Human Subject Research: International Supplemental Guidance

We are currently in Phase 3 as of March 22.

Criteria for Decision-making  
Basis for Triggering Criteria Country Transmission Classification* (WHO) Local Mitigation Measures Local IRB Directions Changes to Research
Phase 0 Potential, but no immediate threat of spread to local researchers and employees Imported cases only; Under investigation; or Interrupted transmission

 

No institutional closures No protocol or reporting changes likely Develop contingency plans
Phase 1 Limited number of cases, minimal risk to researchers and subjects. All cases acquired from outside or known sources of infection; no to minimal local cases Local transmission Limited institutional closures (e.g. targeted nursing homes and schools) Protocol or reporting changes or postponement possible Same as Phase 0

Screen participants for potential infectious risk

Cease sponsor on-site monitoring visits

IRBs will implement triage procedures to prioritize reviews to manage workload

Phase 2 Moderate to significant risks to researchers or subjects; Disruptions to ability to conduct research; Local community spread; High absenteeism; Sporadic institutional closures Local transmission or Community transmission Institutional closures and measures to work from home Protocol or reporting changes or postponement possible Same as Phase 1

Defer enrolling new participants except for Tier 1 and limited Tier 2 studies.

Implement tiered procedures for enrollment/research procedures:

Tier 1: allowable*

Tier 2: must be strongly justified*

Tier 3: direct contact should be paused

Phase 3 Significant risks to researchers or subjects; Massive regional disruption;  Widespread institutional closures Community transmission (where there’s limited ability to relate cases through transmission chains) Widespread institutional closure (schools, large events, public spaces, businesses) limitations on transport, Protocol or reporting changes or postponement likely Phase 3: Updated and effective on 4/3/2020

Tier 1:

Tier 1 studies must cease any in-person visits specifically for research purposes that require subjects to travel from out of state where the Governor of that state has issued a no travel order.

All other in-person interactions may only continue for Tier 1 studies if the PI presents a compelling justification to continue these interactions and the petition to continue is approved by the IRB. Studies at the Sidney Kimmel Cancer Center or JH-ACH must seek the approval to continue in-person activities from their respective review committees.

Requests for new enrollment in this Tier must continue to be submitted to the IRB, SKCCC or JH-ACH review committee as previously established.


Tier 2:

Tier 2 studies must cease all in-person interactions. The IRB will no longer consider requests to continue in-person activities for this Tier. Data collection that does not require in-person participant interaction (e.g. telephone or online) may continue.

No new enrollment is permitted for Tier 2 studies.


Tier 3:

Tier 3 studies must not enroll new participants in studies requiring in-person interaction nor continue to conduct in-person visits. Data collection that does not require in-person participant interaction (e.g. telephone or online) may continue.

International Sites should follow this tiered plan subject to local health authority and local IRB direction.

It is strongly advised that investigators confer with and rely on local partners to ensure appropriate decision-making for your local context.

Definitions:

  • Community transmission is evidenced by the inability to relate confirmed cases through chains of transmission for a large number of cases, or by increasing positive tests through sentinel samples (routine systematic testing of respiratory samples from established laboratories).
  • Local transmission indicates locations where the source of infection is within the reporting location.
  • Imported cases only indicates locations where all cases have been acquired outside the location of reporting.
  • Under investigation indicates locations where type of transmission has not been determined for any cases.
  • Interrupted transmission indicates locations where interruption of transmission has been demonstrated (details to be determined)

Please consult the following table regarding the WHO classifications of the pandemic: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/