Which incident heightened public awareness regarding issues with the IRB system?

Which incident heightened public awareness regarding issues with the IRB system?

• A. Death of Jesse Gelsinger
• B. Establishment of the National Commission
• C. Publication of the Belmont Report
• D. Implementation of the Common Rule

Answer: (A)

The incident that heightened public awareness regarding issues with the Institutional Review Board (IRB) system is the death of Jesse Gelsinger. This case brought significant attention to ethical concerns in clinical research, particularly involving vulnerable populations. Gelsinger was an 18-year-old participant in a gene therapy trial at the University of Pennsylvania, which aimed to treat a rare genetic disorder. His tragic death due to an adverse reaction during the trial highlighted flaws in the informed consent process, ethical oversight, and the responsibilities of researchers to protect participants. Before this incident, many people may not have been fully aware of the complexities and potential risks involved in clinical trials. Gelsinger's case prompted widespread media coverage and public discourse, ultimately leading to increased scrutiny of IRB practices and the ethical standards governing human subjects research. As a consequence, it sparked reforms and a more rigorous examination of the IRB system to ensure the protection of research participants and improve regulatory oversight. The other options represent significant developments in research ethics—such as the establishment of the National Commission, the publication of the Belmont Report, and the implementation of the Common Rule—but they did not individually bring about the same level of heightened public awareness or controversy as Jesse Gelsinger's case did.

The incident that heightened public awareness regarding issues with the Institutional Review Board (IRB) system is the death of Jesse Gelsinger. This case brought significant attention to ethical concerns in clinical research, particularly involving vulnerable populations. Gelsinger was an 18-year-old participant in a gene therapy trial at the University of Pennsylvania, which aimed to treat a rare genetic disorder. His tragic death due to an adverse reaction during the trial highlighted flaws in the informed consent process, ethical oversight, and the responsibilities of researchers to protect participants.

Before this incident, many people may not have been fully aware of the complexities and potential risks involved in clinical trials. Gelsinger's case prompted widespread media coverage and public discourse, ultimately leading to increased scrutiny of IRB practices and the ethical standards governing human subjects research. As a consequence, it sparked reforms and a more rigorous examination of the IRB system to ensure the protection of research participants and improve regulatory oversight.

The other options represent significant developments in research ethics—such as the establishment of the National Commission, the publication of the Belmont Report, and the implementation of the Common Rule—but they did not individually bring about the same level of heightened public awareness or controversy as Jesse Gelsinger's case did.