Applying for ethical approval Dr Gordon Weller, Chair: Health and Social Care Ethics Sub-committee

THIS SESSION Why do we need ethical approval Risk Assessment Types of ethical approval: Literature / desk research External ethics approval (NHS) Internal ethics application

Why do we need ethical approval? As researchers we need to protect those we research and ourselves when we undertake any research involving other people and / or data that can identify other people. Protecting the researched: we need to ensure that research participants data and details are kept confidential (unless they exist in the public domain) and that they cannot be disadvantaged by participating in your research. We need to protect ourselves; researchers must be careful when and where they collect data. Think about the risks in collecting data.

Risk Assessment 1 Risk assessment: for any application, other than a literature review/desk research, you will be required to complete a risk assessment form outlining when and where you will be collecting data (for example interviewing people or holding focus groups). You should ensure that you are in a safe and secure environment. You will be asked to supply a contact number for your next of kin. Where research is carried out overseas, your head of department will be required to approve the risk assessment form.

Risk Assessment 2 The university holds insurance against risks to researchers and researched, which requires that the university follows set ethical and risk assessment procedures. In all cases you must discuss your ethics application and risk assessment application with your supervisor or module tutor. Your supervisor / tutor will be required to ‘sign-off’ your ethics application forms.

LITERATURE / DESK RESEARCH Students undertaking a literature study/ desk research for their final project will need to apply for ethical approval, though will need only to complete the application form. If you intend to analyse data provided by an organisation (including the university), you will be required to provide a letter from the organisation granting access to data. In the application form you should tick the A1 category and complete a short description of your literature survey /desk research. The form will need to be signed-off by your supervisor / tutor before it can be submitted.

External Ethics application If your research involves a study within another organisation, for example the NHS, you must first apply to the appropriate Middlesex Ethics Sub- committee for ethical approval. When you have gained approval from the sub- committee, you may apply to the external ethics committee. The School Office will need to be advised.

EXTERNAL ETHICS APPLICATION 1 You should send an e-copy of your Middlesex ethics approval letter, application and documents to Daniela Pantica in the School Office. You may be required to provide a sponsorship (indemnity insurance) letter from the university, which can be provided by Daniela, though will be subject to agreement by the Chair of School Ethics Committee.

EXTERNAL ETHICS APPLICATION 2 If you are applying for NHS Ethics Approval, this must be obtained via the Integrated Research Application Service (IRAS). You should send your completed IRAS application form to Daniela Pantica for the Chair of School Ethics to firstly accept and then submit via IRAS for authorisation if deemed acceptable. When you have received ethics approval from the external committee, the letter should be sent to Daniela Pantica.

EXTERNAL ETHICS APPLICATION 3 Alternatively, the external ethics board may state you do not require ethics approval. In such a case you should obtain a letter from the external ethics board (or organisation officer) and make an internal ethics application (including participant information sheet documentation) to the sub-committee, attaching the letter from the external ethics committee to your application.

Internal Ethics Application When you apply for internal ethical approval you will need to submit the following completed documents: Ethical Approval Application Form signed by you and your research supervisor Participant Information Sheet Consent Form Risk Assessment form

ETHICAL APPROVAL APPLICATION FORM Ensure that you include future dates for your study: it is not possible to give retrospective approval: try to plan ahead so that your research starts 6-8 weeks after the ethics approval board meeting. Ensure that you apply for the right category of approval. You must discuss your application with your supervisor and gain their sign-off .

Participant Information Sheet 1 A template is provided for the Participant Information Sheet (PIS), try to follow this as closely as possible as it is based on the good practice developed over the many years of practice. The PIS should be typed in font size 14. It should be clearly written and as easy to understand as possible. Try to keep it short and to the point. Try to avoid jargon and clarify where it is used. Include brief details of the methodology.

PARTICIPANT INFORMATION SHEET 2 The participant should understand the benefits and risks to them if they take part. They should understand that their contribution will remain confidential; in accordance with relevant Data Protection Legislation (don’t cite the Act). They should understand exactly what they are being asked to do, when and for how long. They need to know the researcher contact address and e-mail and phone number; which should all be university details (no home or mobile numbers or private e-mail addresses). You need to thank them for reading the PIS

CONSENT FORM The consent form should include the title of the project and the main conditions that the participant is being asked to agree to. Importantly, they will need to agree to the completed consent form being checked by a designated auditor if required as part of the ethical approval auditing process. The participant and you will be required to sign two copies of the consent form, one for them, one for your records. Informed consent; the participant can ask to leave the study and for their information not to be used, up until the point of publication / submission.

Application procedure Completed Applications must be submitted ten working days before the ethics board meets, by e-mail (attachment) to the relevant Ethics Administrator. All forms and informattion is available at the following web site: http://ethics.middlesex.wikispaces.net/Health+Studies

You may be asked to Revise your Application (1) You may receive a letter from the Ethics Committee Administrator requesting that you revise your application to meet specified conditions, which will be listed in the letter. You must discuss your revised application with your Research Supervisor, who must ‘sign off’ the revised application and re-submit it to the Administrator within 20 working days. If you encounter any difficulty in communicating with your Research Supervisor you must contact the Ethics Sub-committee Administrator who will discuss with the Chair: Please Do Not E-mail the Chair directly.

YOU MAY BE ASKED TO REVISE YOUR APPLICATION (2) You must amend the dates for your research on the application form so that the start and finish dates are current/future. You should receive a reply to your revised application within ten working days, which will be sent to your supervisor and yourself. You must contact the relevant Ethics Administrator if you do not receive a reply within ten days.

Any questions ?? You Must Not Start Your Research Until You Have Full Ethics Approval In Letter Form: What does this mean for you?

Optional exercise question: Is it ethical to deceive a participant in research? STANLEYMILGRAM 1961-4, YALE UNIVERSITY Stanley Milgram’s experiment on "Obedience and Individual Responsibility” The experimenter (E) orders the teacher (T), the subject of the experiment, to give what the latter believes are painful electric shocks to a learner (L), who is actually an actor. What are the ethical issues in this research?