Tagged / ethics

Could you help the Health Research Authority improve the research ethics review?

BU research, Clinical Governance, data management, Guidance, nhs, NHS, PG research, Postgraduate Research, Research communication, Research Ethics, research integrity, Research news

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS or social care – email the Clinical Research mailbox, and take a look at the Clinical Governance section of the website.

Panel recruitment: EoI for Deputy Chair (Science, Technology & Health Panel)

BU research, Research Ethics, research integrity

Research EthicsExpressions of interest are invited from members of the Professoriate, for the prestigious and honorary role of Deputy Chair, Science Technology Research Ethics Panel. The central research ethics panels work across the University to champion the highest ethical standards in research undertaken by staff and students (PGR).

This document provides further information about the role and the application process. The opportunity is open to Professors and Associate Professors.

Expressions of interest should consist of a CV and brief statement outlining your suitability for the role. These should be submitted to the RDS (researchethics@bournemouth.ac.uk) by 5pm on Friday 1 July 2022.

For an informal discussion about the role please contact:

– Prof Sam Porter, Chair of the Science, Technology and Health Ethics Panel

If you have any questions regarding the process, please email Sarah Bell or Suzy Wignall by email to researchethics@bournemouth.ac.uk.

Research Ethics in a Clinical setting

BU research, Clinical Governance, Postgraduate Research, Research Ethics

Author: Suzy Wignall, Clinical Governance Adviser

Clinical Research

Clinical Research

This week, we start our focus by looking at research ethics within Health and Clinical Research.

Research conducted within a healthcare setting in most cases will require additional approval to BU ethics. Ensuring that you have the correct approvals and oversight for your study is vital in assuring your participants that you are conducting the study in line with regulations and standards.

Under the UK Policy Framework for Health and Social Care Research, when a student or a member of staff is undertaking their own research within the NHS, then the organisation at which they study or work, should ideally take on the role of the research Sponsor. The Sponsor is defined as an individual, company, institution, organisation or group of organisations that takes on responsibility for initiation, management and financing (or arranging the financing) of the research.

Under new guidance, undergraduate students are no longer permitted to make an application to conduct research in the NHS. In certain cases, Master’s students are also not permitted, but should check their eligibility via the Health Research Authority’s student research toolkit.

Approvals

Research involving the NHS or social care, including patients, carers, human tissue, or data may require ethics approval from an NHS Research Ethics Committee (REC) or Social Care REC.  Application for NHS REC is via the Integrated Research Application System (IRAS) and is coordinated by the Health Research Authority (HRA), so you only need to submit one application.

If you are unsure as to whether your research requires NHS REC approval, the HRA have provided a useful decision tool which determines whether NHS REC approval is required.

If NHS REC is not required, you may need other approvals such as HRA and HCRW Approval (Health and Care Research Wales) – for example if you are using NHS facilities, accessing anonymous patient data, or have NHS staff as participants. You may also in some cases need CAG Approval (access to identifiable data without patient consent).

What the University cannot approve

The storage of human tissue or other relevant materials for research, may require a licence from the Human Tissue Authority, which BU does not currently hold.  If you obtain NHS REC approval, this will allow you to collect and store relevant materials for the duration of the project, and for up to one year after the declaration of the end of the research, for the purposes of analysis and verification of research data.

Research where the research participants are adults (aged 16 and over) and are unable to make decisions for themselves i.e. they lack capacity[1].  An ‘Appropriate Body’ to review this type of Research are limited to flagged RECs (in England and Wales) and the Social Care REC.

The University’s research ethics panels are not recognised as Appropriate Bodies under the Act.

Who to contact for help and further information?

Your first point of contact with any queries should be –

Much of the health research at Bournemouth University involves collaborating with the NHS and therefore requires Trust approval.

The following documents have been compiled by Bournemouth University Clinical Research Unit (BUCRU) and Research Development & Support (RDS):

In contacting potential NHS sites, a full list of appropriate contacts can be found on the Research & Development Forum website. It is always worth contacting the Trust early in the process.

