Safety of scientific medical research is a State obligation

Abstract

Conducting scientific medical research with human subjects presents risks that raise both ethical and human rights concerns. We argue in this article that applying a human rights framework to the problems that arise in the context of scientific medical research can contribute to a better understanding of the impact on individuals, the related obligations of the State, and the avenues to make the State accountable when things go wrong. We start our analysis with a case brought to the European Court of Human Rights, which we use as an illustration throughout the article. We then discuss the relevance of human rights to the field of scientific medical research with a focus on the right to life and the right to health. The article draws on international human rights jurisprudence that deals with concrete disputes arising from the clinical reality. We use case law to highlight the role of human rights law in tackling the real-life problems that may occur during scientific medical research. Our analysis contends that human rights law can provide valuable guidance for healthcare professionals and equip them to handle concrete situations in the clinical reality when the safety of research subjects is at stake.

1. Introduction

Scientific medical research involving human subjects aims to increase knowledge about the causes, development, and effects of diseases and improve their prevention, diagnosis, and treatment (World Medical Association, 1964, as amended in 2024), par. 7; Ministerie van Volksgezondheid, Welzijn en Sport, 2008). Moreover, expanding medical knowledge through research has the potential to provide people with better tools to lead healthier lives. Therefore, it is often emphasised that scientific medical research has high value to society, it generates public good, and it is in the interest of individuals and society in general to advance medical science through research (see e.g., Schaeler et al., 2009; Harris, 2005; Jacob, 2016).

Nevertheless, conducting scientific medical research with human subjects presents risks that raise human rights concerns bearing in mind the possible dangers posed to the safety, health and sometimes, the life of the research subjects (for examples discussed in the literature, see Trouiller et al, 2002; Mills and Singh, 2007). The main purpose of scientific research is to produce new and generalisable knowledge by testing hypotheses and drawing conclusions. As such, scientific medical research aims to benefit the broader population, and usually, it is not a specific goal of research protocols to benefit any specified individual. Although some subjects may directly benefit from the research, this usually happens by luck rather than design (see also Morreim, 2004). On the contrary, some individual research subjects might suffer negative consequences when things go wrong. As we point out in this article, the potential and de facto harm suffered by individuals during scientific medical research extends into the realm of human rights law.

To ensure that participants are duly protected, scientific medical research conducted with human subjects must comply with several safeguards (World Medical Association, 1964, as amended in 2024; Ministerie van Volksgezondheid, Welzijn en Sport, 2008). For instance, before conducting a clinical trial, a Research Ethics Committee (hereafter REC) must approve the research protocol, which describes the procedure of the study and includes arrangements for post-trial provisions. Before approval, a risk assessment is carried out. During this process, balancing the progress brought to medical science with the safety of the individual research subjects is central, and the goal to generate new knowledge may not prevail over the rights and interests of the individual research subjects (World Medical Association, 1964, as amended in 2024 par. 7).

The diligence of this assessment is particularly important when members of a vulnerable target group are involved. Bearing in mind the potential risks involved, conducting such research with vulnerable persons is either not allowed or subject to additional safeguards. Thus, research with vulnerable group members is only justified when it is responsive to the health needs and priorities of the targeted group and it cannot be conducted in any other way (i.e., in a less vulnerable group) (World Medical Association, 1964, as amended in 2024, par. 20). This has also been emphasised by international human rights treaty monitoring bodies belonging to the United Nations framework in their observations concerning national rules and practices related to medical experiments involving humans. In its Concluding Observations for the State of the Netherlands, the United Nations Human Rights Committee emphasised that minors and other vulnerable persons unable to give genuine consent should be removed from medical experiments that do not benefit them directly. Specifically, the UN Committee asked the State of the Netherlands to amend national legislation to ensure that ‘even high potential value of scientific research is not used to justify severe risks to the subjects of research’ (United Nations Human Rights Committee, 2001, par. 7). Furthermore, in its Concluding Observations for the United States, the United Nations Human Rights Committee raised concerns about the practice in the United States to allow for medical experiments to be conducted on persons at risk of undue pressure or coercion. This includes mentally disabled persons, children, pregnant women, prisoners, and poor people. The UN Committee emphasised that the United States should not subject anyone without his/her free consent to medical or scientific experimentation (United Nations Human Rights Committee, 2006, par. 31).

