The human subjects of endometriosis research are humans with endometriosis

There are specific ethics considerations around research with human subjects. These words may – and should – conjure up images of men in white coats measuring the noses and lips of Aboriginal children, and stealing the skulls of their ancestors. Of doctors prescribing drugs to pregnant women that cause deformities over at least three generations, and not stopping when its damaging effects are fully documented. Of Henritta Lacks, and the Tuskegee Experiment. Of electric shocks administered to same-sex attracted people.

These are just a few examples of the crimes of science. Science is not infallible. It is not pure as the driven snow. The notion of purity itself is a white western christian construct, and its adherents have caused enormous harm to people all over the world. The fetishisation of science as all that is noble and good and right has a long and shameful history. Science reflects and reproduces the values of the society in which it is done. In the west, these values are sexist and racist and homophobic, ablist and anti-Semitic.

As a researcher, I am deeply vested in getting the science right, in doing research with integrity, in ensuring that human beings are not harmed by my investigations into their lives. When designing a research proposal, researchers must be cognisant of ethics clearance. Even after funding has been secured, the methodological details are submitted to an ethics committee for approval. As with any institutional process, this is an onerous bureaucratic task. It is even more so if the study is not of birds or buildings or legislation (for example), but human beings.

Research with human and animal subjects

The main ethical distinctions between animal and human subjects are these: animals can not and do not consent to participating in the research, meaning there is no voluntariness. And the purpose of research on animals is almost always to bring some benefit to humans, meaning there is no therapeutic benefit to the animal on which the scientists are carrying out their experiments. The key ethical question with respect to experimentation on animals – and I am not endorsing this priority, just describing it – centre on potential harm to the animal.

Research with human subjects has different ethical standards. Say a person was infected with Hepatitis C while in hospital for a skin graft. She takes on board this information, and despite the fact that the problem was caused in a hospital, she retains some trust in the medical profession, and reports regularly for check-ups, as per advice from her doctor. Three years later, the doctor says there is a new drug which may cure rather than manage Hepatitis C, and asks if she would like to be part of a clinical trial.

The patient hears all the advice, receives all the information, and fully comprehends voluntariness. She knows she can withdraw her consent in the trial at any time.  She signs on, and six months later is free of all symptoms. After a year, she is declared free of the disease. Two more years, and her doctor advises she need not check in for another five years. She has never felt better. The drug is released on the market. It changes lives.

This is a real case study, and the best-case scenario. It is extremely rare, but this is how ethical research with human subjects is supposed to work. The person (human subject of research) is fully informed of the risks, she fully consents and knows she can withdraw consent, and there is a high likelihood of therapeutic benefit, not just to others or society at large, but to the participant herself.

Ethics research standards

Research can be on all sorts of subjects – stormwater drains, algorithms, chemical compounds. Ethical considerations come into play when the drain or the equation or the chemistry affects humans, beyond the research environment. This is because the subject matter of ethics is human interaction, and what is good, and what is right. What is a life well lived? How should we treat other people? Do our decisions impact on future generations, on the planet? Are we integrating our ways with the world around us? This is literally the root of integrity: getting along with others in the society to which we belong.

A stormwater drain is not affected by my observation of its workings. But my interpretation of drain data is influenced by my inherent biases, my background, my prior knowledge of water and drains. Some improvement in stormwater management may result from the research, and this may benefit some humans or society in general. None of this is of any moment to a concrete pipe.

If my job is to test the potential harm of active ingredients of a cosmetic, like allergies or skin conditions, I will probably seek to do so on animals. This can and probably will cause harm to the animal; and will benefit people who later profit from sales of the product. The harm will not necessarily follow, but it is extremely likely, and predictable. The prediction is inherent to the purpose of the research, which is to test for potential harms the product may cause. The experiments are designed to extrapolate any harm caused to the animals in the study to potential impacts on humans.

So research ethics is categorised in these various ways, founded in what philosophers call objective morality. We in the west have an anthropocentric tradition, placing humans at the centre of our pursuits, at the top of a constructed hierarchy. Not all cultures do this: the Aboriginal totem system ensures that people have special responsibility for kangaroo, or frog, or whale. Other forms of Aboriginal social organisation see authority – via birthright, kinship, learning – to speak for a tract of country. From these practices, the ecologies of this continent and her islands are carefully looked after, and have been for upwards of fifty thousand years.

The western tradition, in contrast, is rigidly hierarchical and anthropocentric. Humans are sui generis – in a category (genus) of one (single). We see ourselves as at the ‘top of the food chain’. We punished those who dared to observe that the earth was not at the centre of the solar system in which we exist. The west has not thrown off legacies of pre-Copernican religiosity. Look at contemporary atheism, for example, under the ‘leadership’ of unreflectively privileged men like Richard Dawkins. There is a decidedly religious fervour to the continuing elevation and mythologizing of science.

And it does not matter how onerous the ethics approval standards are if the oversight is left to scientists to self-regulate. As any ethicist (or lawyer) could predict, ethical standards are regularly breached unless a standard-setting body – a professional organisation, the state – allocates resources to compliance and enforcement.

Not all humans

Ethics committee clearance for research with human subjects has rules around potential benefit and harm to human beings. No scholar should seek to obtain knowledge if the net result is harm to the participants. We are not stormwater pipes or algorithms or rats. The potential therapeutic benefit to human participants, as in the Hep C example, is a real consideration.

But the western tradition not only places humans at the top of a misinformed hierarchical way of seeing the natural world, but also grades humans into categories of value. It is not coincidence that the worst crimes of science are committed against black people, and gay men, and pregnant women. This is a function of the specific values of white patriarchal societies. These societies reward domination and control, aggressive competitiveness (called ‘rational self-interest’), and are incapable of seeing or changing its own violent and dishonest core.

