Saints and Sinners: The Development of Medical Research Ethics and Informed Consent (Part 1)

Gill Loomes

1st November, 2017

Introduction

In this post, I’m going to set out some of history of the development of research ethics involving human participants – thinking particularly about issues of capacity and consent. This background is important because it gives a real sense of the  contexts in which ethics have developed. The principles underpinning the ways in which Research Ethics Committees work today, have their roots in ethics that have developed over about the last 250 years, largely as a challenge to the unfettered autonomy of doctor-researchers associated with the paternalistic approach of medicine in classical history.

At the end of the post, I’ll make a couple of points about what I think we can learn from this history, and how it relates to how we work today.

I’m summarising and analysing information on the development of ethics here, in the hope that this will be helpful background for researchers (including practitioner-researchers) attempting to understand and negotiate ethics procedures, and also for members of the public who may be involved in research themselves, or alongside adults whom they support and care for who may be involved in research to which they lack capacity to consent.

This is the first of (at least) two posts on this subject – In it, I’ll be focusing specifically on the development of research ethics prior to the Nuremberg Code of 1947, that was created as part of the trial of Nazi doctors for war crimes relating to medical experimentation and euthanasia.

 

The Development of Research Ethics Before the Nuremberg Code

Much of the development of ethics around medical research involving human participants arose as a result of public and political concern following the injuries of people who had been involved in research without their consent.

A particularly famous example of this is the case of Albert Neisser  (1855-1916) – a professor of dermatology and venereology at the University of Breslau.

[Black and white image: Portrait photo of elderly man with beard and glasses]

Neisser wanted to find a means of preventing syphilis, so he injected a serum from patients with syphilis into other patients who had different illnesses. Most of the patients he injected were prostitutes, and they weren’t told about the experiment, or asked for their consent. Some of them went on to contract syphilis, causing Neisser to conclude that the ‘vaccination’ hadn’t worked – but to argue that the patients contracted syphilis, not as a result of his injecting them, but because they worked as prostitutes.

The story was published in newspapers, and caused a public debate, in which many academic doctors sided with Neisser.

One exception was Albert Moll – a psychiatrist from Berlin.

[Black and white image: Portrait photo of bald man with monocle and moustache. Wearing winged collar, tie and jacket]

Moll has been described as a pioneer of patient autonomy, who emphasised the contractual nature of the doctor-patient relationship. In 1902, he published his ‘Physicians’ Ethics’ (in German: Aerztliche Ethik), which included a collection of 600 cases of unethical, non therapeutic research on humans.

In 1898, this public debate led the public prosecutor to investigate the syphilis case and Neisser was fined. Importantly – the basis of the judgment against Neisser was not that the science of his research was bad, but that he failed to get informed consent from his patients.

This case, and social concern and public pressure led to government action, and to the enacting of the Prussian Regulation of 1900; which was the first example of government regulation of non therapeutic research based on the principle of patient autonomy, and which represented an early model of informed consent – as “for the first time in history, written documentation of subjects’ informed consent, the research process, and explicit clarification of personal responsibility for the experiment are required in the medical record.” (Vollmann and Winau, 1996: 10).

Subsequently, in 1931, the German Reich government issued guidelines for new therapy and human experimentation.

Significantly though, the Prussian Regulation was non binding, and there is little known about whether and how it impacted on human experimentation. It’s also interesting to notice that while Albert Moll, a pioneer in patient autonomy and medical ethics, was distinctly unpopular within his contemporary medical community, with his work being said to be more popular with lawyers, Albert Neisser, who injected prostitutes with syphilis, and was fined by the Royal Disciplinary Court, was still publishing papers on experimental work relating to syphilis in 1908, and being congratulated for his “labours in the cause of science and dermatology”.

What can we learn from this?

I think there are 2 key things we can take from this historical background to the development of the research ethics frameworks with which we work today:

  • The centrality of ‘informed consent’ on early ethical thinking: It wasn’t the harming of patients that got Neisser into trouble, it was the fact that he didn’t seek their permission beforehand. Likewise, the focus of Moll’s ethics was firmly on the ‘doctor-patient’ contract, and on the importance of patient consent. I don’t think anyone would argue that it’s not important that if you’re going to do something potentially devastating to a patient, like inject them with syphilis, you should at least ask them first, and give them the opportunity to decline the invitation. But this focus on consent seems to leave some stones unturned, that are likely to be particularly important to those of us interested in involving people in research who lack the capacity to consent – Issues like:
  • To what extent does focusing on informed consent actually do anything to shift the power relations between physician and patient? What else needs to happen?
  • On what grounds can we justify involving people in research if they lack the capacity to provide informed consent? Why is this important?

These are issues I’m going to be exploring more in future blog posts – but what are your thoughts? Please feel free to comment!

 

  • The adversarial approach: It very much seems that the early development of medical ethics was about social and political forces outside of the medical community attempting to impose restraint on physician-researchers, and the medical community apparently railing against it. This gives food for thought about how Research Ethics Committees work today, and how they are viewed by researchers who apply to them – Here, you can see an interview I did at our ‘Nothing About Us Without Us’ symposium (discussed elsewhere on this blog), with Douglas Morrison, a senior lecturer in medical law at Leeds Beckett University, about his experience as a member of a Research Ethics Committee. In it, I think he is describing a far more collaborative approach to research ethics, where the researcher and the ethics committee are presumed to be commonly concerned with safeguarding the wellbeing of research participants, and with finding ways in which research can be carried out with this in mind.
  • I wonder what’s already happening, and what else can be done to develop this form of collaborative approach.
  • I wonder what resources and information would be helpful to committees and researchers in order to make ethics applications progress smoothly. In the roundtable discussion at ‘Nothing About Us Without Us’ – summarised here, a point that came up was the suggestion that ethics committees didn’t necessarily understand the practice context (e.g. the hospital or the residential home) where the proposed research would be carried out, and therefore that their requirements and recommendations weren’t necessarily appropriate. How can we increase opportunities to talk to each other more, and to understand each other’s priorities and the contexts in which we’re working?

In my next post, I’m going to think about the development of research ethics in the 20th Century, and how we got to where we are now.

2017-11-01T15:20:47+00:00