Views on genomic research result delivery methods and informed consent: a review

Views on genomic research result delivery methods and informed consent: a review
Danya F Vears , Joel T Minion, Stephanie J Roberts, James Cummings, Mavis Machirori & Madeleine J Murtagh
Personalized Medicine, 6 April 2021; 18(3)
There has been little discussion of the way genomic research results should be returned and how to obtain informed consent for this. We systematically searched the empirical literature, identifying 63 articles exploring stakeholder perspectives on processes for obtaining informed consent about return of results and/or result delivery. Participants, patients and members of the public generally felt they should choose which results are returned to them and how, ranging from direct (face-to-face, telephone) to indirect (letters, emails, web-based delivery) communication. Professionals identified inadequacies in result delivery processes in the research context. Our findings have important implications for ensuring participants are supported in deciding which results they wish to receive or, if no choice is offered, preparing them for potential research outcomes.

To consent, or not to consent? The publicness effect on citizens’ willingness to grant access to personal data in the face of a health crisis

To consent, or not to consent? The publicness effect on citizens’ willingness to grant access to personal data in the face of a health crisis
Nicola Belle, Paola Cantarelli, R. Paul Battaglio
Journal of European Public Policy, 16 April 2021
This study contributes to the nascent behavioral governance scholarship by experimentally testing whether individuals’ likelihood of lifting their privacy rights in the face of a health crisis varies based on the public versus private nature of the entity accessing their personal data and the length of time during which records can be used. We run an online, randomized control trial with 1,500 citizens representative of the Italian general adult population. Results show a significant increase in subjects’ willingness to grant access to personal records when the entity analyzing data is public rather than private. Further, the propensity to consenting is higher when access to personal data is granted for a limited rather than an unlimited period of time. We discuss how these patterns of results change remarkably across geographic areas within the country.

Informed consent for linking survey and social media data

Informed consent for linking survey and social media data
Johannes Breuer, Tarek Al Baghal, Luke Sloan, Libby Bishop, Dimitra Kondyli, Apostolos Linardis
IASSIST Quarterly, 2021; 45(1) pp 1-27
Open Access
Linking social media data with survey data is a way to combine the unique strengths and address some of the respective limitations of these two data types. As such, linked data can be quite disclosive and potentially sensitive, it is important that researchers obtain informed consent from the individuals whose data are being linked. When formulating appropriate informed consent, there are several things that researchers need to take into account. Besides legal and ethical questions, key considerations are the differences between platforms and data types. Depending on what type of social media data is collected, how the data are collected, and from which platform(s), different points need to be addressed in the informed consent. In this paper, we present three case studies in which survey data were linked with data from 1) Twitter, 2) Facebook, and 3) LinkedIn and discuss how the specific features of the platforms and data collection methods were covered in the informed consent. We compare the key attributes of these platforms that are relevant for the formulation of informed consent and also discuss scenarios of social media data collection and linking in which obtaining informed consent is not necessary. By presenting the specific case studies as well as general considerations, this paper is meant to provide guidance on informed consent for linked survey and social media data for both researchers and archivists working with this type of data.

Rethinking Informed Consent in the Context of Big Data

Rethinking Informed Consent in the Context of Big Data
Anna Bruvere, Victor Lovic
Cambirdge Journal of Science & Policy, 2021; 2(2)
Open Access
A widely accepted method for addressing digital privacy concerns is the use of informed consent: asking users to agree to privacy policies and consent to the use of their personal data. This approach has come under strain with the emergence of “big data” in which large datasets are collected and analysed. This paper argues that since individuals do not understand or even read the privacy policies they agree to, informed consent ultimately fails to protect privacy. Following the work of Solon Barocas and Helen Nissenbaum, this paper proposes an updated definition of informed consent and argues that the responsibility of protecting privacy should be shifted from individuals to organisations.

