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!
Thank you for this interesting question and I should think a good case study for people to think about. I recently attended a talk on a similar topic from a man involved in setting up a biobank of samples - he was talking about similar issues in human samples, and from this I believe that you do indeed need consent to use residual samples from people (particularly if, for example, you were looking at genetics or anything like that – you don’t say what you are using the samples for?).
I remember there was a lot of talk in this seminar about whether, when routine samples are taken, you can just have people ‘opt in’ or ‘opt out’ of having their samples used for future research, so that on the routine form they’d have taken when they gave the sample for their usual clinical purposes. The upshot was that perhaps it was unethical to have people just ‘opt out’ (i.e., to have a box saying ‘tick here if you do NOT want your samples to be used in future studies’), and that instead you should have an ‘opt in’ (i.e. a box saying ‘tick here if you DO want your samples to be used in future studies’) even though that would likely get you less favourable responses. Their study was US focussed to begin with, but they were trying to make it ethically applicable across all cultures. Therefore, I guess that if the samples are not already taken, you could ask that a section be added to any forms used by doctors when patients obtain samples which would allow you to use them for your study, but of course this would also need discussion with the IRB.
You mention that you’d need to get the additional nose swab, so I guess you’d need to get consent from the patient at the time, to obtain that sample anyway – so perhaps it is simplest to combine the consent in this way? Out of interest, which country are you located in?
It seems to come down to whether the samples being taken are part of the standard care and then if so are extra volumes or frequency of samples being taken? Then a matter of what you are doing with the samples and their personal information.
I notice on this website there is an example template for sampling only studies? this might be helpful? http://globalhealthtrials.tghn.org/articles/informed-consent-templates/
it would be good to hear what others think?
Thank you Tran for your question on informed consent waiver. From my experience informed consent waivers are usuall given only for anonymous surveys of basic health questions. You did not state what tests will be carried out with these residual samples even though anonymised. My opinion is that if these samples will not be screened for genetic testing and these left overs samples are already there in the labs, and the patients have left the hospital, then EC consent waiver can be sought for such an observational study. But with the case of taking an extra nasal swab from in patients I would recommend that you get the patients consent for an extra procedure.
Thank you Aolamba and Vivat. I'm from Vietnam. And the 1st example was a study to test influenza in serum to see the seasonal pattern and viral evolution, no genetics information needed and it is prospective study. The 2nd examples is looking at RSV transmission, the extra nasal swab is not normal care, it's an addition sample to the normal care. I agree that the extra step is not consider to be minimal risks according to US's guideline, therefore not qualified for waiver of consent. The reason we raise the question here is that the steps involve patients are simple, the information collected is for study the diseases and anonymous, but the time and effort taken to explain to patients and get their consent is a burden to doctors who, in Vietnam, often are already overloaded with nornal clinical care. We haven't agreed among ourselves about these cases.
This is a valuable discussion that reminds me of the debates that surrounded the introduction of the Australian National statement on Ethical Conduct in Human Research in 2007 - it contains some guidelines that you may find informative in Chapters 2.2 and 2.3. I will see if I can place the whole document in the resources of this website.
Thanks for that suggestion. The link below takes you to the Australian National Statement on Ethical Conduct in Human Research in 2007 - including an update in 2009.