September 2009 - The IRB is now accepting social applications by e-mail. Researchers need to submit their application using their University of Minnesota e-mail accounts as it will ensure secure password protected authentications. If you are a student researcher, you must carbon copy (CC) your advisor. Send completed applications to: IRB@umn.edu and then you will be able to track the status of your proposal at http://eresearch.umn.edu/erc/.
The IRB has also updated a few of its forms to comply with new regulations and University policies. Revisions were specifically made to sections on human subjects training, oversight and monitoring, the subject profiles, and Appendices E, F and I. You can ensure that you will always have the most current version of IRB forms by downloading your application from the IRB web site: http://www.research.umn.edu/irb/download/
August 2009 - HRPP is adding an additional component to the continuing review process in order to meet current regulations. Starting September 1, the most current version of the HIPAA Authorization forms will be required at continuing review. Please ensure the HIPAA Authorization form is submitted electronically with your consent and assent forms to avoid any delays in approval.
August 2009 - HRPP is now sending all approval letters by e-mail. Approval letters will be attached as a pdf from irbappvd@umn.edu. Sending these letters by e-mail will streamline the communication process, reduce costs, and trim paper usage.
July 2009 - Updates have been made to the Health & Biological/Medical Application Form, version 5.1, and to the Social & Behavioral Sciences Application Form, version 4.7, Medical Record Chart Review (MRCR) Form, and Exempt Screening from IRB Committee Review Application Forms.
The main changes include updates to the training information in the study personnel section, revised funding categories in the funding section, language revisions in the expedited eligibility section, and language revisions in informed consent section.
June 2009--The Human Research Protection Programs has instituted a one-time fee of $2,500 to cover the costs of initial and ongoing IRB review applicable to all business and industry sponsored clinical trials. The decision to implement this fee was based on the significant increase in volume of industry-sponsored research at the University over the last several years. While this is a positive trend, it has led to a dramatic increase in submissions requiring review by the Institutional Review Board (IRB) for human subjects and substantially increased the cost associated with providing thorough, timely reviews.
September 2008--The IRB's Health and Biological/Medical application form is updated as of September 1, 2008. One significant change relates to the Clinical Research Budgeting and Billing Policy established by the Academic Health Center (AHC) which takes effect September 1st. This policy pertains to services provided on a research protocol by Fairview Health Services or University of Minnesota Physicians (see section 3.2 of the revised application).
This updated application also includes changes to Apppendix A (Research Funding) to reflect the IRB fee for initial review of business and industry sponsored research protocols.
Please download the IRB application from the IRB's Web site each time you submit a new study for review to ensure you are always using the most current version.
January 2008 --The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is holding its annual conference in Minneapolis. To quote AAHRPP, “Institutional officials, IRB professionals and chairs, compliance professionals, researchers, sponsors, and patient group leaders should attend.”
The program provides an excellent opportunity to learn from leaders in the field of human research.
The University of Minnesota is proud to hold full AAHRPP accreditation.
Program and Registration Information
|
