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In this workshop, you will: Refresh communication concepts Role play Auditor Principal investigator with noncompliance Impartial observer Regroup for feedback
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Delivering Bad News
Terry VandenBosch, PhD, RN, CIP, CCRPManaging DirectorOffice of Human Research ComplianceUniversity of Michigan
Perception and Practice
What are ways to get information across? What are ways to change behavior? How do we listen to researchers? How do researchers listen to us? How do we listen to ourselves? How do we discover root causes of
noncompliance?
In this workshop, you will:
Refresh communication concepts Role play
Auditor Principal investigator with
noncompliance Impartial observer
Regroup for feedback
Approaches Philosophy of approach: Is it service or
police? Distinguish “Requirement” or “Best
Practice” Professionalism Know everything? A passion for research and education
Audit Analysis Criteria
What should be
Condition What is
Cause Root cause-Why a difference
So what Significance?
Recommendations Based on the root cause CAPA
It’s Social in Nature
NOT a social conversation with a friend Power differential Professionalism
IS social in nature Interaction important to receptivity and
reactivity Audit and clinician behavior change
Communication Model
Person
Encodes
Person
Encodes Decodes
Decodes
Message
Message
Feed
bac
k
Feed
bac
k
Source: Schramm, 1954 adapted by Farias, 2011
Encoding and Decoding Emotions Knowledge Background Biases Ability
Communication Updates Reactivity and responses
Reviewer Principal investigator
Explore root causes Body Language Language
Language Findings vs observations Violations vs deviations Assist you with implementing human subjects protections Noncompliance recommendations vs corrective actions “Human subjects protections” from whom is the subject being
protected? Routine review vs compliance assessment Audit vs review Deficiencies vs corrective actions
What Might You Say?
Listening Responses Action Responses Confirmation
I can appreciate why this might have happened, we often see this when…• You’re not stupid• You’re not the only one
Third person One way I’ve seen other researchers have solved this issue…How might this work
for you?• Receptivity and reactivity
Factual “I found you didn’t do…” vs “As I looked over the records, I noticed many
instances where there was not…”
Phases of the Onsite Review
Preparation Onsite Phases of Relationship Report Follow up
Be Prepared IRB submissions and approvals Informed consent Protocol PI information Audit/Review “Workpapers” Educational materials
Three Phases of Relationship 1) Initiating discussion
Pleasantries and small talk provide comfort and connection
- Introductions all around- Authority and how chosen- Provide reason/goal of the review
- Describe relationship with the IRB
- Describe audit process
Three Phases of Relationship 2) Conduct the review
Develop a relationship and record review
– Challenges in conducting the study
– Friendly non-verbal communication
– Matter of fact observations– Cause of difference “what should
be” and “what is”– Record review
-
Three Phases of Relationship 3) Wrapping up
Answer the question, “How much trouble am I in?”
– Summarize the observations– Focus most on “so what”– Find something positive to say– Provide info on next steps– CAPA– End “pleasure working with you”– Follow up as needed and Is there
anything else I might assist with?
Questions or Comments?