The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the COVID-19 pandemic affects a number of research obligations under the Common Rule. Importantly, OHRP also indicated that the FDA’s Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic is consistent with the Common Rule, even though FDA’s regulations of human subjects research are not identical to those under the Common Rule.
The OHRP guidance serves as a reminder that certain public health surveillance activities are explicitly excluded from the Common Rule. As such, if a public health authority authorizes general screening for COVID-19 for public health surveillance purposes and requests that test results be shared with a public health authority, Institutional Review Board (IRB) review and approval would not be required for investigators to incorporate into an existing research study general COVID-19 screening for public health surveillance purposes (i.e., for public health authorities to identify, monitor, assess, or investigate the outbreak).
Furthermore, OHRP indicates that informed consent document language will not prevent investigators or institutions from reporting COVID-19 test results to a public health authority when required by law. Even the existence of a Certificate of Confidentiality pursuant to 42 U.S.C. § 241(d)—which will typically prevent the disclosure of a subject’s name or information in legal or administrative proceedings or in response to a subpoena or court order—does not alter an investigator’s responsibility to disclose COVID-19 test results to a public health authority when required by federal, state, or local laws. If required to report, however, the investigator should inform the participant that the results will be reported.
The OHRP guidance also clarifies that:
- Actions taken for public health or clinical purposes and not for research purposes, are not research procedures and therefore do not require IRB approval before being implemented.
- Investigators may implement changes to approved research before IRB review and approval if the changes are necessary to eliminate apparent immediate hazards to the subject.
- Investigators may submit any proposed changes to previously approved research to the IRB at any time and the IRB may use an expedited review procedure to approve minor changes.
- Only IRB-imposed suspensions or terminations of approved research are required to be reported to OHRP, and not voluntary suspensions or terminations of studies by an investigator or institution.
OHRP also mentioned that its “Effects of Disasters on Human Research Protections Programs Guidance” from May 14, 2018, may also apply to the COVID-19 pandemic. In that guidance, OHRP suggested that an investigator or IRB affected by a disaster may rely on a qualified investigator or IRB for ongoing research conduct and oversight if it would be in the best interest of the subjects. OHRP also indicated in the 2018 guidance that it will take into account the situations institutions are experiencing in emergency circumstances and will use available flexibility in its decision making. OHRP reiterated this in the guidance issued this week, stating that it will be flexible in its decisions, taking into account the specific circumstances affecting institutions and investigators as they take actions during the COVID-19 pandemic to protect public health, while also appropriately protecting research subjects.