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1st Development Cycle Enhancements (January through May 2006)
and 2nd Development Cycle Enhancements (June through August 2006) The January through May 2006 development cycle and the June through August 2006 development cycle introduce many new changes and enhancements to the eIRB system. Among the many changes there are three especially important ones; please review them below as they will change the way you interact with the eIRB system.
To review all eIRB changes applied during the January to May 2006 development cycle and/or the June through August 2006 development cycle, please visit the eIRB system main page at http://www.ohsu.edu/eirb/ and click on the "eIRB Changes 05.26.06" or the "eIRB Changes 08.28.06" link located under the "Resources" section on the left side of the page. It is no longer possible to submit a study through the eIRB unless all individuals listed on the IRQ (Initial Review Questionnaire) have a current CoIR (Conflict of Interest in Research disclosure form) on file and have all completed "RCR for All", "RCR Involving Human Subjects", and if your study involves a FDA Device or a FDA Drug also the "RCR Involving FDA Regulated Products" training in Big Brain. It will also not be possible to submit continuing review materials, or a modification if one or more individuals listed on the IRQ do not have a current CoIR status and have not completed "RCR for All" and "RCR Involving Human Subjects" training in Big Brain. Please visit the CoIR Committee web site at http://www.ohsu.edu/research/rda/coir/ for more information regarding submission of a CoIR disclosure. To complete the RCR training please use the OHSU Big Brain application at http://www.ohsu.edu/bigbrain/. Special steps are required for studies, which have OHSU students, individuals with administrative responsibilities only, financial contacts, and/or Non-OHSU Employees listed on their IRQ: OHSU Students All OHSU students listed on the IRQ of a study must check the option "I am an OHSU student" on the "Personnel Selection" view that displays when an individual is added to the IRQ of a study. Staff can also be added to a study or removed from a study through a modification by checking option "2.8. Change in study personnel" on the "Modification Request Form" of the modification questionnaire and clicking on the "Continue" button. Staff can be added or removed at continuing review by checking the "14. There has been a change in study personnel" option on the "Continuing Review Form Questions" form and clicking on the "Continue" button. For help on initiating a modification or a continuing review please contact ORIO at (503) 494-7887 or at irbinbox@ohsu.edu. Individuals with Administrative Responsibilities Only and Financial Contacts Individuals who only have administrative responsibilities for a study (those who have no involvement with subjects or data collection or analysis) and/or Financial Contacts must indicate this by checking the "Administrative Responsibilities Only" and/or the "Financial Contact" option and no other option under the "Responsibilities" section on the "Personnel Selection" view that is displayed when an individual is added to the IRQ of a study. It is also possible to modify the study staff listed on the IRQ through a continuing review or a modification. (see paragraph above or contact the ORIO at (503) 494-7887 or at irbinbox@ohsu.edu) Non-OHSU Employees When adding a non-OHSU employee to the IRQ of your study, the following options under the "Non-OHSU Personnel" section on the "Personnel Selection" view must be checked:
If any of the specified options is not checked for Non-OHSU employees and the OHSU CoIR and RCR records do not contain a record for the user, it will not be possible to submit your study, continuing review, or modification. You can update the study staff through a modification or a continuing review. For information on initiating a new modification or continuing review, please see the "OHSU Students" paragraph above or contact the ORIO at (503) 494-7887 or at irbinbox@ohsu.edu. Additional Information When you attempt to submit a study, continuing review, or a modification for which the IRQ contains one or more individuals who do not meet the above specified criteria, you will receive an error explaining what information is missing. Please note that even if there are several individuals who do not meet the criteria and who are listed on the IRQ of your study, the error will mention only the first individual it encounters. For your convenience we have added an overview page of the CoIR/RCR requirements of all individuals listed on the IRQ of your study; the "RCR/COIR Compliance" overview feature is located in the upper left section of the study-workspace, continuing review workspace, and the modification workspace, visible when you open your study, continuing review, or modification respectively. We understand that the new CoIR/RCR requirements enforcement might cause some inconvenience. Compliance with these requirements is, however mandatory under federal law. We are available to provide assistance and resolve any potential obstacles you might encounter. Please feel free to contact us:
You do not need to initiate a separate modification request to update study staff; this can be accomplished along with any modification or continuing review action you may already have begun to prepare. If you do not have any pending modifications or a continuing review but wish to update your study staff immediately, please contact ORIO at (503) 494-7887 or at irbinbox@ohsu.edu. Thank you very much for your understanding and cooperation! CoIR and RCR Status Overview for Study Staff This eIRB upgrade introduces a new feature that provides a convenient overview of the CoIR and RCR status of all individuals listed on the IRQ of your study. In order to use this new feature simply click on the name of your study under the "Protocols" tab located in your eIRB inbox to open the study workspace. Once the study-workspace is open, please click on the "Staff RCR/CoIR" link located on the upper-left section of the page under the "RCR/COIR Compliance" header. The "Staff RCR/CoIR" overview is also available on any Continuing Review or Modification. Please feel free to contact ORIO at (503) 494-7887 or at irbinbox@ohsu.edu if we may be of assistance! E-mail Notification Opt-out Feature We are very excited to finally offer a new feature that will allow you to opt-out of eIRB e-mail notifications independently of your read and edit rights for a particular study. The eIRB will offer you three options regarding the e-mail notifications related to a study:
Customizing the E-mail Notification Settings As noted above, at least one member of the study staff must receive the full set of eIRB communications. If your study is currently in your eIRB inbox (Status: Researcher Preparation, Researcher Revision, Pre-Board Revisions, etc.) you can customize the E-mail notification settings through the IRQ of your study, through the "Customize E-mail Notifications" activity available for your study. If your study, however, has already been approved and its IRQ is locked, you may also customize the e-mail notifications through a modification or a continuing review: Modification
Continuing Review
You do not need to initiate a separate modification request to change your e-mail notifications; this can be accomplished along with any modification or continuing review action you may already have begun to prepare. If you do not have any pending modifications or a continuing review but wish to change e-mail notifications for any of your study staff immediately, please contact ORIO at (503) 494-7887 or at irbinbox@ohsu.edu for help. Many of our eIRB users have expressed the desire for an e-mail notification opt-out feature and we are very happy to finally be able to offer it to you! |
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