A ‘typo error’ turned into an embarrassment for AIIMS, when 12 interventional research trials for resident doctors, submitted before the institute’s ethics committee and sub-committee, were cleared citing decisions taken after meetings held on August 2 and 5 ” calender dates which are yet to arrive this year.
Claiming that they had accidentally converted a future meeting to one in the past, representatives of the clearance committee said all 12 clearance letters would be withdrawn immediately.
The clearance notification for one such research trial accessed by Newsline was dated June 22, but had reportedly reached the faculty advisor only last week. It states, “The above mentioned protocol was discussed and reviewed in the Ethics Sub-Committee meeting held on 02.08.2013 at 3 pm in the Ethics Committee Room and subsequently in the Ethics Committee meeting held on 05.08.2013, at
2 pm in the Ethics Committee Room, AIIMS.”
Under a section titled “remarks of ethics committee”, the notification reads that the “the protocol has been approved from ethical angle, w.e.f. 02.08.2013, for all prospective cases”, directing the applicant to submit six-monthly progress reports to the ethics sub-committee.
Dr Rakesh Yadav, member secretary of the ethics sub-committee and Sub Dean (Academic) at AIIMS, said, “We intended to tell these applicants that their projects would be discussed in meetings scheduled on the mentioned dates. It is a typographical error, where ‘will be discussed’ was accidentally typed as ‘was discussed’ and ‘to be held’ was wrongly mentioned as ‘held’. I think 12 such projects were cleared with this error. By today (Tuesday evening), we will withdraw all the letters.”
Pointing out that the AIIMS ethics committee was known for being “one of the most efficient” bodies, Dr Yadav said, “We grant prospective clearances pending ethics committee approval for applicants to start recruiting patients for trial, with the condition that pending the committee’s decision, the clearance would be withdrawn. It saves time.”
These notifications have perturbed a section of the faculty, especially since the ethics committee calender actually has meetings scheduled for August 2 and 8. A senior faculty member wrote to the committee on July 29, stating that “if it is inadvertent, then also it is a serious lapse, and if it is deliberate then I request you to please inquire into the matter and take appropriate measures and fix the responsibility.”
“If the ethics committee is giving clearances in such a callous manner, even for drug-based trials, where recruits diagnosed with different diseases have to be given drugs during the course of the trial for testing, it is extremely worrying,” a faculty member said.
Asked about the stringent regulation of trials at AIIMS, director Dr R C Deka said, “All research projects at AIIMS have to obtain ethics clearance ” no research is allowed without ethical clearance irrespective of intervention: medical, or surgical, in patients or in animals.”