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First Quarter 2009 |
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New Coverage Supports Participation in Clinical Trials
Professional Liability
Virtually all professional liability insurance policies exclude coverage for claims arising out of the use of drugs, devices, or protocols not approved by the Food and Drug Administration (FDA). This type of risk is excluded in basic policies due to concerns regarding patient safety and the defensibility of claims alleging human experimentation.
As a company owned and led by physicians, The Doctors Company supports participation in clinical trials by its members. A powerful example of this commitment is the broadening of our policy to provide automatic coverage for member participation in clinical trials. It is no longer necessary to obtain preapproval from us for specific institutional review board (IRB) clinical trials. Endorsement MPL240 is added to new and renewal policies issued on or after January 1, 2009, subject to state regulatory approval.*
Typical requirements for clinical trials include the following:- There must be a written protocol for use approved by an appropriate human subjects committee or institutional review board.
- Full disclosure (informed consent) with a clear explanation of all potential risks must be made to the patient, signed, and placed in the patient’s chart. (For samples of informed-consent documents, visit www.fda.gov/oc/ohrt/IRBs/informedconsent.html.)
Coverage applies to clinical research trials conducted within either an institutional setting or in a physician’s office setting— provided the trial has been approved by an IRB.
Please note this change does not convert your professional liability policy into a clinical trial or clinical research organization errors and omissions policy. If you are a sponsor or operate an IRB, you should consult with your insurance adviser regarding your insurance needs.
When a clinical trial protocol for an investigational new drug (IND) or a new drug application (NDA) is submitted by a drug company to an institutional review board for approval, it also submits the protocol to the FDA. The FDA has 30 days to comment (or not comment). This occurs independently of the IRB review. The IRB only confirms that the submission to the FDA occurred. The FDA doesn’t approve the clinical trial per se, and there is no reference to FDA approval or review in either the trial protocol or the IRB review. Presumably, if the FDA comments and the comments affect the clinical trial protocol, this information would be transmitted to the IRB. Once approved by the IRB, the clinical trial takes place, and, when completed, the results are then submitted to the FDA for its approval of the new drug or new application.
Contractual Liability
In the context of clinical trials, a physician must be careful that he or she is not assuming the liability of a drug sponsor simply by signing a contract. Some contracts include a provision that shifts the liability of one party to the other party—these are known as indemnification or “hold harmless” clauses.
A physician who assumes this liability is, in essence, agreeing to be the liability insurer for the sponsor. Because of the almost unlimited liability potential, The Doctors Company cannot extend coverage to its physicians for liability that they assume in indemnification or hold harmless clauses in such situations. Any contracts, particularly those in the arena of clinical trials, should be reviewed with your health care business attorney.
Closing Summary
Our members can rest easy that, of all the administrative tasks required for clinical trial work, malpractice insurance paperwork is not one of them. Your coverage has been broadened and redesigned to fit the reality of 21st century medical practice by automatically covering you for clinical trials.
If you have questions about your policy with The Doctors Company, please contact your agent or broker, or call Member Services at (800) 421-2368.
* The Doctors Company reserves the right to require preapproval of clinical trials in certain circumstances.
The Doctor’s Advocate is published by The Doctors Company to advise and inform its members about loss prevention and insurance issues.
The guidelines suggested in this newsletter are not rules, do not constitute legal advice, and do not ensure a successful outcome. They attempt to define principles of practice for providing appropriate care. The principles are not inclusive of all proper methods of care nor exclusive of other methods reasonably directed at obtaining the same results.
The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.
The Doctor’s Advocate is published quarterly by Corporate Communications, The Doctors Company. Letters and articles, to be edited and published at the editor’s discretion, are welcome. The views expressed are those of the letter writer and do not necessarily reflect the opinion or official policy of The Doctors Company. Please sign your letters, and address them to the editor.