Science Culture and Accountability Plan

The mission of the Department of Anesthesiology is to provide extraordinary care through a unique culture of innovation, education, research, and professional growth.

Research, being central to this mission, is highly integrated with education to provide avenues for medical students, residents, fellows, post‐doctoral associates, visiting research faculty, and regular faculty members to contribute novel information to the foundations and practice of anesthesiology and to foster career development for scientists and physician‐scientists in the future.

The Chair and the Vice Chair of Research for the Department of Anesthesiology contribute to the organizational and ethical leadership for the department, guiding research principles and best practices, and fostering a community of collaboration and open dialogue. The Department has several processes in place to support best practices in research productivity and reproducibility, conduct, education, and accountability.

1) Tissue Banking Inventory

A tracking system for stored research specimens was developed and implemented in 2016. In this system, research biospecimens are barcoded in a manner that allows ready identification of location of the sample within a freezer. Cataloguing of existing samples and retrieval of specimens for analysis has been significantly enhanced. In FY17, we partnered with the biorepository developed by the Department of Surgery. For example, all samples transferred from UNC through the Center for Translational Pain Medicine are being stored in this biorepository.

2) Ensuring Research Progress for Junior Faculty

In order to more effectively develop our junior researchers, we have implemented a plan to conduct biannual reviews of trainees and junior faculty who are in a research track. The objectives of this program are: 1) to provide a mechanism for the department to ensure that trainees/junior faculty wishing to become researchers are “on track” to become successful 2) to provide the trainee with feedback as well as assistance with hurdles that may arise during research 3) to ensure that resources, e.g. seed money, protected/non‐clinical time, are being used wisely. The first such meeting of 4 of our junior researchers, their mentors, and senior research leadership of the Department (including the Chair) took place on July 14, 2014. This process has continued biannually since 2014 and now includes 10 junior faculty and their mentors, as well as our senior research leadership.

3) Extramural Grant Application Pre‐Submission Peer‐Review

We have in place a peer‐reviewed grant application committee, made up currently of three knowledge experts in the department. A timeline for submission of grant materials under the auspices of this program are distributed to researchers planning to submit a DOD or NIH grant.

We strive to sustain a culture of accountability and integrity. Resources available to, and requirements of, our faculty, staff and trainees include the following:

4) Data storage

It is a principle of research that data should be retrievable for independent analysis when required. In 2014 we launched a firewall‐protected data warehouse as a repository of source data used in any peer‐reviewed publication. Datasets are to be submitted to the Research Data Bank upon initial manuscript submission, resubmission or submission to a different journal. Credit for a published manuscript will not be provided unless the appropriate dataset has been uploaded. Access to the Data Bank is also restricted such that once a dataset is uploaded, it cannot be manipulated. Financial incentives tied to publication require that a dataset has been submitted to the Research Data Bank.

5) Grievances and Concerns Regarding Research Integrity

Over the past 10 years, the Department has dramatically matured in its organizational structure and foundation for supporting major growth in its research productivity and training. In order to manage issues that arise in which a party may feel disengaged or perceive conflict with individuals/departmental structures or have concerns about research integrity, we have developed a policy regarding departmental reporting of research‐related grievances and concerns. In 2014 the Department implemented a web‐based reporting system that allows members of the Department of Anesthesiology to report a complaint or concern. Reports will be confidential at all times and can be submitted anonymously, if desired. Once a report is electronically filed, an email containing the complaint will be automatically sent to the following 3 individuals: Chair, Vice‐Chair for Research, and Chair, Senior Research Council. Complaints/concerns will be addressed on a rolling basis with corrective measures implemented as appropriate. After initial review by these 3 Departmental members, and if appropriate, the report will be forwarded to relevant institutional officials. The 3 Departmental members will also meet at least every 6 months to review the status of complaints and corresponding resolutions.

6) Responsible Conduct of Research Training Plan

All faculty and staff engaged in research – those who either design, conduct or report on research projects ‐ will participate in the Faculty and Staff RCR Program. We currently have no plans to implement RCR training at a departmental level and will utilize the three options developed by the ASIST Office and the Trent Center for Bioethics. The requirements and training options, which include both online and in‐person modules as well as the opportunity to test out, will be posted with links on the department Intranet, distributed via our bi‐weekly newsletter, shared at faculty and staff meetings, and emailed directly to those identified as engaged in research by our departmental RCR contact, Beth Peloquin. At time of hire, Ilene Farkas will notify Ms. Peloquin if any new employees will require the training. Ms Peloquin will follow up as needed to ensure 100% compliance.

7) Clinical Research Unit (CRU) Director Metrics

In order to better align the CRU with the needs of the Department and the University, performance metrics for the Director of the Anesthesiology CRU were implemented in 2014. Elements assessed in these metrics include enhancement of the RB protocol process; quality assurance review process; study enrollment; training and oversight; finances; and constituent satisfaction. A copy of these metrics has been submitted to the Vice‐Dean for Clinical Research. We have since implemented a Research Leadership Administration Team (RLT), which is comprised of the department’s Finance Director, Grants & Contracts Manager, Financial Program Manager, and CRU Director of Operations who report to the Chief Department Administrator and CRU Director. This RLT meets every month to discusses research financial and operational items related to the clinical and government related grants. This team provides an enhanced and efficient support to the faculty so the faculty can achieve the necessary targets, enrollments, etc. to be successful. The RLT also provides management oversight of all administrative research areas allowing for cross‐talk and problem solving between all of the individuals listed above.

8) Standard Operating Procedures

By FY17, all Anesthesiology faculty who perform basic research submitted to the Dean’s Office completed Standard Operating Procedures which address basic responsibilities and expectations of all trainees, visiting scholars, staff and faculty, and includes details of content and maintenance of laboratory notebooks, quality and reproducibility of research data and publications, research integrity, protocol for training of lab personnel, and the culture surrounding presentation of data and research objectives to lab members.

Any faculty member new to Anesthesiology and engaged in basic science, will be expected to submit within 6 months a SoP for their laboratory or verify that the lab in which they conduct their research has a SoP on file.

Questions or comments: Contact Dr. William Maixner, Vice Chair for Research, at william.maixner@duke.edu.

Chris KeithScience Culture and Accountability Plan