Broad Consent—Are We Asking Enough?

Broad Consent—Are We Asking Enough?
Lisa E. Smilan
Ethics & Human Research, 1 September 2022
Abstract
Biobanks and health data repositories provide rich reservoirs of information for use in biomedical research. These repositories depend on participants donating identifiable health data and biospecimens that may be used in perpetuity by unlimited numbers of researchers for unnamed research topics. Since 1991, U.S. federal regulatory provisions, collectively known as the Common Rule, have required informed consent of participants in federally funded human subjects research, but recent changes to the Common Rule now sanction “broad consent” in the repository research context. Broad consent is not defined in the revised Common Rule; thus, researchers and their institutions are left to determine ad hoc what broad consent means and requires. Without leadership and guidance from the U.S. Department of Health and Human Services, stakeholders with potential conflicts of interest will reach their own conclusions and craft new and varied standards for consent. The result will be uneven protections for participants.

Blanket Consent and Trust in the Biobanking Context

Blanket Consent and Trust in the Biobanking Context
Original Research
Morten Ebbe Juul Nielsen, Nana Cecilie Halmsted Kongsholm
Journal of Bioethical Inquiry, 6 September 2022
Abstract
Obtaining human genetic samples is vital for many biobank research purposes, yet, the ethics of obtainment seems to many fraught with difficulties. One key issue is consent: it is by many considered ethically vital that consent must be fully informed (at least ideally speaking) in order to be legitimate. In this paper, we argue for a more liberal approach to consent: a donor need not know all the specifics of future uses of the sample. We argue that blanket consent is ethically defensible, and that this is buttressed by considerations of (justified) trust-relations. Given robust institutional oversight, blanket consent is a permissible form of consent in the bio-banking context.

Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process

Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process
Deborah Mascalzoni, Roberto Melotti, Cristian Pattaro, Peter Paul Pramstaller, Martin Gögele, Alessandro De Grandi, Roberta Biasiotto
European Journal of Human Genetics, 5 September 2022
Open Access
Abstract
The Cooperative Health Research in South Tyrol (CHRIS) is a longitudinal study in Northern Italy, using dynamic consent since its inception in 2011. The CHRIS study collects health data and biosamples for research, and foresees regular follow-ups over time. We describe the experience with the CHRIS study dynamic consent, providing an overview of its conceptualization and implementation, and of the participant-centered strategies used to assess and improve the process, directly linked to participation and communication. In order to comply with high ethical standards and to allow broadness in the areas of research, CHRIS dynamic consent was conceived as an interactive process: based on a strong governance and an ongoing tailored communication with participants, it aims to promote autonomy and to develop a trust-based engaged relationship with participants, also relevant for retention. Built within an online platform, the consent allows granular choices, which can be changed over time. In a process of co-production, participants views have been investigated and kept into account in policy development. Participants showed a high degree of participation, thus enabling the consolidation of the CHRIS resources. Even though a low change rate was reported in the baseline, participants valued the possibility of changing their informed consent choices. Communication (language-tailored, ongoing, multimedia) was important for participants, and for participation and retention. In our experience, dynamic consent was proven to be a flexible consent model, which allowed to meet ethical and legal standards for participation in research, and to accommodate participants’ and researchers’ needs.

How Australia’s Policymakers Can Ethically Approach Human Germline Genome Editing Technology

How Australia’s Policymakers Can Ethically Approach Human Germline Genome Editing Technology
Mangiapane M, Foong P
Journal of law and Medicine, 1 August 2022; 29(3) pp 740-759
Abstract
This article undertakes an analysis of Australia’s laws affecting human germline genome editing (HGGE). It draws on research from various ethical frameworks to analyse the values underpinning existing policy and which could underpin future approaches on HGGE. The article emphasises the importance of protecting egalitarianism, mitigating inequality risks, and ensuring stigmas around people with genetic conditions targeted by HGGE are not perpetuated. Doing so makes the philosophical case for a policy allowing HGGE for research use and considers the potential for limited clinical uses as we advance. The article recommends law reform in Australia in the form of an ongoing legislative review every three years, with the first review considering research and informed consent. The second considers appropriate clinical uses based on medical risk and what is agreed upon to be a list of considerations of a severe enough disease to be treated by HGGE. It gives examples of what the reform might look like, pending public engagement methodologies advocated. Finally, this article recommends considering ancillary legal issues raised by HGGE, including anti-discrimination and potential protections from liability.

