Update On Final Rule Announcement

On January 19, 2019, the regulations for human subjects research will look significantly different.  These changes will affect most, if not all, of our researchers at Appalachian.

What are the changes?

1. An expanded definition of "research" which will definitively exclude some activities from requiring IRB oversight.

2. The removal of the the "continuing review" (or renewal) requirement for expedited studies; some exceptions will be applied.

3. Changes in the "exemption" categories which will expand what is considered exempt.

4. The inclusion of data sets and biospecimens in the definition of "human subjects," with additional guidance on appropriately reviewing studies including data sets or biospecimens.

5. A focus on readability of informed consent forms.

As Appalachian prepares Standard Operating Procedures, guidance documents, forms and review criteria to comply with the new regulations, we will provide updates to our research community.  We are also taking this opportunity to revise some of our internal procedures to reduce staff workload and streamline the review process.

Please note:  All IRBs submitted BEFORE January 19 will be subject to the current IRB regulations.  As we transition to the new regulations, we will likely "close" the IRB office for a short period to enable the online form to update and be compliant on January 19, probably the week of January 14.