Good Informed Consent Protocols Boosts Clinical Trial Coverage
Sponsors of clinical trials can be 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.
Establish a Thorough Consent Form
The sponsor must ensure that they include explicit language that states that the expenses of the participant will be covered in the event of injury. This includes all of the costs of treatment. The consent form should also clearly state that the sponsor will pay for any expenses that arise from deleterious health effects of experimental drugs or devices used in the clinical trial.
The informed consent form can contain language that states that the sponsor will first bill the patient's insurance company. However, sponsors must also include language that states that if the participant's insurance does not cover the medical costs, the sponsor will assume responsibility for medical expenses related to the clinical trial.
Use Simple Language In Consent Documents
It's very important that the informed consent form be compatible with all provisions in the sponsor's contract. This will avoid discrepancies between informed consent and contractual agreements. This is a great way to prevent any sort of bizarre litigation proceedings from popping up. Good documentation makes you a lot less vulnerable.
Drafting consent forms can be a long and arduous process. It's extremely important that you have a team of legal and clinical trial experts comb over your informed consent forms. These people can pore through your documents and highlight any inappropriate language. Research coordinators are often required to browse informed consent forms and make necessary adjustments.
It's in your best interest to submit your revisions to the IRB at the time of your initial submission to the IRB. This will greatly increase your chances of getting the proper authorization to conduct your clinical trial.
All subjects are required to sign informed consent forms before participation in the clinical trial. This is an absolute requirement. All clinical trial providers and research coordinators should encourage participants to ask detailed questions. Many subjects are nervous, shy, or simply uneducated when it comes to clinical trials. The providers need to take an active step to communicate the structures and processes of the clinical trial.
The Importance of Diligent Work on Informed Consent Documents
CenterWatch issued a survey that shows that 14% of the participants in clinical trials did not read their informed consent documents. This further highlights the need for clear communication between research coordinators and participants.
Always provide non-English speaking subjects with interpreters or translators. Your company should have established protocols for determining the necessity of such translators. This is a common mistake that is made by many clinical trials providers.
Clinical trials are often considered risky ventures, but if you establish a strict set of standards for your clinical trial, you can save yourself the trouble of litigation.
Overall, clinical trials organizations should purchase an insurance policy that will cover them in case of litigation proceedings or other damages. All providers should consult with experienced insurance professionals so that they can build a life sciences policy that will fully cover their clinical trial.