Each Wednesday, UNMC Today features an informational article about changes affecting UNMC’s Institutional Review Board (IRB) and the research community. Today’s article outlines future changes.
Because of guidance updates from federal regulatory agencies and the IRB accreditation process, the UNMC Institutional Review Board (IRB) is making many changes to the process of human subject protection at UNMC, the University of Nebraska at Omaha and The Nebraska Medical Center.
“What other changes are coming from the IRB?”
More new and revised forms
In addition to the forms mentioned in an earlier article, the following forms will begin appearing on the IRB Web site in the near future:
- Rights of Research Participants (Spanish Version)
- Request for Change Report
- Emergency Treatment Report
- Excess Human Biologic Material Application
- Research Involving Records Research Involving Protected Health Information (PHI)
- Research Involving Prisoners Application Addendum
- Research Involving Genetic Testing Application Addendum
- Humanitarian Use Device Application
- Humanitarian Use Device Consent Form Guidelines/Template
As these forms are released, e-mail notifications will be sent out and training sessions (Lunch and Learn) scheduled.
IRB policies, procedures and guidelines
You may have noticed that the IRB Web site says that “Policies” are available, but if you access it, it only says “Under construction.” As part of the accreditation process, all of the IRB policies, procedures and investigator guidelines have been undergoing massive revision to more closely reflect federal regulations, guidance and nationally accepted practices, as well as the requirements of the national accreditation agency (AAHRP). Eventually, when the IRB has approved all of these changes, the policies, procedures and investigator guidelines will appear on the IRB Web site (http://unmc.edu/irb/forms). In the future, IRB Standard Operating Procedures (SOPs) also will be available.
In the meantime, if you need access to an IRB policy or procedure, do not hesitate to call the Compliance Coordinator, Gail Paulsen, at 559-3853 for assistance.