Conference Explores Misconduct in Clinical Research

June 18-19, 2015
Chevy Chase, MD

The Second Institutional Review Board/ Research Integrity Officer (IRB-RIO) Conference, hosted by the U.S. Office of Research Integrity (ORI), the U.S.  Office for Human Research Protections (OHRP) and Georgetown University, is taking place June 18 - 19 in Chevy Chase, MD.  This conference will bring together professionals from research integrity and human subjects protections to increase institutional coordination in the handling of allegations of misconduct in clinical research settings.

Follow the conference live on Twitter with @HHS_ORI and #IRBRIO.

Conference Agenda

Day 1 – Thursday, June 18, 2015

7:45 a.m. – 8:15 a.m. Registration/Continental Breakfast

8:15 a.m. – 8:30 a.m. Welcome and Introductions (Zimmet)

8:30 a.m. – 8:45 a.m. Setting the Stage and Defining the Meeting’s Purpose (Garfinkel and Hammatt)

• Increasing awareness of research misconduct and the intersection between 42 C.F.R. 93 and 45 C.F.R. 46;
• Fostering efficiency and improving cooperation between IRB chairs and RIOs;
• Desired outcomes.

8:45 a.m. – 9:45 a.m. What is Research Misconduct in Clinical Research? (Grace)

• Universal definition for research misconduct in clinical research, the knowns and the grey areas (40 mins.);
• Interactive Case Study (20 mins.).

9:45 a.m. – 12:15 p.m. Panel Presentations

• 9:45 a.m. -10:30 a.m. Process and Coordination: Starting Out on the Right Track (Bierer and Borror) (45 mins.)
  • In the IRB context;
  • Dissecting the RIO and IRB processes;
  • What are the practical conflicting issues in coordinating these processes?
  • Who is the respondent?
  • Multiple institutions.
• 10:30 a.m. -10:45 a.m. Mid-Morning Break
• 10:45 a.m. – 11:30 a.m. Sequestration (Zimmet and Garfinkel) (45 mins.)
  • Electronic data and methods for establishing and maintaining data integrity;
  • Practical application in clinical research misconduct cases.
• 11:30 a.m. – 12:15 p.m. Confidentiality (Barnes and Lau) (45 mins.)
  • As viewed by IRB vs. RIO notifications (journals, funding agencies, others);
  • Pending patent applications and licenses to industry of intellectual property when provenance/integrity is in question;
  • What to do about grant applications and manuscripts that include the data in question;
  • What to do when a respondent and/or complainant publicizes proceedings.

12:15 p.m. – 1:30 p.m. Lunch

1:30 p.m. – 3:30 p.m. Workgroup Break-Out Sessions (led by panelists)

• Workgroup #1: Process and Coordination: Starting Out on the Right Track (Bierer and Borror)
  • ​Discussion of case study.
    • Research misconduct vs. protocol deviations and the grey areas;
    • Who to notify and when;
    • What should the IRB disclose to researchers about data concerns?
    • Should study be halted? If so, when?
    • Multi-center studies;
    • Timing.
  • Outcome: Create a checklist that addresses basic due process concerns.

• Workgroup #2: Sequestration and Data Integrity (Zimmet)
  • ​Discussion of case study.
    • What to sequester, when and how;
    • Maintaining chain of custody;
    • Ongoing study/patient/participant care.
  • Outcome: Develop guidelines for sequestration of data in clinical research misconduct cases. Review ORI sequestration SOP.

• Workgroup #3: Confidentiality (Barnes and Lau)
  • ​Discussion of case study.
    • Who “needs to know?” How much should the IRB know regarding the research misconduct proceeding?
    • Research participant confidentiality;
    • When to notify participants;
    • What should participants be told and when?
    • Notification to other institutions, funding agencies, journals;
    • What to do when the case goes public;
  • Outcome: Guidelines for when to release information, and possible confidentiality agreements (joint non-disclosure, etc.)

3:30 p.m. – 3:45 p.m. Break

3:45 p.m. – 4:45 p.m. Plenary Session: Summary of Breakout Sessions

4:45 p.m. - 5:00 p.m. Concluding Remarks

5:00 p.m. - 7:00 p.m. Reception

Day 2 – Friday, June 19, 2015

8:00 a.m. - 8:30 a.m. Continental Breakfast

8:30 a.m. – 10:45 a.m. Plenary Session: Refining Outcomes and Next Steps (Panelists)

Continued Development of Outcomes:

• Process and coordination (30 mins.);
• Sequestration and data integrity (30 mins.);
• 15-minute break;
• Confidentiality (30 mins.);
• Future working group activity (30 mins.).

10:45 a.m. – 11:00 a.m. Break

11:00 a.m. - 11:45 a.m. The Increasing Litigiousness of Federal Compliance Proceedings   (Qualkenbush)

11:45 a.m. – 12:00 p.m. Concluding Remarks

12:00 p.m. – Adjourn: Boxed Lunch - Farewell