21CFR50 – §50.20 Scope ​

Question 1

21CFR50 – §50.20 Scope

Answer 1

Code of federal regulations governing protection of human subjects in clinical trials ​

Applies to all clinical investigations regulated by the FDA

Question 2

The IRB is must maintain records for at least X years after the completion of a clinical investigation involving emergency research exceptions

Answer 2

3

Question 3

who signs the short form?

Answer 3

signed by witness and subject

Question 4

who signs the summary?

Answer 4

witness, person obtaining consent signature

Question 5

21 CFR 56

Answer 5

Institutional Review Boards

Question 6

What is the definition of a “legally authorized representative” according to FDA informed consent regulations?

Answer 6

An individual, judicial body, or other group authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in research procedures

Question 7

If an investigator employs the exception from general requirements process for obtaining consent, within how many days must a full report of the circumstances be reported to the IRB?

Answer 7

Within 5 working days after the use of the test article

Question 8

When a conflict arises between the IRB approved informed consent and local laws, the informed consent takes precedence.

Answer 8

False

Question 9

If the consent form is read to the subject, and all questions are answered, no other activities are required to take place before the subject, or subject’s representative signs the consent form.

Answer 9

False, 21 CFR 50.27(a)(1) states: ​

A written consent document that embodies the elements of informed consent required by §50.25. This form may be read to the subject or the subject’s legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.

Question 10

Which signatures are required by FDA regulation to be on a full consent form?

Answer 10

The subject

Question 11

IRBs must ensure special criteria are met prior to approving emergency research that will allow subject entry without first obtaining ICF.

Answer 11

True

Question 12

The IRB must pay particular attention to ensure additional safeguards are taken for vulnerable subjects in federally supported research. Which of these groups are considered vulnerable?

Answer 12

Children, prisoners, pregnant women, mentally disabled persons, Economically or educationally disadvantaged persons

Question 13

In order to have expedited review, must meet either of the following requirements:

Answer 13

no more than minimal risk, minor changes in previously approved research during a period of 1 year (or less)