Archived – Research Response: Human Subjects

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THIS PAGE IS ARCHIVED INFORMATION

HUMAN SUBJECT RESEARCH: INTERNATIONAL SUPPLEMENTAL GUIDANCE
(Updated April 8)

Click here to download the Human Subject Research Coronavirus Phased Contingency Plan: Guidance for Studies 

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 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:

• 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. 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

• 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.

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Working with the IRB:

The IRB staff are available for consultation. Please contact the JHU IRBs at [email protected] (SOM), [email protected] (Homewood), [email protected] (Public Health).

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 [email protected].

More specific information is available from the IRB Websites:

For the JHM IRB:

• For changes in practice related to the Clinical Research Units, please check the ICTR website .
• For tips on how to respond to the changes in research practice or sharing of best practices related to the coronavirus, please check the ICTR website.
• The hospital epidemiology website is the best source for keeping up with how the clinical operation of JHM is addressing the COVID-19 outbreak.

For the JHSPH IRB.

For the Homewood IRB:

• Homewood IRB Updates

Archived Pages:

• Human Subject Research Contingency Plan: Phase 2 Plan may be accessed here (March 15)
• Human Subjects Guidance (March 12)