Henrietta Lacks Book Club
The Paradigm Shift in Medical Research
“The NIH concluded: “In the setting in which the patient is involved in an experimental effort, the judgment of the investigator is not sufficient as a basis for reaching a conclusion concerning the ethical and moral set of questions in that relationship.”
As a result of its investigation, the NIH said that to qualify for funding, all proposals for research on human subjects had to be approved by review boards—independent bodies made up of professionals and laypeople of diverse races, classes, and backgrounds—to ensure that they met the NIH’s ethics requirements, including detailed informed consent.
Predictions of Doom for Medical Progress
Scientists said medical research was doomed. In a letter to the editor of Science, one of them warned, “When we are prevented from attempting seemingly innocuous studies of cancer behaviour in humans ... we may mark 1966 as the year in which all medical progress ceased.”” – Page 101, The Immortal Life of Henrietta Lacks
Striking the Balance: Individual Rights vs Community Benefit
This excerpt resonates with me as it as recognises a decision which forever changed the direction of medical research. In declaring that Southam and Mandel acted unlawfully in their medical practice activities, the NIH’s ratio decidendi dictated that patient’s informed consent was a binding requirement in human-based experimentation. The ethical dilemma of ‘the rights of an individual vs benefit to community’ extends globally.
Henrietta’s Case: A Global Health Context
In the global health context, the case of Henrietta illustrated the immense benefits a seemingly innocuous sample has contributed to the furtherment of medical research worldwide. Henrietta’s case also illustrated the other side of the dilemma, her individual identity was stripped, her life was reduced to a cell line. Henrietta didn’t have anywhere near the level of informed consent that is required in the modern era with regards to human participation in clinical trials, human experimentation or tissue and cell sampling.
Impact on Medical Progress: Procedural Challenges
The letter to the editor of Science illustrated the prevailing attitude of scientists and medical professionals of the time, the breakthroughs which were only possible due to mass sampling without the rigmarole of the consent process had led to the discovery of the HeLa cell line and by instigating a number of procedural requirements to experiment on even one sample, the potential for medical research to make new discoveries was undeniably reduced significantly.
Informed Consent: Limitations and Ethical Implications
The introduction of mandatory informed consent also introduced greater limitations on medical progress. On an individual level, patients which are of potential significant interest to researchers are often those who are incompetent to provide consent due to the very limitations which are of interest. On a global scale, the introduction of global health policies and human rights considerations gives rise to difficulties in creating and enacting public health policies due to the power given to the individual.
A Perpetual Debate: Legal Necessity vs Ethical Responsibility
It is for this reason, there will likely be a perpetual discussion whether informed consent is a legal necessity or an ethical responsibility. Interestingly, in limiting the ability for researchers to make decisions which benefit ‘the greater good’ to the exclusion of an individual’s consent and rights, medical research has changed course and utilised global knowledge sharing and cooperation to make progress through greater specificity in the targeting of clinical trial candidates.
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