Useful documents and links

The clinical governance section on the Research Governance & Integrity website has a wealth of information and links to websites and templates that can be used to make the process easier and less tasking,

A good place to start is deciding whether your study is research. Sometimes what is deemed research at BU, is not classed as such within the NHS. The above tool can help decide for you, as well as the Defining Research table. If your study is not deemed research, then you can proceed with the university ethics route.

If you do need to apply through IRAS, then the Clinical Researcher Checklist (PDF and word formats) can be used to keep track of the tasks required throughout the process.

Further training

External
Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. By undertaking GCP, you’re able to demonstrate the rights, safety and well-being of your research participants are protected, and that the data collected are reliable.

GCP training should be refreshed every 2 years in line with our training policy, which you can read here.

Please note that due to current advice as a result of COVID-19, courses are being provided online via Zoom. If you are interested in booking onto one of these courses, then please email Suzy Wignall who can put you in touch with the relevant contact.

You can undertake the training online by registering for an account here. On this website you can find full GCP e-learning, GCP refresher e-learning and also training surrounding areas such as informed consent in adults lacking capacity.

Internal
As part of the RKEDF Academics and Researchers can book onto the following sessions, either as a one-to-one meeting or a bespoke team session:

If you are a Postgraduate Research Student, there is also a Clinical Governance workshop as part of the Researcher Development Programme.

[1] The Mental Capacity Act 2005 (MCA)

Meet members of the Research Ethics Panels

BU research, Research Ethics, research integrity

This morning we meet members from the Social Sciences & Humanities Research Ethics Panel (SSH REP).

Dr Parisa Gilani, Senior Lecturer in HR and OB, BUBS
I joined the Social Sciences and Humanities Ethics Panel in November 2019 as the departmental representative for People and Organisations (BUBS). As an Early Career Researcher I welcomed the opportunity to actively contribute towards the research community and meet and learn from knowledgeable colleagues across the university. I had also attended a number of SSH Ethics Panels as a researcher and found the experience to be a positive and rewarding one that enhanced the quality of research projects I had been involved in.

I joined the Panel at an interesting time – with the Pandemic hitting just a few short months after joining. I only had the pleasure of meeting my fellow Panel members in person once before we switched to virtual working. The current situation has also challenged our way of thinking about research in the current context. A lot of our recent discussions have focussed on researcher and participant safety and formulating suitable ethical protocols for online forms of data collection – particularly the use of Zoom and Microsoft Teams.

One of the things I have most enjoyed about being an SSH REP member is having the opportunity to learn about the exciting, innovative and important research that goes on across BU – outside of my own discipline. Every month I’m blown away by the innovative research projects that I have the pleasure of reading about. Many of these address current challenges such as the Covid Pandemic, well-being and links to the UN Sustainability goals.

Over the last few months we have changed the way we review Ethics documents that come to the Panel. Each research project is now assigned a lead reviewer and a secondary reviewer, which allows us the space and capacity to really delve into each project we are assigned to in-depth.

Working with fellow Panel members has also enhanced the quality of the Ethics documents I produce and enabled me to further support my own students as they embark on the Ethics process. Sometimes Ethics is seen as a tick box exercise, but if anything being a part of this Panel over the last year has reinforced to me the important role that Ethics plays in ensuring our physical and psychological safety, that of our participants and in strengthening the quality of research.

Finally, there is sometimes apprehension experienced over being asked to present research at Ethics Panels, however I can safely say that we are all a very supportive group of people, who strive to provide proportionate, consistent and high quality of research across the University. I have personally thoroughly enjoyed being part of the Panel. So if you are submitting your Ethics documentation – good luck and we hope to see you at a Panel soon!

Dr Osi Okwilagwe, Lecturer in Strategy, BUBS

A few years ago, whilst fresh out of my PhD journey and as a new member of staff, I joined the SSH REP. As an Early Career Researcher, I was indeed new to the world of research ethics and was especially pleased to be offered a place by Dr Sean Beer who was Panel chair at the time. In my four years on the role and currently working with a new Panel chaired by Prof Jonathan Parker, I have come to appreciate how large the industry of research is and how important it is for the members of the SSH REP to have a real interest in supporting Social Sciences & Humanities research at BU and in protecting potential participants’ interests – to give their opinion on whether the research methodology is ethical and fair. For me it has been an eye opener working with senior and more experienced colleagues reviewing each month an array of ethics checklists submitted by staff and postgraduate research students, all who conduct very interesting research.

