3/16/20 | Message to Investigators Conducting Human Subjects Research from the VPR Office

Investigators conducting human subjects research:

We anticipate that human subjects research will be impacted by the COVID-19 pandemic. As part of your due diligence, please prepare for impact on normal operations. We will continue to provide updates/policy modifications specific to human subjects research as they become available.

In order to:  i) mitigate the risk for both employees and research participants, ii) ensure that providers are available to perform clinical duties, and iii) preserve personal protective equipment for clinical care, we request that you consider the following with regard to your current research projects involving direct contact with research participants.

While human subjects research is not being restricted unilaterally, all PIs must review their protocols to determine whether a pause in research activity may be warranted. We will evaluate the need for further restrictions in the coming days based on the evolving conditions.

Continuation of the following types of studies is deemed appropriate:

  • Therapeutic research wherein there are limited/no treatment alternatives
  • FDA “Treatment” or “Emergency Use” studies
  • Studies in which interruption/delay of research could cause significant harm to current research subjects

For the continuation of all other types of human subject research, the PI must obtain permission from the appropriate departmental chair or center/institute director. Determinations to continue studies must be in alignment with both the ethical principles of human subject research and the safety of employees. We strongly recommend documenting these decisions.

In making a decision to proceed with human subjects research, we recommend the following considerations.

  • Is the risk/benefit ratio for in-person contact acceptable?
  • Does the study provide direct drug or device therapeutic benefit?
  • Is any travel required of participants or employees appropriate, given current travel restrictions?
  • Can study procedures be modified to minimize in-person contact (e.g., remote data collection)?
  • If the study proceeds, what modifications are necessary to mitigate risk to human subjects and employees (note, there are currently restrictions on PPE for research).
  • Is it necessary to pursue new enrollments? Follow-up visits?
  • Note, please review the posted IRB guidance to determine how and when changes should be reported to IRB.  (Please review the COVID-19 guidance on IRB review at: http://research.uthscsa.edu/irb/COVID.pdf)
  • If you have questions or would like additional consultation in making a determination as it relates to protecting human subjects or IRB responsibilities, please contact Dr. Joseph Schmelz (schmelz@uthscsa.edu) or Dr. Kimberly Summers (summers@uthscsa.edu) 210-854-5671.For questions or information related to departmental chair or center/institute director approval for research continuation please contact your respective Research Dean.
    SOM- Dr. Jennifer Potter (potterjs@uthscsa.edu)
    SOD- Dr. Brij Singh (singhbb@uthscsa.edu)
    SON- Dr. Jing Wang (wangj1@uthscsa.edu)
    SHP- Dr. Timothy Reistetter (reistetter@uthscsa.edu)Sincerely,Andrea Giuffrida, Ph.D.
    Vice President for Research
Article Categories: Research, Timely Updates