“Workplace-based testing should not be conducted without the employee’s informed consent.”

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So says the Centers for Disease Control and Prevention (CDC) in its  new guidance on workplace testing programs, which adds to its previous guidance, Testing Strategies: Considerations for Non-Healthcare Workplaces. In the new guidance, the CDC focuses on the need for informed consent for workplace testing by employees and discusses the required disclosures for such consent.

The CDC states that employers should take the following measures when developing a testing program in order to support appropriate decision-making by employees:

  • Ensure safeguards are in place to protect an employee’s privacy and confidentiality.
  • Provide complete and understandable information about how the employer’s testing program may impact employees’ lives, such as if a positive test result or declination to participate in testing may mean exclusion from work.
  • Explain any parts of the testing program an employee would consider especially important when deciding whether to participate. This involves explaining the key reasons that may guide their decision.
  • Provide information about the testing program in the employee’s preferred language using non-technical terms. Consider obtaining employee input on the readability of the information. Employers can use this tool to create clear messages.
  • Encourage supervisors and co-workers to avoid pressuring employees to participate in testing.
  • Encourage and answer questions during the consent process. The consent process is active information sharing between an employer or their representative and an employee, in which the employer discloses the information, answers questions to facilitate understanding, and promotes the employee’s free choice.

The CDC also discusses what should be contained in the disclosures, acknowledging that much of the following information are addressed in the FDA’s Emergency Use Authorization Fact Sheet, which must be given to all individuals prior to receiving the vaccine:

  • The manufacturer and name of the test
  • The test’s purpose
  • The type of test
  • How the test will be performed
  • Known and potential risks of harm, discomforts, and benefits of the test
  • What it means to have a positive or negative test result, including:
  • Test reliability and limitations
  • Public health guidance to isolate or quarantine at home, if applicable

In addition, the CDC states that employers should be prepared to address the following:

  • General considerations, such as why testing is being offered, frequency of testing and consequences of refusing the test.
  • Scheduling and payment, including who schedules the appointments, whether the employee is paid for travel and testing, who pays for the test and any required follow-up care, and accommodations or alternatives to testing.
  • Testing site, such as who administers the test, where the test will be done, and whether any screening will be required prior to the test.
  • Communication and interpretation of results, including who interprets the results, how and to whom results are communicated, and what happens if the employee tests positive.
  • Privacy, such as what personal information must be provided by the employee, how and for what period it is retained, and how it will be kept confidential and secure.
  • Seeking additional help or reporting injuries, such as who to contact for additional information or assistance.