The UAMS Office of Research Compliance announces some new review and feedback opportunities for the UAMS research community:
- We are now able to review any new pandemic-related processes to ensure that those processes meet FDA and OHRP guidelines as well as UAMS IRB policies. These reviews will be conducted upon request from the study team and will involve a desktop review (i.e. no in-person meeting required). No formal report will be submitted to the IRB.
- We also now offer desktop study reviews. These reviews can also be conducted upon request from the study team, or may be performed at random, and will not require an in-person meeting. Again, no formal report will be submitted to the IRB.
- We are modifying the NICE review process. In addition to traditional NICE reviews done before any study enrollment, we are offering NICE+ reviews conducted after the enrollment of 1-2 subjects. These reviews will be conducted upon request from the study team and will be desktop only. They will not require an in-person meeting and no formal report will be submitted to the IRB.
- We are developing a process for “research rounds” wherein we will meet with a study team or department to review risk areas and mitigating factors. We will discuss with the team members any areas where they perceive a potential risk and the procedures in place to mitigate those risks. Recommendations will be given if any improvements could be made, but no formal report will go to the IRB. These research rounds will ideally involve an in-person meeting and therefore will not be fully implemented until safe to do so.
Contact the ORC for more information or to request a review.