Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study-Reference-Cited by-同舟云学术

Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study

Published:2022-01-28 Issue:3 Volume:17 Page:362-372
ISSN:1556-2646
Container-title:Journal of Empirical Research on Human Research Ethics
language:en
Short-container-title:Journal of Empirical Research on Human Research Ethics

Author:

Hu Zhanqing¹,Ouyang Chenxi²,Hahne Jessica³,Khoshnood Kaveh³,Zhang Jinqiang⁴,Liu Xiyu¹⁵,Wu Ying⁶,Wang Xiaomin¹⁵^ORCID

Affiliation:

1. Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha 410013, Hunan, PR China

2. School of Pharmacy, Hunan University of Chinese Medicine, Changsha, 410208, Hunan, PR China

3. Yale School of Public Health, Yale University, 60 College Street, New Haven, CT 06520, USA

4. Department of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha 410013, Hunan, PR China

5. Clinical Research Center, The Third Xiangya Hospital, Central South University, Changsha 410013, Hunan, PR China

6. School of Public Administration, Central South University, Changsha 410075, Hunan, PR China

Abstract

This study aims to investigate the knowledge and attitudes of participants and potential participants in clinical trials toward electronic informed consent. We conducted a survey-based cross-sectional study in Hunan Province, China in March 2021. A total of 547 respondents were included in this study. All questions in an 8-item survey section assessing participants’ knowledge of electronic informed consent received correct answers from at least 70% of participants. In terms of attitude scores, most participants (86.3%) believed that electronic informed consent is more convenient than the paper-based version, and more than half (51.2%) believed that electronic informed consent could completely replace the paper-based version. Responses indicated that common concerns about electronic informed consent were its security and confidentiality, legal benefits, and implications for rights protection.

Funder

the Key Research and Development Project of Hunan Province

National Institutes of Health Fogarty International Center

Publisher

SAGE Publications

Subject

Communication,Education,Social Psychology

Link

http://journals.sagepub.com/doi/pdf/10.1177/15562646221075884

Reference27 articles.

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2. CDE (2021). Guidelines for the management of drug clinical trials during the new crown pneumonia epidemic (draft for comments). Retrieved April 30, 2020, from https://www.cde.org.cn/main/news/viewInfoCommon/f7a2c8bc1cd47b2efd288e220087f691

3. Chen, C., Lee, P. I., Pain, K. J., Delgado, D., Cole, C. L. & Campion, T. R., Jr (2020). Replacing paper informed consent with electronic informed consent for research in academic medical centers: A scoping review. AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science, eCollection, 80–88. PMID: 32477626.

4. Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

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