Our “WMA Declaration of Helsinki”: Opinions and Proposals from Patient and Public for Research Ethics

Our “WMA Declaration of Helsinki”: Opinions and Proposals from Patient and Public for Research Ethics
Book Chapter
Chieko Kurihara, Keiko Inoue, Hiroto Kai, Katsura Suzuki, Haruko Saeki, Yoshikazu Funabashi, Noriko Kishi, Akemi Kuge, Toshie Murakami, Yoshiko Saito, Eiko Uchida, Naoki Tsutsumi, Kyoko Imamura
Ethical Innovation for Global Health, November 2023 [Springer]
Abstract
    The Declaration of Helsinki (DoH) was first issued in 1964 by the World Medical Association (WMA), addressed to physicians, and was amended nine times with the latest version being adopted in 2013. While it has been incorporated into research regulations in many countries and is well known to most researchers, most patients and the public see its title for the first time when they are requested to participate in medical research. We therefore formed a group composed mainly of patients and the public together with experts having perspectives of patients and the public. Our activity was intended to enhance our understanding of the DoH and to have it explained in our own language. In this way, patients and the public would be able to better comprehend its scope and contents.
This chapter is resulting from about 2 years of our monthly web-meetings, during COVID-19 pandemic. We found some discussion points not included in the current version of the DoH, such as the value of research aimed at Sustainable Development Goals (SDGs), patient and public involvement, multidisciplinary collaboration, shared decision-making founded on informed consent, patient-oriented research, diversity and fairness of research ethics committees, assuring the rights of those considered to be “vulnerable populations,” broad informed consent, dynamic consent, and social contract.
We hope that this chapter will contribute to the future revision of the DoH, as well as stimulate discussion for the international research ethics norms being under development, and that can be agreed to uniformly by all relevant stakeholders.

The British Transplantation Society guidelines on ethics, law and consent in relation to deceased donors after circulatory death

The British Transplantation Society guidelines on ethics, law and consent in relation to deceased donors after circulatory death
Review Article
Greg Moorlock, Ellie Asgari, Chris Callaghan, Heather Draper, Peter Dupont, Patty Gilbert, David Nasralla, Peter Veitch, Chris Watson, Stephen O’Neill
Transplantation Reviews, 26 October 2023
Abstract
The British Transplantation Society (BTS) ‘Guideline on transplantation from deceased donors after circulatory death’ has recently been updated and this manuscript summarises the relevant recommendations from chapters specifically related to law, ethics, donor consent and informing the recipient.

Highlights

  • UK nations have moved to deemed consent organ donation systems.
  • ‘Overall benefit’ should be the guiding principle for decisions about end-of-life care in relation to organ donation.
  • The patient’s wishes, especially strength of those wishes, play a significant role in determining what is of overall

Informed consent or empowered collaboration

Informed consent or empowered collaboration
Book Chapter
Samuel J. Knapp, Randy Fingerhut
Practical ethics for psychologists: A positive approach; 2024, [American Psychological Association]
Abstract
Informed consent is the legal and ethical obligation to give information to patients or research participants before they initiate assessment, treatment, or participation in a study. Informed consent procedures reflect respect for patient autonomy. Psychologists should respect the autonomy of their patients except for very narrow circumstances, such as when patients are incapable of giving consent or the lives of individuals are at stake. This chapter discusses these exceptions. It reviews basic information about informed consent and special issues that may arise in couples, family, or group therapy or in supervised services. It describes some ways that psychotherapists can embed respect for patient autonomy beyond the traditional informed consent process. It also covers the desirability of obtaining assent to promote greater participation from individuals who are not legally capable of giving informed consent. In addition, the chapter considers options when patients appear unable to participate in decisions about treatment.

The illusion of explanatory depth in patient consent

The illusion of explanatory depth in patient consent
Correspondence
George Rarichan, Stephen Bacchi, Aashray Gupta, Weng Onn Chan
Eye, 22 November 2023
Excerpt
    Ullrich et al. highlight the importance of informed consent discussions with patients, especially when considering vitreoretinal surgeries and eye removal procedures, where the risk of sympathetic ophthalmia may be a material consideration. Consent with respect to sympathetic ophthalmia can be a vital topic which can be further elucidated with patients through understanding of the concept of the “illusion of explanatory depth”.
The illusion of explanatory depth refers to the tendency of individuals to overestimate their understanding of complex concepts, which has important implications for the informed consent process, especially in intricate medical contexts like vitreoretinal surgery and the risk of developing sympathetic ophthalmia. Informed consent is a fundamental ethical principle, especially entailing patients’ entitlement to a thorough comprehension of the potential risks and benefits of a procedure. Understanding how this cognitive bias may influence both patients and doctors may enrich the consent process. For example, this bias may mean that patients feel they have a greater understanding of a procedure and risks, than they truly do. Similarly, a doctor may feel they have a greater understanding of the circumstances and priority of a patient than is the case…

