Computable Consent – From Regulatory, Legislative, and Organizational Policies to Security Policies
Zoran Milosevic, Frank Pyefinch
International Conference on Enterprise Design, Operations, and Computing, 28 September 2022; Italy
Consumer-facing health applications are increasingly requiring flexible approaches for expressing consumer consent preferences for the use of their health data across multiple providers, and across cloud and on-premises systems. This and the recognition of the need for clear governance and legislative rules that specify enforceable policies over how consumer data is used by the nominated and other providers, including AI vendors, increasingly require machine readable, i.e. computable consent expressions. These expressions can be regarded as additional constraints over security policies, applicable to all stakeholders, while accommodating rules from regulatory and legislative policies. Support for both kind of policies contribute to improving consumer trust in the use of their data. This is applicable to both care delivery processes but also research projects, such as clinical trials. This paper proposes a computable consent framework and positions it in the context of the new developments within Health Level Seven (HL7®) Fast Health Interoperability Resources (FHIR®) standard. The proposal is based on the use of precise policy concepts from the ISO/ITU-T RM-ODP (Reference Model for Open Distributed Processing) standard. The aim is to provide general standards-based policy semantics guidance to interoperability/solution architects and implementers involved in digital health applications. The framework is driven by consent requirements, while leveraging broader policy input from medico-legal community.
Consent form, the highest ethical standard in creating DNA databases for criminal investigation
Renata Jankova, Pavlinka Donevska-Stefanov, Natasha Bitoljanu, Goran Pavlovski, Robert Janevski, Aleksandar Stankov
Forensic Science International: Genetics Supplement Series, 25 October 2022
Preparation of DNA databases for the purpose of criminal investigation opens discussions about ethical-legal issues concerning violation of human rights. The practice shows that one of the human rights that can be misused while creating such a database is the right to freedom, the freedom to make a decision. When preparing DNA databases, the right to freedom refers to free decision of the person to be sampled for carrying out the test. The right to freedom and respect to self-determination of the person implies the necessity of prior consent of the subject when preparing a database on general population level. This is not a case when databases are created from persons under investigation for committing a crime, who are compulsory subjected for obtaining samples for DNA analysis. Legal regulations approve the duty of the police and its authorization in collecting samples for personal or criminalistic identification, analyzing, keeping and eliminating collected personal information when criminal prosecution is concerned. In these cases, consent form from the subject is not necessary. However, we should be aware that the process of taking and collecting of personal information by the national institutions can have direct impact of privacy of the subject, no matter if this information is going to be used or not. In purpose of fair balance between public and private interest, consent form can be redefined and the person from whom the biological material is provided will be unequivocally made aware of the purposes for which his genetic data will be used, how long his DNA will undergo further automated processing, and about the procedure and under what conditions his DNA profile can be removed from the national DNA databases.
Safeguarding Personal Data: Meta Consent as a Remedy to Section 28(2)(c) of Kenya’s Data Protection Act
Strathmore Law Review, 2022; 7(1) pp 127-159
Biometric identity systems have been adopted in the Global South, following the Global North’s lead. The greatest discrepancy, however, is the existence of legal frameworks that govern the use, storage and processing of the data collected. The Kenyan government’s roll-out of the Huduma Namba registration exercise in April 2019 with no existing data protection law in Kenya exemplifies this. Thereafter, Parliament passed the Data Protection Act. Unfortunately, parts of this law are not keen enough to protect personal data. Deviating from the requirement for personal data to be directly collected from the data subject, section 28(2)(c) of the referenced Act permits indirect collection of personal data from a source other than the data subject themselves. Relying on desk-based research and using the Huduma Namba exercise as a case study, this paper examines this permission and the imminent danger it poses to privacy of the personal data of Kenyans. Finding that section 28(2)(c) exposes personal data to the privacy violations of secondary use and exclusion threatens the right to privacy, this research suggests that the meta consent model as embraced by the healthcare sector emerges as a feasible solution. This model allows data subjects to determine their consent preferences i.e., how and when they wish their consent to be sought for further collection and use, at the point of primary collection of personal data. Additionally, this paper recommends that the model should be embraced by the judiciary in its adjudication of matters and finally, that an amendment incorporating the solution should be made.
