South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What must be provided to patients during clinical investigations as mandated by the Kefauver-Harris Amendment?

1. Informed consent

2. Financial support

3. Health insurance

4. Confidentiality agreements

The correct answer is: Informed consent

The requirement for informed consent during clinical investigations, as mandated by the Kefauver-Harris Amendment, is crucial because it ensures that patients are fully aware of the nature of the study, the procedures involved, potential risks, and their rights as participants. This amendment, which was enacted in response to concerns about drug safety and efficacy, emphasized the ethical obligation to prioritize patient autonomy and ensure that individuals are making informed decisions regarding their participation in research. Informed consent involves providing a clear explanation of the clinical trial, allowing individuals to ask questions, and ensuring that they understand this information before agreeing to participate. This process protects the welfare of participants and reinforces the integrity of clinical research, helping to foster trust between patients and researchers. While the other options might relate to healthcare and patient's rights in various contexts, they do not directly address the specific regulatory requirement outlined by the Kefauver-Harris Amendment regarding participation in clinical investigations. Providing financial support, health insurance, or confidentiality agreements may be considerations in clinical trials, but they do not fulfill the primary mandate of obtaining informed consent from patients.