Developing Action Plans for Responding to Noncompliance

Protecting research participants is essential to the clinical research enterprise. When researchers engage in serious and continuing noncompliance with research regulations, institutions must develop and enforce action plans to address this noncompliance. Action plans developed by institutional officials (IOs) often lack complete and accurate identification of the root causes of noncompliance.
This project addresses this challenge by determining what action plan activities would be most effective to change researchers’ behavior. Interviews and a national survey of IOs will identify how to develop effective action plans, including identifying root causes and corresponding remediation activities. A resource guide will be developed for national dissemination to help IOs’ develop better action plans.

We will determine the strategies institutions use to develop action plans for serious and continuing noncompliance and identify root causes and associated actions and activities. This will be done by interviewing institutional officials in the U.S. about action plan procedures, content, and perceived effectiveness. We will also administer a survey to institutional officials at all U.S. health science research institutions (n ≈ 170) to gain an understanding of action plan development practices, action plan content, and perceived effectiveness.

To create an action plan resource guide, we will bring together 6 experts in responsible research to review interview and survey results, root cause and development activities, and relevant professional development literature. We will then use this information to develop a robust action plan resource guide.

We have completed in-depth interviews with 47 IOs: 9 Research Integrity Officers, 13 IRB Directors or Chairs, 7 IACUC Directors or Chairs, 6 Chief Research Officers, 6 Compliance Officers, and 6 Conflicts of Interest Officers. Analysis of interview data is in progress. We have launched the national survey of IOs, with data collection in progress. Resource guide development is underway.

Data collection in progress.