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.
Is the Language of Informed Consent Templates for Dental Treatment Patient Friendly?
Viktoriia Kostenko, Olena Bieliaieva, Iryna Solohor
Eurasian Conference on Language & Social Sciences, 2-3 February 2021; Gjakova, Kosovo pp 324-328
The patient’s voluntary informed consent for medical intervention has been known as an integral part of the modern system of moral, ethical and legal regulation of healthcare provision. Grammar complexity of formal language and terminology differences between healthcare providers and patients may cause communication problems and adversely affect patient access to health information, leading to poor satisfaction for both parties. There have been few reports clarifying the selection of the language means in order to facilitate patients’ complete and unhindered understanding of
the information in informed consent template for dental treatment and to influence them in making the right decision. The aim of the study is to investigate grammar characteristics (sentence structure, voice, the tense and aspect of finite verb phrases) and to analyze the findings from functional perspective and communicative purposes. This empirical research of qualitative descriptive type was based on the corpus of 50 informed consent templates for dental treatment used by the USA healthcare settings authorized to provide oral and dental services Critical discourse analysis is a main analytic technique employed in the study. The main idea behind the informed consent is that individuals having obtained a sufficient amount of special information and clearly understood it should be able to make their own knowledgeable and voluntary decisions concerning the exposure to potentially dangerous dental procedures. Text structuring, headings, metatextual devices in the templates demonstrate doctor’s responsibility for understanding text by the patients, i.e. the respectful and careful attitude to the clients. The average length of the texts and the average length of the sentences are also taken into account, whereas the documents are designed within the patient-centred approach and in patient-friendly manner. Though the texts of informed consent templates are relatively short, they abound in composite sentences: the complex sentences make up 69.3 %, the complex-compound sentences make up to 7.14%. Simple sentences, 21.5%, rank the second position. Composite sentences as well as numerous simple sentences with extended homogenous parts are exploited in the informed consent templates in order to minimize misunderstanding in the interpretation medical information, but, on the other hand, they can to interfere with quick and complete comprehension of the dependency relations among the ideas expressed in the sentences. Sentences in the active voice exceed those in passive voice that makes the text more readable and understandable.
“Why didn’t we do it”? Reproductive loss and the problem of post-mortem consent
Kate Reed, Maria Teresa Ferazzoli, Elspeth Whitby
Social Science & Medicine, 12 March 2021
Informed consent has been a much debated topic within the social sciences. It often forms a central feature of discussions on research in medical settings and in social research methods more broadly. While sympathetic to its’ underlying principles of autonomy and choice, social scientists have tended to argue that these are seldom enacted in research or clinical practice. Rather, such principles are often circumscribed by wider social structures and by a culture of medical dominance. Drawing on data from a qualitative study on perinatal post-mortem, this paper explores informed consent in the emotionally charged clinical arena of perinatal pathology. Our in-depth analysis will provide fresh insight into post-mortem decision-making in the sensitive arena of baby loss. Our findings show how parents often found it difficult to give consent for post-mortem, and also for professionals to take consent from parents. It was also not uncommon for parents to experience regret over non-consent later on. One of our key findings, however, related to the sense of emotional and diagnostic closure often afforded by post-mortem when consent had been given. We conclude by arguing that, although we cannot resolve the tension between the principles of consent and their enactment in practice, we can develop a reflexive approach with which to navigate the process. In doing so, the paper contributes to wider sociological discussions on the meaning and use of informed consent in various settings beyond medical contexts.
