What to Expect

Human Subject Research

Once You've Submitted Your Application For Review

After your application is formally submitted in IRBNet, it will be placed in the IRBNet queue and the status of your application will reflect that it is "pending review". This status of your project will remain as "pending review" until your project is approved, issued an exempt certification, or a formal stipulation letter is issued by the Full Board changing the status to "deferred-modification required" or "deferred-information required".

Once your submission is in the IRBNet queue, it will be assigned to one of the IRB Administrators who will communicate with you via Project Mail throughout the entire review and approval process. Communication will be sent directly to the PI, using the email account that was entered when the IRBNet project account was set up.

If your project will require Full Board Review at a monthly meeting, the IRB Administrator will:

  • Assign it to the next possible meeting agenda;
  • Notify you of the meeting date, deadlines and and other requirements prior to the IRB meeting; and
  • Work with you to ensure your project is complete for the meeting.

If your project will NOT require Full Board Review (i.e., if it qualifies as an expedited or exempt review project), you will work directly with the designated reviewer on any revisions or requirements until the research project may be approved.

What to Expect While the Review is in Progress

  • Preliminary Review

    The designated reviewer will conduct a preliminary review to check your new submission to ensure all the required forms, consents, trainings, and other documents associated with the research project have been attached to the IRBNet package. For some studies additional reviews by another office or individual at DU may also be required. The reviewer assigned to your study will conduct a preliminary review to identify whether additional documents, reviews or approvals are necessary. If the IRBNet package is not complete and is missing any of the necessary information, forms, or documents, the IRBNet package will be unlocked by the reviewer and a Project Mail will be issued to the investigator outlining what information or documents are needed to continue the review process. Please refer to the IRBNet tab for information on unlocking and re-locking an IRBNet package.

  • Faculty Sponsor Review

    If you are a student investigator, you are required to list a Faculty Sponsor on your IRBNet application. The Faculty Sponsor is required to electronically sign your application assuring that they have reviewed and are in support of your study. The student investigator is responsible for granting "full access" to their Faculty Sponsor in IRBNet and notifying them that their review and electronic signature is required. Once this is in place, the preliminary review will continue.

  • Letters of Support or Approval Letters from External Sites

    If your project involves a school or other external site, a letter of support or an approval letter is required to provide the IRB with documentation that the site is aware of the study activities and has agreed to the plan for carrying out the proposed activities.

  • Enterprise Risk Management Review

    If you will travel outside of the U.S. to conduct your research, you are required to register your international travel with Enterprise Risk Management. Students must register as Experiential Learners in DU Passport and Faculty/Staff must submit a request in Pioneer Travel and Expense in order to obtain authorization from Enterprise Risk Management. A copy of the authorization email confirming approval from Enterprise Risk Management should be attached to your IRBNet package.

  • Federally-Funded Project

    If your project is federally-funded, you are required to complete a Financial Conflict of Interest (FCOI) disclosure form for this project and maintain valid Conflict of Interest training offered through the CITI Program. Completion of the form and training will be verified by the designated reviewer.

  • Receiving and Sending Data

    If your proposed project involves sending identifiable data to or receiving identifiable data from an external source outside of DU, a Data Use Agreement (DUA) will be required. Submit a request to DataContract@du.edu for additional information and accessing the required forms. If de-identifiable data is requested from an outside entity, without any codes or access to the key to the codes, it is at the discretion of the outside entity whether they will require a DUA.

  • Blood Draws

    If your project involves a simple blood draw, you are required to submit a separate Blood Draw Protocol application to the DU Institutional Biosafety Committee (IBC) for IBC approval. A copy of the IBC approval should be attached to your IRBNet package.