Category / Research Ethics

Trusted Research – information now live

Within the Research Environment pages on the BU website, there is now a section on the Trusted Research agenda.

The Trusted Research Agenda is a government initiative to secure the integrity of the system of international research collaboration and innovation.

Please visit the page to find out more, including key details and guidance.

Research Ethics Panel meetings in August

Research EthicsA Reminder for Staff and Postgraduate Researchers

There are NO Research Ethics Panel (REP) meetings held during August, so if you’re hoping to start data collection activities over the summer and are in the process of completing your research ethics checklist, please keep this in mind when planning your research activities and submit your checklist in time for the final REP meetings to be held in June and July.  Checklists received during August which need to be reviewed by a full Panel will be deferred until September (dates to be advised).

REPs review all staff projects and postgraduate research projects which have been identified as high risk through the online ethics checklist.  Details on what constitutes high risk can be found on the research governance, research ethics & integrity website.

There are two central REPs:

  • Science, Technology & Health
  • Social Sciences & Humanities

Staff and PGR ‘high risk’ projects are reviewed by one of the central REPs and Researchers (including PGR Supervisors) will normally be invited to Panel for discussions.

Staff Projects which are ‘low risk’

Reviews for low risk projects will continue as normal during August (via email), although turnaround may take longer than normal due to Reviewer availability during this month.

PGR Projects which are ‘low risk’

There are no changes to the review and approval process for low risk PGR projects and reviews will continues as normal throughout August, again subject to Supervisor and the Ethics Champions availability.

More details about the review process and REP meeting dates can be found on the governance, research ethics & integrity website.  Email enquiries should be sent to researchethics@bournemouth.ac.uk.

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

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.

RKEDF Clinical Research Governance Sessions

As you will be aware, RDS offers something called the RKEDF, or Research & Knowledge Exchange Development Framework – as part of this there are a number of sessions available surrounding clinical research governance. These sessions can be booked as a 1:2:1 or in bespoke group sessions with Suzy Wignall, BU’s Clinical Governance Advisor.

As always, general chats/specific discussions can also be booked in too – please just email!

The RKEDF sessions available are as follows:

Please get in touch if you are interested in any of these sessions.

For general guidance, documents and further information surrounding processes, take a look at the Clinical Governance website.

Research Ethics Panel meetings in August

Research EthicsA Reminder for Staff and Postgraduate Researchers

There are NO Research Ethics Panel (REP) meetings held during August, so if you’re hoping to start data collection activities over the summer and are in the process of completing your research ethics checklist, please keep this in mind when planning your research activities and submit your checklist in time for the final REP meetings to be held in June and July.  Checklists received during August which need to be reviewed by a full Panel will be deferred until September (dates to be advised).

REPs review all staff projects and postgraduate research projects which have been identified as high risk through the online ethics checklist.  Details on what constitutes high risk can be found on the research governance, research ethics & integrity website.

There are two central REPs:

  • Science, Technology & Health
  • Social Sciences & Humanities

Staff and PGR ‘high risk’ projects are reviewed by one of the central REPs and Researchers (including PGR Supervisors) will normally be invited to Panel for discussions.

Staff Projects which are ‘low risk’

Reviews for low risk projects will continue as normal during August (via email), although turnaround may take longer than normal due to Reviewer availability during this month.

PGR Projects which are ‘low risk’

There are no changes to the review and approval process for low risk PGR projects and reviews will continues as normal throughout August, again subject to Supervisor and the Ethics Champions availability.

More details about the review process and REP meeting dates can be found on the governance, research ethics & integrity website.  Email enquiries should be sent to researchethics@bournemouth.ac.uk.

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

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 Integrity Week – starting next week

Come join us next week, for an exciting series of keynote speakers and bespoke workshops discussing many subjects under the theme of research integrity.

We start the week of events with a talk by James Parry, Chief Executive of UK Research integrity Office (UKRIO).

UKRIO is an independent charity, offering support to the public, researchers and organisations to further good practice in academic, scientific and medical research. They promote integrity and high ethical standards in research, as well as robust and fair methods to address poor practice and misconduct. They pursue these aims through their publications on research practice, in-depth support and services for research employers, their education and training activities, and by providing expert guidance in response to requests for assistance from individuals and organisations.

Established in 2006, their aims are to:

  • Promote the good governance, management and conduct of academic, scientific and medical research.
  • Share good practice on how to address poor practice, misconduct and unethical behaviour.
  • Give confidential, independent and expert advice on specific research projects, cases, problems and issues.

