Subject Injury Language for Informed Consent Forms
All informed consent forms for clinical trials at UNC must contain subject injury language (SIL). SIL is the part of the informed consent form that explains what the study participant should do if they think that they have been injured as a result of participating in a study. The SIL also specifies who will pay for the healthcare costs and other expenses incurred as a result of a study-related injury. SIL lets potential study participants know the facts about who is financially responsible for paying for medical care for a study-related injury. This is important information for the potential participant to factor into their decision about whether or not to participate in a study.
SIL must be approved by the UNC OCT. This approval is based on the SIL being aligned with both UNC policies on SIL and the finalized clinical trial agreement between UNC and the study sponsor.
If you are writing an ICF and need SIL, please contact the UNC Office of Clinical Trials (UNC OCT) SIL specialists by emailing email@example.com. Your contact email should include the following information (include all of the following that are applicable to your study):
- Sponsor name as it appears in the study contract
- protocol number
- study title
- CRMS #
- IRB #
- RAMSeS #
- PI name/title (i.e. PhD, MD)
- ALICE agreement number
Once the OCT has received this information, a SIL specialist will look up the study in the applicable databases (ALICE, RAMSeS, IRBIS, CRMS) to view the study status, confirm IRB number and view the study contract. Based on that information, the SIL specialist will issue SIL that is appropriate for the study. If there is no finalized agreement with the sponsor, the SIL specialist can provide a memo with template SIL that can be used for IRB applications. However, once the contract with the sponsor is finalized, the study staff may have to go through the SIL request process again in order for the finalized SIL to match what is in the study contract. The SIL specialist will issue an official memo with the approved SIL. Study staff must upload that memo as part of the study’s IRB documents.
Study sponsors, the UNC IRB and the UNC Office of Industry Contracting all look at each study’s SIL very carefully to make sure that it is aligned with the study contract and UNC policies. Having SIL that doesn’t meet those criteria could delay the start date of the clinical trial. SIL must be approved by the UNC OCT, and any revisions to the SIL must also be approved by the UNC OCT.
If you have any questions about subject injury language or the subject injury language approval process at UNC, please refer to the Subject Injury Language FAQ or email firstname.lastname@example.org.