Making an Application to an NHS REC Friday 27 th September 2013

DAVID ANDERSON-FORD LONDON – HARROW NRES COMMITTEE – LAY MEMBER DIRECTOR, RESEARCH ETHICS AND GOVERNANCE CHAIR, UNIVERSITY RESEARCH ETHICS COMMITTEE BRUNEL UNIVERSITY

Is there a checklist? Do all RECs view things the same way? Why an application might be rejected? How to avoid common mistakes.

Reputational Issues: Work as closely as possible with Supervisor prior to sign- off University Review? Attendance at REC meetings – Student / Supervisor The Meeting

A checklist: 1.Key Ethical issues 2.Relevance of the research and research design 3.Suitability of applicant and supporting staff 4.Quality of Facilities 5.Evaluation of anticipated benefits and risks 6.Care and protection of research participan t

A checklist: 7.Hazards, discomforts and distress of participants 8.Consent of research participant (Including justification for research on persons lacking mental capacity) 9.Participant Information Sheet: Adequacy and completeness 10.Recruitment arrangements 11.Confidentiality: Privacy and Protection of Data 12.Indemnity and Compensation

Consent Confidentiality Data Protection Vulnerable Groups Risk

Importance of justification – not over justification Clarity of methodology – Lay members

Student / Supervisor Risk – Supportive Environment? Quality of Facilities

Key element in Risk Assessment Management of Risk Limits

Duty of Care Supportive Environment – Relevant Permissions Clarity and Sufficient detail – Participant Information Sheet Vulnerable Groups Hazards, Discomforts and Distress of Participants

Consent Form – Relevance / Clarity / Appropriate linkage with PIS Conformity with Mental Capacity Act 2005 A Continuing obligation? Covert Surveillance

Clarity Adequacy Completeness

Feasibility Permission Risk

Data Protection Public Interest Exceptions

Committee Options Incomplete paperwork Key Ethical Themes: Omitted Incomplete Misunderstood / Ignored Unsatisfactory responses – commonly through no attendance Poor written presentation – particularly the PIS / Consent Form SSA Flawed methodology – A Research Ethics issue?

NRES / IRES – Continuous development A Learning Training Opportunity – Not an impediment to Research