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Preparing an ethics application

General Considerations

Below are some important items to consider when preparing your ethics application:

  • 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 include any the following:

  • Posters
  • Use of the UoM volunteering website
  • Use of the SONA system
  • Newspaper adverts
  • Email or letter invitations
  • Flyers
  • Social media postings (i.e. Twitter, Facebook, Instagram, etc)

Important notes on advertisements:

  • 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)
    • 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).

Expenses and tax (guidance from the HMRC)

Research volunteers, lay participants and participants in clinical trials

In the course of undertaking research, particularly social science or medical research, volunteers are required to take part in tests, submit to measurements or be interviewed. They are usually paid a small sum to cover out of pocket expenses and as compensation for the time spent. Some of the volunteers may be members of staff of the university, but their participation in the research is not part of their duties of employment and they do it in their own time and are under no obligation to take part.

Closely related to the above is the use of "lay" people or "users" in research. Here the people in question are invited to attend meetings to give their views on various matters to inform the research process and direction. Often they will be former or current patients, representatives of particular groups such as retired people, or representatives from charities. Payment is made to them for their participation in the meetings.

Tax consequences for the university

In the circumstances above, HMRC agrees that the amounts paid to those concerned are unlikely to fall within the definition of “earnings” for PAYE or NI purposes. No employment relationship exists and as such PAYE and NIC would be inappropriate.
Under Section 16, Taxes Management Act 1970, HMRC is entitled to ask for details of payments to non-employees at their discretion; but they would not routinely ask for details for small payments such as these.

Tax consequences for the individuals receiving the payments

There will be no tax or NIC liability arising on the individual if the sums received do no more than reimburse the individual’s reasonable costs of participating in the trial or research, including costs of travel and subsistence.
However should the sums paid exceed those reasonable expenses then the excess may fall to be chargeable to tax as Miscellaneous Income, potentially giving rise to personal tax liabilities of the individuals which should be notified to the Inland Revenue under Self-Assessment.

More information can be found here: 

http://www.hmrc.gov.uk/manuals/eimanual/eim71105.htm

Participant Information Sheets

Here are some important notes to consider when constructing your participant information sheet (PIS):

Important changes: The most important changes to the information sheet include the link to the University’s Privacy Notice for Research Participants as well as the explicit mention of the legal basis for processing personal data, a requirement of the GDPR. You can read copies of our full research privacy notice as well as the easy access version here:
Notes about the new participant information sheet templates:
  • 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. If you will be conducting interviews, focus groups, distributing questionnaires, performing observations or other activities then this template should be suitable (providing 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.
  • Please note that under GDPR, the following information is classed as Special Category and you must inform participants that you will be collecting this information about them, even if you do not collect their name:
    • Race
    • Ethnic origin
    • Political affiliation
    • Religion
    • Trade union membership
    • Genetics
    • Biometrics
    • Health
    • Sexual orientation
Research with Children
The following participant information templates have been produced for research with children. Please note that these are examples which have been created for a fictitious study but that contain wording that is written in age appropriate terms. Please consider the possible differences in reading vs chronological age when drafting your own information sheet and ensure that you produce a version which is suitable for the youngest participant within the group.

Important note: According to the GDPR regulations every child has the right to access their personal data, know exactly what it is being used for and be provided with the details of someone they can go to if they have questions or concerns. To ensure that all children are adequately informed you must ensure you include age appropriate wording in your information sheet which specifically mentions these details. For older children (aged 13 and above) you should also ensure you mention the legal basis for data processing and include a hyperlink to the Research Privacy Notice. Please see the example information sheets for children listed above for suggested wording.

Easy Access Participant Information Sheet

The following participant information sheet template has been produced by colleagues in the Division of Cardiovascular Sciences for research with groups of individuals who need information presented in a clear and simple manner, often accompanied with pictures to reinforce key concepts. 

