SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates The Informed Consent Process 1 — Questions and Answers
Question 1: Under 21 CFR 50.25, which type of language is explicitly PROHIBITED from appearing in an informed consent document?
- Language describing the purpose and duration of the research
- Exculpatory language that waives or appears to waive the subject's legal rights (Correct answer)
- Language explaining that participation is voluntary and may be discontinued
- Language describing procedures for maintaining confidentiality
Correct answer: Exculpatory language that waives or appears to waive the subject's legal rights
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?
- A second parent must co-sign the permission form
- The child's assent must be obtained (Correct answer)
- The IRB must conduct a direct interview with the child
- A court order must authorize the child's participation
Correct answer: The child's assent must be obtained
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?
- The principal investigator, if the IRB grants approval
- The IRB chairperson in cases of emergency
- A legally authorized representative (LAR) (Correct answer)
- Any adult first-degree family member
Correct answer: A legally authorized representative (LAR)
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?
- When the sponsor provides written justification and assumes full liability
- When the research involves no greater than minimal risk and the waiver will not adversely affect subjects' rights and welfare (Correct answer)
- When all study data will be collected anonymously from public records only
- When the FDA grants a special exemption prior to study initiation
Correct answer: When the research involves no greater than minimal risk and the waiver will not adversely affect subjects' rights and welfare
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?
- The sponsor must approve the translated summary before any subject is enrolled
- A witness must be present and sign both the short form and the IRB-approved written summary (Correct answer)
- The IRB must be notified within 24 hours of each enrollment using this method
- The subject must waive their right to receive a copy of the consent document
Correct answer: A witness must be present and sign both the short form and the IRB-approved written summary
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.
Question 6: At what point in the research process must a subject's informed consent be obtained?
- Before the first dose of investigational product is administered
- Before any study-related procedures are performed, including screening procedures (Correct answer)
- Within 48 hours after the initial study visit is completed
- At the time of randomization into active or placebo arms
Correct answer: Before any study-related procedures are performed, including screening procedures
Informed consent must be obtained before any study-related procedures are performed — this includes screening activities such as blood draws or questionnaires conducted to determine eligibility. No research activity may begin until the subject has had adequate time to consider participation and has voluntarily signed the consent form.
SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates The Informed Consent Process 1
Under 21 CFR 50.25, which type of language is explicitly PROHIBITED from appearing in an informed consent document?