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Standard Operating Procedures


The Ethics Committee [in the context of clinical studies carried out in a hospital or similar medical institution] is a recommendatory body set up to advise, guide, and support individuals, departments and institutions in taking decisions with regard to clinical studies and carrying out the same.


The Ethics Committee of this hospital will be known as the Prince Aly Khan Hospital Ethics Committee; in abbreviation, as the PAKH EC.


The PAKH EC shall consist of at least eight members. The President of the hospital shall always be a member but shall not have voting rights.

The Chairperson of the EC shall not be from the Prince Aly Khan Hospital. The EC contains at least one member from a non-scientific background, at least one member from a basic biological or pharmacological background, at least one medical clinician, and has representatives form both sexes. Apart from the Chairperson, at least one member is from outside the hospital. The EC shall be free to co-opt any individual for a purpose that it considers shall be beneficial to its functioning.

The working of the EC shall be coordinated by a member secretary.


The primary role of the Ethics Committee [EC] is to ensure that the rights, safety and well being of inpatients and outpatients, and of trial subjects, are protected. Special attention will be paid to trials that involve vulnerable subjects.

The perusal of documents, and the laying down of systems and processes for the consideration of study proposals, are all in fulfillment of the primary role of protecting the study subjects.

Apart from clinical trials and studies, the Ethics Committee will review all matters submitted to it by the PAKH Management, by its own sub committees [as constituted from time to time], by other committees of PAKH, and by individuals with an interest in the matter requested to be taken up.


Although Ethical Committees are not statutory bodies, and their opinions are of a recommendatory nature only and not binding on individuals or institutions, it has nevertheless been the norm for courts to give due regard to ethics committee decisions during the legal process. Ethics Committees therefore have a high institutional and societal standing.


The EC will consider all clinical studies conducted in the hospital where there is some therapeutic, diagnostic or preventive [eg screening for disease prevalence] intervention. Studies that involve no therapeutic / diagnostic / preventive intervention [for example, a retrospective study of clinico-pathological correlations in any particular disease] may, if the investigator so desires, be conducted without Ethics Committee approval.


The Chairperson of the EC is responsible, and accountable for, supervising and managing the activities of the Committee and maintaining its code of conduct.

It is the joint responsibility of all the members of the EC to be involved in supervising and managing the activities of the Community and to follow its code of conduct. They include the following persons :

  • Chairperson
  • Member Secretary
  • Members
  • Special Invitees

In the absence of the Chairperson, the Member Secretary will chair the meeting.