Research ethics in palliative care: A hallmark in Palliative Medicine

Abstract

Research ethics, which refers to the analysis of ethical issues that may occur when people are involved as research participants,¹ is an area of expanding interest. It is unsurprising that ethical frameworks, guidelines, and international legislation coexist to address the ethical features of research. For instance, the Nuremberg Code,² the Declaration of Helsinki,³ the CIOMS (Council for International Organizations of Medical Sciences) guidelines,⁴ the Charter of Fundamental Rights of the European Union,⁵ and the European Convention on Human Rights⁶ are all well-known frameworks and guidelines that constitute the foundation for national legislation and codes of research ethics.

The mere existence of these documents, however, is not enough to ensure that research is ethically sound. To be so, researchers need to acquire the knowledge expressed in their content, integrate their inherent principles, translate them into everyday research practices, and become critically competent to mobilize them when facing ethical issues and challenges directly relevant to their research.

Research involving human beings as participants raises ethical, legal, social, and political concerns. This is particularly relevant if participants are in a more vulnerable condition due to one or several characteristics: cognitive (Does the person have the capacity to understand and make a decision?), situational (Is the person in a situation in which medical exigency prevents the education and deliberation needed to decide?), medical (Has the person a serious health-related condition with limited prognosis?), allocational (Is the person lacking in important social goods that can influence his or her decision?), social (Does the person belong to a group whose rights and interests have been socially disvalued?), and deferential (Is the person’s deferential behavior masking an underlying unwillingness to decide?).^7,8

Vulnerability is a touchstone in bioethics and a frequent common denominator to research ethics.⁸ The main goal of research ethics is threefold: (1) to protect human participants, particularly those who are more vulnerable; (2) to ensure that research is conducted in a way that serves interests of individuals, groups, and/or society; and (3) to scrutinize research activities and projects for their ethical soundness, looking at issues such as the management of risk, protection of confidentiality, and the process of informed consent.¹

Patients with palliative care needs often exhibit at least one, or several, of the aforementioned categories of vulnerability. This calls for protection, but should not prevent research participation. Excluding vulnerable patients from participating in relevant research could suggest that society is failing in its obligation to improve high-quality, evidence-based healthcare due to misguided paternalism.⁸

Research ethics has been a hallmark in Palliative Medicine. The first publication on research ethics appeared in “Palliative Medicine” in 1994 and discussed some ethical issues inherent to palliative care research.⁹ Other publications followed (works by Speck,¹⁰ Clein,¹¹ Wilkie¹²) in successful attempts to discuss ethical issues while fostering palliative care research. Important arguments for and against placebo-controlled trials in palliative care were debated in the late 1990s.^13,14 In 2001, an editorial highlighted the decision of the editorial board to require all authors to provide a statement outlining how the ethical issues of the studies had been addressed.¹⁵ At the time, this was novel. Now, the requirement remains, together with the need to challenge ourselves. We should go beyond the mandatory statement of ethics approval. Recent articles on research ethics have been contributing to ongoing ethical debates,¹⁶ developing recommendations,¹⁷ exploring reasons for gatekeeping,¹⁸ reflecting on the dying persons’ perspectives and experiences in palliative care research,¹⁹ and even on highlighting the deeply ethical practice inherent to palliative care.²⁰

These articles, now collated in this virtual issue on “research ethics in palliative care,” can only illustrate the importance that research ethics occupies in “Palliative Medicine.” By bringing them together, we hope to contribute to the development of ethically sound palliative care research.

References

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World Medical Association. Declaration of Helsinki—ethical principles for medical research involving human subjects, https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for health-related research involving humans. 4th ed. Geneva: CIOMS, 2016.

European Parliament. Charter of Fundamental Rights of the European Union. Official Journal of the European Communities. 2000/C 364/01, http://www.europarl.europa.eu/charter/pdf/text_en.pdf

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