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!
Wonderful case to think. Informed Consent was collaborated due to legal issues. ANY study I think needs Informed Consent. It's more look like that your first case will have no legal complication but if it have? You will have nothing to defend. It's patients rights to give or not even his residual blood.
And for the second one, no doubt, you have to take consent.
Samples that are archived usually have the express permission and consent from individuals for future studies within clinical research set-up but here your study plans to piggy-back on routine residual samples that consent has not been sought from individuals even though there are costs you will be saving by taking the waiver route but it is not ethical. I would propose that your study protocol goes through approval process for a prospective observational study that will include the swab to enable the individuals be part of the objectives and outcomes of your study. I appreciate your raising this sensitive matter.
I think the problem about considering INformed consent waiver is the additional burden this activity has on their routine work. I think it is not right to waive consent when collecting additional swabs. since this is not an indefinite study, it is important to think not of a consent waiver but maybe additional information on what other analysis will be done on the sample in addition to routine care, so the patient knows he/she is giving valuable contribution to national health. Concerning the first case, it is a challenge and the debate ongoing about what and what situations should consent waivers be acceptable. There definitely will be a lot of discussions on this in the upcoming workshop in Mali organised by the H3Africa initiative. http://www.h3africa.org/ethics_governance_resourcesharing.cfm
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
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.
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 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?