GDPR: Is your consent valid?
Research Article
Stephen Breen, Karim Ouazzane, Preeti Patel
Business Information Review, 17 February 2020
Abstract
The General Data Protection Regulation (GDPR) 2018 imposes much greater demands on companies to address the rights of individuals who provide data, that is, Data Subjects. The new law requires a much more transparent approach to gaining consent to process personal data. However, few obvious changes to how consent is gained from Data Subjects to comply with this. Many companies are running the risk of non-compliance with the law if they fail to address how data are obtained and the lack of true consent which Data Subjects currently give to their data being processed. Consent is a complex philosophical principle which relies on the person giving the consent being in full possession of the facts, this article explores the philosophical background of consent and examines the circumstances which were the point of departure for the debate on consent and attempts to develop an understanding of it in the context of the growing influence of information systems and the data-driven economy. The GDPR has gone further than any other regulation or law to date in developing an understanding of consent to address personal data and privacy concerns.
Physician’s obligations to inform about complications based on a recent warning from drug authorities
Physician’s obligations to inform about complications based on a recent warning from drug authorities
Duttge G, Meyer T
Medizinische Klinik, Intensivmedizin und Notfallmedizin, 7 February 2020
Abstract
Background
Based on a recent warning from the drug authorities about increased suicidality among users of hormonal contraceptives, this article discusses the legal consequences of translating novel findings from clinical trials into altered contents of gaining informed consent during the medical consultation.
Methods and Results
Comprehensive information in accordance with 630e German Civil Code (BGB) requires that rare drug reactions be mentioned by the prescribing physician, when they are associated with serious sequelae. This act regulates the treating physician’s obligations to inform about complications for both preventive and curative treatment options. In this paper, we refer to the scientific evidence level of data from clinical trials as the key feature for implementing altered medical information in the proper conduct of acquiring the consent of the patient in line with 630e BGB. The article discusses how additions and amendments to the package leaflet and the expert information will impact on the obligations for the treating party to provide information for the patient in order to obtain informed consent. In particular, we focus on the relationship between the obligations for the physician prescribing oral contraceptives on an individual case and the generalized information conditions according to 11 and 11a German Medicinal Products Act.
Discussion
Current warnings of the drug authorities in the form of red-hand letters do not necessarily have legal consequences for gaining informed consent during the medical consultation.
Editor’s note: This is a German language publication
Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial
Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial
Research Article
Rachel S Purvis, Leah R Eisenberg, Christopher R Trudeau, Christopher R Long, Pearl A McElfish
Clinical Ethics, 2 February 2020
Abstract
Background
The Pacific Islander population is the second fasting growing population in the United States and Arkansas is home to the largest Marshallese population in the continental US. The Marshallese community have significant health disparities with high prevalence of diabetes, heart disease, and obesity compared to the general US population. Using a community-based participatory research approach, researchers and Marshallese community stakeholders identified diabetes as the top health issue for research.
Methods
From 2014 to 2018, a randomized control trial was conducted comparing standard diabetes management education with a culturally adapted family model of standard diabetes management education delivered in participants’ homes by Marshallese community health workers and certified diabetes educators. Interviews were held with Marshallese participants to document their experiences with and perceptions of the informed consent process for this randomized control trial.
Results
Participants provided feedback on the process of enrolling in the study, describing barriers and facilitators to giving informed consent from their perspective, and offering recommendations for improving the informed consent process.
Conclusion
Findings suggest that informed consent with underserved communities, including immigrant and migrant populations who do not speak English or have limited English proficiency, is possible, and that using a community-based participatory research approach can help facilitate the informed consent process.
Translations of informed consent documents for clinical trials in South Africa: are they readable? [MA DISSERTATION]
Translations of informed consent documents for clinical trials in South Africa: are they readable? [MA DISSERTATION]
Makiti Thelma Leopeng
University of Cape Town, Maternal and Child Health in the Department of Pediatrics and Child Health, February 2019
Open Access
Abstract
Introduction
Obtaining Informed consent is an ethical prerequisite for enrollment in clinical research. There is a perception that Informed consent documents used in biomedical research are lengthy, overly complex and above the reading capability of typical research participants. In South Africa, ethical committees regulating research on human participants (HRECs) are mandated by the Department of Health’s National Health Research Ethics Council’s (NHREC) guidelines to ensure that researchers have made special considerations for vulnerable groups when conducting research. This includes considerations made for populations with low literacy. For example, the Standard Operating Procedure (SOP) of the University of Cape Town’s Human Research Ethics Committee (UCTHREC), requires that the language used in Informed consent documents should be directed at a reading level of grade 6 to 8 and that common, everyday words should be used rather than complex language syntax. The HREC expects researchers to translate the approved English version documents into local languages such as isiXhosa and Afrikaans. Since ethics committee focus approval on the English language consent documents and only acknowledge translated versions, a potential gap in this process is whether the translated versions meet the same required readability levels. This study aims to investigate whether translated versions of English language informed consent documents used at a single busy clinical research site are readable and meet the readability levels specified by UCTHREC. 14
Methodology
A quantitative descriptive statistical design was used to explore readability levels of informed consent documents used at a single clinical research facility based in a semi-rural community. Informed consent documents approved by UCTHREC over the past thirteen years (2004 to 2017) that met the inclusion criteria were analysed for readability. The LIX readability test tool was used to calculate readability scores and the levels of reading difficulty. These scores were then matched to a grade level conversion chart to determine the equivalent number of education years required to be able to easily understand the information. Readability levels were determined for isiXhosa and Afrikaans translations of the documents and compared to the levels of the English document.
