Policies & Guidance
This page contains archived IRB Policy Updates & News, for new updates see Announcements found here.
3/28/11 Important Updates for Human Subjects Research at Iowa. Please review the important updates here regarding consent documents, Hardin Library, the Record of Consent Policy, ClinicalTrials.gov, and the HSO Newsletter. This information was also sent out in a mass email to all Principal Investigators, research team members, and delegates the week of 3/28/11.
1/25/11 Record of Consent FAQ. The Human Subjects Office has created a new Frequently Asked Questions document regarding the Record of Consent Process. This FAQ includes a link to the UIHC policy, contact information, guidance on implementing the policy, and information on the Record of Consent in EPIC. Suggestions on the content of this, or any HSO/IRB FAQ, can be sent to email@example.com.
10/6/10 The Human Subjects Office/IRB is pleased to announce our most recent addition to the HawkIRB electronic application system: "The Human Subjects Research Determination" (HSRD) form. This is an electronic tool to assess whether or not a research proposal constitutes "human subjects research". This tool adapts the "smart form" technology of the HawkIRB electronic application into a series of short questions in order to assess if your proposal meets the regulatory definition of research, thus requiring review and approval from the IRB. For additional details, please review the Human Subjects Research Determination information found here.
9/30/10 IRB Certification Course in Human Subjects Protections. All faculty, staff, and students at the University of Iowa who are engaged in human subjects research are required to complete a course in Human Subjects Protections offered by CITI. The course enrollment page on the CITI website has changed. The curriculum selection page now shows other courses for the University of Iowa. The IRB requirements for the certification of UI researchers in human subjects protections have not changed. UI researchers are required to complete the CITI Basic Course Modules for either IRB-01 (Biomedical) or IRB-02 (Social & Behavioral) listed in the Human Subjects Research Course Enrollment section under Question 1 on the curriculum page. Completion of the courses in the section Responsible Conduct of Research (Question 2) and Lab Animal Research (Question 3) are not required by the IRB. If you have any questions about the IRB requirements for certification of researchers conducting human subjects research, please contact Elona McLees (335-6837) or Dorey Coleman (384-1176) in the Human Subjects Office. Additional information about the IRB certification requirements and instructions for access to the CITI Basic Course Modules may be found here.
7/7/10 Updates to the HawkIRB application. Please review the attached mass email that was sent to all listed Principal Investigators, Research Team members, and Delegates regarding the updates by clicking here.
IRB Policies and Procedures
Guide to Human Subjects Protections in Research with Track Changes (revised April 2009)
UI IRB SOP with Track Changes (revised April 2009)
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If you have any difficulties accessing these documents, please contact the HSO at 335-6564.
IND/Outside Safety Reports Memo (archived)
Other UI Policies and Guidance
Record of Consent Policy The Record of Consent policy can be found on The Point. The link to this policy is located in the first section of the Record of Consent Frequently Asked Questions document. Only those individuals with a formal appointment at UIHC have access to information found on The Point.
Research Subject Payment -- U of I Policy and Procedures -- Revised 8.13.09 (now removed by accounting due to policy update in Jan 2014)
Cash Handling Policy - U of I Policy -- Revised 8.13.09 (now removed by accounting due to policy update in Jan 2014)
August 1, 2008 rollout of new policy and procedures - This rollout contains information on policy regarding the use of Social Security Numbers, the new record of consent template, listing of research team members on the informed consent document, medical record access for sponsor monitors, clarification that the informed consent can not be used as a data collection tool, a revised IRB definition of serious noncompliance, informed consent template language for pregnancy testing in the minor subject population, template letter examples and tips for effective recruitment, and information on VA CITI certification.