Search the University of Manchester siteSearch Menu StaffNet
Search type

Preparing an Ethics Application

General Considerations

  • Select dates of data collection which are far enough in the future to allow for the ethical review process to take place and also allow you enough time to complete the research, even if you experience issues with recruitment.
  • If you are a PGR or staff member, a data management plan will be required and must be appended to your ethics application. You can access the DMP online tool here: https://dmponline.dcc.ac.uk/
  • Ensure the principle research question is in lay language and limited to less than 100 words.
  • Ensure the academic justification is in lay language and provides enough background for the project.
  • Ensure the methodology clearly and concisely describes what will happen to the research participant, how many times and in what order. This must be in lay language and should not be copied and pasted from a research protocol. If using an electronic questionnaire/survey please ensure you adhere to the Guidance on the Use of Survey Tools.
  • The scientific quality of the research should be assessed either by internal or external review to ensure it is sound.
  • If it is quantitative research statistical advice should be sought to ensure the design is appropriate.
  • Ethical issues should be considered and mitigation strategies provided. Common ethical issues include consent, confidentiality, coercion, disclosures, safeguarding and fairness.
  • The number of participants must be accurately listed in the application and you should ensure you take into consideration any potential drop outs.
  • Inclusion and exclusion criteria should be described as appropriate to the research being conducted. Ensure you consider all groups of participants who may not be able to take part (example: if conducting a study where participants must select coloured shapes on a screen you would need to exclude those who are colour blind).
  • If participants are not adult healthy volunteers you will need to provide a justification to their inclusion in the research.
  • You need to consider how you will identify, approach and recruit participants. All methods of potential recruitment should be listed including emails, letters, advertisements and social media text.  If using gatekeepers to assist with recruitment, the strategy should be clearly explained and all necessary permissions should be attached to the ethics application.
  • If you are in receipt of funding for the research, you must clearly indicate this in the form.
  • If participants are to be provided with any compensation, vouchers or tokens as a thank you for participation the sums involve must only cover reasonable out of pocket expenses, reasonable recompense for time given to take part in the study or be in the form of a prize draw.
  • The method of obtaining informed consent should be carefully considered (i.e. written, verbal, implied via the return of a questionnaire/survey) and appropriate supporting documentation appended to the ethics application. It may be appropriate to have more than one consenting method if your study involves different groups of participants.
  • All risks to both the participants as well as the researchers should be carefully considered and mitigation strategies provided. If applicable a full, signed risk assessment, lone working strategy, distress protocol and/or debrief will need to be appended to the application.
  • Participants must be able to withdraw from the study at any time without giving a reason and with an assurance that it will not have a negative effect on them (or if applicable any treatment or service they will be receiving).
  • Although participants are able to withdraw from the study at any time, they are only able to withdraw their data up until the point in which it is anonymised into the full data set, at which point it will no longer be possible to identify their specific data.
  • You should provide details of the outcome to the research such as a publication, dissertation or thesis.

Advertisements

Please note, advertisements may include the following:

  • Posters
  • Use of the UoM volunteering website
  • Use of the SONA system
  • Newspaper adverts
  • Email or letter invitations
  • Flyers
  • Social media postings

Important notes:

  • They must not be coercive and cannot feature any monetary amounts for participation. You may state that participants will be reimbursed for their time, but must not specify the exact amount as this could be deemed as coercive. 
  • They must be limited to information that prospective participants need to determine their eligibility and interest
  • They must not state or imply a favourable outcome or other benefit beyond what is outlined in the participant information sheet and must not emphasise payments or inducements, using means such as large or bold text.
  • They must contain information that is accurate, honest and socially responsible regarding who is conducting the research, its purpose, any risks/benefits, requirements of taking part (inclusion/exclusion criteria) and contact details for further information. Please note the contact details must be a UoM phone number or email address and must not feature personal emails or telephone numbers of the researchers (unless this is a study specific email address or phone number).

Participant Information Sheets

All participants must be given adequate information about the study and this is usually done through a participant information sheet.

Check the grade level of the language you are using (Microsoft Word can do this for you), as the average reading level in the UK is Grade 8. We would advise using no higher than Grade 10 to ensure the language is easily understood by all participants.

Visual aids (pictures) can be extremely helpful to supplement the written information, especially for children and vulnerable gropus. In addition you may wish to consider adding colours to make the study attractive and interesting.

