CRP Informed Consent & Participant Rights Flashcards

Under HIPAA, what authorization is required before using protected health information (PHI) for research?

Answer: A signed HIPAA research authorization or an IRB waiver of authorization

HIPAA requires a research authorization from participants or a waiver granted by an IRB/Privacy Board before PHI may be used in research.

A participant calls a research team and states they want to withdraw from a study. What must the team do?

Answer: Honor the withdrawal immediately without penalty or loss of benefits

Participants have an unconditional right to withdraw at any time without penalty or loss of otherwise entitled benefits.

Which document outlines a participant's rights and who to contact with concerns in a federally funded study?

Answer: The informed consent form, which must include IRB or research contact information

The informed consent form must include contact information for questions about the study and participant rights, typically the IRB.

What is an 'e-consent' process?

Answer: Electronic delivery of consent materials using multimedia tools to obtain participant agreement

E-consent uses electronic platforms—including video, interactive modules, and digital signatures—to deliver and document the consent process.

When is a Certificate of Confidentiality most useful in protecting research participants?

Answer: When protecting identifiable research data from forced disclosure in legal proceedings

A Certificate of Confidentiality shields identifiable research data from compelled disclosure through court orders or other legal processes.

Which of the following best describes 'broad consent' as added by the 2018 Common Rule revision?

Answer: Consent for future unspecified research using stored biospecimens or data

Broad consent allows participants to agree in advance to future, unspecified research using their stored biospecimens or data.