Informed Consent as a Component of Online Research Ethics — The Perspective of the Participants
Nataša B. Matović, Kristinka Č. Ovesni
Globethics.net, 1 November 2021
The paper discusses informed consent as a component of online research ethics. It begins from the analysis of understanding, from the preconditions on which the realization depends, and from the difficulties that accompany the application of the informed consent in practice. The aim of the empirical part of the research is to determine the characteristics of the process of obtaining the informed consent in online research and to examine the factors on which they depend. The sample included 153 teachers. Data were collected with the survey-type questionnaires and with the descriptive assessment scales. For data processing, besides the frequencies and percentages, the χ2 test and Kramer ‘s V correlation coefficient were performed. The results indicate that most of the respondents have had experience of giving informed consent in online surveys in which they have participated so far; that the text often contained information about the purpose and the goal of the research, apart from the tasks of the respondents in the research; that the majority of the teachers evaluate the content of the text as understandable and useful; and also that most of the characteristics depend on the environment of the school in which the teachers are employed. The results are discussed in the context of the possibility of improvement of the process of obtaining informed consent from the respondents in the online survey.
Editor’s note: Globethics.net is a global network of teachers and institutions with the vision to embed ethics in higher education. It hosts a publishing house open to all the authors interested in applied ethics.
Informed consent in psychotherapy: a survey on attitudes among psychotherapists in Switzerland
Klara Eberle, Martin grosse Holtforth, Marc Inderbinen, Jens Gaab, Yvonne Nestoriuc, Manuel Trachsel
BMC Medical Ethics, 12 November 2021; 22(150)
The legal and ethical guidelines of psychological professional associations stipulate that informed consent by patients is an essential prerequisite for psychotherapy. Despite this awareness of the importance of informed consent, there is little empirical evidence on what psychotherapists’ attitudes towards informed consent are and how informed consent is implemented in psychotherapeutic practice.
155 psychotherapists in Switzerland completed an online survey assessing their attitudes regarding informed consent.
Among the surveyed psychotherapists, there was a high consensus on important information that should be communicated to patients in the context of informed consent. Almost all psychotherapists rated confidentiality and its exemptions (95%) and self-determined decision-making (97%) as important. The importance to disclose information regarding fees and the empirical effectiveness of the provided treatment, were both seen as important by more than 80% of participants. The disclosure of personal information about the therapist was rated as important by 60%. Other aspects, which are not direct components of informed consent but rather overarching goals, were also evaluated rather homogeneously: self-determined decision making of the patient was rated as important by almost all of the surveyed psychotherapists (97%). The following components were also judged as important by a majority of the participants: promotion of hope (80%) and discussion of treatment goals (93%). Most psychotherapists described the implementation of informed consent as an ongoing process, rather than a one-time event during the first session of therapy. Therapists’ age, postgraduate training, treated patient group, and setting influenced attitudes towards informed consent.
The present study shows that informed consent is perceived by psychotherapists as both a challenge and a resource. The implementation of informed consent in psychotherapy requires further research from a clinical and ethical perspective.
From Shadow Profiles to Contact Tracing: Qualitative Research into Consent and Privacy
Sacha Molitorisz, James Meese, Jennifer Hagedorn
Law, Technology and Humans, 8 November 2021; 3(2)
For many privacy scholars, consent is on life support, if not dead. In July 2020, we held six focus groups in Australia to test this claim by gauging attitudes to consent and privacy, with a spotlight on smartphones. These focus groups included discussion of four case studies: ‘shadow profiles’, eavesdropping by companies on smartphone users, non-consensual government surveillance of its citizens and contact tracing apps developed to combat COVID-19. Our participants expressed concerns about these practices and said they valued individual consent and saw it as a key element of privacy protection. However, they saw the limits of individual consent, saying that the law and the design of digital services also have key roles to play. Building on these findings, we argue for a blend of good law, good design and an appreciation that individual consent is still valued and must be fixed rather than discarded – ideally in ways that are also collective. In other words, consent is dead; long live consent.
“A Question of Trust” and “a Leap of Faith”—Study Participants’ Perspectives on Consent, Privacy, and Trust in Smart Home Research: Qualitative Study
Mari-Rose Kennedy, Richard Huxtable, Giles Birchley, Jonathan Ives, Ian Craddock
JMIR Mhealth Uhealth, November 2021; 9(11)
Ubiquitous, smart technology has the potential to assist humans in numerous ways, including with health and social care. COVID-19 has notably hastened the move to remotely delivering many health services. A variety of stakeholders are involved in the process of developing technology. Where stakeholders are research participants, this poses practical and ethical challenges, particularly if the research is conducted in people’s homes. Researchers must observe prima facie ethical obligations linked to participants’ interests in having their autonomy and privacy respected.
This study aims to explore the ethical considerations around consent, privacy, anonymization, and data sharing with participants involved in SPHERE (Sensor Platform for Healthcare in a Residential Environment), a project for developing smart technology for monitoring health behaviors at home. Participants’ unique insights from being part of this unusual experiment offer valuable perspectives on how to properly approach informed consent for similar smart home research in the future.
