1. Combining the strengths of UMIST and The Victoria University of Manchester Ethics in non-medical research Karen Schafheutle PhD Research Practice and Governance Co-ordinator The University of Manchester

2. Combining the strengths of UMIST and The Victoria University of Manchester Outline Ethics –what is it? –Why is it relevant to non-medical research? Best practice standards –Current set-up at UoM and proposed changes Best practice - standards into practice –Challenges of local implementation Questions

3. Combining the strengths of UMIST and The Victoria University of Manchester Research ethics = medical ethics? Ethics = The science of human duty The body of rules of duty drawn from this science A particular system of principles and rules concerning duty, whether true or false; rules of practice in respect to a single class of human actions.

4. Combining the strengths of UMIST and The Victoria University of Manchester 1930s A mistake in the formulation of a children's syrup (sulphanilamide in ethylene glycol) caused a number of deaths and led the FDA (US) to set up a product authorisation system 1947 Nuremburg Code (Directives for Human Experimentation) 1950s Japanese government regulated sale of medicinal products 1960s Effects of thalidomide synthetic drug triggered review of practices in Europe 1964 Declaration of Helsinki 1968 Medicines Act (UK) 1989 WHO Conference of Drug Regulatory Authorities produced action plans for regulation of medical research 1990 First ICH meeting held between EU, Japan and US regulatory authorities to harmonise practices 1996/97 ICH Guidelines on Good Clinical Practice 2001 EU Directive on Clinical Trials (2001/20/EC) 2001 Research Governance Framework for Health and Social Care (UK) 2004 Medicines for Human Use (Clinical Trials) Regulations 2004 (UK) 2004 Human Tissue ACT 2004 (UK) 2005 EU Directive on Good Clinical Practice (2005/28/EC) 2005 Mental Capacity Act 2005 (UK) Research ethics = medical ethics?

5. Combining the strengths of UMIST and The Victoria University of Manchester Why not just follow the law? Unethical laws Ethical issues not covered by law Law usually lags behind Laws set by precedent as well as legislation A proper understanding of the law requires – Thinking for yourself – That you make connections between different cases – Judgement – Ethical thinking

6. Combining the strengths of UMIST and The Victoria University of Manchester Laws cannot stipulate everything you must/ must not do. The law is more likely to say that you MUST act ethically.

7. Combining the strengths of UMIST and The Victoria University of Manchester Ethics Ethics = The science of human duty. The body of rules of duty drawn from this science. A particular system of principles and rules concerning duty, whether true or false; rules of practice in respect to a single class of human actions. set of conventions Not set in stone Open to interpretation

8. Combining the strengths of UMIST and The Victoria University of Manchester What is unethical? Technology ethics Excessive claims for the technology Marketing hype? ethical oversight or deliberate omission? Medical ethics Negligence = “conduct that falls short of the standards expected of a person where a duty of care is owed and which causes foreseeable damage to another person” Peter De Cruz, Nutshell Medical Law

9. Combining the strengths of UMIST and The Victoria University of Manchester Ethical standards vary –Foreseeable damage –Expected standards –Duty of care –Example: Unhealthy drink, full of sugar and fat, marketed as a sports/energy drink on TV Same drink endorsed by a medical doctor on TV Is one more unethical than the other?

10. Combining the strengths of UMIST and The Victoria University of Manchester Ethical conduct conforming to accepted standards of social or professional behaviour “being a professional” –Expected standards –Duty of care –Foreseeable impact/damage

11. Combining the strengths of UMIST and The Victoria University of Manchester Research Ethics Conventions safeguarding the rights, dignity and welfare of people participating in research = conventions on “Being a professional” –Doing more than what is required by law/ in your job description –Considering the impact of what you do

12. Combining the strengths of UMIST and The Victoria University of Manchester Research which contravenes ethical conventions or has not been ethically approved is –Unacceptable to society –Unacceptable to funding bodies –Open to legal challenge by an aggrieved participant Purpose of Research Ethics review

13. Combining the strengths of UMIST and The Victoria University of Manchester Principles of Ethics Autonomy –The participant must be free to choose (no coercion) or refuse participation, without any adverse effect Beneficence –The research must be worthwhile in itself. Its potential benefits must outweigh any risks. The methodology must be sound so that robust results will be yielded Non-maleficence –Any possible harm must be avoided or mitigated by robust precautions Confidentiality –The right of the participant and his/her data to remain unknown to all but the research team must be respected (unless participant agrees otherwise Integrity –The researcher must be open about any gains he/she makes from the research

14. Combining the strengths of UMIST and The Victoria University of Manchester What type of non-medical research needs ethical approval? Research which ‘uses’ human beings for the benefit of the researcher, the community or society, with little or no direct benefit to the individual subject, but with the possibility of harm, discomfort or inconvenience to that individual Research is potentially beneficial but not inherently so: requires risk/ benefit analysis –Foreseeable damage –Expected standards –Duty of care Human tissue and data Interaction with adults, vulnerable adults, children Interviews, (incl. via telephone) focus groups, Questionnaires (incl. via telephone)

15. Combining the strengths of UMIST and The Victoria University of Manchester –Life Sciences –Technology/engineering: testing appliances with/on people (incl. simulations) –Social Sciences –Linguistics –Management and Business studies –Education

16. Combining the strengths of UMIST and The Victoria University of Manchester What is reviewed? Research Quality –Is research justified? Is research question sound? –Is research methodology sound? Research participants –How are they recruited? Any coercion or pressure? –Inclusion/exclusion criteria –Remuneration/expenses vs enticement –Hazards, dangers, discomfort, disturbance involved –What steps have been taken to minimise risks / cover possibility of an untoward event (appropriate back-up) –How is confidentiality ensured? When/why might it be broken?

17. Combining the strengths of UMIST and The Victoria University of Manchester What is reviewed? Information sheet –must be sufficiently comprehensive and written in appropriate language –Must explain who you are, why research is being done, what the participants’ involvement will be, what the objectives are –Must explain where they can turn for additional information/help, what will happen if things go wrong –Must state that free to take part and free to withdraw without negative consequences

18. Combining the strengths of UMIST and The Victoria University of Manchester What is reviewed? Consent form –Consent must be positive. The assumption that lack of response means consent is unacceptable –The right to withdraw without explanation should be repeated –Where children are involved, consent should be given both by the parent/carer and the child and consent form needs to be in a format appropriate to age or educational development –Vulnerable adults, arrangements for consent or assent. Must be appropriate to target group (e.g. cognitively impaired)

19. Combining the strengths of UMIST and The Victoria University of Manchester What else is reviewed? Sponsorship Indemnity arrangements Funding

20. Combining the strengths of UMIST and The Victoria University of Manchester Two Approval routes for Research Involving Human Beings NHS involvement Staff, patients or facilities No NHS involvement Ethics review by NHS REC committee (NRES / IRAS route) R&D approvals from all Trusts involved Sponsorship arrangements /Contracts (incl. MTAs) Other approvals Indemnity arrangements Ethics review by University Research Ethics Committee Contracts Other approvals Indemnity arrangements

21. Combining the strengths of UMIST and The Victoria University of Manchester Contact details: Karen Schafheutle, Research Practice & Governance Co-ordinator Research Office, Christie Building, The University of Manchester M13 9PL Tel: 0161 275 7583 Email: Research-Governance@manchester.ac.uk