Informed Consent Form Part-1 (Introduction)
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- เผยแพร่เมื่อ 4 ต.ค. 2024
- What is Informed Consent?
As new medical products are being developed, no one knows for sure how well they will work, or what risks they will find. Clinical trials are used to answer questions such as:
Are new medical products safe enough to outweigh the risks related to the underlying condition?,
How should the product be used? (for example, the best dose, frequency, or any special precautions necessary to avoid problems),
How effective is the medical product at relieving symptoms, treating or curing a condition.
The main purpose of clinical trials is to “study” new medical products in people. It is important for people who are considering participation in a clinical trial to understand their role, as a “subject of research” and not as a patient.
While research subjects may get personal treatment benefit from participating in a clinical trial, they must understand that they:
may not benefit from the clinical trial,
may be exposed to unknown risks,
are entering into a study that may be very different from the standard medical practices that they currently know
To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about:
what will be done to them,
how the protocol (plan of research) works,
what risks or discomforts they may experience,
participation being a voluntary decision on their part.
This information is provided to potential participants through the informed consent process. Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work.
A central part of the informed consent process is the informed consent document. The Food and Drug Administration (FDA) does not dictate the specific language required for the informed consent document, but does require certain basic elements of consent be included.
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Love from Pakistan mam❤❤ God bless you,you help me a lot for my final exams topics 🥰🥰🥰🥰💓💓💓💓❤️❤️❤️❤️
You explain very well, and helps to understand easily, keep uploading all clinical research and pharmacovigilance videos like this.Thank you for making my concept easily clear.
Very informative and helpful videos 🙌, please also make a video on protocol and how to make a protocol.
GCP NIDA Modules ko hi Explain kr diye hote to acha hota uh IRB me bohot help hui Understanding me 4:12
Fantastic for my life mama
Thank you so much mam for it.
Thank you Rajendra, its nice to know that you liked the lecture. Keep connected for more information.
Thanks ma'am
Mam please make the video on Case report form, monitoring and audit all related topics.
Thank you so much ma'am
It's very helpful for us
Thank you
Kisi chiz k liye chapter padhati ho ap
Awesome mam ...thank u so much
Keep watching
Thanks mam❤
Thanks a lot simran mam
Thank you Mohommad! Stay connected for more information 👍
Thanks for sharing this video, although I have a doubt about this subject. How do we take content from someone who cannot read or have any knowledge about consent forms, simply how to take consent from illiterates?
Please see part-2 of this video
Nice
Thank you sandeep, its nice to know that you liked the lecture. Keep connected for more information.
Mam drug discovery phase me lab me experiments kon karta hai?..and eligibility kya hai to do it?
Scientists karte... Uske liye bohot lamba process hota h
@@crgurukul ok ty mam..to i m a BHMS student..medical scientist banne ke liye kya karna padega?
Obtain a bachelor's degree.
Complete a master's degree.
Gain experience.
Pursue certifications.
Consider a doctorate.
@@crgurukul ty mam:)
its irb not rbi
Thanks for correcting ☺️