Ethics submission

The coordinating centre will provide all necessary materials for the application. Your local committee will tell you how many copies of the application documents are required. The application must be submitted by the investigator. The covering letter should record all documents that are submitted.

The coordinating centre will also respond to any requests from the ethics committee for further information or documentation. Regular and timely communication must be maintained between the coordinating centre and the investigator in order to process the application as quickly and efficiently as possible. The trial cannot start until all requests from the committee have been addressed and the committee has confirmed their approval in writing. This may be a record of the committee meeting or an approval letter addressed to the investigator.

Trial materials cannot be sent to the site until a copy of the approval document, together with a list of the ethics committee membership, has been received in the coordinating centre.


3.6 Ethics approval submission	BACK
Each trial site must have a Local Ethics Research Committee (LREC) [or Internal Review Board (IRB)] approval before the trial can start in the hospital. Procedures vary in each country - please refer to your local committee for full instructions of how to apply. Most local ethics committees have regular meetings and issue a list of submission deadlines.
The coordinating centre will provide all necessary materials for the application. Your local committee will tell you how many copies of the application documents are required. The application must be submitted by the investigator. The covering letter should record all documents that are submitted. The coordinating centre will also respond to any requests from the ethics committee for further information or documentation. Regular and timely communication must be maintained between the coordinating centre and the investigator in order to process the application as quickly and efficiently as possible. The trial cannot start until all requests from the committee have been addressed and the committee has confirmed their approval in writing. This may be a record of the committee meeting or an approval letter addressed to the investigator. Trial materials cannot be sent to the site until a copy of the approval document, together with a list of the ethics committee membership, has been received in the coordinating centre.
The ethics committee consists of a mixture of medical, scientific and lay members. The committee reviews the trial protocol to ensure that it complies with the local health authority regulations. They also assess the following: suitability of the investigator and co-investigators suitability of the site: number of potentially eligible patients etc. patient recruitment methods procedure to obtain consent The investigator may in some cases also be a member of the local ethics committee. They should not be involved in any decision making concerning any study that they have an interest in.