ethics handbook 2013-2014

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Oxford Brookes University Faculty of Health and Life Sciences Research Ethics Handbook

HA/09/2013 1

Research Ethics Handbook

2013-2014

For the Departments of:

Clinical Health Care

Social Work & Public Health

Sport and Health Sciences (Physiotherapy,Osteopathy, Rehabilitation and Occupational Therapy

programmes only)

Hazel Abbott

Research Ethics Officer


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HA/09/2013 1

CONTENTS

Introduction 2

Ethics Drop-in Sessions 3

FH&LS Ethics Approval Procedures 4

Making an Application to the FH&LS Research Ethics Committee 6

Making an Application to an NHS Research Ethics Committee 9

Social Care Research 12

Research versus Audit 13

Making an Application to the University Research Ethics Committee 15

Insurance for Oxford Brookes University Researchers 16

Correspondence with Research Participants 18

Commonly Raised Questions about the Ethics Approval Process 19

APPENDICES

APPENDIX 1 FH&LS Research Ethics Committee Terms of Reference 21

APPENDIX 2 University Research Ethics Committee Meeting Dates 2013/2014 23

APPENDIX 3 FH&LS Research Ethics Committee Meeting Dates 2013/2014 24

APPENDIX 4 Procedure for Expedited Ethics Review 25

APPENDIX 5 NRES Criteria for Research, Audit and Service Evaluation 26

APPENDIX 6 Clinical Trials Questionnaire 27

APPENDIX 7 Useful Contact Details 28


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HA/09/2013 2

INTRODUCTION

This handbook explains the process for obtaining ethics approval for staff and students the in thefollowing Departments within the Faculty of Health and Life Sciences: Department of ClinicalHealth Care, Department of Social Work and Public Health and from the Department of Sport and

Health Sciences (for Physiotherapy, Osteopathy, Rehabilitation and Occupational Therapyprogrammes only). It applies to all staff and students intending to undertake primary research,audit or service evaluation involving human participants or their data.

As there is some minor variation in the way applications are managed at Departmental level, staffand students in the Department of Psychology, the Department of Medical Sciences and theDepartment of Sport and Life Sciences (Nutrition, Movement Science, Sport, Coaching andPhysical Education Programmes) should refer to the guidance specific to their Department.

For further guidance about the ethics review and approval processes, please contact the FacultyResearch Ethics Officer for your Department, as below.

Departmental Research Ethics Officers (DREOs)

Hazel Abbott Department of Clinical HealthCare

Department of Psychology,Social Work & Public Health(for Social Work and PublicHealth Programmes only)

Department of Sport andHealth Sciences (for

Physiotherapy, Osteopathy,Rehabilitation andOccupational Therapyresearch projects)

[email protected]

01865-482639

Dido Green Department of Biological &Medical Sciences

Department of Sport andHealth Sciences (for Nutrition,Movement Science, Sport,Coaching and PhysicalEducation research projects)

[email protected]

01865-485277

Morag McLean Department of Psychology,

Social Work and Public health(for Psychology Programmesonly)

[email protected]

01865-483775

Hazel Abbott also holds regular informal drop-in sessions throughout the academic year todiscuss the ethical dimensions of a research project available to all staff / students (see page 3for the dates, times and venues of these sessions).

Hazel Abbott, Research Ethics OfficerDepartment of Psychology, Social Work and Public HealthMarston Road CampusJack Straws LaneMarstonOxonOX3 0FL
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]


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HA/09/2013 3

ETHICS DROP-IN SESSIONS

Hazel Abbott will be holding informal ethics drop-in sessions to discuss the ethical dimensions ofa research project on the following dates and times this academic year:

Semester 1 2013

Week Day Date Time

3 Tuesday 8thOctober 15 pm

6 Wednesday 30thOctober 912.00 am

8 Tuesday 12thNovember 12.302 pm

9 Thursday 21stNovember 25 pm

12 Thursday 12thDecember 25pm

All the above sessions will be held in room MR1/43D

Semester 2 2014

Week Day Date Time

2 Thursday 6thFebruary 24 pm

4 Wednesday 19thFebruary 1012 am

6 Tuesday 4t March 13 pm

8 Thursday 20t March 24 pm

10 Wednesday 2ndApril 1012 am

12 Monday 28thApril 1012 am

All the above sessions will be held in room MR1/43D

To book a 30-minute slot, please contact Hazel Abbott, Departmental Research Ethics Officer [email protected].

Please note: If you are a student, it is expected that you will have discussed your dissertation

plans with your Research Supervisor before booking an appointment. This appointment is todiscuss the ethical dimensions of the project, not the scientific design of the study.
mailto:[email protected]:[email protected]:[email protected]


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HA/09/2013 4

FACULTY OF HEALTH AND LIFE SCIENCES ETHICS APPROVALPROCEDURES

Oxford Brookes University devolves the process of research ethics review to individual Faculties.Each Faculty is required to have in place procedures for the review and approval of projectsinvolving human participants, human data or material (see Appendix 1).

The University and the Faculty of Health and Life Sciences require that all researchers adhere tothe University Code of Practice on Ethical Standards for Research Involving Human Participants -see http://www.brookes.ac.uk/Research/Research-ethics/Research-involving-human-participants---code-of-practice/and maintain high standards in the conduct of their research (see UniversityCode of Practice for Academic Integrity at http://www.brookes.ac.uk/Research/Research-ethics/Information-and-procedures/.

Research projects conducted by taught undergraduate and taught postgraduate students are

reviewed and approved at Departmental level (see procedure below).

Research projects by staff and PhD students are reviewed and signed-off by the relevantDepartmental Research Ethics Officer before being submitted to the University Research EthicsCommittee (see Appendix 2 for UREC Committee meeting dates).

The only exception to this is where a research project [not service evaluation or audit] involvesNHS service users and / or their data. In this case, the project must be reviewed and approvedby the Faculty Research Ethics Committee (FREC) prior to review within the NHS ResearchEthics Service (see page 5).

PLEASE NOTE: Ethical approval MUST be obtained to conduct any research with human

participants before data collection takes place. Within the Faculty of Health and LifeSciences, failure to do this is a disciplinary matter and work submitted for assessment willnot be marked.

Departmental* Review Procedure (Non-NHS / Social Care Research)

*For the Departments of Clinical Health Care, Department of Social Work and PublicHealth and the Department of Sport and Health Sciences - Physiotherapy, Osteopathy,Rehabilitation and Occupational Therapy programmes

Applications from MSc / MA studentsMSc / MA students in a health care related discipline i.e. nursing, midwifery, social work, publichealth, physiotherapy, osteopathy, rehabilitation and occupational therapy, conducting researchoutside of the NHS should complete an E2U application form and submit this to Hazel Abbott, theDepartmental Research Ethics Officer. These applications are reviewed and approved atDepartmental level by the Departmental Review Group.

Applications from Staff / MPhil / PhD / EdD studentsThese applications must be reviewed and signed-off by the Departmental Research EthicsOfficer before they are forwarded to the University Research Ethics Committee for review. AnE2U application form (see http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/) should be completed and sent to Hazel Abbott three weeks before the UREC meeting.

