Monitoring enhances human subject protections by promoting regulatory compliance and supporting institute-wide standards for the ethical conduct of research. At NYSPI, monitoring of IRB approved research activities includes a conventional compliance auditing function, but also enriches the process of ongoing review of approved research by providing data on the experience of subjects participating in the research and interim data on risks and benefits. Finally, the monitoring process contributes to investigator education and training.
- Study Monitoring: More than minimal risk
Record review is aimed at determining compliance with IRB approved recruitment, consent, procedural, exclusion, drop-out and adverse event reporting requirements. For this type of review, the IRB research monitor, or others independent of the research team, examine research files and charts.
In the event of a report of a protocol violation, record review may require a systematic audit of study compliance with consent documentation requirements.
- Regulatory Monitoring: IND or IDE Regulatory Binders
All FDA-regulated studies must maintain a Regulatory Binder with essential documents. These documents individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced and serve to demonstrate the investigators compliance with Good Clinical Practice Standards and all applicable regulatory requirements. When monitoring studies that are FDA-regulated, the IRB Research Monitor will review the Regulatory Binders to ensure that they contain all required documents.
Special Monitoring is usually requested by the Board at the time of initial study approval. It may involve any of the following special monitoring activities:
- Case Reporting
Most often case reporting is requested by the Board as a condition of initial study approval and will focus on a safety concern. The Board may request case-by-case reporting or a report back on the first five enrolled.
The Board regularly requires this information when novel or high- risk procedures are involved.
Case reporting may be conducted at the request of the Board or the Chair. For example, case reports may be requested following the report of an adverse event to ensure that study inclusion and exclusion criteria or study drop-out criteria were met as per the approved protocol.
- Consent Observation
The research monitor observes the consent process to assure that required information is conveyed to the subject, the subject's understanding of the study is facilitated and the choice to participate is carefully considered and discussed. The monitor may focus the assessment on one component of the consent process, at the request of the IRB, when special emphasis is required.
- Procedural Observation
The research monitor observes the subject's participation in a study a procedure or component. Procedural observation assesses the subject's experience during the research procedure, ensures compliance with research procedures as specified in the research protocol, and observes the environment of care and the research team's interactions with the subject with regard to privacy, safety, and respect.
- Subject Feedback Surveys
The IRB may ask the investigator to create a survey tool or instrument to collect subject level data on the experience of participating in the research study. The survey may assess the level of burden a subject experienced during participation, side effects experienced, or how well the consent process prepared them for what they experienced during the study.