To Obtain Informed Consent or Not to Obtain Informed Consent? Drones for Health Programs in the Grey Zone between Research and Public Health
Vyshnave Jeyabalan, Lorie Donelle, Patrick Meier, Elysée Nouvet
Drones 2023, 2 April 2023; 7(4)
Drones are increasingly being introduced to support healthcare delivery around the world. Most Drones for Health projects are currently in the pilot phase, where frontline staff are testing the feasibility of implementing drones into their healthcare system. Many of these projects are happening in remote localities where populations have been historically under-served within national healthcare systems. Currently, there exists limited drone-specific guidance on best practices for engaging individuals in decision-making about drone use in their communities. Towards supporting the development of such guidance, this paper focuses on the issue of obtaining community and individual consent for implementing Drones for Health projects. This paper is based on original qualitative research involving semi-structured interviews (N = 16) with program managers and implementation staff hired to work on health-related projects using drone technologies. In this paper, we introduce a scenario described by one participant to highlight the ethical and practical challenges associated with the implementation and use of drones for health-related purposes. We explore the ethical and practical complexities of obtaining informed consent from individuals who reside in communities where Drones for Health projects are implemented.
“Ethics Ready”? Governing Research Through Informed Consent Procedures
Florence Caeymaex, Carole Wenger, Felicien de Heusch, Jean-Michel Lafleur
International Journal of Qualitative Methods, 11 April 2023
Social Scientists using ethnographic methods are increasingly confronted with ethical clearance procedures imposed by universities, national authorities, professional organizations and funders. In this article, we focus on informed consent procedures in particular and discuss how they govern fieldwork interactions. To do so, we first show how ethical clearance procedures in Europe have been influenced by biomedical science, creating a risk of “governing the social science research in the name of ethics” (Haggerty, 2004) through “anticipatory regulatory regimes” (Murphy and Dingwall, 2007). We subsequently discuss the implementation of ethical procedures negotiated with an ethical review panel in the framework of an EU-funded project in migration studies. In doing so, we show how Research Ethics Committees (RECs) can incentivize researchers to comply with ethical guidelines and procedures in order to be considered as “ethics ready” by the funder. Providing examples of different ethnographic situations, we argue that —while informed consent procedures might reinforce participants’ vulnerabilities— they can also activate their desire to assert power. The article concludes with three recommendations that call for a redefinition of the relationships between institutions, researchers and participants through a co-construction of research ethics.
Decisions to Enter Phase I Oncology Clinical Trials: Effectual and Ethical Informed Consent
Stephanie Solomon Cargill, Natalie Hardy
Patient Education and Counseling, April 2023
When faced with advanced stage cancer, patients consider participating in Phase I oncology clinical research trials. The likelihood of patients benefiting from trial interventions is low (5%). Although scholarship has found that participants overestimate the benefit interventions, research has failed to assess the social context that may influence how potential participants evaluate their decision to participate. This understanding is critical for ethical informed consent procedures. Thus, the aim of this pilot project was to examine oncology patients’ decisions to enroll in Phase 1 trials. In-depth interviews were conducted with eight adults who were invited to participate in Phase 1 oncology clinical trials. Analysis was guided by Problematic Integration Theory (PI, e.g., Babrow, 2001), providing a framework for understanding tensions among desires and expectations, particularly when faced with uncertainty. Researchers took an iterative analytical approach shifting between respondents’ viewpoints and PI theory. Analysis revealed that participants understood that when invited to the trial, their current treatments were ineffective. In facing the tension between the likelihood of benefitting from the trial intervention with the hope that the intervention would be successful (and incur few negative side effects), participants faced an ambivalent situation. Thus, participants entered conversations with research coordinators anticipating to enter the trial with few uncertainties. Participants expressed a desire for more information about the chances the trial would effectively treat their cancer, but trust that the medical team was acting in their best interest, providing hope.
Ethics and the impossibility of the consent form: Ethnography in a Danish nursing home
Emma Jelstrup Balkin, Mette Geil Kollerup, Ingjerd Gåre Kymre, Bente Martinsen, Mette Grønkjær
Journal of Aging Studies, March 2023
Based on ethnographic fieldwork in a nursing home in northern Denmark, this article addresses challenges experienced in putting formal ethics requirements into practice. We consider how to unite procedural ethics with actual, lived ethics, when researching with vulnerable participants who live with a cognitively impairing condition. The article centers on the story of one resident, who wanted to share her experiences with what she had perceived as inadequate care, but who baulked once the wordy consent form was produced. The resident panicked that her words could now be used against her, that talking with the researcher would (further) compromise her care. She was caught in a bind, on the one hand she had a deep desire to tell her story, on the other the piece of paper in her hand threatened to trigger her anxiety and depression. In this article we therefore approach the consent form as an agent. By mapping out these unintended consequences of the consent form, we wish to draw attention to the complexities of ethical research conduct in practice, ultimately arguing that the concept of appropriate informed consent should be broadened so that it is sensitive to the lifeworld of participants.
