Tagged / research ethics

REMINDER – Training opportunity: completing and submitting your IRAS application

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 102, this Thursday 28th March at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

Training opportunity – completing and submitting your IRAS application

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 102 Thursday 28th March at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

Clinical Research Transparency – Responsibilities

Researchers, sponsors and funders have responsibilities – that may be legal requirements or ethical and moral expectations within an accepted governance framework of best practice and standards – to participants in research, patients and the wider public and research communities.’

The HRA have recently released a page of useful links and guidance that encompasses areas such as ‘top tips for transparency’, making your research results public, and also registering your study.
Related to this, hopefully you will have seen a recent blog post regarding the HRA’s commitment to ensuring research transparency. This has been a hot topic lately, and the subject of a recent House of Commons Science and Technology Committee report.

Take a look at the HRA guidance here.

BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. It is free to use.
Despite the name, the system may be used for other clinical research projects.

Informed consent training – sessions available

When conducting research with human participants, it is essential that participants are fully informed as to the details of the study and what is expected of them by participating.

Participants’ informed consent is imperative, and should be in place prior to any data collection activities.

Sarah Bell (Research Governance Advisor) and Suzy Wignall (Clinical Governance Advisor) will be running sessions on informed consent procedure, scheduled for Tuesday 26th March. These sessions are open to staff and postgraduate researchers conducting research/hoping to conduct research with human participants.

We will be running two sessions on this day –

Talbot Campus (P425, Poole House) – 09:30am – 11:00am
Lansdowne Campus (B242, Bournemouth House) – 2:00pm – 3:30pm

If you are interested in attending one of the above sessions, please email Research Ethics.

Training opportunity – completing and submitting your IRAS application

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 102 Thursday 28th March at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

Informed consent training – sessions available

When conducting research with human participants, it is essential that participants are fully informed as to the details of the study and what is expected of them by participating.

Participants’ informed consent is imperative, and should be in place prior to any data collection activities.

Sarah Bell (Research Governance Advisor) and Suzy Wignall (Clinical Governance Advisor) will be running sessions on informed consent procedure, scheduled for Tuesday 26th March. These sessions are open to staff and postgraduate researchers conducting research/hoping to conduct research with human participants.

We will be running two sessions on this day –

Talbot Campus (P425, Poole House) – 09:30am – 11:00am
Lansdowne Campus (B242, Bournemouth House) – 2:00pm – 3:30pm

If you are interested in attending one of the above sessions, please email Research Ethics.

Training opportunity – completing and submitting your IRAS application

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 102 Thursday 28th March at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

HRA responds to paper outlining concerns over study set-up delays

Two researchers from the University of Cambridge recently published an article in which they expressed their concerns over the ethics review and study set-up of a project, that was submitted in 2013.

Their study wished to recruit healthcare staff, which under the current system only requires HRA approval and not NHS Research Ethics Approval. However at the time of this study’s set-up, NHS Research Ethics clearance was a requirement.

Here are a few figures from the article which highlight the inadequacies of the previous system, that researchers had to navigate to undertake NHS-based clinical research.

  • Approx. 89 individuals were involved in the study approvals;
  • 81 named individuals were communicated with regarding ethics and governance approval via email, telephone or in person;
  • 35 of the research participants were healthcare employees, translating to approx. 2 approvers per participant;
  • 491 exhanges took place with the 89 individuals, generating 193 pages of text.

Even though the above are rather off-putting, the Health Research Authority approval system has substantially improved timelines, efficiency and support for researchers and applicants. The new procedure was introduced in April 2016.
Now when you liaise with the HRA and Research Ethics Committee, you have one named contact for each team – a HRA Assessor and the REC Manager.

You can read the HRA’s response here, which signposts the reader to further resources.

Likewise at BU, dedicated support is on offer if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog for guidance, further reading and regular updates.

EoIs invited for BU Ethics Panel Chairs and Deputy Chairs

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

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

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

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

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

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

EoIs invited for BU Ethics Panel Chairs and Deputy Chairs

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

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

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

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

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

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

NHS Research Ethics Committee Members day 2017

Tuesday saw the annual NHS Research Ethics Committee (REC) members training day in London. The learning outcomes of the day were:

  • To provide overview of the pilot work being undertaken in preparation for EU Clinical Trials Regulation
  • To introduce the REWARD Alliance and,
  • To consider how ethics committess can encourage researchers to engage more fully with the scientific literature both before and after studies are conducted

The morning focussed on updates on ethics regulatory procedures, the EU (see link below for slides) and changes in the Data Protection Act (but not the law of confidentiality) that have implications beyond healthcare research. There is also movement for a Public Involvement in Ethical Review (PIER) service, as well as adopting ‘e-consent’ for participation in health research.

EU Regulation_UK Research Ethics Service

The afternoon focussed on the REWARD Alliance and how ethics committees (and researchers) can help reduce waste in research. This group was established to promote a series of articles on research published in early 2014 in The Lancet.

