Determining when to report COVID-19 activities to the Investigational Review Board (IRB) can be a challenge.
The Office for Human Research Protection (OHRP) recently released guidance to answer how the Health and Human Services human subjects protection regulations (45 CFR 46) apply to actions taken by institutions and investigators in response to the Coronavirus (COVID-19) pandemic.
Here are a few common questions to consider.
Do We Need Approval For COVID-19 Screening?
Actions taken for public health and clinical purposes (not research purposes) and actions that are not research procedures do not require institutional review board (IRB) review and approval prior to implementation.
For example, if a hospital implements mandatory COVID-19 screening procedures for everyone who comes to that institution (possibly including research participants), these screening procedures do not need to be reviewed by the IRB before implementation. In addition, since these activities are not research procedures, the hospital does not need IRB approval to share the screening results with a public health authority or directly with the research participants.
Some types of public health surveillance activities are explicitly excluded from the Revised Common Rule, such as the collection and testing of information or biospecimens conducted, supported, requested, ordered, required, or authorized by a public health authority. For example, if a general COVID-19 screening for public health surveillance purposes is authorized and a public health authority requests test results to help map the COVID-19 outbreak, these activities can be incorporated into an existing research study visit without prior IRB review and approval.
Can We Share COVID-19 Test Results With Health Officials?
When investigators or institutions are required by law to provide COVID-19 related information to a public health authority, human subjects protection regulations would not prevent them from doing so.
For example, if a research participant tests positive for COVID-19, an investigator may provide the test results to the public health authority in accordance with the applicable state and/or federal laws without requiring IRB approval.
Should We Report Changes Made To Protect Patients?
Investigators may implement changes to the approved research prior to IRB review and approval if the changes are necessary to eliminate apparent immediate hazards to the research participant. It is recommended that these changes are reported to the IRB when possible. For example, it is expected that most investigators will or have already cancelled or postponed non-essential study visits, and as a result, they are conducting phone or web visits instead.
Do We Need To Report Suspended Research Activities?
Should the IRB suspend or terminate the approved research study, it is required that such actions are reported to OHRP. Conversely, if an investigator or an institutional official suspends or terminates the approved research study, such actions are not required to be reported to OHRP.
What Other Study Changes Require IRB Approval?
If not outlined above, it is recommended that investigators submit any proposed changes to the IRB. The IRB may use an expedited review process if the changes are minor in nature.
These examples provided from OHRP were meant to help sites determine when COVID-19 activities should be reported to the IRB. Institutions and investigators are encouraged to contact OHRP if they have any additional questions regarding the actions being taken or planned in response to the current circumstances.
Navigating clinical trial activities right now can be a challenge for investigators, institutions, and sponsors everywhere. For more tips to get it right during the pandemic, download this short guide, 5 Ways to Maintain Clinical Study Compliance During COVID-19.
What types of activities has your facility implemented during the COVID-19 pandemic? Have you considered whether they should be reported to the IRB?