8 th November 2007 Research: ethics and research governance Rossana Dowsett Research and Regional Development Division [Pre Award Support] University of Sussex
Research ethics and research governance Overview § § § Definitions Legal framework Funders’ requirements Systems: research ethics committees Special Issues The future…
Research ethics and research governance Definitions 1. Research Ethics § Protecting the rights, dignity, and safety of research subjects / participants 2. Research Governance § Standards, management & monitoring of research § Sanctions: research misconduct
Research ethics Ethical issues: human participants § § § The research subject’s welfare Vulnerable groups Equitable distribution of benefits and burdens Informed consent Confidentiality and privacy And more…
Research ethics Ethics: the legal framework Human subjects/participants § Data Protection Acts § Human Tissue Act (April 2006) § Other regulatory requirements Other § Animals (Scientific Procedures) Act o 3 Rs (reduction, replacement, refinement)
Research ethics Ethics in practice Patients (NHS / Medical) - NRES § requires approval from NHS Local Research Ethics Committee (LREC) Other humans (e. g. Social Science research) § usually requires ethical approval e. g. University RECs Animals (usually H&S committee) § Home Office licence required
Research ethics Result § Fire fighting § Ad hoc Codes of Practice… § External regulation and governance of good practice in research § Sponsors introduce guidelines and new terms & conditions based on principles of good practice
Research ethics and… The Wellcome Trust § § Guidelines Integrity Openness Guidance from professional bodies § Leadership and cooperation § Supervision § Training § Use of primary data/samples § Ethical practice § Publication practice § Requirement § formal written procedures for the investigation of allegations of misconduct
Research ethics ESRC Research Ethics Framework § § § Launched July 2005, implementation January 2006 A “benchmark” for all social science research All grant applications must adhere Compliance to be monitored by institutional RECs Sanctions: individual and institutional A minimum set of enforceable standards…
Research ethics ESRC: ten minimum requirements § § § § § Ethical issues always addressed in the research proposal Expedited review Approval by a research ethics committee required Procedures for institutional monitoring in place Complaints procedure should be in place Arrangements should be made for research students Additional costs are FECable Arrangements for multi-funder and multi-performer projects Avoiding duplication of submission Legal and data requirements must be met
Research governance Research Governance - what is it? § § Sets standards for Good Practice in Research including: Management and monitoring of research Mechanisms to deal with Conflicts of Interest Mechanisms to investigate Research Misconduct: complaints, appeals, sanctions
Research governance Research Governance – who and how? Department of Health § Research Governance Framework for health and social care (RGF) DEFRA/FSA/BBSRC/NERC § Joint Code of Practice: Quality Assurance in Research
Research: research governance Do. H RGF I § Launched in 2001, implemented in 2004 § Affects research undertaken in or by the DH/NHS § Social care agencies (health and social care systems) § All research requires a sponsor: not necessarily the funder…
Research: research governance Do. H RGF II § Arrangements to define and communicate clear quality standards § Delivery mechanisms to ensure these standards are met § Arrangements to monitor quality and assess adherence to standards quality
Research governance Quality Assurance in Research § § § Joint Code of Practice DEFRA/FSA/ BBSRC/NERC Implemented June 2004 Quality of research process (QP) Improve public confidence Reduce risk of incorrect findings Formal systems to be audited by independent third parties – has this happened?
Research governance DEFRA - Joint Code of Practice § § § § § Responsibilities Competence of personnel Project Planning Quality control Health & Safety Handling of samples and materials Facilities and equipment Documentation of procedures and method Research / work records
Research ethics and research governance Accountability and Transparency Sponsors Legislation Public confidence Research Ethics Committee USA example Professional standards of conduct
Research: ethics and research governance A typical committee structure (Sussex…) University Research Governance Committee Deans & Directors Lay members School Research Governance Committees
Research: ethics and research governance REC Responsibilities… § Consider ethical implications of all research involving human participants carried out at the University § To receive from members of academic staff proposals for experiments, investigations and procedures and to allow, refer back or disallow such proposals, specifying where necessary any conditions § Make available application forms, guidelines and background documentation § Advise on effective preparation of applications
Research: ethics and research governance For each proposal/project… § The proposed study is scientifically valid and justifiable in terms of its possible benefits compared with any inconvenience or harm § Adequate steps have been taken so that physical or psychological harm does not occur § That confidentiality of all personal and medical information is ensured and privacy maintained § Consent is valid (informed) and given without any form of duress
Research: ethics and research governance Other considerations § § § § § Indemnity insurance Children and consent (Gillick competent child) Protection of those undertaking the research (risk analysis) NHS patients/data/organs/tissue – LREC approval Training: staff and research students Frequency of meetings Transparency Monitoring REC structure…
Research ethics: School review Checklist: § § Formal review required? Consult checklist (School and/or Code of Practice list) Consult School Designated Officer for advice Follow School procedures for submitting project for ethical review § Certificate of Approval (conditions? ) § Ongoing review / monitoring?
Research: ethics and research governance Special issues § § § § Keeping up to date/raising awareness Training Compliance with Terms & Conditions Checks for internal approvals Variations in policy and practice Ongoing monitoring Independence Resource
Ethics and research governance The future - which way? § § § Beyond self-regulation Compliance monitoring? Quality monitoring? Process monitoring? The US experience (Office of Research Integrity)…
Summary: ethics and research governance require… § Ethical approval of research involving human participants § Ethical approval of research using animals § Staff : roles, and responsibilities § Monitoring of research § Management of conflicts of interest § System for investigating allegations of misconduct Thank you…
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