Making an Application to an NHS REC 16 th October 2013

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