James directs UKRIO’s work programme and leads its advisory service, responding to queries and concerns about research practice from researchers and the public.

Join us online or in person on Monday 16 May 2022 at 10.30 am.

You can register your place here via Eventbrite.

BU Integrity Week: 16th to the 20th May 2022

Unlock greater potential by maximising your awareness and understanding of Integrity! 

The ability to utilise integrity in research, writing and teaching is vital for academic success. However, continuing to retain your integrity is fundamental but this can only be achieved by maintaining an ability to keep up-to date with the rules constituting academic dishonesty. Not so unlike technology rules and guidelines are continually changing. How then do you develop and maximise your understanding of honesty and dishonesty and continue to retain Integrity?  BU’s Integrity Week will give you the skills and resources to do just that! 

The importance of Academic Integrity will be highlighted at Bournemouth University’s Integrity Week. 

Organised by cross faculty departments for students, staff and faculty, the week will comprise of a combination of interesting workshops, cross faculty and professional presentations where experts will share their knowledge on differing aspects of honesty and dishonesty. Panel discussions, open to all, will provide a lively forum for the sharing of experiences. 

Reasons to attend! 

  • Unlock and achieve greater success through integrity
  • Discover Integrity resources 
  • Acquire skills to utilise integrity in research, writing and teaching
  • Learn how to maintain integrity in an evolving world of change

This will be an unparalleled week of opportunity for students, staff and faculty to ensure that through awareness and understanding BU stays at the forefront of everything that Integrity represents.  

 

Check out the programme and book here

Research Skills Toolkit – On demand online modules

There have been some updates to our Epigeum Research Skills Toolkit modules. Firstly, all modules as part of the Research Skills Toolkit are now available to all staff using your @bournemouth.ac.uk email address.

The toolkit covers topics such as Becoming a Researcher (available from 1 April), Entrepreneurship in the Research Context, Ethical Research, Research Methods, and Transferable Skills.

You will need to follow these steps to set up an account:

  1. Go to: https://courses.epigeum.com/register.
    Use token 678a512f when completing the form.
  2. An activation link will be sent to your e-mail. Please also check your JUNK mail.
  3. Once registration is complete, log in with this different link: https://courses.epigeum.com/login.

Adding the Research Ethics Modules:

  1. Once you have set up your account and logged in, click the person icon in the top right-hand corner of the screen.
  2. Select ‘Enter Token’.
    Use token 02d34ae8. 

If you already have an account:

If you already have an account set up, you will then need to follow these steps.

  1. Log into your account: https://courses.epigeum.com/login.
  2. Click the person icon in the top right-hand corner of the screen.
  3. Depending on what you are missing either add token 678a512f (for the wider Research Skills Toolkit modules) or 02d34ae8 (for the Research Ethics Modules).

Viewing your modules:

To start viewing and working through your chosen modules, click back on the person icon, and select my courses.


From 1 April the following courses will be added under a new collection named ‘Becoming a Researcher’.

  • Becoming a Researcher: Effective Management of Doctoral and Master’s Research (replacing Transferable Skills: Managing your research project).
  • Becoming a Researcher: Working with your supervisor (replacing Transferable Skills: Working with your supervisor).
  • Becoming a Researcher: Intellectual property in the research context (replacing Transferable Skills: Intellectual property in the research context).

Come along to a short demonstration on how to optimise the toolkit hosted by Epigeum’s Senior Learning Consultant Nick Broom. Register: Wednesday 4 May, 13:00 – 13:45, MS Teams.


If you have any questions please do not hesitate to get in touch:

Natalie Stewart (PGRs &  PGR Supervisors) – nstewart@bournemouth.ac.uk. 

Sarah Bell (ECRs and other BU staff) – sarah.bell@bournemouth.ac.uk. 

Speaking to a journalist

In late 2021 I was contacted by an Indonesian science journalist, Dyna Rochmyaningsih, who was investigating the ethics around international studies on human population genetics to build expand genomic libraries of people in the Global South.  She highlights that “these international studies, often led by Western scientists, have contributed to a more global understanding of ancient patterns of human migration and evolution. But on some occasions, they’ve also sidestepped local regulatory agencies in the developing world, and ventured into murky research ethics terrain as a result”.   The reason for contacting me was because we had published several papers here at Bournemouth University about the need for applying for ethical approval for research in developing countries [1-3].  I had a long Skype conversation with her about the various perspectives on the matter she was investigating.

