JHM IRB Change in Policy for Expiration Dates in Consent Documents

Effective January 1, 2009, the JHM IRB will issue consent documents that will include an approval date. The consent document will not have an expiration date. The approval for the consent document will last the life of the study, or until it is amended - whichever comes first.

It will be the responsibility of the Principal Investigator and the research study team to monitor the expiration date of the study for continuing review purposes. It will also be the responsibility of the Principal Investigator and the research study team to ensure that no participant is enrolled if the expiration date for the study's JHM IRB continuing review has been exceeded.

Below is an explanation of this policy for new, amended and continuing review research studies.

New Research Study: The JHM IRB will issue the consent document with the initial approval date. This consent document will be for the life of the study, or until it is amended.

Change in Research with a revised consent document: The JHM IRB will issue a consent document with a Change in Research approval date. This approval date will last the life of the study, or until there is a further amendment with consent document revisions.

Continuing Review with no changes to consent document: Until such time that all consent documents are issued without an expiration date, the JHM IRB will continue to issue a consent document with the approval date of the continuing review. The document will not have an expiration date and no further consent document will be issued for the study, unless it is amended.

For questions please contact the Office of Human Subjects Research (410) 955-3008 or jhmirb@jhmi.edu.

eIRB Enhancements

Based on feedback from an eIRB advisory group, general eIRB users, IRB members and IRB staff, the Office for Human Subjects Research has introduced a major upgrade to the eIRB system. Many of these changes will affect the way you interact with eIRB and are being implemented to improve the overall functionality of the system for all of our users.

Some noticeable enhancements include:

• a streamlined Further Study Action submission structure
  
• breakdown of the workspace for each study into separate areas for continuing review applications, changes in research and protocol events so that it is easier to track each submission
  
• electronically generated IRB notifications to reduce the time required to prepare PI correspondence following IRB meetings
  
• electronic PI response activity to IRB requests to eliminate the need to upload the response in a word document
  
• new email notification templates to make it easier to identify the action required and link directly to the eIRB study workspace.
  

You will not lose any information that is currently in eIRB, but your workspace will look different. We think most of the changes are self-explanatory, but will have guidance posted on our website and help readily available by email or phone.

Over the course of the next year, more enhancements will be announced, including online IRB committee review and a full conversion of all paper studies to eIRB.

For more information, please visit the eIRB website at http://irb.jhmi.edu/eIRB. If you have any questions, please contact the eIRB Help Desk at 410-955-3008 or via email at jhmeirb@jhmi.edu.

Thank you in advance for your support as we continue to work to improve the eIRB system.

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