Dear Members of the Research Community

During the next few weeks, the UHCMC IRB website will be undergoing several updates as a means to improve its content for users. The Policies and Procedures web page and the Forms and Templates web page will be affected. The changes are a result of our continued quality improvement efforts of the UHCMC HRPP; and to ensure compliance with the Federal regulations. The Staff at the Center for Clinical Research will provide education to our research community, to discuss their impact and implementation.    

What has changed on the Policies and Procedures webpage?
1. The format of the Policies and Procedures webpage is being updated to provide links to both IRB Administrative policies and Investigator policies. Previously, many of the policies were only accessible via the IRB Manual.
2. All policies will include the University Hospitals Case Medical School logo; and the approval date (or latest revision date when applicable).
3. Many policies have undergone minor administrative revisions, aimed to provide additional clarification and guidance of the regulations. However, several IRB policies have more major changes that will impact procedural requirements: Exempt Human Research; Decisionally Impaired Research Subjects; Event Reporting – Unanticipated Problems, Adverse Events and Protocol Deviations; and Chart Reviews and Discarded Tissue Studies. Please note: The Staff at the Center for Clinical Research will be providing education on each area of research.
4. Once all policies are posted, the current version of the IRB manual will be removed. In the near future, a new version of the manual, complete with updated policies will be posted.

What has changed on the Forms and Templates webpage?
1. The UHCMC IRB Standard Research Consent Language has been revised (see Consent Templates - Summary of your Rights as a Participant in a Research Study; Disclosure of Study Records; and Contact Information). In addition, the signature block requirements for both adults and children have been revised.
2. The Consent Language Tutorial has been updated to provide additional guidance regarding the Additional 6 elements of Informed Consent. Information can also be found in the revised Informed Consent policy.
3. The following investigator checklists have been updated to address research resources and investigator/research staff conflicts of interest: New Protocol (N); and Continuing Review (CR).
4. The Investigator checklist for new Chart Review/Discarded Tissue Studies has been updated to address consent procedures; and risk categories.
5. Two new forms relating to exempt research applications have been added. One is entitled, “Request for Exemption”, located under the Forms section; and the other entitled “Exemption Determination Form”, located under the Checklists section. The new Exemption Determination Form replaces the old application form “Request IRB Exemption for a Study EXMPT”.
6. The Emergency Use Involving Human Subjects (EMRG) checklist has been replaced with a new determination form, listing the required regulatory criteria for emergency use.  
7. The Surrogate Consent template has been removed as it is no longer an IRB requirement.

The new/additional requirements will go into immediate effect as they become posted. The IRB staff will work with investigators to help them comply with any new requirements for submissions that the IRB has already received. The timeline for the implementation of all revised requirements is July 1, 2007.

We thank you for your patience during this time of transition and we will keep you updated of the website’s progress. The Staff of the Center for Clinical Research will be available to answer any questions or concerns you may have, and can be contacted on 216-844-1529.

Philip Cola, M.A.
Vice-President for Research and Technology