How to by-pass bioethics for a trivial bio-experiment?

Question

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.

My questions:

• 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?

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Updates:

Declarations:

1. 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.

2. 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)

3. 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:

  1. 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.

  2. Other groups with professionals.

  3. Local hospitals.

  4. Commercial vendors.

Now it is much clearer. I opt for Commercial vendors. Here will be my next steps:

1. Finish the biohazard training.

2. Submit the IRB form and get their permission. (only biohazard issue, not bioethics)

3. Get commercial blood samples (under $100).

4. 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.

Answer 1

First, I'll assume that you don't and can't bypass the statement. The journal isn't going to go along with that.

Second, while this may be an edge case, the line needs to be drawn somewhere and it has been decided that the line is drawn in the most conservative place so that you don't need to make judgements in every case. The reason for conservatism here is the potentially harmful result of getting it wrong - from HIV to Ebola.

Third, there are issues that you aren't considering. While it is your blood and you certainly give permission, there are protocols for handling blood that treat it, properly, as a bio-hazard. Researchers (and medical personnel) who deal with this a lot know the risks and take proper precautions. But you haven't, apparently, indicated that you took those precautions yourself, thinking of them as trivial.

Fourth, it seems like you didn't deal with your institutions IRB (or equivalent) or you would have been told of these issues and how to avoid them. You may be able to go to them now and get the appropriate authorization for what previously happened, but I would guess they might well object.

Finally, I suggest that you abandon the current paper for now, redo the experiment under proper protocols and then re-write it (copying essentially everything from the current version) and then re-submit it with a complete accounting of the experiment. User Anyon suggested using another lab (after getting ok from IRB). Another option would be to (with IRB permission) elicit help from a physician or medical lab to aid in obtaining specimens and dealing with any waste.

Answer 2

This is a much bigger deal than you seem to think it is.

What are the proper, canonical, professional way of handling this?

You (or your research group) should seek to partner with someone with practical experience running experiments on human tissue, which does not have to be from your University. As long as you are running experiments on human tissue, someone in the pipeline needs to have knowledge of the ethical way to do it, and be able to properly document it. If your group is working alone, you have to take that burden on yourself (which is how I interpret the the response from the university's bio-ethics committee.) If you partner with someone, yes you will have to 'spread around the credit', but you won't have to be the ones to ensure that your tissues are handled ethically.

From your questions, it seems to me that you / your group is familiar with the equipment (enough that you were able to get the sample and correctly image it), but it is not clear to me that your group is set up to actually collect the sample in a professional way. You've mentioned CS, so I assume that your facilities are not set up to collect specimens, but rather to analyze the images. (Are you set up to safely handle and observe them? I can't tell from the question.)

It also seems to me that your research is focused on what happens once the sample has been given to you (From calling it a 'trivial experiment', an extremely trivial experiment, a 'few tiny drops of blood', etc.) This says to me that you have no experience running professional experiments on human tissue. That lack of experience is causing you to think that it is unimportant. I would bet that you have not been through Ethics and Compliance Training; you should start there. Yes it will consume time (and therefore money). But isn't the upfront cost of getting properly trained a better price than not being able to have your work published in a decent journal (which is where you currently are)?

One way that may help you think about why this is important: You believe everything is on the up and up because you were there. How do you prove this to someone who wasn't? Where is the paper trail proving you gave your blood with your explicit consent? Was it obtained in a sterile manner? (Prove it.) Was the sample harvested ethically and safely? (Prove it.) *

How can I by-pass the bio-ethics statement?

I am not about to answer this question. I do not suggest you try to do so. Any legal issues would likely come from the tissue source sueing (so, I don't expect you would sue yourself). BUT the questions to your reputation could be something you have not thought about. If you are willing to publish results without a bio-ethics statement (even on something as "extremely trivial" as this), your audience will start to raise questions that will haunt you.

And I do not want to delay the paper submission.

Whether you want to or not doesn't really matter. You have to put publishing this work on hold, until you can find somebody with the proper training to work with you, or you meet the requirements of the university so that your group can collect and handle samples professionally. I suspect that there is a very real chance that you will have to treat this work as a rough draft and repeat it on a new sample (one that comes with the appropriate paperwork).

_{* And, just to be clear, my 'prove it' comments aren't challenges; they are the questions I don't think you are qualified to answer. What medical training do you have? What training in bio-ethics do you have?}

Answer 3

Your results are not publishable.

I think the others are beating around the bush too much.

You didn't deal with procedures for handling human samples. You didn't document your consent, you didn't have any procedures for adverse findings. Could you even prove it was your blood?

Your IRB will not approve you retroactively, a) because they don't do that and b) as far as I can tell, they shouldn't have approved your procedure anyway.

It would have been easy to get approved a priori, and I'm sorry your training in CS didn't prepare you for this, but if you really need this paper ASAP, you need to forget about getting your sample approved and figure out how to get one you can work with.

