How long does the review process take?
There are three types of reviews. These three types are: Exempt, Expedited, or Full-Board --depending on risk to subjects, composition of subject population, and other factors. The review and approval process can take between 2 - 6 weeks. Thorough preparation and planning on your part will ensure an efficient application process.
Can I begin my study without IRB approval?
The short answer is NO! Understand, under no uncertain terms, is an investigator or members of the investigative team allowed to commence with human subject research, including recruitment or initial advertisement or distribution of informed consents, without the express permission and authorization granted by the IRB and another required approval depending on department.
Can I submit a proposal for funding or to an outside sponsor without IRB approval?
Yes, provided the sponsor allows it. The IRB office has an Intent to Apply process for all proposals prior to the submission of the application. Complete this online form and download the documents you will need when you do apply to the IRB. This process does not relieve the investigator from the responsibility to secure IRB approval prior to commencing any human subject research, including recruiting of subjects or initial advertisement.
How can I take Human Subject Protection Training?
The National Institutes of Health (NIH) Office of Extramural Research provided an online research ethics course that used to be a free ethics training program (before September 27, 2018) for researchers conducting research with human subjects. Currently, the course is being updated and a new version will be available from November 6 with a $39.99 fee for the course and the associated certification by the Protecting Human Research Participants Online Training Group, which is not affiliated with NIH. It requires self-registration and the completion of training modules and a quiz. A printable certificate is issued at the end and remains on file in the training site and is required by the IRB.
Wilkes University IRB is in the process of updating the training options. Please check back in for updates in the near future.
If you need any training materials for a class or for professional learning before Wilkes IRB decides on the training and certificate provider, please access the NIH archived course content available for download on the NIH Research Involving Human Subjects website. Please note that this course content is available as a reference and it is not actively maintained or updated by NIH as of September 26, 2018.