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.
A not-for-cause evaluation is a part of the NSU IRB Post-approval monitoring program. Not-for-cause evaluations involve 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. All active studies involving human participants under the purview of the NSU IRB can be selected for review.
Studies are randomly selected for evaluations by the IRB Post-Approval Monitor.
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:
Contact the Post-Approval Monitor within 10 business days of receiving Not-for-Cause Evaluation Selection Memo to set up an evaluation date/time and to discuss evaluation procedures.
The Post-Approval Monitor will send a list of all study personnel that will need to be interviewed (if applicable).
Please obtain contact information and the schedule availability of the Principal Investigator and other study team members listed in Not-for-Cause Evaluation Selection Memo before calling to schedule evaluation (if applicable).
The Not-for-Cause Evaluation Selection Memo will include a list of all required materials for review to the Principal Investigator. The Principal Investigator should collect and organize these materials in order to expedite the evaluation visit.
The Principal Investigator should review the Preparing for your Not-for-Cause Evaluation document to help organize themselves and their files for the evaluation visit.
If you have any questions regarding preparing for the visit, please contact the Post-Approval Monitor for further information.
Upon completion of the review, the Principal Investigator and study team will be notified via Not-for-Evaluation Determination Memo regarding the next steps if any are additional steps are required. Please review the memo in its entirety.
The memo will provide a detail summary of evaluation that will identify areas of improvement and recommendations for improvement. Recommendations and educational support may also be provided on record retention and documentation, and other compliance related issues.
If corrective actions are necessary, the memo will include any necessary actions/reporting required by the Principal Investigator or study team that will need to completed before the study may continue.
The Not-for-Evaluation Determination Memo will need to be signed by the Principal Investigator (and their faculty advisor or thesis/dissertation chair if Principal Investigator is a student) and returned to the Post-Approval Monitor to be included in their study file.
Office for Human Research Protections (OHRP) Policy and Guidance for Investigators http://www.hhs.gov/ohrp/
Food and Drug Administration (FDA) Regulatory Information http://www.fda.gov/RegulatoryInformation/default.htm
For any questions regarding a Not-for-Cause Evaluation, please contact the NSU Post-Approval Monitor. Their contact information can be found on the IRB Staff Contact Us page of the IRB website at: