AREC

IN PARTNERSHIP WITH HRA AND University College London

Making an Application to an NHS REC

16th October 2013

DAVID ANDERSON-FORD

LONDON – HARROW NRES COMMITTEE – LAY MEMBER

DIRECTOR, RESEARCH ETHICS AND GOVERNANCE

CHAIR, UNIVERSITY RESEARCH ETHICS

COMMITTEE

BRUNEL UNIVERSITY

What does an NHS REC look for?

• Is there a checklist?

• Do all RECs view things the same way?

• Why an application might be rejected?

• How to avoid common mistakes.

Preliminaries

• Reputational Issues: Work as closely as possible with Supervisor prior to sign-off

• University Review?

• Attendance at REC meetings – Student / Supervisor

• The Meeting

Do all RECs view things the same way?

A checklist:1.Key Ethical issues2.Relevance of the research and

research design3.Suitability of applicant and supporting

staff4.Quality of Facilities5.Evaluation of anticipated benefits and

risks6.Care and protection of research

participant

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 arrangements11. Confidentiality: Privacy and

Protection of Data12. Indemnity and Compensation

Key Ethical issues

•Consent•Confidentiality•Data Protection•Vulnerable Groups•Risk

Relevance of the Research and Research design

• Importance of justification – not over justification

• Clarity of methodology – Lay members

Suitability of applicant and supporting staff

• Student / Supervisor

• Risk – Supportive Environment?

• Quality of Facilities

Evaluation of anticipated benefits and risks

• Key element in Risk Assessment

• Management of Risk

• Limits

Care and Protection of Research Participant

• Duty of Care• Supportive Environment – Relevant

Permissions• Clarity and Sufficient detail – Participant

Information Sheet• Vulnerable Groups

Hazards, Discomforts and Distress of Participants

Consent of Research Participant (Including justification for

research on persons lacking mental

capacity)• Consent Form – Relevance / Clarity /

Appropriate linkage with PIS

• Conformity with Mental Capacity Act 2005• A Continuing obligation?• Covert Surveillance

Participant Information Sheet:

• Clarity

• Adequacy

• Completeness

Recruitment Arrangements

• Feasibility

• Permission

• Risk

Confidentiality: Privacy and Protection of Data

• Data Protection

• Public Interest Exceptions

Why an application might be rejected?

• 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?

Conclusions

• NRES / IRES – Continuous development

• A Learning Training Opportunity – Not an impediment to Research