Research Compliance Review

Standards for an Effective Research Compliance Program

The National Council of University Research Administrators (NCURA) developed these National Standards to represent the institutional baselines that provide a supportive environment for the conduct of research.  These Standards provide expectations for broad operational and core functional areas for an effective research compliance program (non-financial). 

Unlike an audit, this peer review performs an assessment of your research compliance “program” that goes beyond merely highlighting deficiencies in process.  The assessment contains three interrelated features: senior and experienced research compliance Reviewers, the National Standards, and a philosophical approach that provides consistency in the review process with an understanding of institutional culture.  These key features result in an assessment of effectiveness of the research compliance environment at the institution undergoing peer review.

While recognizing that institutions differ in organizational structure and institutional priorities, these Standards reflect how the institution integrates the research enterprise with its institutional goals and expectations and operationalizes an effective research compliance program resulting in the ethical, responsible and compliance conduct of research. The Standards allow Reviewers to assess how closely that integration relates to institutional and stakeholder goals and expectations.  The emphasis of the standards is on developing a culture of responsibility where roles and responsibilities are clearly defined, and that the relevant programs are developed and implemented as partnership amongst all stakeholders including administrators, faculty and oversight committees; with each individual accepting their responsibility for responsible conduct of research.  The Standards contain a list of over 165 features that are utilized by the Reviewers during their assessment and that are used as the basis for the written report.

 

Institutional Commitments 
1. STANDARD for Institutional and Research Compliance Planning.
2. STANDARD for the Organization of the Research Compliance Program.
3. STANDARD for the Organization of the Research Compliance Committees.

(the full Standards include descriptions of each area; request a copy)

Compliance oversight committees are appropriately established and constituted and represent existing areas of research. The authority and role of compliance committees is clearly defined and understood. Effective operational processes exist between the research compliance program and business functions.

This Standard is accompanied by 8 features used by the Peer Reviewers in their assessment

 

4. STANDARD for Advisory or Other Committees that Support the Research Compliance Program. 
5. STANDARD for Institutional Investment in Facilities Necessary for Research Compliance Programs. 
6. STANDARD for Research Compliance Staffing. 
7. STANDARD for Resources to Support the Research Compliance Program. 

Faculty Engagement and Faculty Burden
8. STANDARD for Faculty Engagement and Faculty Burden. 

(the full Standards include descriptions of each area; request a copy)

The institution has considered the impact on faculty in meeting compliance obligations and mechanisms to reduce or manage that burden. Faculty have opportunities to raise concerns relating to expectations and commitments and there are clearly identified channels for such.

This Standard is accompanied by 6 features used by the Peer Reviewers in their assessment.

Institutional Communications
9. STANDARD for Research Compliance Program Communications. 

 

Research Compliance Policy Development
10. STANDARD for Research Compliance Policy Development. 


Program of Education About Research Compliance 
11. STANDARD for the Program of Education About Research Compliance. 

Assessment and Institutional Preparedness
12. STANDARD for Risk Assessment. 
13. STANDARD for Institutional Preparedness for Research Disasters or Media Exposure. 

Information Management
14. STANDARD for Information Systems Supporting the Research Compliance Program. 
15. STANDARD for Institutional Management of Research Compliance Data. 
16. STANDARD for Research Compliance Data Accessible to Constituents. 

Institutional Affiliations and Relationships
17. STANDARD for Research Affiliations with Other Organizations. 
18. STANDARD for Affiliations with Non-Employed Individuals. 

Clinical Research and Clinical Trial Proposal Development and Administration
19. STANDARD for Clinical Research and Clinical Trial Proposal Development and Administration.

(the full Standards include descriptions of each area; request a copy)

Resources and structures exist to assist faculty in the development of clinical research proposals and clinical trials.
The institution has policies and procedures in place to assure that appropriate clinical trial administration occurs and that there is a consistent application of standard of care of individuals participating in clinical trials.

This Standard is accompanied by 13 features used by the Peer Reviewers in their assessment.

Institutional Integration of Obligations Made with Sponsored Programs Activities
20. STANDARD for Institutional Integration of Obligations Made with Gift, Institutional, or Sponsored Programs Activities. 

Export Controls
21. STANDARD for Export Controls. 

Research Misconduct 
22. STANDARD for Research Misconduct. 

Financial Conflict of Interest 
23. STANDARD for Financial Conflict of Interest. 

Protection and Oversight Related to Research Activities
24. STANDARD for Use of Humans in Research. 
25. STANDARD for Use of Animals in Research. 
26. STANDARD for Controlled Substances. 
27. STANDARD for Biohazards and Select Agents. 
28. STANDARD for Radiation and Laser Safety.  
29. STANDARD for Laboratory Safety. 
30. STANDARD for Human Stem Cell Research. 
31. STANDARD for Human Anatomical Specimens. 
32. STANDARD for Specialized Research Activities. 

 

Request your copy of the Standards for an Effective Program of Research Compliance by contacting us at peerreview@ncura.edu  or via telephone at (503) 364-1847.