In this blog post we address a business and human rights issue that emerged from the recent report of Ireland’s Commission of Investigation into Mother and Baby Homes: that of corporate complicity in unlicensed clinical trials carried out upon incarcerated children. We give some background on the report and the environment where human rights abuses took place, then outline elements of Ireland’s idiosyncratic regulatory environment and medical system, before pointing both to the dim prospects facing remedy-seeking victims and the necessity for proactive corporate engagement in dealing with the past.

The report was published by the Department of Children, Equality, Disability, Integration and Youth in January 2021, addressing the treatment of (mostly) unmarried mothers and their babies from 1922 until 1978. Myriad human rights abuses are detailed throughout the report in addition to a specific section of the report on human rights. Despite it being the most recent in a series of investigations into historical institutional injustice, it has been received with shock and controversy in Ireland both North and South (see Enright for instance).

The Report reflects Ireland’s scrutinising hitherto silenced facets of the ‘conservative revolution’ that underpinned the independent state from the 1920s onwards. Institutional power, especially that of the Catholic Church, reflected and drove social shame about birth outside marriage. Mother and baby homes joined an archipelago of carceral institutions for ‘forgettable minorities’ that, by mid-20^th Century saw 1052 out of every 100,000 people forcibly confined. Social conservatism allied to the private economics of class, inheritance and land saw mothers and their children locked away. The system persisted not just on social mores but on the commercial opportunities offered by exploiting those confined.

Whereas excellent assessments of the report and its limitations already exist from Enright, Ring and O’Toole, business and human rights scholars may be particularly shaken by revelations about vaccine and other clinical trials. These trials took place in the homes, especially across the 1960s, under the auspices of the Wellcome Foundation and Glaxo Laboratories, both now subsumed into GlaxoSmithKline. The Commission identified seven vaccine trials on children that took place in those institutions under investigation, as late as 1973.

The Report found that vaccine trials performed upon children in homes were performed without compliance with applicable regulations (34.57). For one timeline see here. There was ‘no attempt’ to get consent from children (where applicable), or their mothers/parents/guardians. While the Commission concluded that there is no evidence of injury to the children involved as a result of the vaccines, this is strongly disputed by leading clinical experts and by the survivors themselves.

There was also evidence of clinical non-commercial infant milk trials (para 34.32). This is disturbing in the context of the Commission’s record that concerns were raised repeatedly about the higher morbidity and mortality rates of non-breastfed babies (see inspection reports on Bessborough House’s ‘appalling wartime infant mortality rate’, 5.23 onwards; also 18.72 onwards; 13.195). As with vaccines, these trials were carried out on captive children, did not comply with the relevant guidelines, licences were not procured, and there is no evidence that consent was even considered. It seems that the agency of those confined was simply not relevant.

Ireland’s health system and its regulatory environment

Vaccination schemes reflected the growing role of laboratories in medical innovation in Ireland and elsewhere (see Foley p. 156 in Cox and Luddy). This was not without risk, not least as revealed when a child died in an unlicenced vaccination scheme in the late 1930s: the ’Ring College’ scandal (also Dwyer), involving Wellcome’s vaccines, both damaged popular sentiment and drove regulatory change.

The Therapeutic Substance Act 1932 regulated clinical trials under the auspices of an Advisory Committee and mandated that researchers receive a licence from the then Minister for Local Government (Minister for Health from the Health Act1947). The Advisory Committee did not even meet until after the Ring College scandal. Even then enforcement and compliance were weak, as was oversight of medical institutions more broadly. Resistance to ‘socialised’ healthcare was strong, notably regarding the ‘Mother and Child Scheme’ of the early 1950s. Church resistance was itself heavily allied to and influenced by the medical profession who preferred independence from state control.

The absence of process and consent placed the trials at odds with a global shift in medical ethics that saw the doctor’s authority give way to patient autonomy and consent (see Donnelly). The Nuremberg Code enshrined voluntary consent by the late 1940s. Ireland adjusted formally in its legal regime, but practices did not follow. Some corporate scholars have linked corporate innovation and technical logics to rights violations. Regarding the trials at hand, such logics overrode concerns for the autonomy of marginalised mothers and children.

