Core Concepts and Principles Flashcards

Which group requires additional protections under Subpart D of 45 CFR 46?

Answer: Children

Subpart D provides additional protections for children involved as research subjects.

When a child participates in research, which combination is typically required?

Answer: Parental permission and the child's assent when appropriate

Minors cannot legally consent, so parental permission plus age-appropriate assent is generally required.

What is the main goal of a Phase I clinical trial?

Answer: Assess safety, tolerability, and dosing in a small group

Phase I trials focus on safety, dosage range, and pharmacokinetics, usually in a small number of participants.

Which is an example of a protocol deviation?

Answer: Performing a study visit outside the protocol-specified window

Any departure from the IRB-approved protocol, such as an out-of-window visit, is a deviation that must be documented.

Under HIPAA, which item is considered protected health information when linked to health data?

Answer: A participant's date of birth

Dates directly related to an individual, such as birth date, are among HIPAA's 18 identifiers.

What is the purpose of a Data and Safety Monitoring Board (DSMB)?

Answer: Independently review accumulating data to protect participant safety and study integrity

A DSMB is an independent group that periodically reviews safety and efficacy data and can recommend stopping or modifying a trial.

Which sampling method gives every member of the population an equal chance of selection?

Answer: Simple random sampling

Simple random sampling gives each population member an equal probability of being chosen.