Feedback will be given after which before the application is forwarded to the University EthicsCommittee (UREC) for review. For UREC meeting dates for 2013/2014, see Appendix 2).
http://www.brookes.ac.uk/Research/Research-ethics/Research-involving-human-participants---code-of-practice/http://www.brookes.ac.uk/Research/Research-ethics/Research-involving-human-participants---code-of-practice/http://www.brookes.ac.uk/Research/Research-ethics/Research-involving-human-participants---code-of-practice/http://www.brookes.ac.uk/Research/Research-ethics/Information-and-procedures/http://www.brookes.ac.uk/Research/Research-ethics/Information-and-procedures/http://www.brookes.ac.uk/Research/Research-ethics/Information-and-procedures/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Information-and-procedures/http://www.brookes.ac.uk/Research/Research-ethics/Information-and-procedures/http://www.brookes.ac.uk/Research/Research-ethics/Research-involving-human-participants---code-of-practice/http://www.brookes.ac.uk/Research/Research-ethics/Research-involving-human-participants---code-of-practice/


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HA/09/2013 5

Faculty of Health and Life Sciences Research Ethics Committee (FREC)

The FREC is a sub-Committee of the Faculty Research Knowledge and Exchanger Committee(FRKEC).

The H&LS FREC receives and reviews applications from all Departments across the Facultyfor research, service evaluation* or audit* involving:

The NHS National Research Ethics Service (NRES) i.e. research involving past andpresent NHS or Social Care service users (including their relatives and carers, tissuesamples or information).

Private Patients

An application to any other external Research Ethics Committee e.g. Ministry ofDefence Research Ethics Committee

* Although the NRES now only reviews research projects, applications to conduct a clinical auditor a service evaluation within the NHS or in Social Care should be submitted to the FREC forreview. The purpose of this is to ensure that such projects are categorised correctly (according toNRES criteria) and the applicant is permitted to have access to the data. Although theseprojects do not require NRES review, they still require permission from the relevant NHSTrust R&D Department.

The Chair of the FREC is Hazel Abbott. Committee members are drawn from each Departmentwithin the Faculty so as to provide a range of subject knowledge combined with methodologicalexpertise. In order to meet the requirements of the NRES, both the scientific and ethicaldimensions of the research are reviewed by this Committee.

The Committee meets every 3-4 weeks throughout the year, except during August (for FRECmeeting dates for 2013/2014 see Appendix 3).

The Chair communicates the outcome of the meeting to the applicant, in writing.

A maximum of 8 applications can be reviewed at any one meeting. This is on a first come, firstserved basis. If this number is exceeded, the applicant will be informed and the application willbe reviewed at the next Committee meeting.


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HA/09/2013 6

MAKING AN APPLICATION TO THE FREC

An application should be made by completing one of the following forms:

Type of study Form How accessed Review process

Involves past or present NHS /

Social Care service users, theirrelatives / carers, tissuesamples or information

Integrated

ResearchApplicationService (IRAS)application form

http://www.myresearchproject.

org.uk

Application reviewed by

FREC, then forwardedto NRES for review

An audit involving past orpresent NHS / Social Careusers or their information

E2A (Audit)FH&LS

http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/

Application reviewedand approved by FREC.Review by NRES notrequired

Service Evaluation involvingpast or present NHS / SocialCare service users, their

relatives / carers, tissuesamples or information

E2U http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/

Application reviewedand approved by FREC.Review by NRES not

required

Research involving privatepatients

E2U orIndependentSectorapplication form(depending onlocation forstudy)

http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/or

application form used by thePrivate Organisation e.g.Local Authority

Application reviewed atFREC. May requirefurther review andapproval in independentsector

All applications should be made using the electronic versions of these forms; no handwrittenapplications will be accepted.

Six collated, hard copies of the application form (including all supporting documentation e.g.information sheets, consent form, questionnaires etc) should be handed in at Reception, MarstonRoad Campus by 12.00 pm on the deadline date for the Committee meeting. An electronic copyof the complete application should also be sent to Hazel Abbott ([email protected]).

All correspondence with research participants should be on Oxford Brookes University headedpaper. The Research Supervisor can provide students with this. If the research is co-sponsorede.g. by the University and an NHS organisation, guidance on the merging of letterheads can be

sought from the Communications and Marketing Department.

Once the application has been reviewed and discussed at the FREC meeting, the Chair of theCommittee will communicate the decision to the applicant within 14 days of the meeting. Theproject will be either approved, approved subject to amendments or rejected. If the study isapproved subject to amendments, all amendments will be subsequently dealt with by ChairsAction. If rejected, the applicant will be invited to resubmit their application. Formal approval isnotified using the form FH&LS E3.

Once approved, it is expected that the research will be carried out as described in theethics application. Any changes in protocol should be submitted to the Chair of the FREC forapproval. The duration of approval is for a period of three years.

App roval from the FREC mus t be obtained BEFORE appl icat ions are forwarded to th e NHS

Research Ethics Service or to any o ther external Research Eth ics Committee for review.
http://www.myresearchproject.org.uk/http://www.myresearchproject.org.uk/http://www.myresearchproject.org.uk/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.myresearchproject.org.uk/http://www.myresearchproject.org.uk/


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HA/09/2013 7

Expedited Review

In exceptional circumstances an urgent review of an application may be required. Thesecircumstances are likely to be determined by the need to meet contractual agreements or fundingbody arrangements. Please see Appendix 4 for the procedure for expedited review.

Researcher Safety

Any OBU researcher involved in fieldwork should consider their own safety when collecting dataoff site(seehttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn31.html).

The Social Research Association also provides useful guidance on researcher safety athttp://the-sra.org.uk/sra_resources/safety-code/.

Risk Assessment

Oxford Brookes University requires that a risk assessment be undertaken prior to any work-related trips either within the UK or abroad, including trips for the purposes of research. Such arisk assessment must be appropriate and proportionate to the proposed research and the level ofrisk anticipated.

In many cases, the research itself will not pose significant risks or hazards - but this can only beestablished through the process of risk assessment. The purpose of risk assessment is thereforeto establish the level of risk for the researcher and the University. On this basis, the research canbe planned to take all potential safety and security issues into account.

Risk assessment should be carried out in the planning phase of a project in order that additionalsafety measures can be put in place, as required. For guidance on how to undertake a riskassessment, see the OBU Health and Safety Notice - 36 on Risk Assessment(http://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn36.html).

The Dean of the Faculty has overall responsibility for the health and safety of those conductingresearch overseas. This requires an adequate assessment of the risks concerning travel,accommodation, local conditions and the research environment. Researchers themselves mustalso ensure that they are as prepared as is reasonably practicable. Most risks involved withresearch overseas are foreseeable and with careful planning can be reduced or avoided.

