Patient can WhatsApp, SMS or email consent for Covid-19 clinical trials: ICMR draft guidelines
Patients, who have been chosen for clinical trials, can now give their consent electronically through a text message, WhatsApp or other mobile-based applications because of mobility restrictions due to coronavirus disease (Covid-19) pandemic, according to the Indian Council of Medical Research’s (ICMR) draft guidelines for ethics committees that review biomedical and health research in the country.
“A lot has changed because of the pandemic situation, especially restrictions imposed on in-person meetings and physical movements. Many patients won’t be accessible in person because of Covid-19. Besides, we need to maintain social distancing and nobody would like to exchange a lot of papers. We decided to make use of the technology in a bid to ensure that research work doesn’t suffer,” said Dr. Roli Mathur, head, ICMR’s bioethics unit, who drafted the guidelines.
“The onus, more than ever, lies on a researcher to adequately inform the subjects of the pros and cons related to the project since the option of digital consent is readily available. The concept of ‘informed consent’ has assumed more significance, where a researcher needs to explain a patient to the best of ability,” she said.
The ethics committee quorum, where a minimum number of members is required to be present during a meeting, for decisions to be valid can also meet virtually.
“Earlier, it was imperative for ethics committee members to meet in person. But of late, we’re getting a number of queries from various ethics committee members, who are pleading their inability to meet in person. The guidelines weren’t clear about whether the quorum could be held online. But, our experts are of the opinion that it is feasible to conduct ethics committee meetings online,” Dr. Mathur said.
Emerging trends suggest that online ethics meetings are likely to become a permanent feature even after the Covid-19 pandemic eases in the near future.
“We have smoothly transitioned to digital media to conduct meetings, even though there was initial reluctance among a section of members because of perceived technical glitches. However, it has turned out to be a workable idea, as it saves travel time, easier to co-ordinate, etc. It may evolve into a permanent feature in the near future,” she added.
The new guidelines suggest that if members of an ethics panel are not available for any reason, a researcher can approach another ethics committee to seek its consent.
“On the one hand, there is a need to undertake research on a priority basis, and on the other to ensure that this doesn’t compromise scientific validity and ethical requirements. This is the appropriate time to respond to humanitarian emergencies by adopting novel methodologies, designing innovative methods, appropriate use of digital platforms and new technology, effective management of limitations of time, infrastructure, resources, and enable quick communication,” Dr. Balram Bhargava, director-general, ICMR, wrote in the foreword to the draft guidelines.