ICF_Part I
Storyboard Text
- It's my first consent..Have to get it right...cant make a mistake...%...so what all do I need to do....@#$
- What's the matter Zoha? Why are you looking so confused and stressed? Can I help with something?
- I've been referring to GCP, Google, the new CT rules and everything possible to understand the whole process of consenting. Additionally Dr. Vijay informed the patient is illiterate, so now after all this reading, I'm confused about the use of an LAR and an IW....Life is so difficult !!!
- First let's understand what to do when the patient is illiterate as per GCP.
- Now understand, even if someone is illiterate, they are still in good capacity to think of what is good or bad for themselves when explained properly. The challenge is, they cannot read the ICF and hence he cannot verify if the information being given to them by site is exactly what is mentioned in ICF.....
- ....so that's why we need a witness to confirm that the information in the ICF is what is being passed correctly to the subject. Also, this witness cannot be influenced by either of parties, and hence 'Impartial' Witness. But then who can be an IW?
- If the witness is not a person from the study team and is not under direct supervision of the investigator or other members of the team, he/she could be acceptable as an impartial witness.Sometimes, even Hospital NGO members, study nurse from another unit or even a random bystander can be approached for being an IW.
- I just got a brilliant way to remember this!'I' for Illiterate'I' for Impartial WitnessWohooooo!
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