Oversight Q & A

The CIRB is responsible for the regulatory IRB review of studies. The institution is responsible for the oversight of studies. The CIRB requests details on how an institution provides oversight at their institution, to ensure the safe and appropriate conduct of research. Oversight is addressed within the Annual Signatory Institution Worksheet, question 8.

The CIRB needs to understand:

• The process for collecting and reviewing qualifications of the research team. Items that address this question include standard operating procedures that detail the process, forms that are required within the institution to document qualifications, or the name of a system at the institution where this information is maintained. Any recurring requirements should be stated.
• What is happening at the institution. This includes understanding what studies are open and how many study participants are enrolled at the institution; identifying potential noncompliance with a study; knowing when an investigator is being audited and the outcome of the external audit; and determining when the study is completed. This is generally achieved through different communication pathways, including regular meetings, ad hoc meetings, and reports provided to the contact person. Attaching items that are extremely useful in addressing this question include standard operating procedures, committee charters, organizational charts, and reporting schedules.
• Who is monitoring the research team to ensure compliance. Monitoring usually includes, but is not limited to, ensuring the correct consent forms are used, enrolled study participants meet the eligibility criteria, study procedures are conducted per protocol, and study agent is administered per protocol. The monitoring is in addition to the every three-year Network audits. Attaching items that are extremely useful in addressing this question include audit schedules, monitoring plans, standard operating procedures, checklists for chart reviews, and external audit procedures.
• What is done to ensure compliance with human subjects protection requirements. Attaching items that are extremely useful in addressing this question include standard operating procedures and any other documents related to the monitoring to ensure research team compliance.
• How study participants and researchers get their concerns addressed. There should be a way to communicate with the people at the institution as well as a way to resolve any concerns. Attaching items that are extremely useful in addressing this question include standard operating procedures, consent form boilerplate language, and communication plans.