Implications of Noncompliance

1
Implications of Noncompliance
Skye McDougall, PhD Network Research
Officer VISN 22
2
Implications of Noncompliance

• Restriction or Shut Down

3
Research Programs
4
Ongoing Research

• Assurance to conduct research

• Federal Wide Assurance

5
The Research Process
6
Restriction or Shut Down

• Assurance to conduct research

7
Why Does This Happen?

• Do not understand the rules and regulations

• Inadequate resources

• Inadequate documentation

8
Research Stops-Impact

• Confused patients-human subjects

• Upset, angry, frustrated investigators

• Academic affiliate

9
Research Stops-Impact

• The PRESS

10
Research Stops-Impact

• CHAOS

11
Fiscal Impact

• Continuing research slows down

• No new grants

• New staff

• VERA decrease

12
Elements of SuccessStaffing Needs

• IRB and RD committee members

• Where do you find qualified staff?

13
Elements of SuccessProtocol Management

• How many research protocols do you have?

14
Elements of SuccessTracking System

• Resources?

15
Elements for SuccessCommittee Structure
R D Committee Governing Body
16
Elements for SuccessSupport

• Education

• Culture

17
(No Transcript)
18
Unanticipated Problemsin Research

• New approach to local management

19
Mission

• Ensure that local management of unanticipated
  problems in research, including Adverse Events,
  assures maximal protection for research
  participants, and complies fully with all laws,
  regulations, and standards

20
Charge

• Identifying/Reporting
• What should be reported
• When should it be reported
• Where should it be reported

21
Charge

• Tracking/Database
• Monitoring
• Who monitors
• What is monitored
• What trends/patterns require further action

22
Charge

• Research v. Patient Safety
• Corrective Action
• Who takes action
• What are appropriate actions
• When does it become research misconduct
• Education
• Communication