Code of Ethics

• The Institution Ethics Committee (IEC) must draught a constitution and standard operating procedures, as well as terms and conditions for member appointments, resignations, and quorum requirements.
• To protect the study subjects’ rights, safety, and well-being, the IEC will assess the research protocol and Good Clinical Practice (GCP) guidelines.
• In the event of any undesirable incidents, the IEC will investigate and provide its view.
• It will allow Department of Health Research inspectors and officials to enter its premises to inspect any record, data, or document relevant to clinical trials, as well as respond to any questions.
• The committee must keep all clinical trial documentation for at least five years after the trial is completed.
• The registration is valid for two years. In the event that the composition of the committee changes, it must notify the relevant authorities in writing.
• If there are any problems in the registration, the licencing authority has the ability to cancel it.
• The committee shall have a minimum of 7 and a maximum of 15 members, including the chairperson, one member secretary, a basic scientist, clinician, legal expert, social scientist, and a layperson from outside the institution.
• The committee must have a quorum of at least 5 members.
• The members of the committee and the primary investigator should be well-versed in GCP rules.
• There should be no conflicts of interest in the protocol decision-making. The same declaration should be made by all members.
• The committee will invite experts to provide expert opinions on the subject. The invitees will not be involved in any decision-making.