Abstract
BackgroundFew studies have identified the willingness rate of developing countries population to be enrolled in clinical trials.MethodsAll participants including patients (n = 612), healthy volunteers (n = 354) and doctors (n = 134) completed a questionnaire to examine factors affecting the consent to participate in medical research.ResultsOverall, 80 % of the included population agree to participate in health research. This rate was lower for trials dealing with life-threatening diseases (38 %). Altruism and perceived risk of harm were the main reason to respectively accept or refuse to participate in clinical trials. Factors significantly associated with willingness were: age <40 years (Odds Ratio (OR) 1.6 [95 % Confidence Interval (CI) 1.2-2.1]) and prior history of blood donation (OR 2.4 [95 % CI 1.7-3.5]).ConclusionMost participants expressed their willingness to be included in medical research especially if they are young or if they have history of blood donation. However, consent to participate is low when medical research required acute care.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-016-0131-3) contains supplementary material, which is available to authorized users.
Highlights
Few studies have identified the willingness rate of developing countries population to be enrolled in clinical trials
676 (61 %) were younger than 40 years, 21 % had no co-morbidities, and 34.5 % had a previous history of blood donation
Doctors group had the highest proportion of history of prior participation in medical research and blood donation
Summary
Few studies have identified the willingness rate of developing countries population to be enrolled in clinical trials. Many observers noted the underrepresentation of patients from developing countries in these trials, especially Muslim communities which raises concerns about the generalizability of their results [4, 5]. Socio-cultural factors like illiteracy, logistical barriers, and distrust in clinical research may influence people’s decision to participate in biomedical research and possibly limit the rate of consent [6,7,8,9]. There is no study that assessed the willingness of Muslim and Arab communities to participate in individual research trials. The purpose of our study was to evaluate willingness to participate in medical research in a Tunisian population, and determine factors that could influence their consent
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