1. Delivering Bad News Terry VandenBosch, PhD, RN, CIP, CCRP Managing Director Office of Human Research Compliance University of Michigan

2. 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?

3. In this workshop, you will:  Refresh communication concepts  Role play  Auditor  Principal investigator with noncompliance  Impartial observer  Regroup for feedback

4. Approaches  Philosophy of approach: Is it service or police?  Distinguish “Requirement” or “Best Practice”  Professionalism  Know everything?  A passion for research and education

5. 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

6. 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

7. Communication Model Person Encodes Person Encodes Decodes Message Feedback Source: Schramm, 1954 adapted by Farias, 2011

8. Encoding and Decoding  Emotions  Knowledge  Background  Biases  Ability

9. Communication Updates  Reactivity and responses  Reviewer  Principal investigator  Explore root causes  Body Language  Language

10. 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

11. 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…”

12. Phases of the Onsite Review  Preparation  Onsite Phases of Relationship  Report  Follow up

13. Be Prepared  IRB submissions and approvals  Informed consent  Protocol  PI information  Audit/Review “Workpapers”  Educational materials

14. 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

15. Three Phases of Relationship 2) Conduct the review Develop a relationship and record review – Challenges in conducting the study – Friendly non-verbal communicati on – Matter of fact observations – Cause of difference “what should be” and “what is” – Record review -

16. 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?

17. Questions or Comments?