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The research ethics review process Hazel Abbott, Chair University Research Ethics Committee.

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1 The research ethics review process Hazel Abbott, Chair University Research Ethics Committee

2 Research Ethics University Policy All research involving human participants or their data requires ethical review and approval before participants are approached to take part. Human ‘participants’ include:  living individuals,  recently deceased individuals,  human tissue, blood & genes,  human data

3 Research ethics at Oxford Brookes  It is a University requirement for all staff and students to carefully consider the ethical implications of research they conduct with human participants  Research ethics review procedures at Oxford Brookes are designed to monitor the implementation of the University Code of Practice for research involving human participants (see www.brookes.ac.uk/res/policy/ethics_codeofpractice.pdf) and to ensure the dignity, rights, safety and well-being of participants are given primary consideration www.brookes.ac.uk/res/policy/ethics_codeofpractice.pdf  It is a University requirement for staff to follow research ethics review procedures, using either the E2U or the ‘light touch’ application form  Review and approval is a two stage process carried out first at Faculty and then University level  The first ‘port of call’ should be the Faculty Research Ethics Officer

4 When is review by the University Research Ethics Committee (UREC) not required?  When the research consists wholly of:  routine audit, performance review or evaluation conducted by an organisation as part of good practice;  the collection of data for the purposes of evaluating an educational activity;  research of contemporary issues in the public domain e.g. public policy issues, where it involves no interaction with the individuals who are the subject of the study;  research in which individuals are asked to provide information - but in which they are not the subjects of the research  Research involving the NHS / Social Care (see next slide)

5 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 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

6 Timescales – UREC Approval  UREC meets 10 times a year  A calendar of dates and deadlines is published on the web-site (see www.brookes.ac.uk/res/ethics)www.brookes.ac.uk/res/ethics  Proposals should reach the Faculty Research Ethics Officer at least one weeks before this deadline  Expedited reviews of proposals can be carried out between meetings, where contractual arrangements require the research to begin / be completed within a short time frame  ‘Light touch’ proposals can be reviewed between meetings by two members of UREC  A full response from the Committee is normally given within two weeks of the UREC meeting

7 When is light touch review appropriate?  A module evaluation that you are now using for research purposes and wish to publish  Research where volunteers are asked only about their professional roles / job experience and which does not require their employer’s permission to interview them on business premises  Research that involves the use of an anonymous, self-completion questionnaire, or the completion of a standard survey that has no ethical implications (e.g. a transport survey)  Research that replicates a previous study that was approved by UREC. The Chair of UREC may give permission for the original study design to be extended on receipt of a light touch form

8 How to apply for UREC approval  Go to the Research Ethics Web site and save form E2U as a Word document (locked form) www.brookes.ac.uk/res/ethics www.brookes.ac.uk/res/ethics  Complete application form  Attach additional documentation, as required (see next slide)  Discuss with and send to Faculty Research Ethics Officer in person and / or by e-mail, so s/he can sign off  Send to Louise Wood, ethics@brookes.ac.uk at least two weeks before the next meeting dateethics@brookes.ac.uk

9 What additional documentation is required?  Participant invitation letter and information sheets  Consent forms  Draft interview or observation schedules or questionnaires  Any recruitments adverts, such as for Message of the Day, posters, e-mails, announcements for the Research Activity Group  Permission letters from gate-keepers e.g. Head teachers, CEOs, leaders of faith organisations (can be sent afterwards to UREC)

10 Difficult ethics issues These vary from project to project but may include:  Research in your own workplace c/o role conflict  Researching your own students / family / clients / employees / colleagues c/o dependent relationships  Research involving children c/o consent issues  Data protection / Confidentiality of participants, particularly where small samples are involved  Intrusion c/o demands on participants

11 Rights of the research subject  Autonomy – participants must decide voluntarily whether to take part in research and can withdraw at any time  Confidentiality – identities and locations must be protected in storage and reporting research findings  Justice – fair treatment and no-deception  Participants must give their informed consent to opt into research - opting out by default is not sufficient  Freedom from harm – the safety of participants should be paramount. Weigh up risks and benefits

12 For further information  Email ethics@brookes.ac.ukethics@brookes.ac.uk  Visit www.brookes.ac.uk/res/ethicswww.brookes.ac.uk/res/ethics


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