The application and promotion of electronic informed consent_Chinese Journal of Evidence-Based Medicine

Authors：

DONG Yu ^1,4 , QIN Long ² , WU Weiping ³ , TANG Chunzhi ^1,4 , LONG Wenjie ⁵ ,  YANG Zhongqi ⁶ ,  LING Li ² ,  LU Liming ^1,4 , Committee of Clinical Evaluation of Transitional Clinical Trial , Chinese Pharm Aceutical Association

1. Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou 510000, P.R.China;
2. School of Public Health, Sun Yet-Sen University, Guangzhou 510000, P.R.China;
3. Eclincloud (Shenzhen) Technology Co., Ltd, Shenzhen 518038, P.R.China;
4. South China Research Center for Acupuncture and Moxibustion, Clinical Research and Data Center, Guangzhou University of Chinese Medicine, Guangzhou 510000, P.R.China;
5. Department of Gerontology Department of Clinical Research, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510000, P.R.China;
6. The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510000, P.R.China;

Corresponding author：

YANG Zhongqi, Email: yang_zhongqi@163.com; LING Li, Email: lingli@mail.sysu.edu.cn; LU Liming, Email: lulimingleon@gzucm.edu.cn

Keywords：

Electronic informed consent; Clinical trial; Ethics committee; Privacy protection; Law and regulation

DOI：

10.7507/1672-2531.202102042

Video：

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Under the background of the global COVID-19 pandemic, electronic informed consent (eConsent) utilizes technology to provide a new method and idea for clinical trials. It has the advantages of convenience and efficiency, which greatly improves the efficiency of clinical trials. At present, this concept has not been put forward in China while it has been clarified clearly abroad, and some countries have launched a variety of trials and formulated various regulations to further standardize the eConsent. Based on the current situation of eConsent in China, this study analyzed the design and implementation of eConsent, summarized relevant domestic and foreign laws and regulations, and proposed opportunities and challenges for electronic informed consent as well as the relevant preparations for the implementation of this technology in China.

Citation： DONG Yu, QIN Long, WU Weiping, TANG Chunzhi, LONG Wenjie, YANG Zhongqi, LING Li, LU Liming, Committee of Clinical Evaluation of Transitional Clinical Trial, Chinese Pharm Aceutical Association. The application and promotion of electronic informed consent. Chinese Journal of Evidence-Based Medicine, 2021, 21(7): 851-857. doi: 10.7507/1672-2531.202102042 Copy

