Informed Consent: A Monthly Review
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
GE2P2 Global Foundation
David R. Curry
President & CEO
GE2P2 Global Foundation
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_September 2019
Issues of Informed Consent from Persons with Dementia When Employing Assistive Technologies [BOOK CHAPTER]
Peter Novitzky, Cynthia Chen, Alan F. Smeaton, Renaat Verbruggen, Bert Gordijn
Intelligent Assistive Technologies for Dementia, 14 October 2019; Chapter 10
Informed consent is one of the cornerstones and requirements sine qua non of modern medical research and clinical practice. It developed relatively quickly to gain great importance, despite initial setbacks. The requirement of informed consent applies to all subjects of medical research and therapy, including persons with dementia (PwDs), whose impaired competence to provide valid informed consent poses particular challenges…
Differing Understandings of Informed Consent Held by Research Institutions, People with Intellectual Disability, and Guardians: Implications for Inclusive, Ethical Research [BOOK CHAPTER]
Britteny Howell, Karrie Shogren
Research Involving Participants with Cognitive Disability and Differences: Ethics, Autonomy, Inclusion, and Innovation, 5 September 2019; Chapter 3
Approximately 1–3% of the world’s population experiences an intellectual disability (ID)… Despite social and medical gains over the past several decades, people with ID are significantly more likely to experience poorer health and quality of life outcomes than people without… Research participation can play an important role in reducing such persistent disparities; however, people with ID remain under-represented in research for a variety of reasons, including the assumption that they are unable to provide informed consent for participation…
Using Ethnographic Methods to Determine Capacity to Consent amongst Individuals Diagnosed with Chronic Mental Illnesses [BOOK CHAPTER]
Saira A. Mehmood
Research Involving Participants with Cognitive Disability and Differences: Ethics, Autonomy, Inclusion, and Innovation, 5 September 2019; Chapter 14
This chapter reports on an ethnographic research project conducted with people diagnosed with chronic mental illnesses and often economic and educational vulnerabilities as well. It focuses particularly on strategies for assessing capacity to consent…
Repurposing Ethnography to Assess Consent Capacity [BOOK CHAPTER]
Research Involving Participants with Cognitive Disability and Differences: Ethics, Autonomy, Inclusion, and Innovation, 5 September 2019; Chapter 24
Saira Mehmood illustrates how participant observation, an ethnographic method, can be applied to asses research consent capacity for persons with chronic mental illness who use mental health services at a non-profit organization. Through observation of and interaction with prospective participants and organization staff members, Mehmood was able to get a sense of a mental health service user’s decisional capacity and vulnerability. While this is a novel and beneficial approach to assessing consent capacity, questions remain about its application, appropriateness, and usefulness in other contexts.
Decisional capacity to consent to treatment and anaesthesia in patients over the age of 60 undergoing major orthopaedic surgery
Gabriele Mandarelli, Giovanna Parmigiani, Felice Carabellese, Silvia Codella, Paolo Roma, Domitilla Brancadoro, Andrea Ferretti, Lucio Alessandro, Giovanni Pinto, Stefano Ferracuti
Medicine Science and the Law, 1 August 2019
Despite growing attention to the ability of patients to provide informed consent to treatment in different medical settings, few studies have dealt with the issue of informed consent to major orthopaedic surgery in those over the age of 60. This population is at risk of impaired decision-making capacity (DMC) because older age is often associated with a decline in cognitive function, and they often present with anxiety and depressive symptoms, which could also affect their capacity to consent to treatment. Consent to major orthopaedic surgery requires the patient to understand, retain and reason about complex procedures. This study was undertaken to extend the literature on decisional capacity to consent to surgery and anaesthesia of patients over the age of 60 undergoing major orthopaedic surgery. Recruited patients (N=83) were evaluated using the Aid to Capacity Evaluation, the Beck Depression Inventory, the State–Trait Anxiety Inventory Y, the Mini-Mental State Examination and a visual analogue scale for measuring pain symptomatology. Impairment of medical DMC was common in the overall sample, with about 50% of the recruited patients showing a doubtful ability, or overt inability, to provide informed consent. Poor cognitive functioning was associated with reduced medical DMC, although no association was found between decisional capacity and depressive, anxiety and pain symptoms. These findings underline the need of an in-depth assessment of capacity in older patients undergoing major orthopaedic surgery.