Consent Forms

Please see below for some important information to consider when preparing your consent form:

  • All participants must give informed consent and this can be achieved via:
    • Written consent
    • Verbal consent (with a consent script)
    • Implied consent (via the return of a questionnaire/survey and often featuring a tick box at the beginning of questionnaire/survey to verify consent)
  • 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 for consent forms as found here:
  • These new templates features statements compliant with the new GDPR regulations and also contain the required data protection section at the bottom of the form.
  • You are free to adjust the words in red or remove entire statements which are not relevant to ensure the form fits with the details your study.

Research with Children Conducted in Schools, Nurseries or Other Organisations

It is important to note that when we refer to consent in this context it is consent for ethical purposes and for certain studies to also satisfy the common law duty of confidence and not consent for data protection purposes. In all instances the legal basis for the processing of personal data is public interest task and for special category data, the additional condition for research purposes.  Therefore when constructing your consent form you should only include statements related to ethical issues, examples of which can be found in the GDPR compliant templates listed above.1

This type of research falls into 3 distinct categories and guidance for each can be found below.

Please note that in scenario 2 and 3 below it is assumed that the children are of an age where their own capacity to legally consent is ruled out and therefore does not become an issue. In addition, in all cases of consent requirements these must be fulfilled by the parents/guardians and consent cannot be provided by other individuals such as teachers or coaches (no other individual than the parent/guardian is able to provide consent by proxy for research). 

If research relies on parental consent there has to be age appropriate information for children and, except in the case of very small children, an assent procedure.

The following participant information templates have been produced for research with children. Please note that these are examples which have been created for a fictitious study but that contain wording that is written in age appropriate terms. Please consider the possible differences in reading vs chronological age when drafting your own information sheet and ensure that you produce a version which is suitable for the youngest participant within the group.

Important note: According to the GDPR regulations every child has the right to access their personal data, know exactly what it is being used for and be provided with the details of someone they can go to if they have questions or concerns. To ensure that all children are adequately informed you must ensure you include age appropriate wording in your information sheet which specifically mentions these details. For older children (aged 13 and above) you should also ensure you mention the legal basis for data processing and include a hyperlink to the Research Privacy Notice. Please see the example information sheets for children listed above for suggested wording.
 

1. Research taking place without parental/guardian consent but with the consent of the child

Criteria and requirements:

  •  The children must have legal capacity to consent, i.e. they must be able to understand the details of the project and the choice they are being asked to make about participation. This has to be established on   an individual basis for each child, so the project has to contain a mechanism for assessing capacity. Capacity cannot be decided on the basis of chronological age alone but, as a heuristic rule, capacity to  consent to research is not present before the age of 13.
  •  If the project is on a sensitive issue a justification has to be provided for not seeking parental consent. This justification has to be more than ‘it is easier to recruit if the children can consent for themselves’.
  •  The children must be provided with complete information about the University’s data governance procedures and the Research Privacy Notice.

2. Research taking place with parental/guardian opt-out in-lieu of consent

Criteria and requirements:

  •  The children have to be of an age where their assent can be reasonably assumed to be based on an understanding of the project and there has to be no detrimental treatment of the children who do not assent.
  •  All parents/guardians must be informed about any collection of personal data to ensure compliance with the GDPR. The communication to parents must therefore be done by a method that reasonably ensures that they receive the information about the data collection and their opportunity to opt-out; and the opt-out mechanism must be simple.  A paper copy of the information sheet being placed in the school bag of the child is not sufficient. If used it must be accompanied by another more reliable means of communications such as electronic communication to the parents via an emailed school newsletter, direct school email, or text message, or by a letter sent by post.

  The research:

  •  is classified as low or medium risk according to the UREC or School guidelines
  •  is unlikely to cause any distress and if a reward is being offered that all children receive the same reward
  •  only involves activities that normally take place in this particular school, for this particular age group; or the observation of such activities.  Please note that the range of activities taking place in schools from nursery to Year 11-12 is vast and differs from school to school. Examples of what would fall within this category are:  
       1. observation of ordinary teaching or classroom discussion of non-sensitive topics         
       2.short, anonymous questionnaires on some aspect of teaching or the school day in general
       3.student evaluation of teaching of a part of the standard curriculum in a particular way, etc
  •  uses personal, but non-sensitive data already held by the school, or involves the school collecting such data on behalf of the researcher
  •  If using audio recordings, they will only be used for the recording of interviews or focus groups
  •    The research does NOT:
  •    involve a particularly sensitive issue which will be dependent on both context and age of the children. What is a sensitive topic in a religious all-girls school may not be a sensitive topic elsewhere
  •    involve physical testing, invasive techniques or psychological intervention
  •    involve video recording

