The protection of unrepresented patients in emergency care research

ABSTRACT

In emergency care research, it may be the case that neither informed consent nor surrogate consent is possible. In order to nonetheless allow for such research, codes and regulations of research ethics have increasingly incorporated provisions regarding this specific situation. The protection that those provisions offer need to be better understood. This article addresses in what ways they protect individuals, and especially the extent to which the suggested protection compensates for the loss of surrogate consent. The Declaration of Helsinki, the Additional Protocol to the Convention on Human Rights and Biomedicine, and the EU Clinical Trials Regulation serve as the main illustrations.

KEYWORDS:

• Emergency research
• human subjects ethics
• human subjects regulation and oversight
• research ethics
• vulnerable populations
• informed consent
• surrogate consent
• proxy consent

Funding

This work was supported by the Swedish Research Council [Dnr 2012-723].

Notes

¹ WMA Declaration of Helsinki–Ethical Principles for Medical Research Involving Human Subjects (2013).

² Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (2005).

³ Regulation (No. 536/2014) of the European Parliament and of the council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.

⁴ Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997, ETS No. 164).

⁵ For example: According to the Swedish Ethical Review Act, next-of-kin must be “consulted,” when research targets decisionally incapacitated adults, and if the next-of-kin disapproves the subject may not be enrolled in the study. Hence, there is no requirement of a surrogate consent.

⁶ The following summarizes the role of legal representatives according to the traditional model, where such representatives are supposed to make decisions on behalf of individuals found to lack decision-making capacity. Article 12 of the UN Convention on the Rights of Persons with Disabilities questions this model, by taking declarations of incapacity based on cognitive impairments to be illegitimate, and by suggesting, in effect, that supported decision-making should replace substituted decision-making. For an introduction to this alternative paradigm, and a discussion of some of its challenges, see, e.g., Gooding (2015).

⁷ There are, however, several alternative views on the ethical foundation of surrogate decision-making (Broström and Johansson 2009; Brudney 2009; Yarborough 2015).

⁸ Cf. Buchanan and Brock (1989).

⁹ For an overview of the issue of making surrogate decisions for the unrepresented in health care, see Pope (2017).

¹⁰ Cf. the radical position that all “non-therapeutic” research on decisionally incapacitated persons is unethical (Ramsey 1970).

¹¹ Cf. Roberts et al. (2011).

¹² This goes even for the case where “continued research” only involves the processing of already collected data, as section 32 of the Declaration requires consent also in those situations (unless obtaining consent is “impossible or impracticable”). With regard to a code that required consent only for research involving expected physical or mental effects on research subjects, and not for research merely involving the handling of already collected data, the analysis would become more complex. In such a case, the provision that there must be consent to continued research would be redundant with respect to research of the former but not the latter kind. It is not clear what purpose requiring consent for kinds of research that would otherwise not require it would have, as it does not seem to be compensation in kind.

¹³ The Convention on Human Rights and Biomedicine (1997, ETS No. 164) itself contains no emergency rule.

¹⁴ Whether these are substantive protections is a different issue, of course. For example, they include what has been called the same-population condition, according to which non-beneficial research requires that such research must specifically serve to benefit the population to which the research subjects belong. If this condition really contributes to protection is debatable (Johansson and Broström 2012).

¹⁵ The Explanatory Report offers no guidance on this particular question of interpretation.

¹⁶ Another problem, of course, is the difficulty of determining whether the research contemplated falls within the scope of the objection (Moorhouse and Weisstub 1996).

¹⁷ Note that, strictly speaking, the scientific grounds referred to will as a rule only be grounds for predicting certain health outcomes, not grounds for believing that these will have any specific value to the individual concerned, or for determining the personal significance of the burdens involved.

¹⁸ This part of the cushion provided by Article 35 is rather weak, however. The notion that there must be scientific grounds to expect that there is the potential for a clinically relevant benefit for the trial subject (1(b)) is obviously not the same as the idea that one could expect a benefit, much less a net benefit. The relevant benefit need not outweigh risks or burdens, although it is safe to assume that typically it will, since risks and burdens, by the same article, must be minimal. Most importantly, that there is a potential benefit presumably does not mean that such a benefit is likely.

¹⁹ The subject is, however, guaranteed either benefit or minimal harm and burden.

²⁰ For a less probing overview of various emergency rules, see, e.g., Halila (2007).

²¹ Cf., for example, section 32 of the Mental Capacity Act 2005, of England and Wales.

Additional information

Funding

This work was supported by the Swedish Research Council [Dnr 2012-723].