On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations (45 CFR part 46) apply to actions taken by institutions and investigators in response to the COVID-19 pandemic. OHRP emphasizes that it will consider the specific circumstances that institutions/investigators are experiencing during the pandemic and will take into account when actions are necessary to protect public health, while still appropriately protecting research subjects. OHRP also emphasizes that it will exercise flexibility in its decision making. The new guidance contains critical updates related to the privacy of COVID-19 test results, IRB approval for study changes, and reporting standards for the suspension or termination of research.
Notably, the new OHRP guidance is in many ways consistent with – and expands upon – the guidance the Food and Drug Administration (FDA) issued on March 18, 2020 (see FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic). As discussed in our previous client alert, the recent FDA guidance provided general advice to assist sponsors, investigators, and institutional review boards (IRBs) in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during the COVID-19 pandemic.
The key provisions of the new OHRP guidance are as follows:
Privacy of COVID-19 test results. When required by law to provide information related to an individual's COVID-19 test results to a public health authority – including individually identifiable information about individuals who are research subjects – the HHS protection of human subjects regulations do not prevent investigators or institutions from fulfilling this requirement (even if doing so would be inconsistent with statements made in the study's consent form).
IRB approval for pandemic-related actions. Actions taken for public health or clinical purposes, and not for research purposes – such as mandatory hospital-wide clinical screening procedures related to COVID-19 – do not require IRB approval prior to implementation. The guidance specifies that some types of public health surveillance activities are explicitly excluded from the Revised Common Rule (45 CFR 46.102(l)(2)); however, FDA regulations may apply if such activities involve the use of an investigational in vitro diagnostic device (IVD). In addition, changes to approved research may be implemented prior to IRB review and approval if the changes are necessary to eliminate apparent immediate hazards to the subject. This may include cancelling or postponing non-essential study visits, or conducting phone visits instead of in-person visits to reduce COVID-19 transmission risks.
Expedited IRB review. IRBs may use an expedited review procedure to review and approve changes to previously approved research if the changes are “minor,” pursuant to 45 CFR 46.110(b)(1)(ii) under the 2018 Requirements and 45 CFR 46.110(b)(2) under the pre-2018 Requirements.
Reporting of suspensions. Only IRB suspensions or terminations of approved research must be reported to OHRP. If an investigator or an institutional official suspends or terminates approved research, such actions are not required to be reported to OHRP under 45 CFR 46.113.
The guidance notes that OHRP's May 2018 guidance "Effects of Disasters on Human Research Protections Programs" may also be applicable to the current circumstances. The May 2018 guidance states that OHRP will consider the emergency circumstances that institutions are experiencing when making decisions.