Is informed consent ever truly informed?
This is the question posed by Professor Kenneth Boyd, Edinburgh, as he considers the subject in the 40 years of publishing in the Journal of Medical Ethics. Posing more questions than the review itself answers, Boyd surveys the subject in the context of papers published by the journal, showing the evolution of consent in terms of care of the patient.
Although the majority of his remarks concern the ethical dilemmas clinicians face as they deal with patients, Boyd acknowledges that the question of whether or not informed consent is ever truly reached affects medical research as well as clinical treatment. In the clinical setting doctors must present treatment options and discuss side effects, whereas research requires disclosure of all potential known outcomes and studies planned for the sample/data collection. Even though the situations are different, ensuring that the participant is informed enough to adequately give consent is imperative. This review therefore covers a number of key areas pertinent to the duty of care owed by biobanks to their donors. As consent and re-consent issues evolve in the light of ELSI (ethical, legal and social issues) advances, the points raised for consideration are worth reviewing by biobankers.
Over its 40 years of publishing, the journal oversaw a change in outlook from a paternalistic stance by clinicians, recommending a certain line of treatment that the patient could accept or refuse, to one in which doctors respected the patient’s autonomy as a whole person with human rights. In this model, the doctor or researcher must make sure that as much knowledge as possible is transferred to the patient/donor so that they have sufficient information to reach a conclusion—in other words, an informed consent to treatment or involvement in a clinical trial, research study or biospecimen collection.
Boyd raises a number of considerations that question whether the consent obtained in this manner is truly informed.
First, he asks whether it is possible to convey all the knowledge required for informed consent in the limited time available during an appointment. Alongside limited time, he also introduces the possibility of the individual having a limited capacity to absorb such information. It is possible also that the consent process acts as a “social filter,” placing vulnerable and excluded individuals at a disadvantage.
Developing on this theme, Boyd also points out that fully informed consent is not possible where the individual is vulnerable, either through illness, dependence or discrimination, an area reviewed recently on the blog in looking at the pre-enrolment of susceptible individuals in disease-specific biobanks. Moreover, overwhelming an individual with all the potentials confuses instead of informs.
Next, he points out that the professional responsible for obtaining the informed consent is also one of the variables. Informed consent is not possible if the doctor or researcher involved is not a moral character, or is lacking sufficient knowledge of the process under question. If the person administering the request is not capable, then the consent obtained is not truly informed.
However, the professional seeking the consent also has a duty of care to ensure that the individual’s belief system is aligned with the request being made. Informed consent is not possible if the beliefs in place are not rational, so that reasoning and reaching an informed decision are thus impaired. It may therefore be the responsibility of the professional to persuade the patient/donor to abandon irrational beliefs in order to allow informed consent, or at least to recognize the significance of the situation.
In conclusion, having reviewed papers on the subject published in the last 40 years, Boyd suggests that the consent process is returning once more to beneficence towards the patient/donor rather than allowing autonomy to dominate. The consent process seems to be an ongoing process, arising from the development of a trusting relationship between the parties. Boyd suggests that the process should be “user friendly,” providing reassurance, without deception or excess persuasion, that upholds patient/donor autonomy in gaining informed consent.
1. Boyd, K. (2015) “The impossibility of informed consent?” Journal of Medical Ethics, 41 (pp. 44–47), doi: 10.1136/medethics-2014-102308