Ethics in Practice: BSREC and NHS Research Ethics Committees Tuesday 15 th April 2014

1. Ethics in Practice: BSREC and NHS Research Ethics Committees Tuesday 15th April 2014 Graham Hewitt – WMS, Research Ethics and Governance Manager

2. What has this got to do with me? • University of Warwick Research Code of Practice states • “Any University of Warwick student or member of staff, who wishes to undertake research involving human participants, their data and/or tissue (this may also include research involving the data of deceased participants) under the auspices of the University, must obtain appropriate ethical approval.”

3. What has this got to do with me (cont’d)? • Research Ethical Review increasingly required by: • Funders • Journals

4. Ethics CommitteesSummary • Ethics Committees are responsible for acting primarily in the interest of potential research participants • They also take into account the interests, needs & safety of researchers trying to undertake good quality research • But - the goals of research & researchers will always be secondary to the dignity, rights, safety & well-being of research participants • Important that applications to Ethics Committees demonstrate that consideration has been given to these principles & adequate steps taken to address them.

5. Research jargon

6. What ethical review does my study require?

7. Audit, Service Evaluation or Research? • Comparison:

8. Types of ethical approval

9. NHS REC process

10. How to apply for ethical approval via NRES

11. Research Sponsorship (1) • The Research Governance Framework for Health & Social Care (RGF, 2005) outlines the responsibilities of research sponsors. • All studies in the NHS must have a research sponsor • All Clinical Trials of Investigational Medicinal Products (CTIMPS) must have a research sponsor by law

12. Research Sponsorship (2) • The research sponsor is the individual or institution that takes responsibility for the initiation, management, and financing (or arranging the financing) of the study. The sponsor must satisfy itself that the study meets the relevant standards and ensure that arrangements are put and kept in place for management, monitoring, and reporting.

13. Research Sponsorship at Warwick • If you would like the University to act as sponsor for your study please read the University of Warwick Sponsorship Principles for guidance and contact RSS. If you are based in WMS, this will be dealt with when you apply to BSREC, or, if you are submitting a study to an NHS REC, please allow ten working days and e-mail your study documentation to the WMS Research Ethics and Governance Office via: • WMSSponsorship@warwick.ac.uk • http://www2.warwick.ac.uk/services/rss/researchgovernance_ethics/research_code_of_practice/humanparticipants_material_data/sponsorship/

14. BSREC process

15. BSREC Triaging Categories • Out of remit / No review • Delegated to academic supervisor • Light Touch Review (Single reviewer) • Full Review (Two reviewers) • Any of above 3 can reach Committee

16. Out of Remit / No Review • Secondary analysis of published or other freely available data • Clinical Audits • Service Evaluation and Development Projects within the NHS • Minor amendments to previously approved projects • Undergraduate projects with primarily an educational purpose, including projects for the purpose of research methods training, provided they do not: • Seek to recruit participants beyond the students’ social circle, family, peers, or colleagues • Receive external funding • Include any form of deception or coercion • Involve the administration of any substance • Involve participants being subjected to any invasive procedure

17. Out of Remit / No Review • In addition, the Committee would not normally undertake ethical review for: • Interview/consultation with key informants/service users during the development of research proposals/protocols; • Stakeholder consultations during the developmental stage of research proposals/protocols.

18. Delegated to academic supervisor • The ethical review and approval: • Undergraduate and taught postgraduate student (but not masters by research, doctoral student, or staff) research and service evaluation projects • That are limited to interviews, focus groups, and questionnaire completion, or the evaluation of software and e-learning materials, • With non-vulnerable or dependent participants (e.g. Not receivers of health or social care, primary or secondary education, or criminal justice services), • Where the research does not investigate sensitive or intrusive matters (e.g. Health status, criminal activity, or sexual history).

19. Light Touch Review (Single reviewer) • Research using the secondary analysis of existing anonymised collected human data • Research using routinely collected human data within a clinical care team or service provision team, or outside a clinical care team or service provision team where the data has been anonymised prior to its passing to the researcher/s. • Research using routinely collected student assessment data within a course or Department/School where the data has been anonymised prior to its passing to the researcher/s. • Questionnaire and similar low risk studies undertaken by staff or PhD students • Substantial amendments to projects previously approved by BSREC

20. Full Review (Two reviewers) • Research with human participants, their identifiable data, or tissue • That is not excluded on the grounds of criteria detailed earlier

21. BSREC Application Process • Simple Application Form • Protocol • Lay Summary • Ethical Considerations • Informed Consent • Participant Confidentiality and Data Security • Supporting documentation

22. BSREC Amendment Process • Simple Application Form • Copies of any changed documentation

23. BSREC Amendment Guidance • Substantial Amendment • is defined as an amendment to the terms of the application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree: • The safety or physical or mental integrity of the subjects of the study; • The scientific value of the study; • The conduct or management of the study; or • The quality or safety of any investigational medicinal product used in a trial. • Anything else is a Non-Substantial Amendment

24. Substantial Amendments - Examples • Changes to the design or methodology of the study, or to background information affecting its scientific value; • Changes to the procedures undertaken by participants; any change relating to the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study; • Significant changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, letters to GPs or other clinicians, information sheets for relatives or carers; • A change of sponsor(s) or sponsor’s legal representative; • Appointment of a new chief investigator or key collaborator; • A change to the insurance or indemnity arrangements for the study; • Inclusion of a new trial site (not listed in the original application) in a CTIMP; • Appointment of a new principal investigator at a trial site in a CTIMP; • Temporary halt of a study to protect participants from harm, and the planned restart of a study following a temporary halt; • A change to the definition of the end of the study; • Any other significant change to the protocol or the terms of the BSREC application.

