Institutional Review Board
The Institutional Review Board of Children's Hospital of Wisconsin reviews all proposed research projects that involve human subjects to assure that the rights of such subjects are protected, that adequate and informed consent for their participation is obtained, and that any possible benefits of the research are commensurate with the risks involved. The chief objectives of every IRB protocol review are to assess the ethics of the research and its methods, to promote fully informed and voluntary participation by prospective subjects who are themselves capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy) and to maximize the safety of subjects once they are enrolled in the project.
CHW IRB PROCESSES HAVE CHANGED – PLEASE READ
Effective June 30, 2011, the IRB Office has switched the amendment number system from Roman numerals to the Arabic system ( 1, 2, 3, 4, etc.). The IRB Office will not be revising any existing documentation to reflect this change. Please do not discard any existing regulatory documents that use the Roman numerals.
Research involving both CHW and Froedtert facilities or patients.
- IF you are planning any research projects that involve both CHW and Froedtert facilities and/or patients, please contact the IRB office before you submit your protocol. In most cases you will not need to submit your research to both IRB's, however, the IRB office needs to review the basic elements of the proposals to determine which IRB (CHW or MCW/Froedtert) is appropriate to conduct the review. We would prefer to do this before you have put your effort into the submission process for either MCW or CHW review. Please contact the CHW IRB office at 266-7454 to determine if CHW review is the best option for your study.
Reportable events policy has been updated:
- CHW has updated the Reportable Events policy to be in line with new guidance from OHRP. Please review the new policy and associated forms for reporting. In summary, most SAE's that have traditionally been reported are no longer required to be submitted when they occur. Only those that are on-site and are life threatening or result in death need to be reported immediately. All others, including off-site SAEs should be reported at time of continuing review. Unanticipated problems, significant protocol deviations and DSMB/safety letters should be reported ASAP. Please discontinue the use of old SAE and Deviation reporting forms. Instead please use the new combined Immediately Reportable Event form. Please contact the IRB office at 266-7454 if you have questions regard these changes.
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