You would first need an IRB review/approval. The IRB would determine if a written or verbal informed consent (from parents of course) is required or the informed consent could be/better be waived. In general, for a prospective, truly-observational study (intervention is entirely based on clinical practice independent of the research), a verbal consent would suffice, but it depends on extent and sensitivity of data to be collected. The ethical considerations in such studies include not only potential informational harm but also respect for autonomy.

Muhammad M Hammami Thank you very much.

Most probably there is no need for an informed consent. But that need to be decided by IRB/IHEC .However you need to get a letter of waiver either from IRB/IHEC.

Sumathy Ponnambalam Thanks for your answer.

But my doubt is, this waiver letter should be a separate document or we can include it as a point in the approval letter from IRB to conduct the clinical investigation.

Also, when I apply for a waiver, do I require to get authorization from my PI to confirm the same for non-requirement of informed consent.

Since you are using patients data consent is required.

Thank you Shreedhara Avabratha Kadke