Bouida Wahid, Grissa Mohamed Habib, Zorgati Asma, Beltaief Kaouthar, Boubaker Hamdi, Sriha Asma, Boukef Riadh, Nouira Semir
Emergency Department, Fattouma Bourguiba University Hospital Monastir, Monastir, 5000, Tunisia.
Research Laboratory (LR12SP18), University of Monastir, Monastir, Tunisia.
BMC Med Ethics. 2016 Aug 4;17(1):47. doi: 10.1186/s12910-016-0131-3.
Few studies have identified the willingness rate of developing countries population to be enrolled in clinical trials.
All 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.
Overall, 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]).
Most 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.
很少有研究确定发展中国家人口参与临床试验的意愿率。
所有参与者，包括患者（n = 612）、健康志愿者（n = 354）和医生（n = 134），都完成了一份问卷，以调查影响参与医学研究同意率的因素。
总体而言，80%的纳入人群同意参与健康研究。对于涉及危及生命疾病的试验，这一比例较低（38%）。利他主义和感知到的伤害风险分别是接受或拒绝参与临床试验的主要原因。与意愿显著相关的因素有：年龄<40岁（优势比（OR）1.6 [95%置信区间（CI）1.2 - 2.1]）和既往献血史（OR 2.4 [95% CI 1.7 - 3.5]）。
大多数参与者表示愿意参与医学研究，特别是如果他们年轻或有献血史。然而，当医学研究需要急症护理时，参与同意率较低。
