Science and Accountability

Duke Human Vaccine Institute Science Culture and Accountability Plan

June 2024

The Mission of the Duke Human Vaccine Institute (DHVI) is to perform basic, translational and clinical research necessary to discover, manufacture and test enabling technologies necessary to prevent and treat global emerging and re-emerging infections. Maintaining the quality and integrity of basic, translational and clinical research in the DHVI is integral to our mission. The DHVI Science Culture and Accountability Plan (SCAP) is underpinned by ten principles. All trainees, staff and faculty are expected to follow these ten principles to maintain the highest standards for scientific culture and accountability. Principles pertain to Training and Education; Scientific Rigor and Reproducibility; Data Management, Storage and Provenance; and Communication.

1. Maintain an environment in which research results are open and transparent, and DHVI scientists, trainees and technical staff feel comfortable to discuss the data generated. Communication and trust are key to an open and transparent research environment. The DHVI leadership will continually remind staff that due to the resources entrusted to us, the expectations of us are similarly great. In our activities, there can be no road but the high road. We will strive to reinforce this principle in all DHVI-wide meetings as well as individual lab meetings. All DHVI leadership and faculty will model the highest standards of behavior in the conduct of science. This includes promoting credibility and transparency of the research by disclosing any financial or personal relationships through the Conflict of Interest process and in Other Support documents per agency requirements. It also includes ensuring appropriate Material Transfer or Data Use/Transfer Agreements are in place for incoming or outgoing data use. As preparation, all investigators will fulfill Responsible Conduct of Research (RCR) Training, relevant modules for Collaborative Institutional Training Initiative (CITI) and Stewardship and Compliance for Research Investigators (SCRI) training. In turn, we pledge to discuss the pitfalls of publishing incorrect data, the factors that contribute to scientific fraud, and discuss ways for DHVI members to handle work stress that can lead to scientific misconduct.
    
2. Create a research environment in which each research team member feels comfortable and supported to say, “I don’t know the answer to the question” and “I made a mistake.” DHVI leadership and faculty will guarantee that no trainee or staff member is criticized for admitting that they made a mistake. At DHVI-wide meetings and individual lab meetings, DHVI members will be told that the only way to be an A+ scientist is to be able to admit a mistake and to take corrective action and prevent similar mistakes from occurring in the future. We pledge to maintain an environment where there will be no shaming of a person who admits that a mistake has been made.
    
3. Maintain an environment of timely written and verbal communication of data from and to science team members (faculty, trainees, technical staff) that enables open discussion and sharing of generated data. At DHVI, every trainee and research staff member is expected to regularly report, through written communication, the primary data they have generated and their plans for future studies. This reporting can take many forms including but not limited to weekly email updates to the PI or senior investigators of each team and/or reporting to the entire work group.  Senior investigators will document scientific directions for each team member in the form of written and verbal communication during group and individual meetings with the goal of transparency. Group meetings are particularly important in order to let all team members understand what other members of the team are doing. The purpose of these communications is to ensure that DHVI team members are not competing with each other on the same projects, create an open exchange of ideas and information among investigators working on similar projects, and to allow senior team leaders to review all primary data. The overarching goal is to create an environment of openness, and to provide the opportunity for scientific critique.
    
4. Maintain an environment where all DHVI laboratory notebooks, electronic files, and clinical case report forms and databases are securely stored and accessible to appropriate DHVI leadership. Data at DHVI is stored in a designated approved secure location on the SOM server, in REDCap or another approved protected environment. Through appropriate security channels, the expectation is that all at DHVI make primary data available to any IRB or otherwise authorized person who wishes to review it, with the goal of having many eyes review primary data. Hard copy numbered DHVI laboratory notebooks are available to be assigned to individual scientists and are to be retained by the principal investigator of each laboratory. Clinical paper records are stored as required by Duke policies and in accordance with the approved Research Data Storage Plan (if applicable). Electronic notebooks require authentication and automatically time and date stamp entries. Both hard copy and electronic notebooks as well as clinical case report forms and databases will be open for examination by any member of the work group and IRB or otherwise authorized DHVI leadership. All scientists will document their active work each day. All DHVI laboratory and clinical data records (e.g., notebooks, data files) are property of Duke University and will remain at DHVI when team members leave Duke. Faculty members who leave DHVI must meet with a member of the RQMP, CRU or DHVI Leadership team to ensure appropriate storage of records and transfer of data, if applicable.
    
5. All research findings are discussed internally during scheduled lab meetings and ad hoc team meetings, with outside collaborating team members, and are reviewed by external scientific advisors. The DHVI research portfolio includes funding from a number of sponsors, such as the US National Institutes of Health (NIH), Bill & Melinda Gates Foundation (BMGF), the US Centers for Disease Control and Prevention (CDC) and US Department of Defense (DOD). Each sponsor has requirements for the timely reporting of findings to program staff and for the dissemination of scientific findings to the wider community. Many of the sponsors/programs also require independent review by external Scientific Advisory Boards (SABs) or other convened panels. Research findings are discussed within individual research groups, internally at DHVI lab meetings, and externally through regularly scheduled calls and meetings. This matrix of oversight is critical as many research projects could lead to human clinical trials, and the protection of our trial participants is of highest priority for DHVI. This level of oversight ensures that research findings are vetted by independent scientists who can critique the methods and results.
    
