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
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.
Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drives
Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drives
Research Articles
Dalton R. George, Todd Kuiken and Jason A. Delborne
Proceedings of the Royal Society B, 11 December 2019; 286 (1917)
Abstract
Recent statements by United Nations bodies point to free, prior and informed consent (FPIC) as a potential requirement in the development of engineered gene drive applications. As a concept developed in the context of protecting Indigenous rights to self-determination in land development scenarios, FPIC would need to be extended to apply to the context of ecological editing. Without an explicit framework of application, FPIC could be interpreted as a narrowly framed process of community consultation focused on the social implications of technology, and award little formal or advisory power in decision-making to Indigenous peoples and local communities. In this paper, we argue for an articulation of FPIC that attends to issues of transparency, iterative community-scale consent, and shared power through co-development among Indigenous peoples, local communities, researchers and technology developers. In realizing a comprehensive FPIC process, researchers and developers have an opportunity to incorporate enhanced participation and social guidance mechanisms into the design, development and implementation of engineered gene drive applications.
Knowledge, attitude, and practices regarding informed consent for research purposes among postgraduate resident doctors
Knowledge, attitude, and practices regarding informed consent for research purposes among postgraduate resident doctors
Original Research
Noopur Vyas, Pradeep Jadhav, Rohit Sane.
National Journal of Physiology Pharmacy and Pharmacology. 2020; 10(1): 54-58
[country of publication: India]
Open Access
Abstract
Background
Informed consent is an ethical and legal requirement for research involving human participants. Postgraduate (PG) residents are budding doctors who are in their interim phase of education and are engaged in thesis/research work, which mandates adequate knowledge of informed consent and regulatory guidelines. There exists paucity of data in literature on the informed consent process with regard to PG residents; therefore, this study was conducted to assess the knowledge, attitude, and practices (KAP) of informed consent among PG residents.
Aims and Objectives
The aim of the study was to assess the level of knowledge and attitude about the informed consent process and assess practices adopted by PG residents for research purposes.
Materials and Methods
It was a cross-sectional, observational and questionnaire-based study conducted from January 2018 to March 2018 at a tertiary care teaching hospital, Navi Mumbai. The study included PG residents of either sex pursuing specialty MD/MS courses. A validated KAP questionnaire was used to assess KAP of the informed consent process. Responses from the eligible participants were obtained and analyzed.
Results
A total of 100 PG residents participated; 39% of males and 61% of females. Overall, the knowledge score was high and attitude toward informed consent was average. However, 34% participants felt that witness is not necessary, 20% felt that once the patient participates, they should not be allowed to withdraw and few felt that on voluntary withdrawal, participants are not liable for further standard care and compensation. In practice, few participants failed to explain consent in the local language and neglected to take the signature of an impartial witness.
Conclusions
Overall, the KAP of informed consent among PG residents were adequate. Structured continuing medical education/workshops are necessary to advance informed consent practices.
Jordanians’ Perspectives On Open Consent In Biomedical Research
Jordanians’ Perspectives On Open Consent In Biomedical Research
Original Research
Nasr Alrabadi, Hanin Makhlouf, Omar F Khabour, Karem H Alzoubi
Risk Management and Healthcare Policy, 2 December 2019; 2019(12) pp 265—273
Introduction
The informed consent process is an integral step in biomedical research. However, the emergence of biobanks and the need for open consent (also called “broad” or “blanket” consent) create challenges to this process.
Aims and methodology
A survey was used to examine Jordanians’ perspectives on open consent and reuse of stored samples in future research.
Results
The majority of participants had positive perceptions of informed consent and its importance. In addition, they appreciated the challenges that are associated with multiple uses of their biospecimens. About 55% agreed to provide open consent for reuse of their donated biospecimens. Participants (75–80%) also agreed that issues such as the possibility of sharing samples with international research centers, storage duration, and use of biospecimens after their death should be clarified as part of open consent. The inconvenience of the re-contact process, trust in the research team, and the importance of biobanks were all associated with participants’ willingness to provide open consent (P<0.05). On the other hand, privacy and confidentiality, doubt about future use of samples, unknown storage period, and the possibility of cross-border sample sharing were significantly associated with participants’ reluctance to provide open consent.
