If I am conducting independent research (ie no university affiliation), do I need to worry about institutional review board (IRB) approval, if I am working in a field where it is normally required?
This issue actually got some press recently with the case of uBiome, a citizen science startup that raised over $350,000 in crowdfunding.
A statement from the founders of uBiome says they were advised that they don't legally require IRB approval if they aren't receiving federal funding, don't plan to publish, and don't plan to apply for FDA (U.S. Food and Drug Administration) approval:
Before we started our crowdfunding campaign, we consulted with our advisors at QB3, the startup incubator at UCSF, and the lawyers they provided us. We were informed (correctly) that IRBs are only required for federally funded projects, clinical trials, and those who seek publication in peer-reviewed journals. That’s right — projects that don’t want federal money, FDA approval, or to publish in traditional journals require no ethical review at all as far as we know. (No, that doesn’t sound like a great system to us either.)
This is the same institution that works with academic IRBs that need to coordinate multi-site studies, as well as private firms such as 23andme and pharmaceutical companies doing clinical trials.
This incident raises the question of what you plan to do with your independent research (assuming the kind of research you are doing is generally subject to IRB oversight):
- If you plan to publish your research in a traditional peer-reviewed journal, you will usually need an IRB review
- If you plan to develop pharmaceuticals that will require FDA approval, you will need IRB review
- If you plan to get federal funding for your work, you will need IRB review. If you plan to get other funding for your work, it'll be hard to get without IRB review.
- If you plan to create a startup around your research, you may not require IRB review, but not having it can engender quite a bit of criticism (as per uBiome's story)
This really depends on if you are planning on publishing the research. From my understanding many in house studies in industry are not subjected to an IRB process.
Publishing is a different story. Amdur and Biddle (1997) found that 47% of biomedical journals had policies about IRB approval. While I don't have any data to support it, my guess is this number is higher now.
The FDA guidelines for IRB say:
IRBs may agree to review research from affiliated or unaffiliated investigators, however, FDA does not require IRBs to assume this responsibility.
Many university and hospital IRBs will not approve studies from unaffiliated individuals since approval often limits the liability of the PI. There may be some university and hospital IRBs that approve studies from unaffiliated individuals and there are definitely private companies that specialize in this type of thing.
As an independent researcher myself, who has taken a less traditional route of publication (in an open access journal versus a peer-reviewed journal), I am of the understanding that IRB approval is not required unless your study is being featured in a peer reviewed journal. With that said, I think that the participant protections that I put in place to protect my subjects are much more stringent than any IRB requirements. Mine was a case study with two participants and both agreed in writing that they felt adequately protected. They also agreed when reading the study prior to its publication that while they themselves could tell what each part represented, the nonuse of their names, the fictitious place they were said to have grown up, a couple of minor alterations to their stories, which did not change the results or themes, but furthered their anonymity made it so that they were certain that no one could identify them.