Improving the Practice of Obtaining Informed Consent for Biobanking in Clinical Settings
Laura Arregui Egido, María Villalobos-Quesada
Biopreservation and Biobanking, 29 September 2022
Biobanks form key research support infrastructures that ensure the highest sample quality for scientific research. Their activity must align closely and proportionally to the interests of researchers, donors, and society. Informed consent (IC) is a central tool to guarantee the protection of donors’ rights and interests.
This study aimed to analyze the challenges of obtaining IC for biobanking in clinical settings and ways to improve this process.
Biobank Bellvitge University Hospital HUB-ICO-IDIBELL in Barcelona received 8671 IC forms between 2017 and 2020. The mistakes that caused IC forms to be rejected by the Biobank were analyzed. In addition, interventions aimed at physicians to improve the IC process were evaluated through a calculation of the relative risk (RR). Finally, physicians who submitted samples to the Biobank, most of whom are involved in research activities, were surveyed about the barriers to collecting IC and how to improve this process.
During 2017–2020, 19.6% of IC forms were rejected. The most relevant cause of rejection was the use of outdated IC forms, followed by missing patient information or mistakes having been made by the physician. Evaluation of the rejection rates before and after interventions to improve the IC process suggests significant improvement (27.7% before interventions (January 2017–May 2018) compared to 9.6% after interventions (February–December 2020), RR 0.4 95% CI 0.34–0.47; p < 0.0001). According to the physicians, the most important barrier to collecting IC is the time constraint, and they consider digitalization as a viable solution.
Our research offers a view of the less well-understood practical challenges that physicians and biobanks face when collecting IC in clinical settings. It suggests that, despite multiple challenges, continuous monitoring, training, and information programs for physicians are key to optimizing the IC process in clinical settings.
Parental Preferences Surrounding Timing and Content of Consent Conversations for Clinical Germline Genetic Testing Following a Child’s New Cancer Diagnosis
Belinda N. Mandrell, Liza Marie Johnson, Mary Caples, Jami Gattuso, Jamie L. Maciaszek, Roya Mostafavi, Katianne M. Howard Sharp, Kim E. Nichols
JCO Precision Oncology, 20 October 2022
Clinical genomic testing is increasingly being used to direct pediatric cancer care. Many centers are interested in offering testing of tumors and paired germline tissues at or near the time of cancer diagnosis. We conducted this study to better understand parent preferences surrounding timing and content of consent conversations for clinical germline genetic testing of their children with cancer as a part of real-time cancer care.
Patients and Methods
A seven-question survey developed by the Division of Cancer Predisposition and collaborators at St Jude Children’s Research Hospital (St Jude) was distributed to members of the St Jude Patient Family Advisory Council, which included parents of childhood cancer survivors and bereaved parents whose children with cancer had died. Parents were asked to provide free text comments after each question. Qualitative methods were used to derive codes from parent comments, and survey results were depicted using descriptive statistics.
The survey was completed by 172 parents. Ninety-three (54%) endorsed an approach for consent conversations ≥ 1 month after cancer diagnosis, whereas 58 (34%) endorsed an approach at 1-2 weeks and 21 (12%) at 1-2 days. Needing time to adjust to a new or relapsed cancer diagnosis and feeling overwhelmed were frequent themes; however, parents acknowledged the urgency and importance of testing. Parents desired testing of as many cancer-related genes as possible, with clinical utility the most important factor for proceeding with testing. Most parents (75%) desired germline results to be disclosed in person, preferably by a genetic counselor.
Parents described urgency and benefits associated with germline testing, but desired flexibility in timing to allow for initial adjustment after their child’s cancer diagnosis.
Editor’s note: JCO is an American Society of Clinical Oncology Journal.