Semistructured qualitative interviews were conducted with 7 households (16 individual participants) recruited from SPHERE. Purposive sampling was used to invite participants from a range of household types and ages. Interviews were conducted in participants’ homes or on-site at the University of Bristol. Interviews were digitally recorded, transcribed verbatim, and analyzed using an inductive thematic approach.
Four themes were identified—motivation for participating; transparency, understanding, and consent; privacy, anonymity, and data use; and trust in research. Motivations to participate in SPHERE stemmed from an altruistic desire to support research directed toward the public good. Participants were satisfied with the consent process despite reporting some difficulties—recalling and understanding the information received, the timing and amount of information provision, and sometimes finding the information to be abstract. Participants were satisfied that privacy was assured and judged that the goals of the research compensated for threats to privacy. Participants trusted SPHERE. The factors that were relevant to developing and maintaining this trust were the trustworthiness of the research team, the provision of necessary information, participants’ control over their participation, and positive prior experiences of research involvement.
This study offers valuable insights into the perspectives of participants in smart home research on important ethical considerations around consent and privacy. The findings may have practical implications for future research regarding the types of information researchers should convey, the extent to which anonymity can be assured, and the long-term duty of care owed to the participants who place trust in researchers not only on the basis of this information but also because of their institutional affiliation. This study highlights important ethical implications. Although autonomy matters, trust appears to matter the most. Therefore, researchers should be alert to the need to foster and maintain trust, particularly as failing to do so might have deleterious effects on future research.
Multicenter Social Media Community Consultation for an Exception From Informed Consent Trial of the XStat device (PhoXstat Trial)
Shannon W. Stephens, Paige Farley, Sean P. Collins, Monica D. Wong, Ashley B. Panas, Bradley M. Dennis, Neal Richmond, Kenji Inaba, Karen N.Brown, John B. Holcomb, Jan O. Jansen
Journal of Trauma and Acute Care Surgery, 5 October 2021
Community Consultation (CC) is a key step for Exception from Informed Consent (EFIC) research. Using social media to conduct CC is becoming more widely accepted, but has largely been conducted by single sites. We describe our experience of a social media-based CC for a multicenter clinical trial, coordinated by the lead clinical site.
Multicenter CC administered by the lead site and conducted in preparation for a three-site prehospital randomized clinical trial. We utilized Facebook and Instagram advertisements targeted to the population of interest. When “clicked” the advertisements directed individuals to study-specific websites, providing additional information and the opportunity to opt out. The lead institution and one other hospital relied on a single website, whereas the third center set up their own website. Site views were evaluated using Google analytics.
The CC took 8 weeks to complete for each site. The advertisements were displayed 9.8 million times, reaching 332,081 individuals, of whom 1,576 viewed one of the study-specific websites. There were no opt-outs. The total cost was $3,000. The costs per person reached were $1.88, $2.00 and $1.85 for each of the three sites. A number of site-specific issues (multiple languages, hosting of study-specific websites) were easily resolved.
This study suggests it is possible for one institution to conduct multiple, simultaneous, social media-based CC campaigns, on behalf of participating trial sites. Our results suggest this social media CC model reaches many more potential subjects and is economical and more efficient than traditional methods.
The ethics of quality improvement studies: do the needs of the many outweigh the needs of the few?
Peter A. Goldstein
British Journal of Anaesthesia, 4 October 2021
Clinical research involving human subjects and quality improvement (QI) projects share a common goal of seeking to improve human health, whether by directly changing the standard of care (research) or by improving the process(es) by which that care is delivered (QI). Whether a QI project requires informed consent (written or oral) is a function of the risk–benefit analysis of the study; such a determination should not be at the sole discretion of the investigators, but should come from an appropriately constituted review board with expertise in the ethics of biomedical research.
Integration of Social Media With Targeted Emails And In-Person Outreach For Exception From Informed Consent Community Consultation
Cindy H. Hsu, Jennifer Fowler, James A. Cranford, Michael P. Thomas, Robert W. Neumar
Academic Emergency Medicine, 20 August 2021
Exception from informed consent (EFIC) enables the enrollment of research subjects with emergent conditions to clinical trials without prior consent. EFIC study approval requires community consultation and public disclosure. We hypothesized that the integration of social media with targeted emails and in-person outreach is an effective community consultation strategy.
We utilized social media with targeted emails and in-person outreach for the community consultation of the ACCESS cardiac arrest trial. Study advertisements were disseminated using Facebook and Instagram, and targeted emails were sent to emergency medicine, prehospital and cardiology providers. We also interviewed at-risk individuals with cardiac conditions, their caretakers, and patient advocacy groups. Participants were asked to complete a survey about their opinions about the study.
