Each Wednesday, UNMC Today features an informational article about changes affecting UNMC’s Institutional Review Board (IRB) and the research community. Today’s article deals with new or revised applications, forms and guidelines.
Because of the process of accreditation through the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and guidance updates from federal regulatory agencies, the UNMC Institutional Review Board (IRB) has been reviewing, revising, and designing new applications and forms over the past year. These new and revised applications and forms are designed to help the investigator efficiently answer all the questions the Board is required to review.
Very soon, you will notice that the IRB application forms you have grown accustomed to over the years will no longer be available on the IRB Web site (http://unmc.edu/irb/form). One of the major changes is that the IRB will not separate research into “therapeutic” and “non-therapeutic” categories. To more appropriately classify the type of research, two new categories will be utilized, “Biomedical” and “Social and Behavioral Science.”
Most research conducted at UNMC and The Nebraska Medical Center will use the Biomedical Research application. UNO researchers will use the Social Science and Behavioral Research application. If you think your research does not fit the assigned application form, call the Office of Regulatory Affairs (ORA) at 559-6463 for assistance.
The following is a listing of the new or revised applications, forms and guidelines that should appear on the UNMC IRB Web site this month:
- Biomedical Research Application
- Biomedical Consent Form Guidelines/Template
- Social and Behavioral Science Research Application
- Social and Behavioral Science Consent Form Guidelines/Templates
- Exemption Application
- Continuing Review Report
- Addendum for Waiver of Informed Consent
- Expedited Request for Change in Protocol for a Single Subject Report.
- Retrospective Violation Report
- Rights of Research Participants (English version)
When the new applications and forms are ready for primetime, we will let you know by e-mail and schedule future training sessions (Lunch and Learn).