If the REC approves the protocol after careful assessment, the research can start. However, this does not mean that researchers are no longer bound by rules after the approval of the protocol. Even during the conduct of the clinical trials, the research subject’s rights must be safeguarded by the healthcare professionals involved in the research, who must consider the applicable national and international standards and rules (World Medical Association, 1964, as amended in 2024, par. 10).

To illustrate the importance of safeguarding research subjects’ rights, we will use a real-life case judged by the European Court of Human Rights (hereafter the ECtHR) in 2022: Traskunova v. Russia, reflecting a clinical situation. Although the ECtHR has delivered judgments in various disputes pertaining to clinical research (e.g., involuntary inclusion of psychiatric patients in Bataliny v. Russia, 2015; access to unauthorised experimental medicines in Hristorov and others v. Bulgaria, 2013 ; suspension of a clinical trial researcher in Gražulevičiūtė v. Lithuania, 2022), the Traskunova case addresses specifically the protection of research subjects and therefore, it will be used as a touchstone throughout this article. The facts of the case are briefly introduced here and analysed further in Section 4 of the article:

A 57-year-old woman with mental health problems is included in two scientific medical studies on the efficacy of a new drug against schizophrenia. The first study is a double-blind randomised trial. ¹ The duration of this study is one year. The first study aims to compare the safety and efficacy of the new medicine with an existing drug. The second study aims to test the long-term effect of this new drug. To participate in this second study, the research subject needs to have successfully participated in the first study. To measure the long-term effect, the subject is prescribed the same medication as the medication used during the first study. During her participation in this second long-term effect study, the woman dies as a result of acute cardiovascular insufficiency. The national authorities did not establish whether this was due to participation in the study (Traskunova, par. 27–28).

After the woman’s death, her mother takes legal action first at the national level. After unsuccessful attempts to obtain justice at the national level and having no more judicial remedy left for her in her country, the mother brings the case to the ECtHR. ² She claims that accountable errors have been committed during the medical research to which her daughter got subjected and seeks compensation for the harm caused. As an international court, the ECtHR has the power to find that States are responsible for human rights violations committed by non-State actors under their jurisdiction (including healthcare professionals) and can order States to provide just compensation to the victims. After a thorough examination of the complaint, the ECtHR concludes that the respondent State has failed to comply with its substantive and procedural obligations under Article 2 of the European Convention on Human Rights (hereafter the ECHR), also known as the right to life provision (Council of Europe, 1950). Consequently, the ECtHR rules that the State has violated the woman’s right to life. In particular, the State has not ensured an effective implementation and functioning of the legal framework to protect the woman’s right to life – a mentally ill and thus vulnerable individual – in the context of clinical trials of experimental medicinal products, and it has not provided an adequate judicial remedy to the victim’s mother in that connection (Traskunova, par. 87–88). The ECtHR orders the respondent State to pay a compensation to the relatives of the woman who has been a victim of a human rights violation.

As exemplified by this illustrative case, conducting medical research with humans is not without risks and can sometimes go seriously wrong. Yet, the clinical studies this woman participated in were approved by the Ethics Committee at the Federal Body for the Quality Control of Medicinal Products (Traskunova, par. 7 and 15). So, who is responsible for the harm caused to the woman who lost her life during the clinical trial? Can the State be held accountable for scientific medical research that violates the research subject’s human rights? And how can it happen that a fundamental human right, namely the right to life, is violated while conducting an approved clinical trial? What can the State do to prevent such violations and protect the individuals who participate in medical research?

Human rights law stipulates the obligation of States to enhance human dignity, safeguard individual autonomy, and ensure justice and compensation in case of harm. We argue in this article that applying a human rights framework to the problems that arise in the context of scientific medical research can contribute to a better understanding of the impact on individuals, the related obligations of the State, and the avenues to make the State accountable and responsible for preventing such problems from reoccurring. Towards this end, our analysis draws on the relevant jurisprudence of European and international human rights courts and treaty monitoring bodies. Such jurisprudence deals with concrete disputes arising from clinical reality, and we use these cases as tools to highlight the role of human rights law in tackling the real-life problems that may occur during scientific medical research. The analysis draws on the Council of Europe as well as the United Nations human rights frameworks to discuss their respective contributions. In doing so, the analysis explores what human rights are relevant to medical research with human subjects, how can these rights be guaranteed, and how to foster the application of human rights to this field of medical law.

2. Human rights applicable in the context of scientific medical research

A special contribution of human rights law instruments is the adoption of treaties that stipulate rights for individuals in health and healthcare and corresponding obligations for the States that ratified those instruments. These treaties stipulate several rights for individual research subjects.

