Contingency Plan for Human Subject Research Operations Related to the Coronavirus Outbreak
With the declaration of a national emergency because of the spread of COVID-19 and the announcement of cases touching the Johns Hopkins community directly, we are responding to minimize risks to subjects and our community in the conduct of human subject research. Clinical care may soon be responding to limited availability of acute hospital facilities (particularly for intensive respiratory care), increased need for outpatient care, and evaluation in the clinic. Research teams could have individuals with the COVID infection or in isolation. With the work from home policies research teams are already coping with fewer individuals on site.
The risk-benefit ratio drives our changes to our clinical research operations. Many human subject research teams have already made wise decisions in response to issued IRB guidance to reduce their research activity. At this time Johns Hopkins University is activating a more definitive policy on continuity of human subject research so that the University can fairly and efficiently direct resources for support of high priority research activity.
We recognize that research is critical to the mission of Johns Hopkins and that research activities define the career of many Hopkins investigators. Nonetheless, we need to focus on maintaining our ability to safely and effectively conduct research. We are thus establishing a triage framework for study teams and the institution to prioritize decisions regarding continued research in a resource limited environment.
IRB staff/committees are ready to respond to questions or changes in research related to this new policy. If the IRB is overwhelmed with Changes in Research, we will inform the research community and make changes.
The IRB has developed an information sheet that should be provided to all Research Participants that describes any increased risks related to the current COVID environment that they should consider.
Effective March 16, 2020, we will be categorizing all human subject research into three tiers as outlined below—and the following actions must be implemented by researchers depending on the research tier:
Tier 1 – High Direct Benefit to Research Participants
All protocols involving COVID 19 and protocols in which serious or immediate harm could be caused to the research participants if stopped.
Research in Tier 1 can continue if the PI agrees the research can be conducted in a safe manner that protects subjects, research, and the community. PIs must pause on enrolling new research participants unless there is a compelling reason. PIs may petition the IRB if they have a compelling reason for not following this new policy. Requests will be reviewed in order of priority. These guidelines must be followed for studies seeking an appeal until such time as an appeal is granted.
Tier 2 – Moderate Direct Benefit to Research Participants
Protocols which, if stopped, may pose a risk to the research participant. For example:
Research activities in Tier 2 must not enroll new participants in studies requiring in-person interaction nor continue to conduct in-person visits unless the PI petitions the IRB and demonstrates a compelling need to continue. On-line visits or data collection that does not require participant interaction may continue.
Tier 3 – Low Direct Benefit to Research Participants
Research activities in Tier 3 must not enroll new participants in studies requiring face to face interaction nor continue to conduct face to face visits. On-line visits or data collection that does not require participant interaction may continue.
Principal Investigators consider each of their protocols, and decide which tier each falls into. If they have questions, they should consult with their responsible IRB.