1.	No authors listed. Setting guidelines to report the use of AI in clinical trials. Nat Med, 2020, 26(9): 1311.
2.	曹国英, 付海军, 何为, 等. 智能化临床研究专家共识. 中国新药与临床杂志, 2020, 39(6): 321-328.
3.	Topol EJ. Welcoming new guidelines for AI clinical research. Nat Med, 2020, 26(9): 1318-1320.
4.	Vanaken H, Masand SN. Awareness and collaboration across stakeholder groups important for econsent achieving value-driven adoption. Ther Innov Regul Sci, 2019, 53(6): 724-735.
5.	Lentz J, Kennett M, Perlmutter J, et al. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative. Contemp Clin Trials, 2016, 49: 65-69.
6.	US Food and Drug Administration. Use of electronic informed consent, questions and answers: Guidance for institutional review boards, investigators, and sponsors. Silver Spring, MD: US Food and Drug Administration, 2016.
7.	Wood AM, White IR, Thompson SG. Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals. Clin Trials, 2004, 1(4): 368-376.
8.	Thornton J. Clinical trials suspended in UK to prioritise covid-19 studies and free up staff. BMJ, 2020, 368: m1172.
9.	Kaliya-Perumal AK, Omar UF, Kharlukhi J. Healthcare virtualization amid COVID-19 pandemic: an emerging new normal. Med Educ Online, 2020, 25(1): 1780058.
10.	Wind TR, Rijkeboer M, Andersson G, et al. The COVID-19 pandemic: The 'black swan' for mental health care and a turning point for e-health. Internet Interv, 2020, 20: 100317.
11.	CFR FDA. Part 11, Electronic records, electronic signatures scope and application. Washington DC: Technical Report, Food and Drug Agency, 2003.
12.	US Food and Drug Administration. Use of electronic records and electronic signatures in clinical investigations under 21 CFR part 11–questions and answers: Guidance for industry. Washington DC: Food and Drug Agency, 2017.
13.	Singh J. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. J Pharmacol Pharmacother, 2015, 6(3): 185-187.
14.	UK GOV. Medicines & healthcare products regulatory agency (MHRA). London: UK GOV, 2017.
15.	European Medicines Agency. Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic). London: European Medicines Agency, 2018.
16.	国家食品药品监督管理局药品审评中心. 药物临床试验的电子数据采集技术指导原则. 北京: 国家食品药品监督管理局, 2017.
17.	国家食品药品监督管理局药品审评中心. 新冠肺炎疫情期间药物临床试验管理指导原则(征求意见稿). 北京: 国家食品药品监督管理局, 2020.
18.	《中华人民共和国数据安全法(草案)》. Available at: http://www.npc.gov.cn/.
19.	Grain H. e-Consent design and implementation issues for health information managers. Health Inf Manag, 2004, 33(3): 84-88.
20.	Wilbanks J. Design issues in e-consent. J Law Med Ethics, 2018, 46(1): 110-118.
21.	Chhin V, Roussos J, Michaelson T, et al. Leveraging mobile technology to improve efficiency of the consent-to-treatment process. JCO Clin Cancer Inform, 2017, 1: 1-8.
22.	Phillippi JC, Doersam JK, Neal JL, et al. Electronic informed consent to facilitate recruitment of pregnant women into research. J Obstet Gynecol Neonatal Nurs, 2018, 47(4): 529-534.
23.	Biesecker B, Raspa M, Rupert D, et al. Making clinical trials more patient-centered using digital interactive e-consent tools. Research Triangle Park (NC): RTI Press, 2019.
24.	Harle CA, Golembiewski EH, Rahmanian KP, et al. Patient preferences toward an interactive e-consent application for research using electronic health records. J Am Med Inform Assoc, 2018, 25(3): 360-368.
25.	Harle CA, Golembiewski EH, Rahmanian KP, et al. Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial. J Am Med Inform Assoc, 2019, 26(7): 620-629.
26.	Simon CM, Schartz HA, Rosenthal GE, et al. Perspectives on electronic informed consent from patients underrepresented in research in the United States: a focus group study. J Empir Res Hum Res Ethics, 2018, 13(4): 338-348.
27.	Jayasinghe N, Moallem BI, Kakoullis M, et al. Establishing the feasibility of a tablet-based consent process with older adults: a mixed-methods study. Gerontologist, 2019, 59(1): 124-134.
28.	Skelton E, Drey N, Rutherford M, et al. Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting. Int J Med Inform, 2020, 143: 104271.
29.	Annas GJ. HIPAA regulations - a new era of medical-record privacy? N Engl J Med, 2003, 348(15): 1486-1490.
30.	Bholasing J. How the GDPR will change the world. Eur Data Prot L Rev, 2016, 2: 287.
31.	曾途. 《数据安全法》: 数据行业的基础性合规框架. 西华大学学报(哲学社会科学版), 2020, 39(5): 23-25.
32.	国家卫生健康委员会, 国家中医药管理局. 互联网诊疗管理办法, 2018. Available at: http://www.gov.cn/gongbao/content/2019/content_5358684.htm.