25. Non-Substantial Amendment- Examples • Minor changes to the protocol or other study documentation, e.g. Correcting errors, updating contact points, minor clarifications; • Updates of the investigator's brochure (unless there is a change to the risk/benefit assessment for the trial); • Changes to the chief investigator’s research team (other than appointment of key collaborators); • Changes to the research team at particular trial sites (other than appointment of a new principal investigator in a CTIMP); • Changes in funding arrangements; • Changes in the documentation used by the research team for recording study data; • Changes in the logistical arrangements for storing or transporting samples; • Inclusion of new sites and investigators in studies other than CTIMPs; • Extension of the study beyond the period specified in the application form.

26. Ethical Review • Ethical Considerations • Informed Consent • Participant Confidentiality and Data Security • Right of Withdrawal • Process for dealing with sensitive disclosures • Benefits and risks • Other Issues

27. Common mistakes that delay approval • Submission to the wrong Research Ethics Committee • Study design unclear/unlikely to achieve stated objectives • Failure to register study with appropriate NHS Trust(s) • Means of accessing participants unclear • Steps to ensure confidentiality, anonymity, secure storage of data not specified • See University’s Data Protection Policy • Encryption advice.

28. Common mistakes that delay approval (Cont’) • Information in Protocol or Application Form inconsistent with information in other documents • Missing information and/or documents i.e. Informed consent documentation • Poor grammar & spelling particularly in Participant Information Sheet/Consent Forms that materially affect the meaning of the text • Title, submission date & version control missing • Original signed copy (by applicant, & if a student, by their Academic Supervisor) of the Application Form or BSREC Application Form not posted to BSREC Administrator.

29. Other Approvals • Supervisors are responsible for directing students to seek all necessary approvals • These may include: • NHS R&D Approval • Honorary Contracts/Letters of Access • Human Tissue Use Regulations • Mental Capacity Act Regulations • Social Services

30. As laid out by RGF, NHS Trusts must give NHS R&D Approval for a study within the NHS to proceed Honorary Research Contracts or similar may be necessary Can be lengthy and frustrating – 6 months or longer not uncommon! Varies from NHS Trust to NHS Trust NHS R&D Approval (IRAS)

31. Consent and licensing at centre of regulation The HTA’s regulatory aim To create an effective regulatory framework for the removal, retention, use and disposal of human tissue and organs in which the public and professionals have confidence, through process of licensing and inspection How HTA licenses and inspects? Compliance reporting HTA evaluate evidence in compliance report Inspect according to risk Human Tissue Act/Authority

32. Human Tissue Studies • Register Study with Human Tissue Office • Authority to Import Human Samples Form • Attend Training in Human Tissue Use • Complete MRC e-learning module • Undertake Biological Risk Assessment (BRA) • Obtain Materials Transfer Agreement (MTA)

33. Human Tissue Studies (cont’) John Davey (Designated Individual) Tel: 02476 524204 J.Davey@Warwick.ac.uk Emily Dight (HTA Administrator) Tel: 02476 968583 Tel: 02476 151755 E.C.Dight@Warwick.ac.uk http://www2.warwick.ac.uk/services/rss/researchgovernance_ethics/research_code_of_practice/humanparticipants_material_data/research_human_samples-copy/

34. Came into force on 1st October 2007 Covers non-CTIMP research MHRA has remit for persons lacking mental capacity and Clinical Trials of Investigational Medicinal Products(CTIMPs) New research starting after 1 October 2007 must have section 30-33 approval from an NHS REC if involving one or more adults unable to consent for themselves Mental Capacity Act 1

35. The appropriate body can only approve a research project if the research is linked to: an impairing condition that affects the person who lacks capacity, or the treatment of that condition And there are reasonable grounds for believing that the research would be less effective if only people with capacity are involved, and the research project has made arrangements to consult carers and to follow the other requirements of the Act. Mental Capacity Act 2

36. FurtherInformation: Mental Capacity Act 2005 Code of Practice Ministry of Justice Mental Capacity Act 3

37. Approach local Social Services Department/s in first instance! Social Care Research Ethics Committee (SCREC) Accessed via IRAS Meets monthly Still in relative infancy (started June 2009) Approach direct by telephone www.screc.org.uk Research Ethics in Social Care

38. Limited Remit: Research funded by the Department of Health Research that may involve people lacking mental capacity Research that involves sites in England + in one or more other country that makes up the United Kingdom Research on integrated services (health & social care) or multi-site research involving both health & social care contexts, provided no clinical intervention is involved Social Care Research Ethics Committee (SCREC)

39. Avoiding delays • Don’t be tempted to split studies that involve elements of NHS & non-NHS data – describe study in full & submit it to the appropriate NHS REC • Plan ahead: completing documentation properly takes time but may avoid amendments/delays • Allow 3-6 months for Trust Approval • Read NRES/BSREC guidance: submit applications & all relevant documentation in required format(s).

40. If in doubt... • Visit the BSREC website in the first instance: http://www2.warwick.ac.uk/services/rss/researchgovernance/research_code_of_practice/researchethicscommittees/biomed/ • E-mail BSREC Administrator with any queries not answered by the BSREC website: bsrec@warwick.ac.uk