Answer 4

I can think of one (possibly) entirely ethical way to bypass the more onerous demands of the bioethics committee: don't use human blood.

You are working on microscope imagery, rather than immunology or any other functional issue, so any blood cell of approximately the right size ought to be acceptable. I would try contacting a local vet to see about collecting a sample.

It would still be necessary to consult with the committee, since they may well have guidelines for animal experimentation, but presumably the guidelines will be much less demanding, since in general you don't get cross-species infection issues.

Answer 5

It is possible for an IRB to make a determination that your research, though it involves humans, does not rise to the level of human use that would require a whole protocol. I've gone down this road when trying to do 'experiments' that involve students using a web interface and having their activities recorded. It takes a few months and costs several hundred dollars, but it's probably the best case scenario for you.

That said, I do not know if you will be able to get such an exemption when you are drawing, storing and processing blood. Regardless of whose blood it is and whether they gave consent, there are legitimate concerns about infection. In this case, you may need to hire a group that does this kind of work and already has approved protocols in place (or find an extant dataset from such a group that you can use).

Answer 6

I understand how requiring an approval and protocol for a few drops of your own blood may sound like a bureaucratic overkill, but it really isn't. Imagine you badly hurt your finger or catch a bloodborne disease in the process. Since this would've happened in your lab while you were performing your research duties, it would effectively constitute an occupational accident with all its consequences. If you could prove your adviser / head of lab / etc. knew you were doing experiments with your blood, yet didn't provide you with training and equipment required to do it safely, you'd likely have a legal claim against them, or the institution.

So yes, there are potential legal issues with your approach, and you'll have to fulfil the requirements for experiments with human tissue, or do your experiment with something else.

Answer 7

My apologies, I have not gone through the other answers. However, here are some practical tips:

1. There are independent Human Ethics committees that you can apply to who can then rule on them.

2. You can always ask for a waiver if the blood sample is going to be provided by the principal investigator in an investigator initiated experiment.

3. You can simply contact the nearest teaching hospital attached to a medical school or any biomedical research facility, talk to researchers there to collaborate with you on this experiment. Many would be happy to collaborate across disciplines, institutions, etc. Many journals even reward transnational studies.

4. You need to mention in your ethics committee application if this is a non-traditional method or if the method itself is experimental so that they can rule on various aspects of the experiment apart from the ethical part - biosafety, etc.

Hope this helps.

Added: On Independent Ethics Committee: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5839245/#cre292-note-0016 COPE Statement: https://publicationethics.org/files/Full%20set%20of%20English%20flowcharts_9Nov2016.pdf Pay attention to : What to do if you suspect an ethical problem with a submitted manuscript.

Answer 8

I'd say this (given the comments).

While I have not encountered such a situation, I'd suggest that because you are a Computer Science-trained person and not a trained biomedical researcher, the board did act very unreasonably by demanding that you, as such, and presumably with knowledge of your credentials if the institution is even half worth the salt of whatever accreditation it is supposed to have, undergo an even more technical and expertise-requiring, and thus introducing even worse possibilities for screwups, project of building your own bio-lab by yourself. Given that, I can absolutely understand and totally sympathize with (see my username tag) your plight. Personally I would not entrust that task to anyone but a real specialist in that area, i.e. a trained biomedical researcher. Using facilities is one thing. Creating a facility yourself is kind of like, to use a computer-related analogy, amateurs writing their own crypto, I'd think, and the actions of the board like that seeing you were not using proper encryption for secure communications and then demanding that as a response you should go and fashion your own ciphers and programs instead of trying to help you get properly-built stuff.

That said, you cannot expect the journal to lower its standards. While the risk from this is no doubt very small, nonetheless the precautionary principle is always exercised, as the other answers have alluded. As I mentioned in another comment, one could imagine a situation in which one (not saying you do, so don't freak) had an undiagnosed bloodborne infection (many do not immediately produce symptoms, e.g. Hepatitis) and then inadvertently spread it to a lab assistant or other person who contacted the blood. The journals are right to be concerned with the improper procedure used just as you are to be annoyed with ham-handed management.

If the experiment is truly trivial, then I'd suggest that you should not necessarily be too shy about repeating it (plus you may discover that in the course of doing so you could do something even better with a second think-through). The real problem though is getting management to approve, and I'd suggest your focus really should be on finding out why they'd make that demand and to find an alternate solution that will provide the facilities and/or handling required to meet the ethical guidelines correctly without you having to be pushed even further beyond the limits of your expertise.

Moreover, I'd also wonder why you'd need to rush this paper. Is there something of significant negative consequentiality that will happen if you do not submit it "on time"? (e.g. if you fail to deliver by the "desired" time is it going to jeopardize your position, or something else that would seriously affect you and/or others under your trust?) If that is the case, then you might want to take that up in the disputes with management as well and tell them that you are seeking to humour their concern that the experiment be performed according to proper ethical protocol yet also that you have an important reason you need to get it done as soon as possible.