Children’s understanding and consent to heart surgery: Multidisciplinary teamwork and moral experiences
Priscilla Alderson, Hannah Bellsham-Revell, Nathalie Dedieu, Liz King, Rosa Mendizabal, Katy Sutcliffe
Journal of Child Health Care, 27 September 2022
Mainstream law and ethics literature on consent to children’s surgery contrasts with moral experiences of children and adults observed in two heart surgery centres. Research interviews were conducted with 45 practitioners and related experts, and with 16 families of children aged 6 to 15, admitted for non-urgent surgery, as well as an online survey. Thematic data analysis was informed by critical realism and childhood studies.Impersonal adult-centric mainstream literature assumes young children cannot consent. It is based on dichotomies: adult/child, competent/incompetent, respect or protect children, inform or distract them, use time swiftly or flexibly, verbal/non-verbal communication, respect or control children and reason/emotion.Through their moral experiences, adults and children resolve these seeming dichotomies. Through understanding young children’s reasoning and emotions about complex distressing decisions related to heart surgery, adults share knowledge, control, trust and respect with them. They see children’s consent or refusal before non-urgent surgery as a shared personal moral experience within the child’s life course, beyond mere legal compliance. Adults help children to understand and ‘want’ the surgery that offers things they value: better health or to ‘be more like their friends’. If children are not convinced, sometimes surgery is postponed or occasionally cancelled.
Readability and comprehension of paediatric informed consent and assent forms from a single institution in South Africa
Mwanaidi Kafuye, Mariana Kruger
Tanzania Journal of Health Research, 2022; 23 pp 39-39
Informed consent and assent forms are fundamental prerequisites in the conduct of ethical paediatric health research. For paediatric research, parents or the legal caretaker of a child should provide informed consent along with the child or adolescent. Readability and comprehension of consent and assent forms in both therapeutic and non-therapeutic studies play a critical role during the informed decision-making process of study participants.
To assess the readability scores and to determine the school grade level of informed consent forms (ICFs), and informed assent forms (IAFs) also to assess accuracy and completeness of elements of ICFs and IAFs.
We used web-based readability score calculator to determine scores of Flesch Kincaid Reading Ease (FRE), Flesch-Kincaid Grade Level (FKGL) and length (word count) of the assent and consent forms, respectively. We also assessed inclusion of essential elements in the ICFs and IAFs using consent form guidance available in the South African Department of Health: Ethics in Health Research Guidelines (2015) as standard.
The mean Flesch Kincaid readability ease score for 28 ICFs was 57 while that of the23 IAFs was 68. Furthermore, the higher the Flesch Kincaid Reading Ease scores the lower was the Flesch-Kincaid Grade Level score (p < 0.001). The therapeutic ICF and IAF forms were substantially longer than the non-therapeutic ICF and assent forms (p < 0.001). Most ICFs and IAFs provided accurate and complete elements of ICF with regards to research information with adherence to the Ethics guideline of the South African Department of Health.
Conclusion and recommendations
There were higher word counts in both ICFs and IAFs for therapeutic studies versus non-therapeutic studies. The study concludes that both ICFs and IAFs were difficult to comprehend with significantly higher Flesch Kincaid reading grade levels than the NIH/AMA/USDHHS recommended reading grade level 6.
A cost–consequence analysis of eLearning videos designed to supplement the consent process in lower limb arthroplasty
J Brock, A Sale, U Jayaraju, A Chandetreya, P Lee
Royal College of Surgeons of England Annals, 19 October 2022
Since the Montgomery ruling in 2015 surgeons have been tasked with identifying material risk when taking informed consent. Despite this, there has been limited uptake of technological aids to supplement the consent process although such aids are shown to improve patient knowledge and satisfaction. ConsentPLUS is a free-to-access website with bite-sized educational videos designed to clearly explain lower limb arthroplasty procedures to patients and aid their consent.
We performed a prospective cost–consequence analysis, outlining any costs associated with the intervention and any quantitative or qualitative impacts the intervention may have on patients.
A total of 3,143 consecutive patients were identified who were undergoing total knee or hip replacement in 25 elective NHS orthopaedic units. The total cost of development and projected 10-year running fees for ConsentPLUS total £75,000. Health Foundation support means the service is free-to-access for centres throughout the UK. Mean exposure time per patient was 10min 29s, equivalent to £185,437 of additional contact time according to the National Tariff. Mean clinic time was reduced by 17min owing to the earlier identification of material risk. Patient knowledge on pre- and post-video quizzes increased from 7.01 to 9.08 following eLearning (paired t-test = 0.998). The process had an overall satisfaction rate of 97%.
