SOCRA Institutional Review Board (IRB) 3 — Questions and Answers
Question 1: For research involving children that poses greater than minimal risk and offers no direct benefit, which regulatory criterion must be met?
- The research must have a prospect of direct benefit
- The risk must represent only a minor increase over minimal risk and yield generalizable knowledge about the disorder (Correct answer)
- Parental permission alone is sufficient
- The research must be approved by OHRP directly
Correct answer: The risk must represent only a minor increase over minimal risk and yield generalizable knowledge about the disorder
Under 45 CFR 46.406, research with children involving more than minimal risk and no direct benefit must present only a minor increase over minimal risk and offer generalizable knowledge about the subjects' disorder or condition.
Question 2: What is the key distinction between 'assent' and 'consent' in pediatric research?
- Assent is given by parents; consent is given by children
- Assent is the child's affirmative agreement; consent is the legally valid permission from parents or guardians (Correct answer)
- Assent and consent are interchangeable terms in research
- Consent applies only to adults; assent is required for all participants
Correct answer: Assent is the child's affirmative agreement; consent is the legally valid permission from parents or guardians
Assent refers to a child's affirmative agreement to participate, while parental or guardian consent provides the legally authorized permission.
Question 3: Which federal subpart specifically provides additional protections for prisoners as research subjects?
- 45 CFR 46 Subpart A (The Common Rule)
- 45 CFR 46 Subpart B
- 45 CFR 46 Subpart C (Correct answer)
- 45 CFR 46 Subpart D
Correct answer: 45 CFR 46 Subpart C
45 CFR 46 Subpart C specifically addresses additional protections for prisoners involved as research subjects.
Question 4: Which of the following is a required safeguard when prisoners are enrolled in research?
- All prisoner research must receive OHRP approval before the IRB reviews it
- At least one IRB member must be a prisoner or prisoner representative (Correct answer)
- The warden must co-sign the consent form
- Prisoners must make up the majority of IRB membership
Correct answer: At least one IRB member must be a prisoner or prisoner representative
45 CFR 46 Subpart C requires that a majority of the IRB members involved in reviewing prisoner research have no association with the prison, and at least one member must be a prisoner or prisoner representative.
Question 5: When may an IRB waive the requirement to obtain parental permission for research involving children?
- Never — parental permission is always required
- When the research involves no more than minimal risk and the waiver would not adversely affect subjects' rights (Correct answer)
- When the study sponsor requests a waiver
- When the children are over 10 years old
Correct answer: When the research involves no more than minimal risk and the waiver would not adversely affect subjects' rights
The IRB may waive parental permission when the research involves no more than minimal risk and the waiver would not adversely affect the rights and welfare of subjects.
Question 6: What additional protection does 45 CFR 46 Subpart B require for research involving pregnant women?
- Pregnant women may never be enrolled in research with any risk
- Research must offer prospect of direct benefit to the woman, fetus, or both, or present only minimal risk (Correct answer)
- Husband or partner must co-sign the consent form
- Only female IRB members may vote on the protocol
Correct answer: Research must offer prospect of direct benefit to the woman, fetus, or both, or present only minimal risk
Subpart B allows research involving pregnant women when it offers the prospect of direct benefit or the risk to the fetus is no greater than minimal, among other conditions.
Question 7: When a cognitively impaired adult lacks capacity to consent, what is the appropriate procedure?
- The researcher may proceed without consent if the study is important
- A legally authorized representative (LAR) provides consent on the subject's behalf (Correct answer)
- The IRB chair provides consent
- The physician of record automatically consents on behalf of the patient
Correct answer: A legally authorized representative (LAR) provides consent on the subject's behalf
When a prospective subject lacks decision-making capacity, a legally authorized representative (LAR) must provide consent in accordance with applicable law.
SOCRA Institutional Review Board (IRB) 3
For research involving children that poses greater than minimal risk and offers no direct benefit, which regulatory criterion must be met?