Conclusion
The majority of Jordanians accept the idea of open consent. Clarification of issues such as international sample sharing, duration of storage, domains of intended research, confidentiality, and privacy can provide more support for the use of open consent.
Promoting informed consent in a children’s hospital in Tabriz, Iran: a best practice implementation project
Promoting informed consent in a children’s hospital in Tabriz, Iran: a best practice implementation project
Neda Kabiri, Sakineh Hajebrahimi, Gisoo Alizadeh, Solmaz Azimzadeh, Nayyereh Farajzadeh, Amin Talebpour
JBI Database of Systematic Reviews and Implementation Reports, December 2019; 17(12) pp 2570–2577
Abstract
Introduction
Informed consent is a continuous and dynamic process. It is a crucial part of healthcare procedures that becomes more complex in a pediatric clinical practice, where parents must make decisions for their children.
Objectives
The aim of this implementation project was to evaluate the current practice and implement the best practice related to obtaining informed consent in a children’s hospital in Tabriz, Iran.
Methods
A clinical audit was undertaken using the JBI Practical Application of Clinical Evidence System (JBI PACES) tool. Five audit criteria representing the best-practice recommendations for informed consent were used. A baseline audit was conducted, followed by the implementation of multiple strategies. The project was finalized with a follow-up audit to determine change in practice.
Results
The compliance rate of all criteria improved from baseline to follow-up audit. Criteria 1 (obtaining informed consent prior to all nursing procedures) and 5 (provision of information related to the necessity of the treatment) reached 97% compliance in the follow-up cycle. Criterion 4 (provision of information related to the nature and effect of the treatment) achieved 74% compliance. Both criteria 2 and 3 (provision of information related to alternative treatments and consequences of refusing treatment) reached 57% in the follow-up cycle. To improve compliance, meetings were organized with the heads of departments, nurses and residents regarding informed consent. Also, staff were encouraged to report cases where informed consent was not obtained.
Conclusion
The audit results indicated an improvement in obtaining informed consent in the included departments. The interventions that were employed can facilitate the implementation of evidence into clinical practice.
The factors associated with maternal consent to human papillomavirus vaccination among adolescents in Israel
The factors associated with maternal consent to human papillomavirus vaccination among adolescents in Israel
Research Paper
Rana Shibli, Shmuel Rishpon
Human Vaccines & Immunotherapeutics, 24 Jul 2019
Abstract
Purpose
To evaluate the knowledge and attitudes toward the human papillomavirus (HPV) vaccine among mothers of 8th graders in Israel, and to determine the factors associated with maternal consent to the HPV vaccine.
Methods
We conducted a cross-sectional study among mothers of 8th grade students in 27 schools in Haifa and Northern districts of Israel during the 2016–17 school year. Data were collected using a structured telephone questionnaire.
Results
313 mothers answered the questionnaire (response rate = 91.8%). The mean knowledge level score was low (3.96 points [out of 10] ±2.68). Knowledge level was positively associated with Jewish nationality, being secular in religious practice and higher education. The attitude mean score was low-moderate (11.22 points [out of 18] ± 5.01). Attitude score was positively associated with Arab nationality. No significant association was found between knowledge level and attitudes. According to multivariate analysis, mothers’ consent to the HPV vaccine was associated with the knowledge level score (OR = 0.82; 95%CI 0.68–0.98), the attitude score (OR = 1.76; 95%CI 1.53–2.02) and nationality (OR = 27.86, 95%CI 3.41–227.56).
Conclusions
The knowledge level and attitudes toward the HPV vaccine were found to be unsatisfactory with racial disparities between Arabs and Jews. Jewish mothers compared with Arab mothers, mothers with a higher knowledge level or less positive attitudes were less likely to consent to the vaccine. These findings could contribute toward adapting programs to the different Israeli sectors in order to improve the rates of HPV vaccine receipt among adolescents.
