Covering Ethical Issues

This checklist has been developed to promote good practice and to quality assure staff-led Patient Focus and Public Involvement work. It covers both legal and ethical issues, such as Data Protection and informed consent. The checklist is a self-report form which is designed to assist staff who are planning Patient Focus and Public Involvement work.

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Important notes:

  • In general, if the study could be reported so that others can learn from its results rather than simply from its process, then the findings are 'generalisable' and the study requires ethics committee approval.
  • If you are undertaking a study or piece of work which is generalisable then you may need to seek advice from your organisation's Research and Development Department.
  • If the results are pertinent only to the service or locality under study, then it may fall under the broad heading of 'service development' and not require ethics committee approval.
  • Further information is available from the Link opens in a new windowNational Research Ethics Service.
  • If you require any assistance in completing this form you should contact your organisation's Clinical Governance Support staff.

Guidance for completion

Please consider the following points when you develop your Patient Focus and Public Involvement work. The checklist has been divided into sections which relate to the different ethical and legal issues detailed below. Not all sections of the checklist will apply to the work you are planning. Where appropriate use the N/A ('not applicable') option.

Section Issues to consider

1.

Before you start this work it is important to ensure that you are not replicating existing work. It is equally important to ensure that, where appropriate, a patient, carer, member of the public or staff has been involved in the design of the work. To minimise over-commitment and burden of patient, carer, member of the public or staff, staff should ensure that potential recruits are not currently involved in any other surveys or Patient Focus and Public Involvement work.

2.

If there are any potential benefits or hazards these could be noted, as should any measures that you have taken to ensure that any risks to participants have been minimised, e.g. risk assessments. Risks may also relate to 'disclosure' of information or sharing of otherwise sensitive or confidential information. This may relate to the title of your work, for example asking patient, carer, member of the public or staff to complete a questionnaire relating to their experiences of recent eating disorder service may lead to disclosure of information without consent.

3.

All participants should be assured that participation is voluntary and be aware of their right to refuse or withdraw at any time. Assurance should also be given that participation will not affect current or future treatment of the patient, carer, member of the public or staff or family member/carer/friend.

4.

All Paient Focus and Public Involvement work should aim to be inclusive. If any group has been excluded on the grounds of sexual orientation, age, ethnic group, gender, religion, belief or disability you should note your reason for this. All data should be analysed/reviewed to consider issues across diverse groups.

5.

Informed consent is at the heart of ethical research and evaluation of health and Patient Focus and Public Involvement work. Where appropriate, consent of participants should be requested either orally or in writing. An information sheet, or a letter sent to participants, should set out factors relevant to the interests of participants (e.g. commitment, contacts, availability of expenses). This should be made available to all participants prior to obtaining consent and should be available in a range of formats and languages.

6.

Where appropriate, participants should receive reimbursement for any expenses incurred, including any carer or associated costs. Funding should be in place to support this.

7.

All data should be stored according to the Data Protection Act (1998) and staff should ensure that all data is anonymised and appropriately stored.

8.

Once you have completed this work, you should ensure that it is appropriately disseminated, e.g. all participants should receive feedback (feedback can include writing to participants and displaying posters). A copy of your report should also be forwarded to relevant management teams and widely publicised.

9.

All work should include recommendations for outcomes, their delivery and improvement. Staff should also detail how outcomes will be monitored and evaluated.

 

Checklist

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      If Yes, please provide details;
If No, please justify

1.

Have you ensured that this work has not been done before?

Yes/No/NA

 

Have patients, carers, members of the public or staff been involved in the design/development of the project?

Yes/No/NA

 

Will you ensure that potential recruits are not currently involved in any other surveys or Patient Focus and Public Involvement work?

Yes/No/NA

 

2.

Are there any expected benefits to participants?

Yes/No/NA

 

Have any potential hazards been minimised, including unwitting disclosure of medical condition or personal circumstance?

Yes/No/NA

 

3.

Will participants be assured that participation is voluntary and that they can refuse or withdraw at any time?

Yes/No/NA

 

4.

Have you ensured that no participant is excluded on the grounds of sexual orientation, age, gender, religious belief, ethnic group or disability?

Yes/No/NA

 

5.

Will potential participants receive verbal or written information about the project?

Yes/No/NA

 

Will information be provided in languages other than English?

Yes/No/NA

 

Will information be provided in formats other than standard type (eg Braille, large font)?

Yes/No/NA

 

Will informed consent be obtained – either verbal or written?

Yes/No/NA

 

6.

Will participants be reimbursed for any expenses incurred?

Yes/No/NA

 

7.

Will you ensure that all identifying data is removed and that all records (paper and computer) are anonymised?

Yes/No/NA

 

Will data be kept in accordance with the Data Protection Act (1998)?

Yes/No/NA

 

8.

Is there an intention to publish or disseminate this work?

Yes/No/NA

 

Will participants receive feedback?

Yes/No/NA

 

Will results be presented in a way that does not identify individuals?

Yes/No/NA

 

9.

Will any reports/feedback include recommendations for improvement?

Yes/No/NA

 

Will the outcomes be monitored and evaluated?

Yes/No/NA

 

 

Sources and further information

This checklist was developed by Dr Fiona Wardell, Healthcare Improvement Scotland.