Questions for your SupervIsor to OBtain Informed Consent

These are not necessarily meant to be sent all at one time.  Recommend to begin your correspondence with the recognition that it is important to provide an environment for a safe, healthy work force.

• I would like to be notified of my legal rights to opt out of participating in experimental, emergency-use medical devices.
• How will informed consent be obtained and documented for wearing masks? 
• To whom and how do I report harmful adverse effects for wearing an experimental medical      device (mask)?
• Will the Agency provide treatment for any injuries (reoccurring and/or permanent) related to mask wearing?
• Who do I contact to explain to me my rights for informed consent to wearing an experimental medical device (mask)?
• Do you have any documentation on the efficacy of masks as a medical device?
• What is the scope and/or limitations of the emergency use authorization for the use of face masks to prevent the spread of Covid-19?
• Will you be providing facial protection as this is a workplace requirement, like you would provide ear protection or head protection?
• Is the Agency ordering/officially directing me to wear a mask that is fully licensed by the FDA?

◦ If YES, can you please provide the brand name, link to the FDA medical device information, and the licensing date? Which ones are regarded as safe for long term use by the National Institute for Occupational Safety and Health?

◦ If NO, is it my understanding the Agency is directing me to wear a medical device that is under Emergency Use Authorization?

▪ If YES, does the Agency agree that I have a right to informed consent?

▪ If NO, can the Agency giving the official order please provide clarification so that I may have an accurate understanding of the FDA status of wearable medical devices, including masks to combat Covid-19, and so I may have informed consent?

One approach is to ask for FDA-approved masks and tests, if/when they are mandated. If none can be provided (and none can be, as there are no FDA-approved masks or tests for COVID), request a medical supply exemption and exercise your refusal rights, IAW DoDI 6200.02 E3.4, 10 USC sec 1107a(a)(1), and 21 USC sec 360bbb-3(e)(1)(A)(ii)(III).