January 2023
Duke University is committed to maintaining the highest quality and integrity of all its scientific enterprises. Because of this commitment, the School of Medicine is required to have mechanisms to guarantee the responsible management and critical review of scientific data.
The School of Medicine has opted to allow individual departments to adopt their own policies and procedures related to scientific accountability and integrity. For this reason, the Clinical and Translational Science Institute is committed to ensuring that policies and procedures are in place to reflect the highest professional conduct and to promote a culture in which scientific results are critically reviewed with accountability for data integrity.
In the Clinical and Translational Science Institute (CTSI), we recognize this requires the active participation of all parties in the research mission, all students, postdoctoral fellows, visiting scholars and staff are responsible for the documentation of all data generated in the process of performing research. In addition to being essential to the generation of scientific knowledge, proper data management ensures reliability and reproducibility in all work.
The CTSI has prepared the following Science Culture and Accountability Plan. This plan promotes a culture that encourages responsible data management and ensures data of the highest integrity and also reflects these important principles:
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We foster an environment where scientific integrity is the highest priority.
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We emphasize high-quality, reproducible data and results.
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We value constructive critiques of research.
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We allow open discussion of any concerns regarding research conduct or integrity.
All members of the CTSI are expected to reflect and pursue these values. Ours is a shared commitment to the highest standards of scientific activity.
High-quality research begins with careful planning and study design. Engages appropriate collaborators, statisticians, and other relevant team members for constructive input before clinical studies begin. Having well-defined study goals protects against fraud and improves the quality of results.
Most of us rely on our trust of and judgment in others to ensure the integrity of data. However, this alone is not sufficient. While you should continue to put your faith in others, you should reinforce this with specific practices and institute processes to ensure that data are managed responsibly.
All members of the community will endeavor to exhibit the highest level of professionalism in all their work. All members of the community should feel encouraged to report breaches of professionalism to their supervisor, or Deb Chavis-Keeling, CTSI Chief Administrative Officer (CAO).
Primary data must be stored in a manner so that other scientists can independently analyze, so that scientific conclusions do not have to rely on a single person providing the analysis.
Rather than creating an individual clinical research database, strongly consider leveraging institutional resources such as the Duke Biobank, REDCap databases, Pedigene or other similar centralized data infrastructures.
Always strive to utilize best practices in data analysis and statistics. This can involve consulting with a biostatistician both before and after data collection. If statistical analysis is needed, take advantage of resources that provide professional statistical expertise (e.g., the Biostatistics consultation service).
All staff engaged in research in any way are required to participate in the relevant Responsible Conduct of Research (RCR) Program. For new staff, information related to institutional policies and procedures, as well as expectations related to scientific integrity and accountability are included in the onboarding process. Changes to policies and procedures will be communicated to staff engaged in research regularly. Staff engaged in research are encouraged to participate in additional educational opportunities related to professional development and scientific integrity.
Structural Organization of CTSI the Research Quality Team (RQT):
- Ranee Chatterjee Montgomery, MD, Research Quality Officer (RQO)
- Abha Singh, Lead Research Administrator (LRA)
- Deb Chavis-Keeling, Chief Administration Officer (CAO)
The RQO, has primary responsibility for addressing research integrity concerns, keeping research staff informed of relevant updates to institutional policies and procedures, assisting with Clinical Quality Management Plans (CQMP) and data management plans (DMP), and working with the Advancing Scientific Integrity, Services and Training (ASIST) Team to track research related training compliance. Research administration is overseen by the LRA in conjunction with the CAO.
Questions related to Scientific Culture and/or Accountability, or anything related to scientific integrity may be directed to any member of this team at any time.