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Ethics Committee Guidelines

The ACRC has an Institutional Ethics Committee (IEC) where Ethical and other relevant issues are discussed. Every clinical study conducted has to have the approval of the IEC before its commencement. It has several guidelines. Listed below are the most important of these guidelines:

  • IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be given to trials that include vulnerable subject
  • IEC should consider the qualification and experience of the investigator, as evidenced by the curriculum vitae or any other relevant documents.
  • IEC should review the proposed study within a reasonable time and document its views in writing.
  • Only those IEC members who are independent of the investigator and the sponsor of the study should vote/provide opinion on a study-related matter.
  • IEC should perform its functions according to written operating procedures, should maintain records of its activities and minutes of its meetings, and should comply with locally applicable regulatory requirements.
 


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