AfRE /AREC IN PARTNERSHIP WITH HRA AND Manchester University Making an Application to an NHS REC 25 th November 2013

Professor Margaret Rees Chair of Oxfordshire Research Ethics Committee B Member Open University REC present Secretary of the Committee of Publication Ethics (COPE) Editor in Chief of Maturitas Chair Elect of AfRE

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.

What is an ethics committee Expert members Lay members Number maximum 18 Quorum 7 Aim is to protect participants Members need to do regular training and are audited

Preliminaries Reputational Issues: Work as closely as possible with Supervisor prior to sign-off University Review, R and D review, external peer review? Attendance at REC meetings – Student / Supervisor The Meeting

Do all RECs view things the same way? 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/ Consent form: Adequacy and completeness 10.Recruitment arrangements 11.Confidentiality: Privacy and Protection of Data 12.Indemnity and Compensation

Key Ethical issues Consent Confidentiality Data Protection Vulnerable Groups Risk

Side effects of the intervention eg drugs/surgery How many people have received the drug so far Radiation: cancer induction no threshold dose of radiation but larger doses increase risk/ damage to a system eg skin burn where there is a threshold dose 40-year-old male who underwent coronary angiography, coronary angioplasty and a second angiography procedure due to complications, followed by a coronary artery by-pass graft.

Relevance of the Research and Research design Importance of justification – not over justification/ over sell Clarity of the science – Lay members

Advertising Concerns were raised with regard to the wording of the advertisement, as ‘ ’ was felt to send a subliminal message and may suggest unreasonable expectations to participants.

Suitability of applicant and supporting staff Student / Supervisor Risk – Supportive Environment? Quality of Facilities ( R and D)

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/ Consent form Look at current guidance 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?

Mental capacity The research is connected with an impairing condition which can affect capacity. The research cannot be carried out as effectively if it was confined to participants able to give consent as they would not have the relevant clinical condition. The research has the potential to benefit participants lacking capacity without imposing a disproportionate burden on them. Reasonable arrangements were in place for identifying personal consultees, and for appointing nominated consultees independent of the project where no person can be identified to act as a personal consultee. Information is adequate to enable consultees to give informed advice about the participation of persons lacking capacity. Reasonable arrangements are in place for withdrawal from the project

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 Flawed methodology – A Research Ethics issue?

Publication Fabrication and falsification Lack of ethical approval Authorship Conflict of interest Plagiarism Duplicate/ salami slice submission

Conclusions HRA / IRAS – Continuous development A Learning Training Opportunity Not an impediment to Research Ethical approval essential for publication