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?