ICF

Question 1

What are 4 main elements of the ICF?

Answer 1

There are quite a few elements to the ICF.

1. The first is an overview of the trial and trial subjects that will be involved, along with duration.
2. Then it will provide an overview of assessments, randomization , etc. Risk, Injury, Cost, and Confidentiality language is covered too.
3. It will state that it is voluntary, and the subject has had an opportunity to ask questions. Again, there are other elements, but I think I have covered some of the main ones.

Question 2

8 basic elements in the ICF

Answer 2

1. Statement that participation is voluntary and refusal will not lose any benefits they’re entitle to . Discontinuation is ok at any time during trial without any penalty or loss.
2. Reasonable foreseen risks
3. Study involves research/ duration/ procedure/ product experimental
4. To whom contact in case of trial related injury/ protocol questions/ subject’s rights/ questions about research
5. Compensation or treatment available if trial related injury
6. Statement that monitor/ auditor/ IRB and regulatory authorities have access to original records w/o violating confidentially.
7. Alternate procedures or treatments with potential risks and benefits
8. Description of benefits; if none, must tell.