Research Ethics & the UREC · •In support of those seeking GCRF funding … anyone with relevant experience interested in speaking at/being involved in developing this event please
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Research Ethics & the UREC Professor Peter Bath, Chair of UREC
University Research Ethics policy • Applies to all staff and students at the University • Relates specifically to: “all research involving human participants, personal data, or human tissue” and underlying this: • “respect for the participants' welfare and rights” http://www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy
Definition of ‘research’
• ‘a process of investigation leading to new insights, effectively shared’* including:
work of educational value designed to improve
understanding of research process
administrative research e.g. by Professional Services
*definition taken from Research Excellence Framework 2014
Definition of ‘research’
• But NOT including:
Routine audit and evaluation Routine testing and analysis of
materials, components, processes etc
• Ethics is part of doing the best
possible research...with integrity • Ethics is about how we conduct our
research, from start to finish. • Ethics is about how we treat those
involved in, or affected by, our research.
The University’s approach
• UREC – oversight & monitoring (representatives from each Faculty)
• Devolved to departments to ethically review applications
• Each department has: o A pool of ethics reviewers o a Principal Ethics Contact o an Ethics Administrator
The University’s approach
• Based on trusting colleagues but balanced with monitoring
• Based on the belief that disciplines know their own fields best
• Based on policy dissemination and staff development
The University’s approach
• Based on the belief that self-regulation results in greater engagement than top-down regulation
• Based on the belief that involving more people in ethics review results in a greater awareness
• To promote awareness and understanding of research ethics throughout the University
• To advise on any research ethics matters that are referred to it from within the University, including on the interpretation of the Research Ethics Policy
• To regularly review the Research Ethics Policy and monitor the ethics review procedure as administered by departments
• To keep abreast of the external research ethics environment and ensure that the University responds to all external requirements.
UREC’s key tasks…
• The ethical review of individual applications:
• unless an applicant has appealed, or • the department cannot reach a decision.
• Give advice on ethical issues that are not concerned with research.
What UREC doesn’t do…
from UREC
• New Ethics Policy approved Dec 16 • Reviewed and updated throughout • New Policy Note on research involving social media • New Policy Note on re-use of data (& new self-
declaration system to be introduced soon for re-use of anonymised data)
• Review of online system • Survey of system users Summer 2016 • UREC working to prioritise requests for
updates/amends, to take place over coming year
from UREC
• UREC workshop on the risks and challenges of research in developing countries
• Planned for Spring 2017, date TBC soon • In support of those seeking GCRF funding
… anyone with relevant experience interested in speaking at/being involved in developing this event please speak to Lindsay!
Policy Overview Where can approval be gained from?
NHS ethics review procedure/ Social care research ethics committee
An alternative ethics review procedure - Research led by another UK University/ research organisation
- Research conducted outside the UK (These procedures must have been judged to be sufficiently robust by the University Research Ethics Committee (UREC))
Generally applicable for research involving NHS patients (inc. data) or Social Care users
University of Sheffield ethics review procedure
Presenter
Presentation Notes
This slide introduces the alternative routes by which ethical approval can be obtained. While all ‘research projects involving human participants, personal data or human tissue’ are required to undergo an ethical review procedure, this does not necessarily have to be TUOS’ procedure. Indeed, much research is required by its funders/ other regulatory mechanisms to undergo an alternative ethical review process. Alternative review processes are: NHS Ethics review (Ethics Policy Note 5) www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/health-social-care/procedure There is a long established procedure of ethical review within the NHS whereby reviews are undertaken by an NHS Research Ethics Committee (NHS REC). The remit of the NHS REC’s are defined by the Department of Health’s (DOH) Governance Arrangements for research ethics committees. Of note, only NHS RECs can review trials of Investigational Medicinal Products and see Ethics Policy Note 11 for information on research involving Human Tissue (www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/human-tissue). However, if research within the NHS falls outside the requirements for NHS REC review, but still involves human participant, their personal data or tissues it must be reviewed by either TUOS review process or an alternative ethics review process. Social Care Ethics Review (Ethics Policy Note 5) The Social Care Research Ethics Committee (SCREC) can consider applications in relation to certain types of social care research: DoH funded staff led projects with adult participants; staff led social care projects with adults who lack the capacity to consent for themselves; research involving the withdrawal of care; research involves NHS patients or service users as research participants and research which is a social care research project funded by the DoH. Further information on the ethical considerations of work with these groups can be found in Ethics Policy Note 6 (Research with vulnerable people) and the Specialist Guidance papers on researching Young People; Older People; people with learning difficulties and adults lacking the capacity to consent) Other Alternative Ethics Review Procedures If the research is being conducted collaboratively and another University is the lead institution, the ethical review processes should take place in that Institution, provided that they are their ethical review procedure is sufficiently robust. Research which is conducted overseas and which will involve human participants from that country may require the appropriate ethical review for that country. If this is completed, it may not be necessary to complete the University Ethical Review procedure provided that the ethical review procedure for that country has been judged sufficiently robust. A list of institutions (UK and International) where the procedures have already been judged as sufficiently robust, can be found at www.shef.ac.uk/polopoly_fs/1.105598!/file/Alternative-Ethics-Review-Procedure.pdf. If the institutions procedures have not been judged sufficiently robust, the UREC minute secretary should be sent details (outlined in guidance notes) in order to carry out an assessment. For more guidance see: www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure/alternative-review-procedure/judging-another-ethics-procedure.