Figure: Stages of waste in producing and reporting of research evidence (Chalmers & Glasziou, The Lancet 2009).

As a researcher and ethical reviewer, the day was insightful, interesting and relevant. Knowledge of the REWARD Alliance, particularly how researchers should diligently plan and prepare projects with clear pathways to dissemination. Although publishing demands differ between academia and industry (including pharmaceutical companies), all research should be designed fom the outset with clear outputs to communicate the findings.

If you would like further information from the day, send me an email.

James

Research Ethics: Insights from the Centre for Midwifery, Maternal & Perinatal Health and the Centre for Social Work, Sociology & Social Policy

Ethics contributions

Collage of research ethics contributions

Academics based in HSC have experience in a wide-range of research.  In the process of reflecting on all aspects of the research process several members of HSC have published about ethical issues that they have had to address in their own research.    This BU Blog highlights some of these key HCS papers which may help fellow academics and students across the globe address similar ethical questions.  HSC has a history of publishing on research ethics, Professor Emerita Immy Holloway wrote about the researcher who may have a dual role, or even conflicting role, as researcher and health care professional (1).  More recently, several midwifery researchers in the Centre for Midwifery, Maternal & Perinatal Health wrote about the issues facing practitioners doing research in the field where they work, especially concerning the similarities and differences between professional ethics and research ethics (2-3).  Negotiating ethical paths cleaved by competing concerns between protecting research participants and over-managing the ethical process is tricky.

In her book Rainforest Asylum: The enduring legacy of colonial psychiatric care in Malaysia Dr. Ashencaen Crabtree in the Centre for Social Work, Sociology & Social Policy, addresses the problematic issue of gate-keepers in research together with the ethics of critical observation of abuse (potential or actual), as well as the ethics of advocating on behalf of research participants (4).

The fear that the ethical application process in the UK is becoming more and more cumbersome and bureaucratic has been widely recognised as highlighted by Prof. van Teijlingen and colleagues (5-6).

Research ethics review processes are also considered in terms of access to participants regarded as ‘vulnerable’ in a recently published paper by Dr. Ashencaen Crabtree (7) of ethnographers working in health settings who are seeking to understand the context of care and patient/service user experiences.  She concludes that paternalistic control of participation on the grounds of ethical protection of vulnerable people seriously disenfranchises potential participants in preventing them from being able to share their relevant, lived experiences as recipients of service provision.

Prof. van Teijlingen and BU Visiting Fellow Dr. Padam Simkhada highlighted that the social, cultural and economic contexts in which research is conducted often differ between developing and developed countries.  However they stress that researchers need to apply for research ethics approval to the relevant local authority, if national legislation requires one to do so (8).

A new and challenging area of research is the use of discussion boards as a source of research data.  In their paper Dr. Bond and BU colleagues discuss both practical and ethical dilemmas that arise in using such data (9). In earlier research, Prof. Parker of the Centre for Social Work, Sociology & Social Policy, highlighted some of the benefits and dangers of using email and the Internet for research as the potential for electronic media continues its rapid growth (10).

Obtaining informed consent is something that all researchers need to consider. However, in some research situations obtaining consent can be particularly challenging.  Prof. Hundley and colleagues discuss the ethical challenges involved in conducting a cluster randomised controlled trial, where consent needs to be considered at a number of levels (11).  In a second paper issues of consent during pregnancy, where there is the potential for harm to two participants, are considered (12).

In research into the implications of the Mental Capacity Act 2005 for social research, Prof. Parker explored the contested meanings and difficulties associated with informed consent in social research, highlighting some of the challenges raised by an almost unquestioned acceptance of biomedical research ethics in social research and questioning whether potential ‘harm’ is different in this context (13, 14). This research has led to further explorations of the potential for ethical covert research by Prof. Parker and Dr. Ashencaen Crabtree.

 

The way forward

There a plenty of challenges to research ethics in both the health and social care sectors.  Ethical considerations relate to technological developments such conducting research over the Internet or the analysis of tweets.  HSC staff will continue to publish on a range of moral dilemma as well as practical issues related to research ethics.  Moreover, academic from the two centres are planning a Masterclass on research ethics to be held in early 2014.

