Boundaries Between Research Ethics and Ethical Research Use in Artificial Intelligence Health Research
Research Article
Gabrielle Samuel, Jenn Chubb, Gemma Derrick
Journal of Empirical Research on Human Research Ethics, 18 March 2021; 16(3) pp 325-337
Open Access
Abstract
The governance of ethically acceptable research in higher education institutions has been under scrutiny over the past half a century. Concomitantly, recently, decision makers have required researchers to acknowledge the societal impact of their research, as well as anticipate and respond to ethical dimensions of this societal impact through responsible research and innovation principles. Using artificial intelligence population health research in the United Kingdom and Canada as a case study, we combine a mapping study of journal publications with 18 interviews with researchers to explore how the ethical dimensions associated with this societal impact are incorporated into research agendas. Researchers separated the ethical responsibility of their research with its societal impact. We discuss the implications for both researchers and actors across the Ethics Ecosystem.
Month: August 2021
Should Feedback of Individual Results be Integrated into the Consent Process in African Genomics? Participants’ Views from an HIV-TB Genomics Research Project in Botswana
Should Feedback of Individual Results be Integrated into the Consent Process in African Genomics? Participants’ Views from an HIV-TB Genomics Research Project in Botswana
Dimpho Ralefala, Mary Kasule, Ambroise Wonkam, Mogomotsi Matshaba, Jantina de Vries
AJOB Empirical Bioethics, 1 July 2021
Open Access
Abstract
Background
Whilst informed consent is a key component of considering whether individual genomic research results could or should be fed back to research participants, little is known about the views of African research participants on its role.
Methods
We carried out a qualitative study to explore views of adolescents and parents or caregivers regarding informed consent for feedback of individual results from a genomics research project in Botswana. We conducted 24 deliberative focus group discussions with 93 participants (44 adolescents and 49 parents or caregivers) and 12 in-depth interviews (6 adolescents and 6 parents).
Results
Our findings revealed that most participants would like to be informed about the possibility of discovering individual genetic results during the consent process and that consent be obtained for feedback during the enrollment process. They further expressed that in cases where prior consent to feedback was not obtained, then participants should be re-contacted where life-saving genetic information is discovered. Participants emphasized the need for researchers to ensure that participants’ decisions regarding feedback of results are well-informed. Autonomy, transparency, and communication were identified as key values to uphold during the consent process.
Conclusion
In conclusion, obtaining participants’ consent for feedback of results is important to ensure that their rights and wellbeing are protected in research. This is critical in building trust relationships between participants and researchers.
The Ethics of Consent in a Shifting Genomic Ecosystem
The Ethics of Consent in a Shifting Genomic Ecosystem
Sandra Soo-Jin Lee
Annual Review of Biomedical Data Science, July 2021; 4 pp 145-164
Abstract
The collection and use of human genetic data raise important ethical questions about how to balance individual autonomy and privacy with the potential for public good. The proliferation of local, national, and international efforts to collect genetic data and create linkages to support large-scale initiatives in precision medicine and the learning health system creates new demands for broad data sharing that involve managing competing interests and careful consideration of what constitutes appropriate ethical trade-offs. This review describes these emerging ethical issues with a focus on approaches to consent and issues related to justice in the shifting genomic research ecosystem.
Is presumed consent enough for sharing medical data?
Is presumed consent enough for sharing medical data?
Views And Reviews
Helen Salisbury
BMJ, 29 June 2021; 373
Open Access
Excerpt
…Just how formal we need consent to be depends on the situation; asking for written consent before every interaction would be cumbersome and impractical. But whether it’s written, verbal, or implied, for consent to be valid it needs to be informed. Patients must understand what they’re agreeing to, although the depth of the explanation required will vary. If I arrange to take a blood test, I’ll paraphrase what I’m looking for: “I’m going to check that you’re not anaemic and that your liver and kidneys are working normally” is probably enough for most patients. But my surgical colleagues, embarking on something more serious and irrevocable, need to be formal and detailed in their discussions, so that the patient understands the risks and benefits before going under an anaesthetic and the knife… As data controllers, GPs must be sure that patients have given valid consent for their data to be processed by NHS Digital before we can hand it over, at a date currently scheduled for 1 September 2021. As it remains unclear what safeguards will be in place to guarantee the security of personal medical information, we’re not yet in a position to explain to patients the risks and benefits of sharing their data…
Rebooting consent in the digital age: a governance framework for health data exchange
Rebooting consent in the digital age: a governance framework for health data exchange
Nivedita Saksena, Rahul Matthan, Anant Bhan, Satchit Balsari
BMJ Global Health, 4 May 2021
Open Access
Abstract
In August 2020, India announced its vision for the National Digital Health Mission (NDHM), a federated national digital health exchange where digitised data generated by healthcare providers will be exported via application programme interfaces to the patient’s electronic personal health record. The NDHM architecture is initially expected to be a claims platform for the national health insurance programme ‘Ayushman Bharat’ that serves 500 million people. Such large-scale digitisation and mobility of health data will have significant ramifications on care delivery, population health planning, as well as on the rights and privacy of individuals. Traditional mechanisms that seek to protect individual autonomy through patient consent will be inadequate in a digitised ecosystem where processed data can travel near instantaneously across various nodes in the system and be combined, aggregated, or even reidentified. In this paper we explore the limitations of ‘informed’ consent that is sought either when data are collected or when they are ported across the system. We examine the merits and limitations of proposed alternatives like the fiduciary framework that imposes accountability on those that use the data; privacy by design principles that rely on technological safeguards against abuse; or regulations. Our recommendations combine complementary approaches in light of the evolving jurisprudence in India and provide a generalisable framework for health data exchange that balances individual rights with advances in data science.
