Informed Consent: A Monthly Review

November 2019

This digest aggregates and distills 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_November 2019

Informed Consent in the Genomics Era

Informed Consent in the Genomics Era
Shannon Rego, Megan E. Grove, Mildred K. Cho, Kelly E. Ormond
Cold Spring Harbor Perspectives in Medicine, 30 September 2019
Informed consent, the process of gathering autonomous authorization for a medical intervention or medical research participation, is a fundamental component of medical practice. Medical informed consent assumes decision-making capacity, voluntariness, comprehension, and adequate information. The increasing use of genetic testing, particularly genomic sequencing, in clinical and research settings has presented many new challenges for clinicians and researchers when obtaining informed consent. Many of these challenges revolve around the need for patient comprehension of sufficient information. Genomic sequencing is complex—all of the possible results are too numerous to explain, and many of the risks and benefits remain unknown. Thus, historical standards of consent are difficult to apply. Alternative models of consent have been proposed to increase patient understanding, and several have empirically demonstrated effectiveness. However, there is still a striking lack of consensus in the genetics community about what constitutes informed consent in the context of genomic sequencing. Multiple approaches are needed to address this challenge, including consensus building around standards, targeted use of genetic counselors in nongenetics clinics in which genomic testing is ordered, and the development and testing of alternative models for obtaining informed consent.

Prioritising African perspectives in Psychiatric Genomics Research: issues of translation and informed consent

Prioritising African perspectives in Psychiatric Genomics Research: issues of translation and informed consent
Kamaara, Camillia Kong, M. Campbell
Developing World Bioethics, 9 October 2019
Psychiatric genomics research with African populations comes with a range of practical challenges around translation of psychiatric genomics research concepts, procedures, and nosology. These challenges raise deep ethical issues particularly around legitimacy of informed consent, a core foundation of research ethics. Through a consideration of the constitutive function of language, the paper problematises like-for-like, designative translations which often involve the ‘indigenization’ of English terms or use of metaphors which misrepresent the risks and benefits of research. This paper argues that effective translation of psychiatric genomics research terminology in African contexts demands substantive engagement with African conceptual schemas and values. In developing attenuated forms of translational thinking, researchers may recognise the deeper motivational reasons behind participation in research, highlighting the possibility that such reasons may depart from the original meaning implied within informed consent forms. These translational issues might be ameliorated with a critical re-examination of how researchers develop and present protocols to institutional ethics review boards.

Education versus screening: the use of capacity to consent tools in psychiatric genomics

Education versus screening: the use of capacity to consent tools in psychiatric genomics
Extended Essay
Camillia Kong, Mehret Efrem, Megan Campbell
Journal of Medical Ethics, 28 September 2019
Informed consent procedures for participation in psychiatric genomics research among individuals with mental disorder and intellectual disability can often be unclear, particularly because the underlying ethos guiding consent tools reflects a core ethical tension between safeguarding and inclusion. This tension reflects important debates around the function of consent tools, as well as the contested legitimacy of decision-making capacity thresholds to screen potentially vulnerable participants. Drawing on human rights, person-centred psychiatry and supported decision-making, this paper problematises the use of consent procedures as screening tools in psychiatric genomics studies, particularly as increasing normative emphasis has shifted towards the empowerment and participation of those with mental disorder and intellectual disabilities. We expound on core aspects of supported decision-making, such as relational autonomy and hermeneutic competence, to orient consent procedures towards a more educative, participatory framework that is better aligned with developments in disability studies. The paper concludes with an acknowledgement of the pragmatic and substantive challenges in adopting this framework in psychiatric genomics studies if this participatory ethos towards persons with mental disorder and intellectual disability is to be fully realised.

Taking consent for neonatal microarray analysis as a screen for genomic rearrangements: are paediatricians equipped for the genomic era?

