Is There an Ethical Obligation to Disclose Controversial Risk? A Question From the ACCORD Trial

Abstract

Researchers designing a clinical trial may be aware of disputed evidence of serious risks from previous studies. These researchers must decide whether and how to describe these risks in their model informed consent document. They have an ethical obligation to provide fully informed consent, but does this obligation include notice of controversial evidence? With ACCORD as an example, we describe a framework and criteria that make clear the conditions requiring inclusion of important controversial risks. The ACCORD model consent document did not include notice of prior trials with excess death. We develop and explain a new standard labeled risk in equipoise. We argue that our approach provides an optimal level of integrity to protect the informational needs of the reasonable volunteers who agree to participate in clinical trials. We suggest language to be used in a model consent document and the informed consent discussion when such controversial evidence exists.

Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee

“…However, the final decision regarding study participation and accepting the risks is left to the discretion of each potential participant ( Shaw, 2014 ; Van Luijn et al, 2002 ). Therefore, REC members need to ensure that the potential risks of procedures have been appropriately described in participant information sheets, even when they might be minor, uncertain, or even controversial ( DeMarco et al, 2014 ). The risks should also be described in a manner that is easily understandable for each potential participant.…”

Response to the Open Peer Commentaries on “Is There an Ethical Obligation to Disclose Controversial Risk? A Question From the ACCORD Trial”

“…A Question From the ACCORD Trial," (DeMarco et al 2014) consider important the issue we raise: treatment of disputed evidence in clinical trials. Further, these commentators recognize the merit in our proposed standard, risk in equipoise.…”

A 7.0–7.7% value for glycated haemoglobin is better than a <7% value as an appropriate target for patient-centered drug treatment of type 2 diabetes mellitus

“…This evidence indicates that achieving levels under 7% are not shown to decrease mortality. Ethical issues have been raised concerning pharmacologically induced decrease of glycated haemoglobin in patients with diabetes to low values, in particular given the results of the ACCORD trial (25). Furthermore, reducing levels below 7% tends to increase the occurrence of hypoglycaemia (26).…”

“…Informed consent under these circumstances would be flaccid, mere speculation. But given the risky quasi-experimental nature of the treatment, under the schema, a patient has a right to a rigorous informed consent (25).…”