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

Resnik, David B.

doi:10.1136/jme.2009.030338

Cited by 36 publications

(28 citation statements)

References 6 publications

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“…Re-consent can be defined as an action in which a research participant makes the decision to participate in a study once again, or consent to new elements of an existing study: “the process of seeking participant consent to change or update their existing consent to allow their samples and data to be used in a different way from that which was originally agreed” [3]. Re-consent can be readily distinguished from re-affirmation, where the intention is simply to express willingness to abide by a decision already made [12]. …”

Section: Introductionmentioning

confidence: 99%

“…These problems and others may result in the attrition of volunteers and the undermining of research activities [8, 15]. Also non-trivial is the potential for a re-consent process to trigger distress, anger, or other emotional reactions linked to perceptions of violations of privacy or breach of trust [12], the possibility that existing participants may withdraw consent altogether, and the risks that the integrity of a cohort could be undermined by having multiple consents for different purposes from different participants.…”

Section: Introductionmentioning

confidence: 99%

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A qualitative study of participants’ views on re-consent in a longitudinal biobank

et al. 2017

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BackgroundBiomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or “biobanks” over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank.MethodsWe conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method.ResultsWhat participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain.ConclusionsParticipants’ perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A qualitative study of participants’ views on re-consent in a longitudinal biobank

et al. 2017

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“…As explained by Gupta 1 , there are circumstances under which consent has to be sought again from a participant, corresponding to any time the trial protocol is majorly revised. This is a fundamental fact when ensuring to patients’ rights and transparency of a clinical trial 10, 11 . Indeed, as detailed in these Institutional review board (IRB) guidelines ( http://www.irb.pitt.edu/sites/default/files/reconsent guidance.pdf; http://www.mayo.edu/research/documents/29-re-consent-or-notification-of-significant-new-findingspdf/doc-10027714; http://www.yale.edu/hrpp/policies/documents/Reconsentingguidance.pdf), there are many situations where patients re-consent has to be sought or where they should be notified of minor trial issues, such as novel risks, significant changes in the research procedures, and worsening of the medical condition.…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, drawing on ways to collect securely and transparently informed consent, being careful with participants rights, and so empowering them, could improve the enrolment rate. Indeed, the participation rate to clinical trial remains quite weak 10 . Caldwell & All performed a systematic review comparing different enrolment techniques, and showed that, amongst several other explanations, the conditions of collecting patients consent in an open and secure way is better at achieving an improved rate of enrolment 10, 12 .…”

Section: Introductionmentioning

confidence: 99%

Blockchain protocols in clinical trials: Transparency and traceability of consent

Benchoufi¹,

Porcher²,

Ravaud³

2017

F1000Res

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Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. Additionally, it removes the need for third parties, and gives participative control to the peer-to-peer users. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain; thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each revision of the protocol, consent was sought again. We obtained a single document, in a standard open format, that accounted for the whole consent collection process: timestamped consent status with regards to each version of the protocol. This document cannot be corrupted, and can be checked on any dedicated public website. It should be considered as a robust proof of data. In the future, we think that the complex data flow of a clinical trial can be tracked using Blockchain. Moreover, a blockchain core functionality, named Smart Contract, can help prevent clinical trial events not to happen in the right chronological order: including patients before they consented or analysing case report forms data before freezing the database. This will help reaching reliability, security, and transparency, and could be a consistent step towards reproducibility.

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“…Initial consent is designed to provide a comprehensive explanation so potential participants can decide whether to enroll in a given study. Re-consent is designed to provide enrolled participants with all the information they need to decide whether to continue to participate given significant changes, such as identification of serious new risks [20]…”

Section: Discussionmentioning

confidence: 99%

Empirical evaluation of the need for ‘on-going consent’ in clinical research

Smith

Grady

Krohmal

et al. 2011

Aids

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Objective Some commentators argue that informed consent for clinical research should be an on-going process, which begins, rather than ends, with participants’ initial consent. Lacking, however, are empirical data on whether there is a need for ‘on-going consent’. Design Two self-administered surveys—a baseline survey at initial consent and a follow-up survey 2-3 years later—to assess whether participants remain informed over time. Methods Respondents were adults with HIV disease from Argentina, Brazil and Thailand enrolled in a long-term clinical trial. Results Respondents overall were well informed at baseline. At follow-up, many reported being not informed about aspects of the study central to their on-going participation. With respect to the possibility of withdrawal, 38.5% of respondents at follow-up reported being “not at all” informed. At follow-up, 71.1% wanted more information. Yet, 62.8% had not asked any questions during the entire study. Reasons for not asking questions included not having an opportunity (16.4%) and not knowing whom to ask (15.5%). Conclusions The standard consent process resulted in participants being well informed at enrollment. Yet, this process was not sufficient to keep them informed about aspects of the study central to their on-going participation. In addition, participants who wanted more information often did not ask for it. These findings provide empirical support for recommendations that clinical trials should consider including a process of ‘on-going consent’.

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

Cited by 36 publications

References 6 publications

A qualitative study of participants’ views on re-consent in a longitudinal biobank

A qualitative study of participants’ views on re-consent in a longitudinal biobank

Blockchain protocols in clinical trials: Transparency and traceability of consent

Empirical evaluation of the need for ‘on-going consent’ in clinical research

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