Consent based on trust rather than information?

Pär SegerdahlConsent to research participation has two dimensions. On the one hand, the researcher wants to do something with the participant: we don’t know what until the researcher tells. To obtain consent, the researcher must provide information about what will be done, what the purpose is, what the risks and benefits are – so that potential participants can decide whether to consent or not.

On the other hand, potential participants would hardly believe the information and consider consenting, if they didn’t trust the researcher or the research institution. If trust is strong, they might consent even without considering the information. Presumably, this occurs often.

The fact that consent can be given based on trust has led to a discussion of trust-based consent as more or less a separate form of consent, next to informed consent. An article in the journal Bioethics, for example, argues that consent based on trust is not morally inferior to consent based on information. Consent based on trust supports autonomy, voluntariness, non-manipulation and non-exploitation as much as consent based on information does, the authors argue.

I think it is important to highlight trust as a dimension of consent to research participation. Consent based on trust need not be morally inferior to consent based on careful study of information.

However, I get puzzled over the tendency to speak of trust-based consent as almost a separate form of consent, next to informed consent. That researchers consider ethical aspects of planned research and tell about them seems to be a concrete way of manifesting responsibility, respect and trustworthiness.

Carefully planning and going through the consent procedure is an ethical practice that can make us better humans: we change through what we do. It also opens up for respondents to say, “Thank you, I trust you, I don’t need to know more, I will participate.” Information and trust go hand in hand. There is dynamic interplay between them.

I guess that a background to talk of trust-based consent as almost a separate form of consent is another tendency: the tendency to purify “information” as cognitive and to idealize humans as rational decision makers. In addition, there is a tendency to regiment the information that “must” be provided.

This tendency to abstract and regulate “information” has made informed consent into what sometimes is perceived as an empty, bureaucratic procedure. Nothing that makes us better humans, in other words!

It would be unfortunate if we established two one-dimensional forms of consent instead of seeing information and trust as two dimensions of consent to research.

Another article in Bioethics presents a concrete model of trust-based consent to biobank research. Happily, the model includes willingly telling participants about biobank research. Among other things, one explains why one cannot specify which research projects will use the donated biological samples, as this lies in the future. Instead, one gives broad information about what kind of research the biobank supports, and one informs participants that they can limit the use of the material they donate if they want to. And one tells about much more.

Information and trust seem here to go hand in hand.

Pär Segerdahl

Halmsted Kongsholm, N. C., Kappel, K. 2017. Is consent based on trust morally inferior to consent based on information? Bioethics. doi: 10.1111/bioe.12342

Sanchini, V. et al. 2016. A trust-based pact in research biobanks. From theory to practice. Bioethics 4: 260-271. doi: 10.1111/bioe.12184

This post in Swedish

We like real-life ethics : www.ethicsblog.crb.uu.se

3 Responses to Consent based on trust rather than information?

  1. Matthew Cote, MD says:

    Trust as a moral equivalent to information disclosure for medical research participation is an alluring concept. Certainly, trust forms an essential component of any doctor patient relationship. It is an underlying assumption of the modern practice of medicine. It is why a person will voluntarily present to a doctor’s office, change out of their clothes into a gown, and discuss personal problems with their medical provider who is other a complete stranger to them. Patients trust in the training and professionalism of the medical providers. They also trust that the medical providers goal is the best health interests of the patient. There was a time when that trust was so strong, that patient’s didn’t want or need to understand the reasoning behind the doctor’s diagnosis or treatment plan. The modern practice of medicine is swinging away from this paternalistic approach to patient care, but it remains rare for a patient to fully question all the options available to them and select an option different than that recommended by their provider. At the end of the day, patients trust that their physician or medical provider is going to treat them based on a pure motive of what is in the patient’s best interest.

    In the case of most medical research, however, a medical provider can’t make any assertion about whether participation is in the patient’s best interest. By definition, the provider doesn’t know whether the experimental treatment will be better than the standard treatment, or cause health complications or side effects with worse outcomes. The very purpose of the experiment is to answer those questions. Therefore, even under a paternalistic philosophy of medical practice, an honest practitioner cannot recommend participation in a trial to a patient on the basis of it being in the patient’s best interest. It might be, and it might not – or it could be worse. As a result, consent to research cannot be ethically based on trust alone when the basis for that trust is the assumption that the medical provider will only seek the good of the patient. The provider cannot make that assertion in medical research. The danger of trust based consent is that the motivation of the medical provider is no longer purely what is in the patient’s best interest, but is now clouded by the providers desire to pursue the research and the providers need for patients to participate in order to get the project completed. This poses a clear conflict of interest that is unavoidable, necessitating that the provider take themselves out of any decision making role. In a few limited situations, such as the biobank example, participation does not pose additional risk or benefit to the individual, and the burden of informed consent specificity is thereby lessened. It would be wrong, however, to consider the need for informed consent obviated, however. The limitations of informed consent are challenging enough, given that they are predicated on the underlying trust patients have for their doctors and by association, health institutions, making them predisposed to participate. Still, informed consent remains the primary ethically appropriate way to enroll patients in medical research, the burden of which is not overly onerous. Unless, of course, we desire to take advantage of and ultimately erode the underlying trust that forms the basis of the relationship between a patient and their doctor.

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