Can Non-Physicians Own Clinical Trial Sites?

DarshanTalks Podcast

Can non-physicians own independent clinical trial sites? The answer isn’t as simple as it seems. In most states, including Texas, engaging in clinical research is considered the practice of medicine, which means that research sites must adhere to the same rules that apply to medical practices. This includes the corporate practice of medicine doctrine, which restricts ownership and control of medical practices to licensed physicians. As a result, non-physicians generally cannot own or manage research sites that involve clinical procedures requiring medical judgment, diagnosis, or treatment.

A common misconception is that clinical trials are separate from the practice of medicine, but the reality is that many of these trials do involve medical procedures that require compliance with state medical laws. For instance, when your principal investigator (PI) signs a Form 1572, they’re agreeing to comply with medical standards—this reinforces the idea that clinical research is governed by the same rules as medical practice.

Many research sites fail to audit their ownership structures for compliance with the corporate practice of medicine doctrine. While it’s easy to assume that “everyone else is doing it,” cutting corners can lead to disastrous consequences such as lawsuits, regulatory scrutiny, or even unwound deals. That’s why it’s important for sponsors, CROs, and investors to ensure that research sites are structured properly, that investigators are licensed in the trial state, and that sites have appropriate malpractice insurance.

At the Kulkarni Law Firm, we work with clients to ensure that their research operations are compliant, structured correctly, and protected from enforcement risks. Whether you're a sponsor, investor, or site operator, it’s critical to be proactive and audit your practices to avoid costly mistakes down the road.

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