Today she emailed me that her piece ‘Opinion: Genomics’ Ethical Gray Areas Are Harming the Developing World. A recent controversy in the Philippines illustrates the pitfalls and pressure points of international genomics research‘ has been published online.  In the email she made a really nice comment: “It was nice talking to you even though you might see that I disagree at some of your points. However, the discussion gave me insights that there is a wide disagreement on what considers ethical research.”  I think that is what science should be all about, disagreements, discussions, disputes, etc. and, at the same time, learning from these disputes and gaining greater insight.

 

Prof. Edwin van Teijlingen

CMMPH

 

References:

  1. van Teijlingen E.R., Simkhada P.P. (2012)    Ethical approval in developing countries is not optional. Journal of Medical Ethics 38(7):428-30. doi: 10.1136/medethics-2011-100123. Epub 2012 Feb 16.PMID: 22345548 
  2. van Teijlingen, E., Simkhada, P. (2015). Failure to Apply for Ethical Approval for Health Studies in Low-Income Countries. Nepal Journal of Epidemiology5(3), 511–515. https://doi.org/10.3126/nje.v5i3.13609
  3. Regmi, P. R., Aryal, N., Kurmi, O., Pant, P. R., van Teijlingen, E., & Wasti, S. P. (2017). Informed Consent in Health Research: Challenges and Barriers in Low-and Middle-Income Countries with Specific Reference to NepalDeveloping World Bioethics17(2), 84–89. https://doi.org/10.1111/dewb.12123

Request for feedback – MHRA clinical trials consultation

The Medicines & Healthcare products Regulatory Agency (the MHRA) have launched a public consultation into clinical trials.

The aim of the consultation is to streamline approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement.

There will be a 1 hour meeting on Monday 14th February at 1pm until 2pm, where you can offer your thoughts and feedback for BU’s institutional response.

If you wish to attend the meeting, please get in touch to be added to the invitation.

If you are unable to make the above time but wish to offer your thoughts, please email clinicalresearch@bournemouth.ac.uk to ensure your feedback is included.

Research Ethics @ BU

Research EthicsAll research undertaken by BU staff and students is subject to appropriate ethical reflection, leading to a formal ethics review as appropriate.

When is a formal ethics review appropriate?  It is not possible to produce a definitive list, but key examples include all research involving human participants, tissue or personal data, experimentation on animals, animal tissue, genetically modified organisms, research on sensitive issues, research that might have an impact on the environment or our cultural heritage.

An ethics opinion from an appropriate Reviewer must be obtained before you can commence any data collection activity.

  • For staff and PGRs (high risk) this will be provided by a Central Research Ethics Panel
  • For PGRs (low risk) this will be provided by an Ethics Champion (Department)
  • For UG/PGT students (high risk) this will be provided by an appropriate Ethics Programme Team
  • For UG/PGT students (low risk) this will be provided by the Named Supervisor.

Data collection activities should not start until you have received a Favourable Opinion and your checklist has been approved online.

What type of activity may not require a formal ethics review?  Examples include patient and public involvement (PPI) to inform future research, audit, course or service evaluation.  Please refer to the research ethics code of practice (specifically 5.1 and 5.5).

How to seek a formal ethics review

  • Complete the online ethics checklist and don’t forget if recruiting human participants to attach relevant supporting documents such as Participant Information Sheet (PI Sheet), Participant Agreement Form (PAF), a copy of the questionnaire, interview/focus group schedule including questions, recruitment materials such as a poster, social media posts etc – any material that a participant will read needs to be reviewed.

Key Resources

To conclude this week’s spotlight on research ethics, ‘Research cannot be rendered ethical by completing a one-off administrative task… researchers and evaluators need to work in an ethical way throughout the research process[1].’

As we discussed earlier this week, it is important to think of the ethics process as a ‘live’ issue.  Some key examples are given below:

  • The data. What have you collected; does it contain personal information/special category data?  Are your data management plans still relevant?
    • If collecting personal or special category data, you need to consider data minimisation. This means minimising the scope of the data (i.e. data fields) which are necessary for the research.  Steps include limiting the scope of the data collected, deleting data fields when no longer required, masking some data fields to reduce identification risk or fully anonymising data, setting access restrictions in respect of data in an identifiable form.
  • Wellbeing both physical and emotional. This is important when in the field, for you and your participants but also extends to the data analysis phase, particularly if reliving the discussion, which can be traumatic depending on the topic.
  • Planned aftercare: If recruiting participants what relationship might develop between you and your participants? How will the activities conclude and what would be appropriate participant aftercare?
  • Planned dissemination/outputs: could the results be misused by people with different agendas?
  • Ethics submission. It is your responsibility to ensure that where the scope of the research project changes, such changes are evaluated to ensure that the Favourable Opinion you have been issued remains appropriate.    If your agreed research protocol has changed, you should complete an Amendment Request Form before changes are implemented.

