The value of communities and their consent: A communitarian justification of community consent in medical research
Original Article
Pepijn Al
Bioethics, 20 October 2020
Abstract
Community engagement is increasingly defended as an ethical requirement for biomedical research. Some forms of community engagement involve asking the consent of community leaders prior to seeking informed consent from community members. Although community consent does not replace individual consent, it could problematically restrict the autonomy of community members by precluding them from research when community leaders withhold their permission. Community consent is therefore at odds with one of the central principles of bioethics: respecting autonomy. This raises the question as to how community consent can be justified or even required. This paper aims to provide an answer to this question by arguing, based on the work of Taylor and Kymlicka, that community practices are important for the identity and autonomy of community members. When these practices are incompatible with a solitary focus on individual informed consent, they need to be protected by making these decision‐making practices (including asking permission to community authorities) part of the consent process. Since these decision‐making practices are important for the autonomy of community members, community consent with the goal of protecting these practices is not necessarily in conflict with autonomy.

Identification of Informed Consent in Patient Videos on Social Media: Prospective Study
Original Paper
Jane O’Sullivan, Cathleen McCarrick, Paul Tierney, Donal B O’Connor, Jack Collins, Robert Franklin
JMIR Medical Education, 13 October 2020; 6(2)
Open Access
Abstract
Background
The American Medical Association Code of Medical Ethics states that any clinical image taken for public education forms part of the patient’s records. Hence, a patient’s informed consent is required to collect, share, and distribute their image. Patients must be informed of the intended use of the clinical image and the intended audience as part of the informed consent.
Objective
This paper aimed to determine whether a random selection of instructional videos containing footage of central venous catheter insertion on real patients on YouTube (Google LLC) would mention the presence of informed consent to post the video on social media.
Methods
We performed a prospective evaluation by 2 separate researchers of the first 125 videos on YouTube with the search term “central line insertion.” After duplicates were deleted and exclusion criteria applied, 41 videos of patients undergoing central line insertion were searched for reference to patient consent. In the case of videos of indeterminate consent status, the posters were contacted privately through YouTube to clarify the status of consent to both film and disseminate the video on social media. A period of 2 months was provided to respond to initial contact. Furthermore, YouTube was contacted to clarify company policy. The primary outcome was to determine if videos on YouTube were amended to include details of consent at 2 months postcontact. The secondary outcome was a response to the initial email at 2 months.
Results
The researchers compiled 143 videos. Of 41 videos that contained footage of patient procedures, 41 were of indeterminate consent status and 23 contained identifiable patient footage. From the 41 posters that were contacted, 3 responded to initial contact and none amended the video to document consent status. Response from YouTube is pending.
Conclusions
There are instructional videos for clinicians on social media that contain footage of patients undergoing medical procedures and do not have any verification of informed consent. While this study investigated a small sample of available videos, the problem appears ubiquitous and should be studied more extensively.

Patients’ Experiences of Informed Consent and Preoperative Education
Research Article
Elif Akyüz, Yurdagül Erdem
Clinical Nursing Research, 7 October 2020
Abstract
The aim of this descriptive cross-sectional study was to determine adult surgery patients’ experiences of informed consent and preoperative education. Research was conducted between September 2018 and February 2019. The sample consisted of 201 adult patients of a university hospital in Turkey. Data were collected using a 48-item questionnaire developed by the researchers based on literature. More than half of the participants (54.2%) were fully informed while 36.8% were partially informed about their surgery process and 61.2% were informed by physicians. Overall, 33.3% had unanswered questions about surgery, with questions relating mostly to the type of surgery (26.8%) and its effect on their body (25.4%). Participants were least informed about preoperative deep breathing and cough exercises (47.8%). More than half (58.4%) of participants expected healthcare professionals to avoid using medical terminology when informing them. Physicians and nurses perform invasive interventions on patients and, therefore, should be sensitive about informing patients.

Consent for spine surgery: an observational study
Original Article
Angela Li Ching Ng, Lucinda S. McRobb, Sarah J. White, John A. Cartmill, Allan M. Cyna, Kevin Seex
ANZ Journal of Surgery, 5 October 2020
Abstract
Background
The tension between the ideal of informed consent and the reality of the process is under‐investigated in spine surgery. Guidelines around consent imply a logical, plain‐speaking process with a clear endpoint, agreement and signature yet surgeons’ surveys and patient interviews suggest that surgeons’ explanation is anecdotally variable and patient understanding remains poor. To obtain a more authentic reflection of practice, spine surgeons obtaining ‘informed consent’ for non‐instrumented spine surgery were studied via video recording and risk/benefit discussions were analysed.
Methods
A prospective observational study was conducted at a single neurosurgical institution. Twelve video recordings involving six surgeons obtaining an informed consent for non‐instrumented spine surgery were transcribed verbatim and blindly analysed using descriptive quantification and linguistic ethnography.
Results
Ten (83%) consultations discussed surgical benefit but less than half (41%) quantified the likelihood of benefit from surgery. The most discussed risks were nerve damage or paralysis (92%), bleeding (92%), infection (92%), cerebrospinal fluid leak (83%) and bowel and bladder dysfunction (75%). Surgeons commonly used a quantitative statement of risk (58%) but only half of the risks were explained in words patients were likely to understand.
Conclusions
This study highlights inconsistencies in the way spine surgeons explain risks and obtain informed consent for ‘simple’ spine procedures in a real‐world setting. There are wide disparities in the provision of informed consent, which may be encountered in other surgical fields. Direct observation and qualitative analysis can provide insights into the limitations of current informed consent practice and help guide future practice.

