Last month, the Proxima Book Club read The Immortal Life of Henrietta Lacks, which, as a regulatory and clinical research company, was particularly relevant.
If you’re unfamiliar with the case of Henrietta Lacks…her cancer cells were harvested without consent in 1951, and they have played a monumental role in scientific advancements since.
Her story underscores the significance of Good Clinical Practice (GCP), an ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects. These guidelines ensure that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible.
In 1951, there weren't clear rules and standards like we have today regarding informed consent for tissue collection and use. Today, if tissues are removed during a medical procedure, they could potentially be used for research purposes, provided they are anonymized and the patient has not explicitly objected. However, to use identifiable tissue samples(like HeLa) specifically for research, explicit informed consent would typically be required.
While the worls and many companies benefitted from HeLa cells over the years, Henrietta’s family did not. Last week, the family reached a confidential settlement with Thermo Fisher Scientific Inc, a company accused of unjustly enriching itself by commercializing Lacks' cells long after their origin became known. The resolution was reached after prolonged negotiations in a federal courthouse in Baltimore. Both parties expressed satisfaction with the outcome but declined to comment further.
#gcp #clinicalresearch #biology #medicine
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