SOCRA The Informed Consent Process 5

Question 1

A sponsor wants to use a subject's biological specimens collected during a trial for future unspecified research. What must the informed consent include?

Accepted Answer

A specific statement about whether specimens may be used for future research and whether subjects will be asked again for consent

Answer

Only the principal investigator's contact information

Answer

Assurance that specimens will be destroyed after the trial

Answer

Only the study's primary endpoint information

Question 2

Under the HIPAA Privacy Rule, what authorization is typically required alongside informed consent in federally regulated research?

Accepted Answer

A HIPAA Authorization for use and disclosure of Protected Health Information (PHI) for research purposes

Answer

A Business Associate Agreement signed by the subject

Answer

A blanket HIPAA waiver from the sponsor

Answer

No additional authorization is needed if consent is obtained

Question 3

Which of the following best describes the role of a 'witness' to the informed consent process under FDA regulations?

Accepted Answer

The witness attests that the consent was explained to the subject and that the subject appeared to understand and voluntarily agreed

Answer

The witness makes the consent decision for the subject

Answer

The witness must be a licensed physician

Answer

The witness reviews the consent form for scientific accuracy

Question 4

When pregnant women are enrolled in research under 45 CFR 46 Subpart B, whose consent is generally required?

Accepted Answer

Consent of the pregnant woman alone is sufficient

Answer

Consent of both the pregnant woman and the father is always required

Answer

Only the IRB's approval is needed

Answer

The LAR of the unborn child must consent

Question 5

What is the significance of 45 CFR 46.116(c) 'broad consent' provision added in the 2018 Common Rule revisions?

Accepted Answer

It permits prospective consent for future, unspecified research use of stored identifiable biospecimens and data

Answer

It allows any researcher to use any subject's data without consent

Answer

It eliminates the need for IRB review of secondary research

Answer

It applies only to FDA-regulated studies

Question 6

A subject who signed consent 3 months ago now asks for a copy of their consent form. What must the investigator do?

Accepted Answer

Provide the subject with a copy; subjects are entitled to a copy of the signed consent document

Answer

Decline because the consent was already signed

Answer

Refer the subject to the sponsor for a copy

Answer

Only provide a copy if the IRB approves the request

Question 7

Under FDA regulations, which of the following is NOT one of the eight required basic elements of informed consent per 21 CFR 50.25(a)?

Accepted Answer

The name and contact information of the study sponsor's CEO

Answer

A statement that participation is voluntary and refusal will involve no penalty

Answer

A description of reasonably foreseeable risks or discomforts

Answer

An explanation of the purposes of the research and the expected duration of participation