I am from Computer Science (CS) doing microscopy imaging applications, mainly in software side.
Recently we submitted a paper to Scientific Reports on a new algorithm. My own human blood cells (a few tiny drops of blood) were used in the experiments. The experiments are extremely trivial.
However, our paper got quality checked, from the Journal Editor:
Authors reporting experiments on humans and/or the use of human tissue samples must confirm that all experiments were performed in accordance with relevant guidelines and regulations. Additionally the article file must include a statement identifying the institutional and/or licensing committee approving the experiments, including any relevant details, in the “Methods” section. Please check that the information provided in the methods section is unambiguous using the following requirements:
- A statement to confirm that all methods were carried out in accordance with relevant guidelines and regulations.
- A statement to confirm that all experimental protocols were approved by a named institutional and/or licensing committee.
- Must include a sentence confirming that informed consent was obtained from all subjects or, if subjects are under 18, from a parent and/or legal guardian.
Briefly speaking, we need a bioethics statement that says, the blood in the experiments is approved by the University and the donor (which is me).
However, we are from CS and the University bio-ethics committee asked us to build a bio-safe lab before providing such license to us. This is time-consuming, costly, and far beyond our scope. Worse, there is no available human blood cells in the University for now. And I do not want to delay the paper submission.
How can I by-pass the bio-ethics statement? Would there be any law issues? I am the donor and I approve any usage of my own blood. Why would there be an issue?
What are the proper, canonical, professional way of handling this?
Why not use public datasets?
I am not doing machine learning, and our microscopy is specially designed. So I cannot use datasets from other groups.
Are you looking for retroactive permission?
No. We are applying to IRB for a new license. (That said, my previous experiments are unknown personal behaviors, and it has nothing to do with the group and the PI)
Can you use other samples, e.g. animal blood?
I do have other samples. Besides, I have tried mice blood but their red blood cells are x4 smaller and beyond the hardware & software limits. I would like human red blood cells to be in the paper because in convention it is the one to demonstrate the method, and its donut shape helps illustrating one of our major arguments.
A summary for today's talk with IRB (what they really need):
Biohazard: PI, the donor, and the person who is handling the blood, will have to take biosafety training, which is simple and online (I suppose).
Bioethics: The donor's confirmation for the experiments. (Actually, there is much more to discuss; but we skip this part)
How the blood is obtained: IRB does not care whatever interaction between the donor and the person analyzing the blood; they are only responsible for safety of all the persons involved, and that if the donor is from the University, make sure he/she is volunteered. Consequently, we can get the blood from:
Our lab. Additional equipments are required, lancets etc, as long as it qualifies as a bio-safe lab. (the IRB guy does not know the exact items; but can tell there is another committee to deal with...) Now it involves biohazard again.
Other groups with professionals.
Now it is much clearer. I opt for Commercial vendors. Here will be my next steps:
Finish the biohazard training.
Submit the IRB form and get their permission. (only biohazard issue, not bioethics)
Get commercial blood samples (under $100).
Re-do the experiments, and submit the paper again.
In such a way, only the biohazard part is cared by IRB. Bioethics, blood acquisition, IRB does not care. And this is the fastest way to get it done.
Thanks everyone reading and helping me.