The #COVID19 pandemic shows the need for building capacity within the country for critically evaluating ethical issues in health research
We @SangathIndia#Bhopal hub are delighted to have been funded by @thakurfdn to to create an online/digital course on health research ethics
The project is called DRISHTi (Developing capacity in health Research ethics Training) and the digital course will be targeted at health professionals as well as general public. The course is proposed to be 8-10 weeks long, completely digital in format and in the English language
The course has the potential to be a key contributor in developing capacity within India to conduct and evaluate health research from an ethics perspective.
Such a capacity is important to combat the ‘epidemic’ of misinformation, to elevate the quality of health discourse in India, to empower Indian citizens and to sustainably strengthen Indian healthcare, health research and public health interventions.
We are launching the project now, and look out for more details in the near future.
The course should be hopefully ready in about 4-5 months time, we will make the announcements when it is ready to launch. Thanks for your interest and support. 🙏
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The ICMR DG and some other experts have argued that phase 1 and phase 2 data is enough for restricted emergency use approvals, and that phase 3 efficacy data is not necessarily required.
Dr T Jacob John also makes an argument in this regard, though also clarifying that there might have been some early safety data from those vaccinated in the phase 3 which is ongoing as well
BUT if we were going to base a regulatory decision on just phase1 and phase2 data, why did we have to wait till 02nd Jan 2021. That data was available a few weeks earlier, and in fact was considered in the 09th December CDSCO SEC meeting. Why not take the decision then itself?
Have been in touch with Rachna for the last few weeks as we discussed issues with one of the #Bhopal#clinicaltrials site for #Covaxin. Lots of issues with trial conduct as documented in her thread below.
Issues with informed consent, care of trial participants, recruitment.
This issue needs to be highlighted more as it shows us what poor oversight could mean, especially because we are now talking about expanded use of vaccines "in clinical trials mode" (not that I am sure anyone really knows what that means)
Now this is probably just an issue with an inexperienced trial site and investigators who were eager to be part of a prestigious study, but faltered on some aspects of trial conduct. But imagine this happening at scale-- how are we going to ensure protection of the vaccinees?
The 1st Prof MK Bhan Memorial lecture has started live streaming
Please watch at
The Lecture will be delivered by Prof. Vinod K Paul @NITIAayog on topic 'Science & Art of Influencing Health at Transnational Scale: How Visionary Physician Scientists Do it'
Dr @RenuSwarup also announces the launch of a #Fellowship Program to encourage young #researchers to continue their postdoctoral research in India.
The MKB-YRFP scheme @DBTIndia
Dear @PrinSciAdvGoI@PrinSciAdvOff, the issue of recent FCRA amendments on international collaborative #science#health#research needs to be urgently taken up. Lot of uncertainty.
a) sub-agreements now not allowed which impact existing scientific collaborations b/w institutions
b) Interpretations seem to indicate remittance back of FCRA funds will not be allowed. Funders have rules any unspent funds at end of project cycle have to be sent back. But it might not be possible now?
c) Coupled with the #HMSC clearance housed at @ICMRDELHI which is still running delayed with long time for processing even for #COVID19 related #research proposals, this is going to stymie internationally funded collaborative research, often obtained through competitive grants
I am worried that many of us are afraid of speaking truth to power. That scientists, many of them excellent, within our national research bodies would not call out outrageous statements and lack of evidence based steps defies me. Isn't that a basic scientist quality?
Are we so afraid of upsetting status quo, our bosses who might have erred, that we would be willing to let the institution and its credibility be marred? Does that not hurt us at some basic level. Does that not trouble you when you reflect on what it means for Indian Science?
I know many of you are being asked questions in emails, phone calls and whatsapp groups and struggling to respond. We hope you will find the strength to rescue the institutions you represent from losing their sheen. Remember credibility takes ages to build, but easy to lose it.