Instructions for Returning to In-Person Human Subjects Research

Beginning March 2020, most in-person human subjects research was paused due to increased risks associated with the COVID-19 pandemic. Some of these studies were able to continue by converting to “remote” procedures.

The resumption of paused human subjects research will occur in phases that will typically be linked to the phases guiding the University’s resumption of research more generally. These phases may be more conservative than many researchers might prefer, because (1) research participants are volunteers; (2) many studies do not provide direct benefit to individual participants; and (3) it is difficult to ascertain risks due to COVID-19 at a location because there are so many unknowns.

It is important to note that human subjects research may need to return to an earlier, more restricted phase if warranted by epidemiological and healthcare utilization data.

To the extent possible, studies involving human subjects should continue to be done remotely. Research resumption involving interactions with human subjects must consider the risk to the subjects and the subjects’ community, as well as that to the researcher and to the campus. Resumption plans should include social distancing in research space and buildings, as well as cleaning protocols for any instrumentation, computers, etc. that are contacted by research subjects. Potential issues associated with subjects’ transportation should also be addressed.

  1. Review the Harvard University Research Laboratory Re-Entry Plan found here - 

  2. Follow the Harvard University Guidance for Human Subjects Research

  3. Review the Phases for Resumption of Human Subjects Research from your School/Department to identify the current phase and what type of research involving direct contact with study subjects is currently allowed. Attention FAS-Sciences / SEAS researchers, please see FAS / SEAS Phases for the Resumption of Research  

IMPORTANT! For multi-institutional collaborations, the guidelines of the institution where the research is being conducted are to be followed. Resumption of field research either locally, nationally or internationally will be determined on a case by case basis. 

4.  Connect with your School/Department regarding their process to request approval for resumption of your direct contact human subjects research. The principal investigator (PI) of a research program/study will be required to craft a plan to resume these types       of human subjects research activities. The plans will be subject to institutional review. No new work can begin until a lab’s plan or research study receives approval from the School/Department. 

  • A suggested approach is that the PI should submit the following: 

    • Human Subjects Research Resumption Form (see document on this site) 

    • Two attachment documents outlining Standard Operating Procedures (SOP’s, see templates and examples on this site) by: 1) Location, and 2) Specific Experimental Methods.  

  • The following templates have been created for Researchers to use (found on this site): 

    • Template_Human Subjects Research Resumption Form – a form completed by the Researcher to provide the necessary information for a School/Department to review during the approval process for the resumption of direct contact research activities. 

    • Template_Location SOP – to help in the development of an SOP to outline mitigation strategies according to the location of the research.  

    • Template_Specific Experimental Method SOP - to help in the development of an SOP to outline mitigation strategies according to the Specific Experimental Methods.    

    • Template_COVID19_Information Sheet For Participants – to provide pertinent information to study subjects regarding risks of COVID-19 and precautions being taken at the study site. 

    • Template_Screening Procedures for Human Subjects – a brief screening to use with study subjects prior to each study visit. 

  • The following example SOP’s according to Location have been developed: 

    • Center for Brain Sciences – Neuroimaging 

    • Motion Capture Lab 

    • Outdoor Human Subjects Testing 

    • Skeletal Biology and Biomechanics Labs 

  • The following example SOP’s according to Specific Experimental Methods have been developed: 

    • Blood Sampling 

    • Canine MRI 

    • Computer Based Experiments 

    • EEG 

    • Electromyography (EMG) 

    • Motion Capture Methods 

    • Respirometry 

    • Transcranial Magnetic Stimulation (TMS) 

    • Ultrasound Imaging 

    • Wearables  

5. Seek approval from your School and/or Department.

  • The following template has been created for Schools/Departments to use (found on this site): 

    • Template_School-Dept Checklist for Reviewing Human Subjects Research Resumption – to aid in the review of resumption of direct contact human subjects research requests. 

6. Ensure that you have current IRB approval prior to involvement of human subjects.