The Ethics Committee approval is not the end of the obligation

An Ethics Committee approval letter is treated by most start-up trackers as a milestone: a date, a document, a green tick. The New Drugs and Clinical Trials Rules, 2019 do not treat it that way. Registration of the committee, the composition of the committee, the training of its members and its handling of safety reports are all continuing obligations, and every one of them can fail quietly while your study is running.

The failures are rarely dramatic. They surface during an inspection, or when a partner asks for the committee's registration certificate and the date on it has passed.

Two committees, two forms, and the wrong one gets quoted

There is one application form and two registration certificates. Form CT-01 is the application, used for registration and for renewal alike. What comes back depends on what the committee oversees. A committee overseeing a clinical trial or a bioavailability or bioequivalence study is registered by the Central Licencing Authority in Form CT-02, under rules 8, 9, 10 and 14. A committee overseeing biomedical and health research is registered in Form CT-03, under rules 17 and 18.

Sponsors routinely ask a site for its ethics committee registration and accept whichever certificate arrives. If your study is a clinical trial and the certificate is a CT-03, the committee is registered for biomedical and health research, which is a different thing. The reverse happens too. It is worth reading the heading on the certificate rather than the number in the corner.

Form CT-03 registration remains valid for five years from the date of issue, unless suspended or cancelled.

Renewal has a ninety day cliff, and it protects you only if you reach it

An application for renewal is made in Form CT-01 at least ninety days before the existing registration expires. That deadline carries a specific benefit: if the renewal application arrives ninety days before expiry, the existing registration continues in force until the authority passes an order on it.

Miss the ninety days and the protection is gone. The registration then simply expires on its date, whatever stage the application has reached. A committee whose registration lapses mid-study is a problem you inherit, not one the site solves for you, and the studies it is overseeing at that moment are the evidence.

This is a question worth asking at site selection and asking again annually: when does this committee's registration expire, and has the renewal gone in. A committee that is two months from expiry with no application filed is a scheduling risk that nobody has written down.

Membership is a live condition, not a founding document

The rules set composition requirements that have to hold continuously. The committee must 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. A Member Secretary is appointed by the institute or organisation.

Any change in the composition of a registered committee has to be reported to the registering authority. Committees lose members the way every standing body does, through retirement, relocation and resignation, and the reporting step is the one most often skipped because it feels administrative.

There is a sharper provision that is easy to miss. Every member is required to undergo the training and development programmes specified by the Central Licencing Authority, and the rules state that a member who has not successfully completed them is disqualified from holding the post and ceases to be a member.

Read that carefully. It is not a recommendation to train members. An untrained member is not a member. If that person voted in the meeting that approved your protocol, the composition of the committee at the moment of approval is a question someone can ask, and the minutes will answer it.

Safety reports arrive on the committee's desk on two clocks

The committee is not a passive recipient of safety information. Under rule 42, the investigator reports every serious adverse event to the Central Licencing Authority, to the sponsor, and to the Ethics Committee that approved the protocol, within twenty-four hours of its occurrence. An investigator who misses that window has to furnish reasons for the delay to the satisfaction of the Central Licencing Authority.

A second, slower clock then runs. The analysed report goes to the Central Licencing Authority, to the chairperson of the Ethics Committee and to the head of the institution within fourteen days of the event, in the format at Table 5 of the Third Schedule.

Two things follow from this that affect how a sponsor sets up a study. The twenty-four hour report goes to the committee, not only to you, so the committee learns of events on the same day you do and will ask about them. And the fourteen day report is addressed to the chairperson by name of office, so a committee without a currently appointed chairperson has a receiving problem as well as a governance one.

Records outlive the study

The committee maintains its records for five years after the completion of the trial: its constitution and composition, the curricula vitae of all members, its standard operating procedures, the guidelines it follows, protocols and case report forms submitted to it, correspondence with members and investigators, and the agenda and signed minutes of every meeting.

That list is worth reading as an inspection scope rather than a filing rule. Signed minutes of every meeting, together with the composition of the committee and the CVs of its members, is precisely the set of documents from which someone can reconstruct whether the committee that approved your study was properly constituted and properly trained on the day it did so.

The functions and proceedings of the committee, and the maintenance of these records, follow the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.

What to actually check

Which certificate does this committee hold, CT-02 or CT-03, and does it match what my study is.

When does the registration expire, and if it is within a year, has the Form CT-01 renewal been filed with more than ninety days in hand.

Has the composition changed since registration, and was the change reported.

Can the committee evidence that its members have completed the specified training, for the members who were present when my protocol was approved.

Does the committee have a chairperson in post to receive fourteen day reports, and does my safety reporting plan send the twenty-four hour notification to the committee rather than only to the sponsor.

None of these questions is difficult. They are just not on most start-up checklists, because the approval letter looks like the end of the conversation.