I suppose when people think about ethical research, they think of rules for distinguishing between what is considered acceptable and unacceptable behaviour – right from wrong! Submitting ethics checklists for an ethics review or attending an interview with the Panel for a submission assessed as above minimal risk is really not daunting contrary to popular opinion. The SSH REP understands the sometimes complex issues involved in reaching ethical decisions; bear in mind that the Panel’s aim is to promote and facilitate research at BU. Staff and postgraduate research students who submit their ethics checklist should also not despair if the feedback from the Panel entails a long list of suggestions or amendments, as the role of the SSH REP is to ensure that all research carried out, is conducted to the highest possible ethical standards for research and to provides support to staff and students planning research projects. The mixed experiences and backgrounds of members that make up the Panel allow for wide perspectives as possible. Panel members take a robust approach to the consideration of risk and benefits of a research project. Each member brings their own valuable perspective, knowledge, and experience, as well as concern of the ethics checklist submitted for a particular research project to the Panel’s deliberations. Hence, the feedback given are usually suggestions for researchers to take on board to amend the ethics checklist or to improve the participant’s information sheet; invariably helping towards increasing the likelihood of participant recruitment and of generating quality and publishable research results.

The invaluable experience I have gained from reviewing submissions and working with the SSH REP, has allowed me to appreciate the diverse nature of research carried out by our colleagues at BU and has also ingrained in me that as researchers, a key duty is to promote ethical research.

Here are 3 top tips I like to share when considering making an ethics checklist submission:

1. If researchers are new to research, do ask for help, perhaps from a more experienced colleague/supervisor or send an email to the Research ethics team with any questions.

2. Complete the ethics checklist carefully and read the guidance on the documents to be submitted along with the checklist.

3. Spend a considerable amount of time on the Participant Information Sheet; the adequacy of consent is important. So do identify any contentious issues there may be in conducting the research.

Meet members of the Research Ethics Panels

BU research, Research Ethics

On Monday we focussed on the work of the Research Ethics Panel and yesterday we heard from Dr Orlanda Harvey who visited the Social Sciences & Humanities Research Panel as part of her PhD journey.

Today you get to meet some of its members with the focus on the Science, Technology & Health Research Ethics Panel (STH REP).

 

Dr Liam Wignall (Psychology Department)

My research explores different aspects of sex and sexuality, looking at sexual identities and the experiences of non-heterosexuals; changing sexual practices, including during COVID-19; kink activities and the changing role of the internet. Given my research interests on the often personal topic of sexuality, I am keenly aware of the need to consider the ethical implications of any research conducted. I have sat on numerous ethics panels and had fascinating discussions about my research and the ethical considerations. This has ranged from thinking about the wording of the questions and how participants may perceive them, to making sure I think of my own safety when collecting data in the field. These discussions forced me to think about how I conduct research and providing justifications for each step, ultimately improving my studies.

I became a member of the panel so that I could offer the same advice to others when they were conducting research, asking other researchers the same questions that I was once asked: “What precautions have you taken should things go wrong?”; “How are you protecting yourself when conducting research on a sensitive topic?”; “Do participants know what will happen to their data?” Often when conducting research, we can become so focused on one aspect of the project that it’s helpful for others to ask these questions – I see this as one of the jobs of the ethics panel.

The principal role of the STH REP is to ensure that all research is conducted in an ethical way, following principles and procedures set out by BU and associated bodies (e.g., British Psychological Society). I see my role on the panel as encouraging researchers to consider how they can follow these guidelines to conduct great research. Ethics is not about preventing research from being done, it’s thinking about how good research can be done in an ethical way.

On a personal note, it’s also amazing to see the range of research projects being conducted at Bournemouth University. Being on the panel allows me to chat with colleagues across the faculty and ask them about their research. As a panel, we have had ethical discussions relating to how technology can improve the lives of people with physical disabilities; the intricacies of how dating profiles are used; and how to explain research to children to ascertain consent. Three-hour meetings can just fly by…

Dr. Sofia Meacham (Senior Lecturer in Computing Department of Computing and Informatics)

“Why did I become a member?”

