Research Ethics & Compliance Flashcards

Which scenario constitutes an appropriate use of the expedited IRB review category?

Answer: Collection of blood samples from healthy adults within specified volume limits

Expedited review is appropriate for minimal-risk research such as routine blood draws within federally defined volume and frequency limits.

A subject in a randomized controlled trial asks to know which arm they are in. The study is blinded. What should the PI do?

Answer: Follow the unblinding procedures specified in the IRB-approved protocol

Unblinding must follow the IRB-approved protocol, which typically includes criteria such as medical necessity or participant withdrawal.

What is 'respect for persons' as defined in the Belmont Report primarily concerned with?

Answer: Treating individuals as autonomous agents and protecting those with diminished autonomy

Respect for persons encompasses both acknowledgment of individual autonomy and protection of those with diminished capacity to make decisions.

An investigator receives payment from a pharmaceutical company for speaking engagements unrelated to any research. When must this be disclosed under PHS conflict of interest rules?

Answer: When it meets the threshold of a significant financial interest ($5,000 or more) related to institutional responsibilities

PHS regulations require disclosure of significant financial interests of $5,000 or more from an entity whose financial interests could be affected by the research.

Under the FDA's regulations for clinical investigations, what is the maximum time frame for an investigator to report a death possibly related to the investigational product?

Answer: 7 calendar days to the sponsor

Under 21 CFR 312.64(b), investigators must report deaths that may be related to the investigational drug to the sponsor within 7 calendar days.

A researcher proposes using existing biospecimens collected for clinical care, with all identifiers removed by a third party who provides no key. Under the Common Rule, this research is:

Answer: Not considered research involving human subjects because specimens are de-identified with no link

When biospecimens are de-identified with no way to re-identify them, the research does not involve human subjects under the Common Rule's definition.

Which of the following represents a legitimate reason for an IRB to grant a waiver of informed consent under 45 CFR 46.116(f)?

Answer: The research could not practicably be carried out without the waiver and involves no more than minimal risk

An IRB may waive consent when research presents no more than minimal risk, the waiver won't adversely affect rights, and it would be impracticable to conduct the study with consent.