Rethinking Informed Consent in the Context of Big Data
Anna Bruvere, Victor Lovic
Cambirdge Journal of Science & Policy, 2021; 2(2)
Open Access
Abstract
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)
Abstract
Introduction
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.
Method
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.
Result
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).
Conclusion
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
Abstract
Background/Aims
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).
Methods
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.
Results
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.
Conclusion
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
Abstract
Objective
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.
Results
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).
Conclusions
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
Abstract
Background
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.
Methods
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.
Results
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.
Interpretation
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
Abstract
Introduction
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.
Methods
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.
Results
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.
Discussion
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
Abstract
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.
[The consent of adolescents in an outpatient setting].
[The consent of adolescents in an outpatient setting].
Desmarets-Malik V
Soins Psychiatrie, 23 March 2021; 42(333) pp 23-25
Abstract
The part-time therapeutic reception center (CATTP) presented in this article has modified its organization in order to retain the adolescents who attend it. Clinical work on indications and the implementation of a reception protocol mobilized the team in view of admissions. The CATTP, in its current functioning, brings together the adolescent and his family, in search of a double consent.
Editor’s note: This is a French language publication
Social Media Terms and Conditions and Informed Consent From Children: Ethical Analysis
Social Media Terms and Conditions and Informed Consent From Children: Ethical Analysis
Christophe Olivier Schneble, Maddalena Favaretto, Bernice Simonne Elger, David Martin Shaw
JMIR Pediatrics and Parenting, 22 April 2021; 4(2)
Open Access
Abstract
Background
Terms and conditions define the relationship between social media companies and users. However, these legal agreements are long and written in a complex language. It remains questionable whether users understand the terms and conditions and are aware of the consequences of joining such a network. With children from a young age interacting with social media, companies are acquiring large amounts of data, resulting in longitudinal data sets that most researchers can only dream of. The use of social media by children is highly relevant to their mental and physical health for 2 reasons: their health can be adversely affected by social media and their data can be used to conduct health research.
Objective
The aim of this paper is to offer an ethical analysis of how the most common social media apps and services inform users and obtain their consent regarding privacy and other issues and to discuss how lessons from research ethics can lead to trusted partnerships between users and social media companies. Our paper focuses on children, who represent a sensitive group among users of social media platforms.
Methods
A thematic analysis of the terms and conditions of the 20 most popular social media platforms and the 2 predominant mobile phone ecosystems (Android and iOS) was conducted. The results of this analysis served as the basis for scoring these platforms.
Results
The analysis showed that most platforms comply with the age requirements issued by legislators. However, the consent process during sign-up was not taken seriously. Terms and conditions are often too long and difficult to understand, especially for younger users. The same applies to age verification, which is not realized proactively but instead relies on other users who report underaged users.
Conclusions
This study reveals that social media networks are still lacking in many respects regarding the adequate protection of children. Consent procedures are flawed because they are too complex, and in some cases, children can create social media accounts without sufficient age verification or parental oversight. Adopting measures based on key ethical principles will safeguard the health and well-being of children. This could mean standardizing the registration process in accordance with modern research ethics procedures: give users the key facts that they need in a format that can be read easily and quickly, rather than forcing them to wade through chapters of legal language that they cannot understand. Improving these processes would help safeguard the mental health of children and other social media users.
Implementing new consent procedures for schools-based human papillomavirus vaccination: a qualitative study
Implementing new consent procedures for schools-based human papillomavirus vaccination: a qualitative study
Research
Suzanne Audrey, Karen Evans, Michelle Farr, Joanne Ferrie, Julie Yates, Marion Roderick, Harriet Fisher
British Journal of Child Health, 10 April 2021; 2(2)
Abstract
Background
The requirement for written parental consent for school-based human papillomavirus vaccination programme in England can act as a barrier to uptake for some young women, with the potential to exacerbate health inequities.
Aims
To consider the practicalities and implications of implementing new consent procedures, including parental telephone consent and adolescent self-consent, in two local authority areas in the southwest of England.
Methods
Digitally recorded, semi-structured interviews were conducted with 53 participants, including immunisation nurses, school staff, young people, and parents. All interviews were fully transcribed and thematic analysis was undertaken.
Results
Parental telephone consent was welcomed by the immunisation nurses, parents, and young women in the study. Adolescent self-consent was rare. Greater understanding of the barriers to uptake outside of mainstream school-based sessions is needed to further address inequalities in uptake.
Conclusions
The new procedures generally worked well but some important barriers to vaccination uptake remain.
Center for Informed Consent Integrity 