How To Minimize Risks Independent Of Clinical Trials Insurance
The majority of legal jurisdictions require medical research companies to hold clinical trial insurance. Clinical trial insurance is just a part of the process of clinical trials. You should find an insurance provider with experience in clinical trials insurance before you buy.
That being said, there are ways to minimize your liability risk when it comes to clinical trials. Here are a few ways you can reduce that risk.
Outcompete the FDA
Always comply with regulatory boards and administrations, but remember that this won't indemnify you from lawsuits. There are many life science firms that are famous for their FDA compliance, but these firms still get hit with costly lawsuits. FDA regulations do set some basic standards for compliance.
All clinical trial companies should look at these regulations as the minimum, and all should strive to outperform these regulations. In other words, life sciences companies need to ‘raise the bar' when it comes to FDA standards.
Avoid Conflicts of Interest
Stay away from any conflicts of interest associated with clinical trials. There are companies that have structured policies wherein they pay clinical investigators higher salaries if the investigators enroll more subjects. Sometimes, this can result in improper recruitment of subjects. Ensure that there are no financial conflicts between the subject and the investigator.
Recently, the flagship Cleveland Clinic was subject to censure and litigation after discoveries that doctors in the facility had financial ties to medical device firms whose products they were testing at the clinic.
Obviously, blatant forms of bias like this can jeopardize the integrity of clinical trial data. This will basically invalidate the evidence gleaned from the clinical trial. Always disclose any compensation agreements between clinical investigators and members of the IRB. Patients should also sign all disclosures.
Choose Your Employees Wisely
Remember to only recruit experienced investigators who have extensively worked in clinical research. Don't hire someone who has only conducted research in private practices or medical schools. Only investigators with formal training in clinical research will suffice.
This training will facilitate communication between the clinical researchers and the IRB members. This is why it's worth it to invest the time and analyze the investigators' credentials and experience. You'll also pre-empt any arguments by plaintiff attorneys who might claim that you skirted responsibility when hiring clinical researchers.
Ensure Your Researchers are Covered
Only hire clinical researchers who carry third-party liability insurance or specifically there own professional liability coverage. This cannot be overstated. Most clinical trial policies will exclude coverage for the negligence of a 3rd party medical professional. This way, you can avoid contentious conflicts between sponsors and investigators.
Finally, don't just view informed consent as a perfunctory form. View it as an ongoing process. Informed consent is a delicate procedure that must be followed to strict protocol. The patient needs to be fully aware of all risks and benefits.
Take the time to fully explain all procedures, and answer questions thoroughly. This will help prevent litigation from even occurring.
While all of these methods will help minimize the risk of litigation, all providers of clinical trials must arm themselves with a strong clinical trial policy. Only powerful insurance will allow life science researchers to conduct their business securely.
Read more about clinical trials insurance and how to acquire a policy that will keep your life science organization safe.
Questions and Answers
Nowadays, it is becoming increasingly common for insurance companies to offer clinical trial coverage for patients. But very few clinical trial providers and investigators understand the importance of building customized clinical trial coverage that will protect them. Here we present a handy guide regarding clinical trial insurance.
While clinical trial insurance is a necessity for any company that conducts clinical trials, many companies do not adequately fulfill their responsibilities when it comes to informed consent. Informed consent requires a deliberate process. This is not just a form that research coordinators push onto subjects.
ACE Progress Reports has recently published a breakthrough study regarding clinical trial coverage. The study, titled "Managing the Foreign Challenges of a Global Insurance Program: Foreign Clinical Trials Case Study", has received widespread attention in the insurance community and beyond. The study highlights the growth of international clinical trials, and their effect on risk management and insurance policies.
Sponsors of clinical trials are greatly exposed to litigation, and so must acquire clinical trials insurance that will protect them. Many enterprising attorneys will capitalize on vague language in informed consent documents to provide their case. Here are a few tips to build ironclad informed consent documents.
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Nowadays, it is becoming increasingly common for insurance companies to offer clinical trial coverage for patients. But very few clinical trial providers and investigators understand the importance of building customized clinical trial coverage that will protect them. Here we present a handy guide regarding clinical trial insurance.
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