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


METHODS
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.
Rabin
Cheryl
C
Clinical Research Center, Tel-Aviv-Sourasky Medical Center, Tel Aviv, Israel. rabincheryl@hotmail.com
Tabak
Nili
N
D001294:Attitude to Health; D017321:Clinical Trials, Phase I as Topic / Q000451:nursing / Q000523:psychology*; D003220:Conflict, Psychological; D003657:Decision Making; D030881:Disclosure; D006040:Goals; D006301:Health Services Needs and Demand; D064368:Healthy Volunteers / Q000523:psychology; D006801:Humans; D007258:Informed Consent; D007557:Israel; D016014:Linear Models; D016743:Mental Competency; D008606:Mental Processes; D008960:Models, Psychological; D009042:Motivation; D024802:Nurse's Role / Q000523:psychology; D015404:Nursing Methodology Research; D010353:Patient Education as Topic; D018579:Patient Selection; D012108:Research Personnel; D035842:Research Subjects / Q000523:psychology*; D011795:Surveys and Questionnaires