Certification for IRB Professionals (CIP) Practice Exam

Which scenario exemplifies economic vulnerability among research subjects?

1. A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it.

2. A subject agreeing to participate due to extensive knowledge of the treatment process

3. A subject who is motivated by altruism to promote science

4. A subject who has a strong support system for making study decisions

The correct answer is: A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it.

Economic vulnerability among research subjects refers to situations where an individual's financial circumstances significantly impact their decisions regarding participation in research. The scenario where a subject participates in a drug study because treatment is available at no or reduced cost exemplifies this concept effectively, as it highlights how the subject’s financial limitations lead him to pursue participation in research as a means to access necessary medical treatment that he would otherwise be unable to afford. This scenario illustrates the ethical considerations of research recruitment, especially regarding the potential for coercion or undue influence, as financial need can significantly impact an individual's ability to make autonomous decisions about participating in research. When treatment is contingent on participation, it raises concerns about whether subjects are fully consenting or simply acting out of necessity. This understanding of economic vulnerability is essential for Institutional Review Boards (IRBs) to ensure that research is conducted ethically, especially for populations that may be disadvantaged economically. Other scenarios do not reflect economic vulnerability as clearly. Knowledge about the treatment process, motivations rooted in altruism, or strong support systems don't indicate a subject's financial situation influencing their participation. Hence, the correct choice emphasizes how economic factors directly affect an individual's decisions regarding their health and well-being in the context of research participation.