An Introduction to the Ethics Review Procedure for New Ethics Reviewers Lindsay Cooper, Research & Innovation Services 11 March 2010

Putting the Policy into practice All research projects involving human participants, their data or their tissue must obtain ethics approval, via: 1.NHS ethics review procedure 1.NHS ethics review procedure; or 2.Alternative ethics review procedure 2.Alternative ethics review procedure; or 3.University ethics review procedure

NHS Procedure Remit: Patients & users of the NHS (current or previous) Relatives or carers of NHS patients Access to data, organs, other bodily material of past or present NHS patients Foetal material & IVF involving NHS patients Recently dead in NHS premises Use of/access to NHS premises NHS Staff (recruited due to professional role)

Remit: Research conducted outside UK; or Research led by another UK university/ research organisationBUT: if in doubt, apply University procedureThe other procedure must be judged to be sufficiently robust by the UREC; if in doubt, apply University procedure Alternative Procedure

University Procedure Remit: Research project (investigation to gain knowledge & understanding) Is led by this University Involves human participants, personal data or human tissue Does not involve the NHS Takes place within the UK

University ethics review procedure ( UERProcedure )

UERProcedure – Key Points Two versionsTwo versions of application form (staff/PGR and UG/PGT) Minimum requirements: 3 reviewersStaff/PGR: 3 reviewers 2 reviewersUG/PGT potentially high risk: 2 reviewers (1 can be Supervisor) 1 reviewerUG/PGT potentially low risk: 1 reviewer can be Supervisor *school/department policy & process may differ*

Issues for reviewers to consider (1) Has enough information been provided for me to comment? Have the questions been answered fully? What potential risks and benefits does the project pose and to whom? Is participant information appropriate for audience (eg no technical jargon, abbreviations, appropriate versions for children etc) Does the project raise any issues requiring special consideration eg involving vulnerable people or sensitive topics?

Issues for reviewers to consider (2) How will the project: 1.Protect dignity, rights, safety & well-being of participants and the researcher(s)? 2.Inform participants about purpose/method/use of research and obtain their consent? 3.Maintain the confidentiality of the participants? LEVEL OF SCRUTINY SHOULD BE PROPORTIONATE TO RISK OF HARM TO PARTICIPANTS

Issues for reviewers to consider (3) Special consideration needed for Special consideration needed for: particularly vulnerable human participants 1.Research involving particularly vulnerable human participants; highly sensitive topics 2.Research focusing on highly sensitive topics; covert methods 3.Research involving covert methods; no evidence that consent is being sought 4.Where there is no evidence that consent is being sought. Some fundamental ethical principals......

Safety and Well-being Consideration must be given to potential for harm/distress In some research (eg clinical trials), the researcher may need to knowingly cause harm BUT possible harm should be outweighed by the potential benefits; Participants should be informed of procedures for contacting researcher if problems arise; Researcher must inform participant if they obtain evidence of a problem that may endanger participant; Harm to researcher? Factsheet: ‘Principals of Safety and Well- being’

Consenting to Participate Participants should be fully informed about reasons/method and be able to ask questions/reflect (BUT may not be appropriate eg covert research); Participants should give free and voluntary consent, and not be coerced; Consent should be in writing; if not possible, witnessed oral consent instead; Implicit consent may be appropriate (eg completing and returning a questionnaire implies consent); Need consent for data to be used for secondary analysis; Must have right to refuse to participate or withdraw Factsheet: ‘Principal of Consent’

Anonymity, Confidentiality & Data Protection Must comply with Data Protection Act 1998; Participants’ identities should not be disclosed without prior consent; data should be anonymised where possible; Access to data that could identify individuals should be restricted to lead researcher(s); Participants should be informed of: 1.Risks that confidentiality may not be maintained (eg disclosure of criminal activity); 2.Who will have access to data; 3.The purpose for which the data is to be used Factsheet: ‘Principals of Anonymity, Confidentiality and Data Protection’

Key points to take away Each proposed research project should be treated on a case by case basis but there are key principals; Ethics review is about heightening risk awareness – not about preventing ‘potentially high risk’ research; Ethical review is about encouraging researchers to think through potential ethical challenges; An ethically robust research project may still encounter unexpected ethical challenges; Conducting research involving participants is not an exact science-nor is the ethics review process Put yourself in the participant’s shoes....

You are not alone......!

Further Guidance Lindsay Cooper (Minute Secretary to the UREC) ext.21443

Group Discussion: 2.30pm – 3.10pm TASK – Consider the ethics application assigned to your group: Has enough information been provided and is it understandable to the lay person? What are the potential risks to the participants/researcher and how is the researcher proposing to deal with any risks – have all the risks been identified? Does the project raise any issues requiring special consideration eg does it involve vulnerable people/sensitive issues? How is the researcher proposing to inform the participants about the project and obtain their consent? Is it appropriate? How will the participants’ confidentiality be maintained? Is the proposed method sufficient? What would your response to the applicant be?