I became a member of the STH REP three years ago through my strong interest on the subject as part of my own research. Specifically, ethical considerations for Artificial Intelligence decision making and their acceptance from scientific and wider community was the matter that I came across first in my research. This raised an interest in how the two worlds: technical achievement and ethical considerations can be combined and the challenges arising from this combination can be overcome. Finding a community of like-minded academics from several fields was obviously the next step to progress this interest, get accustomed with BU’s processes on the matter and contribute through my previous knowledge on technical and ethical matters. Last but not least, ethics has been an integral part of my education from an early stage such as primary school through ancient Greek philosophy and family traditions.

“What do you like about being a member?”

After becoming a member and although the participation is voluntarily, I enjoyed every aspect of it. Without exaggeration, I have been given the option to reduce my workload by stepping down which I have rejected! Being a member, the panel discussions once a month provide a multi-disciplinary approach opening my personal horizons and patterns of thought. There is a democratic handling of all opinions and there is not a single meeting that was not beneficial and enjoyable. Although the panel meetings are taking place with a pleasant environment, the responsibility that the committee has to academia and the society is being taken very seriously.

Last but not least, I would like to emphasize that ethical considerations are of increasing importance in todays rapid technological and other developments. Academia should play integral role to ensure that research developments are performed in alignment with ethical considerations and STH REP is an excellent place within our BU academic community.

Thank you Liam and Sofia!

Tomorrow you get to meet members from the Social Sciences & Humanities Research Ethics Panel

What it’s like to attend a Research Ethics Panel …. A PGR’s account

BU research, Research Ethics

Undertaking Research – Facing the BU Ethics Panel

By Orlanda Harvey

When you start your PhD journey, one of the first hurdles that you face is gaining Ethical Approval for your study. This can be a very daunting concept at the beginning, as it is often a complete unknown, or it was for me, as this was the first time I had to go through the process. Looking back now; from the very comfortable vantage point of having achieved my doctorate, it is easy to forget the anxiety and mystique surrounding this process. Questions such as: What happens if I do not get approval? dominated my thoughts. I was one of the lucky ones, for although I was seeking approval to investigate people’s experiences of using substances (In this case Anabolic Androgenic Steroids) which would mean I would have to face the BU panel, I did not need NHS ethical approval. Sitting in an office (the joy of life pre-Covid) alongside peers who were facing that experience made me very thankful, for small mercies, as although the BU process feels as if it takes a long time comparatively, with hindsight it is efficient. This, however, does not mean to say that I did not experience a few bumps in the road.

The key to success for me was advice from my Supervisory Team to ensure that I took time to get all my ducks in a row prior to submission and to take the time to prepare all my information sheets and paperwork. This was valuable as there were no changes required to my initial submission, and it went straight through to the panel. I had also looked at the panel meeting deadlines so that I could plan for my submission date and sought advice from the Research Development and Support (Governance) Team to clarify a few points. Going through the online documentation felt a little bureaucratic and at times repetitive but it was very straightforward and easy to use. It certainly made the write up of the ethics and methodology element chapters of the Thesis easier; as one of my supervisors is prone to say, no writing, when it relates to your study, is ever wasted (thank you Edwin).

The panel meeting itself was an interesting experience, for although my supervisor was there to support me (thank you Margarete) it was very clear that the focus was on me and my plans for the research, so all the questions were directed my way. At first, I was apprehensive but actually the experience turned out to be quite enjoyable. After all, at that point I was incredibly enthusiastic about my project and these people wanted me to talk about it! I later learnt to treasure such moments. The questions they asked came from a place of curiosity, and it was not long into the meeting before I realised that they were interested in supporting the research and were ensuring that I had considered key ethical points. If I am totally honest there was only one question that I found a little left field, but you are never going to agree with everything.

