Healthy participants in phase I clinical trials: the quality of their decision to take part.

AIMS AND OBJECTIVE

This study was set out to test the quality of the decision-making process of healthy volunteers in clinical trials.

BACKGROUND

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.

DESIGN

The study design was quasi-experimental, using a convenience quota sample.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.