Independent Ethics Committee

The committee is an independent body comprised of medical and scientific professionals, and non-medical members, whose ultimate responsibility is to:

  • Ensure the protection of the rights, safety and well-being of human subjects involved in a trial
  • Provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects

Clinical trials must be conducted in accordance with the ethical principles that originate in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s) of the country in which they are undertaken

Membership

This committee is an independent body constituted of medical, scientific and lay members. It consists of nine members who collectively have the qualifications and experience to review and evaluate the scientific, medical and ethical aspects of a proposed research project.

Quorum

  • A minimum of five (5) members are required to form the quorum, without which a decision regarding the project should not be taken
  • The quorum must include at least one member whose primary area of interest/specialisation is non-scientific and at least one member who is independent of the institution/site of the trial

Research Resources / Useful Links

The Independent Ethics Committee

The IEC Secretariat can be contacted at:

Phone

  +603 5639 1711

 +603 5639 1988

Email

  Rsdh.iec@rsdhealth.com