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Hi all, we are currently having discussion about waiver of informed consent in some cases. Our country hasn't have guideline on this yet. For example, an observational study needs blood samples to do some tests but only need the residual blood from hospital routine testing and no identificable information is collected to link back to individual patient, just the basic info like sex, age. Will that be possible to apply for waiver of informed consent? If you are a patient of those hospital, are you happy if you blood is tested for something else that you don't asked for and your information is collected by some organization/ someone for some purpose you don't know? We know that IRB will decide this but we need to present IRB with justification. And other case also is observational study and we need to take extra nasal swab which is a very simple procedure for each day in hospital and collect info in hospital chart but not identificable information. Please advise! Thank you all!

  • oaugustine AUGUSTINE ONYEAGHALA - Senior Contributor 16 May 2012

    It is the responsibility of the IRB to critically examine a given study protocol before it gives an approval for such a study. In that protocol, sampling procedures such as the ones detailed above should have been fully stated in the protocol. Introducing procedures mid way post IRB approval, is by all standards unethical. Regulations say that every study that involves minimal risk should seek the consent of the patient for which he may consent or refuse. So, either way, consent of the study subjects should be sought and IRB must give approval of the procedures

  • GHN_Editors The Editorial Team 14 May 2012

    Hi all - this discussion has continued in the discussion group here: http://globalhealthtrials.tghn.org/community/groups/group/informed-consent/topics/182/ - please add your comments here. Thank you!