2.1 The Council of Europe framework

To date, the only binding international treaty in the field of human rights and biomedicine is the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (hereafter the Oviedo Convention) (Council of Europe, 1997). This treaty contains principles and prohibitions against the misuse of biological and medical advances. Pursuant to Article 1, each State Party must adopt measures at the national level to protect individuals’ dignity and integrity. This includes the general rule to safeguard individuals’ free and informed consent (Article 5), which must be given expressly, specifically, in a documented manner, and can be withdrawn at any time (Article 16). To protect research subjects, Article 16 includes safeguards that States must put in place including mitigating the risks, ensuring ethical review, and providing information on rights. Furthermore, Article 2 stipulates that the interests and welfare of the human being shall prevail over the sole interest of society or science. The Additional Protocol to the Oviedo Convention concerning biomedical research establishes further principles that cover the full range of medical research activities involving interventions on human beings (Council of Europe, 2005). A binding treaty itself, the Protocol includes detailed rules on information and consent with specific attention to the protection of individuals unable to consent to research and those in special circumstances (e.g., being deprived of their liberty, in emergency clinical situations, or pregnant/ breastfeeding). The Oviedo Convention requires State Parties to establish sanctions for third parties causing harm and report to the Council of Europe on the way their national law ensures the protection of research subjects.

Regrettably, the Oviedo Convention does not provide for a treaty monitoring body that could find against the States for failing to fulfil their responsibilities and sanction them. This has been considered one of its shortcomings (Raposo, 2016). Nevertheless, national and international courts can refer to the Oviedo Convention principles in the context of disputes concerning the rights of research subjects. Notably, the ECtHR has done so in disputes involving clinical trials (see e.g., Gražulevičiūtė v. Lithuania, 2022; Bataliny v Russia, 2015; Traskunova v. Russia, 2022; see also Seatzu, 2015).

Another Council of Europe treaty that has been invoked in the context of the protection of medical research subjects is the ECHR. Although it contains no specific article on health, the ECHR includes several human rights that are potentially relevant to such disputes (e.g., the right to life (Article 2), the right to privacy (Article 8), the prohibition of inhuman and degrading treatment (Article 3), and procedural rights (Articles 6 and 5)). The ECHR is applicable at national level, which means that individuals can invoke its provisions before national courts. Moreover, if individuals exhaust all judicial remedies available to them at the national level and still feel that justice has not been served, they can turn to the ECtHR. The latter has the power to find that States are responsible for human rights violations and can ensure compensation for the victims. So far, the application of the right to life (Article 2 ECHR) has received specific attention in the related jurisprudence the ECtHR as we will discuss further in sections 3 and 4 of this paper.

2.2 The United Nations framework

The right to life is also set forth in the United Nations human rights framework. The International Covenant on Civil and Political Rights (United Nations (General Assembly), 1966a; hereafter the ICCPR) stipulates the right to life in Article 6. Furthermore, Article 7 ICCPR expressly prohibits medical or scientific experimentation without the free consent of the individual concerned. No derogation is permitted from these ICCPR provisions (Article 4(2)).

Given that coercion or exploitation of individuals’ personal characteristics undermines ‘free consent’ to medical experimentation, the United Nations Human Rights Committee (the international body that monitors the implementation of the ICCPR by the States who are bound by this treaty) emphasised the need for special protection of persons not capable of giving their valid consent. Furthermore, in its General Comment No. 20 including an authoritative interpretation of Article 7 ICCPR, the UN Committee called for the exclusion of individuals at risk of exploitation from clinical trials that might harm their health (United Nations Office of the High Commissioner for Human Rights, 1992, par. 7).

Several instruments in the United Nations framework stipulate a right to health (e.g., the 1946 Constitution of the World Health Organization and the United Nations treaties discussed in Office of the United Nations High Commissioner for Human Rights and World Health Organization, 2008). Notably, the International Covenant on Economic, Social and Cultural Rights (United Nations (General Assembly), 1966b; hereafter the ICESCR) sets forth the right to health as a fundamental human right and a cornerstone of a life in dignity. As stated in Article 12 ICESCR, ‘everyone has the right to the enjoyment of the highest attainable standard of physical and mental health’. This right is inclusive, which means that it extends beyond access to healthcare and the construction of hospitals and encompasses a wide range of factors that can help individuals lead healthy lives (Office of the United Nations High Commissioner for Human Rights and World Health Organization, 2008, p. 3). As such, the right to health contains freedoms for individuals, which include freedom from non-consensual medical treatment and in particular, freedom from medical experiments conducted without the individual research subject’s free and informed consent (United Nations Committee on Economic, Social and Cultural Rights, 2000, par. 8). Given that human rights are interdependent, indivisible, and interrelated (Office of the United Nations High Commissioner for Human Rights, 1993), violating the right to health may impair the enjoyment of other human rights such as the right to life.