Results
The results indicate that informed consent documents used at this single clinical research facility, independent of language type, are difficult to read. A total of 259 sub-sections of informed consent documents from 10 different studies were analysed. The analysis showed that informed consent documents were classified as “very difficult to read” according to the LIX readability tool in a large proportion of English, isiXhosa and Afrikaans languages: 41 (16%), 255 (98%), and 85 (33%) of informed consent sections respectively. Of all the subsections of English, isiXhosa and Afrikaans documents respectively, 98 (38%), 0 (0%) and 126 (49%) were classified as “difficult to read”, while 79 (31%), 3 (1%) and 38 (15%) were found to have an “average” readability level. Twenty eight (11%), 1 (0%) and 10 (4%) were found to be “easy to read” and 13 (5%), 0 (0%) and 0 (0%) had a “very easy” readability level. The mean LIX readability scores across English, isiXhosa, and Afrikaans languages were respectively 42.27 (95% CI 41.20 – 43.34) corresponding to a readability level of “average”, 74.64 (95% CI 73.79-75.49), corresponding to “very difficult to read” and 46.73 (95% CI 15 45.66-47.8) “difficult to read”. These findings suggest a high level of difficulty in reading of the text in the Informed consent documents.
Conclusion
Translations of Informed consent documents used at a single busy clinical research site are difficult to read and are written at high school to tertiary reading level. These reading levels are above the recommended level prescribed by the site’s research ethics committee (UCTHREC). Local ethics committees should employ more stringent guidelines and checks to ensure readability of translated informed consent documents. Researchers and Sponsors should include readability outcomes in the design and with submissions of new protocols.
Consent in Oral Surgery: a Guide for Clinicians
Consent in Oral Surgery: a Guide for Clinicians
Mohammed M Dungarwalla, Edmund Bailey
Dental Update, 17 February 2020; 47(2)
Abstract
The consent process remains a pillar of excellent clinical care. The changes in the law after the Montgomery ruling in 2015 has changed the shape of consent, and now, taking adequate consent can be extensive and sometimes confusing for clinicians and patients. Dentists are sometimes faced with the unenvious task of weighing up what patients should know versus what they want to know. This paper aims to describe the consent process for more common oral surgical procedures, helping clinicians to allow their patients to make informed decisions.
Transparent Defaults and Consent for Participation in a Learning Health Care System: An Empirical Study
Transparent Defaults and Consent for Participation in a Learning Health Care System: An Empirical Study
Research Article
Vilius Dranseika, Jan Piasecki
Journal of Empirical Research on Human Research Ethics, 11 February 2020
Abstract
We report a preregistered study that was designed to answer three questions about using transparent defaults to increase participation in a hypothetical learning health care system. Do default options influence consent to participate in learning activities within a learning health care system? Does transparency about default options decrease the effect of the defaults? Do people reconsider their choice of participation once they are informed about the defaults applied? In our study, application of the defaults did not have influence on rates of consent, nor did transparency about defaults have an effect on the rates of consent. Participants were also not likely to change their choice after being informed that defaults were applied to their previous choice. In general, our study raises doubts that defaults (both covert and transparent) can be used as an effective means in significantly increasing participation in learning health care systems.
How many facts make an “informed patient”? Practical challenges for junior doctors in acquiring surgical informed consent
How many facts make an “informed patient”? Practical challenges for junior doctors in acquiring surgical informed consent
Josephine de Costa, Alan De Costa, Mandy Shircore
ANZ Journal of Surgery, 6 February 2020; 89 (S1) pp 106-1063
Abstract
Purpose
In addition to technical surgical skills, the complete surgeon requires skills in communication and consenting patients. This protects patients, hospitals, and doctors themselves, but also promotes best practice. However, surgical informed consent (SIC) is commonly acquired by junior doctors (defined as PGY1 until completion of specialist training). Little is known about the quality of SIC that doctors at this level may acquire. This study aimed to synthesize known evidence on challenges faced by junior doctors on this issue.
Methodology
The authors conducted a systematic review of all English-language studies published from 1 January 2007 looking at junior doctors (considered to be from PGY1 to the end of specialist training) and any issues that arose around acquiring SIC. A qualitative synthesis was then conducted.
