Post-Approval Monitoring

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:

• Risk level of the study
• Studies involving investigational new drugs (INDs) or devices (IDEs)
• An investigator-held IND/IDE
• Studies enrolling vulnerable populations
• Studies requiring more frequent than annual review by the IRB
• Studies where there are concerns about the consent process

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:

• Participants File Review
• Informed Consent Content/Process (Documentation) Review
• Informed Consent Process (Observation) Review
• Complete Study File Review

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:

• Protocol file/regulatory documentation
• IRB documentation
• Signed informed consent/assent documents
• Individual Participant Records, a random selection may be used to determine if:
  1. Participants met the inclusion/exclusion criteria for the study.
  2. Study related procedures are performed as outlined in IRB protocol.
  3. Study related procedures are scheduled and performed per the study time line.
  4. Data are recorded and stored securely as described in the Consent Form and study IRB protocol.
  5. Adverse Events have been reported according to institutional policy.
  6. Protocol deviations have been reported to the IRB.
  7. Payments were made to participants as outlined in IRB protocol.
  8. Participant ID numbers are assigned as outlined in IRB protocol.
• Interviews with study staff
• Interviews with research study participants
• Observation of the consent process
  1. The timing of recruitment and screening in relation to informed consent.
  2. The appropriateness of the person containing consent.
  3. Steps to aid participants with barriers to understanding or lack of capacity to consent (language, reading level, etc.)
  4. Steps to see if the participant understands components of the consent form such as: the research purpose, risks, benefits, voluntary participation, withdrawal, confidentiality, costs/compensation, and contacts for questions or injuries.
• Observation of research procedures
• Other study related documentation and materials

1. 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). 

2. 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.

3. 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.

4. If you have any questions regarding preparing for the visit, please contact the Post-Approval Monitor for further information.

1. 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.

2. 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.

3. 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.

4. 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:

https://www.nova.edu/irb/staff.html.