Dynamic consent management for clinical trials via private blockchain technology

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Dynamic consent management for clinical trials via private blockchain technology
Original Research
Giuseppe Albanese, Jean-Paul Calbimonte, Michael Schumacher, Davide Calvaresi
Journal of Ambient Intelligence and Humanized Computing, 14 February 2020
Abstract
Clinical trials (CTs) are essential for the advancement of medical research, paving the way for the development and adoption of new treatments, and contributing to the evolution of healthcare. An essential factor for the success of a CT is the appropriate management of its participants and their personal data. According to the current regulations, collecting and using personal data from participants must comply with rigorous standards. Therefore, healthcare institutes need to obtain freely given, specific, informed, and unambiguous consent before being able to collect the data. Some of the major limitations of the current technological solutions are the lack of control over the granularity of consent grants, as well as the difficulty of handling dynamic changes of consent over time. In this paper, we present SCoDES, an approach for trusted and decentralized management of dynamic consent in clinical trials, based on blockchain technology (BCT). The usage of blockchain provides a set of features that allow maintaining consent information with trust guarantees while avoiding the need for a dedicated or centralized third trusted party. We provide a full implementation of SCoDES, made available as a self-contained infrastructure, with the possibility to interact with external services, and using hyperledger as a blockchain framework.

Editor’s note: The SCoDES project is an applied research project on blockchains involving five Hautes Ecoles from French-speaking Switzerland… Its goal is to develop knowledge within the field of blockchain and smart contracts by studying and developing practical cases of use and transferring the acquired knowledge to the regional economic actors.

Research Consent Models Used in Prospective Studies of Neurologically Deceased Organ Donors: A Systematic Review

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Research Consent Models Used in Prospective Studies of Neurologically Deceased Organ Donors: A Systematic Review
Research Article
Frederick D’Aragon, Karen E. A. Burns, Amanda Yaworski, Amanda Lucas, Erika Arseneau, Emilie Belley-Cote, Sonny Dhanani, Anne-Julie Frenette, François Lamontagne, François Lauzier, Aemal Akhtar, Simon Oczkowski, Bram Rochwerg, Maureen O. Meade
Journal of Empirical Research on Human Research Ethics, 13 February 2020
Abstract
Research to inform the care of neurologically deceased organ donors is complicated by a lack of standards for research consent. In this systematic review, we aim to describe current practices of soliciting consent for participation in prospective studies of neurologically deceased donors, including the frequency and justification for these various models of consent. Among the 74 studies included, 14 did not report on any regulatory review, and 13 did not report on the study consent procedures. Of the remaining 47 studies, 24 utilized a waiver of research consent. The most common justification for a waiver of research consent related to the fact that neurologically deceased donors are not considered human subjects. In conclusion, among studies of neurologically deceased donors, research consent models vary and are inconsistently reported. Consensus and standardization in the application of research consent models will help to advance this emerging field of research.

Remote Consent Clinical Research

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Remote Consent Clinical Research
Commentary
Sriram Preethi
Clinical Trials and Practice, 30 October 2019; 1(1) pp 39-41
Open Access
Abstract
Recruitment in clinical research trials can be challenging in trials that are time-sensitive and/or are rare disease and critical care trials. One of the hurdles for recruitment in these types of clinical trials is due to the consent process, and the need to have consent of the patient within a certain timeframe, or the patient unable to consent for themselves. This paper will discuss the usage of the utilization of remote consent options for these trials.

An assessment of provider satisfaction with the use of a standardized visual aid for informed consent for appendectomy in children

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An assessment of provider satisfaction with the use of a standardized visual aid for informed consent for appendectomy in children
Brittany L. Johnson, Eric H. Rosenfeld, Brittany D. Carter, Monica E. Lopez, Annalyn S. DeMello, David E. Wesson, Mary L. Brandt
Journal of Pediatric Surgery, 1 February 2020
Abstract
Purpose
We previously validated a visual aid for the use in the consent process for an appendectomy showing improved parental satisfaction and understanding. In this study, we evaluated provider satisfaction and perceived value of using the visual aid.
Methods
An IRB approved survey was developed assessing provider experience with use of the visual aid. This was distributed and analyzed via Research Electronic Data Capture (RedCap) Database.
Results
We administered 58 surveys (45% response rate). Participants included faculty (n = 2), fellows (n = 1), residents (n = 6), and physician assistants (n = 17). The visual aid was used > 10 times by 50% of providers. The most common reason for not using the visual aid was not remembering it was available. Nearly half (40%) did not feel the visual aid added any time. 9/20 (45%) felt it added a small amount of time. Slightly over half of providers (52%) felt using the visual aid significantly increased family ability to give informed consent and made the consenting process easier for both providers and families.
Conclusion
Using a visual aid in consenting families for appendectomy does not add significant time and subjectively improves the process for providers and increases provider perception of parental understanding.

