MRes Mentorship Programme Preparing an ethics application Lynsay Matthews

MRes Mentorship Programme

Preparing an ethics application

Lynsay Matthews

Overview of Ethics

• See Section 1 (page 14) of the UWS Ethics guidance booklet (in our shared dropbox).

Why is ethical approval needed?

Four ethical principles are relevant to the practice of ethical research. 1. Non-maleficence - Do no harm 2. Beneficence - Do positive good3. Autonomy - Show respect for rights of self-

determination4. Justice - Treat people fairly

• There are also a number of moral rules that derive from the four main principles …– fidelity– veracity – confidentiality – privacy

• Read the UWS ethics guidance booklet (Section 1, page 14) for a detailed outline of ethical principles prior to preparing your ethics application.

Ethics Process

• ALL students require ethical approval from UWS.

• Depending on the nature of your study you may also need to apply for NHS ethical approval (via IRAS).

• If you require both you need to prepare the IRAS application first. UWS Ethics Committee will review this before you submit to the NHS. Then you can submit the UWS ethics application.

1. APPLYING FOR NHS ETHICAL APPROVAL (IRAS)

NHS Research Ethics Committee

There are different types of study recognised by the NHS, including:• Research• Service Evaluation• Audit

Not all require ethical approval.

NHS Research Ethics Committee

Firstly, find out if your study is considered research?

• Read…http://www.hra.nhs.uk/research-community/before-you-apply/determine-whether-your-study-is-research/• Then use this tool …http://www.hra-decisiontools.org.uk/research/

NHS Research Ethics Committee

Secondly, if considered research find out if you require ethical approval?

• http://www.hra-decisiontools.org.uk/ethics/

NHS Research & Development Office

To confirm, contact NHS Lanarkshire’s Research & Development office with details of your proposed study. If you do not need ethical approval they should provide you with a letter stating this.

Email: Raymond.Hamill@lanarkshire.scot.nhs.uk Corporate R&D Manager, NHS Lanarkshire

If you need NHS approval ….

• NHS ethical applications are submitted via IRAS (Integrated Research Application System)

• https://www.myresearchproject.org.uk/

• Please see IRAS Guidance booklet in our shared dropbox.

IRAS

1. Set up account2. Create new project3. Complete form4. Transfer for feedback from supervisors etc5. Ask UWS ethics to review the application6. Obtain electronic signatures7. Submit8. Await decision

Please note …

If an MRes student, the Principle Investigator is

noted as your Director of Studies.

2. UWS ETHICAL APPROVAL

UWS Ethics Process

• There are two options

1. University Ethics Committee (UEC)Or2. School of HNM Ethics Committee (SHNM)

Please read the UWS guidance booklet for further information on both processes (in our shared dropbox).

• The School of HNM ethics contact is Elaine Biggam

• Elaine.biggam@uws.ac.uk

UEC versus SHNM ethics

• Please see the flow diagrams in the guidance booklet for the correct application process i.e. either UEC pathway or SHNM pathway.

• Page 9 & page 25.

INFORMATION REQUIRED FOR ETHICS APPLICATIONS

Information required

• See Appendix 2 for ethics application form.

• If you require to do an IRAS application the sections will be roughly similar, but often more detailed and repetitive.

• An anonymised example application for both IRAS and UWS is in our shared dropbox.

Background

• What is the justification for the research? • What is the background? • Why is this an area of importance?

Study design

• Give a full summary of the purpose, design and methodology of the planned research, including a brief explanation of the theoretical framework that informs it.

Ethical Considerations

• Think about the four ethical principles throughout the application.

• Take a step back and think what the ethics committee might ask about every paragraph you have written.

• Think about the ‘what, how, why, when and where’ for everything you include.

Paperwork required

• You always need the following paperwork:– Participant information sheet – Consent form – Copy of protocol

• Sometimes you might need:– Letter of invitation to participants– Questions for semi-structured interviews/focus groups– Questions for surveys etc. – Any other relevant materials

Templates

• The UWS guidance booklet provides templates for participant information sheets and informed consent forms (Appendix 4-6).

• Remember you can look up example forms and protocols online. Lot’s of help for students on the internet. Two are also in our dropbox.

• Do some research and look up examples ethics applications for an idea of what is required. An IRAS example is in our dropbox.

Tips for Success

• Can be a lengthy and problematic process so: – Be very accurate.– Double check all sections. – Think about the four ethical principles throughout

the application.– Start early. Don’t leave it too late. – Be mentally prepared for problems arising around

the time of submission (don’t worry, they always get sorted!)