March 19, 2020

COVID-19 CLARIFICATION UPDATE: Temporary Halt to Some UW Human Subjects Research

By kenyares

The activity can continue if it meets the following:

 

  1. A significant likelihood of direct and meaningful benefit for individual participants

*Direct and meaningful benefit means that participation in the study has a good probability of directly having a meaningful positive impact on the serious medical or serious psychological condition of individual subjects for one or more of the study groups.

Examples:

  • Cure of a serious disease
  • Significant reduction of serious disease burden
  • Treatment or stabilization of a serious medical or psychological condition that is having a significant negative impact on the participants. For example, this could include treatment of substance abuse.
  • Diagnosis of a serious condition that is treatable and that would otherwise not be known to the participant
  • Pharmacologic or nonpharmacologic self-management for diabetes or cancer symptoms

Examples that do not meet this criterion, unless they are focused on COVID-19 or SARS-CoV-2:

  • Most Phase 1 trials of investigational drugs
  • First-in-human studies of an investigational drug or device
  • In-person interactions for most social and behavioral research
  • A descriptive study of drug use among college students

To the extent possible, study activities that can be done remotely should be done that way. For example, this might include screening or follow-up activities.

  1. A necessary in-person safety monitoring procedure that cannot be eliminated or done in an alternative manner, for subjects who are already participating in study procedures.

This applies only to subjects who are already-enrolled in already-approved, ongoing studies. All other study procedures must occur remotely, unless the study meets one of the other criteria for continuing. New subjects should not be enrolled in a study unless the study meets one or more of the other criteria for continuing.

  1. Clinical trials for which all in-person interactions can occur in the context of a needed clinical care visit

This means, for example, that extra standard care procedures (e.g., MRI, blood samples) that are performed solely for research cannot occur by in-person interaction, unless they are necessary safety monitoring procedures that cannot be eliminated or done in an alternative manner.

  1. Research focused on COVID-19 or SARS-CoV-2

This includes: diagnosis, treatment, interventions, or other directly-related activities which could include some social-behavioral research.

To the extent possible, study activities that can be done remotely should be done that way. For example, this might include screening, follow-up activities, surveys, questionnaires, interviews.

While recognizing the intense interest and scientific benefit of studying COVID-19 patients, the UW IRB is concerned about the cumulative burden of multiple research projects on these seriously-ill patients and patients with similar symptoms or disorders who may be cognitively and emotionally strained. We are relying upon the clinical facilities to manage this issue through coordination so as to minimize the number of separate consent processes, in-person visits, procedures, and specimen collection. It is essential for PIs to (1) obtain permission from the appropriate clinical facility for access to patients and (2) coordinate with other researchers.

This research may also need approval from the UW Institutional Biosafety Committee (IBC) if it involves virus propagation, inactivation, extractions, and PCR.

  1. Studies involving in-person interactions that can all be eliminated or modified to appropriate remote interactions (e.g., phone calls, emails) that don’t compromise participant safety or the scientific integrity of the research.