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.
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This study was financially supported by BIAL (Portela & Co, SA). We thank the study participants and the clinical staff of the clinical pharmacology unit of BIAL (Portela & Co, SA) for their cooperation.
The authors have no conflicts of interest that are directly relevant to the content of this study.
Almeida L, Kashdan TB, Nunes T, et al. Who volunteers for phase I clinical trials? Influences of anxiety, social anxiety and depressive symptoms on self-selection and the reporting of adverse events. Eur J Clin Pharmacol 2008; 64 (6): 575–82PubMedCrossRefGoogle Scholar
Tishler CL, Apseloff G, Bartholomae S, et al. Are normal healthy research volunteers psychologically healthy? A pilot investigation. Exp Clin Psychopharmacol 2007; 15 (6): 539–45PubMedCrossRefGoogle Scholar
Tishler CL, Bartholomae S. The recruitment of normal healthy volunteers: a review of the literature on the use of financial incentives. J Clin Pharmacol 2002; 42: 365–75PubMedCrossRefGoogle Scholar
Tishler CL, Bartholomae S, Rhodes AR. Personality profiles of normal healthy research volunteers: a potential concern for clinical drug trial investigators? Med Hypotheses 2005; 65 (1): 1–7PubMedCrossRefGoogle Scholar
Almeida L, Azevedo B, Nunes T, et al. Why healthy subjects volunteer for phase I studies and how they perceive their participation. Eur J Clin Pharmacol 2007; 63: 1085–94PubMedCrossRefGoogle Scholar
Ayd FJ, Calabresi P. Motivations and rewards for volunteering to be an experimental subject. Clin Pharmacol Ther 1972; 13: 771–81PubMedGoogle Scholar
Tishler CL, Bartholomae S. Repeat participation among normal healthy research volunteers: professional guinea pigs in clinical trials? Perspect Biol Med 2003 Fall; 46 (4): 508–20PubMedCrossRefGoogle Scholar
Bigorra J, Baños JE. Weight of financial reward in the decision by medical students and experienced healthy volunteers to participate in clinical trials. Eur J Clin Pharmacol 1990; 38: 443–6PubMedCrossRefGoogle Scholar
Meyer FP. Psycho- and immunopharmacological factors relevant to selection of volunteers in clinical studies. Int J Clin Pharmacol Ther 2001 Jul; 39 (7): 300–10PubMedGoogle Scholar
Morselli PL. Are phase I studies without drug level determination acceptable? Fundam Clin Pharmacol 1990; 4 Suppl. 2: 125s–33sPubMedCrossRefGoogle Scholar
Xu F. Effect of personality type on pharmacodynamics through changing pharmacokinetics. Med Hypotheses 2007; 69: 1131–4PubMedCrossRefGoogle Scholar
Almeida L, Falcao A, Coelho R, et al. The role of socio-economic conditions and psychological factors in the willingness to volunteer for phase I studies. Pharm Med 2008; 22 (6): 367–74CrossRefGoogle Scholar
Meyer FP, Haschke R, Rohl FW. The healthy volunteer in clinical pharmacology: personality and motivation. Eur J Clin Pharmacol 1995; 48 (2): 91–6PubMedCrossRefGoogle Scholar
Beukman TL. Culture values and work-related values: a theoretical overview. In: The effect of selected variables on leadership behaviour within the framework of a transformational organisation paradigm, chapter 3 [thesis]. Pretoria: University of Pretoria, 2005Google Scholar
Rohan MJ. A rose by any name? The values construct. Pers Soc Psychol Rev 2000; 4: 255–77CrossRefGoogle Scholar
Gordon LV. Survey of interpersonal values: technical manual. 3rd ed. Chicago (IL): Science Research Associates, 1993Google Scholar
Gordon LV. Inventário de Valores Interpessoais (SIV): Manual Técnico. Lisbon: CEGOC-TEA, Ltd, 2001Google Scholar
Rocha D. SIV: CEGOC System, software para cotação informatizada do teste SIV. Lisbon: CEGOC-TEA, Ltd, 2001Google Scholar
Almeida L, Kashdan TB, Coelho R, et al. Healthy subjects volunteering for Phase I studies: influence of curiosity, exploratory tendencies and perceived self-efficacy. Int J Clin Pharmacol Ther 2008; 46 (3): 109–18PubMedGoogle Scholar
Zuckerman M. Psychobiology of personality. New York: Cambridge University Press, 1991Google Scholar
Bardi A, Schwartz SH. Values and behavior: strength and structure of relations. Pers Soc Psychol Bull 2003; 29: 1207–20PubMedCrossRefGoogle Scholar
Van Gelderen CEM, Savelkoul TJF, Van Dokkum W, et al. Motives and perception of healthy volunteers who participate in experiments. Eur J Clin Pharmacol 1993; 45: 15–21PubMedCrossRefGoogle Scholar
Meyer FP. Aspekte einer differentiellen Human-psychopharmakologie. In: Oldigs-Kerber J, Leonard JP, editors. Pharmakopsychologie: experimentelle und klinische Aspekte. Jena: Fischer, 1992: 187–200Google Scholar
Almeida L, Falcao A, Vaz-da-Silva M, et al. Personality characteristics of volunteers in Phase 1 studies and likelihood of reporting adverse events. Int J Clin Pharmacol Ther 2008; 46 (7): 340–8PubMedGoogle Scholar
Almeida L, Coelho R, Albino-Teixeira A, et al. Adverse non-drug-related complaints by healthy volunteers in Phase I studies compared to the healthy general population. Int J Clin Pharmacol Ther 2008; 46 (11): 574–83PubMedGoogle Scholar