It was not all plain sailing, I did pass the panel but still had the email with, a few minor amendments needed. However, these were easily resolved, added clarity to the participant information sheets and could be covered by just replying with the amendments to the panel chair. Overall, the whole experience was beneficial to both my development as a researcher, and my understanding of the ethics challenges.  The positive comments from the panel also proved to be a bolster to my confidence at that early stage in my PhD Journey.

A final unexpected outcome was that, as a result of going through the checklist I had to consider if my population was vulnerable, as people who use illicit drugs are quite often are given this label as a de-facto result of their drug use. This was interesting as although they were using drugs that although not illegal, they do fall into a grey area of the law and was something that we discussed at Panel. This made me think more deeply about the population as a whole, and as a result ended up in me writing a short paper, which was published on the ethics of using AAS and the perceived vulnerability of this group: ‘Shades of Grey’: The Ethics of Social Work Practice in Relation to Un-prescribed Anabolic Androgenic Steroid Use,  which, brings me back to Edwin’s sage advice: nothing you write should ever be wasted 🙂

Integrated Research Application System (IRAS) – survey open

BU research, Clinical Governance, data management, nhs, NHS, Research communication, Research Ethics, research integrity, Research news

IRAS, the Integrated Research Application System, is changing.

The Health Research Authority wants to hear from people who’ve used the system about how it should look in the future.

A short anonymous survey https://www.surveymonkey.co.uk/r/5B5X95H is available until 24th February 2021.

External guides for managing remote research

BU research, COVID-19, data management, Guidance, Research Ethics, research integrity

Given current Government guidance on the pandemic response, a number of research projects will need to be conducted remotely. Below are a number of external help guides/guidance articles that aim to assist researchers with this new way of working.

The UK Data Service’s guidance on online data collection

Warwick University’s article on using Skype to collect data

Guidance on conducting telephone interviews –
Article one
Article two

The resource ‘Fieldwork during the pandemic’

The UK Research Integrity Office’s ‘Internet-mediated research’ guide

Research should remain within the ethics approval that has been granted – if you need to make any changes as a result of COVID 19 (for example moving from face-to-face to remote interviewing) please email researchethics@bournemouth.ac.uk if a member of staff or your supervisor if a student.

Guidance available to support researchers attending an NHS REC meeting

BU research, Clinical Governance, Guidance, nhs, NHS, Research communication, Research Ethics, research integrity

Two new links have been added to the Clinical Governance blog under the ‘Useful Links and Documents’ section which give further information and guidance as to attending an NHS Research Ethics Committee meeting for your project. The links are also provided below-

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – get in touch with Research Ethics. You can also take a look at the Clinical Governance blog for resources and updates.

Setting up clinical research – the ‘Organisation Information Document’

BU research, Clinical Governance, data management, NHS, Research Ethics, Research news

If you are currently conducting research within the NHS or Health & Social Care (HSC), then please bear in mind the following update if you wish/plan to add new NHS/HSC research sites to your study.

As of 5th June, the set-up procedure for clinical research projects involving NHS or HSC organisations changed (see blog post) –

  • If you applying for HRA/NHS REC approval you will be required to follow the new procedure using the Organisation Information Document (OID), as referenced in the above post;
  • If you are already conducting a study with HRA/NHS REC approval, in NHS/HSC organisations, and wish to involve new sites, then please be aware that the OID should be used, even if existing sites were set-up using the previous document, the Statement of Activities.

Further help and guidance

Guidance on the use of the new UK Local Information Pack has now been published in the Site Specific page of IRAS Help to help applicants with the change.

If you have any queries regarding any of the information provided above, information in the referenced blog post, or would like some guidance with regard to implementing your research in a healthcare setting – please get in touch with BU’s Research Ethics team.

You can also take a look at the Clinical Governance blog for documents, links and training opportunities.

RKEDF events next week – spaces available

Events, Research communication, Research Ethics, Research Training, RKE development framework

 

There are spaces available at the following events next week:

Day Date Event and booking link Facilitator
Monday 17th June Ethical Decision making in Practice Dr Helen Kara
Tuesday 18th June Using Creative Research Methods Dr Helen Kara
Thursday 20th June Research Communication Day RDS & M&C

Please follow the links to find out more and to book. The workshops with Dr Helen Kara are now also open to PGRs, who do not need line manager approval to attend.

