On April 8, 2020 the USA’s Office of Human Research Protections (OHRP) released a guidance on  Human Subject Protection Regulations included under regulation 45 CRF part 46, which applies to COVID-19 response. 

Public Health and Clinical Activities:

Actions taken for public health or clinical purposes, and not for research purpose.


 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.

Excluded Public Health Surveillance Activities:

Some types of excluded public health surveillance activities, including collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.


 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.

Legally Required Reporting:

 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).


If a research subject tests positive for COVID-19, an investigator may provide this test result to a public health authority if required to do so under applicable state or federal law. In such circumstances, investigators should inform the participant of the required reporting of results.

Research Changes to Eliminate Apparent Immediate Hazards: 

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.


The OHRP expects that investigators are cancelling or postponing non-essential study visits or conducting phone visits instead of in-person visits to reduce COVID-19 transmission risks. In these situations, 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.

Proposing and Reviewing Study Changes: 

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.

Whether Suspensions of Research Must be Reported: 

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.

OHRP Recommended Guidances:

The OHRP concludes the the following guidances are consistent with HHS Human Subjects Protection regulation 45 CFR PArt 46. 

About Global Regulatory Partners:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.

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