Delivering Bad News

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 • ISsocial in nature • Interaction important to receptivity and reactivity • Audit and clinician behavior change

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

8. Encodingand Decoding • Emotions • Knowledge • Background • Biases • Ability

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

10. Language Findings vsobservations Violations vsdeviations Assist you with implementing human subjects protections Noncompliance recommendations vs corrective actions “Human subjects protections” from whom is the subject being protected? Routine review vscompliance 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 Relationship1) Initiating discussion Pleasantries and small talk provide comfort and connection • Introductions all around • Authority and how chosen • Provide reason/goal of the review • Describerelationship with the IRB • Describe audit process

15. Three Phases of Relationship2) 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

16. Three Phases of Relationship3) 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?