1) whether the real-world study has minimal risk e.g., anonymized data or non-identified data; (2) protection of privacy and confidentiality; and (3) need for consent or waiver of consent before giving approval.

Dr Arun Bhatt is a Consultant - Clinical Research & Development, Mumbai. Readers can send their queries