For further guidance on travelling and working overseas, please see OBU Health and Safety

Notice 38 athttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn38.html.
http://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn31.htmlhttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn31.htmlhttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn31.htmlhttp://the-sra.org.uk/sra_resources/safety-code/http://the-sra.org.uk/sra_resources/safety-code/http://the-sra.org.uk/sra_resources/safety-code/http://the-sra.org.uk/sra_resources/safety-code/http://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn36.htmlhttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn36.htmlhttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn36.htmlhttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn38.htmlhttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn38.htmlhttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn38.htmlhttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn38.htmlhttp://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn36.htmlhttp://the-sra.org.uk/sra_resources/safety-code/http://the-sra.org.uk/sra_resources/safety-code/http://www.brookes.ac.uk/services/hr/health_safety/docs/obuhsn31.html


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HA/09/2013 8

Flowchart demonstrating the ethics review procedures for research involving human participants in theFaculty of Health and Life Sciences

Staff orstudentresearcher (&supervisor)completesapplicationform Application to FREC using

IRAS Application Form

Approved - receiveFH&LSE3

Application toLREC (NRES)

Applicationto UREC

AuditProject

ResearchProject

Involves NHS/Social Carepatients /clients

Study does notinvolve NHS /Social Carepatients / clients

Proposal fulfilsNRES criteria foraudit

Staff / Undergraduate /MSc / MA students / PhD -application to DREO usingFH&LS E2U form

Rejected (resubmitto FREC)

Feedback given byDREO. Studysigned-off byDREO

Staff / MPhil/PhD/EdDstudents - application toDREO usingE2U form

Comply with NHSTrust arrangementsfor audit

ApprovedreceiveFH&LS E3.

Rejected (resubmit toDREO)

ServiceEvaluationin NHS

Application to DREO using

FH&LS E2A (Audit)

Confirmed as audit.

Ensure gatekeeperpermissions in place

Key:DREODept. Research Ethics Officer Route for External NRES ApprovalFRECFaculty Research Ethics CommitteeURECUniversity Research Ethics Committee Route for Internal / University Approval

Seek R&Dpermission

tart here


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HA/09/2013 9

MAKING AN APPLICATION TO AN NHS RESEARCH ETHICSCOMMITTEE

All applications must be approved by the FREC beforea proposal can be submitted externally toan NHS Local Research Ethics Committee (LREC).

THE NHS ETHICS REVIEW SERVICEThe National Patient Safety Agency established a National Research Ethics Service (NRES). Itsmission is to protect the rights, safety, dignity and well -being of research participants and tofacilitate and promote ethical research that is of potential benefit to participants, science andsociety. The Service is managed via a network of Local Research Ethics Committees, eachlocated within and appointed by a Strategic Health Authority.

Each LREC comprises professional and lay members, all of whom are volunteers. All RECsfollow national guidelines for ethics review i.e. the Research Governance Framework for Healthand Social Care (DoH, 2005) (see https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition. Ethics approval is dependentupon the research applicant satisfactorily demonstrating respect for the autonomy of researchparticipants, concern for their welfare and the scientific validity of the project.

THE REMIT OF NHS RESEARCH ETHICS COMMITTEESA Local Research Ethics Committee reviews all research that involves: potential researchparticipants recruited because of their past or present use of NHS / Social Care services, theirstatus as relatives or carers of past or present NHS / Social care users, research that collectstissue from these users or any information that has the potential to identify them.

Audit and service evaluation do not require NHS ethics review. See Appendix 5 for the NHS

criteria for distinguishing between research, audit and service evaluation.

MAKING AN APPLICATION

All applications must be made using the IRAS application form available atwww.myresearchproject.org.uk/or the link from the Health Research Authority website at:http://www.hra.nhs.uk/research-community/applying-for-approvals/.

The application should be completed using the question-specific guidance provided.

This application form must be submitted to the Faculty REC for review and approvalbeforesubmitting it to the NRES.

After Faculty approval, a review slot must be booked either via the NRES CentralAllocation Service or directly with a Research Ethics Committee. Information on how to

apply is available via the Health Research Authority website atwww.nres.nhs.uk/applications/booking-and-submitting-your-application/how-to-book/.

The application will be reviewed at the next meeting to which the applicant will be invitedto attend (or should be available by phone). Further to the meeting, the Committee canseek clarification on specific issues on one occasion only.

NRES decisions have to be made within a minimum 60-calendar day timeframe (althoughthis varies according to the type of study reviewed).

For any queries about the application process, you can contact the NRES [email protected] [email protected].
https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-editionhttps://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-editionhttps://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-editionhttp://www.myresearchproject.org.uk/http://www.myresearchproject.org.uk/http://www.hra.nhs.uk/research-community/applying-for-approvals/http://www.hra.nhs.uk/research-community/applying-for-approvals/http://www.nres.nhs.uk/applications/booking-and-submitting-your-application/how-to-book/http://www.nres.nhs.uk/applications/booking-and-submitting-your-application/how-to-book/mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]://www.nres.nhs.uk/applications/booking-and-submitting-your-application/how-to-book/http://www.hra.nhs.uk/research-community/applying-for-approvals/http://www.myresearchproject.org.uk/https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-editionhttps://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition


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Oxford Brookes University Faculty of Health and Life Sciences Research Ethics Handbook (Interim)

HA/09/2013 10

COMPLETING THE APPLICATION FORM

The Chief InvestigatorThe Chief Investigator (CI) should submit the application form for ethics approval. This is theperson with overall responsibility for the design, conduct, analysis and reporting of the study.PhD / Doctoral students can be identified as the CI in their own right. In the case of other studentprojects (MSc / Undergraduate), the Research Supervisor takes on the responsibility of ChiefInvestigator. In this case the student should complete the ethics application form, on behalfof the CI. The filter questions at the beginning of the application form should be correctlycompleted so the status of the study as a student project is clear.

DocumentationThe documentation submitted for LREC review should include:

A signed and dated application from, completed using the guidance notes

Consideration of the ethical issues involved in the project

A full description of the way in which consent is to be sought and documented

All data collection tools e.g. interview schedules, questionnaires, diaries

All correspondence with participants i.e. poster advertisements, participant invitation letter,

participant information sheet, consent form in plain English (or other appropriatetranslation) and non-technical language. This should be signed (where appropriate) anddated, on appropriate letterhead, contain the study title, NRES study number and versionnumber

A research protocol including supporting reference material

The Curriculum Vitae of the applicant(s)

Details of scientific peer review. The REC will expect to see evidence of the scientific peerreview of the application by the Host organisation. The FREC also reviews the science ofthe study to address this requirement. On approval, an E4 scientific peer review for will beissued that should be sent with the application to the LREC, together with allcorrespondence with the Committee.

A letter confirming who will act as the Sponsor for the research. Oxford BrookesUniversity will act as the Research Sponsor for all research conducted by staff andstudents. Hazel Abbott, Research Ethics Lead, will issue a letter to this effect and shouldbe named as the Sponsors contact with the main REC.

The arrangements for indemnity insurance.

Site-Specific AssessmentStudies that involve only low risk research procedures, including research involving qualitativemethods only, are exempt from Site-Specific Assessment (SSA). Clinical research and studiesinvolving adults unable to consent for themselves do require SSA. Where research is to becarried out at NHS sitesand SSA is required, this is the responsibility of the local R&D office. Forresearch requiring SSA at non-NHS sites, this is the responsibility of the Local Research Ethics

Committee.