We collected 559 surveys over an 8-week period, and 70.5% of the surveys were obtained using social media. The mean age of survey respondents was 45 years; 89.9% were white and 60.1% were women. 91.3% believed ACCESS was an important study. Compared to the in-person group, more from social media (81.8% vs 63.3%, p < 0.05) and targeted email (77.4% vs 63.3%, p < 0.05) groups said they would include their loved ones in the study. More from the in-person group believed that their opinion would be considered seriously compared to the social media (75.9% vs 62.6%, p < 0.05) and targeted email (75.9% vs 54.5%, p < 0.05) groups. The incorporation of social media and targeted emails for community consultation reduced the cost per survey by 4-fold compared to an in-person only strategy.
The integration of social media with targeted emails and in-person outreach was a feasible and cost-saving approach for EFIC community consultation. Future work is necessary to determine the perception and best utilization of social media for community consultation.
“A question of trust” and “a leap of faith”: A qualitative study of participants’ perspectives on consent, privacy and trust in smart home research
Mari-Rose Kennedy, Richard Huxtable, Giles M Birchley, Jonathan C S Ives, Ian J Craddock
JMIR mHealth and uHealth, 1 August 2021
‘Ubiquitous’, ‘smart’ computing technology has the potential to assist humans in numerous ways, including health and social care. Covid-19 has notably hastened the move to remote delivery of many health services. Development of technology involves a variety of stakeholders in the process of testing, refinement, and evaluation. Where stakeholders are research participants, this poses practical and ethical challenges, particularly if the research is situated in people’s homes. Researchers must observe prima facie ethical obligations linked to participants’ interests in having their autonomy and privacy respected.
This research explores ethical considerations around consent, privacy, anonymisation and data-sharing with participants involved in SPHERE, a project developing smart technology for monitoring people’s health behaviours at home. Their unique insights from being part of this unusual experiment offers valuable perspectives on how to properly approach informed consent for similar smart home research in the future.
Semi-structured qualitative interviews (with adults and children) were conducted with 7 households/16 participants recruited from SPHERE. Purposive sampling was used to invite participants from a range of household types and ages. Interviews were conducted in participants’ homes or on-site at the University of Bristol. Interviews were digitally recorded, transcribed verbatim and analysed using an inductive thematic approach.
Four themes were identified: (1) motivations for participating; (2) transparency, understanding and consent; (3) privacy, anonymity, and data use; and (4) trust in research. Motivations to participate in SPHERE stemmed from an altruistic desire to support research directed towards the public good. Participants were satisfied with the SPHERE consent process despite reporting some difficulties: recalling and understanding information received; the timing and amount of information provision; and sometimes finding the information to be abstract. Participants were also satisfied that privacy was assured and judged that reasons for conducting the research compensated for threats to privacy. Participants trusted the project and the team. Factors relevant to developing and maintaining this trust were the trustworthiness of the research team, provision of necessary information, the control participants had over participation, and positive prior experiences of research involvement.
This small study offers valuable insights into the perspectives of participants in smart home research on important ethical considerations around consent and privacy. The findings might have practical implications for future research regarding the types of information researchers should convey, the extent to which anonymity can be assured, and the long-term duty of care owed to participants who place trust in researchers not only on the basis of this information, but also because of their institutional affiliation. This study highlights important ethical implications: although autonomy matters, trust appears to matter most. Researchers should therefore be alert to the need to foster and maintain trust, particularly as failing to do so might have deleterious effects on future research.
Ethical Considerations in Social Sciences: The Dilemmas of Informed Consent
Haji Karim Khan, Hussain, Mir Alam
Research Journal of Social Sciences & Economics Review, April-June 2021; 2(2)
Informed consent is an integral component of research ethics in Social Sciences. It has been observed that in Pakistan, most of the research ethics have been borrowed from the Western context. Therefore, it is vital to see how research ethics are being construed and practiced in Pakistan having different socio-cultural values and norms. In the case of informed consent, the bigger question is ‘how informed the informed consent is?’ Thus, in this paper, through a qualitative exploratory approach, we have explored how active Social Science researchers in our universities, see the notion of informed consent. We interviewed eighteen university teachers for the study. Transcribed the interviews verbatim and analyzed those using robust qualitative approaches. Findings show that ‘informed consent’ becomes a dilemma for the researchers given the variations in the socio-cultural and linguistic contexts of the settings. Findings have pertinent implications for policymakers, university management, and researchers in the context of Social Sciences.
Implementing continuous consent in qualitative research
Fride Haram Klykken
Qualitative Research, 9 May 2021
This article examines ways of approaching informed consent as a relationally constituted process in qualitative research practices. It argues that a researcher’s operationalization of informed consent should be coherent with the overall epistemological framework of the project. Based on empirical examples from an ethnographic inquiry in an educational setting, the principle of informed consent is discussed as a reflexive and ethical tool throughout the inquiry, including its pre-fieldwork, fieldwork and post-fieldwork phases. Strategies of explicitly and implicitly (re)negotiated consent and dissent are discussed and illustrated by drawing on some of the recent discussions of continuous consent practices. The article’s conceptualization of a continuous, situated and relational approach to informed consent is also supported by the concepts of response-ability and thinking with care in research ethics.