Help is always on hand

If you have a question related to research ethics, there are a few avenues where you can seek advice:

  • Students should contact their supervisor in the first instance
  • Staff can contact a member of the Research Ethics Panels for an informal chat.
  • You can also contact a member of the RDS Governance Team by emailing Research Ethics

[1] Helen Kara, 2018. Research Ethics in the real world, Policy Press

Research Ethics – Central Research Ethics Panels

By Prof Jonathan Parker, Chair of the Social Sciences & Humanities Research Ethics Panel

Research EthicsIt can be very easy to become a little confused about research ethics processes within universities. The spread of research ethics review has grown inexorably in the UK since 2005 when the, then, Department of Health introduced research ethics scrutiny into social care following developments since Nuremberg and the Declaration of Helsinki which established biomedical ethical review processes to safeguard against potentially serious harms to research participants. The introduction of research ethics into arts, humanities, and social sciences, alongside biomedical and natural science research, has not always been easy, and confusions with homogenous processes have been critiqued. However, over the last 16 years, UK universities have seen the establishment of research ethics review processes through the formation of research ethics panels. These differ across universities in their operational minutiae and focus, although there are similar forms and underlying criteria in each to ensure that funding bodies, publishing houses and universities can assure themselves of due process and consideration in safeguarding both those participating in research studies and themselves.

At BU, research ethics is governed by an overarching university research ethics committee, which is chaired by an independent lay member. This committee deliberates the processes of research ethics in two operational panels and develops strategies and policy that are presented to Senate for consideration and ratification. It is the two research ethics panels with which most academics are likely to have dealings. We have one panel specifically dedicated to science, technology and health research chaired by Prof Sam Porter and a second concerned with the social sciences and humanities (including practice-based arts) chaired by Prof Jonathan Parker. Both panel chairs are supported by a deputy – Associate Prof. Dr Jayne Caudwell in science, technology and health and Prof Richard Berger in social sciences and humanities. The panels comprise members from across the university’s faculties and departments aiming for broad expertise, disciplinary scope and balance. Roles on the panels are undertaken for a period of three years, with the opportunity of renewal (maximum five years), to ensure there is continual refreshing of the membership, thinking and practice and also continuity.

Each panel meets on a monthly basis to scrutinise research ethics checklists and accompanying documentation, such as Participant Information Sheet and Participant Agreement Forms, from academic staff and PGRs (high risk) to ensure that ethical, moral and governance issues are met and to offer advice and support to researchers. The researchers, themselves, are invited to attend discussion at a panel meeting, which currently takes place online, and to present their studies and engage in debate about the ethical implications of their work and how potential harms can be prevented and mitigated. The process is designed to be collegiate and supportive and to ensure that research can be undertaken. Of course, attending the panel can raise anxieties but members try hard to put people at their ease and to keep the focus on developing the best possible research project in ethical terms. The panels are there to consider first and foremost any ethical issues that may arise within the proposed research and how this is addressed. However, it may be the case that questions are raised about the way the research is presented in outward facing documents or how the research is designed. The reasons for this are not to take issue with the academic thrust or to champion a particular methodology or research philosophy but to consider the effects on people and the confidence they can have in the research – so, they become an ethical concern.

What we look for in a good, ethically sound research proposal is:

  • A clear, coherent approach to the research
  • Explicit consideration of issues affecting potential participants, researchers, general public, discipline and university
  • A concern for moving beyond from simply ‘doing no harm’ to actively benefitting people and society wherever possible
  • A focus on maintaining dignity, privacy and confidentiality
  • Ensuring people are not identified and that participants can be assured of their anonymity, or able to waive that where appropriate and wanted, when research is disseminated
  • Finding ways for people often excluded or hidden from having a voice to participate and be included within research studies
  • Emphasising the voluntary nature of participation and consent for involvement except in the most exceptional circumstances
  • Sound data management plans and safe, GDPR compliant storage of data

The panels only scrutinise PGR (high risk) and staff research and do not get involved in PGR (low risk), undergraduate or PGT projects as these remain within the purview of supervisors, ethics champions (pgr) and the respective programme ethics teams (ug/pgt) within departments. However, where members of staff have developed specific projects as part of the taught curriculum these may be viewed by panel as they become staff research.