R&D management approvalR&D management approval is required at each site before a study can begin. This can beundertaken simultaneously to seeking ethics approval - although final R&D approval will not beconfirmed until after a favourable ethical opinion has been given.

Research PassportsA number of checks must be undertaken on a researcher before they are permitted to conductresearch in the NHS. This process can be lengthy, especially as the same checks are carried outat each site before a research project can begin. In order to increase efficiency of this process,Research Passports have been introduced. A form is completed by the researcher, verified by

their employer and then validated by an NHS organisation. The result is a Research Passportthat can be presented to each NHS organisation for which R&D management approval is sought.See:www.nihr.ac.uk/systems/pages/systems_research_passports.aspx for further information
http://www.nihr.ac.uk/systems/pages/systems_research_passports.aspxhttp://www.nihr.ac.uk/systems/pages/systems_research_passports.aspx


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HA/09/2013 11

Proportionate ReviewA system for the proportionate scrutiny of applications raising no material ethical issues has beenestablished. In this case, a sub-Committee of the main REC reviews the application with a viewto issuing an opinion within 14 days.

A No Material Ethical Issues Tool should be used to determine whether a study is suitable forproportionate review, available at: http://www.hra.nhs.uk/documents/2013/09/no-material-ethical-issues-tool.pdf.

A useful Proportionate Review Frequently Asked Questions fact sheet can be downloaded at:http://www.nres.nhs.uk/applications/guidance/?EntryId62=74111.

To book an application for proportionate review, applicants should contact the ProportionateReview Allocation System on 0161 625 7704. The line is open to speak with an operator between10:00-12:00 and 14:00-16:00 Monday to Friday. Alternatively the PR booking team can be contactedby email at:[email protected] .

OXFORDSHIRE RESEARCH ETHICS COMMITTEES

There are three RECs in Oxfordshire all located within South Central Strategic Health Authority.For meeting dates please contact the administrator (contact details below) or see the NRES web-sitehttp://www.nres.nhs.uk/contacts/nres-committee-directory/?p=7.

Oxfordshire Research Ethics Committee A Oxfordshire Research Ethics Committee B

Chair: Dr Karen Melham Chair: Mr Chris Foy

REC Manager: Stephanie MacPherson REC Manager: Siobhan Bawn

Tel: 0117 342 1331 Tel: 0117 342 1333

Fax: 0117 342 0445 Fax: 0117 342 0445

E-mail: [email protected]


Oxfordshire Research Ethics Committee C

Chair: Professor Nigel Wellman

REC Manager: Rae Granville

Tel: 0117 342 1389


Postal address for committees A, B & C

South West REC CentreLevel 3, Block BWhitefriars

Lewins MeadBristolBS1 2NT
http://www.hra.nhs.uk/documents/2013/09/no-material-ethical-issues-tool.pdfhttp://www.hra.nhs.uk/documents/2013/09/no-material-ethical-issues-tool.pdfhttp://www.hra.nhs.uk/documents/2013/09/no-material-ethical-issues-tool.pdfhttp://www.hra.nhs.uk/documents/2013/09/no-material-ethical-issues-tool.pdfhttp://www.nres.nhs.uk/applications/guidance/?EntryId62=74111http://www.nres.nhs.uk/applications/guidance/?EntryId62=74111mailto:[email protected]%20?subject=Proportionate%20Review%20enquirymailto:[email protected]%20?subject=Proportionate%20Review%20enquirymailto:[email protected]%20?subject=Proportionate%20Review%20enquiryhttp://www.nres.nhs.uk/contacts/nres-committee-directory/?p=7http://www.nres.nhs.uk/contacts/nres-committee-directory/?p=7http://www.nres.nhs.uk/contacts/nres-committee-directory/?p=7http://www.nres.nhs.uk/contacts/nres-committee-directory/?p=7mailto:[email protected]%20?subject=Proportionate%20Review%20enquiryhttp://www.nres.nhs.uk/applications/guidance/?EntryId62=74111http://www.hra.nhs.uk/documents/2013/09/no-material-ethical-issues-tool.pdfhttp://www.hra.nhs.uk/documents/2013/09/no-material-ethical-issues-tool.pdf


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HA/09/2013 12

SOCIAL CARE RESEARCH

The Social Care Research Ethics Committee is part of the NRES. It is appointed by the SocialCare Institute for Excellence (SCIE) and reviews applications involving the social care sector i.e.local authority, private and voluntary settings. It reviews the following type of studies:

Social care research funded by the Department of Health

Social care research involving adults lacking capacity and required under the MentalCapacity Act (2005)

Social care research involving sites in England and another UK country

Own account research undertaken by Councils with Social Services responsibilities,where research team consider there are significant ethical issues

Studies where the investigators do not have access to other review mechanisms

Studies taking place within the NHS using social science or qualitative methods, but wherethe research does not involve clinical interventions or changes to clinical care

Intergenerational studies involving both adults and children or families are researchparticipants

For further guidance, please see the Standard Operating Procedures for Research EthicsCommittees Version 5.0 (NRES, 2011), annex K at: http://www.hra.nhs.uk/resources/after-you-apply/knowledgebase-nhs-rec-review-outcomes/nres_sops_v5-1_2012-03-14-2/.
http://www.hra.nhs.uk/resources/after-you-apply/knowledgebase-nhs-rec-review-outcomes/nres_sops_v5-1_2012-03-14-2/http://www.hra.nhs.uk/resources/after-you-apply/knowledgebase-nhs-rec-review-outcomes/nres_sops_v5-1_2012-03-14-2/http://www.hra.nhs.uk/resources/after-you-apply/knowledgebase-nhs-rec-review-outcomes/nres_sops_v5-1_2012-03-14-2/http://www.hra.nhs.uk/resources/after-you-apply/knowledgebase-nhs-rec-review-outcomes/nres_sops_v5-1_2012-03-14-2/http://www.hra.nhs.uk/resources/after-you-apply/knowledgebase-nhs-rec-review-outcomes/nres_sops_v5-1_2012-03-14-2/


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HA/09/2013 13

RESEARCH VERSUS AUDIT

The distinction between research and audit can be blurred. The NHS National Research EthicsService (NRES) only reviews research projects involving patients, their carers or data.

The NRES does notreview projects for audit or service evaluation, although the former must complywith data protection legislation and local NHS Trust arrangements for the conduct of audit. The NREScriteria for categorising research, audit and service evaluation are contained in Appendix 5.

Staff and students embarking on research or audit projects need to be able to distinguish one from theother to ensure that the correct approvals are obtained prior to the commencement of data.Research is a systematic investigation that aims to generate new knowledge whereas clinical audithas been defined as a quality improvement process that seeks to improve patient care and outcomesthrough systematic review of care against explicit criteriaand the implementation of change (NationalInstitute for Clinical Excellence, 2002).

The following table provides a useful distinction between the two activities.

