SOCRA Ethical Principles in Research 3 — Questions and Answers
Question 1: Under Subpart B of 45 CFR 46, research involving pregnant women must satisfy which condition to be permitted?
- The fetus must not be the direct subject of research
- The risk to the fetus must be minimized and the research holds prospect of benefit to mother, fetus, or both (Correct answer)
- Only female investigators may conduct the study
- Consent from the father is always required
Correct answer: The risk to the fetus must be minimized and the research holds prospect of benefit to mother, fetus, or both
Subpart B requires that fetal risk be minimized and that the research offer the prospect of direct benefit to the pregnant woman and/or fetus, or contribute important knowledge.
Question 2: When research involves prisoners as subjects, Subpart C of 45 CFR 46 requires that the proportion of prisoner subjects must be:
- At least 50% to ensure representation
- Representative of the broader prisoner population
- No more than minimal unless the research has direct benefit to prisoners as a class (Correct answer)
- Approved solely by the facility warden
Correct answer: No more than minimal unless the research has direct benefit to prisoners as a class
Subpart C generally restricts research with prisoners to categories that offer direct benefit or study conditions particularly affecting prisoners, to prevent exploitation.
Question 3: For research involving children, parental permission and child assent are required. Under what circumstance may the IRB waive the requirement for child assent?
- When the child is under 7 years of age in all cases
- When the research offers the prospect of direct benefit important to the child's health or well-being (Correct answer)
- When the sponsor requests a waiver in writing
- When the study is observational and poses no risk
Correct answer: When the research offers the prospect of direct benefit important to the child's health or well-being
The IRB may waive assent when the capability of some or all children is limited, or when the research offers direct benefit not obtainable outside the research context.
Question 4: Which of the following is considered a 'vulnerable population' requiring additional protections in research?
- Healthy adult volunteers aged 25-40
- Economically disadvantaged individuals who may be unduly influenced by payment (Correct answer)
- Faculty members at research universities
- Participants in a fitness study
Correct answer: Economically disadvantaged individuals who may be unduly influenced by payment
Economically disadvantaged individuals may be vulnerable to undue influence from financial incentives, requiring additional safeguards in research participation.
Question 5: A participant with a cognitive impairment is enrolled in a study. Their legally authorized representative (LAR) has provided consent. The participant can express their wishes but cannot fully understand the study. The ethical approach is to:
- Proceed solely based on LAR consent without further participant involvement
- Obtain LAR consent and also seek the participant's assent whenever possible (Correct answer)
- Exclude the participant since they cannot provide full informed consent
- Allow only verbal consent from the participant without LAR involvement
Correct answer: Obtain LAR consent and also seek the participant's assent whenever possible
Best ethical practice requires seeking assent from participants with diminished capacity in addition to consent from their LAR, respecting their remaining autonomy.
Question 6: Regarding research with children defined under 45 CFR 46 Subpart D, which category of research is permitted without direct benefit to the child if it presents only a minor increase over minimal risk?
- Category I — minimal risk research
- Category II — greater than minimal risk with direct benefit
- Category III — minor increase over minimal risk with generalizable knowledge about the disorder (Correct answer)
- Category IV — any research approved by HHS Secretary
Correct answer: Category III — minor increase over minimal risk with generalizable knowledge about the disorder
Category III (§46.406) allows a minor increase over minimal risk without direct benefit if the research yields generalizable knowledge about the child's disorder or condition.
Question 7: An investigator plans to enroll students from their own university class in a study. What ethical concern does this primarily raise?
- Selection bias due to a homogeneous sample
- Undue influence or coercion due to the power differential between instructor and student (Correct answer)
- Insufficient sample size for statistical validity
- Lack of generalizability to broader populations
Correct answer: Undue influence or coercion due to the power differential between instructor and student
Enrolling one's own students raises concerns about coercion because the student-teacher power differential may compromise voluntariness of consent.
SOCRA Ethical Principles in Research 3
Under Subpart B of 45 CFR 46, research involving pregnant women must satisfy which condition to be permitted?