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Ask the IRB Experts

Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB

Ask the IRB Experts

What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?

Ask the IRB Experts

What are the regulations for training home health individuals who are working remotely to collect study data?

Ask the IRB Experts

Should Consent Form updates be aligned with Investigator Brochure updates, or wait for next Protocol amendment?

Ask the IRB Experts

How Should I Handle Changes to Research Made in Response to COVID-19?

Ask the IRB Experts

What are the requirements for parental permission (consent) in studies involving children?

Ask the IRB Experts

Questions regarding the definition of “human subject”

Ask the IRB Experts

What ethical safeguards are needed for research involving observation of group behavior?

Ask the IRB Experts

How do I handle a deviation in the use of blood specimens collected outside the timeframe?

Ask the IRB Experts

Questions on the FDA’s 30-Day IND Review Period and IRB Approval