News and Announcements
Post date 1-22-2019 Announcement:
The long awaited implementation date for the revised human subject regulations is here. We must be compliant with the revised regulations on and after January 21, 2019. ORS is working on revised forms, form instructions, templates, guidance, internal processing documents, letter templates, and educational items that reflect the revised regulations. When we are ready, we will begin providing educational sessions to the campus about the revised regulations and how they impact human subject research here at DePaul. There is a transitional provision that allows protocols approved under the older regulations to remain under them. ORS and the IRB will determine on a protocol-per-protocol basis what is the best for each protocol. Transitioning to the new regulations means being fully compliant with all parts of the revised regulations, for example, revising the consent document to include the newly required elements. So the decision to transition a protocol should be made carefully. We will continue to be in touch with the campus and provide updates on our progress and any changes.
Post date 4-26-2018 Announcement:
The long-awaited revised expedited/full IRB submission form has been posted. All new applications for expedited or full review should utilize this form from this day forward. For a short period of time, the IRB will be accepting protocols submitted on the old form if they have already begun the review process with the IRB. Otherwise, all new expedited or full protocols should be converted to the new form even if they are in the state of partial completion at this time. We hope that the new form will aid in streamlining the IRB review process by getting the information we need to make approval decisions the first time and hopefully minimizing the number of revisions requested as well as the number of times revisions are requested. This is the final form to be converted to the fillable PDF format. From now on, no more signed paper copies of the application need to be submitted to ORS.
Post date 2-21-2018 Announcement:
Effective January 25, 2018, all NIH grant applications are to use the new application package and instructions. One of the actions taken in the new grant package is to have a consolidated human subject and clinical trial form, which has all the information related to human subjects and clincial trials in one place versus scattered over several sections of the application. In addition certain key aspects of the human subject plan are to be included in separate documents attached to the application submitted to NIH. In order for the IRB to comply with federal grant matching requirement, when investigators send us the grant application for review along with the IRB application, we must now also have all human subject-related attachments to the grant. These grant attachments include vital information, such as the overall study design, the methods and materials, risks, benefits, and the consent process.
Post date 1-29-2018 Announcement:
Effective immediately, the limited Student learner group has been eliminated from the CITI human subject training list of learner groups. The correct learner group for students at all levels is now Faculty/Staff/Outside Collaborators/Students. We have made this change in order to provide the best education possible to our students who continue to conduct more and more challenging research at DePaul and research that more often meets the criteria for expedited review versus exempt review criteria.
Post date 1-29-2018 Announcement:
On January 17, 2018 HHS announced a delay in the compliance date for the revised human subject research regulations at 45 CFR 46. The delay allows institutions to get revised policy and procedures in place for the revised regulations. Additionally, the delay allows the federal agency that oversees the IRB (OHRP) to release guidance to assist the IRBs with interpreting and implementing the changes. The new effective date is July 19, 2018.
Post date 9-7-2016-Announcement:
Effective immediately the Local Review Board (LRB) system of pre-review before the Institutional Review Board (IRB) review process has been eliminated. For additional information see the LRB portion of our website. Also an Email has been sent to all active LRB members, IRB members, Deans, and Principal Investigators announcing this change.
Post date 11-5-2015 - Announcement:
The IRB guidance document on the Audio or Visual Recordings of Conversations was revised to reflect a revision to the state law. The revised document is posted on the Guidance section.
Post date- 8-11-2015- Announcement:
The Office of Research Services announces the release of revised consent, assent, and parent/legal guardian templates to incorporate language for conflicts of interest, subject payment guidelines, and sexual and relationship violence reporting.
Post date - 5-22-14 -Announcement:
Recently published research has indicated that data collected through Amazon MTURK may not be anonymous. The DePaul IRB has created template language that should be included in Exempt Information Sheets and consent documents when researchers collect data through the Amazon MTURK system. Please refer to the revised posted templates. For additional information about the issue refer to the following article: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2228728