3. The Committee has suggested that :a. Ethics committees should be set up in all institutions undertaking studies on human subjects and should be registered as per the Act. b. Standard Operating Procedure (SOP) should be written down and followed in all clinical trials/ clinical studies, based on prevailing good clinical practices (GCP)guidelines issued by CDSCO, ICMR ethical guidelines for biomedical research on human participants, Act and Rules. There should be an effective mechanism for monitoring the implementation of the SOPs. 4. Ethics committees should be constituted as per Act, Rules and regulations. All ethics committee members should familiarise themselves with various aspects of ethics guidelines and provisions of Act, rules etc for clinical trials. 5. It is necessary to set up Regional/State training centres with ethics committees of their region/state allocated to them and develop a common minimum syllabus for the course. Attendance in the course could be then made compulsory for persons becoming eligible to be elected members of Institutional Ethics Committees. Continuing education program on ethics should be also organized at these centres and participation for IEC Members made mandatory. Adequate budgetary provisions will be necessary to support travel etc of non-official members of these Committees for attending these courses. Implementation should be monitored. 6. Informed consent procedure should be standardised and simplified. Information given to the patient should include details of risks involved as per the current knowledge. It should also inform about the rights of the participants for