6. When key discoveries are made, they are independently replicated by others. For the purposes of adhering to the 2023 NIH Data Management and Sharing Policy and promoting open science at DHVI, it is expected that all published work is replicated in the laboratory that generated the data, and that all critical discoveries are independently confirmed. Independent confirmation of critical discoveries can take the form of another scientist replicating the experiment in a blinded fashion and/or confirmation by a different laboratory group. DHVI leadership expects that statistical teams will review, analyze and apply the most rigorous standards to publication of data; these teams include both internal DHVI and external statisticians among our collaborators. It is expected that statistical and computational experts will be involved in all projects from their inception, and will participate as key members of all project teams. Furthermore, appropriately de-identified data sets relevant to clinical studies, trials, and patient care decisions will be placed in repositories per NIH policy, to enable evaluation by independent reviewers.
    
7. Before papers are submitted for publication, they will be rigorously reviewed and have comments and changes incorporated.  After publication, data will be made public on appropriate websites and/or on upon request. Manuscripts will be reviewed and approved by each co-author on the manuscript prior to submission. Scientific and statistical teams involved in the work will also approve regardless of their inclusion on the author line. For consortium-derived papers, there may be an additional layer of review by a publication committee before manuscript submission. For all published data generated at DHVI, the data are shared freely with the scientific community, either by posting raw and summary data on appropriate websites (e.g., Immport, GenBank, ClinicalTrials.gov), or by providing data, experimental methods, and/or statistical methods, and analytical tools in accordance with NIH Data Management and Sharing Policy or upon request to promote open access.
    
8. Concerns regarding scientific or research data integrity raised by students, post-doctoral fellows, laboratory and clinical research staff product development and manufacturing staff and faculty are all taken seriously and vetted by DHVI leadership and/or external review.  The open environment in DHVI is expected to make all members, including trainees, feel completely comfortable to question data and ongoing studies. This is accomplished by robust open conversations and good modeling of constructive critical discussions of all data. Each technician, clinical staff member, clinical research coordinator, trainee and investigator is encouraged to raise issues and question either data or the interpretation of data. All will be made aware of the DHVI scientific integrity escalation pathway and other available resources for dispute resolution. If disagreements arise, they are to be resolved in partnership with all relevant parties prior to public presentation or submission for publication.
    
9. A mentoring program is in place for all faculty and trainees. Each faculty member has clearly defined expectations of accountability of science and compliance with all university and federal regulations. This is further documented in annual review letters for each faculty member. DHVI leadership has an open-door policy and encourages all trainees to meet to review data together and hear concerns either individually or in dedicated forums for communication with trainees in the absence of other senior staff. There are dedicated independent meetings for trainees and faculty to review mentoring, scientific literature, career development and updates to regulatory and administrative policies and procedures pertaining to scientific integrity. In addition, these meetings include discussions of data provenance, data reproducibility and best practices for analyzing, reporting and communicating data.
    
10. Data provenance is a priority. Research at DHVI includes discovery science, manufacturing-related science, translational research, trials monitoring and clinical research, and each of these kinds of research have different regulatory guidelines and requirements for data reporting. Where applicable, all data will be maintained in compliance with Health Insurance Portability and Accountability Act (HIPAA), Duke Institutional Review Board (IRB), Good Clinical Practice (GCP), good manufacturing practice (cGMP), and other policies as required. To facilitate good practices for data provenance, DHVI will hold regular meetings with faculty and key staff members to ensure Standard Operating Procedures/Data Management Plans are developed in accordance with the 2023 NIH Data Management and Sharing Policy and when otherwise appropriate. It is expected that each senior investigator and service core director will develop, implement, and maintain Data Management Plans (DMPs) to ensure the integrity and reproducibility of all scientific data generated in their research programs or service cores. It is expected that these DMPs will be regularly reviewed in accordance with their NIH or other DMP protocol. DHVI will work to maintain data systems that provide automated file indexing and version control as well as secure and centralized permanent archives. For data generated pursuant to NIH funding, data will be shared in appropriate repositories or as otherwise stipulated in the Sharing Plan. For non-NIH data generated to support clinical studies and trials, systems that maintain audit trails for files from data acquisition through analysis and reporting will be used.

Culture of Research Infrastructure at DHVI

Scientific integrity is everyone’s responsibility. Those ultimately accountable for ensuring a conducive environment include:

• DHVI Research Quality Management Program (RQMP) Team
  • Derek Cain, Director of DHVI Flow Cytometry Facility
  • Lynn Harrington, Research Practice Manager
  • Maceni Muse, Director of Information Technology
  • Connie Riley, Director of Finance and DHVI Lead Research Administrator
  • Wes Rountree, Lead Biostatistician
  • Emmanuel Walter, CRU Director/Chief Medical Officer
  • Kevin Wiehe, Director of Research
     
• DHVI Senior Leadership
  • Barton Haynes, Director
  • Kevin Saunders, Associate Director
  • Thomas Denny, Chief Operating Officer
  • Michelle Smith, Chief Administrative Officer
  • Kelly Cuttle, Chief of Staff

Addressing Research Integrity Concerns

Members of the DHVI community are encouraged to raise any concerns pursuant to Scientific Culture and Accountability. Depending on the seriousness of your concerns, you may reach out to the following (in order of escalation).

• Direct Supervisor or Mentor
• CRU Director or Research Quality Officer
• DHVI Senior Leadership
• SOM Vice Dean for Clinical Research or Vice Dean for Basic Science, as applicable

Note that matters of data integrity are not necessarily scientific misconduct. Scientific misconduct must be promptly reported to the Vice Dean for Clinical Research or Vice Dean for Basic Science (as relevant) who will investigate the concerns and take appropriate actions. For anonymous reporting, contact the Integrity Line (1-800-826-8109). For other questions, contact the Duke Office of Scientific Integrity.