The panels are constantly refreshing as mentioned above and if you are interested in developing your expertise in research ethics you may wish to put yourself forward as a potential member. Our RDS Research Governance Team, Sarah Bell and Suzy Wignall, without whom the panels could not operate, circulate calls at appropriate times and should you be interested you should contact your Deputy Dean for Research and Professional Practice.

Research Ethics – Pitching the Participant Information Sheet at the Right Level

by Prof Sam Porter, Chair of the Science, Technology & Health Research Ethics Panel

Research EthicsOne of the core principles of ethical research is that people should have a free choice as to whether or not they wish to participate in a research project, and that they should know what that will involve and how it might affect them before they make that choice. In short, they should give their informed consent. What we wish to concentrate on in this blog is the ‘informed’ bit of this phrase. In our work on ethics panels, we have sometimes observed applications in which almost all the concentration is on the ‘consent’ part, making sure that the paperwork giving permission to proceed is correct and watertight. This is unfortunate, because if someone is not properly aware of what they are letting themselves in for, then their consent is meaningless; it is ‘uninformed‘. This isn’t a matter of researchers deliberately setting out to hoodwink and deceive potential participants; it’s more a matter of them pitching the information at a level that compromises clarity and ease of understanding.

What we wish do here is to provide a few pointers that will help ensure that your Participant Information Sheet is written in a style that facilitates effective dissemination to potential participants of the information they require to make an informed decision.

  1. Avoid blinding by science: researchers can be so immersed in their research that the language of their subject area becomes so natural to them they assume that everyone shares that language. Rest assured that they do not. It is really important to avoid technical research terms in a Participant Information sheet and to describe what you are doing in language that will be understood by those not involved in your research speciality.
  2. Indeed, we would go farther than that. The language used in a Participant Information Sheet should be accessible to all those who are being asked to participate. Perhaps because they spend their working lives in tertiary educational environments, researchers tend to greatly overestimate people’s linguistic capacities. The US National Center for Biotechnical Information recommends that a patient information sheet should be pitched at a reading age of 11-12 years old. Indeed, this may not be young enough. There is evidence to indicate that the average adult reading age in the UK is 9 years old. Remember, this is an average which means lots of people have a younger reading age.
  3. Whatever you may think of its editorial line, you could do worse than model your language level on that of The Sun, which has a young reading age and adopts a clear, no nonsense, if sometimes overly aggressive style. While use of the active voice and a conversational tone is much more effective than passive formality, a Participant Information Sheet should always be polite, respectful and invitational in its approach.
  4. Pitching a Participant Information Sheet at a young reading age is not about being patronising but being clear. Indeed, the clarity that it demands is a very good exercise for researchers to make sure that, without the camouflage of technical jargon and convoluted language, their research project has a transparent logic and is practically cogent.
  5. Of course, one size does not fit all. For example, if you were conducting research into a health service organisation, it could be appropriate to include more professionally-oriented information in a Participant Information Sheet seeking to recruit senior health service managers than if members of the general public were being asked to be involved. Still, we would recommend always erring on the side of simplicity and clarity, rather than assuming knowledge that people may not have. If groups with different sorts of knowledge and perspectives are being asked to be involved, we would advise that separate, specifically targeted Information sheet should be used to inform the members of each group.
  6. You can check the reading level of your Participant Information Sheet on Word. We’ve done just that for this blog, and, despite its linguistic informalities, it has come out with a score of 43.8 on the Flesch-Kincaid reading-ease test, which puts it in the category of ‘Difficult to read’! Looks like it’s a matter of doing as we say, not as we do! Though, in our defence, that’s not easy.
  7. We tried harder and came up with: ‘People need to know what’s involved in being in a research project. They need to know before they agree to take part. Researchers need to be clear and simple when they tell them. They shouldn’t use jargon. They should use easy words and short sentences. They should think about using different ways to tell different types of people’. That got us a score of 85.2 – ‘Easy to read. Conversational English for consumers,’ which isn’t too bad in that it’s got us over the NCBI’s threshold of a reading age of 11-12 years, but that’s still two years older than the average UK adult’s reading age.