Not just for surgeons: A qualitative exploration of the surgical consent process

Not just for surgeons: A qualitative exploration of the surgical consent process
Therese M. Gardiner, Sharon Latimer, Jayne Hewitt, Brigid M. Gillespie
Collegian, 22 November 2023
Open Access
Abstract
Background
Obtaining consent for surgery is a legal requirement and a professional practice standard, but little is known about how nurses and other healthcare professionals (HCPs) engage with this process.
Aim
To describe operating room (OR) HCPs’ perceptions of consent processes for adult patients undergoing planned surgery at one health service.
Methods
A qualitative exploratory design and purposive maximum variation sampling relative to age, discipline, experience, and role, were used to ensure broad perspectives were gathered. Semi-structured interviews with 17 OR HCPs were conducted between April and May 2021.
Findings
Thematic analysis identified three themes: the HCPs’ role in verifying consent goes beyond the World Health Organization’s Surgical Safety Checklist, effective communication is crucial for obtaining and verifying consent, and day-of-surgery delays and errors are multi-factorial.
Discussion
Production pressures in surgery can compromise consent processes, undermine communication, and impact patient safety in the OR.
Conclusion
HCPs verify more items than the World Health Organization Surgical Safety Checklist, suggesting the checklist may not go far enough when verifying consent in surgery.

Engaging Women in Decisions About Their Heart Health

Engaging Women in Decisions About Their Heart Health
Chapter
Krystina B. Lewis, Faria Ahmed, Sandra Lauck, Sandra Carroll, Dawn Stacey
Biology of Women’s Heart Health, 19 November 2023 [Springer]
Abstract
Women living with cardiovascular disease face many health decisions throughout their journey. Most women want more information and greater involvement in decision-making about their health in partnership with their clinicians. Yet, facing these decisions can lead to a sense of personal uncertainty about the best course of action. The individualized and intentional communication offered by a shared decision-making approach is particularly important for women with cardiovascular disease, given the limited availability of scientific data about women regarding the risks and benefits for screening and treatment options, making the elicitation and incorporation of personal preferences and values in their decision-making critical. Further, sex and gender considerations are important in shared decision-making particularly as they are associated with various decision-making styles, communication styles, and values and preferences which can influence an individual’s preferred option. In this chapter, we begin by providing a definition of shared decision-making and discuss the evidence related to women’s involvement in health decisions, particularly for cardiovascular conditions. We present the evidence supporting interventions to facilitate shared decision-making in clinical practice such as patient decision aids, decision coaching and question prompt lists. Finally, we present considerations for shared decision-making implementation in clinical practice. Throughout, we highlight opportunities for meaningful patient engagement amidst the challenges of shared decision-making to achieve true patient-centered care for women living with cardiovascular disease.

Perioperative visual loss and consent for adult spine surgery: a national survey of the practice amongst spine surgeons and anaesthetists

Perioperative visual loss and consent for adult spine surgery: a national survey of the practice amongst spine surgeons and anaesthetists
Research Article
Marina Pitsika, Vasiliki-Maria Paschou, Rachel Pollard, Justin J. Nissen
British Journal of Neurosurgery, 9 November 2023
Abstract
Background
Perioperative Visual Loss (POVL) is a devastating complication for patients undergoing spine surgery. Consent process for POVL amongst spine surgeons and anaesthetist remains variable. The aim of this study is to evaluate their practice and views about it.
Methods
Two similar questionnaires were distributed to members of the Society of British Neurological Surgeons (SBNS), British Association of Spine Surgeons (BASS), and Neuroanaesthsia and Critical Care Society (NACCS).
Results
A total of 271 responses were received (SBNS/BASS n = 149, NACCS n = 122). Fewer surgeons considered POVL as a material risk for patients compared to the anaesthetists (57.7 versus 79.7%). Outpatient/pre-assessment clinics were considered as the optimal setting for discussing POVL by the majority of the clinicians (81.2 and 93.4%). POVL should be discussed by both specialists according to 75% of the anaesthetists. Estimated incidence of POVL was considered to be higher by the anaesthetists (0.03–0.2% by 63% of the anaesthetist versus 0.0001–0.004% by 57% of the surgeons). Twenty-three surgeons and 10 anaesthetists had a patient who suffered from POVL, which led to a change of practice in most of them. This questionnaire will lead to a change in practice/consent to 18.1% of the surgeons and 23.5% of the anaesthetists.
Conclusions
Most of the surgeons and anaesthetist feel that POVL is a material risk that ideally needs to be firstly discussed before the day of surgery, by both specialties. However, a significant number of clinicians have an opposite view. A national guidance from respective societies should encourage POVL to be discussed routinely.

