The IRB Office would like to announce that the IRB Post-Approval Monitor will begin implementation of Not-for-Cause Evaluations begining January 2017.
The Institutional Review Board (IRB) at Nova Southeastern University leads the university’s human participant protection program. In addition to reviewing new research submissions to ensure they adhere to basic ethical principles underlying the acceptable conduct of research involving human participants, the IRB is tasked with monitoring research post-approval. The goals of Post-Approval Monitoring are to enhance both the protection of human research participants and the quality of research performed here at NSU. All active studies involving human participants under the purview of the NSU IRB can be selected for review.
Post-approval monitoring will consist of random, not-for-cause evaluations. A not-for-cause evaluation involves a compliance review of study-related documents and/or observation of the consent or research process. Studies are randomly selected for evaluations by the IRB Office.
Certain factors may increase the odds of a study being selected for evaluation, these include but are not limited to, the following criteria:
There are several categories of not-for-cause evaluations. Each category will have different items that will be reviewed by the Post-Approval Monitor. The Principal Investigator will be notified the category of evaluation they are receiving and what documentation they will need to prepare. The evaluation categories are as follows:
The IRB Post-Approval Monitor will officially notify the Principal Investigator, study coordinator, and faculty advisor/dissertation chair (if Principal Investigator is a student) of the study’s selection for evaluation with a Not-for-Cause Evaluation Selection Memo. This memo will list the required materials for review, study personnel requested for interviews, etc. Upon receipt, the Principal Investigator needs to contact the IRB Post-Approval Monitor in order to set up a date/time for evaluation and to discuss evaluation procedures. Not-for-cause evaluations may take place on-site or via webcam conferencing.
The evaluation process may include review of the following:
For any questions regarding a Not-for-Cause Evaluation, please contact the NSU Post-Approval Monitor.