Research Ethics for Staff/PGR

Before beginning any research (funded or unfunded) involving human participants, personal data or human tissue, all staff and PGRs must submit an ethics application for review and approval via the online system. 

When seeking funding, it is important to consult the guidelines of individual funding bodies as they differ according to whether ethics approval is required before submitting an application.

You must not begin any research until you have written confirmation from the School that your application has been approved.

Ethically approved research must be carried out in compliance with any conditions set by the ethics reviewers. If ethics approval is subsequently withdrawn or suspended for any reason, the research must be discontinued. If you need to make a change from your original application, an amendment form needs to be completed and sent to scharr-rec@sheffield.ac.uk for approval.

Online applications

Staff and PGR student (and high risk, UG/PGT student) applications that involve human participants, personal data or human skin require ethics approval via the ScHARR Research Ethics Committee, which meets monthly (please note that there will be no meeting in August). Applications will be reviewed by 3 members of the committee and applicants will be invited to discuss their applications at the meetings. Applications must be submitted online before 13.00 on the day of the deadline to be considered for the meeting (a list of meeting dates and deadlines of the meetings may be found here.

Please note that PGR applications must be approved by the supervisor before the monthly deadline to be considered for the meeting, and PGR students must therefore ensure their application is submitted to the supervisor in advance of the deadline. Any 'required amendments' must be completed to the satisfaction of the supervisor before the application is submitted for committee review. We cannot accept incomplete applications.

Please ensure you complete all the requirements listed below:

1 - Independent Scientific Review (ISR)

If you are a PGR (and high risk, UG/PGT student) you require either: two independent scientific reviews to accompany your application for research ethics review (found in the download box on the right. One of the scientific reviews can be one of your supervisory team), or your PhD needs to have been through it's confirmation/upgrade (please ensure this is clearly stated within the application).

If you are staff you require either: copies of the funder's scientific reviews or three independent scientific reviews, which can be from ScHARR staff who are not involved with the research project.

Your ISRs must be done in advance and included in the ethics application.

2 - Data Management Plans

All research projects handling personal data must include a Data Management Plan which should address data capture, integrity, confidentiality, retention, sharing and publication as per the Research Data Management Policy. There are a number of templates and examples on The University Library pages, the generic DMP template is recommended if your funder is not in the list of available templates.

PGR students are required to complete a DMP on PebblePad as part of the Confirmation Review Process which can be submitted as part of the ethics application.

Please visit the ScHARR Research Information Governance pages for advice on handling research data.

3 - General Data Protection Regulations - 'GDPR'

All research collecting personal data must comply with General Data Protection Regulations. To comply with GDPR, participants must be made aware of the following; the legal basis for collecting their data, which organisation is acting as the Data Controller, who will act as the Data processors, how will their data be stored, when their data will be destroyed and who they may contact to make a complaint regarding the use of their data. The information sheet and consent form templates include further information including the agreed wording. This is a legal requirement.

Applications involving secondary data

Staff and PGR applications involving the use of secondary data now require submission via the online system. 

Select the option that your research involves only existing data. You will then proceed to a questionnaire which will determine whether full ethics approval is required or whether a shorter application may be created for the ethics administrator to generate an approval letter. 

Alternative Ethics Applications

If you are involved in a project which has ethics approval from outside the University, you must register the project on the online ethics system as an Alternative Ethics Application. For example, if you are involved in a project that has NHS ethics or you are acting as a collaborator on a project that has ethics approval from the lead institution, you must upload the submitted alternative ethics application and ethics approval letter to the online system. This also applies to overseas institutions. A list of of organisations recognised by the University as having a sufficiently robust ethics processes can be found here.

To create an alternative ethics application, go into the online ethics system and select 'New Application', proceed to Section B 'Basic Information', there is a tick box inthe 'Suitability' sub-section which asks whether the ethics approval is being led by another UK institution. Select Yes (regardless of whether the institution is UK or international). You will then be asked if the University of Sheffield ethics procedure applies. Select 'No, submit doucmentation.'. Upload the submitted alternative ethics application and alternative ethics approval letter.

