One of the negative aspects of clinical trials is the possibility that a patient will suffer an injury or illness as a result of their study participation. As such, one of the most important pieces of a contract is the subject injury language. ‘Subject Injury’ is defined as an injury, illness, adverse event/reaction, or death caused by a study subject’s involvement in a clinical research study. Prior to the study, the research site and the study sponsor should come to an agreement on what exactly constitutes a Subject Injury, and who pays in the event of a Subject Injury.
Where is Subject Injury Language Addressed?
The topic of Subject Injury should be addressed in two places: the informed consent form (ICF) and the clinical trial agreement (CTA). The ICF informs potential study subjects how Subject Injury costs will be covered and is generally written in straightforward language. The CTA is where legal jargon potentially enters the equation; the ICF and CTA should always be consistent, but the CTA will likely go into more detail regarding compensation/reimbursement, as well as any contingencies tied to these Subject Injury payments.
When reviewing Subject Injury language in a CTA, it is important to look out for language that limits the definition of a Subject Injury to only that which is caused by the drug or device being studied. A Subject Injury should encompass any procedure called for in the study protocol regarding the administration of a study drug or the implantation of a study device. Additionally, be wary of sponsors limiting the definition of Subject Injury to incorporate physical injuries only – if a study drug were to cause a change in a study subject’s mental status, for example, that would not be covered by their agreement to compensate for “physical injuries.”
Who Pays for Subject Injuries?
Study sponsors should be (and generally are) willing to pay for Subject Injury costs. On the other hand, study sponsors will likely not be willing to pay for costs incurred by the institution’s mistakes, negligence, recklessness, or failure to follow the study protocol. Sponsors are also not typically willing to pay for adverse events that would have occurred even if the study subject was not involved in the study (in other words, the research site’s standard of care costs for the disease/condition being studied). These additional contingencies should be outlined in the CTA.
Subject Injury vs. Indemnification
It is not uncommon to see Subject Injury language missing from contracts altogether. Instead, the study sponsor may solely refer to their promise to indemnify the institution for physical injuries related to the study drug/device. This alternative is insufficient. It is crucial that Subject Injury compensation language be separated into either (1) its own provision or (2) a way that it is not tied to legal proceedings.
To clarify, when the sponsor promises to indemnify the institution for Subject Injuries, that means that they will assume and pay for any lawsuits or legal proceedings that a study subject files in relation to those Subject Injuries.
While it is important to include this type of indemnification language so research sites are protected in the event of Subject Injury-related lawsuits, without having the separate Subject Injury language, study subjects would have to file a lawsuit or initiate a civil proceeding to get their medical bills paid. If Subject Injury is promised independently of indemnification language, then the sponsor agrees to pay for those bills without the study subject having to involve the legal system.
During negotiations, you may come across a broad range of sponsor opinions on Subject Injury. Begin negotiations knowing that it is completely reasonable to ask sponsors to incur these costs. Study subjects volunteer their time, medical information, and potentially their health for the sake of these studies. Ultimately, study sponsors benefit financially from this willingness to volunteer, so we believe it is reasonable for Subject Injury costs to be 100% assumed by sponsors.