Procedures How does the University ethics approval process work?
Each department has: - a Principal Ethics Contact (responsible for communicating
the policy and any changes that occur) - an Ethics Administrator (responsible for the day-to-day
administration of the procedure). These contact details can be found at:
- A pool of ethics reviewers who conduct ethical reviews along with supervisors of UG/PGT students
Departmental Devolution
Presenter
Presentation Notes
This slide begins to introduce the processes which take place at a Departmental Level Departmental Devolution: The devolution of decisions to departments is based on the belief that individual disciplines know their fields best and therefore have the fullest understanding of practices and ethical issues in their area. This devolved administration relies on trust and autonomy between colleagues (with a balance of monitoring) and the dissemination of policy and staff development (which itself is enhanced due to greater involvement in the process). Every Department has a designated Principal Ethics Contact (and an Ethics administrator who coordinate and record the process) together with a pool of reviewers. Any University member of staff can become an ethics reviewer (with the approval of their Head of Department). The presentation now continues to look at how the reviews take place using these structures.
Departmental Processes: The process of departmental ethical review is dependent on the applicant type. Processes for Undergraduate/ Taught Postgraduate (both high and low risk and ‘generic applications’) and Postgraduate Research/ Staff are explored in greater detail on the following slides. There is also a process for research undertaken by the professional services within the University. For projects where the funder requires lay input to the process (for example, Economic and Social Research Council), a sub committee of the UREC will be arranged consisting of 2 representatives from the project’s department, a lay member and any additional members as required by the funding conditions. The UREC will also consider appeals against applications from departments or reach decisions where a consensus is not reached in a department (however, a departmental ethics review panel of at least three reviewers from within the department must first have considered the application or the appeal). The following slides therefore address the processes for Undergraduate Projects (both high and low risk); Generic applications and Staff led/ PGR projects.
• Perform Supervisor check • If issues, ask student to re-submit • If happy, sign declaration • Assess the risk & confirm if you will review • Low risk – do ethical review • High risk – Ethics Administrator will assign
2 reviewers
Assessing risk Potentially vulnerable people… •People whose competence to exercise informed consent is in doubt (children, those lacking capacity, poor English) •People who may socially not be in a position to exercise unfettered informed consent (school pupils, prisoners, armed forces, asylum seekers) •People whose circumstances may unduly influence their decisions to consent (those in poor health, relatives of vulnerable people)
Presenter
Presentation Notes
(a) People whose competence to exercise informed consent is in doubt, such as: infants and children under 18 years of age; people who lack mental capacity; people who suffer from psychiatric or personality disorders, including those conditions in which capacity to consent may fluctuate; and people who may have only a basic or elementary knowledge of the language in which the research is conducted. (b) People who may socially not be in a position to exercise unfettered informed consent, such as: people who depend on the protection of, or are controlled and influenced by, research gatekeepers (e.g. school pupils, children and young people in care, members of the armed forces, young offenders, prisoners, asylum seekers, organisational employees); family members of the researcher(s); and in general, people who appear to feel they have no real choice on whether or not to participate. (c) People whose circumstances may unduly influence their decisions to consent, such as: people with disabilities; people who are frail or in poor health; relatives and friends of participants considered to be vulnerable; people who feel that participation will result in access to better treatment and/or support for them or others; people who anticipate any other perceived benefits of participation; and people who, by participating in research, can obtain perceived and/or real benefits to which they otherwise would not have access.