Help applying

Help Applying


When applying for ethics approval, please ensure your online ethics application clearly addresses all of the different sections. Protocols may be attached, but are for reference only so please ensure you are not relying on information included only in the protocol. Reviewers should be able to identify how you have addressed each section from the application itself.

In addition to this, be careful that information is consistent across all documentation, and details included in the information sheets and consent forms match what is stated in your application. All additional documents must include a version number in the footer.

Please see the documents below for help applying, as well as the useful forms and guidance links and documents.

Help applying

Top 10 tips

Tips to help get approval on your ethics application
Advice on completing the application form Goes through each section of the application with advice and guidance links
Ethics Application Checklist Checklist of everything to consider, address and include as part of your ethics application
Staff Online Guide A walk through of how to use the online system for staff
Staff Flowchart Step-by-step of process for staff applications
PGR Online Guide A walk through of how to use the online system for PGRs
PGR Flowchart Step-by-step of process for PGR applications














Health and Social Care Research Governance

If your research is a healthcare research project, i.e. involves the NHS in any way (NHS staff work time, NHS patients, NHS premises, requires NHS ethics or HRA approval) or is a social care provided by a local authority contract, then your project will need to be registered on the Costing Tool so that you have a Project Code number to enter on the ethics application system. For a detailed definition of Research Governance see www.sheffield.ac.uk/rs/ethicsandintegrity/governance/definition.

Your supervisor can either approach Charlotte Claxton, Jon Woodward or Mari Bullock on scharr-bidsupport@sheffield.ac.uk to create the Costing Tool record or do it themselves. The information required is:

  • Student's name
  • Project start date
  • Project end date
  • Title of Project
  • Whether Undergraduate, Post Graduate Taught or Post Graduate Research
  • Name of research governance sponsor under the Additional Details section (usually University of Sheffield, but occassionally a Trust or other institution)
  • Names of the NHS or Local Authority Organisations involved (to be listed in the Collaborators section).

Healthcare and Social care research projects need to go through the research governance procedure. Projects MUST be authorised to commence by a Research Governance Sponsor.

  • All healthcare and social care research projects need to be registered on the Costing Tool, have scientific approval and ethics approval and HRA/Local Authority approval.
  • A Study Governance Administrator must be appointed for the project to take responsibility for compliance with research governance. Notify Charlotte Claxton/Jon Woodward who has been assigned at scharr-rec@sheffield.ac.uk.
  • For more details on what constitutes health care research and the research governance procedure, please see the following links:
  • ScHARR Health Care Research Governance Procedure
  • Research Services Health Care Research Governance

Staff Review Process

PGR Review Process





















Staff






PGR

Please note these flowcharts demonstrate the basic process only, for the full process please see the individual Staff or PGR flowcharts (links above)

Useful forms and Guidance

Forms
Amendment form To be completed by applicant and sent to scharr-rec@sheffield.ac.uk
Independent Scientific Review Form To be attached to ethics application prior to submitting
Further Guidance
Ethics Application Checklist Checklist of everything that should be included in the ethics application
Surveys Collecting data through online questionnaires must be done via Qualtrics. Other survey platforms are not secure enough for risk bearing data. To request use of the ScHARR Qualtrics license please contact ScHARR IT (ScHARR staff and students only).

