Examining human rights gaps in biomedical research

Glasgow LLM student Arjan Singh looks at capacity, safeguards and abuses

Biomedical research is an area of law dampened by human rights abuses. While the protection of participants has certainly improved, clear breaches persist. I argue this is because the ethical standards that protect participants are unsatisfactory in their depth and scope. If these legal frameworks are understood as ethical standards first then we see this deficiency far clearer and the benefits to resolving them become transparent. This gives us an opportunity to bring society closer to Harris’s idealistic view that everyone has a duty to participate in research. As if patients are sufficiently protected then there is no sacrifice for the greater good, just the good itself, allowing this utopic view of biomedical research and law to be compatible.

When evaluating this, I will adopt a descriptive approach, drawing on a variety of legal safeguards, case law and scientific case studies to examine this intersection between law, science and ethics more carefully. This helps aid our understanding that these failures are human rights failures.

A brief history of the laws and flaws of biomedical research

Biomedical research is an essential function of health and social care. It is because of this that the protection of human participants in research is paramount through the scientific advancement it consistently brings. Legal regulation of this was first incepted by the Nuremberg Code in 1947 but its importance was not established until the medical whistleblowers Beecher and Pappworth wrote a set of articles outlining unethical research. Though highly controversial their impact underscored the importance of greater legal-ethical standards when conducting biomedical research. Currently, these standards of protection are governed by the Mental Capacity Act and the Medicines for Human Use (Clinical Trials) Regulations, both of which only outline the parameters of protection. These two statutes along with customary law, like the Declaration of Helsinki and ethical committees such as the Health Research Authority portray a visibly sporadic, and unfinished area of law that I note is easily misinterpreted and misunderstood. This is why it is so easy for these laws to overlook human rights in their pursuit of scientific advancement.

The case law of capacity and competency

In English law, competency and capacity are seen to intertwine, as a competent person is a person with capacity, and capacity is the ability to make decisions, and understand information. This is in accordance with the case of Re MB, which upheld this ‘decision-based’ view of capacity. In practice this means that all children are assumed incompetent, with assessments that conclude otherwise an exception, seen in the Gillick case. Likewise all adults are assumed competent with the withdrawal of competency upon impairment or disturbance, also an exception as discussed in the Re C case. These precedents, despite their relevance to medical law, are blindly transcribed to biomedical research and do not undertake the necessary developments to tailor these ethics accordingly.

The vagueness of ‘capacity’

In summarising the shared precedents of these cases there is a key flaw in these standards in the definition of capacity. By defining it as the ability to make a decision this wording significantly undermines the clarity required to protect participants and determine if they are competent. Phrasing it as this without any further detail or specificity is an ambiguous and subjective benchmark for determining capacity. This is because it does not specify what decisions constitute, what ability means, and the degree of flexibility this offers, making it easy for clinicians who are not qualified to interpret law to misinterpret it. There are a host of issues that stem from this. At best this overlooks vast swaths of people in the suitability assessments for research. A conclusion drawn in the case of Montgomery v Lanarkshire where those with varying levels of health literacy agreed to trials without fully grasping the implications of them. At worst it is deliberately exploited by those brazen enough to take advantage of vulnerable individuals in the pursuit of scientific advancement. The crimes and punishments of the Japanese Unit 731 and the German Nazi experiments that occurred during World War Two is proof that this is a serious possibility. Especially as we witness similar weaknesses in health literacy in the victims of these war crimes.

Secondly, the ambiguous and confusing nature of these competency standards suggests it is improbable for a clinician to accurately identify a competent person, not only because they are not trained in legal competency, but also because these standards are fraught with uncertainty. This assessment was proven in the Re F case, where clinicians proceeded to sterilise a patient based on their best interests as they were classed as vulnerable. Yet because of the patients subsequent discontent at this, we know their competency was not accurately determined as a result. This is a serious negligence that can easily be repeated in biomedical research as if this was a clinical trial, greater misinterpretations can occur with greater consequences in larger studies. While there was legal discussion on remedies, no radical reforms were implemented to seal this gap.