 

 

References

  1. Holloway, I., Wheeler, S. (1995) Ethical Issues in Qualitative Nursing Research, Nursing Ethics 2: 223-232.   Web address:  http://nej.sagepub.com/content/2/3/223.full.pdf+html
  2. Ryan, K., Brown, B., Wilkins, C., Taylor, A., Arnold, R., Angell, C., van Teijlingen, E. (2011) Which hat am I wearing today? Practicing midwives doing research, Evidence-Based Midwifery 9(1): 4-8.
  3. van Teijlingen, E.R., Cheyne, H.L. (2004) Ethics in midwifery research, RCM Midwives Journal 7 (5): 208-10.
  4. Ashencaen Crabtree, S. (2012) Rainforest Asylum: The enduring legacy of colonial psychiatric care in Malaysia, London: Whiting & Birch.
  5. van Teijlingen, E., Douglas, F., Torrance, N. (2008) Clinical governance and research ethics as barriers to UK low-risk population-based health research? BMC Public Health 8(396)                            Web address: www.biomedcentral.com/content/pdf/1471-2458-8-396.pdf
  6. van Teijlingen, E. (2006) Reply to Robert Dingwall’s Plenary ‘Confronting the Anti-Democrats: The unethical Nature of Ethical Regulation in Social Science, MSo (Medical Sociology online) 1: 59-60  Web address:  www.medicalsociologyonline.org/archives/issue1/pdf/reply_rob.pdf
  7. Ashencaen Crabtree, S. (2013) Research ethics approval processes and the moral enterprise of ethnography. Ethics & Social Welfare. Advance Access: DOI:10.1080/17496535.2012.703683
  8. van Teijlingen E.R., Simkhada, P.P. (2012) Ethical approval in developing countries is not optional, Journal of Medical Ethics 38 :428-430.
  9. Bond, C.S,  Ahmed, O.H., Hind, M, Thomas, B., Hewitt-Taylor, J. (2013) The Conceptual and Practical Ethical Dilemmas of Using Health Discussion Board Posts as Research Data, Journal of Medical Internet Research 15(6):e112)  Web address: http://www.jmir.org/2013/6/e112/
  10. Parker, J.  (2008) Email, ethics and data collection in social work research: some reflections from a research project, Evidence & Policy: A Journal of Research, Debate & Practice, 4 (1): 75-83.
  11. Hundley, V, Cheyne, HC, Bland, JM, Styles, M, Barnett, CA.. (2010) So you want to conduct a cluster randomised controlled trial? Lessons from a national cluster trial of early labour, Journal of Evaluation in Clinical Practice 16: 632-638
  12. Helmreich, R.J., Hundley, V., Norman, A., Ighedosa, J., Chow, E. (2007) Research in pregnant women: the challenges of informed consent, Nursing for Women’s Health 11(6):  576-585.
  13. Parker, J., Penhale, B., Stanley, D., 2010. Problem or safeguard? Research ethics review in social care research and the Mental Capacity Act 2005. Social Care & Neurodisability, 1 (2): 22-32.
  14. Parker, J., Penhale, B., Stanley, D. (2011) Research ethics review: social care and social science research and the Mental Capacity Act 2005, Ethics & Social Welfare, 5(4): 380-400.

 

Vanora Hundley, Sara Ashencaen Crabtree, Jonathan Parker & Edwin van Teijlingen

 

 

FIF Networking visit to New Zealand

My Fusion journey started well before the Fusion fund came into being. Medicine 2.0 logoI’ve attended several Medicine 2.0 conferences, increasing my network of people researching in a similar area to myself along the way.  Last year this led to an invitation to visit Prof John Sullivan at the University of Otago, New Zealand. The University of Otago, founded in 1869, is New Zealand’s oldest university.

My research interests are around the role of the Internet and Social Media in supporting people living with long term conditions, and the related implications for healthcare professionals’ practice and education. Prof Sullivan researches in the area of sport concussion, including projects examining the role of the world wide web (www) in facilitating concussion awareness.

I applied to the Staff Networking and Mobility strand for support to take up this invitation, and was awarded funds for a 2 week visit to explore potential collaboration in research and education initiatives.

While I was there I was invited to give a guest lecture, where I shared some recent research I have undertaken into the ethics of using online discussion boards as research data. I was lucky enough to meet other Otago academics with an interest in this, including Dr Lynley Anderson in the Bioethics Centre, and Dr Lisa Whitehead, the Director of the Centre for Postgraduate Nursing.

I had an inspiring fortnight, mainly at the Dunedin campus. The School of Physiotherapy were kind enough to give me office space and computer access during my stay.  The University of Otago has grown over the years and has a historic core, surrounded by a collection of buildings of various ages and styles. Prof Sullivan took me on a walk around the campus and told me something of its history.

University of Otago.  Copyright C Bond
I also visited several local coffee shops, where a lot of networking meetings seem to happen. Prof David Baxter, the Dean, gave me an overview of the work of the School, and I discussed research into low back pain with Dr Ramakrishnan Mani, and use of the Internet in education with Dr Daniel Ribeiro.

I also visited the University of Otago’s Christchurch campus where Dr Whitehead is based.

The Centre for Postgraduate Nursing is located in the City Centre, and while there I took some time out to walk around the areas of the downtown area that have been opened to the public after the devastating earthquakes suffered by the city two years ago.

I’ve come back with ideas for two possible research projects that now need to be developed, and funding found.

If anyone would like to know more about my research, or to discuss the Staff Mobility and Networking fund, please email me (cbond)