Informed Consent: A Monthly Review

July 2019

This digest is intended to aggregate and distill key content around informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:

Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation

David R. Curry
President & CEO
GE2P2 Global Foundation

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_July 2019

Gavi, NEC, and Simprints to deploy world’s first scalable child fingerprint identification solution to boost immunisation in developing countries [PRESS RELEASE]

Gavi, NEC, and Simprints to deploy world’s first scalable child fingerprint identification solution to boost immunisation in developing countries [PRESS RELEASE], 6 June 2019
Gavi, the Vaccine Alliance, NEC Corporation, and Simprints Technology Ltd. have signed a memorandum of understanding on the use of biometrics to improve immunisation coverage in developing countries.

Despite enormous progress over the past two decades, there are still approximately 20 million children who do not receive a basic course of vaccines worldwide, leaving them exposed to some of the world’s deadliest diseases.

One key cause is the fact that only half of all children under 5 in sub-Saharan Africa are currently registered at birth, leaving many without an official identity. This makes it difficult for health practitioners to ensure these infants get the vaccines they need at the right time.

Guided by Gavi’s experience and expertise in immunisation, this new project will combine Simprints’ biometric fingerprint technology and NEC’s reinforced authentication engine to help create digital identities for children 1-5 years of age and boost immunisation coverage in developing countries.

This new partnership will deploy the world’s first scalable fingerprint identification solution to give children aged 1-5 a digital ID linked to an accurate, complete medical record. All biometric records will be stored securely by Simprints, a UK-based non-profit social enterprise, after caregivers give informed consent to having their children’s biometric data taken…

Editor’s note: The Foundation has expressed concern to GAVI about the management and potential misuse of this digital ID system beyond its intent to support infant immunization.

Lack of informed consent for surgical procedures by elderly patients with inability to consent: a retrospective chart review from an academic medical center in Norway

Lack of informed consent for surgical procedures by elderly patients with inability to consent: a retrospective chart review from an academic medical center in Norway
Jorgen Dahlberg, Vegard Dahl, Reidun Forde, Reidar Pedersen
Patient Safety in Surgery, 22 June 2019; 13(24)
Respect for patient autonomy and the requirement of informed consent is an essential basic patient right. It is constituted through international conventions and implemented in health law in Norway and most other countries. Healthcare without informed consent is only allowed under specific exceptions, which requires a record in the patient charts. In this study, we investigated how surgeons recorded decisions in situations where the elderly patient’s ability to provide a valid informed consent was questionable or clearly missing.
We investigated all medical records of patients admitted to surgical departments in a Norwegian large academic emergency hospital over a period of 38 days (approximately 5000 patients). We selected records of patients above the age of 70 (570 patients) and searched through these 570 medical records for any noted clear indications of inability to consent such as “do not understand”, “confused” etc. (102 patients). We read through all the medical records on these 102 patients noting any recordings on lack of informed consent, any recordings on reasoning and process hereto. We also took note whether there were clear indications on the use of coercion.
None of the 102 included patients´ charts contained legally valid recorded assessments (for example related to the patients´ competence to consent) when patients without the ability to consent were admitted and provided healthcare. Some charts contained records that the patient resisted treatment, thus indicating treatment with coercion. In these situations, we did not find any documentation related to legal requirements that regulate the use of coercion.
Discussion and conclusion
We found a substantial lack of compliance with the legal requirements that apply when obtaining valid informed consent. There are many possible reasons for this: Lack of knowledge of the legal requirements, disagreement about the rules, or that it is simply not possible to comply with the extensive formal and material legal requirements in clinical practice. The results do not point out whether the appropriate measures are amending the law, educating and requiring more compliance from surgeons, or both.

Questions about informed consent related to the use of haptic suits as assistive technologies for people with intellectual and developmental disabilities

Questions about informed consent related to the use of haptic suits as assistive technologies for people with intellectual and developmental disabilities
Fiachra O’Brolcháin, Aviva Cohen
International Journal of Applied Ethics, 31 May 2019; 30
Open Access

Technological innovation is witnessing the convergence of haptic technologies with real-time 3D virtual environments and / or augmented reality technologies. Among the diverse applications of these innovations is their use as assistive technologies for people with intellectual and developmental disabilities, or people with cognitive deficits, such as dementia.

This article focuses on the issue of informed consent in relation to research and the use of these technologies (hereafter referred to simply as haptic suits). Informed consent is a standard requirement in the ethics of research, as well as in care settings, so it will be necessary for tests with haptic suits in general and, when used as assistive technology. Given the emphasis on the participation of people with intellectual or developmental disabilities in the research and design of assistive technologies for their use, the issue of informed consent is compelling.

