Consent for Use of Genetic Data among US Hispanics/Latinos: Results from the Hispanic Community Health Study/ Study of Latinos
Sara Gonzalez, Garrett Strizich, Carmen R. Isasi, Simin Hua, Betsy Comas, Tamar Sofer, Bharat Thyagarajan, Krista M. Perreira, Gregory A. Talavera, Martha L. Daviglus, Sarah C. Nelson, Aida L. Giachello, Neil Schneiderman, Robert C. Kaplan
Ethnicity & Disease, 2021; 31(4)
Abstract
Inclusion of historically underrepresented populations in biomedical research is critical for large precision medicine research initiatives. Among 13,721 Hispanic Community Health Study/Study of Latinos (HCHS/SOL) enrollees, we used multivariable adjusted prevalence ratios to describe characteristics associated with participants’ willingness to consent to different levels of biospecimen and genetic data analysis and sharing. At baseline (2008-2011), HCHS/SOL participants almost universally consented to the use of biospecimens and genetic data by study investigators and their collaborators (97.6%; 95%CI: 97.1, 98.0). Fewer consented to biospecimen and genetic data sharing with investigators not affiliated with the HCHS/SOL research team (81%, 95%CI: 80, 82) or any data sharing with commercial/for-profit entities (75%, 95%CI: 74, 76). Those refusing to share their data beyond the study investigators group were more often females, Spanish language-speakers and non-US born individuals. As expected, participants who were retained and reconsented at the six year follow up visit tended to embrace broader data sharing, although this varied by group. Over time, Puerto Ricans and Dominicans were more likely to convert to broader data sharing than individuals of a Mexican background. Our analysis suggests that acculturation and immigration status of specific Hispanic/Latino communities may influence decisions about participation in genomic research projects and biobanks.

The 3-T Model of Informed Consent for Nonstandard Risk Donors: A Proposal for Transplant Clinical Practice
Alessandra Agnese Grossi, Federico Nicoli, Tullia Maria De Feo, Massimo Cardillo, Gabriella Biffa, Renzo Pegoraro, Carlo Petrini, Rosanna Torelli, Francesca Puoti, Giuseppe Rossini, Giuseppe Piccolo, Sergio Vesconi, Enrico Minetti, Barbara Pozzo, Giuseppe Vanacore, David Paredes, Antonio Grossi, Paolo Mario Picozzi
Transplantation Direct, November 2021; 7(11)
Abstract
Background
The risk of disease transmission from nonstandard risk donors (NSRDs) is low, and outcomes are similar or better relative to transplants performed with standard criteria donors. However, NSRDs have posed new ethical challenges to the informed consent (IC) process. Based on the shared decision-making model, coinciding with the 3 main timings of the IC process ([1] pretransplant assessments and waiting list registration, [2] time on the waiting list, and [3] time of the organ offer), we put forward a model (3-T Model) to summarize the knowledge on IC for NSRDs and to deliver conceptual and practical support to transplant providers on this emergent issue.
Methods
We searched PubMed and analyzed data from our area to provide evidence and ethical arguments to promote standardization of the timing of patient information, degree of patient participation, and disclosure of donor risk factors throughout the 3 stages of the time continuum leading to the potential acceptance of NSRDs.
Results
Each of the 3 timings carries special ethical significance and entails well-defined duties for transplant providers relative to patient involvement and information of the benefits and risks associated with NSRDs. Based on our framework, experience, and interpretation of the literature, we put forward a list of recommendations to combine standardization (ie, timing, content, and degree of patient participation) and individualization of IC.
Conclusions
The 3-T Model may enable the prevention of physicians’ arbitrariness and the promotion of patient-centered care. Future studies will assess the effectiveness of the 3-T Model in transplant clinical practice.

