SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates The Informed Consent Process 1

Question 1

Under 21 CFR 50.25, which type of language is explicitly PROHIBITED from appearing in an informed consent document?

Accepted Answer

Exculpatory language that waives or appears to waive the subject's legal rights

Answer

21 CFR 50.25 explicitly prohibits exculpatory language — wording that causes the subject to waive or appear to waive any legal rights, or that releases the investigator, sponsor, or institution from liability for negligence. Such language undermines the protective purpose of the consent process.

Question 2

When a child is capable of understanding the nature of a research study but has not yet reached the age of majority, what must occur IN ADDITION to obtaining parental or guardian permission?

Accepted Answer

The child's assent must be obtained

Answer

When children are capable of understanding, their assent — their affirmative agreement to participate — must be obtained in addition to parental or guardian permission. The IRB determines the appropriate assent process based on the child's age, maturity, and psychological state.

Question 3

When a prospective research subject lacks decision-making capacity, who is authorized to provide consent on their behalf?

Accepted Answer

A legally authorized representative (LAR)

Answer

A legally authorized representative (LAR) is an individual or body authorized under applicable law to consent on behalf of a prospective subject who cannot consent for themselves. The LAR's authority is defined by state or local law, not simply by family relationship.

Question 4

Under what conditions may an IRB waive the requirement to obtain informed consent from research subjects?

Accepted Answer

When the research involves no greater than minimal risk and the waiver will not adversely affect subjects' rights and welfare

Answer

Under 45 CFR 46.116(f), an IRB may waive or alter consent requirements when: the research poses no greater than minimal risk, the waiver will not adversely affect subjects' rights and welfare, the research could not practicably be carried out without the waiver, and subjects will be debriefed where appropriate.

Question 5

When a 'short form' written consent document is used for a subject who does not speak English, which additional procedural requirement must be met?

Accepted Answer

A witness must be present and sign both the short form and the IRB-approved written summary

Answer

When a short form is used, the IRB-approved consent summary must be presented orally in the subject's language. A witness — fluent in both languages — must be present throughout, and must sign both the short form and the written summary. The subject or LAR signs only the short form.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates The Informed Consent Process 1