How and why does the mode of data collection affect consent to data linkage?
How and why does the mode of data collection affect consent to data linkage?
Annette Jackle, Jonathan Burton, Mick P. Couper, Thomas F. Crossley, Sandra Walzenbach
Understanding Society Working Paper Series, April 2021
Abstract
We use experimental data to examine why respondents are less likely to consent to data linkage in online than face-to-face interviews. We find that respondents are less likely to understand the data linkage request, less likely to process the consent request thoroughly, and more likely to be concerned about privacy and data security when answering online rather than in a face-to-face interview. Verbal behaviours of interviewers do not explain the mode effects, and neither do the devices respondents use to complete the web survey. Simplifying the wording of the consent request increases understanding of the request, but does not reduce the gap in consent rates between modes.
An Ageing Population Creates New Challenges Around Consent to Medical Treatment
An Ageing Population Creates New Challenges Around Consent to Medical Treatment
Alice L. Holmes, Joseph E. Ibrahim
Journal of Bioethical Inquiry, 5 July 2021
Abstract
Obtaining consent for medical treatment in older adults raises a number of complex challenges. Despite being required by ethics and the law, consent for medical treatment is not always validly sought in this population. The dynamic nature of capacity, particularly in individuals who have dementia or other cognitive impairments, adds complexity to obtaining consent. Further challenges arise in ensuring that older people comprehend the medical treatment information provided and that consent is not vitiated by coercion or undue influence. Existing mechanisms to address issues surrounding consent for older adults only address incapacity and raise further challenges. As the ageing population increases, these issues are likely to become more profound, thus action is required to address these challenges. Raising awareness, more education, engaging with people with dementia, and conducting further research would assist in beginning to overcome these challenges.
Uninformed consent: Who knows what Ivan Ilyich would have thought?
Uninformed consent: Who knows what Ivan Ilyich would have thought?
Commentary
A D’Imperio, M Ienca, A Maiese, V Fazio, R La Russa
La Clinica Terapeutica, 1 July 2021, 172(4) pp 264-267
Open Access
Abstract
In the modern era, when prolonging life is not an option, the end-of-life discussions are unavoidably influenced by Neuroethics. Despite this, it is interestingly evident how the sentiments of a terminal patient of 1885 and a physician of 2020, are still comparable. This paper presents the arguments behind the so-called “Therapeutic Misconception” and the aim of palliative care to provide dying patients support. It is essential to address priorities of informed consent, signed before any remedy is provided. A key component of the newest Neuroscience research is the analysis of motivation and free will. So, it is necessary to comprehend if the patient struggles to feel at peace with these aspects of his “right to die”: Is he free to choose or is he influenced by the doctors? Is this confusion an example of “Therapeutic Misconception”? Is his Informed Consent totally “Informed”? In order to broaden our understanding, we account for many critical situations, such as the mentally impaired Psychiatric patients or the famous Italian case of Eluana Englaro. In addition, we suggested some current approaches such as Artificial Intelligence, useful in preserving some cognitive functions the patient may have lost. Furthermore, research in this field is very critical and in some Catholic countries like Italy, people faced difficulties accepting the idea of the “Anticipated directives”. In general, whatever the mental status and whatever the terminal state, the patients seem still far from handling their own auto-determination and their Consent, even if the ultimate goal is to die with dignity.
Ethical Aspects of Informed Consent in Dementia
Ethical Aspects of Informed Consent in Dementia
Ethical Viewpoint Paper
Dhruv Parmar
Global Bioethics Enquiry, 2021; 9(1)
Open Access
Excerpt
Informed Consent is an ethical and legal obligation that a medical practitioner or researcher must take in order to explain the treatment plan or enrol a participant in a research trial. In this process the participant or patient is informed about all the aspects of the treatment or trial in detail, which are important for the participant or patient to decide after studying these aspects in detail whether they want to voluntarily confirm their participation in the trial or is willing to undergo the said procedure or treatment. The concept is based on the principle of the Nuremberg Code, The Declaration of Helsinki, and the Belmont Report.
The informed consent is described in ethical codes and regulations for human subject’s research. The goal of the informed consent process is to provide sufficient information to a potential participant, in a language which is easily understood by him/her, so that he/she can make the voluntary decision regarding “to” or “not to” participate in the research study. The same is applicable when an Individual undergoes a medical procedure, surgery or takes certain medications. No individual has the right to infringe a person’s fundamental right, thus “Informed Consent” is an important and ethical tool…
Can I Share Your Ideas With the World? Young Children’s Consent in the Research Process
Can I Share Your Ideas With the World? Young Children’s Consent in the Research Process
Sonya Gaches
Journal of Childhood Studies, July 2021; 46(2)
Open Access
Abstract
Utilizing the four features of informed consent from the guiding document Ethical Research Involving Children, the article illustrates how the informed consent process was carried out with young children from the initial planning stages through the ongoing research’s focused conversations. Specifically, the questions of what would be needed to acquire informed consent from the children and what assurances could there be that young children understood the research and how its results would be disseminated are addressed. The article concludes with suggestions for what other researchers might consider and include in their local contexts.
Editor’s note: The abstract references the 2013 unicef report Ethical Research Involving Children.
Center for Informed Consent Integrity 