Conducting clinical trials is an important part of developing new medical products and procedures.
These trials can be difficult to structure properly, time-consuming, and very expensive. What many people fail to realize, however, is that they can also raise significant legal issues if they aren’t done properly. Whether your business is considering a clinical trial, or you’re already in the middle of one, make sure you know about the following five potential legal issues you could run into.
Identify the Scientific Value of a Trial
In order to run a clinical trial (or most any other type of research) you are often required to clearly state the scientific value of the effort. If there is little to no scientific value, it can trigger federal anti-kickback statutes as well as a variety of issues from the IRS. While you are permitted to make efforts with little scientific value, they can’t be classified or funded as clinical trials without running into serious legal troubles.
Regulatory Compliance
There are state and federal government regulations in place to help ensure clinical trials are performed properly. This is in place not only to help protect those who are taking part in the trials, but also to ensure the results of the trials can be trusted to contribute in deciding how to move forward with any findings. There are regulatory requirements from many different agencies, and it is the responsibility of the company performing the trials to ensure they are always in compliance.
Informed Consent
Anyone taking part in a clinical trial has the right to informed consent. This means that the company performing the trials needs to not just tell them what they will be doing, but inform them of all known risks. If your company institutionally or unintentionally fails to inform those in the trial, it can lead to lawsuits and other problems.
Proper Documentation
From start to finish, everything related to a clinical trial needs to be properly documented. This is necessary for ensuring the results of the trial can be repeated, and so any potential side effects or other risks are known. If you fail to document every step of the trial it not only could invalidate the results, but it could result in lawsuits and other legal issues in the future.
Keep the IRS (and other Financial Issues) in Mind
The way clinical trials are funded is very regulated. The IRS monitors these trials very closely, including where the money comes from and where it goes, to ensure there aren’t any discrepancies or conflicts. There are hundreds of regulations in place, and the company performing the clinical trial is responsible for ensuring compliance to each one.
Getting Objective Help
The best way to ensure your clinical trials meet all legal requirements is to have an attorney experienced in this area help review the process. Contact Phil Crowley to discuss your current or future trials to see how he can offer insights and advice that will protect your company from potential legal issues.
