Dr. Sarah Quinton, sequinton@brookes.ac.uk Research Ethics: a short guide for PhD students 2017/18 Dr. Sarah Quinton, sequinton@brookes.ac.uk 01865 485694

Outline of session Introduction: University Policy Research Ethics Review Process Research Ethics website Getting to grips with practicalities: E2U form Participant Information Sheet Consent forms Common problems

Research Ethics at Oxford Brookes ethics at Oxford Brookes All staff & students are required to consider the ethical implications of the research they conduct with human participants OBU research ethics review procedures are designed to monitor the University Code of Practice for research involving human participants (see www.brookes.ac.uk/research/research-ethics) i.e. to ensure the dignity, rights, safety and well-being of participants are given primary consideration It is a University requirement for staff /research students to follow the research ethics review procedures Ethics review and approval is a two stage process carried out first at Faculty and then University level The first ‘port of call’ should be your supervisors and then the Faculty Research Ethics Officer – listed on the research ethics website

Which Research Ethics Committee should review a study? NHS Research Ethics Committees Research involving patients / social care users or their relatives / carers, recruited through the NHS Research with human tissue, blood, bodies, body parts (Must be reviewed internally by Faculty REO prior to this) Oxford Brookes University Research Ethics Committee Research by staff or research degree students (UREC comprises academic staff, student representatives and two lay members) OBU Faculty Research Ethics Officers / Committees Research by Foundation Degree, UG and taught PG students

University Policy All research involving human participants requires ethical review and approval before participants are approached to take part Dignity, rights, safety and well-being of participants are given primary consideration

PRINCIPLES OF GOOD RESEARCH ETHICS? FREE FROM COERCION: Participants should be free from coercion of any kind and should not be pressured to participate in a study Is there an implicit pressure from management for employees to participate in my research? How can this be mitigated? Are participants my clients? How can I demonstrate that I have separated my research from my work? Are participants dependent in any other way?

Really?

PRINCIPLES OF GOOD RESEARCH ETHICS? CONSENT: Where 3rd parties are affected by the research, consent should be obtained Am I intending to carry out my research through a company or organisation? Do I need permission to carry out my research here? Evidence of formal permission needs to be sought and included with the ethics application.

PRINCIPLES OF GOOD RESEARCH ETHICS? HONESTY: Honesty should be central to the relationship between researcher, participant and institutional representatives Is all relevant information given on my participant information sheet? Could I be accused of deception? Is the participant information sheet understandable and free from jargon

PRINCIPLES OF GOOD RESEARCH ETHICS? CONFIDENTIALITY AND ANONYMITY: Participants’ confidentiality and anonymity should be maintained … How do I practice my duty of confidentiality? What measures can I take to protect anonymity? (use of pseudonyms? Codes?) If anonymity cannot be assured have I informed the participants?

PRINCIPLES OF GOOD RESEARCH ETHICS? USE OF THIRD PARTIES: Are you using any third parties to collect or analyse data, such as transcribers? Do you need a confidentiality agreement?

PRINCIPLES OF GOOD RESEARCH ETHICS? COLLECTION AND STORAGE OF DATA: The collection and storage of data must be secure Are my files/computer password protected? How can security be assured in the ‘field’? DISSEMINATION: Researchers have a duty to disseminate their research findings to all appropriate parties …a summary of findings, available on email request, would suffice.

THE ROLE OF THE FACULTY RESEARCH ETHICS OFFICER (FREO) Give advice on policy, practice and procedures Review application Approve application at Faculty level Submit approved applications to the UREC committee Review applications from other Faculties for the University Research Ethics committee

OBU Research Ethics Website www.brookes.ac.uk/res/ethics Includes: University Research Ethics Code of Practice Procedure / dates for Research Ethics Review Application forms ie E2U form Guidelines / ‘template’ for Participation Information Sheet and Consent Form

The UREC process Meeting with supervisory team Download and draft E2U form and relevant materials Send via email to FREO to review FREO will feedback with written comments Amend draft, if necessary resubmit to FREO FREO confirms approval, print off and SIGN hard copy and deliver to FREO FREO submits hardcopy to UREC administrator 2 weeks prior to committee meeting UREC meeting, applications discussed, conditional approval given, letters sent by email to researchers with conditions

Research Ethics Review Process Submit E2U form and attachments to FREO at least one week before the deadline on website FREO must submit the signed-off E2U form to UREC administration 2 weeks before committee sits UREC reviews application and based on recommendations by the committee, the Chair sends email letter to the Principal Investigator and supervisory team 1 week after committee meeting: Full approval or Approval subject to conditions – reply within 3 weeks & forward relevant material to administrator and UREC Chair or Resubmission or Reject

GETTING TO GRIPS WITH THE PRACTICALITIES Read / download from Website: Code of practice & ‘What does it mean for me?’ E2U form / guidelines for PI Sheet and Consent form … Complete E2U plus relevant documentation/templates Discuss with supervisory team, write draft Contact FREO and send draft Finalise E2U and documentation Arrange sign-off with FREO before UREC submission deadline (hard copy) FREO usually submits application on your behalf

UREC SUBMISSION: DOCUMENTATION E2U Form Participation Information sheet(s) Consent form(s) And if applicable: Advertisements/Posters/Social media posts Letters of permissions (access) Recruitment letter / email Research instruments: questionnaires or interview questions (can be in draft form) Confidentiality agreements

PI HEADINSG TO USE -TEMPLATE IS ON WEBSITE What are the possible benefits of taking part? Will what I say in this study be kept confidential? What will happen to the results of the research study? Who is organising and funding the research? Who has reviewed the study? Contacts for further information (if abroad, also local contact) Thank you and Date Study title Invitation paragraph What is the purpose of this study? Why have I been invited to participate? Do I have to take part? What will happen to me if I take part? What are the possible disadvantages & risks of taking part?

Common problem areas LAY DESCRIPTION your application is read by non-subject specialist Think about your participants when writing the P I Sheet: is it understandable for age, literacy level, education level, culture, profession etc. PARTICIPANT FREEDOM demonstrate this in the recruitment process – full information & time to reflect pre-decision – ‘informed consent’ Consider whether there are any repercussions to the individual from participating/not participating?

More problematic areas! DEPENDENT RELATIONSHIPS students / client / colleagues / employees OVERSEAS / OFF-SITE RESEARCHER SAFETY Risk assessment form is not very user friendly - not all aspects will be relevant so use common sense. NHS Requires separate NRES ethics approval – takes time PI SHEET AND CONSENT FORMS Match with checklists The ‘public face’ of Oxford Brookes, must be correct

Questions? Sequinton@brookes.ac.uk or (48)5694