Additional Consent Language for COVID-19 Research
March 31, 2020
On March 17, the US Secretary of Health and Human Services issued a declaration to provide liability immunity for activities related to medical countermeasures against COVID-19. As a result, potential research subjects need to be informed that their rights to sue may be restricted when they agree to participate in COVID-19 research projects.
DF/HCC researchers who propose new research related to COVID-19 must ensure that this information is added to the informed consent document using the language below:
Due to the coronavirus public health crisis, the federal government has issued an order that may limit your right to sue if you are injured or harmed while participating in this COVID-19 clinical study. If the order applies, it limits your right to sue the researchers, healthcare providers, any study sponsor or manufacturer or distributor involved with the study. However, the federal government has a program that may provide compensation to you or your family if you experience serious physical injuries or death. To find out more about this “Countermeasures Injury Compensation Program” go to https://www.hrsa.gov/cicp/about/index.html or call 1-855-266-2427.
For more information on the declaration, please see: https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures