Ethics

‌How to Apply

‌‌Ethical applications at Manchester Met are submitted and processed via EthOS. Use your standard university credentials to log in and select the application route most appropriate for you. If you are unsure of the application route you should use, please contact your faculty research officer (details can be found below).

Access EthOS

Frameworks & Guidance‌

• Protocol Template for Non-Medical Research (version date 30 July 2019)
• Consent Form Template
• Prevent Duty in Research June 2019
• Participation Information Sheet (June 2019)
• MMU Insurance Checklist document
• Health & Safety Risk Assessment Form 
• Policy for Unit Applications for Ethical Approval
• Information Security Project Template
• Information Security Policies and Procedures ‌
• Procedure for Reviewing External Requests for Access to Staff and Students
• Ethical Framework

Data protection guidance, including full details of how and when to conduct DP Assessments, is available to staff on the intranet.

Research Involving the NHS

If your research involves NHS staff, patients or their data or tissue, you may need to seek approval from the Health Research Authority.

What is HRA Approval?

HRA Approval is the new process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent REC opinion provided through the UK Health Departments' Research Ethics Service.

Applications for HRA Approval are submitted via the Integrated Research Application System (IRAS).

Visit the HRA website to see if your study needs HRA Approval.

For advice of guidance, please contact the Ethics and Research Governance Manager.

Sponsorship Letters for NHS Applications

Once you have identified that your research requires HRA Approval, you will need two letters from MMU to complete your application. One letter confirms Manchester Metropolitan University academic sponsorship of the research study and the second confirms that there are appropriate insurance arrangements in place for the research study.

The University has standard templates for these letters. As soon as you start the process of applying to for HRA Approval, you should send the following information to RKE and Finance and Legal Services who will prepare the letters for you:

1. Title of research
2. Activity (what physical interventions are being done to the participants)
3. Department
4. Faculty Member
5. Sponsor/Collaborator
6. Site the research will take place at
7. Country the research will take place in
8. Start date
9. End date
10. Number of participants
11. Participant selection criteria (Exclusions?)

The information should be sent to the Ethics and Research Governance Manager and the Insurance Officer.

All NHS applications require authorisation by the academic sponsor. The University has one designated person who can confirm sponsorship of the research study. The designated individual at Manchester Metropolitan University is Dr Justine Daniels, Director of Research & Knowledge Exchange.

Please refer to the SOP 8 (Sponsorship) under the Standard Operating Procedures section of the 'Ethics and Governance' page.

The Human Tissue Act (2004) was fully implemented on 1st September 2006. The Act covers the use of tissue for a number of 'Scheduled Purposes' which include research, clinical diagnosis and teaching. The Act makes consent the fundamental principle underpinning the lawful storage and use of human tissue from the living or the deceased for specified health-related purposes and public display. This includes `residual´ tissue remaining following clinical and diagnostic procedures. It also covers the removal of such material from the deceased.

The Human Tissue Authority is the regulatory body for all matters concerning the removal, storage, use and disposal of human tissue (excluding gametes and embryos) for Scheduled Purposes. The Authority has issued good practice guidance in its Codes of Practice and answers to Frequently Asked Questions are available. The HTA also licences a number of activities under the Act, one of which is the storage of tissue for research.

Manchester Metropolitan University currently holds a licence for the storage of human tissue for the purposes of research. The licence is held by Professor Hans Degens.

• HTA Licence 2019

Members of the University who are using human tissue in their research are required to adhere to the guidance and standard operating procedures laid out in the HTA Quality Manual.