The western canon is riddled with false dichotomies: empirical and normative methodology; science and religion; natural and positivist world views. This is because western epistemology is ontologically adversarial. It is not capable of not producing false dichotomies, because simplistic binaries are its basic cultural unit, built into its structures at every (formal) level.

This is fine when designing computer codes, or building cathedrals with as many resources as could feed all the city’s poor for a decade (okay no that is not fine, but it did happen). It is not fine when deciding who may be human subjects of which research, either. These decisions are dominated by the same demographic group who dominate the executive level in all our institutions. Unless the ethics committee is extremely vigilant (and unusually demographically diverse), the hierarchy of humanity ingrained into western culture is reproduced in research culture. It elevates straight white men and devalues the lives of all women and children, of First Peoples and people with disabilities, of Black people, of people of colour, and LGBTQI people.

A study into the sex lives of male partners of people who suffer from endometriosis

Random, you might say, unless following a story this week about a study exploring “the impact of endometriosis on men’s sexual wellbeing”. yes, that is the research topic. It is misguided at best, and very likely poorly served by the relevant ethics committee and research institution.

The parameters on any endometriosis research are determined by the condition. Endometriosis is debilitating. It is painful. There is abundant evidence that doctors minimalise and trivialise the suffering experienced by women, and girls as young as eight, that comes with endometriosis.

Women, and girls, and trans people dealing with menstruation or associated experiences in this context, are routinely disbelieved, spoken over, ignored, and dismissed by the medical profession. The effect is even more pronounced when it comes to our reproductive health. Doctors prescribe dangerous and harmful substances like DES and thalidomide for as mild and normal an experience as morning sickness (chronic all-day nausea during pregnancy is debilitating, but this is much rarer). Such practices cause trauma and hardship to millions and millions of people.  Unnecessarily medicalising experiences like menopause is a hugely profitable industry. It is we who menstruate or get pregnant or stop ovulating, yet it is white cis men who dominate the medical profession and drug industry, and are the wealthiest shareholders.

All this requires that science continuously reproduce the myths of infallibility, the idea that doctors know best. For this dominance and control over our health to be maintained, and the money to be made, we are told that we are not the experts on our own bodies and our own pain. It is ontologically impossible for a cis man to know more about period pain than anyone who has experienced period pain. Similarly, the male partners of a person who has endometriosis can not contribute more value to endometriosis research than those with the condition.

The debate that emerged this week centred on the study of men in such partnerships, and their sex lives. This is what bioethicists call a surrogate end point, which is when researchers create an artificial endpoint for the purpose of obtaining the desired result. For example, a new drug is shown to lower blood pressure, and lower blood pressure is assumed to have a preventative effect on heart disease. Yet the drug has a side-effect that increases the likelihood of heart-attack. Only the first results are tested and reported, and the drug is approved. The subsequent increase in heart attacks of those taking the drug could have been avoided, but for the surrogate end point built into the research design.

Say a bloke recruited to the man sex life endo study broke up with his girlfriend who has endometriosis. Is he still eligible to participate? Not really. The study is on men who are the heterosexual partners of women with endometriosis, and he no longer meets that description. But perhaps his experiences, no matter how vaguely recalled, would still be considered relevant? Why? So the researcher can continue the research.

A study on male partners of those who suffer from endometriosis is ontologically about endometriosis. His response, his experiences, the data he provides, are all contingent on the condition, and their partnership. The ethics clearance for this research would have weighed whether the study will benefit or dis-benefit those men (and society in general). But this is a surrogate end point. The recruitment of participants is dependent on his relationship to the person who has endometriosis. As such, the true subject of the research is endometriosis, so the true ethical question with respect to ‘human subjects of research’  is whether humans with endometriosis are likely to benefit or be harmed by the study.

Will she be better off? Probably not. Will the study cause harm to her? Quite possibly. Who among us has not told a bloke true facts endlessly, for weeks or months or years, only to find him an expert on the topic when told by another source – like, say, the University of Sydney? This is a real and likely harm. It causes anxiety, it messes with our heads.* It is a familiar and tiresomely repetitive experience, and thus can be re/traumatising. The bloke is only relevant to the study for his relationship to another person, and a condition – endometriosis – which does not exist without its human host. His relevance to the study does not either. The potential good or harm that should be taken into account by ethics committees is much wider than the recruited ‘male’ and his ‘sexual well-being’.

Additionally, the likelihood of having a partner with endometriosis is doubled among lesbian couples. Endometriosis is a prevalent and painful condition. But this study is not interested in the sex lives of lesbians. Science is sexist and science is homophobic, and no amount of manufactured sympathy for a researcher (who was not “attacked” by anyone) will change these institutionalised norms.

The defence of the researcher that I saw was not based on research ethics. Instead, most defences focused on the fact that the researcher and the endometriosis sufferer who wrote an op-ed in The Guardian are both women. The men doing this were too dense to realise that their ‘defence’ basically amounted to “Science! Cat fight! Freedom!”. None of this is the issue. Ethics in research with human subjects is what matters, and the ethical analysis shows conclusively that any potential harm to those people who suffer from endometriosis, the humans whose condition and partnership determines the eligibility of participants, should have been taken into account.

*I do not have endometriosis. I have menstruated for 35 years and counting: and have been pregnant four times and given birth three times. This gives me greater insight into the pain and experience of patriarchal medical norms with regard to reproductive health than any man who has never menstruated or given birth.

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