Clinical research studies can pose risks such as illness, injury, adverse reactions, and even death to participants. Although most research-related study sponsors are willing to pay for the costs of some subject injuries, they are not willing to pay for costs incurred due to an institution’s mistakes, reckless or negligent behavior, or failure to follow proper protocol for the study.
Sponsors will also not typically pay for adverse events or allergic reactions that may have occurred even if the study participant was not involved in the study. Before entering a clinical trial, participants should understand “subject injury” liability and the contingencies outlined in their CTA.
The Language of Subject Injury
Physical and psychological research-related injuries, ranging from minor to severe, can occur as a result of participation in a clinical trial or research study and often require various types of medical treatments that can quickly become expensive and overwhelming. Unfortunately, the language in research study contracts that discusses injury liability is often vague or filled with contingencies that are difficult to understand. This language explains who is liable for damages in the event that patient illness, injury, adverse reaction, or death occurs as a result of the clinical study.
The topic of subject injury is typically addressed in two places within the agreement or contract – the clinical trial agreement (CTA) and the informed consent form (ICF).
- CTA – The clinical trial agreement contains legal jargon that discusses specific details regarding compensation for any injuries that occur as a result of the clinical trial. It also discusses any contingencies connected to injury payments.
- ICF – The informed consent form is usually written in straightforward language that most patients can understand. It informs patients who participate in clinical trials on how subject injury costs will be covered.
Participants in clinical trials should fully understand the language of CTAs and ICFs before signing an agreement or contract. CTAs often limit the definition of an eligible injury to only those that are caused by a new drug or device being studied, rather than encompassing broader procedures or other drugs that might be used during the study. Others may limit the definition of subject injury to physical injuries only. If psychological illness or injury occurs, damages will not be paid.
If you or a family member was seriously injured, call a Las Vegas personal injury attorney at Cogburn Law Offices today for a free case consultation.