Are We Meeting the Current Standards of Consent for Anesthesia? An International Survey of Clinical Practice
Tomas Jovaisa, Ieva Norkiene, Juri Karjagin, Iveta Golubovska, Lukas Gambickas, Migle Kalinauskaite, Evaldas Kauzonas, Dhuleep Wijayatilake
Medical Science Monitor, 5 October 2020
Open Access
Abstract
Background
International application of existing guidelines and recommendations on anesthesia-specific informed consent is limited by differences in healthcare and legal systems. Understanding national and regional variations is necessary to determine future guidelines.
Material and Methods
Anonymous paper surveys on their practices regarding anesthesia-specific patient informed consent were sent to anesthesiologists in Estonia, Latvia, and Lithuania.
Results
A total of 233 responses were received, representing 36%, 26%, and 24% of the practicing anesthesiologists in Lithuania, Latvia, and Estonia, respectively. Although 85% of responders in Lithuania reported using separate forms to secure patient informed consent for anesthesia, 54.5% of responders in Estonia and 50% in Latvia reported using joint forms to secure patient informed consent for surgery and anesthesia. Incident rates were understated by 14.2% of responders and overstated by 66.4% (P<0.001), with the latter frequently quoting incident rates that are several to tens of times higher than those published internationally. Physicians obtaining consent in the outpatient setting were more satisfied with the process than those obtaining consent on the day of surgery, with 62.5% and 42.6%, respectively, agreeing that the informed consent forms provided a satisfactory description of complications (P=0.03). Patients were significantly less likely to read consent information when signing forms on the day of surgery than at earlier times (8.5% vs. 67.5%, P<0.001). Only 46.2% of respondents felt legally protected by the current consent process.
Conclusions
Anesthesia-specific informed patient consent practices differ significantly in the 3 Baltic states, with these practices often falling short of legal requirements. Efforts should be made to improving information accuracy, patient autonomy, and compliance with existing legal standards.

Readability of foot and ankle consent forms in Queensland
Original Article
Giuseppe Pastore, Philip M. Frazer, Andrew Mclean, Tom P. Walsh, Simon Platt
ANZ Journal of Surgery, 5 October 2020
Abstract
Background
The aim of this study was to conduct a readability analysis on both patient take‐home information and consent forms for common foot and ankle procedures. Our hypothesis was that the objective reading skills required to read and comprehend the documentation currently in use would exceed the recommendations in place by both national and international bodies.
Methods
The current Queensland Health consent forms are divided into specific subsections. The readability of consent form subsections C and G (sections containing detailed information on risks of the procedure and pertaining to informed patient consent specifically) and patient take‐home information (provided as take‐home leaflet from the consent form which is procedure specific) was assessed by an online readability software program using five validated methods calculated by application of the algorithms for (i) Flesch–Kincaid grade level, (ii) the SMOG (Simple Measure of Gobbledygook), (iii) Coleman–Liau index, (iv) automated readability index and the (v) Linsear Wriste formula.
Results
The mean ± standard deviation reading grade level of risk (section C), grade level of patient consent (section G) and grade level for procedure‐specific take‐home patient information were 8.7 ± 0.9, 11.6 ± 1.2 and 7.5 ± 0.2, respectively.
Conclusion
The readability of sections C and G of the Queensland Health consent form exceeds the recommendations by national and international bodies, but the patient take‐home information appears suitable. Consideration should be given to lower the reading grade level of patient consent forms to better reflect the reading grade of the Australian population.

‘Hobson’s choice’: a qualitative study of consent in acute surgery
Anthony Howard, Jonathan Webster, Naomi Quinton, Peter V Giannoudis
BMJ Open, 25 August 2020; 10
Open Access
Abstract
Objectives
The study aimed to understand through qualitative research what patients considered material in their decision to consent to an acute surgical intervention.
Participants, setting and intervention
The patients selected aged between 18 and 90, having been admitted to a major trauma centre to undergo an acute surgical intervention within 14 days of injury, where English was their first language. Data saturation point was reached after 21 patients had been recruited. Data collection and analysis were conducted simultaneously, through interviews undertaken immediately prior to surgery. The data were coded using NVIVO V.12 software.
Results
The key theme that originated from the data analysis was patients were unable to identify any individual risk that would modify their decision-making process around giving consent. The patient’s previous experience and the experience of others around them were a further theme. Patients sensed that there were no nonoperative options for their injuries.
Conclusion
This is the first study investigating what patient considered a material risk in the consent process. Patients in this study did attribute significance to past experiences of friends and family as material, prompting us to suggest that the surgeon asks about these experiences as part of the consent process. Concern about functional recovery was important to patients but insufficient to stop them from consenting to surgery, thus could not be classified as material risk.