Appropriate inclusion of adult research participants with intellectual disability: an in-depth review of guidelines and policy statements

Appropriate inclusion of adult research participants with intellectual disability: an in-depth review of guidelines and policy statements
Review
Klara Meierer,Pascal Borry, Virginia Sanchini
Accountability in Research, 7 September 2022
Abstract
The history of human-subject experimentation has shown the need for safeguards to protect participants from abuse. Balancing participant protection with adequate representation of the adult intellectual disability population in research presents an important challenge. Our study aimed to analyze guidance on the appropriate inclusion of adults with intellectual disability who are or are not able to consent to biomedical research participation. Terminology, consent and type of ethically acceptable research provisions relevant to adult participants with intellectual disability were comprehensively reviewed in a selection of 17 international and national ethical research guidelines and statements. Most guidelines and statements recommend that adult participants with intellectual disability who are unable to consent be included when it is not possible to conduct the same research with adults capable of independent decision-making, or when there is therapeutic benefit and only minimal risk. Instead of naming specific requirements, the Australian statement stands out by asserting the “individual right” to participate. Assent requirements for incapacitated adults are not explicitly mentioned in most documents reviewed. There appears to be room for further description of the importance of careful capacity assessments and solid assent requirements in ethical research guidance documentation to promote meaningful participation of adults with intellectual disability.

Surrogate consent for surgery among older adult patients

Surrogate consent for surgery among older adult patients
Samuel M. Miller, Nupur Nagarkatti, Vanita Ahuja, Eric B. Schneider, Sanjay Mohanty, Ronnie A. Rosenthal, Lisa M. Kodadek
Surgery, 2 February 2022; Academic Surgical Congress Presentation
Abstract
Background
Surrogate consent for surgery is sought when a patient lacks capacity to consent for their own operation. The purpose of this study is to describe older adults who underwent surgical interventions with surrogate consent.
Methods
A descriptive analysis was performed using data from the American College of Surgeons National Surgical Quality Improvement Program Geriatric Surgery Pilot collected from 2014 to 2018. All patients included were ≥65 years old and underwent a surgical procedure. Demographic and preoperative health characteristics were evaluated to examine differences between those with and without surrogate consent.
Results
In total, 51,618 patients were included in this study, and 6.6% underwent an operation with surrogate consent. Surrogate consent was more common among older patients (median age 83 vs 73, P < .001), female patients (7.7% vs 5.3%, P < .001), patients undergoing emergency as opposed to elective procedures (21.9% vs 1.6%, P < .001), patients with cognitive impairment (50.5% vs 2.4%, P < .001), and patients who were dependent on others for activities of daily living (41.9% vs 4.1%, P < .001). Nearly half of patients with a diagnosis of cognitive impairment signed their own consent.
Conclusion
Surrogate consent was more common among patients who were older, female, had a higher comorbidity burden, and had preoperative disability. Nearly half of patients with documented cognitive impairment signed their own consent. These results indicate that further research is needed to understand how surgeons determine which patients require surrogate consent.

Inclusive Design: Exploring Accessible Informed Consent for People With Aphasia

Inclusive Design: Exploring Accessible Informed Consent for People With Aphasia
Masters Thesis
Geena June Stanley
Auckland University of Technology, Master of Design, 2022
Abstract
This research explores how information design and typographic approaches can help create accessible participant information sheets for people with aphasia to ensure they can be included in research. There are worrying statistics that individuals with communication impairments post-stroke are often excluded from research due to perceptions of vulnerability, and that they do not have the decision-making capacity to provide informed consent. These exclusions have the potential to create health disparities for people with aphasia and contribute to existing generalisations in stroke research that can have a negative impact on the care they receive. Participant information sheets were prototyped using a human-centred design approach by adhering to the information design principles of accessibility and inclusiveness. The prototypes were presented to people with aphasia for feedback to ensure the readability, comprehension, and design preferences were appropriate and accessible to the targeted audience. The outcome of the research was a refined set of prototype participant information sheets that ensure greater accessibility to research for people with aphasia. This research found that implementing information design and typographic principles to participant information sheets for people with aphasia can facilitate their inclusion in research through their readability.

