Consent Conundrums: Challenges obtaining consent in different contexts

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Paper 1: Employees and big data: a virtue ethical approach 

Speaker(s): Lisa Grover

Keywords: informed consent, employees, big data, autonomy, virtue ethics, trustworthiness 

 

Abstract: Can an employee give informed consent for the use of their data in big data analytics? Is their consent enough to make sure that this use is ethical? My work focuses on answering these questions. Big data is a term that describes larger, more complex data sets. HR data analytics is beginning to use big data. For example, using big data to find out why employees leave a business. Understanding ethical use of employee data in this way is important. There is little yet written about informed consent in relation to using employee information in big data analytics. My work makes a new contribution to the literature. I press analytics professionals to think deeply about the ethical use of employee data. I challenge the belief that informed consent makes the use of data ethical. Instead, I propose a new way of thinking about the ethics of big data analysis. This draws upon the virtue of trustworthiness. 

 

Paper 2: Remote recruitment of people with dementia and carers: ethical dilemmas of an RCT study 

Speaker(s): Greene, L., Oh, TM., Manger, L., Gude, A., Weston, L., Sutcliffe, C., Batool, S., Beresford, R., Griffiths, S., Wheat, H., Sherriff, I., Clarkson, P., & Byng, R. 

Keywords: Capacity, dementia, RCT, consent, consultee, remote

 

Abstract: The Dementia Person Aligned Care Team (D-PACT) is an NIHR funded collaboration between the University of Plymouth and the University of Manchester. D-PACT aims to develop and evaluate a person-centred Dementia Support Worker intervention based in primary care for people living with dementia and their carers. The original COVID-19 lockdown resulted in D-PACT developing a flexible recruitment process, enabling us to work remotely during the pandemic. We aim to share our learning and contribute to the ongoing debate about maintaining rigorous ethical practices whilst embedding person-centred approaches throughout remote research processes.

Ethical challenges and learning/solutions

A number of ethical challenges were identified and solutions developed. For example:

1. A need to develop suitable remote materials was acknowledged, accounting for age-related factors (e.g. visual/auditory impairments and fatigue) as well as dementia-specific challenges (e.g. cognitive/communication impairments). This work can be supported by working closely with PPI groups and ensuring choices are informed by guidance on dementia-friendly communication.

2. There was little guidance on gaining verbal consent with a heavy focus on e-consent which can alienate older adults. DPACT received REC/HRA approval to obtain verbal consent. This was well accepted by participants.

3. Judging capacity over video/phone call and starting a conversation about obtaining consultee agreement was challenging. There was a paucity of literature on remote capacity judgements for the team to base their decision on. Our learning suggests it is helpful to have an initial guide, although experience led to a more person-centred/flexible capacity judging approach. Building rapport and gathering information from the first point of contact was crucial and, although time-consuming, should not be rushed. Videoconferencing further facilitated rapport building and recruitment processes, but many individuals did not have access to IT equipment.

4. Working with socially isolated adults during COVID-19. Having details of local services for participants and utilizing peer supervision/reflective practice.

Conclusions: Remote recruitment has been successfully and ethically implemented but research processes were protracted. Future research should be mindful of this. Remote capacity judgements are feasible but can be challenging and researchers may need extra support. Gathering information from the initial point of contact to help build a comprehensive picture of capacity is helpful. Consideration should be given to the effects of COVID-19 on both participants and researchers. 
 

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Paper 3: Ethical approval for use of un-consented human tissues: a clinical research experience.

Speaker(s): Dr Ollie Rupar

Keywords: Archived human tissue, Ethical approval process.

 

Abstract: All human tissue samples assessed for diagnostic purposes within the NHS are kept for thirty years, yet the vast majority are (currently) not used in clinical research. In cases of aggressive malignancies, such as primary liver cancer, it has been possible to release these archived specimens for use in research provided rigorous ethical processes, and appropriate research methodologies, are adhered to. Access to these tumour samples has only been possible following ethical approval by the research ethics committee. This has allowed an otherwise untapped research resource to be used for the first time in Devon and Cornwall. 

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The Clinical Conundrum: Consent for use of these tissues has been granted on behalf of patients, meaning it is possible to undertake research on human tissue without express written, informed consent from the patient. Several ethical issues were raised in the process of gaining ethical approval that necessitated input from both local and national bodies. These included the health research authority (HRA), the research ethics committee (REC), exploring a confidentiality advisory group (CAG), input from a local patient participation group and the hospital Caldicott Guardian. Special dispensation for undertaking this research was approved given the terrible 5-year survival rate (15%), the urgent need for better understanding of the biology of these cancers, and that research would not deplete the tumour samples. Strict stipulations were adhered to alongside ensuring minimal patient-identifiable data was accessed and was only made possible with the help of the local Histopathology department. 

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Conclusion: This approach was used successfully and made possible by close liaison between various ethical bodies, the hospital research and development department and the study sponsor. It has been a privilege to have access to these archived resection specimens and it is hoped this example can serve as a demonstration for potential future research opportunities. The vast source of archived tissues that are currently held in storage can be used as raw research material in centres that may not have either the capacity, time or funding to create their own fresh tissue bio bank. One particular benefit of using archived material being that long-term survival data can be readily extracted from patient records, allowing clinically significant correlations, and results, to become apparent when comparing tumour mutations, or when comparing protein expression with survival data.