Several important changes directly affecting the IRB application process are occurring in July 2012. The Nursing Research Committee and Research Billing under the Joint Office for Compliance now require documentation of their respective review and approval as part of the review of Human Subjects Research projects. What this means is that the IRB will no longer be able to complete the review and approval process of all NEW project application submissions until these two committees have provided their approval in addition to the other committee review requirements already in place. Please review the HRPP flowchart for a comprehensive review of all Human Research Protections Program (HRPP) committee reviews and when documentation of their approval is required. For any questions related to an HRPP Committee review process, please contact the applicable committee directly. Information on the Human Research Protections Program (HRPP) Committees can be found here.
The University of Iowa will be making revisions to the Institutional Conflict of Interest in Research policy to be in compliance with the forthcoming changes to the federal regulations. Information on the changes can be found on the Conflict of Interest website or by reviewing the DRAFT policy here. These changes will affect the HawkIRB application.
Beginning July 25th until Aug. 24th, any HawkIRB new project, modification, or modification + continuing review submissions to the HSO\IRB will automatically generate an email that will be sent to all research team members who have NOT completed an eCOI form to the Conflict of Interest in Research Office. The HawkIRB system will also have a new question under Question II.6 automatically designating the PI and all faculty members listed on the research team as “key personnel.” The Principal Investigator, or their delegate, will be responsible for indicating whether or not all remaining research team members should be designated as “key personnel” on this question in HawkIRB. This question will now be required on all new project submissions, modifications, and modification + continuing review submissions.
"Key Personnel" will automatically be defined as the following:
Any research team members on the HawkIRB application with a UI Faculty appointment
The PrincipaI Investigator will ultimately be responsible for identifying any additional key personnel on the research team. "Key personnel" is further defined as:
Research team members who have the authority to make independent decisions about the direction of the research and the subsequent conclusions about the results. This would include individuals who are likely to be authors on manuscripts or to present research findings at national conferences. It does not include administrative personnel or individuals who perform routine, pre-defined, or incidental tasks related to the project.
Beginning August 24, 2012, if anyone listed on the research team in section II of the HawkIRB application is identified as “Key Personnel” and have not completed a financial interest disclosure form (eCOI), the HawkIRB application form can not be submitted to the HSO\IRB for review.* Any Key Personnel that have not completed the financial interest disclosure form will need to be removed from the research team until the eCOI submission is complete. This means they will not be able to complete any research related activities until they have completed the disclosure form. A modification submission will be required to re add them as a member of the research team.
* Any research team member that is conducting research at the VA only is exempt from this process.
Prior to November 1st, 2012, a modification will be required on all open and active IRB approved research project under all three IRBs (01, 02, & 03) in HawkIRB that has not answered question II.6 documenting key personnel on the project. This requirement will be to bring all University of Iowa researchers in full compliance with the new Conflict of Interest in Research policy. If you have questions over any of these changes, please contact either the Human Subjects Office for any HawkIRB related questions or the Conflict of Interest in Research office for questions over the new disclosure requirements. Thank you for your attention to these important changes.