Consider these familiar scenarios:

Scenario 1

During a site visit, a clinical research coordinator (CRC) observes the principal investigator (PI) deviating from the protocol when she recommends that a patient use an exclusionary medication for an adverse event. The CRC speaks up in the moment, only to be told that he is not to challenge the investigator when it comes to clinical care. The CRC knows the action is incorrect but is scared to speak up again for fear of being reprimanded.

Scenario 2

A clinical research nurse (CRN) in a hospital notices that she does not have the necessary bedding for a new patient. Instead of raising the issue, she goes to the next unit and uses their linens. This causes an unexplained supply issue in both units. The immediate needs were fulfilled, but the root cause was not addressed because the CRN did not want to ruffle feathers.

Scenario 3

A new CRC is hired to work at a site with a seasoned, tight-knit team who have been working together for the last year and have established a smooth operating process. The new CRC notices some operational inefficiencies and brings them to her director, who agrees that improvements can be made. The team members take offense at the suggestions and resist the changes. When they learn the new CRC was the one to propose the changes, they become less welcoming, causing her to question whether she should have made the suggestion in the first place.

What is Psychological Safety?

According to Amy Edmondson, a leading Harvard Business School researcher, psychological safety refers to “perceptions of the consequences of taking interpersonal risks in a particular context such as a workplace.” (1) As shown in the situations above, a lack of psychological safety is harmful to communication and can impact efficiency. In a team with high psychological safety, teammates feel safe to take risks. Edmondson has identified the particular importance of psychological safety in the areas of workplace collaboration and teamwork. Psychologically safe team members “feel confident that no one on the team will embarrass or punish anyone else for admitting a mistake, asking a question, or offering a new idea.” (2) This type of communication and team engagement can impact a site’s adverse event reporting, encourage team members to speak up on ways to improve, and help address the root causes of problems.

How Do You Know if Your Site has Psychological Safety?

What do you think makes a team successful? What separates a high-performing team from an average team? Google worked hard to answer these questions with a study called Project Aristotle (3) which aimed to determine what distinguishes high-performing teams from low-performing teams. Their results showed that the most successful teams had specific traits, with psychological safety as the top trait. When Google was analyzing psychological safety, they consulted Amy Edmondson. She suggested asking employees how strongly they agreed or disagreed with 7 simple statements:

  1. If you make a mistake on this team, it is often held against you.
  2. Members of this team are able to bring up problems and tough issues.
  3. People on this team sometimes reject others for being different.
  4. It is safe to take a risk on this team.
  5. It is difficult to ask other members of this team for help.
  6. No one on this team would deliberately act in a way that undermines my efforts.
  7. Working with members of this team, my unique skills and talents are valued and utilized.

A way to assess if your team has psychological safety is to routinely have each team member take the seven-item survey on psychological safety and other team dynamics. Most importantly, as Edmondson says, “Ask people directly, what are you seeing out there? I need to hear from you. What ideas do you have? What help can I offer?” When you listen carefully to their responses, you’re creating a moment and a culture of psychological safety. (4) If you create this sense of psychological safety within your own team starting now, you can expect to see higher levels of engagement, increased motivation to tackle difficult problems, willingness to take on more learning and development opportunities, and better performance. A team that is empowered with the above qualities will inevitably improve the overall quality of clinical research conducted at the site.
Note: This article originally appeared in the Winter, 2019 edition of SCRS Insite: The Global Journal for Clinical Research Sites.

  1. Delizonna, L. High-performing Teams Need Psychological Safety. Here’s How to Create It. Accessed November 11, 2019 from:
  2. Re:Work. Identify dynamics of effective teams. Accessed November 11, 2019 from:
  3. Rosenquist, S. How to Measure Psychological Safety in Your Team. Accessed November 11, 2019 from:
  4. Harvard Business Review. Creating Psychological Safety in the Workplace. January 22, 2019. Accessed November 11, 2019 from:

About the Author
Nicole Mills is Director of Clinical Research at Medix and currently works in our Scottsdale, Arizona office. Read more of here work here!