Article 12 ICESCR imposes core obligations on the States that have committed themselves to implement it. States are not allowed to deviate from their core obligations, nor are they allowed to balance these against other interests like economic considerations. As stated in General Comment 14, ‘a state party cannot, under any circumstances whatsoever, justify its noncompliance with the core obligations […], which are non-derogable’ (United Nations Committee on Economic, Social and Cultural Rights, 2000, par. 47). Thus, the core obligations pertaining to the right to health constitute the non-negotiable standard of protection to be ensured by the State for all individuals. These are also applicable in the field of medical research: commentators have argued that the core obligations of the right to health contribute to the establishment of a minimum standard of care in clinical trials as a non-negotiable level of protection to which all individuals are entitled (Marouf and Esplin, 2015). ³

Human rights treaties in the United Nations framework compel State parties to respect, protect, and fulfil human rights (United Nations Committee on Economic, Social and Cultural Rights, 2000, par. 33). The obligation to respect requires States to refrain from interfering with or restricting the enjoyment of human rights, by adopting laws or policies with harmful effects (for example, discriminatory norms, policies, or practices). The obligation to protect requires States to protect individuals (and groups of individuals) from human rights violations carried out by third parties/ non-state actors. This includes non-state actors operating in the field of healthcare like pharmaceutical companies, healthcare providers, researchers, healthcare financing institutions, etc. The obligation to fulfil requires States to take positive action to facilitate the enjoyment of human rights. Individuals can challenge the violations of their rights before courts (national and international) as well as human rights treaty bodies and use these as mechanisms to make States accountable for the non-fulfilment of their obligations.

Despite the established applicability of European and international human rights law to scientific medical research, litigation pertaining to the protection of research subjects has been relatively limited so far and mostly taking place at the national level (for an overview of case law based on tort doctrines in the United States, see Morreim, 2004). Nevertheless, medical research subjects can opt for litigation to enforce their rights. They have done so to enhance accountability of clinical trials (see for examples from India, Terwindt, 2014) or to challenge forced discontinuation of their participation in clinical trials (case G.J v. Lithuania, United Nations Human Rights Committee, 2014). When individuals exhaust all judicial remedies available to them at the national level, they may turn to international courts and tribunals to seek justice. However, such cases rarely reach the international level. One notable example for international level litigation is the illustrative Traskunova case introduced above, in which the patient lost her life during a clinical trial and her relatives opted for human rights litigation to seek justice and compensation for the violation of the patient’s right to life. Based on this case and some further examples from the ECtHR’s jurisprudence, the following section discusses the relevance of Article 2 ECHR, and the State obligations triggered by it.

3. The right to life in the ECtHR jurisprudence: substantive and procedural State obligations under Article 2 ECHR

Article 2 ECHR stipulates the right to life as a ‘non-derogable human right’ that should be protected by the State. As emphasised by the ECtHR, this means that the right to life has a fundamental character and in peacetime, it may not be violated under any circumstances (Guiliani and Gaggio v. Italy, 2011, par. 174). ⁴ Consequently, State parties must put in place practical and effective safeguards to fulfil their related obligations.

Article 2 ECHR simultaneously imposes on States substantive and procedural obligations. This distinction is important because the ECtHR has consistently examined States’ compliance with their procedural obligations separately from their compliance with their substantive obligations (European Court of Human Rights, 2022, p. 34). In some cases, the ECtHR has found a violation of Article 2 ECHR on the sole account of a breach of a procedural obligation and in the absence of any complaint or finding pertaining to substantive aspects (Armani Da Silva v. the United Kingdom, 2016, par. 231). Thus, procedural obligations can give rise to a distinct ‘State interference’ that is examined by the ECtHR independently from the substantive limb of Article 2 ECHR.