 

3. Research taking place with explicit parental/guardian consent (opt-in)

Please note: this is the preferred option of the University Research Ethics Committees but for the following categories it is a requirement and ethical approval will not be granted unless this option is used.

 Criteria and requirements

     The research:

  •  includes children with learning difficulties, those who require other types of support or have additional characteristics which may class them as potentially vulnerable[1]
  •  involves physical testing, invasive techniques or psychological intervention
  •  involves accessing medical information or performing medical tests such as eye or dental exams
  •  involves audio recording for purposes other than the recording of interviews/focus groups
  •  involves video recording
  •  involves activities that are outside of the normal school curriculum
  •  involves group activities where there is a possibility that the children could become distressed either through the activity itself or through a reward scheme (e.g. an activity where children are rewarded with stickers and one child ends up with more stickers than the other)
  •  involves a sensitive issue which will be dependent on both the context and age of the children. This includes classroom observation of sensitive topics of discussion.
  •  uses special category or sensitive (e.g. disciplinary or attendance record) data already held by the school, or involves the school collecting such data on behalf of the researcher

[1] In the following we refer to ’school’ for ease of writing. The same criteria apply to nurseries, organised youth clubs, scout and guide groups, sports clubs etc. with the necessary changes for these slightly different contexts.

[1] If research 1) involves class room observation or similar, 2) is performed in an ordinary school setting, and 3) is not focused on children with SEN issues or on SEN issues; then the mere fact that there may be children present in class who have learning difficulties or other SEN issues does not entail that parental consent is required.

Distress Policies and Debrief Sheets

Please see below for examples of distress policies and debrief sheets which you can modify for use in your own research study:

Additional Guidance Documents

Please see below for a selection of additional guidance documents on topics such as emotional media, social media/CCTV, survey tools and the use of recordings:

Insurance

Please see below for information on insurance requirements for research studies at the University:

  • 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.

Generic Risk Assessment form and corresponding guidance on completion

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 and for full UREC applications will be required to prepare a personalised lone working policy which outlines how you plan on keeping yourself safe for the duration of data collection. 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. 

Common Ethics Terminology and Concepts

Please see below for a number of common ethics terms or concepts which you may come across during the course of your research project as well as detailed explanations and links to appropriate resources.

Ethnography

Grounded Theory

Assent

  • When a child, under the age of 16, agrees to participate in the research study and have their data collected, stored and used for publication, they provide assent. Assent can only be given with the consent of the child’s parent or guardian.

Consent

  • When the participant gives permission to the researcher to contact them for a research study, participate in the study, and have their data collected, stored and used for publication, they provide consent. Consent is only to be used for adults over the age of 16

Confidential

  • Data is confidential when personal, identifying information is given and the information is linked to the provider. The details of individuals providing the data are known only to members of the research team and will not be disclosed to anyone else.

Anonymous

  • Data is anonymous when it contains no personal, identifying information and cannot be linked in any way to the provider. The details of individuals providing the data are not known to anyone, including members of the research team.

Social Media

Reporting of Illegal Activity

  • If your research will involve conducting interviews or focus groups, you should consider including a disclaimer that warns participants that any disclosure to the researcher of current/future illegal activity will have to be reported to the proper authorities. Please note that the researcher is not under any obligation to report to the authorities the disclosure of any past illegal activities (except for terrorist offences).  However, researchers might of course feel they have a moral obligation to report past activities if they are of heinous nature (e.g. murder, rape, child abuse, etc).

Reporting of Professional Misconduct

  • Researchers who have a professional standing often have an obligation to their professional standards body to report any evidence of misconduct by other member of the profession. If this applies to you, participants should be give appropriate warning of this.