HUMAN SUBJECT RESEARCH: INTERNATIONAL SUPPLEMENTAL GUIDANCE
(Updated April 8)
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 and 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.
COVID 19 studies may continue in-person interactions subject to IRB approval.
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. 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 – 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.
Working with the IRB:
The IRB is actively working with study teams seeking approval for research options for individuals who test positive for COVID-19. If you are seeking information about options for COVID-19 patients please contact the IRB at firstname.lastname@example.org.
More specific information is available from the IRB Websites:
For the JHM IRB:
For the JHSPH IRB.
For the Homewood IRB: