Interpersonal Values of Healthy Subjects Who Volunteer for Phase I Clinical Trials
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ORIGINAL RESEARCH ARTICLE
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Interpersonal Values of Healthy Subjects Who Volunteer for Phase I Clinical Trials Luis Almeida,1,2 Manuel Vaz-da-Silva,3 Rui Coelho,4 Anto´nio Albino-Teixeira2,5 and Patrı´cio Soares-da-Silva2,3 1 2 3 4 5
Health Sciences Section, University of Aveiro, Aveiro, Portugal Institute of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Oporto, Portugal Department of Research and Development, BIAL (Portela & Co, SA), S. Mamede do Coronado, Portugal Service of Psychiatry and Mental Health, Faculty of Medicine, University of Porto, Oporto, Portugal Institute for Molecular and Cell Biology, University of Porto, Oporto, Portugal
Abstract
Background: Participation in phase I studies of experimental pharmaceuticals depends on informed consent; thus the personality and psychological characteristics of the recruited subjects may have an influence on their decision to volunteer. Here, we report a study aiming to assess whether ‘interpersonal values’ (conditioning the direct interactions with others) of healthy subjects who volunteer for phase I studies are different from the general population. Methods: The study population consisted of 138 consecutive healthy subjects who volunteered for phase I studies. The subjects’ interpersonal values were assessed using the Survey of Interpersonal Values (SIV) and were compared with the general population. SIV contains six scales that characterize the following values: Support (being treated with understanding, receiving encouragement from other people, being treated with kindness and consideration); Conformity (doing what is socially correct, following regulations closely, doing what is accepted and proper, being a conformist); Recognition (being looked up to and admired, being considered important, attracting favourable notice, achieving recognition); Independence (being free to make one’s own decisions, having the right to do whatever one wants to do, being able to do things in one’s own way); Benevolence (doing things for other people, sharing with others, helping the unfortunate, being generous) and Leadership (being in charge of other people, having authority over others). Results: As compared with the general population, phase I study participants reported higher levels of importance on the values of support (p < 0.001), independence (p < 0.001) and benevolence (p < 0.001), and significantly lower levels of importance on the values of conformity (p < 0.001) and leadership (p < 0.001). Conclusion: Interpersonal values of participants in phase I studies differed from the general population. Further studies are needed to assess the possible influence of the personality and psychological characteristics of healthy volunteers on the study outcomes and on the interpretation and generalizability of the results.
Background Phase I studies with new drugs are typically conducted in healthy volunteers and participation is based on informed consent. Therefore, participants are a self-sele
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