Ethics and governance in drugs research

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Presentation transcript:

Ethics and governance in drugs research Dr Anne Whittaker, Associate Professor, NMAHP Research Unit, University of Stirling Anne.Whittaker@stir.ac.uk

Principles UK Policy Framework for Health and Social Care Research Legislation/legal requirements/SOPs Patient & public involvement (PPI) Scientific rationale for study Robust design/methods Dissemination/impact Data archiving

Key issues to address Safety & welfare of participants Recruitment process Written informed consent Confidentiality/anonymity/privacy Risks & how to mitigate them Data management and data protection (GDPR) Sensitive topics/sensitive data Duty of care – intervention research

Research populations & contexts Prisoners/prison Children/Young People Vulnerable adults Mental illness/Cognitive impairment Pregnant women Capacity to consent Risky environments Ethnography/Participatory methods

Ethical approval process University ethics committee approval NHS Research Ethics Committee (REC) review – IRAS application NHS Health Research Authority (HRA) Supporting documentation – Study Protocol, PIS, Consent form, other study materials Sponsor for research (indemnity/insurance) Recommend attending REC meeting! Substantial amendments…

NHS R&D approval process Site management approval to conduct study with NHS patients and staff Caldicott Guardian approval Finance - NHS support & research costs Research Passport / Letter of Access Safe Haven (secure platform) Approved devices Clinical Trials Unit Adverse Events

References/websites UK Policy Framework for Health and Social Care Research https://www.hra.nhs.uk/planning-and-improving-research/policies- standards-legislation/uk-policy-framework-health-social-care-research/ NHS Health Research Authority (HRA) https://www.hra.nhs.uk/ NHS Research Ethics Committee (REC) review https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i- need/research-ethics-committee-review/ Other publications about good research practice: ADASS/SSRG resource pack for social care, ESRC Framework for Research Ethics, the principles of ICH GCP, RESPECT Code of Practice, UUK Concordat to support research integrity, WMA Declaration of Helsinki.

Thank you for listening

Research scenarios… Ethnographic research with homeless injecting drug users Parenting intervention research with drug-using mothers and their preschool aged children Experiences of family members who have lost someone due to a drug overdose Blood borne virus testing in prison Clinical trial of methadone vs subutex in pregnant women Young people’s use of new psychoactive substances