COVID-19 and Human Subjects Research Activities - Updated June 7, 2022
This webpage provides guidance to the Brown University research community and aligns with University policies as they apply to human subjects research activities.
Refer to the Healthy Brown website for Brown’s response to COVID-19 (which includes information for visitors, travel policies, and FAQs).
Brown's MRI Research Facility (MRF):
If approved research requires use of the MRI, Brown will provide disposable surgical-type masks to research participants undergoing the MRI. Please see below for PREP Act language that must be included in consent documents when a study participant will be entering the MRI as part of a research procedure. The MRF will revisit the requirement for participants to wear a mask in the scanner in the coming weeks as they continue to monitor COVID-19 rates in Rhode Island.
- The MRF retains the authority to decide the spacing between scans and to determine appropriate masking requirements in accordance with Brown Policy.
Public Readiness and Emergency Preparedness (PREP) Act Declaration
The Secretary of HHS issued a Public Readiness and Emergency Preparedness (PREP) Act Declaration for certain COVID-19 countermeasures on March 10, 2020. In August and September 2020, the FDA and HHS released expanded guidance, allowing Brown to refine the applicability of the COVID-19 countermeasures covered by the Declaration and update the required consent language.
When does the PREP Act not apply?: Brown requires that all participants wear an appropriate face covering to protect themselves and those around them when they come to campus. If a participant visits without a face covering or the face covering does not meet Brown requirements, the University will provide them with a face covering.
When does the PREP Act apply?: The PREP Act only applies to Brown research protocols which specifically provide covered countermeasures (i.e. face masks, face shields, gowns) to participants as part of an approved research procedure, instead of allowing participants to use a face mask they may have for personal use. For example, due to the safety protocols at the MRI Research Facility (MRF), participants asked to use the MRI as a research procedure, are required to wear a face mask provided by the MRF that is safe to use in the MRI.
Consent Form Language for COVID-19 Countermeasures
Human subjects protection regulations require that participants be informed if any of their legal rights are affected, and what recourse is available. To comply with this, Brown University requires that the following additional statement be included in study consent documents.
**As a note, this additional language is unique to COVID-19 countermeasures and does not replace the risks of study procedures that must be included in order for participants to make an informed decision about study participation.
"Due to the coronavirus public health emergency, the U.S. government issued a Declaration under the Public Readiness and Emergency Preparedness (PREP) Act. This Declaration may apply to this study if it involves procedures or other actions that are related to or in response to coronavirus. If it applies, this Declaration limits your right to sue the researchers, healthcare providers, study sponsors, manufacturers, distributors, and potentially others that are involved with this study. However, the U.S. government has a program that may provide compensation to you or your family if you experience serious physical injuries or death related to procedures or other actions taken in this study. To find out more about the 'Countermeasures Injury Compensation Program,' please visit https://www.hrsa.gov/cicp."