HAMMERSMITH, QUEEN CHARLOTTE’S & CHELSEA AND ACTON HOSPITALS 

RESEARCH ETHICS COMMITTEE

STANDING ORDERS

REMIT

1.1  	All research projects involving human subjects, whether patients or healthy volunteers which are to be carried out within the ICSM (Hammersmith Campus), Hammersmith, Queen Charlotte's & Chelsea or Acton hospitals and by General Practitioners in the Hammersmith area, must be referred to the Research Ethics Committee (REC) for its consideration and approval.

The Committee will report to Ealing, Hammersmith and Hounslow Health Authority (EHHHA).

2. MEMBERSHIP

The Committee will have the following membership (appointed in consultation with the EHHHA and Hammersmith Hospitals Trust:

Chair
Vice Chair (normally a lay member)
At least two lay members (one being the Vice Chair), not trained in or practising any medical or paramedical discipline.
A Radiation Protection Advisor
A General Practitioner
A nurse
Up to ten clinicians or scientists (one being the Chair)
A non-voting Secretary

2.2	Members will be invited to serve on the Committee for three years, which may be extended by the appointing bodies for a further three years.  Members may not normally serve on the Committee for more than six consecutive years.

3. FREQUENCY OF MEETINGS

The Committee meets monthly, except in August, and applications should be submitted to the Secretary not less than ten working days before each meeting.  In the event of insufficient business the Chair may cancel a meeting and may, if the volume of business so demands, call additional meetings.

4. APPLICATIONS

Applications for approval must be made on the Committee’s application form (except MREC approved applications).  All the relevant sections of the form must be completed and the Secretary will return incomplete forms.  The Principal Investigator will normally hold a consultant contract with the HHT.  All internal applications (except MREC approved applications) must be approved by the appropriate Divisional Scrutiny Committee(s) before being submitted to the Research Ethics Committee. MREC approved applications should be submitted with a letter from the investigators Head of Department acknowledging that the department were aware of the proposed research and that they were satisfied with the investigators’ qualifications/suitability in conducting this research.

Applications are made to the Committee in strictest confidence. Members should not discuss the details of protocols outside the Committee without prior permission from the applicants. The Chair or Secretary may on occasion consult external experts, but confidentiality must be maintained at all times.

5. AGENDA

5.1	The agenda will be prepared by the Secretary, in consultation with the Chair.

The order of business shall be:

•	Apologies for absence.
•	Welcome of new members.
•	Approval of the new minutes of the last meeting.
•	Matters arising from the minutes not otherwise included on the agenda
•	Ratification of Chair's Action 
•	Report of Executive Sub-Committee's action in reviewing MREC approved protocols
•	Consideration of re-submitted protocols
•	Consideration of new protocols
•	Any other business
•	Date of next meeting

Members submitting items for discussion shall send details in writing to the Secretary not less than ten working days in advance of the date of the next meeting.

6. MINUTES

6.1	Minutes, shall be taken of all formal meetings.  These shall be made available to EHHHA. The Committee's deliberation will be confidential and the minutes written to reflect corporate responsibility

7. EXTRAORDINARY MEETINGS

An extraordinary meeting of the Committee can be called by the Chair or on receipt by the Chair of a request in writing from not less than three members. The request shall state the business of the special meeting at which no other business shall be discussed.  At least ten days notice counting from the day the request is received shall be given of any special meeting.

8. QUORUM

The Committee will have a quorum of five members to include the Chair or Vice Chair, three practising clinicians and one lay member.

9. DECISIONS

Whenever possible the Committee's decisions should be unanimous, however, if this is not possible majority decisions will be appropriate, but only when the majority includes at least one lay member, In cases where a unanimous decision is not reached this should be minuted.  Objection by one lay member will normally mean that the protocol is not approved

Should any member of the Committee have a personal interest in a particular research protocol, that member will not be involved in the evaluation of the protocol. Normally this will require the member to leave the Committee room.  This should be minuted.

10. EXPERT ADVICE

The Chair, in consultation with the Committee, will have the power to seek advice should expertise in a particular field be required.

11. CHAIRMAN'S ACTION

11.1	The Chair of the Committee, or in his/her absence, the Vice Chair will have the power to approve or reject applications to the Committee. However, the Chair should only approve by Chair’s action:

i)	trivial procedures that have not been considered by the Committee
ii)	protocols that have been re-submitted after amendment following consideration by the full Committee
iii)	protocols that have been previously approved by one of the Research Ethics Committee’s associated with Imperial College School of Medicine (i.e. Riverside REC, Royal Brompton REC, St. Mary’s REC)
 
Chair’s action must be confirmed by the Committee at the next meeting. The Vice Chair will only be contacted in emergencies (e.g. an adverse occurrence) and not to carry out normal business, unless the Chair is unavailable for a protracted period of time, in which case the Vice Chair must be informed in advance that he/she may be called upon to make decisions by Chair’s actions.

12.	EXECUTIVE SUB-COMMITTEE FOR REVIEWING MREC APPROVED              
       APPLICATIONS	

12.1	The Executive Sub-Committee will have the power to approve or reject applications to the Committee that have previously received approval from a Multi-centre Research Ethics Committee (MREC). In addition, the Executive Sub-Committee will also possess the powers invested in the Chair noted in para. 11.1. The sub-Committee's action will not need to be confirmed by the full Committee, but will be reported at the next meeting.
12.2	Membership – All members of the Research Ethics Committee will be members of the Executive Sub-Committee. 
12.3	Quorum - The Executive Sub-Committee will have a quorum of two members to include the Chair or Vice Chair, and one other member.
12.4	Upon receipt of an MREC application copies will be sent immediately to the delegated members of the Executive Sub-Committee and the Chair or Vice-Chair by internal mail. Members will be allocated applications to review on a rotating basis. MREC applications will be sent to lay members for their advice (if a lay member has not been allocated to initially review the application), or other expert advice sought, where this is considered helpful to do so by the Executive Sub-Committee. The allocated members will return their comments on the applications and recommendations to the Secretary who will then present them to the Chair for his comments and a final decision within ten working days from receipt. Applicants will be notified of the executive Sub-Committee's decision within five working days. A formal sitting of the Sub-Committee can be called by the Chair or on receipt by the Chair of a request in writing from any member of the Sub-Committee. At least five days notice counting from the day the request is received shall be given of any formal meeting. Applications may be passed to the full Committee for review where the Sub-Committee decide that this is appropriate.

13. ADMINISTRATIVE ARRANGEMENTS
	
The Secretary of the Committee will be appointed by Hammersmith Hospitals Trust in agreement with the EHHHA.

14. ANNUAL REPORT

The Committee will provide an annual report to the EHHHA of the activities of the Committee.  The annual report will state the number of protocols considered and the number of those which have been rejected, amended or approved and the membership of the Committee during the preceding year.

15. ADVERSE OCCURRENCES

Any adverse occurrence in connection with procedures carried out under protocols approved by the Committee, whether due to negligence or otherwise, must be reported to the Chair or Secretary of the Committee.  On receipt of this information the Chair shall consider suspending the protocol and shall initiate an investigation and the Committee shall decide whether a protocol can be reactivated.

16. AUDIT

The Committee shall ensure that protocols it approves are audited on a regular basis.  The Committee shall check that its procedures have been adhered to and that studies are carried out as specified in the approved protocols.