Educational eLearning videos are an accessible and digestible way to supplement the consent process. This enables earlier identification of material risk in clinics owing to improved patient knowledge, leading to increased patient satisfaction with arthroplasty consenting.
Digitized and structured informed patient consent before contrast-enhanced computed tomography: feasibility and benefits in clinical routine
Markus Kopp, Jan Peter Roth, Frederik Geisler, Sascha Daniel, Theresa Ruettinger, Christoph Treutlein, Eva L. Balbach, Rafael Heiss, Matthias Wetzl, Nouhayla El Amrani, Alexander Cavallaro, Michael Uder, Matthias S. May
Insights into Imaging, 11 October 2022; 13(164)
To evaluate the feasibility and benefits of digitized informed patient consent (D-IPC) for contrast-enhanced CT and compare digitized documentation with paper-based, conventional patient records (C-PR).
We offered D-IPC to 2016 patients scheduled for a CT. We assessed patient history (e.g., CT examinations, malignant or cardiovascular diseases) and contraindications (red flags) for a CT (e.g., thyroid hyperfunction, allergies) using a tablet device. We evaluated the success rate of D-IPC and compared patient age between the subgroups of patients who were able or unable to complete D-IPC. We analyzed the prevalence of marked questions and red flags (RF). RF were compared with the documentation from C-PR. We estimated greenhouse gas (GHG) emissions for paperless workflow and provide a cost–benefit analysis.
Overall, 84.4% of patients completed D-IPC. They were younger (median 61 years) than unsuccessful patients (65 years; p < 0.001). Patients who marked questions (21.7%) were older than patients without inquiries (median 63.9 vs 59.5 years; p < 0.001). The most prevalent RF was thyroid disease (23.8%). RF were considered critical for contrast-agent injection in 13.7%, requiring personalized preparation. The detection rate for RF documented with D-IPC was higher than for C-PR (n = 385 vs. 43). GHG emissions for tablet production are 80–90 times higher than for paper production. The estimated costs were slightly higher for D-IPC (+ 8.7%).
D-IPC is feasible, but patient age is a relevant factor. Marked questions and RF help personalize IPC. The availability of patient history by D-IPC was superior compared to C-PR.
Informed consent for third molar extraction; a comparison of conventional verbal consent versus video-assisted consent
Trinity College Dublin, Dental Science Thesis, 2022
The goal of the informed consent process is to provide patients with the necessary educational information, defend their autonomy, and allow active involvement in treatment planning and decision-making. The informed consent process must not only describe the operation in full, but also provide information on the procedure’s rationale, alternative therapies, associated benefits, risks, and complications. However, the process of acquiring informed consent is fraught with issues.
This research aims to assess if presenting information about third molar extraction via an informative, narrated, animated video changes a patient s perception of the consent process for third molar extraction when compared to conventional verbal/written consent. The outcomes that are evaluated include patient understanding, patient satisfaction and patient anxiety.
In this post test-only control clinical trial patients scheduled for surgical removal of an impacted mandibular third molar that fulfilled the predetermined criteria were invited to participate in the study. The criterion variable was the presentation of an animated information consent video. Participants were randomly assigned into 2 equal groups receiving either verbal consent or video-assisted consent. After signing the consent form patients then filled out an electronic questionnaire rating their experience of the consent process. At the postoperative review, 7-14 days after the procedure, patients were asked to fill out a questionnaire rating their experience of the consent retrospectively. The outcome variables were patients self-reported level of understanding, patient anxiety measured on the Dental Anxiety Scale and patient satisfaction. The data were analysed with Pearson s chi-squared tests, Fisher s Exact test, and linear regression analysis.
Ninety patients fulfilled the inclusion criteria and were included in the study. The video-assisted group reported higher levels of understanding of the proposed procedure (P<0.001) and the associated risks/complications (P<0.004 ). Patients were more satisfied with information delivered to them via video. 98% of patients in the video consent group felt that the video-assisted consent was beneficial. There was no statistically significant change in the reported level of anxiety when video-assisted consent was used.
The present study suggests that video-assisted consent may improve patients level of understanding of the potential postoperative risks and complications involved in surgical removal of an impacted mandibular third molar. This improved understanding did not increase patients dental anxiety compared with conventional verbal/written consent but improved patients level of satisfaction with the amount of information that they received.