073: Improving Consent with a Visual Tool for Communicating Surgical Risks

073: Improving Consent with a Visual Tool for Communicating Surgical Risks
SJ Tingle, JK Ramsingh, RD Bliss, PP Truran
British Journal of Surgery, 27 April 2021; Volume 108(Supplement 1)
Patients must understand the risks of a procedure to provide valid consent. Guidance from the General Medical Council and Royal College of Surgeons of England highlights that surgeons need to communicate risks in a way that patients can understand, and both institutions specifically mention the use of written information. We aimed to improve communication of surgical risks to patients undergoing thyroid surgery.
Over 3 months, all patients undergoing thyroid surgery in a tertiary referral centre were included (n=51). Participants were given a 10 point questionnaire after the consent process. Each question had 4 options (very common, common, uncommon and rare) and tested participant understanding of surgical risks. Our intervention was a single page annotated graphic, which used a traffic-light system to explain surgical risks.
When consented prior to our intervention (n=28), patient understanding of the magnitude of surgical risks was poor; median questionnaire score was 4.5 out of 10, and for some questions <15% of participants selected the correct answer. Following introduction of our surgical risk tool (n=23) median overall participant score increased from 4.5 (range 2-7) to 8.0 (4-10) out of 10 (P<0.0001; Mann-Whitney U test).
Patients must understand the risks of an operation, and the magnitude of those risks, in order to provide valid consent. Addition of a visual surgical risk tool enabled us to increase patient understanding of surgical risks, improving the consent process. This has implications not just for thyroid surgery, but for any procedure requiring consent.
Take-home message
Clear communication of surgical risks is essential to obtain valid consent. The use of a visual surgical risk tool increases patient understanding of risks, and therefore improves the consent process.

Randomized comparison of two interventions to enhance understanding during the informed consent process for research

Randomized comparison of two interventions to enhance understanding during the informed consent process for research
Research Article
Holly A Taylor, Daphne Washington, Nae-Yuh Wang, Hiten Patel, Daniel Ford, Nancy E Kass, Joseph
Clinical Trials, 23 April 2021
Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies).
In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process.
A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process (p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process.
This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.

Multimedia for Delivering Participant Informed Consent in Cardiovascular Trials

Multimedia for Delivering Participant Informed Consent in Cardiovascular Trials
Niamh Chapman, Rebekah Mcwhirter, Matthew Armstrong, Ricardo Fonseca, Julie Campbell, Mark Nelson, Martin Schultz, James Sharman
Journal of Hypertension, April 2021; 39 pp e217-e218
Open Access
Obtaining informed consent is a cornerstone requirement of conducting ethical research. Traditional paper-based consent is often excessively lengthy, legalistic in character, and may fail to achieve desired participant understanding of study requirements. Multimedia tools including video and audio may be a useful alternative. This study aimed to determine the efficacy, usability and acceptability of stand-alone multimedia delivery of participant consent relating to a cardiovascular trial.
Design and method
A total of 298 participants (63 ± 8 years; 51% female) were randomised to delivery of cardiovascular research study information and signed consent via multimedia (intervention; n = 146) compared with standard paper-based approach (control; n = 152) in a clinical research setting. Intervention was free of research staff and included short audio-visual explanations, with computer-based finger-signed consent. Efficacy, usability and acceptability were assessed by questionnaire.
All participants successfully completed allocated interventions. Efficacy parameters were significantly higher among intervention participants, including better understanding of study requirements compared with controls (P < 0.05 all). Intervention participants were also significantly more likely to engage with the study information and spend more time on the consent process and study questionnaire (P = 0.038 and P = 0.007, respectively). Both groups reported similar levels of acceptability of the consent process, although more control participants reported that the study information was too long (24% versus 14%; P = 0.020).
A standalone multimedia consent process is effective for achieving participant understanding and obtaining consent on cardiovascular research in a clinical research setting free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs, and achieve informed consent in clinical cardiovascular research.

Assessment of capacity to give informed consent for medical assistance in dying: a qualitative study of clinicians’ experience

