IRB & Informed Consent Flashcards

An IRB is composed of 10 members. A quorum is present when at least how many members are present, and what additional requirement must be met?

Answer: A majority (at least 6) must be present, including at least one nonscientist member

45 CFR 46.108(b) requires a majority of members, including at least one nonscientist, to constitute a quorum for IRB review.

A subject enrolled in a long-term study becomes decisionally incapacitated due to a stroke. The study PI wants to continue collecting data. The most appropriate next step is:

Answer: Seek consent from the subject's legally authorized representative (LAR) and assess whether the subject's previously expressed wishes should guide continued participation

When a subject loses capacity, the investigator must seek LAR consent and consider the subject's prior expressed wishes regarding continued participation.

FDA regulations at 21 CFR 50.25 differ from the Common Rule primarily in that FDA requires an additional consent element disclosing:

Answer: That the FDA may inspect records and that, in certain circumstances, confidentiality cannot be guaranteed

21 CFR 50.25(a)(5) requires a statement that the FDA may inspect study records, a disclosure not explicitly required by the Common Rule.

Under the Belmont Report, the principle of 'justice' in the context of subject selection requires that:

Answer: The burdens and benefits of research be distributed equitably across social, racial, and economic groups

The Belmont principle of justice requires fair distribution of research burdens and benefits, preventing exploitation of vulnerable groups while not excluding them from beneficial research.

A sponsor's protocol specifies a particular ICF template. The local IRB modifies the template significantly. According to GCP guidelines, the PI should:

Answer: Use the IRB-approved version and notify the sponsor, because the IRB-approved form takes precedence at the local site

The IRB-approved consent form governs at the local site; the PI must use it and inform the sponsor, who may need to update their master template.

Which of the following scenarios requires a full-board IRB review rather than expedited review?

Answer: A Phase I first-in-human drug trial involving intravenous administration to healthy volunteers

First-in-human drug trials with intravenous administration exceed minimal risk and cannot qualify for any expedited review category, requiring full-board review.

A subject requests a copy of their signed informed consent form. Under GCP and standard research ethics, the investigator should:

Answer: Provide a copy of the signed consent form to the subject, as this is a right guaranteed by ICH E6(R2)

ICH E6(R2) Section 4.8.11 explicitly states that subjects should be given a copy of the signed and dated consent form.