H3Africa Report on Informed Consent and Commercialisation
Ruth Chadwick, Patricia Marshall, Charmaine DM Royal
H3Africa Report, February 2021
…In light of the vast amount of genetic diversity in African populations, H3Africa provides an unparalleled research resource for the benefit of people in Africa and across the globe. Thus, the sharing of data is a guiding principle for H3Africa, and the translation of research findings to commercial products, resources, and services is consistent with its mission. Driven by a commitment to transparency and accountability, the H3Africa leadership convened a panel of experts (authors) to review the research ethics processes and practices being employed in the H3Africa Consortium projects with the aim of identifying gaps and making recommendations for improvements going forward with regard to commercialisation. Specifically, the panel was asked to review H3Africa consent documents and talk with key members of the Consortium, including members of the Ethics Working Group, to determine how H3Africa Consortium projects have implemented informed consent procedures for studies involving biobanking and the sharing of data and/or biospecimens…
Ethical issues in using ambient intelligence in health-care settings
Nicole Martinez-Martin, Zelun Luo, Amit Kaushal, Ehsan Adeli, Albert Haque, Sara S Kelly, Sarah Wieten, Mildred K Cho, David Magnus, Li Fei-Fei, Kevin Schulman, Arnold Milstein
The Lancet Digital Health, 21 December 2020
Ambient intelligence is increasingly finding applications in health-care settings, such as helping to ensure clinician and patient safety by monitoring staff compliance with clinical best practices or relieving staff of burdensome documentation tasks. Ambient intelligence involves using contactless sensors and contact-based wearable devices embedded in health-care settings to collect data (eg, imaging data of physical spaces, audio data, or body temperature), coupled with machine learning algorithms to efficiently and effectively interpret these data. Despite the promise of ambient intelligence to improve quality of care, the continuous collection of large amounts of sensor data in health-care settings presents ethical challenges, particularly in terms of privacy, data management, bias and fairness, and informed consent. Navigating these ethical issues is crucial not only for the success of individual uses, but for acceptance of the field as a whole.
Digital tools in the informed consent process: a systematic review
Francesco Gesualdo, Margherita Daverio, Laura Palazzani, Dimitris Dimitriou, Javier Diez-Domingo, Jaime Fons-Martinez, Sally Jackson, Pascal Vignally, Caterina Rizzo & Alberto Eugenio Tozzi
BMC Medical Ethics, 27 February 2021; 22(18)
Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process.
We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio–video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia.
Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes.
Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact.
The effect of animated consent material on participants’ willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study
Elizabeth Nelson, Cade Shadbolt, Samantha Bunzli, Angela Cochrane, Peter Choong & Michelle Dowsey
Pilot and Feasibility Studies, 8 February 2021; 7(46)
Placebo-controlled surgical trials are recognised as the gold standard way to test the efficacy of a surgical procedure. Despite a rise in arthroscopic subacromial decompression (ASD) surgeries for the treatment of shoulder pain, only two placebo-controlled surgical trials have been conducted. These trials encountered significant recruitment challenges, threatening the external validity of findings. Difficulties with recruitment are common in clinical trials and likely to be amplified in placebo-controlled surgical trials. This mixed method feasibility trial aims to address the following questions: (i) Feasibility: What proportion of patients who have consented to undergo ASD report that they would be willing to enrol in a placebo-controlled trial for this procedure? (ii) Optimisation: Can patients’ willingness to enrol in, or understanding of, such a trial be improved by supplementing written consent materials with a brief visual animation that outlines the details of the trial? And (iii) exploration: What factors influence patients stated willingness to enrol in such a trial, and how do they believe the recruitment process could be improved?
This study aims to recruit 80 patients on the waiting list for ASD. Participants will be randomised (1:1) to either view a brief video animation explaining the hypothetical placebo-controlled trial in addition to written information or to written information only. Participants in both groups will be required to state if they would be willing to opt-in to the hypothetical ASD trial after immediately being presented with the consent material and again 1 week after completion of the consent process. Patients in both groups will also be required to complete a measure of trial literacy. Twenty participants will be purposively sampled to take part in an embedded qualitative study exploring understanding of trial concepts and factors contributing to willingness to opt-in.
This feasibility study will provide evidence for optimising participant recruitment into a placebo-controlled trial of ASD by consenting patients using animated trial information in addition to written information. This pilot and feasibility data may also be relevant to placebo-controlled surgical trials more broadly, which are characterised by recruitment challenges.
Can a Checklist Improve the Informed Consent Process?
