1. Introduction

This paper outlines the work plan for the East of Scotland Research Ethics Service REC 1 as it carries out its role in the financial year 2011/12. The work plan describes the key tasks that the Committee will carry out during that year.

2. Executive Lead Officer

The executive lead officer is Dr Andrew Russell, Medical Director, NHS Tayside.

3. East of Scotland Research Ethics Committee (EoSRES) REC 1

Items for the agenda should be submitted to the Committee Support Officer who is Mrs Lorraine Reilly, EoSRES Senior Committee Co-ordinator. Mrs Reilly can be contacted at Ninewells Hospital & Medical School, Dundee DD1 9SY, tel 01382 383878.

4. Purpose of Committee

The purpose of the East of Scotland Research Ethics Service (EosRES) REC 1 in reviewing proposed studies is to protect the dignity, rights, safety and wellbeing of all actual or potential research participants.  It shares this role with others as described in the Research Governance Framework for Health & Community Care.

5. Membership

EoSRES REC 1

Dr Carol MacMillan, Secondary Care Clinician, Chair
Mrs Sandra Forbes, Professional Member, Vice-chair
Dr Penny Kehagioglou, Secondary Care Clinician, Alternate Vice-chair
Dr Lloyd Carson, Professional Member
Mrs Shona Carson, Clinical Trials Pharmacist
Dr Graham Cormack, Secondary Care Clinician Member
Mrs Jacqueline Dunlop, Genetic Counsellor
Mr Sam Eljamel, Secondary Care Clinician Member
Mrs Wanda Howard, Lay Member
Dr Gary Lyon, Non-Clinical Scientist Member
Dr Robert W Y Martin, Professional Member
Mr John McLeod, Lay Member
Mr David McFarlane, Lay Member
Mr Charles McMurray, Lay Member
Dr Neil Merrylees, GP Member
Mrs Anne Simpson, Lay Member
Dr Wendy Stevenson, Lay Member
Dr Astrid Schloerscheidt, Professional Member

Deputies

Mr Shadi Botros, Pharmacist Member (for Shona Carson)
Dr Susan Law, GP Deputy Member (for Neil Merrylees)
Dr Roberta Littleford, Deputy Nurse Member (for Jackie Dunlop)
Dr Carlos Wigderowitz, Secondary Care Clinician Member

In attendance

Committee meetings are chaired by Dr Carol Macmillan.

Mrs Lorraine Reilly, REC Senior Co-ordinator and Mrs Caroline Ackland, Scientific Officer, are in attendance for full Committee meetings, Sub-committee meetings and Proportionate Review Meetings.

6. Quorum

The quorum for full Committee meetings shall consist of seven members and include the Chair and/or Vice-Chair or Alternate Vice-Chair, at least one expert member with the relevant clinical and/or methodological expertise, one lay member and at least one other member who is independent of the institution or specific location where the research is to take place.

The quorum for Sub-Committee meetings shall consist of at least two Committee members, including the Chair or Vice-Chair.

7. Frequency of Meetings

Meetings will be held monthly on the third Friday of the month (December excepted, when the meeting will be usually brought forward to accommodate the festive period).

8. Role

The role of the Research Ethics Committee (REC) is to provide independent advice to participants, researchers, funders, sponsors, employers, care organisations and professionals on the extent to which proposals for research studies comply with recognised ethical standards.

The REC are responsible for acting primarily in the interest of potential research participants, but they also take into account the interests, needs and safety of researchers who are trying to undertake research of good quality. However, the goals of the research and researchers, while important, should always be secondary to the dignity, rights, safety and wellbeing of the research participants.

The REC also take into consideration the principle of justice, requiring that the benefits and burdens of research be distributed fairly among all group and classes in society taking into account age, gender, economic status, culture and ethnic considerations.

The REC provide independent, competent and timely review of the ethics of proposed studies. Although operating within the Governance Framework determined by the Scottish Executive Health Department, REC have independence from political, institutional, professional-related or market influences in their decision-making and demonstrate competence and efficiency in their work and to avoid unnecessary delay.

The REC have due regard for the requirements of relevant regulatory agencies and of applicable laws.

9. Remit

The remit of the East of Scotland Research Ethics Service (EosRES) REC 1 is as follows:

To give appropriate advice for any research proposal involving:

a. Patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user’s past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions;

b. Individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above;

c. Access to data, organs or other bodily material of past and present NHS patients;

d. Fetal material and IVF involving NHS patients;

e. The recently dead in NHS premises;

f. The use of, or potential access to, NHS premises or facilities;

g. NHS staff – recruited as research participants by virtue of their professional role

The REC also provide an opinion on the ethics of similar research studies not involving the categories listed above carried out, for example, by private sector companies, the Medical Research Council (or other public sector organisations), charities and Universities.

10. Authority

The authority is detailed in Tayside NHS Board Standing Orders.

11. Reporting Arrangements

The East of Scotland Research Ethics Service (EoSRES) REC 1 report to the Tayside NHS Board.

12. Work Plan

12.1 The East of Scotland Research Ethics Service (EoSRES) REC 1 will carry out the following work plan and the main business of these will be:

1 At each meeting of the Committees, the following business will be carried out:

• Minutes and any matters arising from previous meetings of the Committees or Sub-Committee
• Review of research proposals
• Discussion of any other relevant business, including amendments that have been passed to the full Committee by the Sub-Committee.

2 At each meeting of the Sub-Committee, the following business will be carried out:

• Site Specific Assessment review for local Principle Investigators for Non-NHS Sites only (since NHS Sites are now reviewed by the relevant NHS R&D department)
• Review of amendments to research proposals
• Any other business delegated to the Sub-Committee by the main Committee

13. Timetable for submitting agenda items and papers

The dates for submitting agenda items and papers is as follows:

The EoSRES REC 1 meeting is held on the third Friday of the month at 12.30pm, usually in the Board Room, TASC offices, Residency Block, Level 3, George Pirie Way, Ninewells Hospital.  The dates for the meetings for 2011/12 are set out below.  Papers must be submitted in hard copy to the East of Scotland Research Ethics Service Office, TASC offices, Residency Block, Level 3, George Pirie Way, Ninewells Hospital, Dundee, DD1 9SY as set out in the National Research Ethics Service Standard Operating Procedures for Research Ethics Committees, but by the latest due date noted in columns two below:

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