June 28, 2021
As the COVID-19 pandemic continues to evolve, various Harvard restrictions and processes that were in place have now been re-visited. Moving forward, take the following into consideration when conducting research with human subjects:
- All research and on-campus activity, should still follow Harvard and local school/department guidelines. For instance, this means that personnel who have not yet been authorized to work on campus will need to check with their departments (or divisions or schools) about the appropriate process to obtain authorization prior to the August 2nd general return date.
Please continue to refer to the following resources regarding on-campus:
- Note that Harvard continues to require masks indoors, regardless of vaccination status. This guidance will be updated as Harvard requirements and local community incidence changes. Please also check local school or division for more local guidance.
- Some previous restrictions placed on human subjects research have been lifted. Currently physical distancing is no longer required for those vaccinated in all research locations. Please check with your school/division/department for any local guidelines.
- Irrespective of location, individuals interacting with human subjects are advised to continue to wear surgical masks as vaccination status of study participants cannot be assumed. Research study personnel should let participants decide if they would like to wear a mask if the study procedures allow it.
- Researchers may wish to inform their study population of the current COVID-19 status on campus, or in the study location if elsewhere, including level of community transmission of COVID-19 and COVID-19 vaccination coverage. It continues to be recommended that those that are unvaccinated and at high-risk for COVID-19 complications or immunocompromised not take part in research.
- It is recommended that researchers conduct a brief screening with study participants prior to the study visit. Sample questions may be found below.
- Other restrictions such as those involving travel and working in other locations or at other institutions are still in place. It is important for researchers to follow any guidelines or instructions from the specific facility or location where in-person research 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. It is the responsibility of the Study Team to keep apprised of potential restrictions and conduct their study accordingly.
- Researchers planning to hire professional companies (survey organization and the like) in other states or countries should do due diligence to make sure that these organizations are taking reasonable coronavirus precautions and are fully aware of local conditions and government restrictions. In particular, Harvard should not be asking these organizations to be engaging in practices that are riskier than their normal business operations.
As restrictions relax, there are still ongoing public health best practices and guidelines to pay attention to:
- Practice safe distancing, when necessary and appropriate.
- Wash or sanitize your hands often and continue respiratory etiquette.
- Perform disinfection of frequently touched objects and surfaces.
Harvard has upgraded its ventilation systems, including installing HEPA filtration units as needed, and will continue to routinely assess airflow. Should you have any questions, please check with your department administrator or building manager. For research off-campus, please be aware that a ventilated space (particularly with open windows) is safer than an unventilated one.
You may access the archive of COVID-19 research information, research restrictions and processes here - https://cuhs.harvard.edu/questions-about-covid-19-and-your-research-ARCHIVE
Sample questions for COVID-19 screening https://projects.iq.harvard.edu/files/scictr/files/crimson_clear_paperform_as_of_06072020.pdf
Q1: ARE YOU EXPERIENCING ANY OF THE FOLLOWING SYMPTOMS? (CHECK ALL THAT APPLY)
☐Fever, chills, or feeling feverish
☐ New cough (not related to chronic condition)
☐Shortness of breath or difficulty breathing
☐Muscle or body aches
☐New loss of taste or smell
☐New nasal congestion or new runny nose (not related to seasonal allergies)
☐Nausea or vomiting
If ANY of the above apply, inform the study participant that they will not be permitted to come to the study visit on that day and that they should contact their health care provider. For medical emergencies, call 911.
If NONE of the above apply, proceed to Q2
Q2: IN THE LAST 14 DAYS, HAVE YOU BEEN IN CLOSE CONTACT WITH ANYONE WHO HAS TESTED POSITIVE FOR COVID-19? (CHECK BOX)
If Yes, the study participant believes that they were exposed to a confirmed case of COVID-19, inform them that they will not be permitted to attend the study visit on that day and that they should contact their health care provider. For medical emergencies, call 911.
If No, inform study participant that they may come to the study visit. Remind them to always wear a facemask as well as any location or study specific information that they should know about.