Under their substantive obligations, States must protect the right to life by legislative means and refrain from intentional and unlawful deprivation of life. Pursuant to Article 2(1) ECHR, this also entails a positive obligation for States to take appropriate measures to safeguard the lives of individuals under their jurisdiction (European Court of Human Rights, 2022, p. 8; Centre for Legal Resources on behalf of Valentin Câmpeanu v. Romania, 2014, par. 130). Such measures must be adopted in the context of any activity – public as well as private – where the right to life might be affected. This also includes healthcare, as established by the ECtHR in Calvelli and Ciglio v. Italy (2022) and Vo v. France (2004).

The State must fulfil its positive obligation to safeguard individuals’ lives by establishing an effectively functioning regulatory framework and adopting preventive operational measures (European Court of Human Rights, 2022, p. 8). The State is responsible for the implementation, supervision, and enforcement of this regulatory framework (Lopes de Sousa Fernandes v. Portugal, 2017, par. 186, 189, 190; Traskunova, par. 69). In the context of healthcare, this entails adopting regulations that oblige hospitals and healthcare facilities in general, to take appropriate measures for protecting patients’ lives. As an essential component, this includes safeguarding the principle of the patient’s informed consent. As emphasised by the ECtHR in Traskunova (par. 70), patients facing health risks must be able to assess those risks, and ensuring their access to information is crucial towards this end. Therefore, the State must establish rules that compel healthcare professionals to (1) appropriately assess the impact of a medical procedure on the patient’s health and (2) adequately inform the patient of the consequences of the medical intervention so that informed consent can be duly obtained. Vulnerable patients, such as persons with mental illnesses, must be provided with heightened protection. This also entails that particularly strong safeguards must be adopted that consider the specificities and development of such patients’ conditions. As pointed out by the ECtHR, such patients’ decision-making capacity must be objectively established to remove the risk that their consent was obtained without a full understanding of the procedure and its consequences (Arskaya v. Ukraine, 2014, par. 87–90; Traskunova, par. 79).

Under their procedural obligations, States must put in place provisions to carry out effective investigations into alleged violations of the right to life and prevent, deter, suppress, and punish violations (European Court of Human Rights, 2022, pp. 6 and 32; Armani Da Silva v. the United Kingdom, 2016, par. 229; McCann and others v. The United Kingdom, 1995, par. 161). The ECtHR has emphasised this as a distinct obligation inherent in Article 2 (European Court of Human Rights, 2022, p. 34; Šilih v. Slovenia, 2009, par. 153–154). The purpose of the investigation is to ensure effective implementation and enforcement of national laws safeguarding the right to life. The investigation must be initiated by the authorities even in the absence of any formal complaint by the victim’s relatives (Al-Skeini and Others v. the United Kingdom, 2011, par. 165). Furthermore, the procedural obligations require the State to establish an effective and independent judicial system to ensure accountability of those responsible for violations and provide appropriate compensation for the victims (Ciechońska v. Poland, 2011, par. 66). The ECtHR has established the minimum required standards related to the duty to investigate as: independence, adequacy, promptness, public scrutiny, and participation of the next-of-kin (for further discussion on the minimum standards, see European Court of Human Rights, 2022, pp. 36–40).

The ECtHR has extended the scope of procedural obligations under Article 2 ECHR to violations of the right to life in the context of healthcare (Lopes de Sousa Fernandes v. Portugal, 2017, par. 214). It has established that the procedural obligations require the State to put in place an effective and independent judicial system that operates in practice to determine the cause of death of patients and ensure the accountability of those responsible (Šilih v. Slovenia, 2009, par. 192; Lopes de Sousa Fernandes v. Portugal, 2017, par. 214; McCann and others v. The United Kingdom, 1995, par. 161). This concerns healthcare provided in the public as well as the private sector. Civil redress usually satisfies the requirement of an ‘effective judicial system’ in case of unintentional harm caused to patients (Vo v. France, 2004), although criminal proceedings and disciplinary measures may also be used (Nicolae Virgiliu Tănase v. Romania, 2019, par. 159).

As emphasised by the ECtHR, independence (both formal and de facto) is especially important in the context of medical negligence, which is a particularly complex issue (Lopes de Sousa Fernandes v. Portugal, 2017, par. 217). This is illustrated by the difficulty of obtaining independent medical reports from expert witnesses, which are given special importance in the assessment conducted by the courts. Apart from independence, another requirement relevant to the context of healthcare and specifically, to medical negligence in a hospital setting, is the timely completion of the investigation of the circumstances of an individual’s death (Šilih v. Slovenia, 2009, par 196). Timely investigation is crucial for ensuring patient safety, correcting deficiencies, and preventing future malpractice (Oyal v. Turkey, 2010, par. 76).

