When Do You Need IRB Approval? Legal vs. Practical Requirements for Human Subjects Research

If you're a startup founder venturing into human subjects research, you've likely encountered the term "IRB review." IRB stands for Institutional Review Board, a committee of independent experts who, on behalf of the federal government, ensure that your research protects participants' rights and safety as codified in the law. But is it always necessary? Not legally in every case. In this post, we'll clarify when IRB review is required by law and when it's advisable (or unavoidable) for other reasons. This guide is tailored for startups unfamiliar with human subjects regulations, helping you avoid potential pitfalls.

Understanding “Human Subjects Research”

The first question to ask yourself is whether you are even doing “human subjects research”. Under the Common Rule, this generally means you are doing systematic work designed to produce generalizable knowledge that involves living people, their identifiable data, or their biospecimens. If you only use fully de-identified public data with no way back to individuals, you may be outside the rule. NIH’s overview is an excellent explainer.

Legal Requirements for IRB Review

Legally, IRB review isn't mandated for every study involving human subjects research, but certain conditions make it essential. Consider this the mandatory category where compliance is non-negotiable.

• Federal Funding from Common Rule Agencies: If your research receives funding from U.S. federal departments that adhere to the Common Rule, IRB review is required. The Common Rule provides guidelines for ethical treatment of human subjects and is followed by agencies including the Department of Health and Human Services (HHS), the Department of Defense, and around 20 others. In essence, it ensures participants are informed, treated fairly, and protected from unnecessary risks. For more details, refer to the HHS Common Rule page and the relevant federal regulations in 45 CFR Part 46.

• Research Involving FDA-Regulated Products: This is particularly relevant for health tech or biotech startups. IRB review is mandated for "clinical investigations" as defined in the FDA regulations, which is any research the data from which may end up in an FDA marketing application (e.g., a 510(k) submission or IND) or be held for inspection by the FDA (e.g., as part of a Design History File). This usually means any and all preclinical or clinical studies involving a new drug, device, or diagnostic. The FDA's regulations overlap with the Common Rule but emphasize product-specific protections. Learn more on the FDA's human subjects protection page and the relevant federal regulations in 21 CFR Part 50 and 21 CFR Part 56.

If your startup's research doesn't involve federal funding from these agencies or a “clinical investigation” as defined above, you may not be legally obligated to seek IRB approval. That said, this isn't the complete picture. Practical considerations often come into play.

Practical Reasons for IRB Review

Even without a legal mandate, forgoing IRB review can create challenges down the line. This category encompasses the legal requirements plus situations where ethical oversight enhances credibility and opportunities.

• Publishing in Peer-Reviewed Journals: If you aim to share your findings in peer-reviewed journals, IRB approval is typically essential. Most reputable journals ask for IRB approval or an IRB’s formal “not human subjects” or exempt determination. Surveys show that ~80% of journals require IRB approval, and top journals follow ICMJE policies that expect ethics review.

• Building Credibility with Researchers and Partners: IRB approval demonstrates to collaborators, investors, and the scientific community that your research upholds high ethical standards. For startups partnering with universities, hospitals, or other entities, this oversight is often expected. It addresses key aspects like risk management, informed consent, and privacy, fostering trust in a competitive landscape.

In many cases, the practical benefits of IRB review outweigh the requirements of the law. It's an investment in your research's integrity and your startup's reputation.

Final Thoughts: Navigating IRB for Your Startup

As a startup focused on innovation and growth, dealing with IRB might feel like an added layer of complexity. However, it safeguards participants, validates your data, and supports long-term success. If you fall into the legal category, it's unavoidable; if practical needs apply, it's a wise choice.

Uncertain about your situation? Tempus IRB specializes in reviews for startups. Schedule a call with us today!

This post is for informational purposes only and does not constitute legal advice.