1. No authors listed. Setting guidelines to report the use of AI in clinical trials. Nat Med, 2020, 26(9): 1311.
2. 曹国英, 付海军, 何为, 等. 智能化临床研究专家共识. 中国新药与临床杂志, 2020, 39(6): 321-328.
3. Topol EJ. Welcoming new guidelines for AI clinical research. Nat Med, 2020, 26(9): 1318-1320.
4. Vanaken H, Masand SN. Awareness and collaboration across stakeholder groups important for econsent achieving value-driven adoption. Ther Innov Regul Sci, 2019, 53(6): 724-735.
5. Lentz J, Kennett M, Perlmutter J, et al. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative. Contemp Clin Trials, 2016, 49: 65-69.
6. US Food and Drug Administration. Use of electronic informed consent, questions and answers: Guidance for institutional review boards, investigators, and sponsors. Silver Spring, MD: US Food and Drug Administration, 2016.
7. Wood AM, White IR, Thompson SG. Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals. Clin Trials, 2004, 1(4): 368-376.
8. Thornton J. Clinical trials suspended in UK to prioritise covid-19 studies and free up staff. BMJ, 2020, 368: m1172.
9. Kaliya-Perumal AK, Omar UF, Kharlukhi J. Healthcare virtualization amid COVID-19 pandemic: an emerging new normal. Med Educ Online, 2020, 25(1): 1780058.
10. Wind TR, Rijkeboer M, Andersson G, et al. The COVID-19 pandemic: The 'black swan' for mental health care and a turning point for e-health. Internet Interv, 2020, 20: 100317.
11. CFR FDA. Part 11, Electronic records, electronic signatures scope and application. Washington DC: Technical Report, Food and Drug Agency, 2003.
12. US Food and Drug Administration. Use of electronic records and electronic signatures in clinical investigations under 21 CFR part 11–questions and answers: Guidance for industry. Washington DC: Food and Drug Agency, 2017.
13. Singh J. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. J Pharmacol Pharmacother, 2015, 6(3): 185-187.
14. UK GOV. Medicines & healthcare products regulatory agency (MHRA). London: UK GOV, 2017.
15. European Medicines Agency. Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic). London: European Medicines Agency, 2018.
16. 国家食品药品监督管理局药品审评中心. 药物临床试验的电子数据采集技术指导原则. 北京: 国家食品药品监督管理局, 2017.
17. 国家食品药品监督管理局药品审评中心. 新冠肺炎疫情期间药物临床试验管理指导原则(征求意见稿). 北京: 国家食品药品监督管理局, 2020.
18. 《中华人民共和国数据安全法(草案)》. Available at: http://www.npc.gov.cn/.
19. Grain H. e-Consent design and implementation issues for health information managers. Health Inf Manag, 2004, 33(3): 84-88.
20. Wilbanks J. Design issues in e-consent. J Law Med Ethics, 2018, 46(1): 110-118.
21. Chhin V, Roussos J, Michaelson T, et al. Leveraging mobile technology to improve efficiency of the consent-to-treatment process. JCO Clin Cancer Inform, 2017, 1: 1-8.
22. Phillippi JC, Doersam JK, Neal JL, et al. Electronic informed consent to facilitate recruitment of pregnant women into research. J Obstet Gynecol Neonatal Nurs, 2018, 47(4): 529-534.
23. Biesecker B, Raspa M, Rupert D, et al. Making clinical trials more patient-centered using digital interactive e-consent tools. Research Triangle Park (NC): RTI Press, 2019.
24. Harle CA, Golembiewski EH, Rahmanian KP, et al. Patient preferences toward an interactive e-consent application for research using electronic health records. J Am Med Inform Assoc, 2018, 25(3): 360-368.
25. Harle CA, Golembiewski EH, Rahmanian KP, et al. Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial. J Am Med Inform Assoc, 2019, 26(7): 620-629.
26. Simon CM, Schartz HA, Rosenthal GE, et al. Perspectives on electronic informed consent from patients underrepresented in research in the United States: a focus group study. J Empir Res Hum Res Ethics, 2018, 13(4): 338-348.
27. Jayasinghe N, Moallem BI, Kakoullis M, et al. Establishing the feasibility of a tablet-based consent process with older adults: a mixed-methods study. Gerontologist, 2019, 59(1): 124-134.
28. Skelton E, Drey N, Rutherford M, et al. Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting. Int J Med Inform, 2020, 143: 104271.
29. Annas GJ. HIPAA regulations - a new era of medical-record privacy? N Engl J Med, 2003, 348(15): 1486-1490.
30. Bholasing J. How the GDPR will change the world. Eur Data Prot L Rev, 2016, 2: 287.
31. 曾途. 《数据安全法》: 数据行业的基础性合规框架. 西华大学学报(哲学社会科学版), 2020, 39(5): 23-25.
32. 国家卫生健康委员会, 国家中医药管理局. 互联网诊疗管理办法, 2018. Available at: http://www.gov.cn/gongbao/content/2019/content_5358684.htm.

Chinese Journal of Evidence-Based Medicine

The application and promotion of electronic informed consent

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