Can a witness sign remotely during the electronic informed consent (eIC) process?
Dr Minal Kelkar
Indian regulations don’t have provisions for eConsent process. However, ICH E6(R3) and US FDA do allow eIC process. US FDA 2016 guidance on eIC emphasizes: - Patient understanding ? Use of multimedia, interactive elements, and comprehension checks.
- IRB oversight ? IRBs must review and approve the eIC format.
- Identity verification ? Digital signatures must be secure and legally valid.
- Data security & Audit trails ? eIC must have timestamped records, access logs, and encryption.
- Remote consent allowed ? If patient identity is verified, consent can be given remotely.
The eConsent may take place at the study site when both the investigator and participant are at the same location, or remotely e.g., at the participant’s home or another convenient venue where the participant reviews the consent document in the absence of the investigator.
If any or all of the consent process takes place remotely and is not personally witnessed by study personnel, the electronic system must include a method to ensure that the person electronically signing the informed consent is the participant who will be participating in the research study or is the participant’s LAR. The impartial witness can also sign remotely during the informed consent process. Identity e.g. ID card, Biometry, of all personnel -the participant, LAR, or impartial witness should be documented.
We plan to host an electronic platform for inviting patients to join clinical trials. We are interested in incorporating testimonials from patients and healthcare professionals (HCP) onto the website. Do we need to get approval of Ethics Committee (EC) for the incorporating testimonials?
Arvind Tanwani
In Western countries, direct advertising for participants is not considered an objectionable practice. Direct advertising usually includes newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective participants. However, this doesn’t include: (1) communications intended for HCPs e.g. ‘dear doctor’ letters and doctor-to-doctor letters (2) news stories and (3) publicity intended for other audiences e.g. advertisements directed toward prospective investors. However, any information intended for the potential participants displayed on an electronic platform should be reviewed and approved by Ethics Committee.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com |