SOCRA The Informed Consent Process 3

Question 1

Which condition must be met for an IRB to approve a waiver of informed consent for research under 45 CFR 46.116(f)?

Accepted Answer

The research could not practicably be carried out without the waiver

Answer

The research must involve only healthy volunteers

Answer

The sponsor must request the waiver in writing

Answer

The study must be double-blinded

Question 2

What is 'therapeutic misconception' in the context of informed consent?

Accepted Answer

When subjects confuse research participation with receiving individualized medical care

Answer

When subjects believe placebos will cure their disease

Answer

When investigators withhold treatment information

Answer

When sponsors misrepresent study benefits in advertising

Question 3

Under FDA regulations, how long must signed informed consent documents be retained?

Accepted Answer

At least 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued

Answer

2 years after the study ends

Answer

3 years after completion of the study

Answer

5 years after the last subject's last visit

Question 4

A CRC discovers that an enrolled subject did not fully understand the risks when signing consent. What is the most appropriate immediate action?

Accepted Answer

Re-consent the subject with a thorough explanation of all risks before any further study procedures

Answer

Withdraw the subject from the study immediately

Answer

Notify the sponsor and await instructions

Answer

Document the finding and continue study procedures

Question 5

Which of the following is an example of undue influence in the consent process?

Accepted Answer

A physician-investigator implying poorer care will result if the patient refuses to enroll

Answer

Providing a subject with a bus pass to cover travel costs

Answer

Offering fair market value compensation for study participation

Answer

Explaining all risks clearly in simple language

Question 6

In emergency research under 21 CFR 50.24, what must occur within how many days after enrollment without consent?

Accepted Answer

The subject or LAR must be asked for consent as soon as feasible

Answer

The subject or LAR must be informed within 5 business days

Answer

The IRB must be notified within 3 working days

Answer

The community must be notified within 30 days of study closure

Question 7

When must an investigator obtain re-consent from a study subject?

Accepted Answer

When there is a protocol amendment that materially affects subject risk or willingness to participate

Answer

Only when the study sponsor requests it

Answer

Re-consent is never required once initial consent is obtained

Answer

Only when the IRB conducts a continuing review