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The community college I attend has an IRB that is not registered with the FDA and is supposed to review projects conducted by students or faculty. I (as a student) would like to conduct a survey (that involves minimal risk) through a mobile application that would be meant for, and open to the general public. I contacted my institution’s IRB and they said that this type of research would be out of the scope of my community college’s IRB. Is this true? Do I even need IRB approval for my research? I do not plan on publishing any information or receiving any federal or state funding, but the data collected through my survey might be used to create a product/service that might require FDA approval. Again, the survey and the mobile application through which the survey is conducted will not be submitted for FDA approval, but a product created from the data I collect (which is all anonymized before I receive it) might be. What do you recommend for my situation? I do not have the resources to get approval from a commercial IRB, and the universities I have contacted (who have federally registered IRBs), say they cannot review research from a student of another institution.

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    I voted to close as out of scope because you're getting out of the university IRB category and moving towards "do I need an IRB to approve my study for a commercial product" which isn't about Academia.
    – Bryan Krause
    Feb 5 at 22:59
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    Why are you doing this study? If it is not for a class or under the direction of faculty, it wouldn't be in their purview. Feb 5 at 23:01
  • IRB is registered with HHS through the NIH site, not FDA. hhs.gov/ohrp/regulations-and-policy/guidance/faq/… Feb 5 at 23:11
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    You don't need IRB approval if you're not doing it through the school or in the context of some academic project. You are instead personally liable for your actions. Don't do anything you couldn't explain in court.
    – user133933
    Feb 6 at 3:28
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Do I even need IRB approval for my research?

Quite probably, but if you are exempt you must get the exemption from an IRB.

What do you recommend for my situation?

You are trying to use a community college to solve a problem (research and product development) that community colleges are not intended to solve. Don't do that. If you want to learn to do research, get a PhD at a research university. If you want to make a product, go get a job at a company that makes products.

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What is the scope of an unregistered IRB?

To uphold the university's ethical guidelines. If you are doing research on behalf of your community college, this IRB can give you the green light on behalf of the community college. Since it is unregistered, it cannot give the green light on behalf of the FDA. Other stakeholders, like funding agencies or journals, may or may not accept this IRB's determination.

I (as a student) would like to conduct a survey (that involves minimal risk) through a mobile application that would be meant for, and open to the general public. I contacted my institution’s IRB and they said that this type of research would be out of the scope of my community college’s IRB. Is this true?

This depends on your particular institution's policies. However, since you are not doing this work "on behalf of the college" (i.e., it is not part of a class, and you are not an employee), it may well be that your institution does not require or allow you to get your extracurricular endeavors approved by an IRB.

that involves minimal risk....which is all anonymized before I receive it

The fact that you believe your research poses minimal risk has no bearing at all on your situation. Researchers don't get to exempt themselves. If an IRB were required (and I'm not saying it is, more on that below), you would still need to get an official document from the IRB saying that you are exempt.

I do not have the resources to get approval from a commercial IRB.

Yes, even getting a commercial IRB to acknowledge that your research poses minimal risk and you are exempt will cost hundreds or thousands of dollars.

Do I even need IRB approval for my research? What do you recommend for my situation?

IRBs are not a legal requirement. Private companies like Facebook can - and do - perform human subject research without an IRB all the time. IRB determinations are typically required by funding agencies, employers, and journals. If you have none of these, you can do whatever you like inside the bounds of the law.

Now if you proceed without the IRB and you do eventually decide to publish, or take a university job, or seek funding, you will probably not be able to use this data or anything that builds on it. But you could always redo the survey if it gets to that point.

Of course, I cannot "recommend" that you proceed without an IRB. It is a decision you will have to make carefully based on the specifics of your academic, legal, and ethical situation.

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    IRBs are a legal requirement when any sort of federal funding touches the research, directly or indirectly. I would want to be very very certain I was clear of those requirements before undertaking human subjects research without an IRB. Likely almost everything Facebook does with data does not meet the legal definition of research in the context in which IRBs matter.
    – Bryan Krause
    Feb 6 at 5:13
  • "Private companies like Facebook can - and do - perform human subject research without an IRB all the time." I strongly suspect that is only because it does not meet the legal definition of research. Feb 6 at 6:58
  • My initial knee-jerk reaction was also to say "of course you need an IRB." But I think this reaction is entirely from a federally-funded perspective: there is some discussion of this here
    – cag51
    Feb 6 at 16:58

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