Eric Shirley, Veronica H. Mai, Kevin M. Neal, Kathryn V. Blake
Cureus, 5 February 2021; 13(2)
Informed consent often fails to provide patients and families with a full understanding of the proposed procedure. We developed an informed consent checklist for identifying specific aspects of the surgical consent that were not fully understood by families. The purpose of this study was to measure the effect of using this checklist on families’ knowledge, satisfaction, experience, and decisional conflict during the consent process. The families of pediatric patients scheduled for an orthopaedic preoperative visit were prospectively randomized into one of two groups: checklist or traditional appointment. Families in the checklist group completed the informed consent checklist which was then used by the surgeon to further discuss aspects of the surgery that needed clarification. Those in the traditional group had similar discussions about surgery without the aid of a checklist. Sixty-one families participated in the study; 27 in the checklist group and 34 in the traditional group without a checklist. The checklist group reported no difference in mean scores for all satisfaction (P = 0.37), decisional conflict (P = 0.51), and knowledge items (P = 0.31). For patient experience, the traditional group reported the visits were significantly more relaxed (mean 4.9, 95% confidence interval (CI) 4.8-5.0) than the checklist group (mean 4.5, 95% CI 4.3-4.7). Our results suggest that having a family member complete the informed consent checklist prior to meeting with the surgeon did not improve, and may worsen, the consent experience for some families. Other methods need to be evaluated to determine the optimal consent process from the family’s perspective.
Educational Informed Consent Video Equivalent to Standard Verbal Consent for Rhinologic Surgery: A Randomized Controlled Trial
Joseph P. Penn, Rohit Nallani, Erin L. Dimon, Taylor C. Daniels, Kevin J. Sykes, Alexander G. Chiu, Mark R. Villwock, Jennifer A. Villwock
American Journal of Rhinology & Allergy, 2 February 2021
Informed consent is an integral part of pre-operative counseling. However, information discussed can be variable. Recent studies have explored the use of multimedia in providing informed consent for rhinologic surgery.
To measure impact of an educational video (Video) compared to verbal informed consent (Verbal) on knowledge gained, alleviation of concerns, and efficiency.
Patients undergoing endoscopic sinus surgery (ESS), septoplasty, or ESS+septoplasty were prospectively enrolled and randomized to receive Video or Verbal consent. The Video group watched an educational video; the Verbal group received standard verbal consent from an Otolaryngology resident per institutional protocol. Both groups had the opportunity to discuss questions or concerns with their attending surgeon. Prior to, and after, consent was signed, both groups completed surveys regarding knowledge of purpose, risks, and benefits of surgery as well as surgical concerns. Decision regret and patient satisfaction were also assessed post-operatively.
77 patients were enrolled (39 Video, 38 Verbal). Demographics were not significantly different between groups. Overall knowledge significantly improved (p < 0.005) and concerns significantly decreased (p < 0.001) following consent in both groups. Improvements in these metrics were equivalent between groups (p < 0.02). Furthermore, resident time to complete consent, patient satisfaction, and decision regret were not significantly different between groups.
Use of an educational video was equivalent to standard verbal informed consent for patients undergoing rhinologic surgery. Otolaryngologists can consider developing procedure-specific videos to allow allocation of time to other tasks, standardized education of patients, and streamlining of the informed consent process.
Consent, Informed: Rethinking Informed Consent & Competency for Patients with Schizophrenia & Anosognosia
Boston College Law Review, 24 February 2021; 62(2)
Anosognosia is a common symptom of schizophrenia and schizoaffective disorder that renders individuals unable to understand that they are living with a disease. This symptom often leads people to refuse anti-psychotic medication, and may increase an individual’s likelihood of becoming homeless or incarcerated. When courts find individuals to be a danger to others or themselves, states can impose involuntary commitment. When a state grants involuntary commitment, however, a court may find the individual remains competent to refuse medication. This Note argues that documented anosognosia requires a finding of incompetency, whether people are a danger to themselves or not. Science suggests that a person with severe anosognosia lacks the insight to refuse treatment. This Note proposes a novel statutory definition of competency, encompassing the specific needs of people with anosognosia, and grapples with the significant interests at stake in taking away an individual’s right to choose or refuse treatment, including antipsychotic medication.
Informed Consent or Assent Strategies for Research with Individuals with Deafblindness or Dual Sensory Impairment: A Scoping Review
Archives of Rehabilitation Research and Clinical Translation, 22 February 2021
Abinethaa Paramasivam, Atul Jaiswal, Renu Minhas, Walter Wittich, Roxanna Spruyt-Rocks
To synthesize evidence on existing informed consent/assent strategies and processes that enable the participation of individuals with deafblindness or dual sensory impairment in research.
Five scientific databases (PubMed, MEDLINE, CINAHL, Web of Science, and PsycINFO) and other sources such as Google Scholar, the Journal of Visual Impairment and Blindness, and the British Journal of Visual Impairment were hand-searched from January 2015 until July 2020.
Studies were selected using a priori inclusion criteria of sensory and cognitive disabilities and focused on consent/assent strategies and processes in research within this population. Articles related to the medical or sexual consent processes were excluded.
