humantrials

In a recent announcement, Elon Musk's company Neuralink revealed the successful implantation of a brain device in a human, pushing the boundaries of neurotechnology.
 In our latest short, we discuss key considerations for those venturing into such groundbreaking work. 
We emphasize the importance of having a clear investigational plan that outlines study design, methodologies, endpoints, and analysis strategies. 
Additionally, we also highlight the significance of obtaining adequate informed consent to address potential health risks 
The need for meticulous record-keeping for regulatory compliance, including maintaining detailed delegation logs and up-to-date resumes.
These measures are crucial for navigating the complexities of both technological advancements and regulatory policies in this innovative field.

ICMR's 2017 ethical guidelines need a revision, with more focus on fundamental principles that govern the moral decisions and on ethical dilemmas that arise while conducting clinical trials/biomedical and health research.

Sowmya Nandan talks to Sunila Dixit and Shambhavi Naik about the evolution of ethical guidelines in India and about the proposed ethical guidance questionnaire that will assist researchers and ethics committees to ensure that the research is within the ethical boundaries.

Read Sunila's research document here:
https://takshashila.org.in/takshashila-discussion-document-ethical-guidelines-for-clinical-trials-and-research-in-india/

You can follow Sowmya on twitter: @sowmyanandan
(https://twitter.com/sowmyanandan)

You can follow Sunila on twitter: @SunilaDixit
(https://twitter.com/SunilaDixit)

You can follow Shambhavi on twitter: @TheNaikMic
(https://twitter.com/TheNaikMic)

See omnystudio.com/listener for privacy information.