CPI Informed Consent & Subject Rights Flashcards
6 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CPI Informed Consent & Subject Rights flashcards as text
Which document informs research subjects of their rights regarding the use and disclosure of their protected health information under HIPAA?
Answer: The HIPAA Authorization Form
The HIPAA Authorization Form specifically describes how a subject's protected health information may be used or disclosed for research purposes, satisfying Privacy Rule requirements.
Which federal office is responsible for overseeing human research protections, including informed consent compliance?
Answer: Office for Human Research Protections (OHRP)
OHRP oversees compliance with the Common Rule (45 CFR Part 46) and is the primary federal office responsible for protecting human research subjects.
Which of the following represents a violation of informed consent principles in a clinical trial?
Answer: Telling a subject their care will be affected if they do not enroll
Implying that a subject's medical care will be compromised if they refuse to enroll constitutes coercion, which directly violates the principle of voluntary participation.
What is the difference between 'consent' and 'HIPAA authorization' in clinical research?
Answer: Consent covers participation in research procedures; HIPAA authorization covers use and disclosure of health information
Informed consent addresses a subject's agreement to participate in research activities, while HIPAA authorization specifically permits the researcher to access, use, and disclose protected health information.
At what reading level should informed consent documents ideally be written, per FDA and OHRP guidance?
Answer: 8th grade or below
FDA and OHRP recommend consent documents be written at an 8th-grade reading level or below to ensure comprehension across diverse subject populations.
Which of the following is an 'additional element' of informed consent under 21 CFR 50.25(b) that must be included when applicable?
Answer: Statement that significant new findings will be disclosed to the subject
Disclosure of significant new findings discovered during the study that may affect willingness to continue is an additional element required under 21 CFR 50.25(b) when applicable.