Protocol violation and ECs

[Guest guest]

Hi,

Anita and Rakesh raised the issue where it technically amounts to " protocol

violation " . Hence it is mandatory that the EC must sign each page of the

approved protocol and return one copy of such protocol to the applicant and

similarly keep another copy in its office records. This is done to ensure that

some page is not replaced at a later stage. ECs are aware of this but do not

practice this for obvious reasons.

If protocol violation is there, in that event investigators must immediately

report it to EC and get the re-permission, e.g. if it is compelling to continue

the study with changed methodology.

The EC is empowered to have interim review of the study. If protocol violation

is reported by others or noticed by EC, it can issue a show cause notice to the

investigators and sponsors and even withdraw the permission if the violation is

serious.

It is impossible to cover all that falls under ethics in few pages. The ICMR has

given guidelines. All ethical issues are not covered by any single guideline.

Hence it is desired that the best from the world should be adopted and

incorporated in SOPs of the institutional EC - which is the next topic of

discussion now. Moderator Dr Smita Sontakke to take over the discussion please.

Dr Vijay Thawani

Groupie