Waiver of informed consent (March 3, 2006) Category: Research ethics

Most prospective research studies require the informed consent of the participants, so it is interesting to find exceptions to this rule. I found a recent publication that has a common sense reason to bypass informed consent.

• TREC-Rio trial: a randomised controlled trial for rapid tranquillisation for agitated patients in emergency psychiatric rooms [ISRCTN44153243]. G. Huf, E. S. Coutinho, C. E. Adams. BMC Psychiatry 2002: 2(1); 11. [Medline] [Abstract] [Full text] [PDF]

This article describes a research protocol that tests tranquilization of agitated patients in an emergency psychiatric situation.

The Helsinki Declaration [26], the European Directive on Clinical Trials [9], and the Nuffield Council documents on bioethics [19] state that trials in non-consenting patients are permitted on two conditions: i. no other context exists in which to answer the question; and ii. all trial participants get clear therapeutic benefit from whichever arm they are randomised to.

Aggressive patients in a situation of psychiatric emergency are not able to give consent for their participation in a study. Drugs are usually given against the will of the patient. So, in the same way that doctors are responsible for the choice of a treatment, they take responsibility for the recruitment of a patient into the study.

However, TREC-Rio will not involve administering an inactive compound to those who clearly need sedation/tranquillisation. Both treatments can calm the patient and there is no 'experimental' intervention. What is still uncertain is the speed for the onset of action, the duration of the effects and the different kinds of adverse reactions. TREC-Rio will answer clinical questions to help the care of these people be more informed. TREC-Rio will also produce widely applicable findings, so that the treatment of people beyond Rio de Janeiro should also be safer.

TREC-Rio has been approved by the ethics committees of institutions in charge of research and local ethics committees of each hospital involved.

A patient/carer information leaflet about TREC-Rio is available for all for whom a TREC-Rio box is opened. Carers will always be free to decide that their relative should not be entered. Not being involved in TREC-Rio will not affect the person's standard of care.

Other examples where informed consent is sometimes bypassed involves care of patients who may be unconscious at the time of treatment.

Interestingly enough, several of the studies of prayer bypassed informed consent, even though it was possible to use consent. Here's a well known example of such a study.

• A Randomized, Controlled Trial of the Effects of Remote, Intercessory Prayer on Outcomes in Patients Admitted to the Coronary Care Unit. William S. Harris, M. Gowda, J.W. Kolb, C.P. Strychacz, J.L. Vacek, P.G. Jones, A. Forker, J.H. O'Keefe, B.D. McCallister. Archives of Internal Medicine 1999: 159(19); 2273-2278. [Medline] (Ethics, Informed Consent)

The rationale was that the researchers wanted to avoid volunteer bias. A major consideration, I suspect, was that most people would not be offended if they found out that someone was praying for them.

This web page was written and was last modified on 09/24/2007.