Research Policy

  1. All publications involving the use of Clinical Simulation Center resources must acknowledge the Clinical Simulation Center.

  2. All research proposals to the Clinical Simulation Center (CSC) must be reviewed by the CSC research committee.

  3. If you wish to submit a proposal that draws on existing CSC data, or data from trainees or departments other than your own, you must submit a proposal and receive prior approval from the research committee. Three members of the Research Committee, excluding the Center Director, will review the proposal. The Principle Investigator of the original research must be invited to participate in the review process. In the event that the PI has not completed the use of data associated with his/her project, s/he has the right to restrict access to those data. The PI must provide written authorization for use of data collected for other projects in secondary analyses before the research committee considers granting approval.

  4. If a proposal is accepted, the Director of the Clinical Simulation Center will review the projectís feasibility and resource support requirements.

  5. The Clinical Simulation Center will maintain an IRB for studies of center-wide research.

  6. The Clinical Simulation Research Committee will identify and track scholarly outcomes associated with the Simulation Center. The Clinical Simulation Centerís website will include a list of projects and publications.

  7. The Clinical Simulation Research Committee will identify and review policies and manuscripts generated from other Simulation Centers, focusing on those that have included translational outcomes, as needed.

The following policy statements are intended to make explicit the plans, programs, and practices that the Clinical Simulation Center uses to protect, deliver, and enhance the value of data and information gathered with the resources of the Clinical Simulation Center resources:

I. CSC Policies related to Data Management and Integrity

  1. All educational and research projects conducted with the Clinical Simulation Centerís resources must identify a lead faculty member. If more than one faculty member is involved in the conduct of the project, the lead faculty member on the project should provide to the Clinical Simulation Center a comprehensive list of those faculty members. Student projects must identify a faculty member responsible for the supervision of the project.

  2. Each educational project and research project will be assigned a unique numerical identifier. For educational projects, the identifier will be assigned at the time of the lead faculty memberís submission of an instructional plan for the project. For research projects, the Clinical Simulation Research Committee will assign the identifier at the time of the completion of the projectís review.

  3. Lead faculty members must provide to the Clinical Simulation Center a copy of the description of each project; the Clinical Simulation Center will keep a copy of the project descriptions in a secure setting in its archives. Lead faculty responsible for the project should provide a paper or electronic copy of assessment instruments associated with the project. This policy is intended to protect the integrity of data gathered. Access to the assessment instruments for other projects must be explicitly negotiated by the interested faculty member with the faculty member leading the project. Access to the data gathered must be explicitly negotiated by the interested faculty member with the faculty member leading the project.

  4. Data security measures are intended to keep information gathered safe from corruption or unauthorized access. These measures apply to written and electronic data. Practices followed to protect data integrity in the physical environment include: making servers accessible only to network administrators, keeping transmission media (such as cables and connectors) covered and protected, and protecting hardware and storage media from power surges, electrostatic discharges, and magnetism. Information stored on the Clinical Simulation Center server will be backed up electronically at least weekly. The Clinical Simulation Center will maintain current authorization levels for all users, documenting system administration procedures, parameters, and maintenance activities, and creating disaster recovery plans for occurrences such as power outages, server failure, and virus attacks.

  5. Copies of data stored on the Clinical Simulation Center server will be provided on request to the lead faculty member on educational projects and the Principal Investigator of research projects. The associated core data on the Clinical Simulation Center server will be maintained, not destroyed.

  6. Lead faculty on educational and research projects can request preliminary reports on electronic data gathered or stored at the Clinical Simulation Center in order to assure the validity of the data gathered.

II. CSC Policy statements related to Resource Allocation

The following resource allocation policies are intended to promote transparency and guide responsible use of Center resources, for both education and research:

  1. All projects require review and approval of the Clinical Simulation Center. Policies related to prospective review of budgets associated with the conduct of both educational and research projects include:

    • Educational or research projects that annually require less than $1,000 in costs for materials or products and less than 5% of one Clinical Simulation Centerís staff time are not required to provide the Center with a budget for review prior to the implementation of projects approved by Simulation Center review on the merits of their proposed education or research.

    • Educational or research projects that annually require more than $1,000 in costs for materials or products and/or more than 5% of one Clinical Simulation Centerís staff time are required to provide the Center with a budget for review prior to the implementation of the project.

  2. All equipment and non-consumables purchased with CSC funds to support either education or research projects remain the group property of the CSC and do not follow the faculty member after completion of the project.

  3. The Center Director has the authority and responsibility for timely review of both educational projects, for which instructional plans have been submitted, and research projects, which have been reviewed by the Clinical Simulation Research committee, in terms of coordinating proposed use of Center resources with existing commitments. The Center Director should communicate in writing to the lead faculty and the Executive Committee if it appears that commitments to existing projects would be compromised with the implementation of educational and research projects accepted on the basis of their merit by the Steering or Research Committees.