4. Violation of Article 2 ECHR in practice: lessons from the illustrative Traskunova case

In the case of the 57-year-old patient who lost her life during the clinical trials, the ECtHR concluded that the respondent State had failed to comply with its substantive and procedural obligations under Article 2 ECHR (Traskunova, par. 87–88). But how did the ECtHR reach such a decision? This section highlights the relevant elements of the ECtHR’s reasoning.

According to the jurisprudence of the ECtHR, the question of whether there had been a failure by the State in its regulatory duties called for a concrete assessment of the alleged deficiencies rather than an abstract one (see, for example, Lopes de Sousa Fernandes v. Portugal, 2017, par. 188, 290 and for further examples, European Court of Human Rights, 2022, p. 13). When carrying out this assessment in the illustrative case under review, the ECtHR considered several issues, outlined below.

4.1 Protection of life: substantive state obligations

The ECtHR has pointed it out that the mere fact that the regulatory framework may be deficient in some respects is not sufficient to find a breach of Article 2 ECHR. For the latter, it must be shown that the deficiency has operated to the patient’s detriment (see also Lopes de Sousa Fernandes v. Portugal, 2017, par. 188, 290). As explained above, in the context of healthcare, the State’s substantive positive obligations relating to medical treatment are limited to a duty to regulate and ensure the effective operation of that regulatory framework (Traskunova, par. 69). In addition, it is important for individuals facing risks to their health to have access to information enabling them to assess those risks. States are bound to adopt the necessary regulatory measures to ensure that doctors provide adequate advance information to patients so that they can give informed consent (Traskunova, par. 70).

The ECtHR observed that at the outset the circumstances went beyond the scope of mere medical negligence. The woman’s safety during clinical trials of a new medicine was at stake. It is in the nature of experimental drugs that their quality, efficacy, and safety are subject to doubt, so, clinical trials of such products entail inherent risks to the research subjects’ health and lives. As such, they constitute a form of dangerous activity, which must engage the State’s positive obligation to adopt and implement measures designed to ensure the safety of those involved in such trials (Traskunova, par. 72). Thus, the State must ensure that the risk is reduced to a reasonable minimum. This obligation arises when the State undertakes, organises, or authorises dangerous activities.

However, this positive obligation of the State also has its limits. For example, if the damage has been caused by the negligent conduct of an individual or an accumulation of unfortunate events, it does not constitute a violation of the State’s positive obligations (Traskunova, par. 73). Therefore, the ECtHR emphasised that the key question was ‘whether, when engaging the woman in clinical trials of a new medicinal product, the authorities fulfilled their positive obligation to ensure, through a system of rules and sufficient control, that the risk to her life was reduced to a reasonable minimum’ (Traskunova, par. 74).

When examining this question, the ECtHR first observed that the regulatory framework applicable in the respondent State at the relevant time was not contested. Safeguards and procedures to be followed when organising and carrying out a clinical trial were established in a relevant legal measure and their practical implementation was established in a relevant by-law (Traskunova, par. 75, par. 46–54).

Second, the ECtHR considered that the practical implementation of that legal framework was open to doubt (Traskunova, par. 76). The ECtHR noted, firstly, that the relevant protocols required that a comprehensive medical check-up of participants be carried out before their admission to the trial and that such admission was subject to participants being in a satisfactory state of health. However, the relevant medical information available showed that no such examination had been carried out before the woman’s admission to the clinical trial. In addition, the expert reports attested to the lack of information in the medical records regarding adequate monitoring of the woman’s state of health, during the conduct of both clinical trials. It appeared that the first electrocardiogram was taken only after the woman had fallen into a coma. It was also relevant that after the first clinical trial, the woman displayed symptoms which argued against her participation in the second clinical trial. Nevertheless, she was invited to take part in the second trial without a proper examination of her health condition (Traskunova, par. 76; see also par. 9, 19, 26–27, 40, 42). The ECtHR found it unacceptable that the woman was admitted to, and continued to participate in, the clinical trials in breach of the rules and safeguards created by the domestic system itself, especially bearing in mind what was at stake for her (Traskunova, par. 77).