What do patients want? Surgical informed‐consent and patient‐centered care – An augmented model of information disclosure
What do patients want? Surgical informed‐consent and patient‐centered care – An augmented model of information disclosure
Original Article
Gillie Gabay, Yaarit Bokek‐Cohen
Bioethics, 2 December 2019
Abstract
The ideal moral standard for surgical informed‐consent calls upon surgeons to carry out a disclosure dialogue with patients so they have as full as possible an understanding of the procedure before they sign the informed‐consent form. This study is the first to empirically explore patient preferences regarding disclosure dialogue. Twelve Israelis who underwent life‐saving surgeries participated in a narrative study. Three themes emerged from the analysis: objectification of patients, anxiety provoking processes and information, and lack of information that was essential for patients. Findings contribute to existing debates among surgeons regarding the scope and importance of some disclosure components. Analysis led to our formulation of an augmented subjective model of information disclosure that participants prefer, which extends beyond the immediate present of the surgery to the period after discharge, and until return to routine. Surgeons should be aware of patient preferences in disclosure, and gaps between perceptions of surgeons, and preferences and needs of patients.
Perception and confidence of medical students in informed consent: A core EPA
Perception and confidence of medical students in informed consent: A core EPA
Tiffany N. Anderson, Lauren R. Aalami, Edmund W. Lee, Sylvia Bereknyei Merrell, Michael D. Sgroi, Dana T. Lin, James N. Lau
Surgery, 24 December 2019
Abstract
Background
Informed consent discussions have been identified as a core entrustable professional activity for medical students by the Association of American Medical Colleges. Medical students, however, rarely receive formal instruction on how to appropriately conduct informed consent discussions before residency, resulting in inconsistent levels of experience and deficiencies in performance. This study explores medical students’ understanding of the elements of informed consent discussions and their readiness to perform a comprehensive informed consent discussion.
Methods
Using expert consensus, cognitive interviews, and piloting, we iteratively developed a 15-item survey aligned with entrustable professional activity guidelines concerning informed consent discussions consisting of multiple choice, free text, and 5-point Likert-type questions. The instrument covered domains of experience, confidence, medical-legal knowledge, and recall of informed consent discussion elements. The full survey was distributed anonymously to undergraduate medical students at our institution. An abbreviated survey was administered to postgraduate students who were new interns at our institution. Responses were analyzed quantitatively using descriptive statistics. The free text data were coded for inclusion in this analysis.
Results
A total of 75 undergraduate medical students across all years responded (response rate [RR] = 86%), and 34 (RR = 77%) of the postgraduate students who were new interns participated. A total of 45 (75%) undergraduate medical students reported no training on informed consent discussions, and 9 (15%) undergraduate medical students had never witnessed an informed consent discussion. The undergraduate medical students agreed that informed consent discussions could be legally performed by residents and advance practice providers but were unsure whether the same applied to medical students. On a 5-point scale (anchored to “Not at all,” “Somewhat,” and “Extremely”), they were “somewhat confident” in their ability to perform an informed consent discussion. When asked to list the 7 elements of an informed consent discussion, 2 undergraduate medical students (3%) were able to identify all the elements. Although 3 undergraduate medical students (9%) had experience leading an informed consent discussion and 11 (32%) reported formal instruction in informed consent, the ability (3.7 ± 0.9 standard deviation [SD]) of the postgraduate students who were new interns to recall the 7 elements was similar to that of the undergraduate medical students (3.4 ± 1.2 SD); P = .31.
Conclusion
These findings suggest that undergraduate medical students and postgraduate students who are new interns are not confident or competent in their ability to perform an appropriate informed consent discussion. Our study findings support the creation of a needs-based, entrustable professional activity–aligned informed consent discussion teaching program and the need for an ongoing evaluation of the success of such a program.
Legal and Ethical Considerations for Radiology Procedural Consent [CHAPTER]
Legal and Ethical Considerations for Radiology Procedural Consent [CHAPTER]
Adrienne N. Dixon, Meghan Stepanek
Advanced Practice and Leadership in Radiology Nursing
Springer, 17 December 2019; pp 225-234
Abstract
This chapter will introduce readers to the legal and ethical principles of patient autonomy as well as the consenting process in the context of scenarios such as types of consents, capacity determination, communication, and liability risks.
Center for Informed Consent Integrity 