Office of Research, UC Riverside
Office of Research Integrity

Additional Guidance for Restarting Human Subject Research (HSR) at UCR

Revised July 30, 2020

The information provided on this page is not meant to supersede the UCR Principles and Framework Guiding a Phased Approach for Ramp-Up and Ramp-Down of On-Campus Research-Related Activity. Rather, the purpose is to provide additional guidance for the range of research involving human subjects from behavioral studies to clinical trials, in order to protect the health and safety of researchers, research participants, and students. The plan incorporates both CDC recommendations and UCR’s EHS guidance. Understanding that a one-size fits-all set of guidelines may not capture the risks and benefits across all types of human subjects research, individual colleges, departments, and laboratories may need to tailor their plans for mitigating risk to fit the specific circumstances and scope of their research activities. Since human subjects and clinical research may be conducted off-campus or within affiliated sites, research teams should also be familiar with and follow the guidelines, procedures and timelines developed by those entities. As new information about COVID-19 becomes available and its prevalence within our environment changes, these guidelines will be periodically re-evaluated and adjusted, and researchers may need to modify their safety plans.

  1. All researchers performing activities on or off campus that involve interactions (whether with study participants or other study staff) are required to complete the following:
  2. This web page provides guidance on the minimum required strategies for mitigating risk for each level of COVID-19 exposure risk. Some situations may require additional mitigation strategies (such as COVID-19 testing and temperature checks), which should be assessed by the principal investigator and members or the research team. Please review the 4 UCR phases for which activities are allowed in each phase.
  3. For studies involving participants or research staff with elevated risk for COVID-19, additional safeguards should be considered. Based on current CDC guidelines, elevated risk is defined as all persons age 65 or older, or persons of any age with a medical condition including lung disease or moderate-severe asthma, serious heart condition, immune system compromise, obesity (BMI < 39), diabetes, or chronic kidney or liver disease.
  4. Whenever possible, research involving human subjects should be conducted using methods that remove or diminish contact between researchers and participants (such as online surveys, telephone or audio-video conferencing, mail surveys, data analysis, either secondary use projects or data analysis activities on other projects).
  5. Researchers should determine the highest potential level of COVID-19 exposure risk for both research personnel and participants and implement mitigation strategies.
  6. Some studies may require more than one research participant to be present in the study area at a given time. For participants who reside together (e.g., a parent accompanying a child or spouses), no additional precautions are necessary. For participants who do not reside together, physical distancing at a minimum of 6 ft (2m) between participants must be strictly maintained, and participants must wear a face covering at all times (over both their mouth and nose).
  7. Studies requiring more than one research visit must use mitigation strategies that are appropriate to each visit. For example, the requirements for behavioral testing may be different than a visit for blood draws and/or MRI.
  8. Adequate physical distancing (minimum 6 ft or 2 m) between all participants and research personnel is to be maintained unless person-to-person contact allowed in the current phase. Plans for maintaining social distancing should consider additional factors, such as how participants will travel to and from the research setting, ingress/egress from the laboratory and building (aka flow), use of waiting areas, and scheduling additional time between visits to allow for the required disinfecting of spaces.
  9. All research staff should review the CDC guidance on handwashing and the use of hand sanitizer. Researchers must wash their hands before/after each research visit, and immediately before/after any direct physical contact with a research participant.
  10. All research staff should self-screen daily using the UCR COVID-19 screening tool available on the EHS website. All faculty, staff or students who are experiencing COVID-19 symptoms or have been exposed to individuals with COVID-19 must refrain from engaging in face-to-face human research. Please call this UCR Employee COVID-19 hotline.
  11. Participants must be fully informed of the COVID-19 risks and the mitigation strategies that will be employed during the study. Use of the screening questions for screening purpose only (not research) does not require separate IRB review or approval. Researchers need to document that each participant has indicated that they understand the information and accept the risk.
  12. Community-based studies or studies that take place at affiliated facilities should follow these same UCR guidelines with the addition of any guidance and/or rules imposed by the community partners and/or other facilities.