Q&A on legalities of contracting a sub-investigator for a clinical trial

Question:

We are planning on using a sub-investigator to support a clinical trial at our site. What do we need to include in the contract to ensure that we are compliant with the Florida sunshine law and the Stark law?  Should we explicitly state in the contract that we are compensating the sub-investigator for services and that we not paying for subject referrals? What is a good compensation for a sub-investigator?
- Staff at research site

Response: 

The Sunshine law in Florida requires that 1) meetings of boards or commissions must be open to the public; 2) reasonable notice of such meetings must be given, and 3) minutes of the meeting must be taken.  There is no mention of payments to investigators or sub-investigators. 

However, under the Centers for Medicare & Medicaid Services Open Payments Program, there is a national disclosure program that promotes a more transparent and accountable health care system by making the financial relationships between applicable manufacturers such as pharmaceutical companies and health care providers available to the public.  Under the Open Payments program, you are required to report the only the names of principal investigators and not sub-researchers.  The report may include up to five principal investigators for each research payment reported. 

The Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Financial relationships include both ownership/investment interests and compensation arrangements.  The Stark law is a strict liability statute, which means proof of specific intent to violate the law is not required.  Therefore, so long as the sub-investigators does not have any financial interests as stated above and does not make such referrals, he/she is likely to be compliant.  Click here for more information.

Unfortunately, we cannot comment on the compensation for this sub-investigator.  However, it should be noted that all payments for services related to clinical trials must be within fair market value.  Some of the considerations that help determine if payments are considered fair market value include:  is the payment usual and customary fees for similar services; does the payment reflect the local jurisdiction in which the services are performed; and, are the fees defensible when judged against other fees paid to investigators working on the same study?  Please be advised that one of the critical components in scrutinizing payments to investigators and sub-investigators is the division of labor.  Paying an investigator and sub-investigator for the same services is not acceptable as it violates the maxim that compensation requires the performance of a service.

Please note that the above is not legal advice and we suggest you discuss your question with a qualified lawyer in your area.

About the Author

Marco Capasso, JD | Chief Legal Officer

As Chief Legal Officer, Marco is responsible for WCG’s worldwide legal, risk management, and corporate governance. In this capacity, Marco’s oversight includes all legal matters related to the company’s contracts, operations, insurance, intellectual property, privacy, compliance, and finance functions. Marco’s career before law school was as a clinical researcher in New York. Marco served as a clinical research coordinator at Memorial Sloan-Kettering and Mount Sinai Medical Center where he worked on numerous clinical trials in genetics, internal medicine, and cardiology. Marco is listed as a co-author for his research and has received acknowledgment in numerous peer-reviewed medical journals.

More Content by Marco Capasso, JD | Chief Legal Officer
Previous Post
Is IRB review required for publication of a case study?
Is IRB review required for publication of a case study?

Next Post
Meet Yvonne Higgins
Meet Yvonne Higgins

Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years.

Ask The IRB Experts

Submit Question