The Differences between Research and Audit

RESEARCH CLINICAL AUDIT

A systematic investigation which aims togenerate new knowledge may be qualitative orquantitative in approach

DEFINES best practice/standards

A systematic peer review of healthcare in order tomonitor or improve services

MONITORS current practice against bestpractice/known standards

May involve an experimental approach (e.g.randomly allocating patients to different treatmentgroups)

Never involves an experimental approach (e.g. willnever involve allocating patients to differenttreatment groups)

May involve giving patients different treatments butthese alternatives will all be accepted as normal

practice, and patients would normally be allowed tochoose

May involve a new treatment Never involves a new treatment

May involve extra disturbance to patients overand above normal clinical management. Thismay take the form of specially arrangedinterviews, focus groups, interventions, clinicalassessments or postal communications

May involve asking people about their satisfactionwith care or health state following specifictreatment, but not much else

Usually involves well-defined, often strictselection criteria for participants recruited

Recruitment criteria not usually as well defined orstrict

Generalisable; hopes to inform/influence careacross the NHS and beyond

Not generalisable; hopes to influence the caregiven by local health services

Intention to publish/widely disseminate outputs Primarily local dissemination, principally to serviceproviders; outputs may be published where it willassist other audit

Often commissioned/funded externally by thosefrom outside the local service (e.g. MedicalResearch Council, Department of Health,Pharmaceutical Company)

Funded by local health services

Often conducted by those outside of the localservice e.g. Universities)

Usually conducted by those providing the servicelocally

From: How to conduct a clinical auditReproduced with permission from the Clinical Effectiveness Team, CGSU, ORHT

If in any doubt as to whether a project should be categorised as research or as audit, pleaseconsult the DREO or seek clarification from the Research and Development Office within therelevant NHS Trust.


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HA/09/2013 14

Conducting an auditIn the first instance, information should be sought from the local NHS Trust to establish whetherthey have a policy for the approval of audit projects and corresponding guidelines for conductingan audit. Such information would be available from the Clinical Effectiveness Team or the ClinicalGovernance Support Unit.

In Oxfordshire, all audit projects should be registered with the Clinical Effectiveness Team andsuch details are maintained on a database.

The ethical dimensions of auditGenerally, the main ethical issue with audit is the protection and use of patient information. Allaudit projects must comply with the Data Protection Act (1998), the recommendations of theCaldicott Committee (1997) and the NHS Confidentiality Code of Practice (2003). All of thesedocuments can be viewed atwww.doh.gov.uk.

The main points that should be noted are that:

Data should be used only for the purposes for which it has been collected

Patients must be fully informed about the uses to which information about them may beput

Clinicians are notentitledto access patient records for either audit or research purposeswithout the appropriate permission

Any researcher requiring access to patient records must seek permission from either theNRES or the Local NHS Trust (usually via the Clinical Effectiveness Team)
http://www.doh.gov.uk/http://www.doh.gov.uk/http://www.doh.gov.uk/http://www.doh.gov.uk/


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HA/09/2013 15

MAKING AN APPLICATION TO THE UNIVERSITY RESEARCH ETHICSCOMMITTEE (UREC)

Any research to be carried out by staff orresearch students(MPhil/PhD/EdD) must be forwardedto the University Research Ethics Committee (UREC) for approval. The only exception to this iswhere the project involves NHS patients their carers or their data. In this case, the project needsto be approved by the Faculty REC and then forwarded to a Local Research Ethics Committee(LREC) for approval by the National Research Ethics Service instead - see page 9).

In the first instance, an E2U application form should be completed, which is accessible via theUniversity research ethics web site http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/.

This form should then be forwarded to the relevant Departmental Research Ethics Officer (DREO)three weeks before the UREC meeting for feedback and signing-off. Once approved by the

DREO, the application can be forwarded to the University Committee for review.

Applications are reviewed and then discussed at the Committee meeting.

A light touch procedure is also in place for those projects raising no material ethical issues.Seehttp://www.brookes.ac.uk/Research/Research-ethics/Determining-light-touch-review/. The DREOcan advise on whether a study fits the criteria for light touch review.

The membership of UREC comprises all the Faculty Research Ethics Officers, lay representativesand the University Information Compliance Officer. The Chair of the Committee is currently HazelAbbott ([email protected]).

The Committee meets five times per semester usually in weeks 1, 4, 7, 10 and 13 and twiceduring the vacation period. One complete hard copy of the application, signed by the relevantFaculty Research Ethics Officer, should be send to Louise Wood, the University Research EthicsCommittee Administrator ([email protected] / 01865 484445), two weeks before themeeting date.

The dates for the University Research Ethics Committee meetings for the academic year 2013 /2014 are listed in Appendix 2.
http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Determining-light-touch-review/http://www.brookes.ac.uk/Research/Research-ethics/Determining-light-touch-review/mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]://www.brookes.ac.uk/Research/Research-ethics/Determining-light-touch-review/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/http://www.brookes.ac.uk/Research/Research-ethics/Ethics-review-forms/


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HA/09/2013 16

INDEMNITY INSURANCE FOR OXFORD BROOKES UNIVERSITYRESEARCHERS

The University has public liability insurance that provides third party cover for loss and damagefor which the University is legally responsible, with a few exceptions e.g. wilful damage. This

policy covers claims made against staff, students and all participants in research projects,regardless of whether the research takes place on University property.

No cover for personal injuries/damages is held by the University but it does have personalaccident cover that provides death and disability benefits.

A standard indemnity form has been produced by the University to be used by staff and studentsvisiting external organisations to carry out research work. The normal situation is that theorganisation will have insurance against its own legal liability towards visitors by virtue of a publicliability policy.

Occasionally staff may be asked to produce proof of insurance cover to external persons. In

addition, staff may wish to print proof of covers for their own use. Staff needing to print suchdocumentation can do so from the link http://fls.jamkit.com/Insurance/Insurancecertificates .However, copies of insurance certificates for clinical trials must be requested directly from theUniversity Insurance Officer (see below).

The University Insurance Policy applies to all staff and students registered for a programme ofstudy at Oxford Brookes. This includes students undertaking research work overseas.

CLINICAL TRIALSInsurance cover for clinical trials requires special arrangements because such research isconsidered to be high risk by the University Insurers.

A clinical trial is defined as an investigation or series of investigations conducted by any personfor a medicinal purpose. A medicinal purpose shall mean:

Treating or preventing disease

Diagnosing disease or ascertaining the existence, degree or extent of a physiologicalcondition

Assisting with or altering in any way the process of conception or investigating orparticipating in methods of contraception

Inducing anaesthesia

Otherwise preventing or interfering with the normal operation of a physiological function

Cover for clinical trials will be automatic in many cases e.g. if the trial is within the UK and isbased solely upon questionnaires, venepuncture, measurements of physiological processes orcollections of body secretions by non-invasive methods, or the administration by mouth of foodsor nutrients or variation of diet other than the administration of drugs or other food supplements.

