Category / BU research

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 Integrity – Research Misconduct

Today’s spotlight is on Research Misconduct.

The University’s Research Misconduct Policy & Procedure defines research misconduct to include (but is not limited to):

  • fabrication: making up results or other outputs and presenting them as though they were real;
  • falsification: manipulating research processes or changing or omitting data without proper cause;
  • piracy: the deliberate exploitation of ideas from others without proper acknowledgement;
  • plagiarism: the copying or misappropriation of ideas (or their expression), text, software or data (or some combination thereof) without permission and due acknowledgement;
  • misrepresentation: the deliberate attempt to represent falsely or unfairly the ideas or work of others, whether or not for personal gain or enhancement;
  • academic fraud: deliberate deception which includes the invention or fabrication of data and/or experimentation;
  • improprieties of authorship: including improper inclusion or exclusion of individuals as authors; misrepresentation or duplication of substantially similar material that has previously been the focus of one’s own published research findings without due referencing;
  • non-compliance of research governance: failure to comply with appropriate internal and external requirements such as regulatory, financial, legal and/or ethical approval;
  • serious breach of research ethics as defined in 8B – Research Ethics Code of Practice and where not dealt with through student/staff disciplinary or other University procedure;
  • facilitating misconduct in research: deliberate concealment of research misconduct by others or collusion in such research;
  • inciting others to commit research misconduct; deliberate encouragement of others to conduct research in an untruthful or unfair manner;
  • improper dealing with allegations of research misconduct: failing to address possible infringements such as attempts to cover up research misconduct and reprisals against whistleblowers.

BU acknowledges that whilst ‘honest errors and differences in, for example, research methods and interpretations are not examples of research misconduct, academics [researchers] are expected to maintain their knowledge and awareness of relevant internal and external requirements’[1].

How to report research misconduct

The Deputy Vice Chancellor (DVC) has overall responsibility for the policy and procedure and its implementation when a formal allegation of research misconduct against a member of the University is received.

Formal allegations of research misconduct should be put in writing to the DVC.  If you are unsure whether to report a breach of research integrity under the Research Misconduct Policy, you can seek confidential advice from the University’s Research Ethics Panel Chairs.  The Panel Chairs can help you to establish whether concerns related to research integrity should be reported for investigation.  Click on the University’s Named Contacts.

Further details about the reporting procedure can be found in the Research Misconduct Policy (section 6).

You can also report a concern about serious malpractice under the Public Interest Disclosure legislation – “Whistleblowing” (Disclosure in the Public Interest) Policy.

Breaches to research integrity can be damaging to individuals and cause reputational harm to both our research community and the University.  It undermines public trust and causes harm.  Therefore, understanding what constitutes misconduct and attending appropriate workshops is key to avoid making mistakes and to prevent breaches in research integrity.

Don’t forget

We are planning Research Integrity Week 2022, when keynote speakers and interactive workshops will be available, giving you the opportunity to find out more about research integrity, how it might impact your research, and the opportunity to discuss with others when dealing with issues which can come up in the field or working within your Teams.

More details to be announced over the coming weeks.

[1] 6M – Research Misconduct: Policy and Procedure

At the end with Endnote? Need a hand?

Why not join the Endnote Workshops to support your research….
EndNote is a tool designed to help you manage the large numbers of references accumulated through your research and it will interact with your word processor to produce in-text citations and references in many thousands of journal styles, including BU Harvard. It is also particularly valuable for supporting the production the systematic reviews. This practical session will guide you through creating your own EndNote database which you can use to search and sort your references.
Workshop: Endnote Desktop as a research tool 
  • Wednesday 9th February at 3-5pm in the Bournemouth Gateway Building BGG16
  • Wednesday 20th March 2-4pm
  • Tuesday 10th May 2-4pm
  • Tuesday 5th July 10am-12pm

Research Integrity – Clinical Research

by Suzy Wignall, Clinical Governance Adviser

All clinical research, whether a simple interview study or a clinical trial of a new medicine, must adhere to a set of standards called Good Clinical Practice, or in other words, ‘GCP’.

It is the international ethical, scientific and practical standard to which all clinical research is conducted and is in place to protect the rights, safety and wellbeing of research participants and to ensure the data collected through the research is credible and of a high quality.

GCP is a legal requirement in the UK, which stresses the importance of ensuring it is inherent throughout all research activities, regardless of the study type. Good data management and participant management guarantees the integrity of the research and the integrity of the researcher and their team.

Participants donate their time freely, and trust their sensitive data to the research team, therefore it is vital that said data is handled with care and their participation is valued.