Editor’s note: This is a Spanish language publication. In reviewing available definitions for haptic technologies we found the following: “the science of applying touch sensation and control to interact with computer developed applications”.

Research ethics for mobile sensing device use by vulnerable populations

Research ethics for mobile sensing device use by vulnerable populations
Samantha Breslin, Martine Shareck, Daniel Fuller
Social Science & Medicine, July 2019; 232 pp 50-57
Devices equipped with sensors to track mobility, such as through Global Position Systems (GPS) and accelerometery, are increasingly being used for research. Following Canadian, US, and International guidelines there is a need to give special consideration when conducting research with vulnerable populations. This paper examines specific ethical concerns for conducting research with mobile sensing devices for use by vulnerable populations, considering aspects of both research design and research process. Drawing on insights from feminist design and aligned fields, such as participatory design and action research, we contend that any research design and process for working with vulnerable populations must be developed in collaboration with the particular groups and communities who are part of the research. As part of this process of collaborative research, we discuss risks in terms of the lack of control over data associated with choosing commercial devices, as well as practicality and obtrusiveness of devices for the wearer. We also discuss the significance of informed consent and refusal and issues relating to security and safety during research. As part of the collaborative research design and process, we argue that participants should be given as much control over their data as possible. Based on this discussion, we provide recommendations for researchers to consider, which are broadly relevant for research using mobile sensing devices but particularly significant in relation to vulnerable populations.

A randomized, controlled trial of video supplementation on the cataract surgery informed consent process

A randomized, controlled trial of video supplementation on the cataract surgery informed consent process
Journal Article 
Zhang MH, Haq ZU, Braithwaite EM, Simon NC, Riaz KM
Graefe’s Archive for Clinical and Experimental Ophthalmology, 30 May 2019; pp 1-10
To assess the effects of the American Academy of Ophthalmology’s 2015 patient education video on patient information retention and anxiety preoperatively, on the day of surgery and postoperatively.
This is a prospective, surgeon-blinded randomized controlled trial at the University of Chicago Medical Center. Ninety-one patients with a diagnosis of first-eye cataract were randomized into either a video or control group. Subjects in both groups received face-to-face discussion with the surgeon and an informational brochure at the preoperative evaluation. Participants in the video group then viewed a four-minute educational video at the preoperative evaluation and on the day of surgery. Both groups completed an information retention quiz and a state anxiety assessment at the preoperative visit, on the day of surgery, and on the postoperative week one visit. Subject understanding of cataract surgery was measured using a twelve-question multiple choice quiz. State anxiety was measured by State Trait Anxiety Inventory-Y1 survey score.
Participants in the video group did not score significantly higher on the information retention quiz compared with the control group at the preoperative evaluation (8.7 ± 2.4 vs 7.7 ± 2.5, P = 0.07), but did so on the day of surgery (11.2 ± 0.8 vs 8.4 ± 1.7, P < 0.001) and postoperative week 1 visit (10.8 ± 1.5 vs 9.0 ± 2.0, P < 0.001). Subjects in the video group were significantly less anxious on the day of surgery (26.4 ± 5.1 vs 41.1 ± 10.3, P < 0.001).
Video supplementation to the traditional informed consent process demonstrated an improvement in patient understanding of cataract surgery at multiple timepoints and decreased anxiety on the day of surgery.

Clinical Image Consent Requirements: Variability among Top Ten Medical Journals

Clinical Image Consent Requirements: Variability among Top Ten Medical Journals
Juan N. Lessing, Nicholas M. Mark, Matthew K. Wynia, Ethan Cumbler
Journal of Academic Ethics, 21 June 2019; pp 1–5
The consent process for publication of clinical images in medical journals varies widely. The extent of this variation is not known. It is also not known whether journals follow their own stated best practices or the guidance of the International Committee of Medical Journal Editors (ICMJE). We assessed consent requirements in a sample of 10 top impact factor general medicine journals that publish clinical images, examining variability in consent requirements for clinical image publication and congruence of requirements with the recommendations of the ICMJE. Clinical image consent requirements varied widely from journal to journal. None of the studied journals, even amongst n = 4 ICMJE members or n = 8 journals who self-report adherence to ICMJE guidelines, comply with all of the recommendations of the ICMJE. Half of studied journals require a journal-specific consent form. Among top medical journals there is significant heterogeneity in consent requirements for clinical images. Variability of consent requirements is neither practical nor rational; inconsistent requirements create uncertainty for authors, present impediments to dissemination of scholarship, and undermine a shared professional understanding of how best to protect patient privacy. We propose adopting a standardized consent form and process for publication of identifiable images in medical journals, with uniform elements and explicit definitions.

