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.
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.
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
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 Nepal. Developing World Bioethics, 17(2), 84–89. https://doi.org/10.1111/dewb.12123
All 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.
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).
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.’
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:
Help is always on hand
If you have a question related to research ethics, there are a few avenues where you can seek advice:
 Helen Kara, 2018. Research Ethics in the real world, Policy Press
By Prof Jonathan Parker, Chair of the Social Sciences & Humanities Research Ethics Panel
It 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:
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.
by Prof Sam Porter, Chair of the Science, Technology & Health Research Ethics Panel
One 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.
by Professor Richard Berger. Deputy Chair and member of the Social Sciences & Humanities Research Ethics Panel
This 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:
Concern for Welfare:
Concern for Justice:
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.
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.
Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?
If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?
The course has been developed by the University of Leeds and is be available from Monday 29th June, via this link.
It is completely free and all online, lasting 4 weeks.
This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.
Please see below for a recent update from the Health Research Authority with regard to a new amendment tool and the online submission of amendments.
If you have any queries please email Suzy Wignall in Research Development & Support.
Online submission of amendments and a new amendment tool will go live across the UK on Tuesday 2 June 2020.
These new processes for handling amendments are part of our ongoing Research Systems programme to improve services for applicants.
From 2 June, all applicants making an amendment to project-based research will need to complete the amendment tool and submit their amendment online. The tool replaces the Notification of Substantial Amendment (NoSA) and Non-Substantial Amendment forms. Amendments to Research Tissue Banks and Research Databases will also be submitted online from this date.
To help with these changes, we have now published:
For queries on how to complete the tool, questions on the results from the tool, once complete or how to submit your amendment online, please contact firstname.lastname@example.org
The new amendment tool should be used for all project-based research including amendments being made under the COVID-19 fast-track process, from 2 June. (Research Tissue Banks and Research Databases will continue to use the IRAS generated substantial amendment forms.)
The tool categorises the amendment and provides tailored guidance on how to submit. It will identify any review bodies the amendment needs to be sent to, based on the changes that are being made to the study. It also provides detailed information about the amendment to participating sites.
The Notice of Substantial Amendment/annex 2 form can be generated by completing the tool. This version of the form can then be submitted to the REC and the MHRA (as required) when making a substantial amendment to a trial.
The amendment tool is based in Excel, but in the longer term we plan to fully integrate the tool functionality into IRAS.
The introduction of the amendment tool may require changes to Sponsor’s quality system (e.g. SOPs, guidance documents and templates etc.). Organisations should do this in accordance with the new process in good time. Given the additional demands placed across the healthcare research systems at this time, the MHRA has confirmed that it will adopt a pragmatic approach during inspection.
Submitting amendments online
Once you have completed the amendment tool, you should follow the submission guidance provided in the submission guidance tab of the tool. If the amendment needs to be submitted, then the amendment tool, together with all the supporting documents, should be uploaded into a new part of IRAS and submitted using the online system.
For amendments to Research Tissue Banks and Research Databases the IRAS substantial amendment form should be submitted online in place of the amendment tool.
Applicants will need to set up a new login and password for the new part of IRAS. We are sharing a login process with NIHR systems for the new parts of IRAS that provide online booking, the Combined Ways of Working (CWoW) pilot, and this new amendment system. If you already have a login for any NIHR system or one of these new parts of IRAS you can use the same details. If you do not already have a login for those systems, you will need to set up a new login and password as guided by the system.
Once you have logged in, applications will need to input the IRAS ID for the study as well as some other information regarding the study and amendment, some of which will need to be copied directly from the tool itself. Applicants can upload documents including a pdf of the tool itself. The system will issue an email to confirm the amendment has been submitted.
Please see below for an update from the Health Research Authority with regard to the new system for booking in applications.
Any queries please get in touch with Suzy Wignall, Clinical Governance Advisor.
A new online booking service will be rolled out for IRAS studies on Tuesday 19 May – replacing the current Central Booking Service (CBS) telephone line. This is part of our ongoing Research Systems programme of work to improve our services for applicants.
Applicants submitting research projects through IRAS will no longer need to call the Central Booking Service to book a Research Ethics Committee, or to enable IRAS Form submission. Instead applicants will access the new online booking service via IRAS to book their application for review. The service is quick and easy to use and, unlike the current Central Booking Service, will be available 24 hours a day, seven days a week, making it easier for research applicants. If you need help and support with the new system you can call 0207 104 8008 between 8.30am and 4.30pm Monday to Friday.
In order to make use of this new functionality, applicants will be directed to a new part of IRAS which hosts the online booking service. A separate login will be required, but support will be provided. You will need to set up a new login and password for this area unless you already have a login for a NIHR system or as part of the Combined Ways of Working pilot (CWoW) pilot. In this case you can use your existing log in details.
Applicants will need to answer a series of questions online before being able to book a slot. This directs the applicant to the appropriate REC. The questions will be familiar to anyone who has used the CBS. Once you have completed your online REC booking, you will still need to electronically submit your application in IRAS using the normal process.
The work to build the online booking service began before the current COVID-19 pandemic. It is being rolled out now so that the system can support research applicants with non-COVID-19 studies.
Training and guidance will be available via the IRAS website. You can also watch a short video to see how to use the online booking service.
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.
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 email@example.com if a member of staff or your supervisor if a student.
You may have seen an earlier blog post with regard to a halt on the review and approval of undergraduate and master’s clinical research projects. The HRA have released another update with regard to all other research and the state of play due to COVID-19.
To recognise the significant pressures on the NHS at this time, the National Institute of Health Research (NIHR) announced that all new and existing studies supported through its Clinical Research Network would be paused to focus instead on COVID-19 research. You can read the full statement on the NIHR website.
Research Development & Support are also updating the following help page regularly for academics and researchers.
Tuesday 25th February 10:00 – 12:00 Talbot Campus
BU is committed to promoting and upholding the highest quality academic and ethical standards in all its activities, and requires that all research is subject to ethical consideration.
If ethical approval is needed, approval must be obtained before any data collection activities commence.
This workshop is designed to assist Researchers in the process of obtaining ethical approval.
Are you currently undertaking research within the NHS, and your Good Clinical Practice (GCP) training is due to expire? Or has it expired recently?
GCP certification lasts for two years, so if your training is due to expire, has expired, or you want to validate your learning, then take advantage of the upcoming refresher half day session, taking place at Dorset County Hospital, Dorchester on Tuesday 18th February, 9:00am – 12:30pm.
Spaces are still remaining, so if you’d like to enrol, get in touch with Research Ethics.
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.
Following the implementation of GDPR in May of this year, the Health Research Authority released transparency wording for use in Participant Information Sheets.
The recommended wording for data transparency has been updated following consultation with various stakeholders and public involvement and feedback on the initial published wording to provide a clearer more layered approach.
The user group developed a short summary text for the Participant Information Sheet which is supplemented by a generic leaflet. The text for both is now live on the HRA website.
To access the text to be used in preparing the leaflet to accompany your PI Sheet, click here. If you are on the HRA website section, the text appears once you click the heading ‘Template wording for generic information document’.
If you have any queries or concerns please email Research Ethics.
Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?
Yes? Then you may want to take advantage of this training opportunity.
Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS) will be running a training session on how to use, and complete your own application within the IRAS system.
IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.
The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.
The training will take place in Studland House – Lansdowne Campus, room 103, Tuesday 20th August at 09:30am – 12:30pm.
Get in touch with Research Ethics if you would like to register your interest and book a place.
The latest podcast from the National Institute for Health Research is available and this time concentrates on Research Ethics Committees.
All research with human participants should have appropriate ethical reflection – the podcast this month contains the thoughts and guidance of Dr Hugh Davies who is an established Research Ethics Committee Chair and former Ethics Advisor for the Health Research Authority.
If you are interested in learning more about NHS Research Ethics Committees you can view the dedicated section on the HRA website here, and even register your interest to sit as an observer at a committee meeting.