SOCRA Ethical Principles in Research 3

Question 1

Under Subpart B of 45 CFR 46, research involving pregnant women must satisfy which condition to be permitted?

Accepted Answer

The risk to the fetus must be minimized and the research holds prospect of benefit to mother, fetus, or both

Answer

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:

Accepted Answer

No more than minimal unless the research has direct benefit to prisoners as a class

Answer

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?

Accepted Answer

When the research offers the prospect of direct benefit important to the child's health or well-being

Answer

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?

Accepted Answer

Economically disadvantaged individuals who may be unduly influenced by payment

Answer

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:

Accepted Answer

Obtain LAR consent and also seek the participant's assent whenever possible

Answer

Best ethical practice requires seeking assent from participants with diminished capacity in addition to consent from their LAR, respecting their remaining autonomy.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Ethical Principles in Research 3