We intend to perform a study with a device we developed (approved for medical research). The tests are non-invasive and only require a very low power laser to be exposed to the skin (complying with all the existing norms).

People will have to travel from their place to our facilities periodically to perform this test.

We want to publish the results of our study, but we are afraid that at the end the journal might require an ethical committee approval (which costs a lot of time and money).

In what cases shouldn't be necessary an ethical committee approval? Are there dermatology journals where this is not an issue for publication?

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    If you have an ethical committee at your university, then it should not cost money. It may still take time. Other than that, if you do stuff to humans it is usually hard (and unethical) to avoid an ethical committee approval. We are usually very invested in our own research, which means that we are not the best judge of ethical issues arising from that research. Having a set of independent persons look at these potential ethical concerns is helpful. May 23, 2017 at 9:21
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    I would think the best place to discover an answer regarding dermatology journal policies would be from the websites of such journals -- specifically the ones you want to publish with. (It doesn't matter what random strangers on the internet think if the actual journals disagree).
    – virmaior
    May 23, 2017 at 10:00
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    I am not in this field, but I'd be really surprised if any reputable journal would touch your study with a ten-foot pole if it didn't have ethics approval before it was begun. Not to mention potential legal consequences. I'm actually pretty startled that you would even consider proceeding without it. May 23, 2017 at 22:31
  • Some years ago, a research project in my department involved having some people fill out a questionnaire. That was the only "human subjects" aspect of the research. Not only did this require IRB approval, but later, when some of the questions were modified, IRB approval was required again. May 24, 2017 at 20:26

1 Answer 1


The exact regulations differ per country, but prospective studies with human subjects almost always need approval.

Since you tagged your question with "Netherlands", the relevant law is the WMO = "Wet medisch-wetenschappelijk onderzoek met mensen". Any research that falls under this law requires approval.

Research falls under the WMO if the following criteria are met:

  1. It concerns medical/scientific research and
  2. Participants are subject to procedures or are required to follow rules of behaviour

There is a lot of information on the website of the Central Committee on Research Involving Human Subjects (CCMO).

You can usually also apply for a waiver from the IRB (at least in the Netherlands). You submit a request with a description of your intended research and the IRB will review your plans to determine whether your research does fall under the WMO and needs approval, or whether this requirement can be waived.

From the description of your plans, it seems likely that you need approval. Not having approval would not only mean that journals won't accept your paper, it would also mean that you'd be doing something illegal.

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