COVID-19 FAQs Relating to Human Subjects Research

This webpage provides important information reflecting our current guidance and best practice recommendations for responding to changes and disruptions to human research as a result of the COVID-19 pandemic. We will continue to update this page with relevant information as it becomes available.

The following FAQs are organized topically; however, please be advised to read them in their entirety to ensure you receive the most up to date and complete information.

GUIDANCE FOR REQUESTING IN-PERSON CONDUCT OF RESEARCH  – Updated 6/30/21
REMOTE RESEARCH TECHNOLOGY
RESEARCH-RELATED TRAVEL
REQUESTING PRIORITY IRB REVIEW FOR COVID-19 RESEARCH
HOW YOUR RESEARCH STUDIES/ACTIVITIES MAY BE IMPACTED
CONSIDERATIONS FOR CEDED RESEARCH
ADDITIONAL RESOURCES/TIPS FOR INVESTIGATORS


GUIDANCE FOR REQUESTING IN-PERSON CONDUCT OF RESEARCH
Q. How do I request resumption of in-person human research activity?
A. To the extent possible, human research activities should continue to be done remotely; however, the University’s reopening plan does allow for the resumption of in-person human research activities to occur with additional review and approval. This process requires that the principal investigator (PI) develop a plan that includes the justification for the resumption and the COVID-19 precautions that would be in place. These plans are subject to School/Department review and approval. No in-person research may begin until a plan receives School/Department approval. To request in-person conduct of human research, contact your department-assigned IRB Review Specialist or Leslie Howes at lhowes@hsph.harvard.edu to obtain further instruction.

Q. How should I screen participants to account for COVID-19 ?
A. 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 to follow.

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
☐ New fatigue
☐ Muscle or body aches
☐ New headache
☐ New loss of taste or smell
☐ Sore throat
☐ New nasal congestion or new runny nose (not related to seasonal allergies)
☐ Nausea or vomiting
☐ Diarrhea
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)

☐ Yes
☐ No

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.

REMOTE RESEARCH TECHNOLOGY
Q. What technologies can I use to conduct my research remotely?
A. Researchers need to ensure that any technologies used to conduct research remotely are vetted and approved by Harvard Information Security. A full list of vetted technologies can be found here. The use of Harvard Zoom is approved up to Data Security Level 3. Additional guidance can be found here on how to apply additional security features in Zoom (e.g. turning off meeting recordings, authenticating users, setting meeting passwords). For questions about specific technology options, contact your Harvard School-Specific Information Security Officer. Please note that any change in technologies used for research may impact the study’s Data Security Level.

RESEARCH-RELATED TRAVEL
Q. Can I travel to conduct my research?
A. 
Per Harvard University guidance, all University-related travel, both international and domestic, is prohibited until further notice and should not be planned or scheduled at this time. Harvard University also strongly discourages personal travel, both international and domestic. The Office of the Vice Provost for International Affairs (OVPIA) has established a petition process for travel directly and immediately related to the COVID-19 pandemic or that enables critical research activity. However, they expect these exceptions to be rare. Further details on the petition process can be found here.

REQUESTING PRIORITY IRB REVIEW FOR COVID-19 RESEARCH
Q. Can I request Priority IRB review for new coronavirus research or modifications to existing protocols due to COVID-19?
A. Yes. In order for the IRB to prioritize the review of COVID-19 research or changes to existing research because of the virus, include a comment within the ESTR record that explains that this is an urgent COVID-19-related research study.
Some Harvard researchers have already started conducting novel coronavirus research or have made changes to existing research due to the virus. We expect that many more studies will be developed. If such research needs to consider exposures, we recommend consultation with the Committee on Microbiological Safety before crafting your protocol.

HOW YOUR RESEARCH STUDIES/ACTIVITIES MAY BE IMPACTED
Q. What should I do if I decide to temporarily suspend/pause study activities, e.g., enrollment, study procedures, etc.
A. If the Principal Investigator decides to voluntarily suspend/pause study activities, s/he should submit as Reportable New Information (RNI) in ESTR within 5 business days of the suspension. If submitting a COVID-19 related RNI, please include “COVID-19” somewhere in the title of the RNI submission.

Q. Do I need to report to the IRB if a participant or member of the study staff tests positive for COVID-19 and/or is hospitalized or dies as a result?
A. No. Unless the hospitalization or death is determined by the site investigator or PI to be unexpected, i.e., not identified as a risk to participants as described in the protocol and/or consent form, and possibly related to the research, e.g., the participant/study staff member was known to be exposed through their participation/involvement in the study.

CONSIDERATIONS FOR CEDED PROTOCOLS
Q. I am pausing recruitment and/or study procedures on a project reviewed by an external IRB of Record (i.e., the IRB of Record is not the Harvard Longwood Campus (HSPH/HMS) IRB, should I notify that IRB?
A.
 It depends. You should follow the requirements of the IRB that oversees your research regarding reporting changes and whether any review/approval will be needed prior to resumption of study procedures.

ADDITIONAL RESOURCES/TIPS
Q. What additional resources exist?
A.
Many resources have been developed and continue to be updated regularly. Here are some that exist to support the research community at Harvard:

• Harvard University: https://www.harvard.edu/coronavirus
• Harvard University Office of the Vice Provost for Research – COVID 19 and Research Operations: https://vpr.harvard.edu/node/1132734
• Harvard Chan School: https://www.hsph.harvard.edu/communications/covid-19-information-harvard-chan/
• NIH Guidance: https://grants.nih.gov/grants/natural_disasters/corona-virus.htm
• FDA Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic
• PRIM&R: https://blog.primr.org/covid-19-and-coronavirus-updates-for-the-oversight-community/
• For guidance on working remotely, refer to Harvard University Information Technology’s website on working remotely
Research Data Safety Resources
• Additionally, general guidance may be sought from WHO and CDC websites.

Q. How do I locate/identify other researchers conducting COVID-19 research with whom I may want to collaborate?
A. Many hubs and platforms exist online that aim to centralize collaborative research efforts, connect researchers, and reduce duplicative studies. A few that may be useful include the COVID-19 Collaboration Platform, Elsevier’s COVID-19 Research Collaborations, ClinicalTrials.gov COVID-19 Clinical Trials List, and the Center for Leading Innovation and Collaboration (CLIC) COVID-19 website. Additionally, both the Harvard Chan School and Harvard Medical School have created websites with up-to-date expert analysis from our affiliates giving insight into the COVID-19 pandemic.