New eIRB System Coming Q2
Dear Research Community,
The MetroHealth Institutional Review Board (IRB) is excited to announce plans for a new electronic system for IRB application. The new system will provide a simpler, more understandable and streamlined approach for submitting studies for IRB review. The development process is intensive – so please bear with us. We are currently configuring the smart-form questions for our unique environment. Some of the highlights of the new system include:
- Concise submission forms reducing the number of steps to navigate
- A new updated interface reducing guesswork and duplicative effort
- Increased compliance with the Common Rule regulations
- Integration with other Huron modules such as CONI (MetroHealth Conflict of Interest disclosure system)
In the next few weeks we will be testing and training on the new system. We will be reaching out to members of the research community to help out with testing. Be on the lookout for announcements for upcoming training opportunities. I encourage you to check the homepage of the eIRB system for the most recent updates.
We are excited about the transition to the new electronic system and know that the research community will embrace this new streamlined IRB submission system.
MetroHealth IRB Information Regarding COVID-19
(29 April 2020)
The MetroHealth IRB is fully operational and we expect this to continue. IRB Staff have been mandated to work from home, so email is the best method of communication.
For IRB research, highest priority will be given to all inquiries, requests and modifications related to COVID-19. Given the current pandemic, please note the following:
- Any changes to your protocol or the conduct of your research procedures still require an amendment with the IRB with the exception of those made to prevent immediate hazards (see below). Please be sure to include COVID-19 in the title so that we can prioritize those amendments.
- All changes should be documented in your regulatory binder. Be sure to include details about communication with the funding agency, sponsor, or FDA as well as justifications for any changes made.
Changes to Prevent Immediate Hazard:
- Any changes in IRB-approved research must be reported to the IRB and may not be implemented prior to review and approval by the IRB except when necessary to eliminate apparent immediate hazards to the subject. This is permitted by both the Common Rule and FDA regulations.
- Examples of modifications or safety changes include, but are not limited to:
o Cancelling non-essential study visits
o Conducting phone visits in lieu of in-person visits
o Conducting safety screening (initiated by the Principal Investigator) prior to in-person visits occurring.
o Other changes as deemed appropriate to eliminate immediate hazards to subjects because of the risk of exposure to this highly communicable disease.
- Please make all reasonable efforts to report deviations according to IRB policy and submit required amendments to the IRB promptly.
MHS Relying on Another IRB:
- Please monitor any communications from the IRB of Record and ensure compliance with the IRB of Record’s policies and procedures.
- Email David Webb directly at email@example.com with single IRB questions as we cannot access our IRBReliance@metrohealth.org email.
* Please check the eIRB homepage for frequent updates.