Human Subject Research: Contingency Plan – Phase 2

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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.

For example:

• Research protocols involving treatments for acute, life threatening health conditions (e.g. some treatment trials for cancers)
• Protocols where stopping the intervention (e.g., some investigational drugs or vaccines or preventative drug regimens) could be harmful

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:

• Protocols in which research participants are receiving interventions or clinical care that is very interrelated to their research participation (e.g., test results coming back that might have clinical implications for their care)
• Some protocols evaluating treatments for chronic conditions (e.g., asthma, hypertension, depression, etc.).
• Protocols involving assessment of the safety or efficacy of an intervention in which, if stopped, the potential societal benefit of the science would be significantly and adversely impacted, for example where a research assessment (blood collection or imaging study) is only valuable if collected at a very specific time. This must be measured against the risk to participants, including the risk of exposure of COVID-19.

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

• Cohort and natural history studies where delays in data collection have limited impact on scientific objectives
• Protocols in which delays to starting or pausing of research does not substantively impact on research objectives of the research protocol
• Protocols in which risks to research participants are higher (e.g., potentially exposing elderly vulnerable individuals to COVID) and benefits of the study to the participants remain minimal
• Research with healthy volunteers
• Any minimal risk studies that require research subjects to travel, that involve undergraduate students, or that are in a community setting and require direct interaction with researchers

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.