Each Wednesday, UNMC Today features an informational article about changes affecting UNMC’s Institutional Review Board (IRB) and the research community. Today’s article examines whether the new application forms are different.
As discussed in the Institutional Review Board (IRB) article in the May 12 UNMC Today, all of the IRB applications have been undergoing revision and will begin appearing on the IRB Web site (http://unmc/edu/irb/forms.html). This is being done at this time because of guidance updates from federal regulatory agencies and the IRB accreditation process. This time we will discuss what new things you may find in the revised forms.
“How are the new application forms different?”
At first glance, the new applications appear even longer than the old ones. In reality, much the same information is required, but the sections are subdivided and the applications contain more investigator guidance. For example, you will find expanded sections on:
- Target Accrual
- Age Range of Subjects
- Methods and Procedures
- Methods of Subject Identification and Recruitment
- Process of Consent
Some sections have been added, or expanded, in response to specific requirements from AAHRPP, or the Association for the Accredition of Human Research Protection Programs (the IRB accreditation agency), changes in guidance from federal regulatory agencies, or changes in practices nationally. The IRB now needs to obtain new or additional information about:
- Protection of subjects (including contraception requirements)
- Use of drugs and devices
- Data and safety monitoring
- Financial conflict of interest
- Prior IRB review of research
- Ongoing process of informed consent
Finally, the IRB is now required to obtain assurance from the investigator and the institution that research has been reviewed for scholarly merit and that adequate resources are available to conduct the research. The chairperson, authorized delegate, or a representative of an appointed review committee of the principal investigator’s school, department or division must now provide certification of scholarly merit and peer review on the IRB application form. If the certification is not present, the IRB cannot review the protocol.