Routine Reviews are a mechanism to provide feedback regarding the conduct of research.
Routine Reviews are a mechanism for the Human Research Protections Program (HRPP) to provide verification of the conduct of human research projects. Routine Reviews are conducted on a scheduled basis by the HRPP Quality Improvement staff. Investigators can request a Routine Review of their research project by contacting the QI staff.
Routine Reviews serve multiple purposes.
- A Routine Review provides feedback to the principal investigator and research team regarding the conduct of the research project in accordance with the approved protocol, MCW policies/SOPs, federal regulations and good clinical practices.
- The principal investigator and research team can use this information in assessing their current research activities and the plan for continuation of the research project.
- Routine Reviews provide an opportunity for the investigator and study team members to address any questions or concerns they have.
- A Routine Review provides information regarding the conduct of the research project from another source to the IRB.
- The IRB considers the information upon receipt and during continuing review of the research project.
- Routine Reviews allow the IRB and the HRPP to better fulfill its mission to protect the rights, welfare and privacy of all individuals participating in IRB approved research by ensuring the conduct of human subject research adequately meets safety, regulatory compliance, scientific quality, and ethical standards.
- Aggregate information obtained from the routine reviews is an important measure of the overall effectiveness of the Human Research Protections Program activities.
Routine Review Process
- Routine Reviews are mandatory, and are scheduled to take place during a time that is convenient for the members of the research teams. The principal investigator, primary contact and the identified point of contact are notified of the upcoming Routine Review.
- Only research projects that meet the selection criteria are eligible for Routine Review. Research projects approved at a fully convened IRB meeting, or by expedited review, including Registered Projects are eligible for Routine Review.
- Routine Review activities include
- an interview to discuss the conduct and documentation of the research project
- review of signed consent forms
- review of collected research data
- may include review of the regulatory file
- discussion of the review activities and subsequent findings and recommendations
- A written Routine Review Summary is provided to the principal investigator and primary contact.
- The Routine Review summary, and if applicable the research teams corrective action plan, is forwarded to the overseeing IRB and filed in eBridge.
Routine Review Schedule
The Human Research Protections Program (HRPP) Routine Review Schedule was developed based upon information received from MCW departments and the divisions within the departments of Medicine and Surgery involved in human subject research. The schedule lists each department and applicable division in which the Quality Improvement (QI) staff will conduct a mandatory Routine Review and the agreed upon review period.