OHRP Guidance on on COVID-19 for IRB protocol applications
The Office for Human Research Protections (OHRP) recently issued “OHRP Guidance on COVID-19” to respond to questions OHRP received from the research community regarding how the human subjects protection regulations (45 CFR part 46) apply to actions taken by institutions and investigators in response to the COVID-19 outbreak.
The OHRP also wants to reassure the research community that OHRP will take into account the specific circumstances that institutions and investigators are experiencing, and will use available flexibility in its decision making as institutions and investigators implement actions necessary to protect public health, while still appropriately protecting research subjects.
The guidance document can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html.
UMBC has stated in its Research Maintenance Mode directive, the use of social distancing and the use of telephone/videoconferencing must be followed in place of in-person interactions. The OHRP encourages the use of such measures as well.
Human subject's use research conducted on our campus usually does not involve public health surveillance or reporting individual's COVID-19 test results to a public health authority. These would not be of concern with human subjects use protocols currently approve by the IRB. The ORPC has already informed the campus community that the use of use telephone or virtual/online formats, such as WebEx, may be substituted for in-person study activities. The OHRP guidance makes reference to submitting proposed changes to previously approved research to the IRB at any time. If at any time investigators must make a change, please follow the IRBs protocol modification submission process.
Posted: April 20, 2020, 3:35 PM