Difference between revisions of "Resource:6db91721-501b-4ec2-aff7-a2c732c4806f"
From The Embassy of Good Science
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|Resource Type=Cases | |Resource Type=Cases | ||
|Title=Jesse's Intent | |Title=Jesse's Intent | ||
| − | |Is About=This is a | + | |Is About=This factual case describes the story of a teenage boy who died during a clinical trial in which a gene therapy for a rare metabolic disorder was tested. The story is told in great detail from the perspective of the father of the boy. After the death of his son, the father discovered that the researchers leading the trial had conflicts of interest and that he and his son were not properly informed of the risks of the trial. |
| − | |Important For=Researchers | + | |Important Because=Participants of clinical trials must be well informed of the risks they are taking by participating in the trial, especially when the investigated treatment is a non-therapeutic intervention. The benefits should outweigh the risks in the case of such a non-therapeutic intervention, which was not true in the tragedy described here: adverse effects were reported in previous cases, whilst no efficacy of the gene therapy was observed in humans. As noted in the article, the trial most likely progressed regardless of these risks due to the conflicts of interests of the trial’s principal investigator and faults by the responsible regulatory institutions. Therefore, this case is a prime example of how conflicts of interest may seriously harm the health of patients and trial participants. To prevent unnecessary deaths as detailed here in the future, it is important to keep these stories in the collective memory and draw lessons from them. The detailed account presented here may just do that. |
| + | |Important For=Researchers; Academic institutions; All stakeholders in research; Research Ethics Committees; Clinical researchers | ||
}} | }} | ||
{{Link | {{Link | ||
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}} | }} | ||
{{Related To | {{Related To | ||
| − | |Related To Theme=Theme:88b73549-fec0-4fb9-99f6-fe1055d6b76a | + | |Related To Theme=Theme:88b73549-fec0-4fb9-99f6-fe1055d6b76a;Theme:0d054575-ca21-4209-b7c5-6120fc0ed647;Theme:6d71bd59-c3bc-4cd5-9c9f-1ab4e53fc320 |
}} | }} | ||
{{Tags | {{Tags | ||
|Has Timepoint=1998 - 1999 | |Has Timepoint=1998 - 1999 | ||
|Has Location=USA; United States | |Has Location=USA; United States | ||
| − | |Has Virtue And Value=Respect | + | |Has Virtue And Value=Respect; Autonomy; Accountability; Care; Honesty; Openness; Transparency; Objectivity |
| − | |Has Good Practice And Misconduct=Patient safety | + | |Has Good Practice And Misconduct=Patient safety; Informed consent; Deception |
|Related To Research Area=Clinical medicine | |Related To Research Area=Clinical medicine | ||
}} | }} | ||
Revision as of 15:54, 11 August 2021
ResourcesCases
Jesse's Intent
What is this about?
This factual case describes the story of a teenage boy who died during a clinical trial in which a gene therapy for a rare metabolic disorder was tested. The story is told in great detail from the perspective of the father of the boy. After the death of his son, the father discovered that the researchers leading the trial had conflicts of interest and that he and his son were not properly informed of the risks of the trial.
Why is this important?
Participants of clinical trials must be well informed of the risks they are taking by participating in the trial, especially when the investigated treatment is a non-therapeutic intervention. The benefits should outweigh the risks in the case of such a non-therapeutic intervention, which was not true in the tragedy described here: adverse effects were reported in previous cases, whilst no efficacy of the gene therapy was observed in humans. As noted in the article, the trial most likely progressed regardless of these risks due to the conflicts of interests of the trial’s principal investigator and faults by the responsible regulatory institutions. Therefore, this case is a prime example of how conflicts of interest may seriously harm the health of patients and trial participants. To prevent unnecessary deaths as detailed here in the future, it is important to keep these stories in the collective memory and draw lessons from them. The detailed account presented here may just do that.
For whom is this important?
ResearchersAcademic institutionsAll stakeholders in researchResearch Ethics CommitteesClinical researchers
