On April 8, the Office for Human Research Protections (OHRP) released guidance on human subject protections matters related to COVID-19. The guidance should be viewed as recommendations rather than binding requirements. The OHRP encourages researchers to prioritize public health and safety and indicates that it permits flexibility as needed to achieve such goals in the research setting.

In the guidance, the OHRP clarifies that actions taken for public health or clinical purposes are not considered research even where conducted on research subjects. Further, OHRP regulations will not prevent reporting of a research subject’s COVID-19 test results when such reporting is required by federal, state or local laws. OHRP reiterates existing regulations and prior guidance that are particularly relevant during this crisis. Specifically, investigators may implement changes to research protocols prior to review and approval by an institutional review board (IRB) where such changes are necessary to eliminate immediate hazards to research subjects. Proposed changes for previously approved research may be submitted to IRBs at any time, and such IRB review may occur through an expedited procedure.

The OHRP’s guidance is consistent with the U.S. Food and Drug Administration’s (FDA) March 18 Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic. In its guidance, the FDA recognizes that potentially unavoidable deviations from trial protocols may be necessary to maintain the safety of study participants and providers, and has provided recommendations on how to implement such deviations while minimizing risks to trial integrity. For on-going trials, the FDA has stressed that ensuring the safety of subjects is of paramount importance. The FDA asked sponsors to consider whether to continue trial recruitment or the use of the investigational drug or device and whether the use of virtual visits, remote monitoring or other distance alternatives could be safely adopted. If it is determined that changes to protocol or an investigational plan are necessary to protect the safety of research participants, these changes may be implemented without IRB approval or before filing an amendment to the IND or IDE. However, IRB submission is required as soon as possible after implementation.

Sponsors and clinical investigators should document how restrictions related to COVID-19 led to the changes in study conduct, note the duration of those changes, and indicate which, and how, subjects were impacted. The FDA recommends capturing subject-specific information in the case report form explaining the basis of the missing data, including the relationship to COVID-19.

Generally, the FDA recommends that sponsors, clinical investigators and IRBs establish or revise policies and procedures to describe approaches used to protect participants and manage study conduct during possible disruption of the study as a result of COVID-19 control measures at study sites. If COVID-19 screening procedures are mandated by the healthcare system where the clinical trial is being conducted, these screenings (even if performed during study visits) do not need to be reported as an amendment to the protocol unless the sponsor is incorporating the data collected as part of a new research objective.

OHRP: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html

FDA: https://www.fda.gov/media/136238/download

Authorship Credit: Payal Cramer and Kyle Gregory