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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.
Interested in learning more about the Standards? Contact us to request a copy of the full Standards, which contains the detailed description of what NCURA Peer Reviewers consider when conducting a Peer Review.
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.
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.
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.
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.
Institutional Integration of Obligations Made with Sponsored Programs Activities
20. STANDARD for Institutional Integration of Obligations Made with Gift, Institutional, or Sponsored Programs Activities.
21. STANDARD for Export Controls.
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.
The institution has established programs of education for physicians engaged in research, staff, teaching and research faculty, postdoctoral fellows, and graduate and undergraduate students, as appropriate, regarding institutional and sponsor expectations for the conduct of research related to research compliance oversight requirements. The institution has on-going educational programs for unit-level (department, college, center, other) research compliance administrators where such exist. The educational programs are developed with consideration for various roles, responsibilities, and activities of the individuals rather than a single package for all.
The research compliance program recognizes the importance of introducing new physicians engaged in research, faculty, staff, senior administrators, and unit-level research administrators to appropriate compliance resources and information. Mechanisms are in place to identify such individuals.
(This Standard is accompanied by six features used by the Peer Reviewers in their assessment.)