First Do No Harm? The Development of Medical Research Ethics and Informed Consent (Part 2)

Gill Loomes

14th November, 2017

Introduction

In my last post, I wrote about the early history of the development of ethics for research involving human participants. You can read that post here.

In this post, I’m going to be looking at what happened to research ethics in the latter half of the 20th century. I’m going to start with the Nuremberg Code, that followed the Second World War, and then at the international ethics frameworks that were created subsequently.

I’m also going to be thinking about how social and political events have shaped the development of research ethics, and exploring questions about the extent to which specific events should influence such research policy.

 

The Nuremberg Code

The Nuremberg Code was constructed from discussions about medical ethics during the ‘Doctors’ Trial’ – a trial that investigated the actions of Nazi doctors who carried out horrific experiments on those imprisoned in Concentration Camps during the Second World War.

It sets out 10 principles for ethical research involving human participants, and has been called the ’10 Commandments of Research Ethics’ (Herbert, 1969).

  1. Required is the voluntary, well-informed, understanding consent of the human subject in a full legal capacity.
  2. The experiment should aim at positive results for society that cannot be procured in some other way.
  3. It should be based on previous knowledge (e.g., an expectation derived from animal experiments) that justifies the experiment.
  4. The experiment should be set up in a way that avoids unnecessary physical and mental suffering and injuries.
  5. It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury.
  6. The risks of the experiment should be in proportion to (that is, not exceed) the expected humanitarian benefits.
  7. Preparations and facilities must be provided that adequately protect the subjects against the experiment’s risks.
  8. The staff who conduct or take part in the experiment must be fully trained and scientifically qualified.
  9. The human subjects must be free to immediately quit the experiment at any point when they feel physically or mentally unable to go on.
  10. Likewise, the medical staff must stop the experiment at any point when they observe that continuation would be dangerous.

 

The Doctors’ Trial took place between 9th December 1946 and 19th July 1947. It involved 23 defendants, with 32 prosecution witnesses and 53 defence witnesses (including each of the defendants). 1471 documents were introduced to the record.

As a result of the trial 16 defendants were found guilty – 7 were sentenced to death by hanging; 5 to life imprisonment; 2 to 25 years in prison; 1 to 15 years in prison; and 1 to 10 years in prison.

Harvard Law School Library holds records of thousands of documents relating to the Nuremberg Trials, which can be accessed online as part of the Nuremberg Trials Project. This is a really useful resource, and can be accessed here.

A comment that I found particularly significant when looking at transcripts of the Doctors’ Trial is this one, from Werner Leibbrand (one of 3 physicians who had central roles in discussions regarding medical ethics in the Trial, and the formation of the Nuremberg Code). He says:

“The morality of the physician is to hold back his natural research urge, which may result in doing harm, in order to maintain his basic medical attitude that is laid down in the Oath of Hippocrates” (Transcript of NMT 1, Medical Case)

This stands out to me, because it describes a particular perspective on the role of the researcher – as someone whose ‘urge’ to pursue knowledge must be held back and controlled. So, the relationship between researcher and research participant (and, more widely, of researcher and society) becomes an adversarial one, where researchers must be restrained – according to this approach, it is in the context of this adversarial relationship that ethical codes are constructed.

How does this view of the role of researchers sit with how you view research and researchers?

 

After Nuremberg

Following the Nuremberg Code, informed consent has become a key priority in research ethics involving human participants. Other international declarations on ethics in biomedical research involving human participants also follow this pattern. These include the World Medical Association Declaration of Helsinki, of 1964, and the Council of Europe Convention for the Protection of the Human Rights and Dignity of the Human Being (the Oviedo Convention) of 1997. These instruments enshrine the importance of informed consent, and prescribe conditions for research in which people who lack the capacity to consent may lawfully participate. Such conditions include:

  • The possibility for ‘proxy’ consent, and the requirement for researchers to consult with family or other carers on the wishes and feelings of the individual about proposed research participation. This is often provided for in national legislative frameworks (as in s.32 MCA 2005).
  • The condition that research may only lawfully be carried out with people lacking capacity to consent if the research could not effectively be carried out with people able to consent (as in s.31(4) MCA2005)
  • The requirement of a link, or relationship between the focus of the research and the condition that the person is experiencing that causes them to lack the capacity to consent to research participation (as in s.31(2) MCA 2005)

 

This approach to the ethics of research participation interests me – particularly the way in which, as illustrated in the above quote from the Doctors’ Trial, research ethics have developed in a way that sees researchers as in need of outside constraint in order to help them control their ‘natural research urge’.

 

A Disability Rights Approach to Research Participation? 

I think it interests me as it goes to the very heart of what we think research is for, and why, as researchers, we do research. My own ‘journey’ into research was via an involvement with disability politics, and specifically via a research job as a recent law graduate for an international Non Governmental Organisation. I was UK researcher on this International Disability Rights Monitor Regional Report on Europe. This role enabled me to engage with the history of the disability rights movement in the UK while being part of a project that was concerned with producing grassroots research on law and policy that was prepared by, and intended to be used by, disabled activists across Europe. It was exciting! And it was inspiring!

It also gave me a view – and introduced me to a body of literature – that suggested that research could, and should be produced by, with, for disabled people. You don’t get far in disability politics without coming across the phrase ‘Nothing About Us Without Us’ – and the argument that research should be concerned with producing tangible social change for disabled people, according to the priorities of disabled communities.

This feels a world away from the model of research I’ve looked at above, and in my previous post, where participants must be protected from researchers working to their own agendas in order to feed their “natural research urge.” And reflecting on these positions makes me think about the phenomenally wide range of research situations in which people may consider participating; the huge range of reasons why research is carried out – what research assumes; what it explores, what it seeks to achieve; what it considers as salient …

Indeed, there have been criticisms of the way in which modern research ethics have developed with such a key focus on the atrocities of the Second World War – Rosamund Rhodes in 2005 provides one such criticism, in challenging the fundamental focus on ‘informed consent’. Rhodes’ work, and the scholarship that has arisen around it are fascinating, and in my view, are well worth exploring – particularly in this issue of the American Journal of Bioethics.

And considering briefly my own overarching research focus – that of the Mental Capacity Act 2005, and its operation in practice, it becomes clear from reflecting on this narrow area of the Act’s scope (that of research participation by adults lacking the capacity to consent), the plethora of ways in which social, political and historical contexts have shaped ethics and the law – and the ways in which this law operates in a socio-political context.

Research participation – and the perceived importance of (the capacity to provide) informed consent – are social issues, and they are political issues. These issues are constantly evolving as research evolves, and through this process of evolution, the ways in which disabled people can impact on the world through research is evolving. This is an area that should be of concern and interest for the disability rights movement, and for disabled communities.

In my next post, I’m going to explore some of the literature of Disability Studies concerning research participation. I’m going to look at the Social Model of Disability, and how it leads to, and influences emancipatory disability research agendas, and I’m going to consider what this means for the material and social relations of research involving adults whose disability or illness means they lack the capacity to consent. 

 

Herbert, L.Jr (1969) “Federal law and patient consent” Food, Drug, Cosmetic Law Journal 24(11) 520-526

2017-11-16T00:44:19+00:00