Informed consent: some reservations Julius Sim Keele Clinical Trials Unit Research Institute for Primary Care and Health Sciences Keele University, UK

Outline of talk The nature and moral basis of informed consent Absolute versus relative views of consent How authentic is consent? How achievable is consent?

Informed consent ‘The basic idea of informed consent is that a researcher is only (ethically and/or legally) justified in using a research subject in a project if the research subject has consented to being so used.’ Holm & Madsen, 2009 ‘…no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.’ Declaration of Helsinki, 2013

Moral basis of consent

Consent and autonomy Informed consent derives its moral weight from the fundamental moral principle of respect for autonomy. ‘Personal autonomy is, at a minimum, self-rule that is free from both controlling interference by others and from limitations, such as inadequate understanding, that prevent meaningful choice’. Beauchamp & Childress, 2001

The stringency of consent

The stringency of consent Alternative views of the requirement for consent: of equal stringency in all cases – ‘absolute’ or of varying stringency, adjusted to the situation – ‘relative’

Consent as absolute The absolute view of consent suggests a belief in the supremacy of autonomy as a moral principle. Is this plausible?

Consent as relative We tend to think that, in certain instances, informed consent is of particular importance…

Consent as relative Procedures that have potentially serious side-effects Procedures whose effects are irreversible Procedures that may be physically or psychologically invasive Procedures that offer no direct benefit to the person asked to consent

Consent as relative We tend to think that, in certain instances, informed consent is of particular importance. So, consent does not have a single, fixed level of stringency. It seems to follow that in some other instances the importance of consent may be particularly low. The consent requirement is prima facie.

The authenticity of consent

The moral force of consent The moral force of informed consent depends upon the extent to which, factually: Participants are adequately informed (disclosure and comprehension) Participants genuinely feel free to give or withhold consent

Understanding and recall Empirically, it is very difficult to secure understanding and recall in those to whom trial procedures are explained, however conscientiously this is done (Snowdon et al, 1997; Sugarman et al, 1999; Featherstone and Donovan, 2002).

Therapeutic misconception ‘Just over half of the participants indicated that they had expected to receive treatment based on their diagnosis and an assessment of their specific needs by a clinician… in the way they perceived normal clinical practice to occur’. Featherstone and Donovan, 2002

Is consent achievable?

Consent in cluster trials In a cluster-cluster trial, the intervention is delivered at the level of the cluster (e.g. community, primary care practice, hospital ward). Can individual participants meaningfully consent to: The trial taking place? participation? data collection?

Consent in cluster trials Consent may be dispensable in some cluster-cluster trials, because: The trial is incompatible with an insistence on individual consent The potential value of the trial is substantial Individual consent is not really expected (Sim & Dawson, 2012)

Conclusion Consent should not be seen as absolute, but is not thereby unimportant We should not attach too much moral weight to the gaining of consent Sometimes, consent is dispensable

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References Beauchamp TL, Childress JF (2008) Principles of Biomedical Ethics. 6th edn. Oxford University Press, New York. Featherstone K, Donovan JL (2002) “Why don't they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomised controlled trial. Social Science and Medicine 55: 709-719. Holm S, Madsen S (2009) Informed consent in medical research – a procedure stretched beyond breaking point? In Corrigan O et al (eds.) The Limits Of Consent: a Socio-legal Approach to Human Subject Research in Medicine. Oxford: Oxford University Press; 11–24. Sim J, Dawson A (2012) Informed consent and cluster randomized trials. American Journal of Public Health 102: 480–485. Snowdon C et al (1997) Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Social Science and Medicine 45: 1337-1355. Sugarman J et al (1999) Empirical research on informed consent. Hastings Center Report 1999;29(suppl):S1–S42.

WHO requirements for consent Communicate to the prospective subject all information necessary for adequately informed consent Give the prospective subject full opportunity and encouragement to ask questions Exclude the possibility of unjustified deception, undue influence and intimidation Seek consent only after the prospective subject has adequate knowledge of the relevant facts and of the consequences of participation, and has had sufficient opportunity to consider whether to participate Obtain a signed form as evidence of informed consent