Book now so that appropriate catering can be arranged.

 

NHS R&D Forum response to Mental Capacity Act Code of Practice consultation

BU research, Clinical Governance, data management, NHS, Research Ethics, research integrity, Research news

The NHS R&D Forum Research Management Working Group have released their thoughts on how they feel that the Mental Capacity Act Code of Practice can be refined and improved, to reflect current needs.

‘The Research Management Working Group is a group of members of the NHS R&D Forum with a wealth of experience
and expertise in both managing and delivering research activity within NHS organisations.’

You can read the group’s response here. The consultation is now closed, however the current Code of Practice can be found here.

If you are planning to conduct research with human participants that lack the capacity to consent or who may eventually lack capacity to consent, then the research application must go to an ethics committee that is flagged to review Social Care research.

BU ethics panels are not authorised to undertake this review or issue approval, and so an application via the IRAS system must be made. Further information can be gained via the HRA website and by emailing Research Ethics.

RKEO alternative 12 days ‘to’ Christmas – 5 Ethics gold rings

BU research

On the fifth day to Christmas, my RKEO friend gave to me, five ethics gold rings.

Bournemouth University (BU) is committed to promoting and upholding the highest quality academic and ethical standards in all its activities. All research undertaken by BU staff and students must have ethical approval. Please ensure you consult the Research Ethics Code of Practice and gain ethical approval before commencing research.

Find out more here, including how to apply for ethical approval, guidance on the ethics checklist, and much more.

EoIs invited for BU Ethics Panel Chairs and Deputy Chairs

Research Ethics

Expressions of interest are invited for the Chairs and Deputy Chairs of the Social Science and Humanities Ethics Panel and the Science, Technology and Health Ethics Panel. These prestigious and honorary roles work across the university to champion the highest ethical standards in research undertaken by staff and students.

This document provides further information about the roles and the application process.

Expressions of interest, consisting of a CV and brief statement outlining suitability for the chair/deputy chair role, should be submitted to RKEO (researchethics@bournemouth.ac.uk) by 5pm on Wednesday 14 November 2018 (please note the deadline has been extended).

For an informal discussion about the roles please contact one of the current Chairs:

  • Dr Sean Beer, Chair of the Social Science and Humanities Ethics Panel
  • Prof Holger Schutkowski, Chair of the Science, Technology and Health Ethics Panel

If you have any questions regarding the process, please email Sarah Bell/Suzy Wignall using the researchethics@bournemouth.ac.uk email address.

Important update regarding human DNA from acellular materials

BU research, Clinical Governance, Guidance, policy, Research Ethics, Research news

The revised Governance Arrangement for Research Ethics Committees document was released recently.

Amongst updates to incorporate legal, policy and operational developments, following a public consultation by the Human Tissue Authority, research involving human DNA extracted from acellular material is now included in the document, as requiring NHS Research Ethics Committee review.

If you are collecting ‘relevant materials‘ and rendering them acellular, then storage of the samples does not require a HTA license – however, a license is required for distribution of the samples, or if you are extracting DNA from these materials.

Please get in touch if you have any queries or wish to discuss the samples being collected/stored at BU.

EoIs invited for BU Ethics Panel Chairs and Deputy Chairs

Research Ethics

Expressions of interest are invited for the Chairs and Deputy Chairs of the Social Science and Humanities Ethics Panel and the Science, Technology and Health Ethics Panel. These prestigious and honorary roles work across the university to champion the highest ethical standards in research undertaken by staff and students.

This document provides further information about the roles and the application process.

Expressions of interest, consisting of a CV and brief statement outlining suitability for the chair/deputy chair role, should be submitted to RKEO (researchethics@bournemouth.ac.uk) by 5pm on Friday 9 November 2018.

For an informal discussion about the roles please contact one of the current Chairs:

  • Dr Sean Beer, Chair of the Social Science and Humanities Ethics Panel
  • Prof Holger Schutkowski, Chair of the Science, Technology and Health Ethics Panel

If you have any questions regarding the process, please email Sarah Bell/Suzy Wignall using the researchethics@bournemouth.ac.uk email address.