Taking consent for neonatal microarray analysis as a screen for genomic rearrangements: are paediatricians equipped for the genomic era?
Post Script Letter
Katrina Andrews, Matina Prapa, Elizabeth Radford, Ingrid Simonic, Simon Holden, Gusztav Belteki
Archives of Disease in Childhood, 28 September 2019
Microarrays are increasingly requested as a first-line genetic investigation for chromosome anomalies in the neonatal population. Consent is usually taken by paediatricians, frequently trainees, often without specific training in how to consent for genetic tests. Unlike in the paediatric population,1 there are no consensus guidelines on the indications for neonatal microarray testing. Our local guideline recommends microarray testing in babies with multiple congenital anomalies or ambiguous genitalia. However, studies have also suggested the utility of microarray testing in congenital heart disease2 and intrauterine growth restriction (IUGR) without congenital anomalies.3

Informed genetic consent needs to cover prognostication (most pathogenic copy number variants (CNVs) are associated with a significant risk of learning disability); potential implications for family members; incidental findings and the risk of identifying variants of uncertain significance (VUS)…

Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices

Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices
Saskia Hendriks, Christine Grady,  Khara M. Ramos, Winston Chiong, Joseph J. Fins, Paul Ford, Sara Goering, Henry T. Greely, Katrina Hutchison, Michael L. Kelly, Scott Y. H. Kim, Eran Klein, Sarah H. Lisanby, Helen Mayberg, Hannah Maslen, Franklin G. Miller, Karen Rommelfanger, Sameer A. Sheth, Anna Wexler
JAMA Neurology, 17 October 2019
Developing more and better diagnostic and therapeutic tools for central nervous system disorders is an ethical imperative. Human research with neural devices is important to this effort and a critical focus of the National Institutes of Health Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative. Despite regulations and standard practices for conducting ethical research, researchers and others seek more guidance on how to ethically conduct neural device studies. This article draws on, reviews, specifies, and interprets existing ethical frameworks, literature, and subject matter expertise to address 3 specific ethical challenges in neural devices research: analysis of risk, informed consent, and posttrial responsibilities to research participants.
Research with humans proceeds after careful assessment of the risks and benefits. In assessing whether risks are justified by potential benefits in both invasive and noninvasive neural device research, the following categories of potential risks should be considered: those related to surgery, hardware, stimulation, research itself, privacy and security, and financial burdens. All 3 of the standard pillars of informed consent—disclosure, capacity, and voluntariness—raise challenges in neural device research. Among these challenges are the need to plan for appropriate disclosure of information about atypical and emerging risks of neural devices, a structured evaluation of capacity when that is in doubt, and preventing patients from feeling unduly pressured to participate. Researchers and funders should anticipate participants’ posttrial needs linked to study participation and take reasonable steps to facilitate continued access to neural devices that benefit participants. Possible mechanisms for doing so are explored here. Depending on the study, researchers and funders may have further posttrial responsibilities.
Conclusions and Relevance  
This ethical analysis and points to consider may assist researchers, institutional review boards, funders, and others engaged in human neural device research.

Enhancing the Informed Consent Process Using Shared Decision Making and Consent Refusal Data from the CLEAR III Trial

Enhancing the Informed Consent Process Using Shared Decision Making and Consent Refusal Data from the CLEAR III Trial
Amanda L. Porter, James Ebot, Karen Lane, Lesia H. Mooney, Amy M. Lannen, Eugene M. Richie, Rachel Dlugash, Steve Mayo, Thomas G. Brott, Wendy Ziai, William D. Freeman, Daniel F. Hanley
Neurocritical Care, 30 September 2019; pp 1–8
The process of informed consent in National Institutes of Health randomized, placebo-controlled trials is poorly studied. There are several issues regarding informed consent in emergency neurologic trials, including a shared decision-making process with the patient or a legally authorized representative about overall risks, benefits, and alternative treatments.
To evaluate the informed consent process, we collected best and worst informed consent practice information from a National Institutes of Health trial and used this in medical simulation videos to educate investigators at multiple sites to improve the consent process. Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) (, NCT00784134) studied the effect of intraventricular alteplase (n = 251) versus saline (placebo) injections (n = 249) for intraventricular hemorrhage reduction. Reasons for ineligibility (including refusing to consent) for all screen failures were analyzed. The broadcasted presentation outlined best practices for doctor–patient interactions during the consenting process, as well as anecdotal, study-specific reasons for consent refusal. Best and worst consent elements were then incorporated into a simulation video to enhance the informed consent process. This video was disseminated to trial sites as a webinar around the midpoint of the trial to improve the consent process. Pre- and post-intervention consent refusals were compared.
During the trial, 10,538 patients were screened for eligibility, of which only three were excluded due to trial timing. Pre-intervention, 77 of 5686 (1.40%) screen eligible patients or their proxies refused consent. Post-intervention, 55 of 4849 (1.10%) refused consent, which was not significantly different from pre-intervention (P = 0.312). The incidence of screen failures was significantly lower post-intervention (P = 0.006), possibly due to several factors for patient exclusion.
The informed consent process for prospective randomized trials may be enhanced by studying and refining best practices based on trial-specific plans and patient concerns particular to a study.