Loose safeguards and human rights abuses

With this foundation we know the impacts of such loose standards is human rights abuses because they open the floodgates for vulnerable persons, such as children, to be harmed. Injury to participants is exactly what these standards should be aiming to prevent, and the very existence of abuses committed by law is indicative of their inadequacy. For example the MK-Ultra trials, where the supreme court criticised the enforcement of the Nuremberg Code because it allowed children to be drugged, hypnotised and abused to discover new methods of treatment for psychological trauma.

Despite the clear ethical violations because all children were deemed to have understood the nature of the drugs being administered, through the loose competency standards where the absence of the more stringent Nuremberg Code was justified. It is self-evident that children cannot be reasonably expected to understand the effects any drug can have because of the explicit and complex nature of them. Thus the opportunity for more information should have been offered as it has been before. This accentuates what these competency standards continue to lack today. Such impacts are forgotten when cases such as Re MB are given credence in their assessment of capacity, despite the subjectivity they promote.

What consent is missing

These inadequacies persist when we look at the use of consent also. Currently, consent is defined as the informed decision that allows a patient to be adequately informed of any and all information relevant to the research at hand. Only once this is achieved can a participant perform informed consent in accordance with the GCP guidelines. This is supported by Montgomery v Lankashire which established the nature of consent as informed, individualised, and patient centred. Just as with capacity and competency, this rather simplistic and general framework is the extent of legal scope for this, meaning we know the inadequacy of informed consent lies in its failure to provide a research-specific definition of consent. Leading to the same infringements on human rights. For the law to be effective it must be precise and because consent standards are not detailed to biomedical research and tied to flawed competency standards, this causes a chain reaction of endangerment in clinical trials.

The TGN1412 Disaster

In the TGN1412 Trial six healthy volunteers were given TGN1412, leading to severe inflammatory reactions. Despite the researchers alignment with the safety principles in the Clinical Trials Regulations, as participants signed consent forms, the catastrophic outcomes suggest that if all information had been provided this could have prevented such reactions. This is because similar reactions were shown in similar drugs that treat leukaemia, but were omitted from information sheets. Since participants were not informed, their best interests cannot be argued to be upheld, and in order to satisfactorily protect patients, the “patients interest must be put first“. Illustrating current consent protocols do not attain the truly informed criteria the law sets for it. In conjunction with this, Ferguson stated that the understanding of an experimental drug’s risks, and the process for explaining these risks to the participants were not as rigorous as they could have been. Thus highlighting the existence of insufficient practice that reiterates concerns over a medical practitioner’s suitability to interpret law.

Conclusion

In our assessment of capacity, competency and consent standards in protecting human participants in biomedical research, we see a link between improper safeguards and human rights abuses. This surmounts to both a moral failure and a scientific one. To resolve this I have emphasised a mandate for radical reform in the legal frameworks of research.

There is a serious gap in the application of current standards for participant safety and a subsequent need for the construction of further legislation that is targeted and exclusive to biomedical research.

The major shortcomings we see in these areas should prompt us to think far more critically about the intersections of law, science, and ethics. In this case the relationship between participant protection and scientific advancement in biomedical research should not be framed as a conflict, but as an interdependent partnership. For future lawyers, these cases show why safeguarding in research is primarily there to learn from historical failures, and how the law is not in touch with this lesson.
English medical law has lagged in this respect for too long. Raising standards is not a barrier in fact it is the only way research can be both ethical and credible. This allows me to conclude that safeguarding standards in biomedical research exposes an urgent gap that must be rectified. The law must evolve beyond its uneven approaches and strive to create a more comprehensive system that remains in touch with the case law around it.

Arjan Singh is an LLM student at the University of Glasgow, exploring the intersection between law, science and ethics in the relationship between human rights and biomedical research. His main interests include public law and policy.