Assessing risk Potentially highly sensitive topics… •'race' or ethnicity; •political opinion; •religious, spiritual or other beliefs; •physical or mental health conditions; •sexuality; •abuse (child, adult); •nudity and the body; •criminal activities; •political asylum; •conflict situations; and
•personal violence.
Presenter
Presentation Notes
Key word is potentially- It should never simply be assumed that the above kinds of research participants and topics are under all circumstances 'vulnerable' or 'risky': an unreflective 'box ticking' approach in this respect is strongly discouraged. In the first place, researchers should reflect upon the specificities of each research project, and the risks and vulnerabilities it may, or may not, present or create should be documented and evaluated as part of the ethics review process. In the second, departments are encouraged to develop local definitions of risk and vulnerability that are appropriate to the nature of their particular research activities, providing these definitions are endorsed by the UREC.
PGR/staff applications
Generic/en bloc applications
Presenter
Presentation Notes
The administration of the Research Ethics Review process can now be facilitated by the online system if the Department has signed up to this: https://ethics.ris.shef.ac.uk/admin/ethics_applications (for more information contact the R&IS team via [email protected] Individual Applications: PGR and Staff applications PGR/ Staff applications require a panel of at least 3 reviewers which, in the case of a Postgraduate Researcher ,should not include members of the students’ supervisory team. The application should be made on the form specifically for PGR researcher and staff applications. Additionally, in the case of PGR researchers, the application should be countersigned by the supervisors. As previously mentioned, in cases where the funding requirements state that lay representation is needed, this will be run in conjunction with the UREC.
Possible outcomes of the Procedures:
- Approval
- Approval with suggested amendments
- Compulsory amendments required
- Compulsory amendments required with further suggested
amendments
- Not approved
- No decision – referred to Departmental Ethics Panel and then
Possible Outcomes: Approval – the project can go ahead with no changes Approval with suggestions – the project can go ahead but the applicant may wish to consider suggestions made by the reviewer(s) but these are optional Approval with compulsory amendments – the project cannot go ahead until the required changes have been made; the reviewer(s) must see the revised version of the application and subsequently approve it. Approval with suggested and compulsory amendments – as per above. The reviewer must see the revised version (incorporating the compulsory changes) and the applicant may wish to consider the remaining suggested amendments Not approved – a rejection of the application. The project cannot proceed (for reasons which have to be clearly stated by the reviewer) No decision – this indicates a contentious projects, which will need to be reviewed by an ethics review panel (or equivalent) and, if not decision is reached, by the UREC). After the decision Once the decisions are reached, the project must be carried out in accordance with any conditions laid down. If the project changes after the decision is made the researcher must consider whether the change(s) represent a significant change which could have a potential impact on the welfare, dignity and rights of the participants. A significant change refers to a new research approach/ method which would have been mentioned in the original application including (but not exclusively): different group of participants, different method of recruitment; different means of gaining consent, different method of data gathering and a different venue for data collection. If there is doubt the researcher should contact the ethics administrator who will provide details to one of the original reviewer. A record should be kept of amendments and the subsequent action.
This presentation addresses the overarching issues which an ethics reviewer should consider when assessing an application for ethical review. We have included a check list in your information pack to help you think through the key issues as you review an application. It should be emphasised that the ethical review process is not about preventing High Risk research but about ensuring the outcomes of the research are proportionate to the risk involved and that this risk is mitigated in as many ways as possible.