A Qualitative Analysis of Ethical Perspectives on Recruitment and Consent for Human Intracranial Electrophysiology Studies
Joncarmen V. Mergenthaler, Winston Chiong, Daniel Dohan, Josh Feler, Cailin R. Lechner, Philip A. Starr, Jalayne J. Arias
AJOB Neuroscience, 2 February 2021; pp 57-67
Intracranial electrophysiological research methods, including those applying electrodes on the cortical surface or in deep structures, have become increasingly important in human neuroscience. They also pose novel ethical concerns, as human studies require the participation of neurological patients undergoing surgery for conditions such as epilepsy and Parkinson’s disease. Research participants in this setting may be vulnerable to conflicts of interest, therapeutic misconception, and other threats to valid recruitment and consent. We conducted semi-structured interviews with investigators from NIH-funded studies involving recording or stimulation inside the human skull. We elicited perspectives on study recruitment and consent procedures, and analyzed transcripts using a modified grounded theory approach. We interviewed 26 investigators from 19 separate intracranial electrophysiology studies, who described two study types: opportunity studies (n = 15) and experimental trials (n = 4). Respondents described significant heterogeneity in recruitment and consent procedures, even among studies employing similar techniques. In some studies, clinician-investigators were specifically barred from obtaining consent, while in other studies clinician-investigators were specifically required to obtain consent; regulatory guidance was inconsistent. Respondents also described various models for subject selection, the timing of consent, and continuing consent for temporally extended studies. Respondents expressed ethical concerns about participants’ vulnerability and the communication of research-related risks. We found a lack of consensus among investigators regarding recruitment and consent methods in human intracranial electrophysiology. This likely reflects the novelty and complexity of such studies and indicates a need for further discussion and development of best practices in this research domain.
Ethical review and informed consent guidelines of high impact anthropology, business, and education research journals
Antti Mikael Rousi
Learned Publishing, 11 January 2021
Whereas participant protection protocols are norms in medical research, they are only recently being adopted in social and behavioural sciences. This study examined human subject guidelines in the top 40 high‐impact anthropology, business, and education research journals according to their impact factor as released in 2019. For these 120 journals, a unified classification framework was developed to capture the central elements of their ethical review and informed consent requirements. The findings suggest that the investigated journals do not view ethical review as an established norm for interview and survey studies. Only 10 (8%) journals required ethical review from all studies involving human participants. Informed consent was more frequently addressed, but none of the fields exhibited widely established guidelines similar to medical research journals. A total of 31 (26%) journals required informed consent from all studies involving human participants. There was little difference between the three disciplines investigated. Although the investigated journals represented social and behavioural sciences, their guidelines often concerned medical or intervention research with few requirements for interaction (e.g. survey) research. There is an opportunity for high‐impact journals to establish norms for adoption by researchers and other journals.
Evaluating survey consent to social media linkage in three international health surveys
Zeina N. Mneimneh, Ronny Bruffarets, Yasmin A. Altwaijri, Colleen McClain
Research in Social and Administrative Pharmacy, 10 August 2020
The use of Twitter data for health-related research has been increasing over time. While the organic nature of the data offer new opportunities, the limited understanding of how and by whom the data are generated poses a challenge for advancing health-related research. Individual-level data linkage could shed light into the data generation mechanism.
This paper investigates whether consent to link survey data with Twitter public data is associated with socio-demographic and Twitter use pattern factors and whether consenters and non-consenters differ on health-related outcomes.
Data from three health related surveys that use probability samples of the target population were used: 1) A college population web survey in KU Leuven University, 2) An adult population web survey of the US population, and 3) A population face-to-face survey in the Kingdom of Saudi Arabia (KSA). In all surveys, respondents reported whether they have a Twitter account, and Twitter users were asked to provide consent for linking their survey responses to their public Twitter data.
Consent rate estimates from the two web surveys in Belgium and the US were 24% and 27% respectively. The face-to-face survey in KSA yielded a higher consent rate of 45%. In general, respondent’s sociodemographic characteristics were not significantly associated with consent to link. However, more use of social media and reporting sensitive information in the survey were found to be significantly correlated with higher consent. Consenters and non-consenter were not found to be statistically different on any of the health related measures.
Very few differences were found between those who consented to link their survey data with their Twitter public data and those who did not. Modifiable design variables need to be investigated to maximize consent while maintaining balance between consenters and non-consenters.
Ethics and access when consent must come first [BOOK CHAPTER]
Hugh Busher, Alison Fox
Implementing Ethics in Educational Ethnography
Taylor & Francis, 2019; Chapter 4
Formalised procedures to obtain and document informed consent from research participants are at the heart of the shift from informal to formalised research ethics. Critiques claim that the requirements to obtain consent from all potential participants before the onset of a study will make it impossible to do ethnographic research and participant observation in institutional settings such as schools. Drawing on experiences from an ethnographic research project in secondary schools in Norway, the aim of this chapter is to discuss the ethical considerations and, embedded in these, the methodological and analytical challenges involved in doing participant observation in schools where not all pupils and parents have consented to participation in the research. The chapter suggests possible ways forward for tackling these challenges for ethnographic researchers working in schools.