It is a common question that follows an informed consent document revision- does the subject need to re-sign? The answer could be yes or no depending on the type of revision that was made to the document.
To help sites, sponsors, and investigators navigate through the regulations and secure compliance, IMARC monitors use the FAIR ShakeTM. The FAIR ShakeTM is an easy and comprehensive way to work through challenging situations in clinical research in which the solution or answer may not clear and straightforward. The FAIR ShakeTM allows for IMARC monitors to be consistent, thorough monitors no matter what study, site, or problem they are working on. One answer at one site for one study might not be the same answer for another site for the same or different study. So how does IMARC keep it all straight? Give your question The FAIR ShakeTM:
- Federal Regulations
- Agreements between the sponsor and investigator
- Investigational Plan
- Requirements of the IRB
Let’s use the FAIR ShakeTM to decide if a site needs to have a subject re-sign the informed consent after a revision!
Federal Regulations: According to 21 CFR 50.25(b)(5), subjects will be informed of any significant new information that becomes available during the study. Changing an investigator or typos to in the informed consent would most likely will not qualify as significant. Adding added adverse event information or changing the contact information for questions or issues would be information that a currently enrolled participant would need to know, therefore re-consent would be required.
Agreement: It is unlikely that information related to re-consenting subjects would be addressed in the agreement between the investigator and the sponsor. It may be a good idea to ask the project manager if the sponsor is requiring that all subjects be re-consented. Ask for documentation that you can file in the regulatory binder regardless of the project manager’s response.
Investigational plan: The investigational plan typically notes that the subjects will be consented according to 21 CFR 50 but will most likely not address consenting subjects in the level of detail related to conditions of re-consenting.
Requirements of the IRB: Often, the approval of the informed consent document will provide guidance if currently participating subjects require re-consent. If the approval letter does not address re-consent, the site, along with the monitor, should review the consenting policies and procedures of the IRB. These policies may provide additional direction on the requirements of re-consenting and when it is appropriate or required. The IRB’s primary focus is the protection of human subjects, therefore, if further clarification is needed, reach out to a contact at the IRB and confirm if re-consent is required.
Do you have examples of when subjects did or did not need to be re-consented? What have IRBs or sponsors considered significant, new information? Please share here.
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