A key component of GCP, is the feasibility process, or in other words, making sure those interested in conducting the research have the necessary facilities and measures in place to run the study safely and appropriately. This might be a hospital team, a GP practice, or even just an external colleague. Regardless, all involved must be appropriately trained and experienced, in turn again ensuring the integrity of the research and the research activities being conducted.

Research integrity and GCP go hand in hand and should be considered at every stage of the study, from design and planning, to receiving consent and data collection, right through to publication of the results.

Part of ensuring that research integrity is maintained, is by good documentation and filing. Under GCP, the ALCOAC general principles are key –

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Complete

If a total stranger was to review your study records, they should be able to re-create the study through the contents of the files. Indeed, clinical research is often monitored and audited, by both the organisations responsible for the study, and by regulatory bodies. Organisations can be prevented from conducting future studies if any critical findings arise from inspection, so integrity of the research and data is key from a reputational standpoint too.

Appropriate file-keeping and using the correct versions and dates of documents likewise ensures participant safety. When a participant is invited to a study, they should receive all the information they require and have the opportunity to ask questions or for additional documentation to allow them to make an informed decision. Not only does this then ensure you are receiving fully informed consent, but you are ensuring GCP standards are maintained.

Although this post has concerned integrity in clinical research, a lot of the good practice is transferable to non-clinical, particularly when studies involve human participants.

There are a number of documents available on the Research Governance & Integrity website (click explore Clinical Governance) such as a template file index, a new researcher checklist and template participant-facing documents. We advise that researchers at BU use these for all types of studies, to ensure the highest standards of research governance, ethics and integrity.

Research Integrity – Researchers’ Responsibilities

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

UKCGE Recognised Research Supervisors: Calling all doctoral supervisors

 

 

 

 

 

 

Come and find out about getting external accreditation for your wonderful doctoral supervision!

The UK Council for Graduate Education (UKCGE) runs a national recognition scheme for doctoral supervisors.

The Doctoral College is running two lunchbites to introduce staff to the scheme.

The Faculty of Health & Social Sciences is also running 3 sessions to support staff in reflecting upon their practice, and build in underpinning evidence. This is open to staff from all faculties to find out about the scheme and start to think about the different components. To submit the portfolio, you must have at least one doctoral completion. To book onto the sessions listed below, please contact Debbie Holley.

 The sessions are as follows:

Date/ Facilitators Time Description
Wednesday 16 February 2022

Professor Debbie Holley and  Professor Edwin van Teijlingen

13.00

Zoom

Session 1:

An introduction to the UKCGE scheme and aims of the Recognised Research Supervisor scheme

Tuesday 1 March 2022

Professor Debbie Holley and Professor Vanora Hundley

13.00

Zoom

Session 2:

An overview of the 10 areas of evidence and discussion

Thursday 26 May 2022

Professor Debbie Holley

Dr Vanessa Heaslip,

Dr Jacqui Hewitt-Taylor

13.30 – 16.30

F-2-F

UKCGE Panel Q&A and writing afternoon
Tuesday 21 June 2022

Professor Debbie Holley and Professor Sue Way

12.00

Zoom

Session 3:

Final polishing and ensuring a consistent reflective approach throughout the document

For further information contact Debbie Holley or The Doctoral College

Influencing Policy Workshop with Professor Mark Reed

If you would like your research to have an impact on government policy, or would like to influence the policy of large organisations, then this half day workshop by impact expert, Professor Mark Reed, of Fast Track Impact, is for you.

This online half-day workshop is open to all academics and there are limited places, so book via OD now! Once booked, you will be sent a Zoom link to join the session nearer the time.

The workshop is running on 1st March from 13:00-16:30 and places will be allocated on a first come first served basis.

During this workshop, you will discover quick and easy tools you can use immediately to:

  • Prioritise which policy actors to engage with first and how to instantly get their attention.
  • Create a powerful impact plan that will guarantee your research makes a difference without wasting your time.
  • Learn how to design an effective policy brief.
  • Pitch evidence-based policy options powerfully in meetings and seminars.
  • Learn how to get your research into policy, wherever you work in the world, by building trust and working with intermediaries.
  • Track, evaluate and evidence policy impacts, discovering time-efficient ways to keep track of impacts as they arise, and design an impact evaluation that convincingly attributes impacts to your research.
  • Be inspired by primary research and case studies that illustrate each point.

For more information, please contact Amanda Lazar.

 

 

 

Research Integrity and Institutional Support

Integrity should be integral throughout the whole project life cycle, from planning (design/proposal), study set up (methods, collaborations, data management), project management (finance, compliance, data collection), reporting (publication, impact & public engagement) to data sharing (closing your project).

