Ethics and Ethical Practice in Research

1. Ethics and Ethical Practice inResearch Prof. Christine Milligan School of Health and Medicine Lancaster University

2. Key Terms • Research Ethics: moral principles guiding research; • Ethical Principles: concerned with rights, dignity & safety of researched; • Research Governance: development of shared standards and mechanisms for monitoring/management of research (& sanctions if required).

3. 6 key principles • Research should be designed, reviewed and undertaken to ensure integrity and quality; • Informed consent of both research staff and subjects; • Confidentially of information and anonymity of respondents must be respected; • Participation must be voluntary and free from coercion; • Harm avoidance; • Independence of research - any conflicts of interest or partiality must be explicit.

4. Implementation • Responsibility for conduct of research rests with the principal investigator (PI); • Responsibility for gaining appropriate ethical review & monitoring lies with the institution employing the PI and researchers; • Research involving primary data collection or use of organs/tissues etc. will ALWAYS raises some ethical issues; • Use of secondary datasets is often uncontroversial BUT we cannot automatically assume so (e.g. novel use of existing databases or data linkage)

5. Research Councils and their REFs: • Breaches of good ethical practice can bring to bear both individual AND institutional level sanctions.

6. Ethics in Practice • Proposals need to demonstrate what ethical approval is required & how this will be achieved - in signing off a proposal an institution is indicating it concurs with this; • All legal requirements must be met, e.g. data protection, health and safety, privacy laws, IPR etc. Data cannot be stored or transferred to a country outside the EU unless to country has equivalent levels of protection for personal data or UNLESS data stripping has occurred. • Researcher needs to be alert to unanticipated ethical issues that arise in course of carrying out research;

7. Expedited Review • Where potential risk or harm to participants minimal, e.g. use of secondary datasets or published data in public domain; • May also be needed where projects have short lead time or in response to demand of pressing importance; • Often carried out by Chair or sub-group of REC or ‘virtual committee’.

8. Informed Consent • Information sheets; • Content of signed consent forms; • Who signs? (working with vulnerable groups) • Staged consent?

9. Anonymity & Confidentiality • Anonymity (people and text) refers to concealing the identity of participants/places in all documents resulting from the research; • Confidentiality is concerned with who has the right of access to the data provided by participants.

10. Risk in Social Research • Refers to the potential physical or psychological harm, discomfort or stress that might be generated by research. • Wide range of methods used in research means there is a diverse range of potential risks that may need to be managed; • Includes risk to a subject’s personal social standing, privacy, personal values and beliefs, links to family & wider community and position within an occupational (work-related) setting; • Potential for harm can also arise from revealing information related to illegal, sexual or deviant behaviour; • Highlights importance of informed consent .

11. Social Research incurring more than minimal risk • Research involving vulnerable groups; • Research involving sensitive topics; • Research requiring access through gatekeepers; • Covert research; • Research involving access to confidential records or personal information; • Research that could induce psychological stress, anxiety, humiliation or more than minimal pain; • Research involving intrusive interventions.

12. Ethics Resource • http://www.lancs.ac.uk/researchethics/