The investigators who participate in the design of the protocol will also be responsible for preparing all necessary material for review by the ethics review board.

The investigators must be aware of such responsibilities as the following:

• the appropriate medical care of patients in the study:

• the ethical requirements for the trial (such as selection of patients, advice to patients);

• a knowledge of the product used in the trial,

• an appreciation of research methodology and the conduct of clinical trials (such as the recording and evaluation of results);

• an appreciation of the importance of careful monitoring of the trial and the need to take necessary action, to alter or terminate the trial if patients appear to be harmed by some aspect of the trial.