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Procedures

FASS Guidelines for the Ethical Approval of Research

Within Lancaster University’s procedures, all funded and PhD research needs to be ethically approved. In addition all unfunded staff research and undergraduate and postgraduate coursework that involves the generation of data with human participants needs to be ethically approved BEFORE any data is generated. The following pages set out:

• General Principles of the Ethical Approval Procedures
• The University's Code of Practice (Research Ethics and Governance)

The Ethical Approval Procedures for:

• Undergraduate and Taught Postgraduate Students
• Research Students
• Non-Externally Funded Staff Research (including those with Visitor Status)
• Externally Funded Staff Research (including those with Visitor Status)

Please note: these pages are based on our current understanding of the University’s procedures for the ethical approval of research. As such, they are subject to regular amendment and updating as the University strategy on Ethics in Research is developed further.

Full details of the University’s approach to the Ethical Research can be found at: http://www.lancs.ac.uk/depts/research/lancaster/ethics.htm

If you have any comments on these pages then please contact Gill Harrison.

General principles for the ethical approval of research

1. It is the responsibility of those applying for ethical approval to ensure that the information that they provide is accurate and sufficient in order to allow the ethical issues involved in the research to be properly assessed;
2. Once ethical approval is granted, it is the responsibility of the student/researcher(s) to ensure that the project is carried out in line with the description of the project that has been ethically approved;
3. If the design of the research project changes, for example alternative or additional research methods are used or the sample population changes, then it is the responsibility of the student/researcher(s) to discuss these changes with whoever has approved the project (tutor, supervisor, Head of Department, department, the University’s Research Ethics Committee [UREC]) and agree whether further ethical approval is required;
4. Whilst these guidelines mainly focus on the generation of primary data, students/researchers also need to ensure that they have the relevant permissions to use secondary data, for example materials from the internet such as blogs.
   
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Undergraduate and Taught Postgraduate Students

1. For any coursework (including assignments, essays, projects, dissertations) involving the generation of empirical data involving human participants, undergraduate and taught postgraduate students complete ethical approval forms.
2. Mimimum specification forms can be downloaded here: Stage 1 and Stage 2. Departments are free to amend these forms, providing the resulting forms elicit the equivalent information to the minimum forms. For example, for taught postgraduate students, it may be thought that more discursive forms are appropriate. An example of such an alternative form from Education Research can be found here.
3. Whichever forms are used need to be approved by the relevant tutor, module convener, supervisor PRIOR to any empirical data being generated. Students need to be aware that this may take some time, as they may need to make amendments to their proposed research BEFORE they gain approval.
4. Once the forms have been completed and signed by the student, and approved and signed by the relevant academic member of staff, the student should be given a copy and the originals should be filed by the relevant programme administrator. This can either be in the student’s file or in the relevant module file. The forms should be kept for a minimum of 5 years. It is the student, rather than the department, who keeps any participant consent forms and associated paperwork.
5. If students require a letter to confirm they have received ethical approval for their project, then this is issued by the relevant member of academic staff. An example of such a letter can be found here.
6. Work on Part 1 of Doctoral Programmes, which initially leads to an MRes, can follow the procedures for taught postgraduate students but must follow the procedures for Research Students in Part 2 of the programme.
   
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Research Students

1. All research students registered since August 2006 must gain ethical approval for their projects early in the first year of their MPhil/PhD.
2. In order to do this they complete:
   • A project outline detailing their methodological approach including, if necessary, a sample information sheet and consent form for research participants;
   • The University’s Student Stage 1 Self-Assessment Form;
   • If necessary (see 6 below), Stage 1, Part B of the Self-Assessment Form;
   • The University's Project Information and Ethics Questionnaire.
     