All that said, while debates persist about children and others in clinical trials, the ethical failings here depended on the incarceration, silencing and marginalisation of mothers and their children. Understanding rights breaches around consent must begin from there.

How might Business and Human Rights instruments apply?

“As long as corporations have been involved in historic wrongs and remain part of a system, Toft argues, “they may accrue both backward-as well as forward-looking duties” (also Arnold). What do backward looking duties mean in respect of vaccine trials on incarcerated children that took place half a century ago at the behest of actors long absorbed into new corporate groups and configurations? How is GlaxoSmithKline responsible as a successor to the corporate beneficiaries from the trials (see chapter 34)? This especially when, as GSK pointed out in a recent letter, the trials were themselves not carried out directly but were managed by researchers on the companies’ behalf.

The UN Guiding Principles on Business and Human Rights (UNGPs) help articulate and frame the failings. The state made no efforts to “prevent, investigate, punish and redress abuse through effective policies, legislation, regulations, and adjudication,” as per Principle 1. Systemic non-compliance with and lax enforcement of regulations highlights failures to “enforce laws that are aimed at, or have the effect of, requiring business enterprises to respect human rights” (Principle 3).

Corporate actors for their part failed in their responsibility to respect human rights, not least in weak appreciation of the Nuremberg Code, and so infringed “the human rights of others”, and made little or no attempt to “address adverse human rights impacts with which they are involved” (Principle 11).  The UNGPs articulate such regulations as rights protections and emphasise corporate responsibilities to attend to regulation, not as a cost but as a fundamental aspect of their operations.

The problem with historic abuses in settings like the homes however, is that marginalisation and displacement means that harms in such settings were de facto not even entertained as worthy of judicial attention (Principle 26): nobody recognised unmarried mothers and their children as full bearers of rights both more broadly and in carrying out the trials.

Does a path to remedy currently exist?

How might half-century old backward obligations be defined when the marginalisation that drove the harm still insulates complicit parties from consequences, especially when beneficiaries of past harms have been subsumed within corporate groups? Litigating such harms would be difficult and costly. Yet it seems inadequate that corporations associated with harms can draw a line by registering only that their “thoughts are with the families” or that historical practices “make for difficult reading.”

Remedy as the UNGP’s ‘third pillar’ can be judicial or non-judicial, state-based or non-state based, encompassing as Ruggie sees them: “apologies, restitution, rehabilitation, financial or non-financial compensation and punitive sanctions…as well as the prevention of harm through, e.g. injunctions or guarantees of non-repetition”. The difficulties here are legion however.

While GlaxoSmithKline provided documentation about the clinical trials, corporate responsibility for their role was not addressed in the Report. Nor was access to effective remedy for victims raised (Principle 25) until after publication. From GSK’s perspective (also here), distance from the trials in time and process, the lack of adverse findings in the Report, plus an inherent value they claim for vaccine trials, dictates against them engaging on compensation. They did commit to exploring possible access to information for victims.

Commissions can both establish truth and also in effect block access to remedy. They may even serve to ‘reintegrate’ corporations into society. Responses emphasise ‘moving on’; the state defines and controls routes; and serious questions remain about the quality of record-keeping in the report’s administration, knowledge can increase while pathways to remedy fade.

Conclusion

The experience of the mother and baby homes suggests that corporate due diligence processes must develop an archival bent in addition to forward-looking audit frames. They must develop an eye for their past, which combined with proactive and constructive acknowledgement and remediation would reaffirm corporate commitments to respecting human rights and open the possibility of true “reconciliations”. An opportunity to promote now-routine remediation practices, if not dispositions, has been missed. As has a moment when corporate actors might have been drawn into open discussions about present management of past harms. The past is not another country. It is a place, especially in the absence of justice, where many people must continue to live.

O’Kelly, Hackett and Patton are staff at QUB School of Law. Hopkins is a 3^rd year DfE funded PhD student.