Truly Informed Consent: The Balance of Patient & Science
This post expands upon the article found here https://www.bbc.com/news/health-68831061
A recent BBC article examines the medical trials conducted on children in the UK during the 1970s and 80s, involving the use of infected blood products. These trials, conducted without proper consent from families, were aimed at researching the effectiveness of new treatments for blood clotting disorders, and conducted by doctors who prioritized research goals over patient safety. As a result, many children were infected with life-threatening viruses such as hepatitis C and HIV.
It illustrates more than the need for informed consent and patient assent. It begs the question of innovation 'at what cost?' It is evident that the scientists involved in these studies were aware of the high risks to which they were exposing the children, with seemingly very little reward beyond testing new therapeutic options and advancing their own careers. Tying career advancement with innovation is not a novel endeavor, nor a presently uncommon one, but when it supersedes safeguards of patient autonomy, respect, and beneficence, it can have devastating consequences.
Research staff and administrators often find regulatory compliance challenging, but regulations are the safeguards that ensure patient safety, particularly in high-risk clinical trials. Study forms in such trials must clearly state and explain the benefits to the community from the high risk and how study subjects will be monitored and cared for to minimize their burden and potential harm. Consent forms for these trials must also clearly state the risk for harm without potential benefit to the study subjects, to allow truly informed consent for participating in high-risk trials. Clinical research should never be about ‘science for the sake of science’ nor ‘results over all else’. There are ethical safeguards to ensure that any high-risk intervention carries high reward for the patient. In the case of the trials described in this article, there was no clear benefit to the children involved, and there were no documented safeguards. In the case of the patient with mild hemophilia, the patient had no benefit at all. His medical history was a benefit to the study design for blood sampling, as he had never received any prior infusions of clotting factor.
These are the cases that illustrate the need for a true process of informed consent that:
Outline risks and benefits, even if the benefits are for future patients.
Enable a person to volunteer wholly and without duress with a complete understanding of the study procedures.
In the cases of protected populations, for example children, the caregivers should make the decision with a clear view of what the research entails for the child, and if the child is of age for assent (usually between six and eight years of age), the child should be given clear information to be able to freely choose whether they would like to participate.
Places predetermined safeguards for when a study should be stopped to ensure the safety and wellbeing of participants.
Patients grant research teams the privilege to be involved in their clinical care, often in very vulnerable moments, and research teams should reciprocate that trust with respect and care for the patient’s wellbeing as persons, not as research subjects.