 

Research Ethics – Why Ethics is Important to Consider When Developing a research proposal

by Professor Richard Berger.  Deputy Chair and member of the Social Sciences & Humanities Research Ethics Panel

Research EthicsThis blog-post is about why thinking about ethics right at the start of your project – rather than at the end as almost an after-though (and yes, we have all done that) – is crucial to having a successful outcome. First of all, it is good research practice, and an important aspect of your identity as an active researcher. If that doesn’t persuade you, then the requirement from most funding bodies (all the good ones, anyway) is that all projects must be overseen by a robust ethics process. The ESRC’s Research Ethics Framework regards ethics procedures as an indicator of the project’s quality. So, thinking through the ethical implications of what you want to do, right at the very beginning of your research, should ensure that there are no hiccups along-the-way. For Gary Thomas, “[ethics] is about the conduct of your work: it is about how you think about inquiry, how you think about this research project; it is about your respect for others” (2013, p.38).

BU has not just a responsibility towards you, but to your participants, and so it is vital that you plan well-ahead for their welfare and well-being. All research should be ethical, for as Martyn Denscombe writes: “[Research] should strive to produce something for the public good, and should never be frivolous, selfish or malicious in its aims” (2021, p.221). Alan Bryman’s book on social research methods – see References below – demonstrates very effectively that research which has been designed with ethics as an after-thought often leads to dubious practices, and unreliable and unverifiable data (2008, pp.114-115). As a researcher, you have a duty of care to your participants, and so the core of your ethics planning then, should be ‘consent’, and how you are going to gain it.

If you are going to anonymise your participants, then you need to plan in advance how you are going to remove any identifying markers; you will then need to explain this in your Participant Information Sheet (PI Sheet) – which is part of your ethics preparation, along with the checklist: “During the planning phase you must clarify and resolve issues of confidentiality and anonymity” (Davies, 2007, p.45). Similarly, you are going to need to plan for how you are going to handle and store your data/findings – and communicate this to your participants in the same way. So, spending some time at the start of your activity, thinking about this, should help in shaping your approach. If you are called to an ethics panel (and we are a friendly and supportive bunch!), then they will be interested in this relationship between the researcher and the researched.

Inevitably, further ethics issues often arise during the research project, so it is also important to think of the ethics process as a ‘live’ issue, and not something that just needs to be got-out-of-the-way. To help with this, Cheryl N. Poth has a series of questions, under three headings which you should be continually thinking about (2012, pp.26-27):

Respect for persons:

  • How will you ensure free and informed participation in your research?
  • How will you avoid interference or coercions?

Concern for Welfare:

  • How will you minimize hard and maximise the benefits of your research?
  • How will you protect the privacy and confidentiality of those involved in the research?

Concern for Justice:

  • How will you treat people fairly and equitably in your research?
  • How will you select participants, collect data, and report findings and avoid bias?

Finally, with the academic freedom we all enjoy, comes great responsibilities. Thinking about your ethical conduct throughout, and asking yourselves these questions continuously, should ensure that your project is as successful as it can be, and will have the most value, as a ‘complete’ piece of scholarship.

References & Further Reading.

Arthur, J, Waring, M, Coe, R & Hedges L, V., 2012. Research Methods and Methodologies in Education. London: Sage.

Bryman, A., 2008. Social Research Methods. Oxford: Oxford University Press.

Cohen, L, Manion, L & Morrison, K., 2011. Research Methods in Education. London: Routledge.

Crotty, M., 1998. The Foundations of Social Research: meaning & perspective in the research process. London: Sage.

Davies, M, B., 2007. Doing a Successful Research Project: using qualitative or quantitative methods. Basingstoke. Palgrave Macmillan.

Denscombe, M., 2021.The Good Research Guide. London: McGraw Hill.

Poth, C, N., 2021. Little Quick Fix: Research Ethics. London: Sage.

Thomas, G., 2013. How To Do Your Research Project. London: Sage.

Research Ethics in a Clinical setting

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)

Request for feedback – MHRA clinical trials consultation

The Medicines & Healthcare products Regulatory Agency (the MHRA) have launched a public consultation into clinical trials.

The aim of the consultation is to streamline approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement.

There will be a 1 hour meeting on Monday 14th February at 1pm until 2pm, where you can offer your thoughts and feedback for BU’s institutional response.

If you wish to attend the meeting, please get in touch to be added to the invitation.

If you are unable to make the above time but wish to offer your thoughts, please email clinicalresearch@bournemouth.ac.uk to ensure your feedback is included.