Current Status on Research at Harvard University

In an effort to minimize the risk of contracting or spreading COVID-19 in human participant research interactions, Harvard Schools and Departments are requiring that human subjects research involving direct interaction with study subjects AT HARVARD UNIVERSITY be paused until further notice and that no study subjects should travel to Harvard University. Please see the Questions About Covid-19 menu for more information.

Why must some human participant research studies be paused?

Given the current COVID-19 coronavirus outbreak, the need to prioritize the real or perceived risk of exposure and the risk/benefit ratio for in-person contact associated with research activities must be assessed for each protocol. Ethical principles of research and federal regulations for the protection of human research participants require an acceptable risk/benefit ratio.

Which studies should be paused?

• ​​Studies involving face-to-face interaction with participants at Harvard University with NO direct therapeutic benefit or those studies where stopping procedures would NOT cause harm to the study subject. To the extent possible, study activities that can be done remotely by telephone or electronically, such as screening or follow-up, should be done in this way. If you choose to modify your study, submit a modification to the IRB. We will be prioritizing modifications that pertain to COVID-19 (see “Submitting a Modification” below).
• Those studies taking place at other locations should follow any guidelines or instructions from the specific facility where study subject interaction would occur. As some research may occur in another state, with another institution, or under the direction of another IRB (as in a reliance agreement situation), this is especially important.

Pausing a study (as long as it does not have adverse effects on study subjects) does not need to be reported to the HUA IRB.

What about new studies that involve face-to-face contact - will these studies be approved by the IRB?

As many locations, nationally and internationally, have placed restrictions on face-to-face interactions with individuals, it is the responsibility of the Study Team to keep apprised and conduct their study accordingly. Should further restrictions be imposed at any time, the study team is required to follow the above guidance regarding when to pause a study, impose immediate modifications (which offer direct therapeutic benefit to participants or those studies where stopping procedures would cause harm to the study subject), or to submit a modification to the IRB.