What is a Best Practice Review (BPR)?

A听 BPR is a voluntary opportunity for PI's conducting human research to recieve quality improvement recommendations and an on-site, low pressure evaluation of how their projects and protocols are being conducted in accordance with their IRB approval, regulations, and university policies.听

The intention of the BPR program:

Protecting the rights and welfare of human research subjects

Ensuring the quality and intergrity of the data obtained.

Assist with regulatory guidance and research management.

Give faculty confidence that research is being conducted in accordance with regulations, policies, and best practices. WE ARE HERE TO HELP YOU!

To request a BPR for your protocol, email:听Isabel.Weber@colorado.edu

What a BPR Entails

A Best Practices Review will involve you requesting the QA/QI Office Coordinator to visit your office or laboratory to review research documentation, procedures, data management, and anything else you desire to ensure compliance and consistency with the research file information that the University retains. A BPR can be requested at any part of your research project's lifecycle.

DISCLAIMER: If any noncompliance is discovered during the course of a BPR, the overarching compliance office responsible for approving your research will be notified and corrective action will be required. THIS IS A GOOD THING as the purpose of a BPR is to scan your research in order to eliminate risk involved with noncompliance.

BPRs are temporarily only available for research falling under IRB听approval. At a later date, researchers whose work involves Export Controls and IACUC approval may be able to request BPRs, however we are directing them to human research projects only at this time. Research falling IRB approval will be reviewed based on the standards of听that respective office's Investigator Program Manual.

When you request a BPR, you are asked to list what exactly you would like the QA/QI office to focus on during the review. This way, you can tailor the BPR to your needs and/or concerns.

Here is the general list of research听information that our office offers to review during a BPR:

Record Keeping & Documentation
The Consent Process
Procedures
Data Management
Personnel & Proper Training

Reasons to Consider a BPR

You are an investigator looking for some outside perspective and feedback on how your research project is functioning.
You have come across variables that have lead you to make adjustments and changes to your protocol, and you would like confirmation that you and your staff are using only approved IRB procedures and documents.
Your research operation and team is LARGE and you need a helping hand to confirm that things are being done consistently among team members and that all your ducks are in a row.
For peace of mind, you want to confirm that only IRB approved procedures and proper documentation are being implemented in your research for the following reasons:
- You anticipate an external audit (i.e. FDA).
- You recently began working on a new protocol.
- You've made amendements and adjustments to your protocol recently.
You are in need of general help and recommendations for managing your research protocol.

Doing your own BPR

If you would rather perform your own abbreviated Best Practices Review to evaluate if all of your ducks are in a row, we offer the following checklist for your use:

Self-Administered BPR Worksheet

This self administered BPR is an abbreviated version of the in-person BPR but is a good representation of what will be looked at during that on-site visit. If you are finding the self assessment to be not helpful, vague, and would like a more in depth, 1 on 1 review of your research and how its managed, feel free to contact the QA/QI Office to schedule an in person, Best Practices Review. We Don't Bite :)

For your contemplation, below are the positive and negative aspects of conducting your own self administered BPR

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Positives

You may feel more comfortable in performing this informal evaulation of your own research.
The Self-Administered BPR can be done on your time and is abbreviated, making it a quicker process.
Use it as a tool to teach your lab manager on how to properly manage a protocol with best practices in mind.
A quick way to tell if anything might be lacking in how research is being conducted/documented.

Negatives

The Self-Administered BPR is an abbreviated version of what the QA/QI office can provide you in-person and is not as in-depth.
Your own bias towards your project may hinder your evaluation of how the research is being conducted.
Can be time-consuming (let us do it!)
Lacking a third-party opinion can close your mind from considering different avenues or practices to improve research integrity.

NOTE: A BPR is not a tool to be used for checking and approving changes made to your protocol and study documents associated with it. All changes must be reviewed and approved by the IRB prior to implementation.

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