Dear District and State Decision Makers,
As parents of Rhode Island middle and high-school athletes, we write today with valid concerns. Parents are coerced into consenting to test our asymptomatic children weekly with BinaxNow Covid tests as a requirement for participation in school sports. As we learn more about this mandated testing program our concerns grow.
This test has not been mandated by the Rhode Island Department of Health nor by the RI Interscholastic League as a requirement for participation in sports. School district administrators have taken it upon themselves to mandate these unapproved medical products for serial use on RI student athletes.
There are many procedure violations from guiding bodies of the FDA and CDC.
1) The essential elements of informed consent as defined by the FDA, include voluntary participation.
A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (21 CFR 50.25(a)(8).)
In summary: coercing parents to sign consent forms on threat of exclusion is not voluntary.
2) There is a clear violation of the defined Emergency Use Authorization of BinaxNow Antigen testing. It is only approved for use in symptomatic individuals. (https://www.fda.gov/media/141570/download)
3) There are specific guidelines released by the CDC for antigen testing; none of which are being applied to the testing occurring in the school or athletic setting.
I join with Rhode Island parents in respectfully urging you to end the policy of exclusionary mandatory asymptomatic testing in our schools. Thank you.