The Office for Human Research Protections (OHRP) has released guidance regarding how the Common Rule regulations should be applied in response to the COVID-19 outbreak. Given the current circumstances, “the research community is encouraged to prioritize public health and safety.”
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 April 8, 2020 guidance on specific activities includes:
- 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.
- Example: if a hospital implements mandatory clinical screening procedures related to COVID-19 for all people who come to that institution, including research subjects, these screening procedures do not need to be reviewed by an IRB before they may be implemented. As these activities are not research procedures, the hospital does not need IRB review in order to share the screening results with a public health authority or the research subjects, although other permissions or notice may be necessary under applicable law or policy.
- Some types of public health surveillance activities, including collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority, are explicitly excluded from the Revised 2018 Common Rule (45 CFR 46.102(l)(2)). However, FDA regulations may apply if this involves use of an investigational in vitro diagnostic device.
- Example:If a public health authority authorizes general screening for COVID-19 for public health surveillance purposes, and requests that test results be shared as necessary with a public health authority to allow the public health authority to identify, monitor, assess or investigate the COVID-19 outbreak, an investigator may incorporate these activities into an existing research study visit without prior IRB review and approval.
- 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). The existence of a Certificate of Confidentiality (CoC) does not alter an investigator’s ability to disclose a research subject’s COVID-19 test results when required by federal, state, or local laws. In such circumstances, investigators should inform the participant of the required reporting of results.
- Investigators may implement changes to approved research prior to IRB review and approval, if the changes are necessary to eliminate apparent immediate hazards to the subject (45 CFR 46.108(a)(3)(iii).
- Example: investigators may cancel or postpone non-essential study visits or conduct phone visits instead of in-person visits to reduce COVID-19 transmission risks. Investigators may make such changes to the research to reduce risks without prior IRB approval, but they should report those changes to the IRB when possible.
- Investigators may submit any proposed changes to previously approved research to the IRB at any time. The IRB may use an expedited review procedure to review and approve those changes if the changes are minor (45 CFR 46.110(b)(1)(ii).
- Only IRB suspensions or terminations of approved research are required to 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.
Additionally, OHRP stated that the FDA Guidance on the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic (https://www.hhs.gov/ohrp/sites/default/files/fda-covid-guidance-2apr2020.pdf – PDF), is consistent with the HHS human subjects protection regulations at 45 CFR part 46, even if the research is not also regulated by FDA.
An additional guidance also may be applicable to the current state of affairs: “Effects of Disasters on Human Research Protections Programs.” This guidance indicates that OHRP will take into account the situations institutions are experiencing in emergency circumstances such as the COVID-19 outbreak, and will use flexibility in its decision making (See https://www.hhs.gov/ohrp/regulations-and-policy/guidance/effects-of-disasters-on-human-research-protections-programs-guidance/index.html ).
OHRP Guidance on COVID-19 (issued April 8, 2020)