Ethical Relativism and Circumstances of Social and Cultural Contingencies on Informed Consent in the Conduct of Research: Clinical Trials in Nigeria
Sola Aluko-Arowolo, Saheed Akinmayọwa Lawal, Isaac A. Adedeji, Stephen Nwaobilor
Asian Bioethics Review, 13 October 2022
There have been debates across the globe for a social and culturally sensitive ethics to meditate a catalyst of template for informed consent (IC) in the conduct of social researches and clinical trial. The study adopted ethical relativism theory to explore social and cultural contingencies on IC with descriptive research design and snowball sampling techniques with a pool of 23 participants randomly and purposively selected amongst the stakeholders including researchers. Seven lecturers and 5 medical practitioners from selected universities, 5 clergy members of different genders and denominations with 2 Imams, 1 chief and 2 traditional health practitioners completing the pool. The data were compiled separately with pseudonym to maintain the anonymity of the participants and content analysed thematically to probe awareness, understanding, patriarchy and religious dimensions on IC. The paper argued that ethics and law regulations must be strengthened to leverage on different individual values, norms and social indices. The paper concluded and suggested that researchers can avoid and resolve ethical dilemmas and maintain research regularity when ethical obligations are well understood and strictly adhered to, and to develop the Informed Consent Evaluation Feedback Tool (ICEFbT) with oversight function from Institution Review Board (IRB) in the universities and research institutes before the commencement of research and/or medical procedures.
Web-Based Perspectives of Deemed Consent Organ Donation Legislation in Nova Scotia: Thematic Analysis of Commentary in Facebook Groups
Alessandro R Marcon, Darren N Wagner, Carly Giles, Cynthia Isenor
JMIR Infodemiology, 14 September 2022; 2(2)
The Canadian province of Nova Scotia recently became the first jurisdiction in North America to implement deemed consent organ donation legislation. Changing the consent models constituted one aspect of a larger provincial program to increase organ and tissue donation and transplantation rates. Deemed consent legislation can be controversial among the public, and public participation is integral to the successful implementation of the program.
Social media constitutes key spaces where people express opinions and discuss topics, and social media discourse can influence public perceptions. This project aimed to examine how the public in Nova Scotia responded to legislative changes in Facebook groups.
Using Facebook’s search engine, we searched for posts in public Facebook groups using the terms “deemed consent,” “presumed consent,” “opt out,” or “organ donation” and “Nova Scotia,” appearing from January 1, 2020, to May 1, 2021. The finalized data set included 2337 comments on 26 relevant posts in 12 different public Nova Scotia–based Facebook groups. We conducted thematic and content analyses of the comments to determine how the public responded to the legislative changes and how the participants interacted with one another in the discussions.
Our thematic analysis revealed principal themes that supported and critiqued the legislation, raised specific issues, and reflected on the topic from a neutral perspective. Subthemes showed individuals presenting perspectives through a variety of themes, including compassion, anger, frustration, mistrust, and a range of argumentative tactics. The comments included personal narratives, beliefs about the government, altruism, autonomy, misinformation, and reflections on religion and death. Content analysis revealed that Facebook users reacted to popular comments with “likes” more than other reactions. Comments with the most reactions included both negative and positive perspectives about the legislation. Personal donation and transplantation success stories, as well as attempts to correct misinformation, were some of the most “liked” positive comments.
The findings provide key insights into perspectives of individuals from Nova Scotia on deemed consent legislation, as well as organ donation and transplantation broadly. The insights derived from this analysis can contribute to public understanding, policy creation, and public outreach efforts that might occur in other jurisdictions considering the enactment of similar legislation.
Editor’s note: JMIR Infodemiology focuses on determinants and distribution of health information and misinformation on the internet, and its effect on public and individual health.