The Effect of Framing and Placement on Linkage Consent 

The Effect of Framing and Placement on Linkage Consent 
Joseph W Sakshaug, Alexandra Schmucker, Frauke Kreuter, Mick P Couper, Eleanor Singer
Public Opinion Quarterly, 20 June 2019
Numerous surveys link interview data to administrative records, conditional on respondent consent, in order to explore new and innovative research questions. Optimizing the linkage consent rate is a critical step toward realizing the scientific advantages of record linkage and minimizing the risk of linkage consent bias. Linkage consent rates have been shown to be particularly sensitive to certain design features, such as where the consent question is placed in the questionnaire and how the question is framed. However, the interaction of these design features and their relative contributions to the linkage consent rate have never been jointly studied, raising the practical question of which design feature (or combination of features) should be prioritized from a consent rate perspective. We address this knowledge gap by reporting the results of a placement and framing experiment embedded within separate telephone and Web surveys. We find a significant interaction between placement and framing of the linkage consent question on the consent rate. The effect of placement was larger than the effect of framing in both surveys, and the effect of framing was only evident in the Web survey when the consent question was placed at the end of the questionnaire. Both design features had negligible impact on linkage consent bias for a series of administrative variables available for consenters and non-consenters. We conclude this research note with guidance on the optimal administration of the linkage consent question.

Linking Survey and Twitter Data: Informed Consent, Disclosure, Security and Archiving

Linking Survey and Twitter Data: Informed Consent, Disclosure, Security and Archiving
Luke Sloan, Curtis Jessop, Tarek Al Baghal, Matthew Williams
University of Essex Research Repository, 11 June 2019
Linked survey and Twitter data present an unprecedented opportunity for social scientific analysis, but the ethical implications for such work are complex – requiring a deeper understanding of the nature and composition of Twitter data to fully appreciate the risks of disclosure and harm to participants. In this paper we draw on our experience of three recent linked data studies, briefly discussing the background research on data linkage and the complications around ensuring informed consent. Particular attention is paid to the vast array of data available from Twitter and in what manner it might be disclosive. In light of this, the issues of maintaining security, minimising risk, archiving and re-use are applied to linked Twitter and survey data. In the conclusion we reflect on how our ability to collect and work with Twitter data has outpaced our technical understandings of how the data is constituted and observe that understanding one’s data is an essential prerequisite for ensuring best ethical practice.

A limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelines

A limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelines
Original Article
Rafael Dal−Ré, Cristina Avendaño−Solà, Anthoniusde Boer, Stephan K. James, Frits R. Rosendaal, Richard Stephens, John PA Ioannidis
Journal of Clinical Epidemiology, 15 June 2019
European regulations do not allow modification or waiver of informed consent for medicines randomized controlled trials (RCTs) where the three 2016 Council for International Organizations of Medical Sciences (CIOMS) provisions are met (consent would be impractical or unfeasible, yet the trial would have high social value and pose no or minimal risk to participants). We aimed to identify whether any such trials of medicines were being conducted in Europe.
Study design and Setting
Survey of all phase 4 ‘ongoing’ RCTs on the EU clinical trial register between 1/July/2016 and 30/June/2018, to identify those with potentially high levels of pragmatism. Trials that were excluded: those conducted on rare diseases; masked (single-, double-blind) trials; single-center trials; those where one could expect to lead patients to prefer one intervention over the other; and miscellaneous reasons. The degree of pragmatism of the RCTs was self-assessed by trials’ investigators by means of the PRECIS-2 tool. Investigators of those trials considered to be highly pragmatic, assessed the fulfillment of the three CIOMS provisions. Seven patients assessed the social value of the RCTs. Finally, 33 members of 11 research ethics committees (RECs) assessed the social value of the trials and whether they posed no more than minimal risk to participants. Investigators, patients and REC members assessed the fulfilment of the CIOMS provisions as ‘Yes’, ‘Not sure’ or ‘No’.
Of the 636 phase 4 trials, 420 were RCTs, and 21 of these (5%) were candidates to be pragmatic. Investigators of 15 of these 21 RCTs self−assessed their trial’s degree of pragmatism: 14 were highly pragmatic. Of these 14, eight fulfilled the three CIOMS provisions. Assessments by patients and RECs were inconsistent for several trials.
We found few low−risk participant−level pragmatic RCTs that could be suitable for modified or waived participants’ informed consent. European regulators should consider amending the current regulation and encouraging the conduct of such trials.