You are so right. There are too many sites that do not understand the language or complications of cross indemnification clauses in CTA's, and physicians who are willing to sign them anyway. Many individual physician's mal practice insurance policies have paragraphs that state "you agree not to hold harmless or indemnify any other business or entity". This simple sentence makes it clear that if you sign such a document and something happens in your practice (does not even have to be related to a research subject), your insurance provider could refuse to represent you as you are in breach of your insurance contract. Should a patient decide to sue you, all your office practices and contacts can be reviewed. Once it is noted that you signed a cross imdemnifcation contract you may be standing all by yourself in a court, as you have breached your insurance agreement.
Education is the best practice. All research sites should understand that signing a cross indemnification contract, could void your mal practice policy for any medical services you provide to the general public and your patient population. Sponsors and CRO's should also be aware that most physician's have mal practice insurance, but these clauses are usually within their insurance binder. Just because the physician's have a malpractice policy, it does not mean that they are covered -- if you make them sign a cross indemnification clause. You may be creating an area of lack of mal practice coverage for each physician if any medical suit should arise. Paragraphs of responsibility are what the smarter, more versed, CRO's and Pharmaceutical companies of today are offering sites, in place of the cross indemnification.
The more all parties involved understand the risks upfront-- the less chance of issues later. Working together we can protect each others interests.
Terry Stubbs MA,CCRC
President and CEO
ActivMed Practices & Research
One Water Street Suite A
Haverhill MA 01830