Difference Between Irb And Iec+Clinical Research Paper

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Difference between IRB and IEC
(10/29/2014)

Question 1:

I am preparing a training directed to CRAs in [redacted], and I have some doubts:

Reviewing the GCP definitions, I can't note a difference between IRB and IEC I do not understand why at Code of Federal regulations they only mention the IRB and no mention IEC. I also do not understand the definition of IRB: “Independent body”; the term independent refers “to the Institution” or refers “That it is independent from the PI and Sponsor”

Answer 1:

There is no difference between IRB and IEC. The IRB term in used in the US, generally IEC is used in the EU, and REB (Research Ethics Board) is used in Canada. There is no difference in their function to protect the rights, welfare, and safety of research subjects. Please see a few guidance links below that might be helpful to you.

Guidance documents included under the umbrella title of FDA Information Sheets represent the agency's current thinking on protection of human subjects in research.

IRBs -Frequently Asked Questions - Information Sheet.

Guidances > Institutional Review Boards Frequently Asked Questions - Information Sheet

www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm

ICH-E-6 Guidance on Good Clinical Practice -

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf

This is the document in Spanish.

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073128.pdf


Search the FDA-GCP database

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