Updated COVID-19 Guidance Regarding Human Subject Research (November 2020)
Governor Herbert issued a temporary statewide COVID-19 executive order on November 9, 2020. The Human Research Protections Program in consultation with BYU administration, express our concern for the safety of our research subjects and research personnel.
We remind researchers that information provided earlier this year to eliminate immediate risks of exposure to COVID-19 still apply.
If you made changes to your protocol to move research procedures online, you will continue to use these methods.
If you find that it is difficult to adhere to COVID-19 safety precautions for in-person research procedures, please pause research activities. Report any safety issues or issues that may impact your ability to safely continue your research to the IRB as a modification to your research study in iRIS.
All changes to the research protocol still need to be reviewed and approved by the IRB except for the incorporation of screening and changes necessary to eliminate immediate risk of exposure to COVID-19. Changes implemented to eliminate these risks should be promptly reported to the appropriate IRB as a modification to update your research.
The principal investigator (PI) is responsible to review research procedures and any need for immediate action to protect the safety and wellbeing of the subjects.
Develop Contingency Plans:
Investigators should proactively prepare contingency plans for their research. Investigators are required to submit a modification of these changes and obtain IRB approval prior to implementation. Consider whether disruption of a research protocol will impact the safety of your research subjects, and how you can manage that disruption:
- Consider Pausing Study Procedures: For studies where appropriate, individual investigators may choose to temporarily pause enrollment. PIs need to assess whether any reduction in research personnel makes it unsafe to complete the planned research procedures. Even routine research interventions might not be easy or safe if experienced personnel are not available.
- Timely review of research data – If research personnel are not available, integration of research care such as reviewing lab results or monitoring data in a timely manner might not be possible and will require special attention under the direction of the study PI. Investigators should consider the availability of appropriate back-ups to the PI to make safety assessments.
- Utilization of alternate visit options: Include telephone or zoom visits for subjects who are unable or unwilling to come to on-site visits.
- Home visits: Some essential research visits may require blood draws or simple measurements like BP and BMI assessments that could be accomplished with a home visit. Before moving to home visits, research teams need to consider: can the activity be done safely in the home, as PI do you acknowledge that the research personnel doing the home visits have been appropriately trained, does the research personnel have any health conditions or current symptoms related to the coronavirus, and does the research subject or other individuals in the home have symptoms that would indicate a high risk of coronavirus transmission.
Please refer to the following sources for additional information:
BYU The University’s latest updates
OHRP Guidance on Coronavirus
NIH Guidance for Funded Clinical Trials
Utah Latest Updates from the Governor
Human Subject Administrative Support
In response to the current Coronavirus circumstances, the Human Research Protections Program (HRPP) at BYU, in consultation with campus administration, has produced the following guidance for investigators conducting research with human participants.
With the adoption of the iRIS system and videoconferencing capabilities, the Institutional Review Board (IRB) will continue to process applications and conduct review processes on campus or remotely as needed. This includes full-board IRB reviews. All deadlines related to the submission and expiration of protocols remain in effect.
Using Ethical Principles to Assess Current Risks
Given the real or perceived risk of exposure to COVID-19, the risk/benefit ratio for research participation must be reassessed by each PI. Ethical principles of research and federal regulations require an acceptable risk/benefit ratio [(45 CFR 46.111(a)(1-2)]. All researchers should develop plans for continued data collection, communication and data management to protect themselves and their participants from COVID-19. Face-to-face studies for which there is little to no prospect for direct benefit to participants may need to pause data collection until such a plan is in place.
Regulations require researchers to ensure prompt reporting to the IRB of proposed changes in research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject (45 CFR 46.108(3)(iii). Therefore, changes from face-to-face to remote data collection may be implemented immediately without IRB approval. All other prospective changes must be submitted, reviewed and approved by the IRB. Please submit a modification form in iRIS.
Researchers engaging in social behavioral data collection with populations at higher risk of COVID-19 or in settings that put the study team at higher risk (e.g., nursing homes, homeless shelters, schools) are responsible to create plans for ensuring that they are aware of COVID-19 cases in their data collection settings and for following recommended guidelines for reducing exposure and, if prudent, pausing the studies. Study teams need to have plans for regular communication to ensure everyone is operating under the procedures recommended by the University. Researchers should conform to the Center of Disease Control guidelines when face to face contact cannot be avoided.
If research participants will have in-person interactions with researchers or other study participants, all study teams should immediately implement procedures to screen research participants for potential infectious risk prior to any interaction and incorporate mandatory screening prior to scheduled study visits. The incorporation of this screening procedure does NOT require IRB approval.
Guidelines for reducing exposure:
- Reduce Study Visits: To the extent reasonable and appropriate, researchers should propose to replace in-person study visits with virtual study visits, using phone, email, and internet- based video technology. Please contact BYU IRB promptly for guidance on submitting protocol amendments to address proposed changes to study procedures. If you are uncertain about whether a change requires IRB approval prior to implementation, please contact the IRB office immediately.
- Consult BYU Travel: Given the University’s restrictions on travel, researchers should consult the BYU COVID-19 website (https://www.byu.edu/coronavirus) for up to date information. Currently, all domestic and international travel is suspended for employees of BYU.
- Develop a Script for Participants: Research teams should consider developing a script outlining for research participants how you are making the environment as safe as possible when they come in for their research visit.
Develop Contingency Plans:
Study teams should proactively prepare contingency plans for their active research protocols. These changes will require IRB approval prior to implementation. Consider whether disruption of a research protocol will impact the safety of your research participants, and how you can manage that disruption.
Specific examples could include:
- cancelling non-essential study visits
- conducting phone visits in lieu of in-person visits
- conducting safety screening (initiated by the Researcher) prior to in-person visits occurring
- shipping investigational products directly to research participants
- other changes as deemed appropriate to eliminate immediate hazards to subjects because of the risk of exposure to this highly communicable disease. In some cases, changes may include temporarily stopping subject recruitment or placing a temporary hold on all study procedures.
Protecting the safety of research participants and study personnel is everyone’s responsibility. Please contact the HRPP at 801-422-1461 if you have any questions.
(March 16, 2020)