Decision making by healthy volunteeers in clinical trials

The study reported inthis article set out to test the quality of the decision-making process of healthy volunteers in clinical trials.

Researchers fear that the decision to volunteer for clinical trials is taken inadequately and that the signature on the consent forms, meant to affirm that consent was 'informed', is actually insubstantial. Over a period of a year, candidates were approached during their screening process for a proposed clinical trial, after concluding the required 'Informed Consent' procedure. In all, 100 participants in phase I trials filled out questionnaires based ultimately on the Janis and Mann model of vigilant information processing, during their stay in the research centre.

The results were that only 35% of the participants reached a 'quality decision'. There is a definite correlation between information processing and quality decision-making. However, many of the healthy research volunteers (58%) do not seek out information nor check alternatives before making a decision.

The research conluded that full disclosure is essential to a valid informed consent procedure but not sufficient; emphasis must be put on having the information understood and assimilated. Research nurses play a central role in achieving this objective.

Rabin C, Tabak N. Healthy participants in phase I clinical trials: the quality of their decision to take part. J Clin Nurs. 2006 Aug;15(8):971-9. PMID: 16879541