     
3. These forms are then discussed with and approved by their supervisor.
4. They are then approved by the Head of Department or their nominated delegate, which could include a departmental ethics committee;
5. If the project is categorised as ‘low risk’ and does NOT involve human participants or other potential areas of ethical concern, then the forms are sent to the Research Support Office for filing. The department should also file a copy. If the student requires a letter of confirmation of ethical approval, then this is provided by the department. Click here to see a sample letter.
6. If the project is categorised as 'low risk' but DOES involve human participants or other potential areas of ethical concern, then the student also completes the Stage 1, Part B Self-Assessment Form and the forms are sent to the Research Support Office for approval, a process that will normally take two weeks. There are three potential outcomes of this process:
   • Approval;
   • A request for further information required before the research starts (for example, if participant information and consent forms have not been provided);
   • Referral to UREC for further review, in which case the applicant will be asked to complete a Stage 2 form.
7. If the project is categorised as ‘high risk’, then a Stage 2 form is completed. All of the papers are then sent to the Research Support Office, who will arrange for the approval of the proposal to be discussed by the University’s Research Ethics Committee (UREC). In this case, it is the Research Support Office that issues a letter of confirmation of ethical approval.
8. The student and the supervisor should continue to discuss the ethical issues involved in the study over the course of the MPhil/PhD and ensure that if the ethical issues related to the project change substantially then they reapply for ethical approval.
9. Students should discuss their approach to dealing with ethical issues involved in their project in the final thesis.
   
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Non-Externally Funded Staff Research (including those with Visitor Status)

1. Academic and related staff must gain ethical approval for any non-externally funded research that involves the generation of empirical data involving human participants.
2. In order to do this they complete:
   • A project outline detailing their methodological approach including, if necessary, a sample information sheet and consent form for research participants;
   • The University’s Stage 1 Self-Assessment Form;
   • If necessary (see below), Stage 1, Part B of the Self-Assessment Form;
   • The University's Project Information and Ethics Questionnaire.
     
     
3. They then discuss these forms with their Head of Department or, if departments prefer, a departmental ethics committee;
4. If the project is categorised as ‘low risk’ and does NOT involve human participants or other potential areas of ethical concern, then the forms are signed and sent to the Research Support Office for filing. The department should also file a copy.
5. If the project is categorised as 'low risk' but DOES involve human participants or other potential areas of ethical concern, then the member of staff also completes the Stage 1, Part B assessment form and the forms are sent to the Research Support Office for approval. There are three potential outcomes of this process:
   • Approval;
   • A request for further information required before the research starts (for example, if participant information and consent forms have not been provided);
   • Referral to UREC for further review, in which case the applicant will be asked to complete a Stage 2 form.
6. If the project is categorised as ‘high risk’, then a Stage 2 form is completed. All of the papers are then sent to the Research Support Office, who will arrange for the approval of the proposal to be discussed by the University’s Research Ethics Committee (UREC). Once approved, the Research Support Office is responsible for issuing a letter of confirmation of ethical approval.
   
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Externally Funded Staff Research (including those with Visitor Status)

1. Externally funded staff research is dealt with through the pFACT procedure.
2. In addition to completing the questions on pFACT, staff complete:
   • the University's Stage 1 Self-Assessment form;
   • if necessary (see below), Stage 1, Part B of the Self-Assessment form;

   and discuss these forms with their Head of Department or, if departments prefer, departmental ethics committee.

3. If the project is categorised as ‘low risk’ and does NOT involve human participants or other potential areas of ethical concern, then the forms are signed and sent to the Research Support Office for filing. The department should also file a copy.
4. If the project is categorised as 'low risk' but DOES involve human participants or other potential areas of ethical concern, then the member of staff also completes the Stage 1, Part B assessment form and the forms are sent to the Research Office for approval. There are three potential outcomes of this process:
   • Approval;
   • A request for further information required before the research starts (for example, if participant information and consent forms have not been provided);
   • Referral to UREC for further review, in which case the applicant will be asked to complete a Stage 2 form.
5. If the project is categorised as ‘high risk’, then a Stage 2 form is completed. This is sent with a project outline including, where appropriate, sample Consent Forms and Information Sheets for research participants, to the Research Support Office, who will arrange for the approval of the proposal to be discussed by the University’s Research Ethics Committee (UREC). Once approved, the Research Support Office is responsible for issuing a letter of confirmation of ethical approval.
   
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