Institutional Review Board (IRB)/Independent Ethics Committee (IEC) - homeopathy360

Institutional Review Board (IRB)/Independent Ethics Committee (IEC)

 An independent body constituted of medical professionals and non medical members whose
responsibility  is to ensure the protection of the rights,safety and well being of human subjects
involved in a trial and to provide public assurance of that protection.
IRB / IEC : Purpose
To assure the public at large that :
1. The risks have been minimized
2. Benefits outweigh the risks
3.The research exposes participants to no unnecessary pain & suffering
4.In general it is safe to participate in clinical trials
5.Ethics committee provides public assurance of human subjects participating in clinical trial by :

  • Reviewing and approving trial protocol
  • Approving the suitability of investigators
  • Approving research facilities at the site

6.Approving the methods and material to be used in obtaining and documenting informed consent
of trial subjects.

  • Approving all written material given to the subjects
  • Provides continuous review of the trial
  • IRB/IEC is to function in agreement with GCP guidelines, local laws and regulations.
  • Should have written working procedures

EC composition
At least 7 members
Chairperson from outside the institution
Member secretary conducts the business and communicates the decisions

  • Other members –a mix of medical/scientific, non medical/scientific including lay public to reflect different view points. At least one whose primary area of interest is non scientific
  • At least one member who is independent of the institution / trial site
  • Appropriate gender representation in EC

EC Approval
Investigator submits the necessary documents to institutional review board(EC)for approval to conduct the study at that site.
If investigator’s institution does not have a GCP compliant IRB, investigator can approach an Independent Ethics Committee for approval.
Trial site may accept approval granted by EC of another site provided that EC is willing to accept the responsibilities of that site and the protocol version is the same at both places
Documents to be submitted for EC approval

  • final protocol with version details.
  • investigator brochure with version details
  • protocol amendments if any with version details.
  • final written informed consent form in English and required translations in to local languages with version details.
  • investigator’s current CV
  • patient diaries/information sheets/questionnaires with translations as required.

Documents to be submitted for EC approval

  • insurance policy/compensation for participation and any SAEsduring the study period.
  • subject recruitment procedures (advertisements) if  any
  • investigator’s agreement with sponsor
  • investigator undertaking
  • regulatory approval for the study
  • any other documents requested by EC

Investigator responsibility
No protocol amendment be implemented without prior approval by EC except where necessary to eliminate an immediate hazard to the subjects or involve only logistical or administrative aspects.
Investigator should communicate to EC as soon as possible, any implemented exceptional deviations  justifying the same and seeking approval.

  • Investigator be available and answer any study related queries/clarifications from EC during the study period.
  • Initiate study only after the receipt of written approval from EC and regulatory authority.

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