Patient consent
I am interested in knowing how you obtain patient consent in your laboratories.
Although the ISO 15189 standard in the note for item 7.2.4.3 a) mentions "For most routine laboratory procedures, consent can be inferred when the patient willingly submits to the sample collecting procedure, for example, venipuncture." I am not sure that this justification is sufficient to use the information obtained (the result of the tests performed) in a subsequent investigation.
Our institution receives samples from laboratories throughout the country. The samples arrive with a test request, without the patient consent attached. This means that when research is carried out with the data (anonymizing the corresponding data) and an attempt is made to publish, high-impact journals reject the publication for not having informed consent.
We can try to generate an informed consent and send it to the laboratories that refer samples to us. However, it will be difficult to ensure that every sample arrives with the patient consent, and the analyses must be performed anyway. Sometimes, we do not even receive samples, but microorganisms isolated from samples.
Could a justification by an ethics committee be valid to resolve this issue?
Thanks
Comments
This is the process in my lab, since my lab also receive samples from referral lab. We do not have formals consent form since HIV patients is enrolled in ART service and agree upon treatment procedure. The consent of blood collection is by talking directly to the patients and additional consent letter need is for survey purpose only.
Ensure that the patient's consent is obtained. If the patient is not of legal age or competent to give consent, consent is obtained from the accompanying guardian. if the patient refuses, the person collecting the sample keeps a record of the refusal and notifies the healthcare provider. The patient is allowed to withdraw consent at any time. In emergency situations which consent might not be possible, under these circumstances it is acceptable to carry out necessary procedures, provided they are in the patient’s best interest.
Informed consent becomes strict when it comes to research and publications due to conventions. I think your facility can apply for ethical clearance and let the board know how you receive your samples. The board can further advice on the effective way or the recommended way to obtain consent as a referral institution. But your team should also be prepared for the worse case scenario where individual consent from patient/subjects should be obtained.
Thanks @Nadia Bueno for bringing this agenda to discussion forum. also, thanks to @Pich Sopanha for the comment.
From my own point of view especially in routine laboratory activities serving patients directly, we have to abide to the note ISO 15189:2022 Clause 7.2.4.3 (a)
NOTE: For most routine laboratory procedures, consent can be inferred when the patient willingly submits to the sample collecting procedure, for example, venipuncture.
But also, in case the patient is under unconscious condition, other medical procedures (including laboratory works) can take place even in absence of his/her consent (willingness) as stated in ISO 15189:2022 Clause 7.2.4.3 (c) in order to serve someone's life.
c) If obtaining consent is not possible in emergency situations, the laboratory may carry out necessary procedures, provided they are in the patient’s best interest.
For research laboratories the story may be a bit different just because of the intention / scope of using the specimen (apart from clinical/treatment services). That's why it's always recommended to obtain a written consent from the research participant.
I concur with @Musa Shija ,
I think the ISO is very clear in the clauses highlighted above.
Thank you all for your comments!
We definitely need to create an informed consent model and start asking laboratories that refer samples to us to implement it.
To Nadia
I agree with the discussion that ethical clearance is the easiest way to cover consent in terms of research.
An option could be to get an overall clearance from the ethics committee that covers you for all samples received by your lab through your referral process, ensuring that you are not held responsible for the consent forms.
All the best with the process.
Thank you, Janet!