However, the University insurance policy excludes the following:

Trials outside the United Kingdom

Trials involving more than 100 participants

Trials involving the use of drugs or surgery

Trials requiring no-fault cover

Research subjects known to be pregnant at the time of the trial

Research subjects under 5 years of age
http://fls.jamkit.com/Insurance/Insurancecertificateshttp://fls.jamkit.com/Insurance/Insurancecertificateshttp://fls.jamkit.com/Insurance/Insurancecertificates


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HA/09/2013 17

Clinical trials in which the medicinal purpose is:(a) assisting with, or altering, the process of conception(b) investigating, or participation in, methods of contraception

Clinical trials involving genetic engineering (other than trials in which the medicinal purpose istreating, preventing and diagnosing disease)

Trials where the substance under investigation has been designed and manufactured by the

University

In the event of the above, specific insurance cover needs to be negotiated by the Insurance &Risk Officer before the trial takes place. The Faculty Research Ethics Officer must refer allclinical trials involving the above exclusion list to the University Insurance Office. Researcherswill be asked to complete the Clinical Trial Questionnaire (see Appendix 6).

Please note that, in addition to the above,

All relevant clinical trials must be conducted in accordance with the Medicines (Application forGrants of Product Licenses) (Products for Human Use) Regulations 1993 and the Medicines(Standard Provision for Licences and Certificates) Amendment (No. 2) Regulations 1992

The University shall obtain the Association of the British Pharmaceutical Industryrecommended indemnity or equivalent where a clinical trial is sponsored by a pharmaceuticalmanufacturer or similar organisation

Gary Lambourne is the University Insurance Officer and he may be contacted on 01865-483498.For further information about insurance, seehttp://fls.jamkit.com/Insurance.
http://fls.jamkit.com/Insurancehttp://fls.jamkit.com/Insurancehttp://fls.jamkit.com/Insurancehttp://fls.jamkit.com/Insurance


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HA/09/2013 18

CORRESPONDENCE WITH RESEARCH PARTICIPANTS

All correspondence should be on Oxford Brookes headed paper. For student research, it is theresponsibility of the Research Supervisor to ensure that headed paper is used. If the research isbeing co-sponsored by another agency e.g. ORH NHS Trust or a commercial company, both

organisations / logos can be included on the correspondence. Guidance on the positioning suchlogos can be obtained from the Marketing Department.

Please no te:

If the study invo lves NHS pat ients/carers yo u MUST fol low th e NRES guidance o n

the required format for part ic ipant inform at ion sheets and cons ent forms . See:

ht tp: / /www.nres.nhs.uk/appl icat ions/guidance/consent-guidance-and-forms/.

The following information may be helpful when compiling / designing correspondence withparticipants:

Invitation LetterIt is good practice to send potential research participants an invitation letter. An invitation lettershould include:

who you are (i.e. a student/member of staff at Oxford Brookes University)

how you have obtained access to them as potential research participants and why you arewriting to them (i.e. you are inviting them to take part in a research study because they )

an invitation to read the accompanying information sheet containing more detailedinformation about the study

a statement that says there is no obligation to take part. However, if invitees do wish toopt in to the research, you need to explain how they do this

a thank youfor reading the letter/information sheet

the signature of the Research Supervisor, if you are undertaking the research as a student

Participant Information SheetA participant information sheet contains the finer details about a proposed investigation. Potentialrecruits to the research study must be given sufficient information to allow them to decide whetheror not they want to take part.

An information sheet should be written in simple, non-technical terms and be easily understoodby a lay-person. A question and answer format should be used. In order to facilitate ease ofreading, use a minimum font size of 12 points. It is preferable to use the word would rather thanwill throughout. Will implies consent has already been given and could be considered coercive,whereas would implies a decision has yet to be made.

Version numbers and dates should be included at the bottom of the protocol, invitation letters,information sheets and consent forms. This should be updated each time the documents arerevised.

The University template for a participant information sheet is available at:http://www.brookes.ac.uk/Research/Research-ethics/Guidelines-for-informed-consent/

Consent FormWhere interviews are the method of data collection, a clause should be added to the consent formseeking permission to use anonymous quotes in the presentation of research findings andagreement to the tape/video-record the interview.

The University template for a consent form is available at:http://www.brookes.ac.uk/Research/Research-ethics/Guidelines-for-informed-consent/.
http://www.nres.nhs.uk/applications/guidance/consent-guidance-and-forms/http://www.nres.nhs.uk/applications/guidance/consent-guidance-and-forms/http://www.brookes.ac.uk/Research/Research-ethics/Guidelines-for-informed-consent/http://www.brookes.ac.uk/Research/Research-ethics/Guidelines-for-informed-consent/http://www.brookes.ac.uk/Research/Research-ethics/Guidelines-for-informed-consent/http://www.brookes.ac.uk/Research/Research-ethics/Guidelines-for-informed-consent/http://www.brookes.ac.uk/Research/Research-ethics/Guidelines-for-informed-consent/http://www.brookes.ac.uk/Research/Research-ethics/Guidelines-for-informed-consent/http://www.nres.nhs.uk/applications/guidance/consent-guidance-and-forms/


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Oxford Brookes University, Faculty of Health & Life Sciences Research Ethics Handbook

HA/09/2013 19

COMMONLY RAISED QUESTIONS ABOUT THE ETHICS APPROVALPROCESS

The following questions represent those commonly asked about the ethics approval procedure.

I am a member of staff within the FH&LS and current ly registered on a Masters progr amme

at the Universi ty. Do I seek ethics appro val for the research project I am und ertaking for

my d issertat ion in my capacity as a member of staff or as a student?

Ethics approval is required in your capacity as an MSc student. In the first instance, approval forthe study must be sought from the DREO. If the study involves NHS patients, staff or premises,the application will need to be reviewed by the FREC before it is forwarded to an NHS ResearchEthics Committee for approval. If the study does not involve NHS patients, staff or premises,approval only at Departmental level is required.

I am emplo yed as a nurs e/midw ife/phys iotherapist in the NHS. I have recently sou ght andobtained ethical approval from th e NRES for a research study I am intendin g to carry o ut

relevant to my w ork. However, I have also sub sequently registered on an MSc degree

programme at Oxford Brookes Univers i ty and intend to conduct th is research for my

dissertat ion. What should I do about Faculty research ethics appro val and who wil l

indemni fy me for th is project?

If you submitted the original application to the NRES in the capacity of Chief Investigator, theFREC requires that you forward a complete copy of the REC application and the approval letter tothe Chair of the Committee. Details of the study will be entered onto the Faculty Research EthicsCommittee database and you will be deemed to have complied with the Faculty Ethics ApprovalProcedure.

If your research is a small component of a larger study and you did notmake the original NRESapplication yourself, you need to complete Form E2U. This requires you to consider the ethicaldimensions of the research you are proposing to undertake. This form should be forwarded to theDREO, together with relevant all correspondence with research participants and a copy of theREC approval letter for the entire project. The application will not be reviewed at a Committeemeeting unless the Chair of the Committee has any concerns about either the ethics or thescience of the study. Having done this, you will have complied with the Faculty requirements forethics approval. Indemnity insurance will be provided either by your employer or the University,depending on who is identified as the Sponsor for the research.

I am unclear wh ether my intended stud y is research or audit . Should I seek ethicsapproval for my work?

In the first instance, discuss this with both your Research Supervisor and your Manager in theplace where you work. Seek guidance from the Clinical Effectiveness Team if required. Consultyour DREO if clarification still required. If the project is considered to be audit, complete FH&LSform E2 (Audit) and forward it to the DREO.


