Routine On-Site Reviews of Human Research Protocols
If you are currently conducting non-exempt research on human subjects that has been approved by CU Boulder's IRB, your protocol is subject to on-site reviews.
The purpose of this review program is to assist CU Boulder and investigators in conducting human research that is of the highest ethical quality and is compliant with relevant federal and university requirements. The program works towards the above goals by seeking to improve investigator performance through monitoring, education, and measurements of the overall quality and effectiveness of protocol management. The reviews are intended to help PIs performing human research improve their processes and to be an educational exercise on good research practices for lab personnel.
The reviews specifically aim to:
- Ensure that what was approved by the IRB is being implemented in a PI's research practices and is appropriately documented.
- Provide support to research teams in assessing, implementing, and maintaining compliance.
- Assure the continued protection of human subjects and their rights when they are taking part in a research study.
If your protocol is selected to undergo a routine on-site review, please visit the Preparing for an on-site review page or contact the QA/QI office directly with any questions/concerns.
Overview of the On-Site Review Process
The Investigator will be notified via email that their protocol has been selected for an on-site review. This email will contain logistical information, the scope of the on-site visit as well as requests to observe certain study procedures and the consent process (if protocol is in open enrollment).
We recommend preparing for your upcoming human research protocol on-site review. To do so, we offer guidance on the on-site review preparation webpage. If you have any additional questions/concerns, please contact the QA Coordinator. We are here to help.
On an agreed upon date, the on-site review occurs, beginning with an opening meeting to discuss the scope of the review and to allow for questions to be asked by the investigators. Total, the review can take anywhere from 2-4 hours and can possibly be split between different days due to scheduling restraints.
Through a combination of discussions and observations, the protocol review takes place. Here, we are assessing whether what was approved by the IRB is actually being implemented in your research practices. See below for the 5 areas of a protocol that are examined during an on-site visit.
Following the visit, a final report will be written noting any findings (and their required corrective actions) and recommendations for improvement. A "close out" meeting will then be scheduled where the QA Coordinator will issue a final report to the PI (and lab staff if available) and review it with them, as well as answer any questions.
If the review's final report contained any findings of noncompliance, the PI will be required to respond to them via the corrective action worksheet supplied with the report duing the close out meeting. Some findings will require an amendment to be submitted. Once the lab has responded with the appropriate corrective action, the on-site review will be officially closed out - no further aciton will be required.
For a more detailed description of the on-site review process or the corrective action process, please see the Human Research Protocol Review Procedure or the Corrective Action Procedure.
During the on-site visit, the following areas of a human research protocol are reviewed:
FAQ