Which ethical rule(s) or document(s) were responsible for required elements to the ICF?

Question

Required elements of the ICF are a direct result of the various ethical rules and documents that have been established by the US government. Which ethical rule(s) or document(s) were responsible for required elements to the ICF? Choose all that apply.

 

Group of answer choices

Common Rule

Declaration of Helsinki

Belmont Report

Risks/Benefits

Answer 1

The answer would be Common Rule, Declaration of Helsinki, and the Belmont Report because all three of these were rules/documents that dictated what elements had to be in an ICF, whereas Risks/Benefits is an element of the ICF. Each of these documents clarified what information had to be included in an ICF in order to conduct an ethical trial.

If you need more information about what specific elements were laid out by each document, the link below has a summary table of the elements that each document added to the ICF process.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2632196/