What should a research compliance professional do when an employee refuses a Hep B vaccination?

When an employee refuses a Hepatitis B vaccination, requiring the employee to sign a form declining the vaccine is a standard practice that ensures informed consent and documentation of the refusal. This approach is important for several reasons.

First, the Hepatitis B vaccination is a recommendation for employees who may be exposed to blood or body fluids, particularly in healthcare or clinical research settings. By having the employee sign a form, the employer can confirm that the employee is aware of the risks associated with refusing the vaccine.

Secondly, this documentation serves to protect the organization against potential liability issues in case the employee later contracts Hepatitis B or suffers any adverse effects due to exposure in their role. It also ensures compliance with occupational safety regulations that guide vaccination policies, including the Occupational Safety and Health Administration (OSHA) requirements.

This practice aligns with the principles of informed consent and helps maintain compliance with health and safety regulations within the workplace, thereby supporting the overall integrity of the research environment.

Other options might suggest removal or adjustments that could disrupt operational continuity without adequately documenting the refusal or addressing the underlying issue of informed choice.