Automating dynamic consent decisions for the processing of social media data in health research

Automating dynamic consent decisions for the processing of social media data in health research
Chris Norval, Tristan Henderson
Journal of Empirical Research on Human Research Ethics, September 2019
Open Access
Social media have become a rich source of data, particularly in health research. Yet, the use of such data raises significant ethical questions about the need for the informed consent of those being studied. Consent mechanisms, if even obtained, are typically broad and inflexible, or place a significant burden on the participant. Machine learning algorithms show much promise for facilitating a ‘middle ground approach: using trained models to predict and automate granular consent decisions. Such techniques, however, raise a myriad of follow-on ethical and technical considerations. In this paper, we present an exploratory user study (n = 67) in which we find that we can predict the appropriate flow of health-related social media data with reasonable accuracy, while minimising undesired data leaks. We then attempt to deconstruct the findings of this study, identifying and discussing a number of real-world implications if such a technique were put into practice.

Access to an Online Video Enhances the Consent Process, Increases Knowledge, and Decreases Anxiety of Caregivers with Children Scheduled for Inguinal Hernia Repair: a Randomized Controlled Study

Access to an Online Video Enhances the Consent Process, Increases Knowledge, and Decreases Anxiety of Caregivers with Children Scheduled for Inguinal Hernia Repair: a Randomized Controlled Study
Friederike Book, Jan Goedeke, Alicia Poplawski, Oliver J. Muensterer
Journal of Pediatric Surgery, 25 October 2019
There is limited time within the clinical workflow of most pediatric surgeons to obtain a comprehensive, well informed consent. This study evaluates whether ad-lib access to an online video on the consent dialogue enhances the consent process for inguinal hernia repair (IHR) in children.
The study was approved by the state ethics board. A 6-min video of a consent speech on IHR was produced and uploaded to a nonpublic online channel, explaining the condition, procedure, complications, and postoperative expectations. A total of 50 families were randomized to conventional, face-to-face consenting in clinic either with (intervention) or without (control) access to the online video. During their child’s IHR, the parents were asked to complete the State–Trait-Anxiety-Inventory (STAI), a modified Friedlander questionnaire on assessing knowledge sufficient to provide informed consent, and a validated satisfaction survey. Scores of the intervention and control group were statistically compared.
The intervention group demonstrated significantly decreased anxiety measured with the STAI (p = 0,026) and increased knowledge (p = 0,016) compared to controls. There was no difference in satisfaction (p = 0,557).
Preoperatively providing access to an online consent video regarding IHR reduces anxiety and enhances knowledge without altering satisfaction level. Adjunct online videos are a useful tool to enhance the consent process.

Patients’ Preference for Receiving Informed Consent Information Regarding Third Molar Surgery

Patients’ Preference for Receiving Informed Consent Information Regarding Third Molar Surgery
Daniel M.Laskin
Journal of Oral and Maxillofacial Surgery, 15 October 2019
It is important that patients have adequate information about a surgical procedure and its risks and benefits prior to giving consent to proceed. The purpose of this study was to determine patients’ satisfaction with various methods of presenting such information and their preferred method.
Patients and Methods
Patients presenting for removal of impacted third molars were shown an informational video discussing the diagnosis of impacted teeth, the potential risks of not having them removed, their treatment, surgical complications, and anesthetic options and risks. They then met with the treating doctor who again reviewed the material shown in the video and answered any questions prior to the patient signing the informed consent document. Patients then completed a brief questionnaire asking them to rate their satisfaction with the two presentation methods and to indicate their preferred method.
Fifty patients (18 males, 32 females; average age – 26yrs) completed the questionnaire. Fifty-eight percent had high school education, whereas 42% had some college or a college degree. Sixty-six percent of patients found the video very helpful and 78% found the oral presentation very helpful. However, when asked which format provided the best information, 62% indicted the video whereas 38% indicted the oral presentation.
Because there was no clear consensus among patients regarding the best format, providing both the video and an oral presentation is the ideal situation.