The effects of a humorous video on memory for orthodontic treatment consent information

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The effects of a humorous video on memory for orthodontic treatment consent information
Original Article
Timothy P. Levine
American Journal of Orthodontics and Dentofacial Orthopedics, February 2020; 157(2) pp 240-244
Abstract
Introduction
Communication of treatment information is critical in orthodontics. The challenge lies in doing so effectively such that patients will understand and remember, which is the definition of true informed consent. Previous studies have established that information is more readily remembered when presented using multimedia presentations. Likewise, humor has been shown to increase information retention.
Methods
Two videos, 1 humorous (H) and 1 unhumorous (U), were produced with identical information about orthodontic treatment consent. Thirty-eight new orthodontic patients were randomly selected and divided into H (n = 20) and U (n = 18) video groups. Identical questionnaires with multiple-choice responses to judge memory of the content were completed by both groups immediately after watching the video (T1) and 6 weeks later (T2). A one-tailed Welch’s t test was used to analyze the scores.
Results
At T1, there was no significant difference in the scores of the questionnaire between H and U groups, whereas at T2, there was a significant difference between groups. The intragroup score difference was also analyzed, with a significant decrease from T1 to T2 in the U, but not H, group. Subjective questions were also asked regarding content. No significant differences were found between the groups regarding the informativeness of each video; however, willingness to watch again and memorability of the content were significantly higher in the H group.
Conclusions
Patients who received orthodontic treatment information presented with humor retained significantly more of that information after 6 weeks compared with patients who received the same information without humor. Patients who received the humorous content subjectively stated they were more likely to rewatch the video and also found the information presented in this manner to be more memorable.

Multimedia in improving informed consent for caesarean section: A randomised controlled trial

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Multimedia in improving informed consent for caesarean section: A randomised controlled trial
Original Article
Alice Truong, Lenore Ellett, Lauren Hicks, Gabrielle Pell, Susan P. Walker
Obstetrics & Gynaecology, 28 January 2020
Abstract
Background
Multimedia modules have been used as an adjunct to improve patient knowledge and recall for various elective surgical procedures, but have been incompletely evaluated in patients undergoing caesarean section.
Aims
To compare the use of a supplementary multimedia module with written information in improving the informed consent process prior to elective caesarean section.
Materials and methods
This was a prospective randomised controlled trial (ACTRN12616000430437). Primary outcomes were knowledge and anxiety scores immediately following the intervention and on the day of surgery. Secondary outcomes were patient satisfaction, length of stay, time to cessation of analgesia, and patient assessment of the consent types.
Results
Seventy‐five patients completed the study. Both multimedia module and written information groups demonstrated a significant increase in knowledge scores with no difference between the groups. In the multimedia‐assisted consent group, scores improved from baseline by +2.31 (P < 0.001) immediately after watching the multimedia module and by +2.41 (P < 0.001) on the day of surgery. In the written information group, scores improved by +1.76 (P < <0.001), and +2.31 (P < 0.001) respectively. There was no adverse impact on anxiety in either group. Patient‐reported understanding (92.4% vs 78.5%, P = 0.001), and helpfulness (90.1% vs 73.3%, P = 0.001) was significantly higher in the multimedia module group than in the written information group. The multimedia module was assessed as ‘slightly too long’ and provided ‘slightly too much information’.
Conclusions
Multimedia modules are a valuable adjunct to traditional processes of obtaining informed consent for elective caesarean section and should be offered and made available to patients prior to surgery.

