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Research Ethics. Dr Mary Tully School of Pharmacy and Pharmaceutical Sciences & Chair of Salford & Trafford NHS Ethics Committee (2007-2009). Presentation. Remit of NHS ethics committees Imminent changes Ethics application process within NHS

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Research Ethics

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    1. Research Ethics Dr Mary Tully School of Pharmacy and Pharmaceutical Sciences & Chair of Salford & Trafford NHS Ethics Committee (2007-2009)

    2. Presentation • Remit of NHS ethics committees • Imminent changes • Ethics application process within NHS • Information required for ethical consideration of research

    3. Key Principles of Ethical Research • Well-being of subject takes precedence over interests of science and society • It is the duty of the physician to protect the life, health, privacy and dignity of the human subject • Conform to generally accepted scientific principles by appropriately qualified persons • Assessment of predictable risks and burdens in comparison with foreseeable benefits – the former should outweigh the latter • Subjects must be volunteers and informed participants

    4. NHS Research Ethics Committees Organisation • NHS ethics committees were previously independent bodies • Now controlled by a single body (NRES) with a single set of Standard Operating Procedures • Operate under the Governance Arrangements for Research Ethics Committees (GAfREC) • Use a single form for all ethics committees • Approval from a single ethics committee is acceptable to all other committees

    5. Currently - Studies Needing NHS REC Approval • Those that involve: • patients and users of the NHS • relatives or carers of patients and users of the NHS • access to data, organs or other bodily material of past and present NHS patients • foetal material and IVF involving NHS patients • the recently dead in NHS premises • the use of, or potential access to, NHS premises or facilities • NHS staff - recruited by virtue of professional role

    6. GAFREC version 2 – out for consultation • 2.3.2 Those that involve: • past or present users of NHS & adult social services • relatives or carers of past or present users of these services; • collection of tissue/information from users of these services; • use of previously collected tissue or information from which individual past or present users of these services could be identified

    7. 2.3.5 – Legislation requires REC review of research involving: • (a) people who lack (or lose) the capacity to give informed consent to take part (or to keep taking part) in the research; • (b) processing of confidential patient information without consent where this would otherwise breach confidentiality; • (c) material consisting of or including human cells (unless anonymous & obtained with consent); • (d) people who are cared for in the private and voluntary sector, e.g. in nursing homes or residential care homes; • (e) exposure to ionising radiation; • (f) medical devices that are not CE-marked (i.e. not compliant with European Directives) or CE-marked medical devices that have been modified or are being used for a new purpose; • (g) investigational medicinal products; • (h) practising midwives conducting a clinical trial; or • (i) protected information from the Human Fertilisation and Embryology Authority register.

    8. “No material ethical issues” • Proportionate ethical review pilot in London from 1st September 2009 • Research using data or tissue that is anonymous TO THE RESEARCHER • Research using existing tissue samples already taken with consent for research • Research using “extra tissue” (e.g. further blood taken at time of routine sampling or tissue taken at “clinically directed” operation) • Questionnaire research that does NOT include highly sensitive areas or where accidental disclosure would NOT have serious consequences • Research interview / focus group that does NOT include highly sensitive areas or where accidental disclosure would NOT have serious consequences • Research surveying the safety or efficacy of established non drug treatments, involving limited intervention and NO change to the patients’ treatment


    10. From April 2009 Sponsor ensures scientific review Complete ethics application form Phone to book in & get number Submit study to R&D office at each site Submit completed form and supporting documentation Application reviewed by main REC Modifications & reapply Favourable Provisional Unfavourable Appeal Trust approval at each site Modifications


    12. Salford & Trafford as an example Pharmacist Paediatric oncologist GP Nurse x 3 Anaesthetist Medical statistician Clinical psychologist Community health care worker Retired physicist Engineer Professor in Cell Biology Builder Membership of committees

    13. How to really annoy an ethics committee! • Assume we are all experts in your area • Assume that we are all stupid • Assume that the research participant is an expert in your area • Don’t answer the questions on the form • Don’t bother proofreading • Be really careless

    14. Lay language • “It is crucial that your answers to these questions are written in a way that will be understood by lay members of the Committee. • Lay members may not have worked in the NHS or have any experience of clinical research. • It is not acceptable to cut and paste from the protocol. • You could be asked to rewrite your answers if you do not adhere to this guidance.”

    15. “The principal objective is to study the frequency of different allelic forms of immune response genes that may contribute towards the pathogenesis of various rheumatic and/or autoimmune diseases. Specific genetic polymorphisms may contribute to either the development of disease (susceptibility), the development of specific disease features (e.g. pattern of joint involvement and extra-articular manifestations) or alternatively may contribute to disease severity.”

    16. What does committee look for? • Scientific design & conduct of study • Recruitment of research participants • Consent • Care & protection of research participants • Protection of participants’ confidentiality • Other considerations

    17. Scientific design & conduct of study e.g. • Will this research answer the question the researcher has posed? • Does the research involved a placebo? How ethical is this? Have subjects being told? • What are the criteria for prematurely withdrawing research participants? • Etc …

    18. Recruitment of research participants e.g. • How will initial contact and recruitment be conducted? • What are the inclusion and exclusion criteria for research participants, and are they justified? • Etc …

    19. Consent e.g. • How will consent to be obtained? • Is the information given appropriate, complete and understandable? • What is the justification for including individuals who cannot consent? • Etc …

    20. Subject Information Sheets e.g. • Question and answer format – standard NRES format • Plain, concise English • Should be true and not withhold information • Risks and benefits outlined - of both arms in a controlled study • Etc …

    21. Care and protection of research participants e.g. • Are there any plans to withhold or withdraw standard therapies? • Will the research participants received any compensation/reward for their participation? • Etc …

    22. Protection of participants’ confidentiality e.g. • Who will have access to the personal data of the research participants? • To what extent will information about participants be anonymous? • Will data be sent outside the EU? • Etc …

    23. Conclusions • Changes are coming to the system in next 6 months • New GAFREC • Proportionate review system • Take advice from as many people as you can • Take advice from ethics committee members or coordinator • Getting ethics approval may not be as awful as you think!