REB105250: Exploring the Influence of Procedural Approaches on Surgical Training and Assessment
Dear Potential Research Participant,
You are being invited participate in a study exploring how multiple procedural approaches influence surgical training and assessment. This study is being conducted by Tavis Apramian, MD/PhD Student in the Schulich School of Medicine & Dentistry’s Centre for Education Research & Innovation and the Faculty of Health Sciences’
Graduate Program in Health & Rehabilitation Sciences. The primary investigator for this study is Dr. Lorelei Lingard from the Department of Medicine and the Centre for
Education Research & Innovation. The co-primary investigator is Dr. Sayra Cristancho from the Department of Surgery and the Centre for Education Research & Innovation. Participation in this Study
This study involves residents and surgeons in surgical training programs and will take place from June 2014 to August 2015. The study will take place in the participants’ current place of work. Participation in this study is voluntary and has no effect on your professional or educational standing. You may choose to participate in one and/or more of the elements of the study. You are being asked to allow a trained observer to observe your work in the hospital during a shift, to participate in informal interviews during a shift, or informal interview(s) outside working hours. You may refuse to participate, refuse to answer any questions, or withdraw from the study at any time. You can request that the observer or interviewer stop taking notes or recording at any time. Since this study follows an emergent design, the interview questions are not determined in advance; however, both observation notes and interview questions will pertain exclusively to the phenomenon of variations in the conduct of surgical procedures and effects of those variations on surgical training. An example of a pertinent question is: do you keep a list of the procedural approaches you have observed during your surgical training?
There is no minimum commitment to participate. A single interview or short period of observation is sufficient. The maximum commitment is to be observed by a single researcher during your work over the course of one shift in the hospital per week for three blocks (i.e. 18 days) as well as participating in formal interview(s), which may take between approximately 30-60 minutes. This maximum commitment is not binding in any way. Participation is voluntary and you can withdraw at any time for any reason or without providing any reason whatsoever.
Potential Benefits, Risks, & Inconveniences
There are no known immediate benefits to participating in this study. However, in being afforded time to reflectively discuss their process of training trainees (for surgeons) or their process of being trained (for residents), it may be that participants are able to gain personal insight into their own educational and procedural practices.
There is a potential risk that discussing events that occur during the process of surgical training, especially contentious events such as differences in procedural approaches, may lead participants to feel a minimal degree of retrospective frustration.
Depending on the participant’s interest and degree of participation, surgeons and residents participating in this study may experience some inconvenience by volunteering to spend time being observed or in formal or informal interviews. Surgeons and residents who agree to participate are agreeing to permit a trained observer to enter the operating room suite and take field notes about the interactions of the surgical team. The degree of inconvenience of being observed can be determined by the participant depending on the participant’s interest in entertaining questions from the research team that interrupt or slow his or her natural workflow. Attempts will be made by the researchers to minimize interruptions. Observations will be stopped immediately if a participant indicates that the process is interfering with their work or requests the research to end for any reason whatsoever. Additionally, and similarly, the degree of inconvenience of participating in interviewing will be determined by the participant’s interest in being involved in the research. Surgeons and residents who agree to participate in interviews agree to be contacted by the research coordinator to schedule a formal interview at a time, date, and location that is convenient for the participant. The participant can cancel an interview at
any time without cause. Participants who indicate during the research process that he or she is not interested in participating in informal or formal interviews or return of finding analysis will not be expected to participate.
Confidentiality
In order to preserve the confidentiality of participants, all collected data will be de-identified with a generic code. Any audio recordings will be digitally anonymized. All data will be stored on a password-protected, secured network server. Only the members of the research team will have access to the information collected by this study. Any presentation of the results obtained from this study will only appear in de-identified form.
Representatives of the University of Western Ontario Health Sciences Research Ethics Board may contact you or require access to your study-related records to monitor the conduct of the research.
Contact information
Please feel free to ask any questions that you may have regarding this study by contacting the study coordinator, Tavis Apramian, at [email protected] or
If you have any questions about your rights as a research participant or the conduct of the study you may contact Dr. David Hill, Scientific Director, Lawson Health Research Institute. You will be presented with a copy of this Letter of Information for your own records.
With regards, Sayra M. Cristancho S., PhD.
Schulich School of Medicine & Dentistry University of Western Ontario
Health Sciences Addition, Room 110B London, Ontario, Canada, N6A 5C1 Phone: (519) 661-2111 Ex: 89253
Email: [email protected]
Lorelei Lingard, PhD
Schulich School of Medicine & Dentistry
University of Western Ontario
Room 112, Health Sciences Addition London, Ontario, Canada, N6A 5C1 Phone: (519) 661-2111 ext 88999 Email: [email protected] Tavis Apramian, MA, MSc
Schulich School of Medicine & Dentistry University of Western Ontario
Health Sciences Addition, Room 110
London, Ontario, Canada, N6A 5C1