2003-001
Faculty and Staff Ethics Application Case Files
Research Ethics, Office of
| Records | Active retention (in office) | Semi-active (records centre) | Total retention | Final disposition |
|---|---|---|---|---|
| Faculty and Staff Ethics Application Case Files: Minimal Risk (Paper & Electronic) | CY data collection terminated | 3 years | CY data collection terminated + 3 years | Destruction |
| Faculty and Staff Ethics Application Case Files: Non-Minimal Risk (Paper) | CY data collection terminated | 3 years | CY data collection terminated + 3 years | Full Retention by Archives |
| Faculty and Staff Ethics Application Case Files: Non-Minimal Risk (Electronic) | CY data collection terminated | 3 years | CY data collection terminated + 3 years | Destruction |
CY = Current calendar year; CFY = Current fiscal year; CS = Current semester; S/O = Superseded or obsolete; OPR = Office of Primary Responsibility; Non-OPR = All other departments.
Records relating to the ethics review and approval of faculty and staff initiated research protocols or projects involving human subjects. Research involving human subjects occurs when data are derived from: 1) information that is collected through intervention or interaction with a living individual (e.g. interviews, questionnaires, observations taken that are noticeable by the individual); 2) secondary sources/non-public sources (e.g. interviews about a living individual, company personnel records, student records collected by an educational institution); and 3) identifiable private information about a living individual. Such research forms part of a faculty member's teaching activities or research portfolio or a staff member's duties. The Director of the Office of Research Ethics (DORE) reviews all applications and classifies them according to their category of risk (minimal risk or non-minimal risk). All applications must then go to the Research Ethics Board (REB) for review. The REB has the authority to approve a protocol or project, approve a protocol or project subject to modifications, or reject a protocol or project.
Faculty and staff are required to submit their applications for review through on-line web forms. These forms include: Request for Ethical Approval of Research; Sample of Informed Consent by Subjects to Participate in a Research Project or Experiment; Informed Consent for Minors or Captive and Dependent Populations; Project Information Document; Subject Participation Feedback; Subject Information Document; Supplementary Information to Follow by Mail; and Checklist. Case files may also include additional materials that are required or submitted as part of the application process such as correspondence, memoranda and e-mail, notice of approval with attached summary prepared by the DORE, debriefing forms, samples or descriptions of research instruments (e.g. questionnaires, surveys, equipment, etc.) research paper abstracts, and progress reports.
Data submitted through web forms is stored in a FileMaker Database maintained by the ORE. Additional materials that are required or submitted in support of the application review process may be in either paper form or electronic form as word processed documents, pdf documents, scanned text, graphic files, etc. Currently, the ORE creates a parallel hard copy case file by printing out all submitted electronic documents, including the data submitted through web forms, as an assurance against data loss or corruption through technological obsolescence or digital media fragility. As a result of this print-to-paper practice and the occasional receipt of supporting paper documents, the ORE maintains two versions of a case file, a paper one and an electronic one. The paper case file is treated as the authoritative “original” and will be sent to the Archives to be disposed of according to the retention rules described in this RRSDA. ORE staff are responsible for deleting/destroying the electronic records that comprise the electronic version of the case file at the end of the total recommended retention period.
The DORE acts as Secretary to the REB, making the Office of Research Ethics the Office of Primary Responsibility (OPR) for this records series.
See also the following RRSDAs:
2003-002, Student Ethics Application Case Files 2003-003, Course Ethics Application Case Files
This series is a Personal Information Bank; click here for PIB description.
These records are created, used, retained and managed in accordance with the following authorities:
Health Canada's Good Clinical Practice: Consolidated Guideline recommends that REBs should retain records for a period of at least three years after termination of data collection. Pursuant to this recommendation Minimal Risk Faculty and Staff Ethics Application Case Files will be destroyed after the total retention period (CY data collection terminated + 3 years) has expired. Non-Minimal Risk Faculty and Staff Ethics Application Case Files will be retained in full as a permanent record of the university's ethics oversight function and of the types of potentially contentious research involving human subjects conducted at ¶ˇĎăÔ°AV.
As explained in the Purpose and Description of Records, the ORE maintains two versions of a case file, an electronic one and a paper one. The paper case file is treated as the authoritative “original” and will be sent to the Archives to be disposed of according to the retention rules described in this RRSDA. ORE staff are responsible for deleting/destroying the electronic records that comprise the electronic version of the case file at the end of the total recommended retention period.
Faculty and Staff Ethics Application Case Files form part of the record-keeping system of the Office of Research Ethics which acts as secretariat to the Research Ethics Board. All paper case files are coded according to the ORE's file classification plan. Note that the reserved secondaries associated with the Faculty and Staff Ethics Applications primary have a total recommended retention period of CY + 7 years. See file plan for details.
At the end of the active retention periods, box the paper files and transfer to the University Records Centre (URC). Box minimal risk and non-minimal risk case files separately because they have differing final dispositions. Separate boxing will ensure that the correct disposition is applied to the two sub-series identified in this RRSDA. For each box transferred to the URC prepare a box contents listing, itemizing all files contained in the box. Always include ONE copy of the file list inside the box sent to the URC taped to the underside of the lid; keep ONE copy for your own records; and send ONE copy (paper or electronic) to the Archives (see Procedures for Transferring Records to the University Records Centre).
RRSDA is in force.
Approved by the University Archivist: 29 May 2003