Regulatory and Ethical Requirements
Regulatory and Ethical Requirements tests your command of the rules that make a trial lawful and ethical: ICH GCP, FDA 21 CFR Parts 50, 56, and 312, the Declaration of Helsinki, and privacy law including HIPAA and GDPR.
Approval and oversight
An IRB or IEC must review and approve the protocol, consent form, recruitment materials, and investigator qualifications before enrollment (21 CFR 56.109; ICH E6 3.1). Continuing review is required at least annually, and the site must report protocol deviations, unanticipated problems, and changes to the research. Amendments generally require approval before implementation unless needed to eliminate an immediate hazard.
Informed consent elements
21 CFR 50.25 requires, among other elements: a statement that the study involves research and its purpose; expected duration and procedures; foreseeable risks; benefits; alternatives; confidentiality protections; compensation and medical treatment for injury; contact persons; and a statement that participation is voluntary, refusal involves no penalty, and the subject may withdraw at any time. No exculpatory language may waive the subject's rights (50.25(a)(5)). Consent is signed and dated by the subject or legally authorized representative and by the person obtaining consent.
Worked example
A CRA reviewing a consent form finds the voluntariness and withdrawal statement missing. Reasoning: that element is mandated by 21 CFR 50.25(a)(8); without it the consent is not compliant. Correct action: flag it to the investigator and sponsor, suspend enrollment under that version, have the IRB approve a corrected form, and re-consent currently enrolled subjects if the IRB requires. The trap is to let enrollment continue with a "verbal explanation."
Safety and essential documents
Individually reportable serious adverse events go to the sponsor within 24 hours per most protocols; the sponsor files IND safety reports within 15 calendar days, or 7 days for unexpected fatal or life-threatening SUSARs. Essential documents are filed before, during, and after the trial and retained per regulation.
Traps that cost marks
- Confusing IRB approval with sponsor approval - both are needed for different purposes.
- Assuming a waiver of consent for retrospective chart review can be granted by the sponsor rather than the IRB.
- Treating "coded" data as anonymous under HIPAA or GDPR.
- Missing that consent must be re-obtained when new risk information arises.