Results
Junior doctors understanding of the legal standards of consent, including both capacity/competence and the concepts of material risk, varied considerably across studies. Documentation and discussion of possible complications in surgery was found to be highly variable within both trainees and consultants consenting practices. Few junior doctors discussed alternative treatment options, including the possibility of having no treatment; evidence on discussion of benefits and recovery were conflicting. Overall documentation of the SIC process was poor.
Conclusions
While junior doctors are commonly responsible for acquiring SIC, this study shows that there are significant practical deficiencies in how they discharge this duty. As a result, SIC acquired by junior doctors may not always comply with required legal standards, which may open up this cohort, and their hospitals, to legal action.
Montgomery in, Bolam out: are trainee surgeons ‘material risks’ when taking consent for cataract surgery?
Montgomery in, Bolam out: are trainee surgeons ‘material risks’ when taking consent for cataract surgery?
Review Article
Omar Qadir, Yusuf Abdallah, Helen Mulholland, Imran Masood, Stephen A. Vernon, Simon N. Madge
Eye, 4 February 2020
Abstract
Trainee involvement in cataract surgery is vital to allow proper training of the next generation of ophthalmic surgeons. However, recent changes in the UK Law, coupled with open publication of National Cataract Dataset results, lead us to conclude that the status of being a trainee is itself a material risk that now needs to be divulged to patients during the consent process. The opinions of current trainee surgeons in the UK were sampled via questionnaire and clinical negligence counsel was involved in the authorship of the paper in order to analyse the legal issues at stake. Attitudes towards consent regarding trainee involvement in UK cataract surgery need to change.
Informed consent for invasive procedures in the emergency department
Informed consent for invasive procedures in the emergency department
Max M. Feinstein, Janet Adegboye, Joshua D. Niforatos, Richard M. Pescatore
The American Journal of Emergency Medicine, 28 January 2020
Abstract
Background
Informed consent for procedures in the emergency department (ED) challenges practitioners to navigate complex ethical and medical ambiguities. A patient’s altered mental status or emergent medical problem does not negate the importance of his or her participation in the decision-making process but, rather, necessitates a nuanced assessment of the situation to determine the appropriate level of participation. Given the complexities involved with informed consent for procedures in the ED, it is important to understand the experience of key stakeholders involved.
Methods
For this review, we searched Medline, the Cochrane database, and Clinicaltrials.gov for studies involving informed consent in the ED. Inclusion and exclusion criteria were designed to select for studies that included issues related to informed consent as primary outcomes. The following data was extracted from included studies: Title, authors, date of publication, study type, participant type (i.e. adult patient, pediatric patient, parent of pediatric patient, patient’s family, or healthcare provider), number of participants, and primary outcomes measured.
Results
Fifteen articles were included for final review. Commonly addressed themes included medical education (7 of 15 studies), surrogate decision-making (5 of 15 studies), and patient understanding (4 of 15 studies). The least common theme addressed in the literature was community notification (1 of 15 studies).
Conclusions
Studies of informed consent for procedures in the ED span many aspects of informed consent. The aim of the present narrative review is to summarize the work that has been done on informed consent for procedures in the ED.
Infringement of the right to surgical informed consent: negligent disclosure and its impact on patient trust in surgeons at public general hospitals – the voice of the patient
Infringement of the right to surgical informed consent: negligent disclosure and its impact on patient trust in surgeons at public general hospitals – the voice of the patient
Gillie Gabay, Yaarit Bokek-Cohen
BMC Medical Ethics, December 2019; 20(1)
Abstract
Background
There is little dispute that the ideal moral standard for surgical informed consent calls for surgeons to carry out a disclosure dialogue with patients before they sign the informed consent form. This narrative study is the first to link patient experiences regarding the disclosure dialogue with patient-surgeon trust, central to effective recuperation and higher adherence.
Methods
Informants were 12 Israelis (6 men and 6 women), aged 29-81, who underwent life-saving surgeries. A snowball sampling was used to locate participants in their initial recovery process upon discharge.
Results
Our empirical evidence indicates an infringement of patients’ right to receive an adequate disclosure dialogue that respects their autonomy. More than half of the participants signed the informed consent form with no disclosure dialogue, and thus felt anxious, deceived and lost their trust in surgeons. Surgeons nullified the meaning of informed consent rather than promoted participants’ moral agency and dignity.
Discussion
Similarity among jarring experiences of participants led us to contend that the conduct of nullifying surgical informed consent does not stem solely from constraints of time and resources, but may reflect an underlying paradox preserving this conduct and leading to objectification of patients and persisting in paternalism. We propose a multi-phase data-driven model for informed consent that attends to patients needs and facilitates patient trust in surgeons.
Conclusions
Patient experiences attest to the infringement of a patient’s right to respect for autonomy. In order to meet the prima facie right of respect for autonomy, moral agency and dignity, physicians ought to respect patient’s needs. It is now time to renew efforts to avoid negligent disclosure and implement a patient-centered model of informed consent.
Center for Informed Consent Integrity 