Understanding the Electronic Signature Legality for Drug Testing Consent Agreement in India

How to eSign a document: electronic signature legality for Drug Testing Consent Agreement in India

[Music] [Music] welcome everyone i hope everyone is doing well so far this week so we're going to be talking about the use of electronic consents and how we're adapting that as we move along in this interesting time so we're going to be talking about informed consent and first i wanted to ask what is the purpose of obtaining legally effective consent what purpose does that serve you can type that in the chat panel if you will why do we have to get it everyone's shy when we think about assuring participants understand what they're agreeing to right thank you tanya so got to make sure that people understand what it is they are signing up to do right provide them with clear information ah here we go provide them with clear information making sure they're well informed about risks and benefits and procedures right what procedures are going to be expected which of those procedures are experimental in nature absolutely give them information so that they can make an informed decision about participation right so we have that as forward facing or outward facing to our participants or potential participants that they can gather information and do that risk benefit comparison themselves what we've already been doing right the fda or ohrp or the investigator or the sponsor and certainly the irb we're all balancing those risks and benefits but finally it comes down to that individual and they say yeah let's do it okay so we want to make sure that it is informed consent which is different than just having someone sign a document and now we are challenged to use electronic consent which has its pros and cons for sure but that obtaining legally effective consent that process allows us all to meet our obligations each of us involved in clinical research is working towards protecting the public's health ultimately i like to think of it as our product is good data from protected people so by doing that by an investigator obtaining legally effective consent they are not only protecting those participants but they're meeting their obligations their quality system obligation of ensuring that we are protecting the right safety and welfare of participants sponsors are ensuring too that legally effective consent was obtained that protects participants of course but it also protects the integrity of their data ethics committees irbs are established solely to support the conduct and oversight of that study as it pertains to protecting individuals so that document is kind of like the key to unlock everything else we can do in clinical research we look i'm an auditor so we look and see how all these things work together and they are interdependent even when they appear to be independent so we have to have legally effective consent before we can give someone any investigational product we know that right we're always taught that you've got to have legally effective consent prior to any study related procedures but by allowing us to do that the investigator is also meeting their regulatory obligation because they're only allowed to provide investigational product to individuals who are qualified authorized to receive it so they have consent and they've been assessed for for eligibility criteria which is a safety assessment so this document is really important and i know that that goes without saying or it should go that thing and i am very sorry for telemarketers but what we find is that oftentimes it's just necessary evil in that we will see consent is documented and we move along and we forget about how critical it is so if we start using it in an electronic format we have a lot of questions we have to be prepared to ask and answer so we have to let people know how long is this going to take what's expected of you in the consent process do you have enough time do you have the capability to access this and we've learned quite a bit during the pandemic in terms of who has accessibility just to internet access and what do we do with people who can't really navigate these systems or they have you know impaired motor skills or or visual issues so how do we make sure that we're giving them everything they need to make that informed decision so we get a sense that we have your roster here i think many of you are working together but our focus in this course is going to be thinking about how critical informed consent is and how we can apply it in different ways especially given our current circumstances [Music] [Music] you