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
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

Consent for babies born following surrogate pregnancies
Short Report
Heather Sharon Hodgson, Abigail Nye, Fiona Finlay
Diseases in Childhood, 14 January 2020
Abstract
Surrogate pregnancies are becoming more common, but the law governing who can give consent following surrogate births is complex. Parental responsibility (PR) may be held by a variety of individuals, depending on the specific circumstances.

We conducted a survey of paediatric medical staff within Health Education South West to establish knowledge regarding consent for a baby before a parental or adoption order is obtained. Our results showed that 19% of the 47 respondents answered all scenarios correctly. 43% of respondents knew that the surrogate mother had PR in all scenarios; however, 13% incorrectly assumed that either intended parent always had PR. Knowledge of other individuals who could provide consent in the scenarios was variable.

Our survey revealed poor understanding regarding medicolegal aspects of consent in these complex situations, emphasising the need for more specific published guidance for primary and secondary healthcare professionals encountering these babies in the early postnatal period.

Autonomy in organ donations v family consent: a South African legislative context
Magda Slabbert, Bonnie Venter
De Jure Law Journal, 2019
Open Access
Summary
The lack of availability of transplantable donor organs remains the main obstacle to improving organ donation rates on a global level. The purpose of this article is to investigate the role of family consent in the donation process from a legal perspective. The question is posed whether family members should be approached to provide consent for deceased organ donation or whether the right to self-determination of the deceased should be honoured. The article analyses Chapter 8 of the National Health Act 61 of 2003 to determine the current legal position with regard to consent in the organ donation process. It is concluded that due to the continued stagnant state of the availability of donor organs in South Africa, at the very least appropriate, valid consent should not be nullified by a relative’s objection.

National Electronic Health Record Systems and Consent to Processing of Health Data in the European Union and Australia
Danuta Mendelson
Legal Tech and the New Sharing Economy, 13 December 2019; pp 83-99
Abstract
This study focuses on the single most important regulatory aspect of data processing, namely consent to data processing. It compares approaches to consent under the General Data Protection Regulation (EU 2016/679) of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data (and on the free movement of such) (GDPR) in the context of European Union (EU) national electronic health record (NEHR) schemes (also referred to as “national digital health networks”) with the approach of the Australian national health record scheme called My Health Record (MHR). The GDPR, subject to derogation in limited circumstances, is binding on all 27 EU member countries. Under Articles 168 (2) and (7) of the Treaty on the Functioning of the European Union (2007), while the EU has a duty to “encourage cooperation between the Member States…to improve the complementarity of their health services in cross-border areas,” the European Union Member States retain the power to manage their own health services. However, in doing so, subject to narrow derogations, the management of their NEHR systems must conform to the GDPR. The GDPR governs the processing of data in any form including data contained in national electronic health systems (European Commission Recommendation on a European Electronic Health Record exchange format (C(2019)800) of 6 February 2019… Given that, unlike the Australian MHR scheme, national electronic medical/health records systems of EU Member States are at different stages of development, and that derogations enable a measure of variance in compliance, individual European systems will not be discussed. Australia is a non-EU jurisdiction, and does not have the European Commission’s certificate of adequate level of data protection (GDPR Article 45 empowers the European Commission to determine whether a country outside the EU offers an adequate level of data protection, whether by its domestic legislation or of the international commitments it has entered into. For further discussion, see below). One of the reasons for the absence of certification might be the effectively non-consensual nature of the My Health Record system that administers, collects, stores, and provides access to health and clinical data of Australians.

Too Dense and Too Detailed: Evaluation of the Health Literacy Attributes of an Informed Consent Document
Vanessa W. Simonds, Dedra Buchwald
Journal of Racial and Ethnic Health Disparities, 10 December 2019
Abstract
The US government recently updated the Common Rule, a set of federal regulations to ensure the ethical conduct of human subjects research. The new regulations require that consent documents provide information that is clear and concise enough to enable truly informed consent. This study explores potential American Indian research participants’ understanding and perceptions of an example consent document, focusing on possible improvements to better serve the requirements of the revised Common Rule. Participants completed a survey that collected demographic data and measured health literacy, numeracy, and comprehension of the example document. Next, they participated in focus groups to answer open-ended questions regarding their views on the example document. We calculated mean scores and frequencies of response to analyze quantitative survey data and performed a qualitative thematic analysis of focus group transcripts. Results demonstrated that American Indian participants with relatively strong health literacy skills clearly understood key elements of the consent document, including the purpose of signing it, confidentiality, compensation, and whom to contact for questions. However, they were overwhelmed by details on research procedures and were concerned about the document’s layout. To make consent documents more readily comprehensible, participants recommended the addition of headings, bullets, graphics, and relevant pictures. They also recommended a two-step consent process, comprising a short introduction to the research project followed by a longer explanation of procedures. These results illustrate the potential advantages of community engagement in drafting consent materials. Health researchers would likely benefit from community recommendations like the ones we elicited as they design consent documents adherent to the revised Common Rule.

Does content of informed consent forms make surgeons vulnerable to lawsuits?
Original Article
Perihan Elif Ekmekci, Müberra Devrim Güner, layda Nurelif Toman, Gülce Karaca, Berkem Karakoyunlu, Rabia Çatal, Merve Erdem, Emre Ömeroğlu
Asian Journal of Surgery,19 October 2019
Open Access
Summary
Background
Written informed consent forms (ICFs) are important for ensuring that physicians disclose core information to patients to help them autonomously decide about treatment and for providing substantial evidence for the surgeon in case of a legal dispute. This paper aims to assess the legal and ethical appropriateness and sufficiency of the contents of ICFs designed for several elective surgical procedures currently in use in Turkish hospitals.
Methods
One hundred and twenty-six forms were randomly selected and were analyzed for 22 criteria. The results were compared using the Fisher’ exact test, and 95% confidence intervals were calculated.
Results
More than 80% of ICFs contained information about the risks of the proposed treatment, the diagnosis of the patient, and the patient’s voluntariness/willingness, as well as a designated space for the signatures of the patient and the physician and a description of the proposed treatment. Some ICFs were designed for obtaining blanket consent for using patients’ specimens.
Conclusions
The ICFs for general elective surgery contain many deficiencies regarding disclosure of information, and there is significant variation among primary healthcare providers. Unrealistic expectations regarding the surgery or the post-operative recovery period due to insufficient information disclosure may lead patients, who experience post-surgical inconveniences, to file lawsuits against their surgeons. Although all ICFs, regardless of their institution, are generally insufficient for defending hospital administrations or surgeons during a lawsuit, ICFs of private hospitals might be considered better equipped for the situation than those of state or university hospitals. However, further research is needed to show if private hospitals have lower lawsuit rates or better lawsuit outcomes than state or university hospitals in Turkey.