When Should Re-consent of Subjects Participating in a Clinical Trial Be Requested? A Case-Oriented Algorithm to Assist in the Decision-Making Process

Abstract

Investigators, sponsors, and institutional review boards have to decide when re-consent of clinical trials' participants must be obtained when new information becomes available. We present an algorithm to help in the decision-making process, which takes into consideration the kind of new information, the risk of exposure (patients could be on the treatment or in the follow-up phases), and the possibility of managing the case. Re-consent should be obtained in three of the eight possible situations.

GDPR: an impediment to research?

“…The time and resources needed to re-consent, depending on the size of the study involved, could prove insurmountable. According to the Department of Health, this may not be a valid reason when approaching the declaration committee, but is clearly a matter of significant concern to clinical researchers c. Re-consent can produce anxiety or confusion in some subjects and may make some feel that their privacy has been violated, if they did not give permission to be recontacted [1,2].…”

“…Becoming compliant with GDPR starts with GDPR awareness, understanding data subject rights, choosing the appropriate lawful basis for data processing activities (Article 6 GDPR), and understanding the principles which are embedded in GDPR, including those relating to processing of personal data (http://eugdpr.org/the-regulation/). It is stated under Article 4 (2) of GDPR that virtually any use of personal data, from collection and recording, to retrieval and dissemination, storage, and finally erasure or destruction, constitutes Bprocessing^, with significant accountability required. An integral part of achieving compliance with these regulations requires a developed understanding of the responsibilities of the users of personal data, including Bdata controllers^and Bdata processors^.…”

The International Committee of Medical Journal Editors trial data sharing requirement and participants' consent

“…This could also be applicable to ongoing trials in which participants have not been asked to consent on their de‐identified IPD: participants should be informed – and their re‐consent obtained as in other circumstances – taking advantage of a trial scheduled visit. Ongoing trial in this context is any trial in which all participants have at least one scheduled visit pending after participant information sheet informing on access of de‐identified IPD to future investigators is approved by the relevant research ethics committee.…”

Re-consenting human subjects: ethical, legal and practical issues

“…Whereas most guidelines and codes also require that informed consent be properly documented, informed consent is much more than signing a piece of paper: It is a continuous process of communication between the investigator and the research subject 7. Because the body of knowledge impacting a study frequently changes, subjects should receive information from investigators after they have enrolled in a study, such as significant new findings that may affect their decision to participate in research or clinically useful tests results 8 9 10. In large studies, some investigators use newsletters to update subjects on the progress of research and other developments 11…”

“…Re-consent can produce anxiety or confusion in some subjects and may make some feel that their privacy has been violated, if they did not give permission to be re-contacted 8 9. Re-consent may be difficult to implement, due to problems with re-contacting subjects (such as missing or incorrect contact information) or resource constraints (such as insufficient time, staffing, or money).…”