健康志愿者参与临床试验的动机、障碍和伦理问题

IF 0.8 4区 医学 Q4 TROPICAL MEDICINE Biomedica Pub Date : 2023-03-26 DOI:10.24911/biomedica/5-869
Rajabzadeh Asghar, J. Saleem, Muhammad Ishaq
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引用次数: 0

摘要

招募足够数量的健康志愿者对临床试验的成功至关重要,但关于促使健康志愿者参加临床试验的因素的研究有限,特别是在发展中国家。在2019冠状病毒病大流行期间,巴基斯坦的研究人员也面临着招募足够健康志愿者的问题,当时巴基斯坦开始了一些临床试验。巴基斯坦国家生物伦理委员会(NBC)在过去两年中处理了大约117个研究提案。这些临床研究的主要目标是健康人群作为主要研究对象或对照。许多研究调查了动机、障碍、风险等因素。影响招募和参与临床试验的健康志愿者的利益和伦理价值。我们对相关文献进行了回顾,以了解激励或阻止健康人志愿服务的因素以及相关的伦理问题。经济激励是健康志愿者参与临床试验的主要动机,此外还有利他主义、对科学、研究和他人健康的贡献、参与重要活动的愿望、对科学和医学的更多了解、获得医疗保健和免费体检的机会以及扩大社交网络的前景,而时间不便、保密、可能的副作用和给药途径以及对接触疾病的恐惧被认为是重要的障碍。应用这些动机和障碍的知识将有助于巴基斯坦研究人员为他们的临床试验招募足够数量的健康志愿者。
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Participation of Healthy Volunteers in Clinical Trials – Motives, Barriers and Ethical Issues
Recruitment of adequate number of healthy volunteers is vital for success of clinical trials but there is limited research on factors motivating the healthy volunteers to participate in clinical trials especially in developing countries. Pakistani researchers also faced the problems in enrollment of enough healthy volunteers during COVID-19 pandemic when a number of clinical trials began in Pakistan. Around 117 research proposals were processed by the National Bioethics Committee (NBC) of Pakistan in last two years. A major proportion of these clinical research studies target healthy populations as primary research subjects or as controls. Numerous studies have investigated factors such as motives, barriers, risks. benefits and ethical values affecting recruitment and participation of healthy volunteers in clinical trials. We have reviewed the literature to learn about factors that motivate or prevent the healthy persons to volunteer along with the pertaining ethical issues. Financial incentive is the principal motive for healthy volunteers to participate in clinical trials along with altruism, contribution to sciences, research and other people’s health, desire to take part in something important, learning more about science and medicine, access to healthcare & free medical checkup and prospects of one’s social network expansion whereas time inconvenience, confidentiality, possible side effects & route of administration of drug and fear of contacting the disease were identified as important barriers. Application of knowledge of these motives and barriers will help Pakistani researchers to enroll adequate number of healthy volunteer for their clinical trials.
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来源期刊
Biomedica
Biomedica 医学-热带医学
CiteScore
1.60
自引率
0.00%
发文量
76
审稿时长
>12 weeks
期刊介绍: Biomédica is the quarterly journal of the Instituto Nacional de Salud of Colombia [Colombia’s National Health Institute]. Its purpose is to publish the results of original research that contributes meaningfully to knowledge in health and biomedical sciences.
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