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Standards for an Effective Research Compliance Program
The National Council of University Research Administrators (NCURA) developed these 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 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 239 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.
Institutional Planning and Investment in Cultivating a Culture of Responsibility
I. STANDARD for Institutional Recognition and Commitment to a Culture of Responsibility.
II. STANDARD for Institutional Investment in Facilities Used for Regulated Research Activities..
Components and Structures of the Research Compliance Program
III. STANDARD for How the Research Compliance Program is Organized.
IV. STANDARD for the Organization and Interaction of the Research Compliance Committees and Other Related Advisory or Standing Services.
V. STANDARD for the Staffing Infrastructure to Support the Research Compliance Program.
VI. STANDARD for Institutional Resources Supporting the Research Compliance Program.
Research Compliance Communication and Outreach
VII. STANDARD for Research Compliance Program Communications.
VIII. STANDARD for Outreach Efforts and Program of Research Compliance Education for Stakeholders.
Faculty Engagement and Faculty Burden
IX. STANDARD for Faculty Engagement and Faculty Burden in Research Compliance.
Risk and Policy Management in the Research Compliance Program
X. STANDARD for Research Administration Risk Assessment.
XI. STANDARD for Research Compliance Policy Development and Implementation.
XII. STANDARD for Business Continuity in the Research Compliance Program.
Research Compliance Systems and Management of Program Data
XIII. STANDARD for Technology and Systems Supporting Research Compliance Operations.
XIV. STANDARD for Management of Data Relevant for Programmatic Oversight and for Researchers.
Partnerships and Non-Employees Interacting with the Research Compliance Program
XV. STANDARD for Affiliations Impacting Regulatory Research Compliance Oversight.
XVI. STANDARD for Non-Employed Individuals Engaged with Research and the Role of Regulatory Compliance Oversight.
Clinical Research and Clinical Trial Proposal Development and Administration
XVII. STANDARD for Clinical Research and Clinical Trial Proposal Development and Administration.
Institutional Integration of Research Compliance Obligations Made with Sponsored Programs Activities
XVIII. STANDARD for Institutional Integration of Research Compliance Obligations Made with All Research Funding.
XIX. STANDARD for Export Controls.
XX. STANDARD for Research Misconduct.
Financial Conflict of Interest
XXI. STANDARD for Financial Conflict of Interest.
Protection and Oversight Related to Research Activities
XXII. STANDARD for Use of Humans in Research.
XXIII. STANDARD for Use of Animals in Research.
XXIV. STANDARD for Controlled Substances.
XXV. STANDARD for Biohazards and Select Agents.
XXVI. STANDARD for Radiation and Laser Safety.
XXVII. STANDARD for Laboratory Safety.
XXVIII. STANDARD for Human Stem Cell Research.
XXIX. STANDARD for Human Anatomical Specimens.
XXX. STANDARD for Specialized Research Activities.
For questions or further information, please complete our information request form.
The research compliance program has created and extends programs of education for physicians engaged in research and teaching and research faculty, staff, postdoctoral fellows, and graduate and undergraduate students, as appropriate to institution size and as meet regulatory requirements. Included in education is information regarding institutional and sponsor expectations for the conduct of research. 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 research resources, information. Mechanisms are in place to identify such individuals.
(This Standard is accompanied by five features used by the Peer Reviewers in their assessment.)