Under the new GDPR regulations you must use the standard University templates shown below for participant information sheets if you are seeking ethical approval from a Division/School Committee, Proportionate UREC or full UREC.

Please note, if your study has a component which was approved by the HRA, you should follow the relevant GDPR guidance on the HRA website and discuss as appropriate with your University’s Sponsor Representative.

Information Sheets for Children or Vulnerable Groups

Notes about the new participant information sheets:

These templates have been created to provide additional guidance and examples of the content that should feature in your participant information sheet and consent form. The required information in relation to GDPR can be found in all templates but is worded differently depending on the nature of the study. Therefore you should select the template which is best suited to the type of research you will be conducting. 

The template for general studies is applicable to most research, except those using special category data. If you will be conducting interviews, focus groups, distributing questionnaires, performing observations or other activities then this template should be suitable (providing you are not collecting special category data and your study is not medically focused as described below).

The template for medical studies should be used if your study has a specific medical component (i.e. taking blood, taking tissue samples, accessing medical records, etc). The content of the medical templates contains specific guidance information and examples (such as circumstances in which you may wish to contact the GP of the participant) for these types of studies but the content in relation to GDPR is the same as the other templates. If your study has a medical component but is also obtaining special category data from participants, please use the Special Category template.

The template for special category data should be used if you will be collecting information about an individual’s:

  • Race
  • Ethnic origin
  • Political affiliation
  • Religion
  • Trade union membership
  • Genetics
  • Biometrics
  • Health
  • Sexual orientation

Consent Forms

All participants must give informed consent and this can be achieved via:

  • Written consent
  • Verbal consent
  • Implied consent (via the return of a questionnaire/survey)

If consent is to be obtained in possibly difficult or complex situations, the researcher should show that they have experience in administering consent.

Under the new GDPR regulations you must use the standard University templates shown below for consent forms if you are seeking ethical approval from a Division/School Committee, Proportionate UREC or full UREC.

Please note, if your study has a component which was approved by the HRA, you should follow the relevant GDPR guidance on the HRA website and discuss as appropriate with your University’s Sponsor Representative.

Distress Policies and Debrief Sheets

Insurance

Insurance cover must be confirmed or, if necessary, special cover arranged, through the Insurance Office.

The insurance cover is available for research sponsored, managed, designed or conducted by, or on behalf of, the University (including research undertaken by students under supervision). 

The University provides insurance cover in respect of research involving human subjects undertaken in the United Kingdom for:

  • Harm to participants, on a ‘no-fault’ or ‘non-negligent harm’ basis, and
  • Financial loss by participants and participating organisations, on a legal liability basis.
  • The University also provides insurance cover in respect of research involving human subjects undertaken abroad that does not have a medical content, on a legal liability basis.
  • To ensure that your proposed research project is covered by the University insurance, please ensure you:
    • If seeking ethical approval via the HRA or NHS REC, complete the Insurance Assessment Form and return to the individual reviewing your ethics application form.   
    • If seeking ethical approval via the University’s ERM system, complete Section C of the application form and ensure you read the guidance information available in the help bubble to the right of the questions. Insurance cover will then be automatically arranged on your behalf.

The only exception to this procedure would be for a researcher who had obtained REC approval for a commercially sponsored project which included insurance, negotiated by the Funding Services Team in the University of Manchester Research Office, for both negligent and non-negligent harm.

If you will be travelling outside of the UK during the course of the research project you will need to contact the Insurance office to verify whether separate travel insurance is required. Please email insurance@manchester.ac.uk with details of your planned research project.

Fieldwork

If you will be conducting fieldwork as part of your research project you must ensure you have completed and signed a risk assessment form appropriate to the location in which you will be travelling and appended this to your ethics application. If you are a student, the risk assessment must be signed by your supervisor and should be completed under their guidance. If you require additional advice on completing your risk assessment form, please contact your School Safety Advisor (SSA). Please ensure you contact your relevant School Administrator for detailed information on fieldwork requirements for your School.

For a copy of the Generic Risk Assessment form and corresponding guidance on completion, click here.

Lone Working

If during the course of your research project you will be working alone, off University premises or outside of normal working hours it will be classed as lone working.

As part of your ethics application you will need to confirm that you have read and understood the University’s Lone Working Policy. Please ensure you also specify in your risk assessment form and/or ethics application what arrangements will be made to ensure your safety while lone working.