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

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

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 and to ensure the dignity, rights, safety and well-being of participants are given primary consideration  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

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)

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

Timescales – UREC Approval  UREC meets 10 times a year  A calendar of dates and deadlines is published on the web-site (see  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

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

How to apply for UREC approval  Go to the Research Ethics Web site and save form E2U as a Word document (locked form)  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 , so s/he can sign off  Send to Louise Wood, at least two weeks before the next meeting

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, s, 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)

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

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

For further information   Visit