• Researcher’s obligations: honesty minimising risks integrity cultural sensitivity
Considerations
Safety and Wellbeing (Ethics Policy Note 3):
• Consideration must be given to potential for harm/distress
• Steps should be taken to minimise harm/distress (e.g. informing participants of possibility; providing help/support after participation)
• In some research (e.g. clinical trials), the researcher may need to knowingly cause harm BUT possible harm should be outweighed by the potential benefits
• Participants should be informed of procedures for contacting researcher if problems arise
• Safety/well-being of researcher should also be considered
This, and the following two slides address, in greater detail, three key areas which contribute towards the consideration of an ethics review. Safety and wellbeing of the participants It is important to note that this includes the Safety and wellbeing of the researcher. Specific guidance is provided on this on the R&IS Ethics webpages: www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/safety-well-being Key points for consideration include: - People participating in research should not be exposed to risks greater than those encountered in normal life.. Harm can be psychological as well as physical, eg does the research involve asking questions on a sensitive subject that may cause the participant distress such as their experiences of a relative’s death through cancer? - Problems endangering participants well-being could be discovery of a participant being HIV positive. Researcher can recommend professional advice if they are not qualified to assist. - Also risks to the researcher themselves as mentioned earlier – safety and well-being
See Ethics Policy Note 2 – Principles of Consent (http://www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/consent) And also: specialist guidance papers (Including adults lacking ability to consent; research with young people; older people; learning disabilities; human tissue): http://www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/further-guidance/special-guidance/papers Key points for consideration include: Coercion – careful consideration needed when participants are potentially dependent on researcher (eg patients, students, employees). Participants may be paid for inconvenience and time but not so much that they are encouraged to take greater risk than they would otherwise. Informed consent – information about the research should be provided in writing but also verbally where possible. Should include all aspects that might reasonably affect decision to be involved: objectives, methodology, what they will have to do, what data is being sought, potential risks and benefits, who to contact if problems etc. Witnessed oral consent – when participant is unable to provide written consent (eg unable to speak English, mental incapacity that prevents them from providing written consent ) - oral consent should be obtained in the presence of at least one witness; researcher should keep a written record which the witness signs. Secondary analysis – participants should be informed if their data is going to be used again by other researchers, and that the data will be subject to robust safeguards to protect confidentiality. More guidance available on obtaining consent for incapacitated adults, children, covert research, research in public contexts etc
See Ethics Policy Note 4 - http://www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/confidentiality-anonymity-data-protection … and also Specialist Guidance Paper - http://www.sheffield.ac.uk/polopoly_fs/1.165639!/file/SREGP-Anonymity-Confidentiality-Data-Protection.pdf Key points for consideration include: - Personal information should be considered privileged information; should be dealt with in a way that does not compromise personal dignity of participant or infringe upon their privacy. - Data should be made anonymous wherever possible, and identifying information limited to as few people as possible;. - Deliberate disclosure may be necessary where the researcher becomes aware that the participant has committee a crime or is about to commit one (legal requirement), or has been the victim of one (moral obligation – careful consideration needed eg violent partner finding out the participant has spoken about their experiences) – Participants should be informed of any potential reason why confidentiality may need to be deliberately breached. - Who will have access – eg researcher may need to hold de-brief sessions with research team following interviews with participants. - Purpose – eg using video material for teaching purposes. - Participants should have right to withdraw at any time and for their records to be destroyed.
TUOS has a large amount of advice and guidance on the ethics pages of the University’s website through www.sheffield.ac.uk/ethics Firstly, a Statement of TUOS principles on Research Ethics can be found at (General Principles and Statements of Research Ethics): www.shef.ac.uk/polopoly_fs/1.112655!/file/General-Principles-and-Statements.pdf. This sets out broad principles including the rights of participants/ obligations of the researcher/ objectives and scope of the policy. The Ethics Review Procedure document (www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure) sets out the University procedure including the application process; assessing risk; the role of the departments and alternative review procedures. Research Ethics Policy Notes (12 no.) discuss specialist issues in more detail (including key types of research (health and social care/ administrative/ archival etc); ethical principles (safety and well being; informed consent etc.) and information of the policy of retrospective ethical review. Specialist Research Ethics Guidance Papers: (http://www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/further-guidance/special-guidance/papers) Papers designed to complement the information in the policies and provide further guidance to researchers in more complex areas. Other Guidance and Advice: includes FAQ’s; Student Guides; Model forms (including application forms; consent forms and information sheets; processes for amendments etc.)
Thank you for listening/ reading. For further information, or if you have specific questions, please visit the University ethics webpages; your own departmental ethics webpages or contact Anita Kenny or Lindsay Unwin with the contact details above.
TASK – Consider the two ethics applications assigned to your group: •What risk level would you assign the project ; low or potentially high? •Has enough information/documentation been provided and is it understandable to a lay person? •What are the potential risks to the participants/researcher and how is the researcher proposing to deal with any risks – have all the risks been identified? •Does the project raise any issues requiring special consideration e.g. does it involve vulnerable people/sensitive issues? •How is the researcher proposing to inform the participants about the project and obtain their consent? Is it appropriate? •How will the participants’ confidentiality be maintained? Is the proposed method sufficient?
What would your response to the applicant be?
Group Discussion:
Digital Resources
Applying for ethics approval & the online system
Supporting resources & the Policy
Resources for training
Guidance on specialist areas
Online system guidance
Helpsheets for different users
Flowcharts for each version of process
Word version of form
Top ten tips for applicants
1-page reviewer checklist
Ethics videos
Presenter
Presentation Notes
What ethical issues tend to arise in research? Personal experiences with ethics applications? What do you look for in an ethics application?
