COVID-19 Resources for IRB

This page will serve as the JHSPH Resource page to help investigators navigate the COVID 19 situation as it affects human subjects research.

The University is at Phase 3 of the Human Subjects Research Preparedness Plan . Research protocols in other countries must follow the University guidance, and investigators should check the WHO daily situation report to check country-specific conditions. University policies apply to all research operations conducted under a JHSPH or JHU Institutional Review Board protocol, and should be consulted prior to making any decisions.

JHU Contingency Plan for Human Subject Research Operations Related to the Coronavirus Outbreak, research is divided into Tier 1 (High Direct Benefit to Research Participants); Tier 2 (Moderate Direct Benefit to Research  Participants); and Tier 3 (Low Direct Benefit to Research Participants). Regardless of which Tier a research study falls into, efforts should be made to screen research participants for signs and symptoms of the virus and whenever possible, conduct the research visit using remote mechanisms.  Guidance and resources to help investigators and study staff conduct these visits remotely and securely will be continuously updated.

Research staff are available and working remotely to answer study specific questions. The JHSPH RB office is working remotely and the IRBs are continuing to meet remotely. The IRB will process all Amendment submissions required to change research plans and data collection procedures and all other submissions. Please consult the resources below before sending in individual questions to .

The JHSPH IRB will continue to provide a list of updated resources and materials for investigators to ensure the safety of research participants and staff during this time.

Guidance Documents:

• FAQ COVID 

• New Consent language for drug and device (including diagnostics) studies seeking to treat, diagnose, or prevent COVID 19 under the Public Readiness and Emergency Preparedness Declaration (PREP) 

   

  Documents to Help Study Participants:

• COVID 19 Study Pause Guidelines

•  COVID 19 Risk Information Sheet for Participants

• FAQs providing COVID 19 information for participants and mental health and other resources for U.S. based participants, with a focus on the Baltimore area.  Studies conducted internationally and outside of Baltimore may use this FAQ as a guide to what resources to think about and look for.​

• ---

  JHSPH - IRB

  OneDrive Folder
  Resources for research teams. Note: you must have JH OneDrive Access to see the folder - be sure to be logged in with JHED ID to access

  
  
  OneDrive Folder – Research COVID 19 Screening Forms
  Examples of screening tools that can be used by research staff to evaluate research participants for symptoms of COVID 19

  OneDrive Folder – Remote Data Collection
  Resources on how to set up a google voice account and collect data remotely using REDCap.

  
  JHSPH

  COVID-19 Digital Library
  Primarily outward/public facing materials on COVID-19, news from JH on outbreak response

  JHU

  COVID-19 Information
  Compendium of official University guidance materials on prevention, operations, travel, messages (log of all JHU-wide messages), info for undergrads, and research preparedness.

  Research Preparedness
  Overview + statement that updates will be posted here; links to general guidelines; federal guidance; human subjects guidelines; animal resources, remote access and funding opportunities.

  Research preparedness – general guidelines
  Links to official university policies on managing staff and research operations; overall planning guidance

  Research preparedness – federal guidance
  Links to official federal communications (by agency) about grant management during shutdown period

  Research preparedness – human subjects
  Definitions of Tiers of response (currently Tier 2) and compendium of communications around engaging human subjects. Includes link to international supplemental guidance.

  Research preparedness – animal resources: Information for researchers and investigators
  Series of bulletins and resources outlining steps to take day by day to manage animal lab resources. Includes (1) emergency contact submission form; (2) priority and ongoing treatment request form; (3) print templates for labeling cages

  
  COVID Funding Opportunities
  Running list of funding announcements

  JHURA

  Main page
  All links go to the HUB pages – main page and direct links to each of the sub pages

  MEDICINE – IRB

  Essential information for Human Subjects Research Teams Related to COVID-19
  Compendium of announcements; link to JHU HUB Research Preparedness Human Subjects page; link to FAQs; links to guidance on communicating risks to research subjects (NOTE – these are the same as the ones Greg circulated earlier today).