BU is committed to maintaining the highest standards of research integrity in all aspects of its research.  To support Researchers in this endeavour we provide our research community with relevant policies & processes to appropriate codes of practice, robust review processes (compliance) and training opportunities.

We also provide contacts for those who might need confidential advice on concerns relating to research integrity.

Polices & Procedures

Navigating through the project life cycle can bring up many challenges and to support the research community we have a number of policies & guidance documents available.  These documents should be referred to at the very start, not just when a problem arises or for a particular milestone such as an ethics review.

For example….

Research data management is very important, particularly if you intend to collect personal information from a research participant.  You need to have a clear idea on the type of data do you intend to collect.  In this case, a data management plan is an invaluable tool which ensures the integrity of the data you want to collect.  There is a BU template available for you to use (see DMP online – link below).

Publication and authorship e.g. recognition of contributors, authorship, declaration of any conflicts of interest, meeting requirements for open access should also be considered early.  Having an open dialogue can prevent issues later down the line.

Ethics Review Process

Another way the University demonstrates a commitment to promoting and upholding the highest quality academic and ethical standards is to ensure we have a robust ethics review process in place.

The ethical design and management of research is the responsibility of the researcher and the task of the Reviewers/central research ethics panels is to ensure that the researcher (staff or student) has met their responsibilities and research will be conducted ethically.

More about the research ethics and why it matters next week!

Training Opportunities

There are numerous training opportunities via the Research & Knowledge Exchange Development Framework. Workshops are available to all academics and researchers.

For postgraduate research students, there are training opportunities available via the Research Development Programme.  See introductory video to the Programme and Researcher Development website for further details.

There are also a number of online resources via the Research Skills Toolkit which is available via the Research Governance & Integrity Website (training opportunities).

As different disciplines will have different issues of integrity, do check with your department as there may be discipline specific guidance on good research practice also available.

Resources

More details about the Concordats can be found on the Research Concordats website, specifically research integrity at  https://www.bournemouth.ac.uk/research/research-environment/research-concordat/concordat-support-research-integrity

Coming later this year

We are planning Integrity Week 2022, when keynote speakers and interactive workshops will be available, giving you the opportunity to find out more about research integrity, how it might impact your research and the opportunity to discuss with others when dealing with issues which can come up in the field or working within your Teams.  This will include both non-clinical and clinical research settings.

So, watch this space for more details.

Research process seminar this Tuesday at 2pm on Zoom. Applying Conversation Analysis to media texts. All welcome

You are warmly invited to this week’s FMC research process seminar. This week we are covering conversation analysis. Applied through examples of media texts but applicable across other disciplines too.

Applying Conversation Analysis to media texts – by Dr Spencer Hazel (Newcastle University)

​​This session will consider synergies between the work of the Conversation Analyst and the work of those in the media and/or performing arts tasked with producing representations of social interaction for an audience. We’ll consider both the possibilities and limitations of applying CA to media texts, and also how we can extend the field of CA by considering more closely the work that goes into producing dramatisations of social interaction.

Tuesday 18th January 2pm-3pm on Zoom

https://bournemouth-ac-uk.zoom.us/j/9292103478?pwd=UzJnNTNQWDdTNldXdjNWUnlTR1cxUT09

Meeting ID: 929 210 3478

Passcode: rps!4fmc

Hope to see you there

 

Concordat to Support Research Integrity

This week we focus on research integrity, and specifically on the Concordat to Support Research Integrity and why it matters.

Why is it important?

Integrity includes principles about the conduct of researchers, such as the practices of authorship, publication practices, peer review practices and the way in which research data is managed. It also includes the informed consent process. Good research practice instils public trust in our outputs and helps prevent research misconduct.

BU has adopted the Concordat to Support Research Integrity (2019) as a framework.  The Concordat contains basic commitments that underpin a research environment where best practice can thrive, and our Code of Good Research Practice interprets this in a practical way to highlight issues a Researcher may come across as part of the project life cycle.

The framework is top level, as good research practice can mean different things in different disciplines but by adopting these principles, it means the same standards apply across the board, but with freedom of implementation.

Definition of Research Integrity (as described in the concordat)

Honesty in all aspects of research, including in the presentation of research goals, intentions and findings; in reporting on research methods and procedures; in gathering data; in using and acknowledging the work of other researchers; and in conveying valid interpretations and making justifiable claims based on research findings.

Rigour, in line with prevailing disciplinary norms and standards, and in performing research and using appropriate methods; in adhering to an agreed protocol where appropriate; in drawing interpretations and conclusions from the research; and in communicating the results.

Transparency and open communication in declaring potential competing interests; in the reporting of research data collection methods; in the analysis and interpretation of data; in 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; and in 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. Those engaged with research must also show care and respect for the integrity of the research record.

Accountability of funders, employers and researchers to collectively create a research environment in which individuals and organisations are empowered and enabled to own the research process. Those engaged with research must also ensure that individuals and organisations are held to account when behaviour falls short of the standards set by this concordat.

More about the Concordat to Support Research Integrity

The Concordat (published by the Universities UK (UUK) provides the principles and commitments to ensure that research produced by, or in collaboration with, UK universities, research institutes and others undertaking research is underpinned by the highest standards of rigour and integrity. The Concordat was first published in 2012 and revised in 2019 in response to the recommendations set out in the Science and Technology Committee’s report on research integrity.

The Commitments

By acting in accordance with this concordat, members of the research community can demonstrate that they[1]:

  1. uphold the highest standards of rigour and integrity in all aspects of research
  2. ensure that research is conducted according to appropriate ethical, legal and professional frameworks, obligations and standards
  3. support a research environment that is underpinned by a culture of integrity and based on good governance, best practice, and support for the development of researchers
  4. use transparent, timely, robust and fair processes to handle allegations of research misconduct when they arise
  5. work together to strengthen the integrity of research

During this week the spotlight will also focus on:

  • BU’s Commitment to creating an environment that promotes an understanding of responsible conduct
  • Researchers’ responsibilities
  • Integrity as it relates to Clinical Research
  • Research Misconduct

 

[1] Concordat to Support Research Integrity

New BU publication on academic writing

Congratulations to Dr. Orlanda Harvey in the Department of Social Sciences & Social Work, Dr. Pramod Regmi in the Department of Nursing Science and FHSS Visiting Faculty Jillian Ireland, Professional Midwifery Advocate in Poole Maternity Hospital (UHD/University Hospitals Dorset NHS Foundation Trust) whose paper ‘Co-authors, colleagues, and contributors: Complexities in collaboration and sharing lessons on academic writing‘ was published today.[1] 

The paper argues that academic writing, especially in the health field, is usually an interdisciplinary team effort. It highlights some of the trials, tribulations, and benefits of working with co-authors. This includes collaborations and co-authorship between academics from different disciplines, academics of different level of careers, and authors from countries of varying economies i.e., high-income countries (HICs) and from low-and middle-income countries (LMICs). This paper also provides advice in the form of several useful tips to lead authors and co-authors to support collaborative working.  Our other co-authors are: Aney Rijal, postgraduate student and Executive Editor of the journal Health Prospect based in Nepal, and Alexander van Teijlingen postgraduate student in the Department of Pure and Applied Chemistry (University of Strathclyde, Glasgow, Scotland).

 

Prof. Edwin van Teijlingen

Centre for Midwifery, Maternal & Perinatal Health

 

Reference:

  1. Harvey, O., van Teijlingen, A., Regmi, P.R., Ireland, J., Rijal, A., van Teijlingen, E.R. (2022) Co-authors, colleagues, and contributors: Complexities in collaboration and sharing lessons on academic writing Health Prospect 21(1):1-3.

Free event – Q&A about engaging with Parliamentary Select Committees

If you would like your research to have policy impact, this free event being run by UCL is a great opportunity to find out more about  select committees and how to engage them with your research.

“This year marks the 120th anniversary of the IOE, UCL’s Faculty of Education and Society, and we will be bringing experts, senior academics, doctoral students and early career researchers together online on 27 January 2022 at 12.30pm to discuss effective ways researchers and the professionals who collaborate with them can work with Select Committees, engage policy makers with their scientific findings and achieve real-world change!

Join us for an insightful talk and Q&A with:

Much of the work of the UK House of Commons or House of Lords takes place in committees. There is a Commons Select Committee for each government department, examining three aspects: spending, policies and administration. These departmental committees have a minimum of 11 members, who decide upon the line of inquiry and then gather written and oral evidence. Findings are reported to the Commons, printed, and published on the Parliament website. The government then usually has 60 days to reply to the committee’s recommendations.

This interactive session consists of a brief introduction of the work of Select Committees, before sharing inside knowledge on how best to translate research findings into actionable recommendations that are included in their evidence reports, and launching into a Q&A session. Audience members are free to submit questions prior to and during the session.”

Places are limited and will be allocated on a first come, first served basis. Sign up to guarantee your ticket below:

https://www.eventbrite.co.uk/e/ioe-impact-meet-ups-online-working-with-uk-parliament-select-committees-tickets-229339248867