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听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听program听works towards the above goals by seeking to听improve investigator听performance through monitoring, education, and measurements of the overall quality and effectiveness of protocol management. The reviews are intended to help PIs听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

1. Notification of on-site review

The Investigator will be notified via email听that their protocol has been selected for an on-site review. This听email will contain听logistical information, the scope of听the on-site visit as well as听requests to observe听certain study procedures and the consent process (if protocol is in open enrollment).

2. Preparation

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.

3. Starting the on-site review

On an agreed upon date, the on-site review occurs, beginning听with an opening meeting to discuss the scope of the review and to allow for questions to be asked by the investigators.听Total, the review can take anywhere from 2-4 hours听and can possibly be split between different days due to scheduling听restraints.

4. During the on-site review visit

Through a combination of discussions and observations, the protocol review takes place. Here, we are assessing whether听what听was approved by the IRB is actually听being implemented in your research practices. See below for the 5 areas of a protocol that are examined during an on-site visit.

5. Post review

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.

6. Correction Action and Close Out

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.

听

For a more detailed description of the on-site review process or the corrective action process, please see the Human Research Protocol Review Procedure听or the Corrective Action Procedure.

During the on-site visit, the following areas of a human research protocol are reviewed:

1. Recordkeeping and Documentation

It is the PI's responsibility to maintain accurate and complete study documents. See the听IRB Investigator Manual听for more information on what is expected when it comes to your research. This听documentation list听provides further guidance on what documents to have readily available when performing human research.

2. The Consent Process

Aside from the inspection of consent form documentation, if your study is selected to undergo a routine review while you are currently in open enrollment, the QA/QI office will request to observe the consent process.

3. Procedures

We will request to observe 1-2 study procedures performed on/by a study subject if the protocol is still gathering data. We will also interview available lab personnel听on procedures described in the protocol that detail how your research is conducted and managed.

4. Data Management

听How you are storing and protecting sensitive human subject data is just as important as obtaining results from that experimental data.

5. Personnel & Proper Training

听Are all personnel actively involved in working with human subjects listed on the protocol and are they trained on the protocol's procedures and through CITI?

FAQ

No, you didn't do anything wrong that caused your study to be selected for a review. The study was chosen randomly from a list of approved protocols that fit certain criteria that increase risk. See the Routine On-Site Review procedure on this webpage for more information on how studies are selected.

Routine On-Site Reviews are similar to an audit in that the reviews are systematic and their purpose is to determine if the conduct complies with regulatory and university policy standards. Routine on-site reviews are not performed in response to a concern or complaint. Instead, these reviews are done for any study that involves export controls or is IRB-approved and meets the criteria for conducting a QA review (See Routine On-Site Review Procedure for this criteria). Routine on-site reviews are听intended to be done at a quick pace in order to cover more protocols and to provide a 鈥渟napshot鈥� overview of the study鈥檚 compliance with regulations and university policies.

Most Routine On-Site reviews are completed in less than four hours during a single visit if we can coordinate in a procedural observation. Additional visits may be needed, as studies will require atleast 1 procedural observation (and for newly approved studies, observation of the consent process).

Read the "Preparing for an On-Site Review" page (link on the QA/QI program's homepage). It will give you all the information you need on how to prepare. In short, make sure that the relevant documents and records are available for the review (can be electronic or hardcopy). The best approach to present your study records for review is: "as-is." That way, should any previously unknown problems be found, they can be brought to your attention for follow-up, reporting (if applicable), and corrective action.

Once the onsite review is completed, a report will be provided to you detailing any findings and recommendations yielded from the review. If the review identifies any non-compliance such as protocol deviations which have not already been reported to the IRB, these will be noted in the report for follow-up and reporting by the PI. Within 2 weeks of completing the on-site review, a date/time will be established for an in person meeting between the QA/QI office and the PI to deliver a report. If any action is needed on the PI's part after that meeting, it will be discussed at that meeting. If serious non-compliance is discovered during the routine on-site review, a final report will be emailed to the Pi within 24 hours of the on-site review and immediate corrective action will be required.

The report is provided to the PI of the study, the CU IRB, and Associate Vice Chancellor of Research. No other parties are notified unless we must disclose that a serious violation has occurred (human rights issue to OHRP, Export control issue to the US government).

Please see the "Purpose of On-Site Reviews" webpage. The link can be found on the QA/QI program's homepage.