Assessment of capacity to give informed consent for medical assistance in dying: a qualitative study of clinicians’ experience
Ellen Wiebe, Michaela Kelly, Thomas McMorrow, Sabrina Tremblay-Huet, Mirna Hennawy Abstract
Canadian Medical Association Journal, 13 April 2021;9(2) pp E358-E363
Open Access
Under the Canadian Criminal Code, medical assistance in dying (MAiD) requires that patients give informed consent and that their ability to consent is assessed by 2 clinicians. In this study, we intended to understand how Canadian clinicians assessed capacity in people requesting MAiD.
This qualitative study used interviews conducted between August 2019 and February 2020, by phone, video and email, to explore how clinicians assessed capacity in people requesting MAiD, what challenges they had encountered and what tools they used. The participants were recruited from provider mailing listserves of the Canadian Association of MAiD Assessors and Providers and Aide médicale à mourir. Interviews were audio-recorded and transcribed verbatim. The research team met to review transcripts and explore themes as they emerged in an iterative manner. We used abductive reasoning for thematic analysis and coding, and continued to discuss until we reached consensus.
The 20 participants worked in 5 of 10 provinces across Canada, represented different specialties and had experience assessing a total of 2410 patients requesting MAiD. The main theme was that, for most assessments, the participants used the conversation about how the patient had come to choose MAiD to get the information they needed. When the participants used formal capacity assessment tools, this was mostly for meticulous documentation, and they rarely asked for psychiatric consults. The participants described how they approached assessing cases of nonverbal patients and other challenging cases, using techniques such as ensuring a quiet environment and adequate hearing aids, and using questions requiring only “yes” or “no” as an answer.
The participants were comfortable doing MAiD assessments and used their clinical judgment and experience to assess capacity in ways similar to other clinical practices. The findings of this study suggest that experienced MAiD assessors do not routinely require formal capacity assessments or tools to assess capacity in patients requesting MAiD.

Impact of Age on Consent in a Geriatric Orthopaedic Trauma Patient Population

Impact of Age on Consent in a Geriatric Orthopaedic Trauma Patient Population
Research Article
Madeline M. McGovern, Michael F. McTague, Erin Stevens, Juan Carlos Nunez Medina, Esteban Franco-Garcia, Marilyn Heng
Geriatric Orthopedic Surgery & Rehabilitation, 30 March 2021
Open Access
Persistent misconceptions of frailty and dementia in geriatric patients impact physician-patient communication and leave patients vulnerable to disempowerment. Physicians may inappropriately focus the discussion of treatment options to health care proxies instead of patients. Our study explores the consenting process in a decision-making capable orthogeriatric trauma patient population to determine if there is a relationship between increased patient age and surgical consent by health care proxy.
Patients aged 65 and older who underwent operative orthopaedic fracture fixation between 1 of 2 Level 1 Trauma Centers were retrospectively reviewed. Decision-making capable status was defined as an absence of patient history of cognitive impairment and a negative patient pre-surgical Confusion Assessment Method (CAM) and Mini-Cog Assessment screen. Provider of surgical consent was the main outcome and was determined by signature on the consent form.
510 patients were included, and 276 (54.1%) patients were deemed capable of consent. In 27 (9.8%) of 276 decision-capable patients, physicians obtained consent from health care proxies. 20 of these 27 patients (74.1%) were 80 years of age or older. However, in patients aged 70 to 79, only 7 health care proxies provided consent. (p = 0.07). For every unit increase in age, the log odds of proxy consent increased by .0008 (p < 0.001). Age (p < 0.001), income level (p = 0.03), and physical presence of proxy at consult (p < 0.001) were factors associated with significantly increased utilization of health care proxy provided consent. Language other than English was a significant predictor of proxy-provided consent (p = 0.035). 48 (22%) decision-making incapable patients provided their own surgical consent.
The positive linear association between age and health care proxy provided consent in cognitively intact geriatric orthopaedic patients indicates that increased patient age impacts the consenting process. Increased physician vigilance and adoption of institutional consenting guidelines can reinforce appropriate respect of geriatric patients’ consenting capacity.

Consent, refusal of care, and shared decision-making for pediatric patients in emergency settings

Consent, refusal of care, and shared decision-making for pediatric patients in emergency settings
Morrison SN, Sigman L
Pediatric Emergency Medicine Practice, 2 May 2021, 18(5) pp 1-20
Involving patients or their surrogate decision-makers in their care is an important element of modern medical practice. General consent, informed consent, treatment refusal, and shared decision-making are concepts that are used regularly but can be more complex in pediatric emergency settings. This issue summarizes these concepts and provides case examples that may be encountered. It explains the essential elements of informed consent, the distinction between the informed consent process and the document, how to approach treatment refusal, and approaches to involving patients and their surrogates in shared decision-making. Special circumstances include treatment for sexual and mental health conditions, emancipated minors, mature minors, and situations when custody is unclear. Implementation of these concepts can increase patient satisfaction, resolve conflict, and reduce risk.