Evaluation of a blockchain-based dynamic consent platform (METORY) in a decentralized and multicenter clinical trial using virtual drugs
Ki Young Huh, Seol Ju Moon, Sang-Un Jeong, Min-Ji Kim, Wooseok Yang, Myeonggyu Jeong, Min-Gul Kim, SeungHwan Lee
Clinical and Translational Science, 14 February 2022
Abstract
Blockchain is a novel data architecture characterized by a chronological sequence of blocks in a decentralized manner. We aimed to evaluate the real-world feasibility of a blockchain-based dynamic consent platform (METORY) in a decentralized and multicenter trial. The study consisted of three visits (i.e., screening and 2 follow-up visits) with a 2-week interval. Each subject was required to report the self-measured body temperatures and take a virtual investigational drug by entering the unique drug code on the application. To simulate real-world study settings, two major (i.e., changes in the schedule of body temperature measurement) and three minor protocol amendments (i.e., nonsignificant changes without any changes in the procedures) were set. Overall study completion rates, proportion of consent, and response time to each protocol amendment and adherence were evaluated. A total of 60 subjects (30 in each center) were enrolled in two study centers. All subjects completed the study, and the overall proportion of consent to each protocol amendment was 95.7 ± 13.7% (mean ± SD), with a median response time of 0.2 h. Overall, subjects took 90.8% ± 19.2% of the total drug, whereas compliance with the schedule was 69.1% ± 27.0%. Subjects reported 96.7% ± 4.2% of the total body temperature measurements whereas the adherence to the schedule was 59.0% ± 25.0%, which remarkably decreased after major protocol amendments. In conclusion, we evaluated a blockchain-based dynamic consent platform in real clinical trial settings. The results suggested that major changes should be avoided unless subjects’ proper understanding is warranted.

How to obtain valid consent for research?
Manel Ben Fredj
International Journal of Research and Ethics, 1 February 2022; 5(1)
Abstract
There is a broad agreement on the need to protect humans participating in biomedical research. Research ethics encompasses three fundamental principles: autonomy, beneficence, and justice. In practice, valid consent from participants is considered as the main tool to protect the participants and to ensure their rights. Obtaining a valid consent for research requires the voluntariness and the capacity of participants with disclosing an adequate and clear information. Nevertheless, in some circumstances, the institutional review board (IRB) may make an exception and approve the waiver of consent. An approval by the IRB is always needed. This workshop introduces candidates to fundamental principles in ethics research and to the rules of consent writing in research. It addresses also the specific situations under which a waiver consent may be acceptable. The workshop proceeds in two sessions in which we: present the principles of research ethics with explaining the steps of obtaining a valid consent for research and organize work groups.

Recruitment, consent and retention of participants in randomised controlled trials : a review of trials published in the National Institute for Health Research (NIHR) Journals Library (1997–2020)
Original Research
Richard M Jacques, Rashida Ahmed, James Harper, Adya Ranjan, Isra Saeed, Rebecca M Simpson, Stephen J Walters
BMJ Open, 30 January 2022; 12(2)
Open Access
Abstract
Objectives
To review the consent, recruitment and retention rates for randomised controlled trials (RCTs) funded by the UK’s National Institute for Health Research (NIHR) and published in the online NIHR Journals Library between January 1997 and December 2020.
Design
Comprehensive review.
Setting
RCTs funded by the NIHR and published in the NIHR Journals Library.
Data extraction
Information relating to the trial characteristics, sample size, recruitment and retention.
Primary and secondary outcome measures
The primary outcome was the recruitment rate (number of participants recruited per centre per month). Secondary outcomes were the target sample size and whether it was achieved; consent rates (percentage of eligible participants who consented and were randomised) and retention rates (percentage of randomised participants retained and assessed with valid primary outcome data).
Results
This review identified 388 individual RCTs from 379 reports in the NIHR Journals Library. The final recruitment target sample size was achieved in 63% (245/388) of the RCTs. The original recruitment target was revised in 30% (118/388) of trials (downwards in 67% (79/118)). The median recruitment rate (participants per centre per month) was found to be 0.95 (IQR: 0.42–2.60); the median consent rate was 72% (IQR: 50%–88%) and the median retention rate was estimated at 88% (IQR: 80%–97%).
Conclusions
There is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Although the majority of (6 out of 10) trials in this review achieved their final target sample; 3 out of 10 trials revised their original target sample size (downwards in 7 out of 10 trials). Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections.