Category / Research Ethics

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

Research Ethics

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

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)

Request for feedback – MHRA clinical trials consultation

NHS, Research Ethics

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 Integrity – Researchers’ Responsibilities

Research Ethics

Today’s spotlight is on the Researchers’ Responsibilities

BU requires all those undertaking and/or contributing to research to adhere to the highest standards of performance and ethical conduct and embed good practice in all aspects of their work.  Researchers must operate honestly and openly in respect of their own actions and in response to the actions of others involved in research[1].

This means you need to:

  • Comply with and operate in accordance with the principles and practices set out in BU’s Code of Good Research Practice
  • Understand key university policies and procedures that relate to research. Know where to find them!  For those in receipt of external funding, you need to be aware of funder policies and guidance on research integrity.
  • Consider research ethics, this includes ascertaining at what stage of your research you will need a formal ethics review.
  • Make the most of training and other resources that are available to you.
  • Know who you can contact if you have concerns on matters related to research integrity (scroll down to BU contacts) or ethics.
  • Understand what constitutes Research Misconduct, so that it can be avoided.

Remember, there are a number of resources available to help you be that responsible researcher. The UK Research Integrity Office (UKRIO) have also produced a helpful Checklist for Researchers. This is a one-page, non-technical checklist highlighting key points of good practice in research.[2]

Remember the core elements of research integrity[3]

Honesty – in all aspects of research, including in the:

  • presentation of research goals, intentions and findings
  • reporting of research methods and procedures
  • gathering data
  • using and acknowledging the work of others
  • conveying valid interpretations and making justifiable claims based on research findings

Rigour in:

  • following disciplinary standard and norms
  • performing research and using appropriate methods
  • adhering to agreed protocol
  • drawing interpretations and conclusions from the research
  • in communicating the results

Transparency and open communication in:

  • declaring potential competing interests
  • the reporting of research data collection methods
  • the analysis and interpretation of data
  • making research findings widely available, which includes publishing or otherwise sharing negative or null results to recognise their value as part of the research process
  • presenting the work to other researchers and to the public

Care and respect for

  • all participants in research, and for the subjects, users and beneficiaries of research, including humans, animals, the environment and cultural objects
  • the integrity of the research record

Accountability:

  • of all those involved in the research process to collectively create an empowering and enabling research environment
  • to take action when behaviour falls short of the accepted standards of good research practice.

[1] Good Code of Research Practice

[2] UKRIO

[3] Concordat to Support Research Integrity

Updated HRA amendment tool now live

Guidance, NHS, Research Ethics

Please see below and note that from now any amendment made should be using version 1.6 of the document.

‘What: An updated amendment tool has been released for use when submitting amendments for health research studies

Who: All researchers and sponsors

When: Released 6 December

We’ve also made some other changes to the amendment tool to make it easier to use including:

  • improved guidance in the submission tab
  • changes to the radio selection buttons to make it clearer to complete and view once converted to a pdf
  • changes to help users avoid common mistakes

You can get all details on the changes we’ve made in the Change Record in General Guidance tab on the tool. Please start to use the new version (1.6) for all new amendments from 6 December 2021. We will continue to accept amendments using version 1.5 for two weeks. We will not accept amendments submitted on V1.5 after 20 December 2021.’

Please see this link for further information.

Paper published outlining good practice for receiving informed consent

NHS, Publishing, Research Ethics, Training

A paper has been published by Hugh Davies (Chair, Oxford A NHS Research Ethics Committee) and the members of Oxford A Research Ethics Committee (REC) which includes a model for what the REC considers to be good practice in terms of consent for research participation. The paper proposes that there are four simple steps which consent processes should be built around:

  • Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues.
  • Step 2: Explaining all the details of the study using the detailed Participant Information Sheet.
  • Step 3: After a gap, if necessary, reviewing and checking understanding.
  • Step 4: Reaching agreement and recording consent.

The paper outlines common issues such as information provision to participants, inadequate public involvement, and lack of proportionality.

You can access the paper here.

Remember that RDS offers training in informed consent, as does the National Institute for Health Research. If you are interested in accessing this training, please email Research Ethics.

Template documents are also available via the Health Research Authority website.

PGR Member Required – University Research Ethics Committee

PG research, Research Ethics, Research Integritiy

A fantastic opportunity has arisen for a new PGR member of the Research Ethics Committee (REC).

REC is responsible on behalf of Senate to promote best ethical practice in relation to research and research-related activities. Additionally, REC is responsible for the over-arching university-wide research ethics policies and procedures. REC considers ethical issues related to research and research-related activities brought to its attention by the Research Ethics Panels, researchers and the wider university community. REC is also responsible for constructing and maintaining the Research Ethics Code of Practice which informs local practices and procedures across the University, you can also view the REC Terms of Reference.

We are looking for someone to bring the student voice to this committee. The member must have a substantive understanding of research ethics, a keen interest and able to feed into the conversation of the committee. The committee meets 3 times per year of which it is expected that all members are present.

Next meeting dates: Wednesday 10 November, 2 March & 6 July; 2 pm – 3.30 pm and currently online.

If this is something you would like to be part of please email Natalie Stewart at pgrskillsdevelopment@bournemouth.ac.uk a short (~100 words) expression of interest (EoI) by Friday 15 October. If I receive more than 1 EoI we will go to a student vote where your EoI will be shared.

If you have any further questions about the committee please contact Sarah Bell or Suzy Wignall at researchethics@bournemouth.ac.uk.

Health Research Authority – new final report requirements

Guidance, NHS, Research Ethics

Please see below for an update from the HRA –

Changes to the way you submit your final report

The Health Research Authority has implemented changes to final study reporting requirements. The changes apply to all studies across the UK which require ethics approval and which have not yet submitted a final report.

The Make It Public strategy set out our commitment to make transparency easy, make transparency the norm and make information public. We have now developed a standard dataset on research transparency which will be collected in the study final reports. Coupled with changes we have already made to help you plan at the start of a study how you will inform participants at the end, these changes are steps towards fulfilling that commitment.

In the future we will be able to see more clearly what proportion of studies are fulfilling transparency requirements, including information about study registration, publication of results, informing participants of the outcome of the study and the sharing of data and tissue (if applicable).

In standardising the information we request from you and the form for collecting this, we hope it will be easier for you to know what is expected.

If you have any questions, please email research.transparency@hra.nhs.uk

Health Research Authority’s new student research eligibility criteria – live from today

Guidance, NHS, Research Ethics, student research

New eligibility criteria for standalone student research go live today (1 September 2021). These changes are designed to ensure that students’ experience of research reflects how modern health and social care research is conducted.

This new criteria encourages innovative approaches to student research like group research, mock Research Ethics Committees (REC) or shadowing a range of people in an existing project.

The changes mean some master’s students will now be eligible to apply for approval to carry out their research.

To help students plan their research we have created a new student research toolkit. The toolkit has been designed to pull together the resources a student will need to understand what approvals are required and whether they are eligible to carry out their research in the UK.  It contains links to existing decision tools as well as some new ones developed especially for students. It uses a simple question and answer format and will provide answers to the following questions:

  • Is my study research?
  • Is my research taking place in the NHS and will it need NHS approval?
  • Do I need NHS REC review?
  • What type of NHS ethics review do I need?
  • Can I carry out my research?

Completing the tool will provide students with an understanding of what activities they can do and ensures that they do not waste time applying for approval for research that they are not able to carry out under the new student eligibility criteria. Through completion of the toolkit, students can access supplementary declarations that need to be completed by their academic supervisor, confirming that they meet the criteria for the type of approvals they need for their research. There are three separate declarations depending on the approvals needed – the toolkit guides the student to the right one based on their responses.

Please share this update and new resource with colleagues and students who might benefit. Further details about the new eligibility criteria can be found on the HRA website.

Please see our question and answer section for further information. If you have any other queries about the eligibility criteria, please contact queries@hra.nhs.uk.

Please contact Suzy Wignall, Clinical Governance Advisor in RDS if you have any queries or concerns.

Health Research Authority Releases Question and Answers: Student Eligibility Criteria

Guidance, NHS, Research Ethics, student research

The Health Research Authority have published some questions and answers in relation to student research – this is in relation to the recent update regarding the upcoming changes to eligibility criteria.

You can find the Q&As here.

If you have any queries please contact Suzy Wignall, Clinical Governance Advisor in Research Development & Support.

Health Research Authority UPDATE: undergraduate and master’s research projects

Guidance, NHS, Research Ethics, student research

New eligibility criteria from 1 September 2021

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.

The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.

In March 2020 the HRA paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, they are introducing new eligibility criteria for standalone student research.

The new criteria mean that some master’s level students will be able to apply for ethics review and HRA/HCRW Approval or devolved administration equivalent. Standalone research at undergraduate level that requires ethics review and/or HRA/HCRW Approval (or devolved administration equivalent) cannot take place. Arrangements for doctoral research remain unchanged. Full details are in table one – permitted student research table. They have also made it clear when students are able to take the role of Chief Investigator, see table two – which type of students may act as Chief Investigator.

It is possible for students to learn about health and social care research without completing standalone projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of the HRA event ‘Exploring good practice in Student Research’ to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read the HRA website for further information and ideas https://www.hra.nhs.uk/student-research/.

The HRA are giving notice now so that course leaders and students have time to prepare for the new arrangements, including ensuring that any changes to institutional policies and procedures are made.

If you have any queries about the eligibility criteria, please contact queries@hra.nhs.uk or swignall@bournemouth.ac.uk

Free online course – Improving Healthcare Through Clinical Research

NHS, Research Ethics, Training

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 24th May, 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.

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

NIHR welcomes new vision for the Future of UK Clinical Research Delivery

NHS, Research Ethics

The National Institute of Health Research (NIHR) and partner organisations across the health research ecosystem have welcomed the publication of a bold and ambitious vision for the future of clinical research delivery in the UK.

This UK-wide vision sets out the ambition to create a patient-centred, pro-innovation and data-enabled clinical research environment, which empowers everyone across the health service to participate in delivering research and enables people across the country to take part in research that is of relevance to them.

The vision has been developed through the cross-sector Recovery, Resilience and Growth programme, with NIHR working alongside the NHS, regulators, medical research charities, life sciences industry, the UK government and devolved administrations.

You can read more here.

NIHR virtual event – Equality, diversity and inclusion in applied health and social care research

Guidance, NHS, Research Ethics, Training

The NIHR Research Design Service South East is hosting an event to discuss and explore what is meant by equality, diversity and inclusion in research and the importance of thinking about it when planning your health or social care research project.

Professor Kamlesh Khunti, Director of the NIHR Applied Research Collaborations East Midlands and Centre for BME Health, will talk about his recent research on COVID-19 in ethnic minority populations. Dr Esther Mukuka will talk about her new role as the Head of Equality, Diversity and Inclusion at the NIHR, and the increasing emphasis being put on those that apply for any NIHR funding to demonstrate their commitment to equality, diversity and inclusion and a healthy research culture more generally.

The presentations will be followed by informal workshops to look at different case studies demonstrating the application of equality, diversity and inclusion principles in research.

The event is open to anyone with an interest in applied health and social care research.

Sign up online

https://www.nihr.ac.uk/events/equality-diversity-and-inclusion-in-applied-health-and-social-care-research/27216?utm_source=newsletter-fs&utm_medium=email&utm_campaign=fs-2021-04