Third, the ECtHR examined the issue of the woman’s consent to her participation in the clinical trials. It noted that the woman was competent to decide to participate in the study and she was properly informed of the general health risks inherent in the trials. However, due to the lack of implementation of the elementary medical checks, the woman was not aware of her actual medical situation and health condition, which prevented her from making a proper assessment of the potential risks of participating in the study (Traskunova, par. 78; see also par. 6, 22, 26, 70, 76). Furthermore, the woman suffered from a serious mental illness for many years already. As previously explained, members of vulnerable groups including people with mental illnesses, must be guaranteed heightened protection and their participation in clinical trials must be accompanied by particularly strong safeguards. However, the facts of the case revealed that the woman’s mental illness worsened during the first clinical trial (Traskunova, par. 24–25). Nevertheless, she was invited to participate in the second clinical trial and her consent was accepted although the record did not show that the responsible doctor properly assessed whether she was indeed capable of making rational decisions about her continued participation in the trial (Traskunova, par. 79).

Considering the arguments outlined above and bearing in mind the woman’s vulnerability and the serious consequences of those decisions for her, the ECtHR concluded that ‘the practical implementation of the existing framework was deficient and the existing guarantees ensuring the informed consent of participants of clinical trials were not complied with’ (Traskunova, par. 80). Therefore, the ECtHR ruled that the State had breached its substantive positive obligations under Article 2 ECHR.

4.2 Procedural state obligations

As explained above, States are required to set up and operate an effective and independent judicial system so that the cause of death of patients under the care of medical professionals, whether in the public or the private healthcare sector, can be determined and those responsible made accountable. As emphasised by the ECtHR, the issue in this case was whether the State had fulfilled its responsibility under the ECHR (Traskunova, par. 85). The State obligation ‘will be satisfied if the legal system ensures for the victims a remedy in the civil courts, either alone or in conjunction with a remedy in the criminal courts, enabling any responsibility of the doctors concerned to be established and appropriate civil redress to be obtained. Disciplinary measures may also be envisaged’ (Traskunova, par. 81).

The ECtHR observed that the applicant’s attempts to have disciplinary proceedings instituted against those responsible were unsuccessful as the Healthcare Committee ‘established no defects in the conduct of the clinical trials and the treatment’ of the woman: (Traskunova, par. 82, 29–31). The applicant has not attempted to bring a civil lawsuit against the healthcare professionals and therefore, the case did not discuss the availability of civil proceedings, nor did it address the issue of whether a civil law remedy would have added any essential elements not covered by the criminal proceedings (Traskunova, par. 86). Nevertheless, the applicant sought a criminal law remedy but after several rounds of pre-investigation inquiry, the request was refused. Refusal was based on the written consent of the patient to both clinical trials, the lack of defects in the patient’s treatment, and the experts’ findings about ‘the absence of a direct causal link between her participation in the two clinical trials under examination and her death’ (Traskunova, par. 44, 83).

The ECtHR noted that the national authorities did not consider all the relevant facts, such as the experts’ pointing to counter-indications of the woman’s participation in the second clinical trial. In fact, the authorities disregarded the experts’ conclusions regarding ‘the apparent lack of a comprehensive medical examination’ of the woman or the monitoring of her health during the two clinical trials. The latter was indicative of the breach of the relevant national legal framework (Traskunova, par. 84). The national authorities should have examined whether the clinical trials had been carried out in compliance with the relevant legal framework and had implemented the required safeguards. Since no such assessment took place, the ECtHR concluded that no effective remedies were available to the victim and her relatives (Traskunova, par. 85). Thus, the State failed to fulfil its responsibilities under the procedural limb of Article 2 ECHR.

Although the ECHR also stipulates specific procedural rights under Articles 6 (the right to a fair trial) and Article 5 (right to liberty and security), the ECtHR did not refer to these when discussing the State’s procedural obligations in Traskunova. Instead, it grounded the arguments solely on the procedural limb of Article 2. This is in line with the ECtHR’s earlier approach in cases involving patients who lost their life in the context of medical care (see e.g., Asiye Genç v. Turkey, 2015). The ECtHR thus seems to consider that in such disputes, the procedural limb of Article 2 provides sufficient grounds to determine the States’ responsibility and assess whether the national level response concerning the investigation of the circumstances of the patient’s death were appropriate and the judicial reaction was adequate.

