Al-Shami Kamal M, Ahmed Wesam S, Alzoubi Karem H
Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, 22110, Jordan.
Faculty of Biosciences, University of Heidelberg, Heidelberg, 69120, Germany.
Patient Prefer Adherence. 2023 Mar 28;17:895-903. doi: 10.2147/PPA.S402769. eCollection 2023.
Biospecimen repositories and big data generated from clinical research are critically important in advancing patient-centered healthcare. However, ethical considerations arising from reusing clinical samples and health records for subsequent research pose a hurdle for big-data health research. This study aims to assess the public's opinions in Jordan toward providing blanket consent for using biospecimens and health records in research.
A cross-sectional study utilizing a self-reported questionnaire was carried out in different cities in Jordan, targeting adult participants. Outcome variables included awareness of clinical research, participation in clinical research, and opinions toward providing open access to clinical samples and records for research purposes. Descriptive analysis was utilized for reporting the outcome as frequency (percentages) out of the total responses. Univariate and multivariate logistic regression were used to investigate the association between independent variables and the outcome of interest.
A total of 1033 eligible participants completed the questionnaire. Although the majority (90%) were aware of clinical research, only 24% have ever participated in this type of research. About half (51%) agreed on providing blanket consent for the use of clinical samples, while a lower percentage (43%) agreed on providing open access to their health records. Privacy concerns and lack of trust in the researcher were cited as major barriers to providing blanket consent. Participation in clinical research and having health insurance were predictors for providing open access to clinical samples and records.
The lack of public trust in Jordan toward data privacy is evident from this study. Therefore, a governance framework is needed to raise and maintain the public's trust in big-data research that warrants the future reuse of clinical samples and records. As such, the current study provides valuable insights that will inform the design of effective consent protocols required in data-intensive health research.
生物样本库以及临床研究产生的大数据对于推进以患者为中心的医疗保健至关重要。然而，将临床样本和健康记录用于后续研究引发的伦理考量给大数据健康研究带来了障碍。本研究旨在评估约旦公众对于在研究中提供使用生物样本和健康记录的全面同意的看法。
在约旦不同城市开展了一项采用自填式问卷的横断面研究，目标人群为成年参与者。结果变量包括对临床研究的知晓度、参与临床研究情况，以及对于为研究目的提供临床样本和记录的开放获取的看法。描述性分析用于将结果报告为总回复中的频率（百分比）。单因素和多因素逻辑回归用于研究自变量与感兴趣的结果之间的关联。
共有1033名符合条件的参与者完成了问卷。尽管大多数人（90%）知晓临床研究，但只有24%的人曾参与过此类研究。约一半（51%）的人同意为使用临床样本提供全面同意，而同意开放获取其健康记录的比例较低（43%）。隐私担忧和对研究人员缺乏信任被列为提供全面同意的主要障碍。参与临床研究和拥有健康保险是同意开放获取临床样本和记录的预测因素。
本研究表明约旦公众对数据隐私缺乏信任。因此，需要一个治理框架来提高和维持公众对大数据研究的信任，以确保未来能够重复使用临床样本和记录。就此而言，本研究提供了宝贵的见解，将为数据密集型健康研究所需的有效同意方案的设计提供参考。
