The third ethical concern in the Jessie Gelsinger case concerned its lack of safety. In the aftermath of Jesse’s death, it was found that the University and Wilson did not disclose of other adverse reactions to patients already in the clinical trial to Jesse or the FDA (R. Wilson, 2010). It also did not advise the National Institutes of Health’s Recombinant DNA Advisory Committee (RAC) about changes to study design, like the change in route of administration of the adenovirus (R. Wilson, 2010). In addition, it was not safe because the selection of trial subjects was not ethical as the trial’s aim was to help infants with the disorder, yet it enrolled asymptomatic adult who had everything to lose and nothing to gain (J. Wilson, 2009). Furthermore,
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Informed consent is a necessary process that it is supposed to protect the participant, not the research. During the process, the patient is informed of all aspects of the trial, informed of their rights, the purpose of the study and all of its procedures, potential risks and benefits, and length of study (Nijhawan, 2013). Consent can only be voluntarily given if the participant is given full information and understands the documents and the explanations regarding the trials and furthermore does not receive any other encouragement or reinsurances that the trial will end with a positive result. In Jesse’s case, exactly the opposite happened. He was never fully informed of all aspects of the trial that would have allowed him to give his informed consent. Had the true relationship of the financial involvement of the parties involved, the deaths of animals in pre-clinical trials been disclosed, the regulatory agencies been informed of all the changes to the study protocol to include them on the consent form, the study protocol followed without error, and the level of uncertainty in gene therapy and the study design been communicated to Jesse and his family; the reality would be that he never would have participated in the trial and would still be alive today. Unfortunately, the lack of attention to these details has caused huge public and regulatory …show more content…
In addition to the US Department of Justice imposing fines and sanctions on the University, Dr. Wilson, his colleagues, and their research; shortly after Jesse’s death the FDA and the NIH formed two new programs: The Gene Therapy Clinical Trial Monitoring Plan and the Gene Transfer Safety Symposia designed to increase patient protection (Sibbald, 2001). The Gene Therapy Clinical Trial Monitoring Plan requires all disclosures, financial and pre-clinical, before a trial can even begin while the Gene Transfer Safety Symposia allows researchers to gather together to share data and clinical experience, while focusing on adverse events (Sibbald, 2001). In addition, the FDA has made policies forbidding researchers and their team who are directly involved in patient selection, informed consent, or clinical management from holding equity, stock, or other benefits from sponsoring companies and through their Center for Biologics Evaluation and Research (CBER), have increased the surveillance of gene therapy clinical investigators and their studies in recognition of the potential dangers of gene therapy study (Sibbald, 2001; US Food and Drug Administration, n.d.). Lessons from Jesse’s death continue to spill over to other research areas, particularly the more recent CRISPR gene-editing
Informed consent is a necessary process that it is supposed to protect the participant, not the research. During the process, the patient is informed of all aspects of the trial, informed of their rights, the purpose of the study and all of its procedures, potential risks and benefits, and length of study (Nijhawan, 2013). Consent can only be voluntarily given if the participant is given full information and understands the documents and the explanations regarding the trials and furthermore does not receive any other encouragement or reinsurances that the trial will end with a positive result. In Jesse’s case, exactly the opposite happened. He was never fully informed of all aspects of the trial that would have allowed him to give his informed consent. Had the true relationship of the financial involvement of the parties involved, the deaths of animals in pre-clinical trials been disclosed, the regulatory agencies been informed of all the changes to the study protocol to include them on the consent form, the study protocol followed without error, and the level of uncertainty in gene therapy and the study design been communicated to Jesse and his family; the reality would be that he never would have participated in the trial and would still be alive today. Unfortunately, the lack of attention to these details has caused huge public and regulatory …show more content…
In addition to the US Department of Justice imposing fines and sanctions on the University, Dr. Wilson, his colleagues, and their research; shortly after Jesse’s death the FDA and the NIH formed two new programs: The Gene Therapy Clinical Trial Monitoring Plan and the Gene Transfer Safety Symposia designed to increase patient protection (Sibbald, 2001). The Gene Therapy Clinical Trial Monitoring Plan requires all disclosures, financial and pre-clinical, before a trial can even begin while the Gene Transfer Safety Symposia allows researchers to gather together to share data and clinical experience, while focusing on adverse events (Sibbald, 2001). In addition, the FDA has made policies forbidding researchers and their team who are directly involved in patient selection, informed consent, or clinical management from holding equity, stock, or other benefits from sponsoring companies and through their Center for Biologics Evaluation and Research (CBER), have increased the surveillance of gene therapy clinical investigators and their studies in recognition of the potential dangers of gene therapy study (Sibbald, 2001; US Food and Drug Administration, n.d.). Lessons from Jesse’s death continue to spill over to other research areas, particularly the more recent CRISPR gene-editing