Urology Consent Forms at a District General Hospital – a Quality Improvement Project
D Bernstein, A West, E Preston, P Premakumaran, N Suleyman, S Undre
British Journal of Surgery, 12 October 2021; 108 (Supplement 6)
Abstract
Aim
Consent is a core component of interaction between patients and healthcare professionals. Prior to surgery, forms are completed to record patient consent. As well as containing risks and benefits of the procedure, the consent form, as per guidelines1,2, must be legible and suitable to a patient’s capacity. To evaluate compliance with local and national guidelines, a quality improvement project was undertaken at a district general hospital.
Method
Over a three-week period 30 urology consent forms were selected to assess adherence to local and national guidelines. The appropriateness of consent form, patient signature, legibility, acronym use and whether the patient was offered a carbon copy were assessed. After initial data collection, all urology staff consenting patients were notified of the findings and how best to improve guideline adherence. A further three-week data collection was undertaken, though the sample set was small due to Coronavirus and Christmas.
Results
The results confirmed that patients had appropriate consent forms filled out and were signed appropriately. After intervention, there was clear improvement in legibility, with no low legibility consent forms, and 100% vs 83% high or moderate legibility between data sets. Intervention also resulted in significant reduction of acronym use; 33% vs 60%. More patients were also offered to retain a carbon copy; 89% vs 40%.
Conclusions
Through this intervention of highlighting local and national guidance as compared to current practice, compliance drastically improved. As the pandemic subsides, we hope regular emails to surgical teams will improve consent form completion to better patient care.

Infrainguinal Bypass Informed Consent: An Audit Driven Standardisation Of Perioperative Risk Profiling
K Muhammad, H Al-Khaffaf
British Journal of Surgery, 12 October 2021; 108 (Supplement 6)
Abstract
Introduction
It is a fundamental good clinical practice in our medicolegal rights era to obtain standard, adequate, and transparent informed consent before any planned intervention. Currently, there are neither national approved vascular intervention-specific consents nor explicit guidelines for it. We aim to achieve a standardisation of perioperative risk profiling of infrainguinal bypass surgical consents and produce a model one.
Method
A retrospective analysis of 45 infrainguinal bypass consents (audit/reaudit) between (2013-2019) retrieved to evaluate quality and completeness against GMC 2008 guidance: “Consent: patients and doctors making decisions together”. Data included basic consent requirements according to guidelines and specific risks of infrainguinal bypass. It was registered with the Trust Clinical Audit Department.
Results
(100%) of audit and reaudit consents documented the intended benefits of surgery. Inclusion into the National Vascular Registry (NVR) was achieved (0%) in audit vs (80%) in reaudit forms. Of the 19 documented postoperative complications, reaudit significant improvement observed in % of documenting 16 items with 9 complications recorded above 50%. The maximum number of audit documented risks was 15 (79%), the median 8 (42%), and the least was 3 (16%) compared to maximum 16 (84%), the median 10 (53%) and the least was 4 (21%) when reaudited, respectively.
Conclusions
Deficiencies in performing and adequately completing surgical consents still occur. Introducing a national pre-printed vascular intervention-specific consent is vital for accomplishing and maintaining a good clinical practice. It should include all complications with relative % risk to minimise errors, provide good quality consent, and promote clinical practice at a national level.

A Question of Consent—Coercion and Consent to Lobotomy, 1946–1958 [BOOK CHAPTER]
Jesper Vaczy Kragh
Lobotomy Nation, 10 October 2021; pp 291-335 [Springer]
Abstract
This chapter investigates a topic that has not been addressed in the literature on psychosurgery, i.e. the question of consent to lobotomy. The performance of lobotomy required the psychiatrist to obtain the consent of the patient, or his or her next of kin, to the treatment. The chapter analyses the role played by the consent requirement when neurosurgery was being considered. The consent issue gives an insight into the patient-doctor relationship and how psychiatrists interpreted patients’ rights in the 1940s and 1950s. In addition, consent practices show that there were tensions between psychiatrists and neurosurgeons who had different views about this. The consent question was significant to the discontinuation of psychosurgery, since the initial criticism of the treatment was raised due to complaints concerning lacking consent.