• HTA Quality Manual
• Appendix 1A NonNRES Consent Form
• Appendix 1B NRES Consent Form
• Appendix 1C Participant Information Sheet
• ‌
• Appendix 8 A: AUDIT ACTION A - Action A - Consent Audit (Forward)
• Appendix 8 B: AUDIT ACTION B - Action B - CONSENT AUDIT (Reverse)
• Appendix 8 C: AUDIT ACTION C - Action C - Traceability Audit (Forward)
• Appendix 8 D: AUDIT ACTION D Traceability Audit (Reverse)
• Appendix 8 E: AUDIT ACTION E – USE/DISPOSAL AUDIT
• Appendix 8 F: AUDIT ACTION F – TRAINING AUDIT
• Appendix 8 G: AUDIT ACTION G – DOCUMENT CONTROL AUDIT

• Standard Operating Procedures For HTA Compliance
• MMU Human Tissue MTA
• MMUHTA001 Obtaining Consent
• MMUHTA002 Adverse Event Reporting
• MMUHTA004 Transport of Human Tissue 2017
• MMUHTA005 Cleaning and Decontamination
• MMUHTA006 Storage of Human Tissue
• MMUHTA007 Disposal of Human Tissue
• MMUHTA008 Training for HTA
• MMUHTA009 Internal Audit
• MMUHTA011 Issue and Return of Human Tissue

What is a Participant Information Sheet?

The information sheet is an important part of recruiting research participants. It ensures that the potential participants have sufficient information to make an informed decision about whether to take part in your research or not. All participants should be given an information sheet to take away. This ensures that participants can consider whether to take part without pressure and have the information that they need in order to give informed consent.

What should an information sheet contain?

The information sheet should give a brief summary of the research project and its aims, the language used should be for a non-expert audience.

It should also outline what participation means in practice; how long participation takes, where it takes place and what it involves. The following list provides an overview of the type of information that should be included, it is not exhaustive:

• A statement explaining that participation is voluntary and that participants can withdraw at any time
• Outline the nature and aims of the research
•  An explanation of what participation means in practice (when, where, who, what)
• Outline clearly the inclusion and exclusion criteria for the study
• Outline any risks, inconvenience or discomfort that could reasonably be expected to result from the study
• Describe the benefits for participants (if relevant, as there might not be any direct benefits for the participant)
• Explain how privacy and confidentiality would be maintained
• Who should the participant contact if they are not happy with any aspect of the research?  At MMU the first point of contact is the Researcher, however you should always provide a named person who is not involved in the research, normally the Research Institute Director.

Participant Information Sheets will vary in different fields of research dependent on the audience and the nature of the research.  The points below are intended to provide help and support:

• Use clear, non-technical language. If you need help with this refer to e recommend that you refer to the Plain English Campaign
• Acronyms should only be used if you have already written the full phrase with the acronym in brackets. Even then an Information Sheet that is filled with acronyms can seem confusing to participants.
• Use appropriate language for the target audience. For example, consider the different ways needed to communicate to primary school children as opposed to their teachers, or people with expertise in the area of study as opposed to people with no expertise
• Divide the text into paragraphs for ease of reading
• Consider using sub-headings for clarity (such as a questions and answers)
• Make sure the font and font size are legible (the MMU standard is Arial size 12)
• Ask colleagues to proof read your information sheet before you circulate it to participants
• Multiple information sheets, provide different sheets for children and adults, experts and non experts. Different participants maybe undertaking different activities, some might complete questionnaires, whilst others are interviewed, for clarity these participants should receive different information sheets.

Participant Information Sheet

Why do we need consent?

Potential recruits to your research must be given sufficient information to allow them to decide whether or not they want to take part.

Where research involves face-to-face interviews, focus groups, direct observation or similar methods of data collection, participants should normally be given a Participant Information Sheet and asked to sign a consent form.

Consent Form

Clear evidence must be obtained that the participant has given informed consent to take part in the study. The University expects that this will normally be in the form of a signed consent form although other evidence may be acceptable (for example by audio recording consent). If you are considering an alternative way of obtaining consent, you should seek advice from your Faculty Head of Research Ethics and Governance.

Where participants are asked to complete and return a questionnaire, the questionnaire should be accompanied by a covering letter but no consent form is needed: consent is implied by returning the questionnaire. The covering letter, however, should include information similar to that in a Participant Information Sheet.

When is consent unnecessary?

• When using anonymised secondary data.
• Retrospective medical chart studies
• When using published literature
• When consent is implied (for example by the returning of a questionnaire)

There are very few situations, if your research involves people where consent is not required.