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I've got a project underway that involves human subjects, and I got IRB (Wikipedia Link) approval. I'm thinking about my next project while working on this one. I'd like to collect some exploratory data for the next one, and potentially make use of it in any resultant publications. Nothing involves any real risks to respondents, so I feel that there are no ethical constraints binding me.

But as a practical matter, will anyone ever check that any findings were pre-approved by an IRB to be looked-for? What might the consequences of ignoring IRB be?

This is social science.

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I would assume that the journals don't care, as IRBs seem to be only an US thing. However, presumably, your university might get very upset as circumventing IRB approval might get them into legal trouble. –  xLeitix Jun 20 at 6:28
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IRBs are most certainly not only an US thing. Every paper in a reputable psychology journal that reports on a study done with humans will need to adhere to the Declaration of Helsinki, which calls for independent ethical review - meaning an IRB. –  Stephan Kolassa Jun 20 at 6:39
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IRB=Institutional Review Board, aka Ethical Review Board. I had to google it. People in fields relevant to the question and answerers will certainly know, but for the culture and the sake of the reader, I think good question should be self-contained. –  Taladris Jun 20 at 6:49
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I'd say it's a slippery slope thing. You might not think that this study involves no risks to the respondents, but you might be wrong, and if you're not you may be the next time. Better be on the safe side and not get used to circumventing these regulations. –  Johannes Bauer Jun 20 at 8:07
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@BrianP Perhaps I should have said "significantly modifying" rather than "eliminating" and "much" rather than "most". –  Thomas Jun 21 at 12:59
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5 Answers 5

I have never heard of a journal checking for IRB approval. However, as @xLeitix notes, your university may care very much, since doing studies on humans without IRB approval may get it into legal issues.

And I personally know of one case where departmental colleagues initiated a scientific audit of a professor, requiring her to dig up all documentation (filled-in questionnaiers, raw data, ... and IRB approvals) for some studies they were concerned about. Everything checked out all right, but if the IRB approvals had not been there, the PI would have been in very deep doo-doo.

So: get your IRB approval, and make sure it's safe and sound, with scans and electronic backup. Keep it for the requisite number of years, even after the study has ended and been published. Inquire of your university how long that is. Given today's cost of storage, I would keep the scan around indefinitely.

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I've never had a journal check, but I've published in a number of journals who require you to out and out say it's been approved by an IRB, and lying on that...is a bad idea. –  Fomite Jun 22 at 8:38
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To add to Stephan's answer, most university IRB's have specific protocols for exploratory research which does not involve going through the full IRB panel. Such things are variously named (with various levels of fact-checking and paper work):

  1. Exemption from IRB.
  2. Expedited IRB.

Here is one relevant link to get your started. Moreover, you can always file for amendments or extensions to your existing approved IRB protocol which are usually granted pretty quickly.

One of my advisers always told me to have your IRB bases covered. You never know when or if you could be scientifically audited.

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These are not just for exploratory research. Most social science research qualifies for exemption, provided it meets certain criteria and involves minimal risk. –  Thomas Jun 20 at 16:01
    
Agreed. To give one specific example, for our full 2 year project (on usable privacy and security) we had to go through the full IRB review. However, when we wanted to spin-off a part of the study to collect data for exploratory work for another study, we received an IRB exemption. –  Shion Jun 20 at 17:24
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I submit to a biology education journal and they have just started requiring the IRB number or a letter from your IRB saying the project is exempt.

It's possible to get a backwards exemption if your institution is the forgiving type and your protocol is sensible... Getting signed consent and so on.

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This is generally not possible with the social sciences. Consent involves making somebody aware of their risks and benefits BEFORE participating in the research. It is not informed consent going back to the individual AFTER they have participated in the study. –  Brian P Jun 21 at 14:27
    
Sorry I wasn't clear - I meant using a consent form signed by the subject before they participate, even if you have no "official" study information sheet or an IRB number on the form. If you treat the subjects as if you did have an IRB in place, it makes it more likely you can get an IRB approved afterwards. Still not as sure as getting one to begin with, of course... but sometimes a researcher does want a bit of a beta test. –  Adrienne Jun 21 at 15:03
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Nothing involves any real risks to respondents

While potential risks count against approval, no risk doesn't imply no need for approval.

E.g., if I'd want to measure native blood cells (no treatment but immediately dilute with physiological NaCl, place under the microscope, measure, and destroy). As for the amount, a drop from the finger-tip is more than enough.

For this*, the safest possible sample is my own: I cannot infect myself due to the contact with my own blood. Nevertheless, ethics approval does not distinguish who the human in question is, and I'm treated the same as any one else: I need approval.

There are even ethical guidelines that just plain forbid this:

1.5 No one should work with his or her own blood.

Obviously, for all experiments on students & colleagues there is always the question how to ensure that there is no pressure for them to participate. As this pressure could come from superiors, it logically has to include oneself. IMHO this alone is sufficient to require ethical approval for such experiments.

* things would be completely different if the sample were cultured or transformations were involved, etc.: there risks would increase if working with own samples.

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I agree with all the posted answers that emphasize adherence to all IRB issues. I disagree with anything that suggests it is not that important for social science researchers. Indeed, there are some forms of social science research that is exempt (e.g., use of de-identified and publicly available data sets), but a lot of it must go through the review process.

The part of your question that has not been answered is the consequences of ignoring IRB. Federal regulations exist with respect to IRB, so you can be sure that your institution will take it very seriously.

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

At minimum, you can fully expect an IRB to shut down your program of research if you are in violation of IRB rules and regulations. This is a very serious issue, and you must adhere to all aspects of IRB throughout your research. Indeed, it can be very challenging, but the challenges will be far easier to manage than the consequences if you are in violation.

If you are in doubt about any IRB issue with your research, talk to your IRB directly. Do not assume your research is exempt.

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