Rehearsal’s effect on long-term recall and comprehension of orthodontic informed consent
Original Article
American Journal of Orthodontics and Dentofacial Orthopedics, 5 October 2021
Alexander R. Desman, Henry W. Fields, Andy Ni, Fonda G. Robinson, Brennan Skulski, Allen R. Firestone, David J. Heinlein
Abstract
Introduction
The purpose of this study was to determine if written rehearsal of informed consent improved 6-month recall and comprehension compared with the current best practices.
Methods
A consultation was provided and subjects read the modified informed consent document. They were randomized to group A (received the core and up to 4 custom elements of treatment, wrote what each image displayed) or group B (presentation of the 18 elements with core elements chunked at the end followed by up to 4 custom elements). Interviews recording knowledge recall/comprehension occurred immediately and after months later.
Results
Overall, no significant differences in baseline or 6-month follow-up scores were found between groups. Initially, group A outperformed group B in some core domains. There were no significant differences between groups in the change of scores from initial to follow-up. Follow-up scores were significantly lower than baseline scores (P <0.05). Higher initial scores were associated with larger drops at follow-up. A decrease in knowledge >20% was common.
Conclusions
Overall the methods are comparable at baseline and 6-months. Initial content retention was roughly 60+%, with 6%-9% deterioration. For areas of treatment methods, risk, discomfort, and resorption at 6-months, the current processes failed the patient and left the practitioner vulnerable to risk management issues. Results support the rehearsal method with immediate feedback for misunderstandings as the preferred method for informed consent.

Consent for septoplasty: Are we meeting patients’ expectations?
Research Article
Haseem Raja, Rishi Talwar
Medico-Legal Journal, 4 October 2021
Abstract
The requirements for informed consent were modified in 2015 following the UK Supreme Court judgment of Montgomery v Lanarkshire Health Board. This marked a decisive shift from the traditional paternalistic ‘doctor knows best’ model towards a more patient-centred approach. This study examines the current standard of consent for septoplasty and whether it complies with the law. We also report whether the ‘reasonable patient’ and surgeon agree about which risks should be discussed during the consent process. Ten complications were identified as common or serious via a literature search. Using questionnaires, 21 Ears, Nose and Throat surgeons were asked which of these they routinely discussed, and 103 patients were asked how seriously they regarded those complications. Results were compared using the Test of Proportions. Most surgeons routinely discuss all risks except negative change in sense of smell and numbness of upper incisors. The ‘reasonable patient’ regarded these two complications as serious or very serious. However, less than 70% of surgeons mentioned them. A significant proportion of Ears, Nose and Throat surgeons do not routinely mention all the risks that the ‘reasonable patient’ would want to know about before undergoing a septoplasty. This may result in more clinical negligence claims, as managing a patient’s reasonable expectations is an important factor.

Informed Consent, Advance Directives, and Shared Care Planning [BOOK CHAPTER]
Giuseppe Renato Gristina
Palliative Care in Cardiac Intensive Care Units, 30 September 2021; pp 83-97 [Springer]
Abstract
Knowing patient wishes regarding treatment acceptance or refusal is an essential aspect of care strategy, based on the principle of autonomy. In clinical practice, ignoring patient wishes or not taking them into proper consideration can lead to ethical and legal issues. In most cases patients hospitalized in general or specialized intensive care units (e.g., ICUs or cardiac intensive care units—CICUs), are unable to make autonomous decisions regarding their treatment due to disease severity. As a consequence, advance directives (ADs) could be a particularly effective tool to adequately guide doctor conduct with respect to patient values and wishes. In the USA and in many European countries, ADs have now been integrated in their legal systems but, despite their popularity, ADs have not yet achieved the expected result. In contrast, shared care planning (SCP) has been more successful. SCP is the process by which the quality of future patient care is discussed and planned according to the patient’s values and preferences. Planning involves the patient, the healthcare professionals, and the family members. On one hand SCP can improve planning of future care for patients with advanced cardiovascular disease and document their preferences; on the other hand, it is unclear what role SCP has in improving the quality of patient life, reducing depression often associated with the disease, and increasing the caregiver satisfaction.