Ethical issues concerning the use of commercially available wearables in children: Informed consent, living in the spotlight, and the right to an open future

Ethical issues concerning the use of commercially available wearables in children: Informed consent, living in the spotlight, and the right to an open future
Andrie G. Panayiotou, Evangelos D. Protopapadakis
European Journal of Bioethics, 19 August 2022; 13(1)
Open Access
Summary
Wearable and mobile technology has advanced in leaps and bounds in the last decade with technological advances creating a role from enhancing healthy living to monitoring and treating disease. However, the discussion about the ethical use of such commercial technology in the community, especially in minors, is lagging behind. In this paper, we first summarize the major ethical concerns that arise from the usage of commercially available wearable technology in children, with a focus on smart watches, highlighting issues around the consent process, mitigation of risk and potential confidentiality and privacy issues, as well as the potential for therapeutic misconceptions when used without medical advice. Then through a relevant thought experiment we move on to outline some further ethical concerns that are connected to the use of wearables by minors, to wit the issue of informed consent in the case of minors, forcing them to live in the spotlight, and compromising their right to an open future. We conclude with the view that mitigating potential pitfalls and enhancing the benefits of wearable technology especially for minors requires brave and comprehensive moral debates.

Patient Decision Aids Before Informed Consent Conversations for Image-Guided Procedures: Controlled Trials at Two Institutions

Patient Decision Aids Before Informed Consent Conversations for Image-Guided Procedures: Controlled Trials at Two Institutions
Shanmukha Srinivas, Isabel G. Newton, Maciej Waradzyn, Nishita Kothary, Eric J. Keller
American Journal of Roentgenology, October 2022
Abstract
Background
Patient decision aids (PDAs) improve informed consent practices. Available PDAs for image-guided procedures are of limited quality.
Objective
To evaluate the impact of PDAs on understanding and satisfaction among patients undergoing informed consent conversations before outpatient image-guided procedures.
Methods
This prospective study included patients awaiting an interventional radiology clinic visit to discuss and obtain informed consent for an image-guided procedure. The study was conducted at two academic medical centers (site A: visits from August, 2020 to July, 2021; site B: January, 2021 to October, 2021). Patients were assigned systematically at site A, and randomly at site B, to electronically receive or not receive a 2-page PDA before the visit. PDAs described procedures and their benefits, risks, and alternatives at a 6th-8th grade health literacy level, and vetted by diverse patient focus groups. Patients completed a post visit survey (site A: phone; site B: online) assessing understanding of the procedure and satisfaction with the consent conversation using 5-point scales. Data were pooled between sites.
Results
The study included 105 patients (59 male, 46 female; median age, 67 years; 51 from site A, 54 from site B; 53 who received PDA, 52 who did not). Survey response rate was 100% (51/51) at site A and 67% (62/92) at site B. Patients who received, versus not received, a PDA reported greater understanding of benefits (4.5 vs 4.0, p<.001), risks (4.4 vs 3.6, p<.001), and alternatives (4.0 vs 3.3, p<.001), and of what procedures involved (4.4 vs 4.1, p=.02); and were more likely to feel that they were provided with enough time with the clinician (4.7 vs 4.5, p=.03), listened to carefully (4.8 vs 4.4, p<.001), free to choose any option including not to have the procedure (4.7 vs 4.3, p<.001), given enough time to make a decision (4.8 vs 4.3, p<.001), encouraged to ask questions (4.8 vs 4.5, p<.001), and had questions answered (4.8 vs 4.4, p=.001).
Conclusion
Well-vetted plain-language PDAs provided before image-guided procedure consent conversations improve patients’ self-perceived understanding of the procedure and satisfaction with the conversation.

Video Consent for Upper Endoscopy and Colonoscopy Improves Patient Comprehension in a Safety-net, Multi-lingual Population

Video Consent for Upper Endoscopy and Colonoscopy Improves Patient Comprehension in a Safety-net, Multi-lingual Population
Original Paper
Zoe Lawrence, Gabriel Castillo, Janice Jang, Timothy Zaki, Demetrios Tzimas, Alexandra Guttentag, Adam Goodman, Andrew Dikman, Renee Williams
Journal of Immigrant and Minority Health, 24 September 2022
Open Access
Abstract
The challenges of consenting for procedures are well documented and are compounded when patients have limited English proficiency (LEP). Standardized video consent has been studied, but research in gastroenterology is limited. We created educational videos in English and Spanish covering the elements of traditional consent for colonoscopy and upper endoscopy. All participants underwent traditional verbal consent and a subset viewed the language and procedure specific video. Participants from a multilingual, safety-net hospital patient population were then given a questionnaire to assess their comprehension and satisfaction. Participants who watched the video had higher comprehension scores than those who received traditional verbal consent alone. This difference persisted when data was stratified by language and procedure, and when controlled for educational level and prior procedure. Video consent improves comprehension and satisfaction for endoscopy and may mitigate some of the challenges encountered when consenting patients with LEP.