The Patients Have a Story to Tell: Informed Consent for People who use Illicit Opiates in a Qualitative Research Project
Jane McCall, J. Craig Phillips, Andrew Estefan
Canadian Society of Addiction Medicine, November 2018
This paper discusses the ethical issues that arise when seeking informed consent from people who use illicit opiates. There is a significant discourse in the literature that opines that people who use illicit opiates are unable to provide informed consent due to withdrawal symptoms and cognitive impairment as a result of opioid use. This paper outlines the ethical issues that have been discussed in relation to this issue, reviews the findings of a study in which staff were asked their opinions about their patients’ ability to provide informed consent and discusses the issues that arise when patients are not allowed to consent to research.
Consent for mobile phone surveys of non-communicable disease risk factors in low-resource settings: an exploratory qualitative study in Uganda
Erisa Mwaka, Janet Nakigudde, Joseph Ali, Joseph Ochieng, Kristina Hallez, Raymond Tweheyo, Alain Labrique, Dustin G. Gibson, Elizeus Rutebemberwa, George Pariyo
mHealth, 5 July 2019; 5(26)
Lack of data for timely decision-making around the prevention and control of non-communicable diseases (NCDs) presents special challenges for policy makers, especially in resource-limited settings. New data collection methods, including pre-recorded Interactive Voice Response (IVR) phone surveys, are being developed to support rapid compilation of population-level disease risk factor information in such settings. We aimed to identify information that could be used to optimize consent approaches for future mobile phone surveys (MPS) employed in Uganda and, possibly, similar contexts.
We conducted an in-depth qualitative study with key stakeholders in Uganda about consent approaches, and potential challenges, for pre-recorded IVR NCD risk factor surveys. Semi-structured interviews were conducted with 14 key informants. A contextualized thematic approach was used to interpret the results supported by representative quotes.
Several potential challenges in designing consent approaches for MPS were identified, including low literacy and the lack of appropriate ways of assessing comprehension and documenting consent. Communication with potential respondents prior to the MPS and providing options for callbacks were suggested as possible strategies for improving comprehension within the consent process. “Opt-in” forms of authorization were preferred over “opt-out”. There was particular concern about data security and confidentiality and how matters relating to this would be communicated to MPS respondents.
These local insights provide important information to support optimization of consent for MPS, whose use is increasing globally to advance public health surveillance and research in constructive ways.
Editor’s note: mHealth covers “clinical telemedicine practice, advances in health technology, health services research, highlights of emerging products, public health implications of health technology, health policy and regulation and management of health care systems and other related fields”
Usability Inspection of Multipurpose Scalable Informed Consent Platform
Finkelstein J, Robins D, Liu J
Studies in health technology and informatics, 4 July 2019
We developed a multipurpose scalable electronic informed consent platform (E-Consent) which is reusable for any informed consent in a multitude of settings. The platform allows research staff to easily upload multimedia information about a research protocol with an approved informed consent into the system, which delivers this content interactively for prospective study candidates in a user-friendly way. Consistent with user-centered design, E-Consent underwent usability inspection via cognitive walkthroughs accompanied by surveys that captured task complexity on a 5-point Likert-type scale. The System Usability Scale (SUS) provided a standardized reference for usability and satisfaction. Overall, the E-Consent framework was considered by participants to be easy-to-use, satisfying, and timely, while delivering complex information such as that on a consent form. E-Consent ranked in the top 10th percentile for usability as measured by SUS. This extensible framework successfully delivered complex information and recorded user consents, all in an easy-to-understand and highly usable fashion.
Digitizing the Informed Consent: the Challenges to Design for Practices [CONFERENCE PAPER]
Michela Assale, Erica Barbero, Federico Cabitza
2019 IEEE 32nd International Symposium on Computer-Based Medical Systems, 5-7 June 2019; Spain
This paper reports a user study performed to assess the usability of a Web-based electronic informed consent application called DICE, which is aimed at supporting patients in the process of reading, understanding and using the informed consent as a trigger for further interaction with the team of care givers. In particular, we performed a questionnaire-based study and a series of individual semi-structured interviews to understand whether the application is usable and can be used in real-world settings, respectively. We found that patients could appreciate the availability of interactive tools like DICE, but health professionals believe that its actual adoption in current workflows and practices could be hampered by the chronic lack of time and health operators who could timely address the licit requests that such a tool could bring to light.