An Excel spreadsheet was used to extract data from the eligible sources. Discrepancies were resolved in discussion with team members.
A total of 2163 sources were screened, of which 16 articles were included in the review. Seven sources only examined consent strategies, whereas the remaining eight included a combination of consent/assent and dissent strategies. Using thematic analysis, three key themes emerged – consent/assent strategies, researcher capacity, and capacity to consent tools. Key identified strategies included the accessibility of the consent/assent process, building relationships with participants and caregivers, identifying behavioural cues, and communication training for researchers.
Despite the absence of literature on consent/assent strategies within the deafblind population, the review found promising strategies applied to individuals with other cognitive or sensory disabilities that researchers can adopt. Researchers are encouraged to use best practices in creating an inclusive research environment to include individuals with deafblindness.
Decisional capacity to consent to treatment and research in patients affected by Mild Cognitive Impairment. A systematic review and meta-analysis
Giovanna Parmigiani, Antonio Del Casale, Gabriele Mandarelli, Benedetta Barchielli, Georgios D. Kotzalidis, Fabrizia D’Antonio, Antonella Di Vita, Carlo de Lena, Stefano Ferracuti
International Psychogeriatrics, 15 February 2021; pp 1-14
To perform a meta-analysis of clinical studies on the differences in treatment or research decision making capacity among patients with Mild Cognitive Impairment (MCI), Alzheimer’s disease (AD), and healthy comparisons (HCs).
A systematic search was conducted on Medline/Pubmed, CINAHL, PsycINFO, Web of Science, and Scopus. Standardized mean differences and random-effects model were used in all cases.
The United States, France, Japan, and China.
Four hundred and ten patients with MCI, 149 with AD, and 368 HCs were included.
The studies we included in the analysis assessed decisional capacity to consent by the MacArthur Competence Assessment Tool for Treatment (MAcCAT-T), MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), Capacity to Consent to Treatment Instrument (CCTI), and University of California Brief Assessment of Capacity to Consent (UBACC).
We identified 109 potentially eligible studies from 1672 records, and 7 papers were included in the metaanalysis. The meta-analysis showed that there was significant impairment in a decision-making capacity in MCI patients compared to the HCs group in terms of Understanding (SMD = − 1.04, 95% CI: − 1.31 to − 0.77, P < 0.001; I 2 =52%, P= 0.07), Appreciation (SMD = − 0.51, 95% CI: − 0.66 to − 0.36, P <0.001; I 2 = 0%, P = 0.97), and Reasoning (SMD = − 0.62, 95% CI: − 0.77, −0.47, P< 0.001; I 2 =0%, P=0.46). MCI patients scored significantly higher in Understanding (SMD = 1.50, 95% CI: 0.91, 2.09, P =0.01, I 2 = 78%, P= 0.00001) compared to patients affected by AD.
Patients affected by MCI are at higher risk of impaired capacity to consent to treatment and research compared to HCs, despite being at lower risk compared to patients affected by AD. Clinicians and researchers need to carefully evaluate decisional capacity in MCI patients providing informed consent.
Surrogate Informed Consent: A Qualitative Analysis of Surrogate Decision Makers’ Perspectives
Trevor Lane , Elinor Brereton , Carolyn Nowels , Jeffrey McKeehan , Marc Moss , Daniel D Matlock
Annals of the American Thoracic Society, 2 February 2021
Clinical critical care research often hinges on surrogate informed consent as patients commonly lack decision making capacity due to their acute illness. The surrogate informed consent process has been identified as having flaws and needing improvement. A better understanding of surrogates’ perspectives is required in order to understand and address these shortcomings and thereby improve this process.
To explore the perspectives of surrogate decision makers of critically ill mechanically ventilated patients about being approached about having their loved one participate in hypothetical research studies.
We performed semi-structured qualitative interviews of surrogate decision makers of critically ill mechanically ventilated patients exploring their decisional needs surrounding participation in research. These interviews were recorded and transcribed verbatim. A thematic analysis of transcripts was performed with an iterative group framework using a mixed inductive and deductive approach.
A sample of 21 surrogate decision makers were interviewed. Thematic saturation was achieved by consensus of the investigators. We identified trust as a unifying domain for the themes that emerged through the analytic process. Embedded within the domain of trust, two central themes became apparent: knowledge-based trust and context-based trust. Knowledge-based trust includes sub-themes of logistics, accountability, and mutual respect, whereas context-based trust includes trust in the individual clinicians and trust in the hospital system.
Our findings highlight the nuanced layers of trust central to the surrogate informed consent process. To enhance the surrogate informed consent process for participation in critical care research studies it is crucial that researchers recognize the inherent importance of trust to ensure an effective informed consent process.