Case study: Support given by CRN KSS to the ‘Examining healthcare professionals’ understanding and experience of ethical preparedness in the practice and delivery of genomic medicine (EPPiGen)’ study

Background

Study title

Examining healthcare professionals’ understanding and experience of ethical preparedness in the practice and delivery of genomic medicine (EPPiGen).

The study was part of the wider Ethical Preparedness in Genomic Medicine (EPPiGen) project, a Wellcome Trust funded Collaborative Award in Humanities and Social Science (2017-2022) (grant number 208053/A/17/Z) £1.2M) between Brighton and Sussex Medical School and the University of Southampton.

The Principal investigators were Professor Bobbie Farsides (BSMS) and Professor Anneke Lucassen (previously University of Southampton now University of Oxford).

CPMS number: 41105

Aims

The study aimed to investigate whether healthcare professionals and medical scientists operating in the wider NHS feel prepared to deal with any ethical challenges they identify as part of the expanding genomic agenda.
1. To provide a rich and nuanced account of the experiences of Healthcare Professionals (HCPs) engaged with the NHS genomics agenda.
2. Explore how practitioners in the field present and/or see themselves situated in relation to the widening scope of genomic medicine.
3. Establish what practitioners see as barriers and/or facilitators in the implementation of policy around genomics.
4. Investigate how accounts of HCPs and medical scientists’ experiences contribute to a conceptual understanding of ethical preparedness?
5. Investigate whether and how the concept of ethical preparedness can be articulated in a way that allows it to be used to good effect in this and other areas of medicine?

Recruits

51 healthcare professionals were interviewed.

Method

Semi-structured in-depth interviews and two ethical discussion groups took place, one in primary care and another one in secondary care.
The methodological approach involved interviews and Ethical Discussion Groups (EDGs).

Support provided by CRN KSS

Dr Shadreck Mwale is a social scientist and while at Brighton and Sussex Medical School (BSMS) as a Senior Research Fellow, he undertook a study examining the beliefs, attitudes and experiences of healthcare professionals and medical scientists regarding the mainstreaming of genomic medicine in the NHS. The project was overseen by Professor Bobbie Farsides Professor of Clinical and Biomedical Ethics at BSMS, and Co-PI of the EPPiGen project. A particular focus was on whether healthcare professionals and medical scientists operating in the wider NHS feel prepared to deal with ethical challenges they identify as part of the expanding genomic agenda.

The CRN KSS Study Support Service, which included a Research Delivery Manager, Senior Project Coordinator and a Project Coordinator helped Dr Shadreck Mwale successfully deliver the study within the NHS in Kent, Surrey and Sussex.

Working with the NHS

Dr Mwale said: “My previous research had not involved working with the NHS directly, but working with Contract Research Organisations. Working with the NHS was a new experience, especially coming from a social science background.

“I thought recruiting would be easy - just contacting identified sites and they would agree to take part, but in practice that wasn’t as easy as I thought. Sites needed a lot of  documentation on the study and evidence of CRN support before they could agree to participate. That is where the CRN KSS team came in handy. The CRN KSS team introduced me to healthcare professionals and teams from acute trusts and primary care GP surgeries. Those who were interested were asked to contact the CRN, whose details were forwarded to me to arrange an interview.

CRN KSS advised Dr Mwale on exactly which trusts and which clinicians to approach, either by making a direct approach following approvals, or via the R&D team. They helped refine his approach so that it would make more sense to the sites too. They advised Dr Mwale to target Principal Investigators (PIs) and others in paediatrics, oncology, haematology and other specialties where clinicians have worked on genetics/genomics studies.

Dr Mwale: “CRN introductions and use of our established networks (particularly the GPs and paediatricians) was very important and they were able to find GPs with an interest in genomic medicine.”

Oncology is a particularly important area for the genomics agenda that Dr Mwale had not been aware of. Therefore, there was a combined approach of targeting some individuals at sites and sending information out to see who was interested.
 

The CRN can provide this essential site and participant intelligence.
 

Dr Mwale continues: “I had some problems recruiting in secondary care but the Research Delivery Manager helped me to revise the strategy. Sites needed a lot of chasing up about this study which CRN KSS provided a lot of support with.

“In the end 28 people from acute trusts - a combination of registrars consultants in oncology and paediatrics and six research nurses were recruited. I had to turn some of them down as I had reached the maximum number we wanted to interview. In addition, 23 GPs were recruited to the study.”

Methodology support and feedback on study design

Dr Mwale: “Working with the CRN KSS team was the solution to most of the challenges I thought I would face. I had an initial meeting with one of the Project Coordinators where we discussed what I was trying to achieve and my suggested approach. The study was already designed and I received feedback and advice on the methods.

“Having feedback on the design was really useful, not only in preparing me for what to expect in the field, but also reflecting on the suitability of my methodological approach and what adjustments could be made. I originally planned to carry out observations on the wards and with teams but CRN KSS advised me that carrying out observational work would be incredibly challenging and they advised me to focus on interviews/focus groups. This proved to be right.”

Approvals

Dr Mwale said: “CRN KSS gave me guidance on the documents I needed to submit to the Health Research Authority (HRA) Integrated Research Application System (IRAS) process. I thought I had to apply for ethical approval but as the study was with health care professionals, I did not need to go through that process and could go straight through the HRA process. I completed my application in record time. I submitted it to the HRA in February 2019 and by the end of March, I had approval to go ahead with this study. The team also helped me manage my anxieties about going to an ethics committee by providing useful feedback on the contents of the participant information sheet and the consent forms.”

Single point of contact

“Having a point of contact within the team was really helpful, knowing that I could email one of the Project Coordinators for advice as the research got underway. It gave me confidence to go ahead.

“For social researchers venturing into the NHS to conduct research, working with your local CRN and having that particular contact can transform your experience. It is very overwhelming to have to manage all those processes and protocols that you need in place to start the research. The study team was small, on the BSMS side, initially it was just me and Professor Farsides the chief investigator on this project, but somehow working with the CRN KSS felt like we were working in a bigger team."

Published papers

“Imagining genomic medicine futures in primary care: General practitioners’ views on mainstreaming genomics in the National Health Service”
Journal: Sociology of health and illness.
First published: 13 November 2021.