Model information sheet

A model information sheet for research

Children's information sheet Guidance on how to create an accessible children's information sheet
Model consent form A model consent form for research
Safe Working Practices Guidance on researcher safety

Guidance for audio/video
Information from the UK Data Archive on the retention and re-use of audio/video recordings and transcribed interviews
Online survey design Guidance on research ethics for online survey design. To request use of the ScHARR Qualtrics license please contact ScHARR IT (ScHARR staff and students only)
Health services or evaluation A useful guide to whether your NHS project is 'research', 'service evaluation', or 'audit'
Health and Social Care Research Governance Information for health and social care research projects (involving the NHS or local authorty contracts).
Specialist guidance Link to R&IS pages on specialist issues

Information for Reviewers and Supervisors

Reviewers and Supervisors
Reviewer Checklist Checklist for reviewers of areas to consider in applications
Ethics Application Checklist Checklist of everything that should be included in the ethics application
Questions to Consider A comprehensive list of questions to consider when completing and approving ethics applications
Quick reference guide for new ethics reviewers Basic introduction to the ethics review procedure with links to further information and guidance
Guidance fact-sheet Further guidance for University Ethics Reviewers
Supervisor Online Guide Step-by-step walkthrough of how to review an application online

Other Types of Research

There are different types of research that may not need ScHARR Ethics Approval.

NHS Ethics

If your research involves NHS patients you will require NHS Research Ethics Review (you no longer require NHS ethics review for research involving staff). This is a typically lengthy process and may take up to six months. Details can be found at: www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/

This still requires a full IRAS application and may still prove to be a lengthy process.

Do I need an NHS Research Passport?

A Research Passport is designed to allow non-NHS staff to obtain an Honorary Research Contract or Letter of Access in order to do research in the NHS. The Research Passport system establishes a common system of pre-engagement checks which conform to the standards required by all NHS bodies, so are therefore transferrable across NHS Trusts.
For full details please see:

http://www.sheffield.ac.uk/rs/ethicsandintegrity/governance/passport

Health Service Research or Evaluation?

A useful guide to whether your NHS project is 'research', 'service evaluation', or 'audit' can be viewed here. Details about sponsorship are found at: www.sheffield.ac.uk/rs/ethicsandintegrity/gov-ethics/governance/rgp

The Department of Health defines research as 'the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods'. It defines healthcare research as 'Concerned with the protection and promotion of public health undertaken in or by the Department of Health, its non-Departmental Public Bodies and the NHS including:

1. clinical and non-clinical research
2. research undertaken by universities within the health care system that might have an impact on the quality of those services'.

The NHS has a narrower definition of research than the University which requires research ethics approval for all research that involves human participants, personal data or human tissue. Therefore, projects classed as 'service evaluation' in the NHS may still require University ethics approval. More detail on University definitions can be found at: www.sheffield.ac.uk/polopoly_fs/1.89609!/file/General-Principles-and-Statements-vs2.pdf

Health and Social Care Research Governance

If your research is a healthcare research project, i.e. involves the NHS in any way (NHS staff work time, NHS patients, NHS premises, requires NHS ethics or HRA approval) or involves social care provided by a local authority contract, then your project will need to follow the research governance procedure before it can be authorised to commence. More detail is provided here:

ScHARR Healthcare and Social Care Research Governance Procedure

R&IS Health Care Research Governance

Overseas Research

Research that will take place in another country and will involve human participants from that country may require ethics approval via an appropriate ethics review procedure in that country. A review and assessment of how local approval is obtained is an essential part of the ethical review process. Where such a procedure exists, it may not be necessary for the researcher to seek ethics approval via the University of Sheffield's Ethics Review Procedure, providing that the overseas procedure is judged to be sufficiently robust by the UREC.

The following link provides information on which research ethics procedures are recognised by the University as being sufficiently robust so as not to require University Research Ethics review.

Judging the Robustness of Another Institution's Ethics Review Procedure

You register the project as an alternative ethics application on the online ethics system. When you click 'New Application', in Section B 'Basic Information', there is a tick box in the 'Suitability' sub-section which asks whether the ethics approval is being led by another UK institution. Select Yes (even when the institution is international). You will then be asked if the University of Sheffield ethics procedure applies. Select 'No, submit documentation.' Upload the submitted alternative ethics application and alternative ethics approval letter.