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I wish to con duct a study that is relevant to my job as a nurs e manager. This would

require me to col lect data within m y place of wo rk. Are there ethical dif f icul t ies with this?

Conducting research within the place where you work does potentially raise ethical difficulties.

Role Confl ictA researcher has to ensure that the roles of researcher and clinician are clearly separated.Information that is gathered for the purposes of providing clinical care cannot be used as researchdata. Likewise, data gathered as part of the research process may have implications for clinicalcarebut the researcher is bound by a duty of confidentiality to the research participant. Thishas to be balanced against the clinicians Code of Professional Conduct/duty of care that can, onoccasion, over-ride the duty of confidentiality. Similar dilemmas exist where researchers are alsowork colleagues. As part of their employment contract, they may be required to report incidentsand or actions taken by others. This has the potential to compromise the researcher / workcolleague relationship.

Recruitment

The potential exists for coercion in recruitment. If potential participants are work colleagues, theymay feel obliged to participate because they depend upon the researcher for a good workingrelationship. Furthermore, if you have managerial responsibility for potential participants, theymay feel that their work performance would be negatively appraised by declining to participate oreven that their promotion opportunities could be compromised by refusal to take part.Patients/clients are similarly in a vulnerable position if they are dependent upon the researcher fortheir health care.

Data Collectio nIf the research participant knows the researcher, openness and truth telling may be compromised

during data collection thus compromising the validity of the data. The participant may provideinformation that they believe the researcher wishes to hear!

Data AnalysisThe researchers inside knowledge about the workplace has the potential to influence theinterpretation of the data.

Steps to address/minimise these issues should be taken in the design phase of a study.


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HA/09/2013 21

Appendix 1

FACULTY OF HEALTH AND LIFE SCIENCES RESEARCH ETHICSCOMMITTEE

TERMS OF REFERENCEPurposeTo review and approve research to be undertaken in the NHS by staff and students from theFaculty of Health and Life Sciences

Terms of Reference

To establish, implement and review ethics procedures and guidelines for research projectsinvolving the NHS and to disseminate these throughout the Faculty

To ensure that the procedures for ethics review within the Faculty of Health and LifeSciences reflect the principles of the Research Governance Framework for Health andSocial Care (DoH, 2005) and enable researchers to meet these requirements

To review and approve research involving human participants or human data to be carriedout in the NHS by staff and students from the Faculty of Health and Life Sciences

To carry out an independent peer review of the scientific dimensions of the research tomeet National Research Ethics Service requirements

To provide informational support, advice and guidance to staff and students on conductingresearch involving human participants / human data in the NHS

Modus Operandi1. Meetings will be monthly throughout the calendar year, except during August. Additional

meetings may be convened to manage the capacity of work during busy periods or inextraordinary circumstances

2. A maximum of 8 applications will be reviewed and discussed at any one meeting3. The Chair of the Committee, or nominated Committee member in the Chairs absence, will

undertake all correspondence with applicants and sign all Approval Forms (Form E3) onbehalf of the Committee

4. In the unusual event that an expedited review is required, the Research Ethics Lead, onbehalf of the Committee, will undertake this

5. Outstanding issues arising from a proposal that has been reviewed at a Committeemeeting will subsequently be dealt with by Chairs Action

6. Committee decisions will be notified to applicants within 10 working days of the Committeemeeting

Membership

Departmental Research Ethics Officers (To Chair meeting) Representatives from the Departments of Clinical Health Care, Psychology, Social Work &

Public Health, Sport and Health Sciences and Biological and Medical Sciences

In the event that discipline-specific expertise is required, other members of the Faculty willbe co-opted onto the Committee

Members of the Committee should be knowledgeable about research, have an interest inresearch ethics and normally hold a Masters degree

The Committee will be quorate with 5 members present, one of who must be the Chair (ornominated representative in the Chairs absence)


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HA/09/2013 22

Organisational Relationships

Key

Representative relationship

Reporting relationship

Associate Dean ofResearch and Knowledge

Transfer

Faculty ResearchEthics Management

Committee

UniversityResearchEthicsCommittee

Faculty ResearchEthics Committee

Faculty ResearchKnowledge and

Exchange Committee


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HA/09/2013 23

Appendix 2

UNIVERSITY RESEARCH ETHICS COMMITTEE MEETING DATES

2013/2014

UREC Meeting date Applicationdeadline to REO

Application deadline toLouise Wood

Semester One 2013

Tuesday 24 September 2013(week 1)

3 September 10 September

Wednesday 16 October 2013

(week 4)

25 September 2 October

Tuesday 5 November 2013(week 7)

15 October 22 October

Wednesday 27 November2013 (week 10)

6 November 13 November

Tuesday 17 December 2013(week 13)

26 November 3 December

Semester Two 2014

Wednesday 29 January 2014(week 1)

8 January 15 January

Thursday 20 February 2014(week 4)

30 January 6 February

Wednesday 13 March 2014(week 7)

19 February 26 February

Thursday 3 April 2014 (week10)

13 March 20 March

Wednesday 7 May 2014(week 13)

16 April 23 April

Vacation

Thursday 12 June 2014 22 May 29 May

Wednesday 16 July 2014 25 June 2 July

Applications should be submitted to the relevant Departmental Research Ethics Officer forfeedback and signing off three weeks before the UREC deadline. After this, one complete copyof the application should be submitted to Louise Wood, two weeks before the UREC deadline.

Contact for further information: Louise Wood, UREC Administrator

[email protected] or 01865-484445
mailto:[email protected]:[email protected]


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HA/09/2013 24

Appendix 3

FACULTY OF HEALTH AND LIFE SCIENCES RESEARCH ETHICSCOMMITTEE MEETING DATES

2013/2014

REC deadline date REC meeting date

Semester One 2013

Monday 23 September 2013 Tuesday 01 October 2013

Monday 14 October 2013 Tuesday 22 October 2013

Monday 04 November 2013 Tuesday 12 November 2013

Monday 02 December 2013 Tuesday 10 December 2013

Semester Two 2014

Monday 13 January 2014 Tuesday 21 January 2014

Monday 17 February 2014 Tuesday 25 February 2014

Monday 17 March 2014 Tuesday 25 March 2014

Wednesday 03 April 2014 Tuesday 29 April 2014

Monday 12 May 2014 Tuesday 20 May 2014

Monday 16 June 2014 Tuesday 24 June 2014

Monday 14 July 2014 Tuesday 22 July 2014

No meeting in August No meeting in August

Semester One 2014

TBC TBC

Sixcollated,hard copiesof the application (plus all supporting documentation/correspondence)should be handed in at Reception, Marston Road by 12.00 pm on the deadline datefor reviewat the next Committee meeting.

One electronic copy should also be forwarded to Hazel Abbott, Chair of the FREC([email protected]).


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Appendix 4

PROCEDURE FOR EXPEDITED ETHICS REVIEW

Expedited reviewIt is recognised that there may be some exceptional circumstances where an urgent review of anethics application is required, outside of the normal Faculty ethics review mechanism. Thesecircumstances are likely to be determined by the need to meet contractual agreements withfunding bodies.