Relationships of health information orientation and cancer history on preferences for consent and control over biospecimens in a biobank: A race‐stratified analysis

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Relationships of health information orientation and cancer history on preferences for consent and control over biospecimens in a biobank: A race‐stratified analysis
Soo Jung Hong, Bettina Drake, Melody Goodman, Kimberly A. Kaphingst
Journal of Genetic Counselling, 28 January 2020
Abstract
In this study, we investigated how patients’ self‐reported health information efficacy, relationship with health providers, and cancer history are associated with their preferences for informed consent and need for control over biobank biospecimens. We recruited 358 women aged 40 and older (56% African American; 44% European American) and analyzed the data using multivariable regression models. Results show that African American participants’ health information efficacy was significantly and negatively associated with their need for control over biospecimens and preference for a study‐specific model. European American participants’ dependency on doctors was a significant and negative predictor of their preference for a study‐specific model. Several significant interaction effects, which varied across races, were found with regard to health information efficacy, personal cancer history, need for control, and preference for a study‐specific model. The study findings suggest it is important to consider health information efficacy, relationship with providers, and need for control when developing large diverse biobanks.

Eliciting consent from patients with dementia in general X-ray departments: Law, ethics and interpretation of context [CONFERENCE PAPER]

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Eliciting consent from patients with dementia in general X-ray departments: Law, ethics and interpretation of context [CONFERENCE PAPER]
Katie Kelly, Lisa Booth, Paul K. Miller
United Kingdom Imaging and Oncology Congress 2020: Pathways and Communication, 1-3 June 2020; ACC, Liverpool
Open Access
Abstract
Background
While the numbers of individuals suffering from dementia syndromes in the UK steadily increase, many practitioners in the allied healthcare professions, and particularly junior staff, still feel ill-equipped for face-to-face communicative encounters with such individuals (Miller et al., 2019; Tullo et al., 2016). An elemental feature of effective communication in healthcare contexts is the seeking of proper consent to perform given procedures. The propositions above, however, raise questions regarding how ‘properly’ consent is being acquired when dementia is at stake. This paper, thus, reports findings from a qualitative study of general radiographers’ experiences of acquiring consent from patients with dementia, specifically exploring participants’ interpretations of correct legal and ethical practice therein.
Methods
With institutional ethical approval, N=6 general radiographers with less than ten years of clinical experience were recruited to sit for extended interviews. Verbatim transcripts were analysed using the domain-established techniques of Interpretative Phenomenological Analysis (Miller et al., 2017).
Results
Four key areas of extremely variable interpretation and practice were identified. (1) How to assess capacity for informed consent; (2) How to effectively modify communication when gaining consent; (3) Managing carer involvement during consent-acquisition and; (4) Constituting the ‘best interest’ of the patient.
Conclusion
Participants’ own accounts often indicated that they were often not lawfully implementing the Mental Capacity Act (MCA) when acquiring consent. Moreover, as previously identified by Miller et al. (2019), the situational confusion did little for participants’ confidence, with prospectively damaging import for future encounters. Stronger training in practical application of the MCA is recommended.

‘Delusional’ consent in somatic treatment: the emblematic case of electroconvulsive therapy

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‘Delusional’ consent in somatic treatment: the emblematic case of electroconvulsive therapy
Original Research
Giuseppe Bersani, Francesca Pacitti, Angela Iannitelli
Journal of Medical Ethics, 13 February 2020
Abstract
Even more than for other treatments, great importance must be given to informed consent in the case of electroconvulsive therapy (ECT). In a percentage of cases, the symbolic connotation of the treatment, even if mostly and intrinsically negative, may actually be a determining factor in the patient’s motives for giving consent. On an ethical and medicolegal level, the most critical point is that concerning consent to the treatment by a psychotic subject with a severely compromised ability to comprehend the nature and objective of the proposed therapy, but who nonetheless expresses his consent, for reasons derived from delusional thoughts. In fact, this situation necessarily brings to light the contradiction between an explicit expression of consent, a necessary formality for the commencement of therapy, and the validity of this consent, which may be severely compromised due to the patient’s inability to comprehend reality and therefore to accept the proposal of treatment, which is intrinsic to this reality. With the use of an electric current, the symbolic experience associated with anaesthesia, and the connection to convulsions, ECT enters the collective consciousness. In relation to this, ECT is symbolic of these three factors and hooks on to the thoughts, fears, feelings and expectations of delusional patients. These are often exemplified in the violent intervention of the persecutor in the patient with schizophrenia, the expected punishment for the ’error’ committed for which the depressed patient blames himself and the social repression of the maniacal patient’s affirmation of his inflated self-esteem.