Registration of Ethics Committees attached with the Clinical Trial Organisations for conducting clinical trials in the country has been made mandatory. The Union health ministry has issued a notification in this regard.
As per the notification, “No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with the Licensing Authority as defined in clause (b) of rule 21: Provided that any Ethics Committee existing on the date of commencement of the Drugs and Cosmetics (Third Amendment) Rules, 2013, who has already reviewed and accorded approval to clinical trial protocol, shall obtain registration within a period of forty-five days from the date of commencement of the Drugs and Cosmetics (Third Amendment) Rules, 2013”.
The registration, unless it is suspended or cancelled, shall be valid for a period of three years from the date of issue, provided that if the application for re-registration is received by the Licensing Authority within three months before the expiry, the registration shall continue to be in force until orders are passed by the said authority.
As per the notification, the Ethics Committee shall review every clinical trial proposal and evaluate the possible risks to the subjects, expected benefits and adequacy of documentation for ensuring privacy, confidentiality and justice. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyse and forward its opinion as per procedures specified in Appendix XII of Schedule Y.
The Ethics Committee shall consist of not less than seven members and one among its members, who is from outside the institute, shall be appointed as chairman; one member as a member secretary and rest of the members shall be from medical, scientific, non-medical and non-scientific fields including lay public.
The committee shall include at least one member whose primary area of interest or specialisation is non-scientific and at least one member who is independent of the institution. Besides, there should be appropriate gender representation on the Ethics Committee.
The Ethics Committee can have as its members, individuals from other Institutions or Communities, if required. Members should be conversant with the provisions of clinical trials under this Schedule, Good Clinical Practice (GCP) guidelines for clinical trials in India and other regulatory requirements to safeguard the rights, safety and well-being of the trial subjects.
For review of each protocol the quorum of Ethics Committee shall be at least five members with the representations: basic medical scientist (preferably one pharmacologist); clinician; legal expert; social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian or a similar person; and lay person from community.
The members representing medical scientists and clinicians should have post graduate qualification and adequate experience in their respective fields and aware of their role and responsibilities as committee members.
As far as possible. based on the requirement of research area such as HIV, genetic disorder, etc., specific patient group may also be represented in the Ethics Committee. There should be no conflict of interest. The members shall voluntarily withdraw from the Ethics Committee meeting while making a decision on an application which evokes a conflict of interest which may be indicated in writing to the Chairman prior to the review and be recorded so in the minutes. All members shall sign a declaration on conflict of interest.
The Ethics Committee shall be open to inspection by the officers authorised by the CDSCO, who may include an officer of the State Drug Control Authority concerned, to verify compliance to the requirements of Schedule Y, GCP guidelines and other applicable regulation for safeguarding the rights, safety and well-being of the trial subjects.