Duke Human Vaccine Institute Science Culture and Accountability Plan
The Mission of the Duke Human Vaccine Institute (DHVI) is to perform basic, translational and clinical research necessary to discover the enabling technologies 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 10 principles to maintain the highest standards for work ethics and research integrity.
- 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 is 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. To this end, 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.
- 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.
- 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 are 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.
- Maintain an environment where all DHVI laboratory notebooks, electronic files, and clinical case report forms and databases are open to appropriate DHVI leadership. The expectation is that all at DHVI make primary data available to any 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. 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 authorized DHVI leadership. All scientists will document their active work each day. All DHVI laboratory and clinical data records (eg, notebooks, data files) are property of Duke University and will remain at DHVI when team members leave Duke.
- 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), 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.
- When key discoveries are made, they are independently replicated by others. Another key to open science is replication of experimental data and statistical analyses by others. DHVI leadership expects 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, data sets relevant to clinical studies, trials, and patient care decisions will be independently analyzed by external statistical reviewers.
- 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 (eg, Immport, GenBank, ClinicalTrials.gov), or by providing data, experimental methods, and/or statistical methods, and analytical tools upon request to promote open access.
- Concerns regarding scientific or research data integrity raised by students, post-doctoral fellows, laboratory 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. If disagreements arise, they are to be resolved prior to public presentation or submission for publication.
- 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, and career development. In addition, these meetings include discussions of data provenance, data reproducibility and best practices for analyzing, reporting and communicating data.
- Data provenance is a priority. Data provenance a DHVI priority. Research at DHVI includes discovery science, translational research, trials monitoring, and clinical research, and each of these kinds of research have different requirements for data reporting. 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 when 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 by faculty and updated at least once every two years as data provenance principles continue to evolve. 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 to support clinical studies and trials, systems that maintain audit trails for files from data acquisition through analysis and reporting will be used.