Communicating New Risks

When a protocol undergoes initial approval, the protocol’s consent document is reviewed to ensure that all known risks to research subjects are included and communicated in a way that can be easily understood. These risks can vary depending on the type of research study that is being conducted.

There are several ways that new risks can be identified. The most common way is from events that occur on a research protocol. These could be physical or mental adverse events which were not included in the consent document or that occurred at a greater severity or frequency than previously known. Another example would be a large data breach that affected all your research subjects. This should sound familiar because these are examples of unanticipated problems that are reportable to the IRB. If you are reporting a possible unanticipated problem to the IRB, you should be considering if there is a new risk that needs to be communicated to subjects.

New risks to your research participants may also be identified outside of your protocol. The most common ways are through new research publications, drug safety-related labeling changes, and sponsor’s or manufacturer’s IND Safety reports:

• Recent publications related to your research might contain new information that identifies additional risks to your subjects or raises questions about the efficacy of your research.
• Drug safety-related labeling changes (SrLC) were formally known as MedWatch notifications. If your study involves FDA approved drugs, then new risks may be identified after the initial FDA approval through Phase 4 trials or through community adverse event reporting. It is the responsibility of the investigator to keep informed of any major changes, such as a new boxed warning. The FDA has a database where you can search for SrLCs. You can also sign up to receive email notifications directly from the FDA.
• If your study involves a drug/device that is not FDA approved and under an IND/IDE, then you may receive Safety Reports from a sponsor/manufacturer. These reports may contain new risks that apply to your research that need to be communicated to participants. If the information in these reports rises to the level of needing to be reported to the IRB, then you should also consider if participants also need to be informed.

FDA: Drug Safety-related Labeling Changes

FDA Guidance: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format