4.3 The ECtHR’s ruling

All these considerations led the ECtHR to conclude that the respondent State had failed to comply with its substantive and procedural obligations under Article 2 ECHR and the victims were entitled to appropriate compensation. As pointed out in the ruling, the State ‘has not ensured an effective implementation and functioning of the legal framework with a view to protecting the right to life of the woman – a mentally ill and thus vulnerable individual – in the context of clinical trials of experimental medicinal products, and it has not provided an adequate judicial response to the applicant in that connection’. (Traskunova, par. 87).

5. Final remarks

The illustrative ECtHR case analysed above raises some compelling questions: How can it happen that a core human right such as the right to life, is violated while conducting scientific medical research that has been approved by the authorities? Is the State responsible? What is the State required to do to ensure justice for the victims and prevent such violations? What human rights are relevant to medical research with human subjects, how can these rights be guaranteed, and what is needed to ensure that the human rights framework permeates this dimension of medical law?

The case exemplifies how violations of clinical trial subjects’ human rights can occur through medical research activities insufficiently regulated by the State. The application of the ECHR and specifically, the ruling delivered by the ECtHR in Traskunova shows that the State can be held responsible for violating Article 2 ECHR stipulating the substantive and procedural aspects of the right to life. Such violation occurs if the State fails to effectively implement and operate a legal framework that protects the research subjects and provides an adequate judicial remedy. Even when the scientific medical research is carried out by non-state entities (third parties) such as researchers or healthcare professionals acting in a hospital environment, the State is not exempted from responsibility.

Regardless of the public or private character of the research (e.g., in terms of sponsorship, organisation etc.), the ECtHR case law makes it clear that the State is the main duty-bearer when it comes to protecting the research subjects. Therefore, the State must regulate clinical trials in a manner that ensures appropriate standards of care. Failure to regulate the research activities of non-state healthcare actors in a way that prevents them from causing harm constitutes a violation of the right to life.

Another human right that is relevant to medical research with humans is the right to health. While the ECHR does not include a right to health, the latter is set forth in several treaties within the United Nations human rights framework and notably, in Article 12 ICESCR. A genuinely free and informed consent of research subjects is a core element of the right to health and so is the protection of their safety and wellbeing. Failure of States to effectively safeguard research subjects’ rights constitutes a violation of the State’s obligation to protect under Article 12 ICESCR, as indicated in General Comment 14 (United Nations Committee on Economic, Social and Cultural Rights, 2000). Consequently, if clinical trials are conducted in ways that are not consistent with the right to health, the State is to be held accountable under the UN human rights framework as well. This also implies that the State must compensate the victims and ensure that such violations do not reoccur. To date, litigation invoking the right to health in the context of medical research has very rarely reached UN treaty monitoring bodies. The notable exception of G.J. v. Lithuania (2014) submitted to the UN Human Rights Committee ended with an inadmissibility decision. Nevertheless, this Committee has repeatedly emphasised the importance of free and informed consent to medical or scientific experimentation and the responsibility of States to protect research subjects from risks (United Nations Human Rights Committee, 2001, par. 7 and 2006, par. 31). The right to health remains thus relevant and future litigation with hopefully result in strengthening its application to this field of medical law.

Of course, the emphasis on State responsibility does not exempt medical researchers and healthcare professionals from their obligation to act as good caregivers and properly implement the protocols as approved. Instead, the added value of examining medical research from a human rights perspective is extending the focus beyond the subject-researcher relationship. Human rights law emphasises the responsibilities of the State including its obligation to effectively regulate medical research, protect the individuals who become research subjects, ensure access to justice and effective remedies for victims when things go wrong, and put in place properly functioning mechanisms that prevent similar violations. Moreover, human rights treaties and their interpretation by courts and treaty monitoring bodies can provide valuable guidance for healthcare professionals and equip them to handle concrete situations in the clinical reality when the health and even the life of research subjects are at stake. To date, litigation in this field has been relatively limited, and further case law on research subjects’ rights is needed to ensure that human rights permeate this dimension of medical law. Therefore, courts should take up the challenge of applying the human rights framework to disputes involving the rights of medical research subjects and continue ascertaining that safety of clinical trials is a State responsibility. Courts should also clarify what elements of medical research constitute human rights obligations. Such elements are likely to include research ethics review including proper risk assessment, and possibly, other aspects like peer review and pre-registration of clinical trials. Examining the medical research infrastructure through a human rights lens is a valuable contribution that courts and treaty monitoring bodies could make. And finally, what is needed is that States assume their responsibility to help research subjects become aware of their rights and have access to effective judicial remedies.