Challenge of achieving truly individualised informed consent in therapeutic endoscopy

Challenge of achieving truly individualised informed consent in therapeutic endoscopy
Original Research
Philip Berry, Sreelakshmi Kotha
Frontline Gastroenterology, 8 November 2023
Abstract
Objective
Guidance covering informed consent in endoscopy has been refined in the UK following the obstetric case of Nadine Montgomery, and in light of updated General Medical Council guidance. All risks likely to be material to the patient must be explored, as well as alternatives to the procedure. Despite this, departments and endoscopists still struggle to meet the current standards. In this article, we explore the challenges encountered in achieving individualised consent in therapeutic endoscopy through real-life scenarios.
Methods
Five realistic therapeutic endoscopy (hepatobiliary) scenarios are described, followed by presentation of possible or ideal approaches, with references related to existing literature in this field.
Results
The vignettes allow consideration of how to approach difficult consent challenges, including anxiety and information overload, urgency during acute illness, failure to disclose the risk of death, the role of trainees and intraprocedural distress under conscious sedation.
Conclusions
The authors conclude that a high degree of transparency is required while obtaining consent for therapeutic endoscopy accompanied by full documentation, involvement of relatives in nearly all cases, and clarity around the presence of trainees who may handle the scope. A greater focus on upskilling trainees in the consent process for therapeutic endoscopy is required.

A Scoping Review of Adverse Outcomes Associated With Cardiac Resynchronization Therapy Device Implantation: Implications for Informed Consent

A Scoping Review of Adverse Outcomes Associated With Cardiac Resynchronization Therapy Device Implantation: Implications for Informed Consent
John Mancini, Aanand Naik, Parag Goyal
Circulation, 6 November 2023
Abstract
Background/Objectives
Cardiac Resynchronization Therapy (CRT) is a treatment option for many adults with heart failure with reduced ejection fraction (HFrEF). While the benefits of CRT are well-established, the downstream implications of adverse events are not well-characterized. We sought to better understand the ramifications of CRT-related adverse events on length of hospital stay (LOS) and mortality—information relevant for patients and clinicians to make informed decisions about pursuing CRT.
Design
Scoping Review
Methods
We conducted an initial PubMed search using terms including “Congestive Heart Failure” or “Heart Failure” and “Cardiac resynchronization” or “Cardiac re-synchronization” or “Biventricular pacing.” We reviewed resulting articles that were written in English, studied CRT devices, and outlined adverse events related to CRT device placement. We separately searched PubMed for additional articles outlining individual adverse events identified using search terms “event name,” “mortality,” and “hospital stay.” We read articles and summarized data regarding the impact of reported adverse events on hospital LOS and mortality.
Results
Our search identified 18 full length articles with relevant data. The most common adverse events included device implant failure/non-response, lead dislodgment, coronary sinus dissection, and pocket hematoma. The LOS and mortality rates of each event are shown in Table 1. Of note, LOS for implantation in the ambulatory setting is up to 1 day; LOS for uncomplicated implantation during hospitalization is 4.6 days. Implantation during hospitalization with complication is mean 13.6 days.
Conclusion
While absolute risks for adverse events associated with CRT implantation are low, several have important implications on hospital LOS and mortality. These findings warrant inclusion in discussion regarding the risks of CRT when clinicians and patients engage in informed decision making related to CRT.

Developing an International Framework for Informed Consent in Plastic Surgery: A Focus on Cosmetic Breast Augmentation

Developing an International Framework for Informed Consent in Plastic Surgery: A Focus on Cosmetic Breast Augmentation
Rodney D. Cooter, Louise A. Brightman, Anand Deva, Robert X. Murphy, Jr, Mikko Larsen, Ahmed Khashaba
Plastic & Reconstructive Surgery-Global Open, November 2023
Abstract
Background
Informed consent is a fundamental pillar of patient rights and is an essential part of good clinical practice. In 2019, the International Confederation of Plastic Surgery Societies launched a survey to collect feedback on informed consent practices, with an aim to develop an international guideline for cosmetic surgery
Methods
A 15-question survey was sent to delegates of the International Confederation of Plastic Surgery Societies for dissemination to their national society members. The survey comprised a range of quantitative and qualitative questions. Descriptive and thematic analysis was performed.
Results
There were 364 respondents. Over half of the respondents reported no local informed consent policy, whereas others noted national society, specialist college, or government policies. The majority of respondents believed that the performing surgeon should be responsible for obtaining informed consent with at least two face-to-face consultations. Most respondents agreed with a cooling-off period (duration based on procedure type and use of high-risk devices). Regarding cosmetic breast augmentation, the majority of respondents felt that the performing surgeon should be responsible for postoperative management, including cases that occur as part of surgical tourism. Some respondents incorporate financial consent as part of their informed consent practice. Most supported the development of an international informed consent guideline.
Conclusions
Informed consent should result from face-to-face consultations with the performing surgeon. There should be a minimum cooling-off period. Postoperative surveillance should be available in all settings. The findings of this survey will help inform an international standardized informed consent guideline for cosmetic surgery.