‘Scraping’ Reddit posts for academic research? Addressing some blurred lines of consent in growing internet-based research trend during the time of Covid-19
Nicholas Norman Adams
International Journal of Social Research Methodology, 18 August 2022
The global scale of Covid-19 has constrained academics from conducting much person-facing research. Reactively, trend is increasing for digital-based methodologies capturing already existing online data. Scholars often ‘scrape’ user-postings from internet forums using coding algorithms and text capture tools, before analysing data, drawing conclusions and publishing findings. The online social news aggregation and discussion website Reddit is a particularly rich source of data for researchers. The public nature of Reddit materials may suggest rationale for user-data to be replicated, analysed and archived; indefinitely and in multiple locations, for scholarly research. However, this position overlooks several key ethical considerations. This paper presents an overview and explanation of Reddit, followed by an exploration of studies that use Reddit-acquired data. Arising ethical issues are discussed, and solutions to salient dilemmas presented. This is to enhance awareness of potential problems and improve protections for those whose data is unknowingly used for research.
Privacy Risks in Microbiome Research: Public Perspectives before and during a Global Pandemic
Andrea Shin, Huiping Xu
Ethics & Human Research, 8 July 2022; 44(4) pp 26-33
We assessed public perspectives of microbiome research privacy risks before and after a nationwide emergency was declared in the United States regarding the Covid-19 pandemic. From January to July of 2020, we conducted an online survey of perceived privacy risks of microbiome research among U.S. adults. Among 3,106 participants (the preemergency group), most expressed that the microbiome posed privacy risks similar to those associated with DNA (60.3%) or medical records (50.6%) and that they would prefer detailed explanations (70.2%) of risk in consent materials. Only 8.9% reported moderate to high familiarity with microbiome privacy risks. In adjusted analyses, individuals who participated in the study after the Covid-19 emergency was declared (the Covid-19 emergency group) were less likely to express that microbiome privacy risks were similar to those of DNA or medical records and more likely to report familiarity with the privacy risks of microbiomes. There was a trend toward increased concern after the Covid-19 emergency was declared (p = 0.053). Overall, the study revealed that many U.S. adults believe that microbiome privacy risks are similar to those associated with DNA or medical records, and they prefer detailed explanations in consent documents. Individuals who participated after the Covid-19 emergency was declared reported greater knowledge of microbiome privacy risks but had more concern.
When is public private? Tweets, privacy and consent in health research
Sabitra Kaphle, Rachel Kornhaber, Susan Hunt, Roger Watson, Michelle Cleary
Nurse Education in Practice, August 2022; 63
Online social media platforms provide opportunities for the global community to share and express their views, opinions, reactions, and feelings openly. The use of social media for the purpose of information sharing surged during the COVID-19 pandemic due to mandated physical distancing requirements. This is a seemingly consensual catharsis at a time of heightened need for alternative social activity and critical information sharing. Communication on open social media platforms has created opportunities for researchers to access and analyse rich, publicly available data to study a range of topics and issues. The creation of this abundant public data has also led to fundamental methodological and ethical challenges for social science researchers. Namely, is the use of this public data for research a breach of privacy and confidentiality? Are social media users becoming involuntary research participants as their communications and personal information are mined and published on without participant insight and informed consent? In this discussion, we aim to highlight some of the critical methodological and ethical issues that researchers must consider while using Twitter as a data source to publish from.
Assessment of Social Trust in Relatives of Discharged Patients With Personal Consent and Other Relatives of Patients
Hamid Reza Moretza Bagi, Zhila Khamnian, Forough Hatami, Samad Shams Vahdati, Reza Yazdani, Sama Rahnemayan
Journal of Patient Experience, 6 July 2022
Lack of social trust in the physician–patient relationship will disrupt health. Since social trust has not been sufficiently studied in patients’ companions, this study investigates and compares social trust and its dimensions in companions of patients discharged against medical advice with total patients’ companions in the emergency room. In this cross-sectional descriptive-comparative study, 385 patients’ companions were enrolled. This study was done by a questionnaire with five subscales: honesty, frankness, cooperative tendency, confidence, and trust. Data were analyzed using descriptive statistics and analytical statistics methods. In this study, there was no significant difference between the mean score of social trust between companions of patients discharged against medical advice (61.11 ± 9.01) and patients discharged after treatment (62.27 ± 6.97). There was a significant relationship between the mean score of the 2 groups only in the frankness domain (P-value = .001). The level of social trust in the patients’ companions was moderate in both groups. Companions of discharged patients after completing the treatment process are more explicit than the companions of patients discharged against medical advice.