Criteria:

Exceptional circumstances refer to unusual situations where the time frame for the studyprecludes the normal internal ethics review process. Evidence of such time constraintswill be required

The expedited review process will consider only the ethical dimensions of the proposedstudy. An independent scientific review of the research must therefore accompany theapplication

An experienced researcher (does not apply to student research or student researchers)

Previous experience of making a submission to a Research Ethics Committee

Process:

An approach should be made to the Chair of the Faculty Research Ethics Committeerequesting an expedited review

If the Chair agrees to the request and the above criteria are met, the DREO, or nominateddeputy*, will undertake an expedited review of the study on behalf of the Committee

Where the DREO, or nominated deputy, is able to sign off the application on behalf of theFaculty, the necessary paperwork will be provided (E3 form, insurance form and ResearchSponsor letter)

If the DREO considers the application raises significant ethical issues that need resolutionprior to submission to a NHS Research Ethics Committee, the application will either bediscussed with another DREO or referred to the Faculty Ethics Committee for review

Any decisions made via the expedited review process will be reported to the FacultyResearch Ethics Committee at the next meeting

The outcome of applications submitted to external Ethics Committees via this route will bemonitored

* Nominated deputy refers to a member of the Research Ethics Committee

HAb/09/2011


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HA/09/2013 26

Appendix 5

NRES CRITERIA FOR RESEARCH, AUDIT AND SERVICE EVALUATION

This table was developed by the NRES Ethics Consultation E-Group (April, 2007) and is

reproduced from the guidance for researchers and reviewers on the NRES web site.

RESEARCH CLINICAL AUDIT SERVICE EVALUATION

The attempt to derivegeneralisable new knowledgeincluding studies that aim togenerate hypotheses as well asstudies that aim to test them

Designed and conducted toproduce information to informdelivery of best care

Designed and conducted solely todefine or judge current care

Quantitative researchdesignedto test a hypothesis

Qualitative researchidentifies/explores themesfollowing establishedmethodology

Designed to answer the questiondoes this service reach apredetermined standard?

Designed to answer the questionwhat standard does this serviceachieve?

Addresses clearly definedquestions, aims and objectives

Measures against a standard Measures current service withoutreference to a standard

Quantitative researchmayinvolve evaluating or comparinginterventions, particularly newones

Qualitative researchusuallyinvolves studying howinterventions and relationshipsare experienced

ONLY involves an intervention inuse. (The choice of treatment isthat of the clinician and patientaccording to guidance,professional standards and/or

patient preference).

ONLY involves an intervention inuse. (The choice of treatment isthat of the clinician and patientaccording to guidance,professional standards and/or

patient preference).

Usually involves collecting datathat are additional to those thatare for routine care but mayinclude data collected routinely.May involve treatments, samplesor investigations additional toroutine care

Usually involves analysis ofexisting data but may includeadministration of simple interviewor questionnaire

Usually involves analysis ofexisting data but may includeadministration of simple interviewor questionnaire

Quantitative researchstudydesign may involve allocatingpatients to intervention groups

Qualitative research uses aclearly defined samplingframework underpinned byconceptual or theoretical

justifications

No allocation to interventiongroups: the health careprofessional and patient havechosen the intervention beforeclinical audit

No allocation to interventiongroups: the health careprofessional and patient havechosen the intervention beforeservice evaluation

May involve randomisation No randomisation No randomisation

Research requires NRES RECreview

Audit does not require NRESREC review

Service evaluation does notrequire NRES REC review

Please note:Although clinical audit and service evaluation do not require NRES review, theseprojects will require R&D permissionand may raise ethical issues.


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HA/09/2013 27

Appendix 6

CLINICAL TRIALS QUESTIONNAIRE(FOR INSTITUTION SPONSORED TRIALS ONLY)

If the Trial is within the UK and refers to the following there is no need to complete this Questionnaire:

Trials solely based upon quest ionnaires, venepuncture, measurements of physiological

processes or col lect ions of bod y secret ions by non-invasive methods, or the administrat ion by

mo uth of foods or nutr ients or variat ion of diet other than the adm inistrat ion of drugs or oth er

food s upplements

Institution (sponsor): ________________________________________________

Title of Trial ________________________________________________

Number of research subjects (participants) ______________________________________

1 Advise details of the Trial and attach copy of the Protocol submission to the Ethics Committee

2 Is the Trial to be held in UK?If No please provide full detail

3 Who will be involved in conducting the Trial? _______________________________

If medical practitioners are involved, willthey be covered by the MDU or other organisation?

4 Does the Trial involve use of drugs or surgery?

5 Are any of the research subjects known to be pregnant?

6 Are any of the research subjects under 5 years of age?

7 Is the purpose of the Trial :a) investigating or participating in the methods of contraceptionb) assisting with or altering the process of conception?

8 Does the Trial involve genetic engineering?

9 Will the Trial use a pharmaceutical productdesigned or manufactured by the Institution?

10 Proposed commencement date AND period of the Trial

If any of the answers to 49 are Yes please provide full details

ON NO ACCOUNT MUST THE PROJECT COMMENCE UNTIL INSURANCE APPROVAL IS GIVEN

Signed Dated

PRINT NAME: _____________________ SCHOOL: _____________ EXTN: ______

Definitions:Clinical Trial meansan investigation or series of investigations conducted on any person for a Medicinal Purpose

Medicinal Purpose meanstreating or preventing disease, diagnosing disease or ascertaining the existence degree of or extent of aphysiological condition, assisting with or altering in any way the process of conception or investigating or participating in methods ofcontraception inducing anaesthesia otherwise preventing or interfering with the normal operation of a physiological function.


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USEFUL CONTACT DETAILS

The Caldicott Committee: Report on the review of patient-identifiable information - December1997, NHS Executive

Also available atwww.doh.gov.uk

Data Protection Act (1998) London, The Stationary Office.Also available athttp://www.legislation.gov.uk/ukpga/1998/29/contents

Department of Health (1996) Health Service Guideline: The Protection and Use of PatientInformation, HMSO. Also available atwww.doh.gov.uk

Department of Health (2005) Research Governance Framework for Health and Social Care, 2 ndedition, London, The Stationary Office

Economic and Social Research Council (2006) Research Ethics Framework, ESRC. Available at:

http://www.esrc.ac.uk/about-esrc/information/research-ethics.aspx

Medical Research Council (2002) Personal Information in Medical Research, MRCAlso available atwww.mrc.ac.uk

National Ethics Advisory Committee (NEAC) (2003) Ethical review of observational research,audit and related activities. Available atwww.neac.health.govt.nz

National Institute for Clinical Excellence (2002) Principles for Best Practice in Clinical Audit, NICEAlso available atwww.nice.org.uk

National Patient Safety Agency (2007) Guidance for applicants to the National Research EthicsService, London, NPSA

National Patient Safety Agency (2007) Defining research, London, NPSA

National Patient Safety Agency (2007) Explaining research, London NPSA

Smith R (1992) Audit and research. British Medical Journal, 305: 905Also available atwww.bmj.com
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ethics handbook 2013-2014

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