Can you help?
We are doing research to assess patient satisfaction with information provided about breast reconstruction.
The information we collect will help to guide us in further developing resources for patients like yourself. We appreciate your feedback!
Informed Consent Form for Participation in a Research Study
Development of a Patient-Centered Breast Reconstruction e-learning Platform
Protocol ID: HREBA.CC-18-0477
Researcher: Dr. Jennifer Matthews, Section of Plastic Surgery, Department of Surgery, Foothills Medical Centre, Calgary, AB, Number: 403-474-0113
Co- Investigator(s): Dr. Claire Temple-Oberle (403-521-3012); Dr. William De Hass (403-571-3150); Dr. David McKenzie (403-571-3131)
Study Team: Anna Todd, Resident, arschmid@ucalgary.ca
Funder(s): Calgary Surgical Research Development Fund
Sponsor: University of Calgary
WHY AM I BEING ASKED TO TAKE PART IN THIS RESEARCH SURVEY?
You are being invited to participate in a research study because you have an upcoming consultation with a plastic surgeon regarding breast reconstruction, or have requested further information about breast reconstruction. The purpose of this study is to understand what resources are most helpful in educating patients about breast reconstruction.
Taking part in this study is voluntary. You may choose whether or not you take part. If you choose to participate, you may leave the study at any time without giving reason or without penalty. Deciding not to take part or deciding to leave the study early will not result in any penalty or effect current or future care or employment.
If you decide to participate in this study, you will need to digitally sign this consent form. You will receive a copy of the form.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
Up to 50 people will take part in this study. We plan to enroll participants from amongst those patients being seen by plastic surgeons based at the hospitals in Calgary, AB.
WHAT WILL HAPPEN DURING THIS STUDY?
If you are participant in this study, you have received educational material about breast reconstruction. We ask that you take your time to review the material. Once you feel you have adequately reviewed the provided resources, we then request that you complete a very short survey about your satisfaction with the information provided.
The results of your study will not be given to you, the researcher, study team or your personal care doctor. The survey results are completely anonymous and recorded in a secure database.
WHAT ARE MY RESPONSIBILITIES SHOULD I DECIDE TO PARTICIPATE?
If you choose to participate in this study, you will be expected to:
1. Access and utilize the breast reconstruction educational resources available to you
2. Complete the less than 10 minute survey provided once you feel you have utilized the resources to the extent applicable to yourself.
WHAT WILL HAPPEN IF I CHOOSE TO WITHDRAW FROM THE STUDY EARLY?
You can choose to end your participation in this research study (called early withdrawal) at any time without having to provide a reason and without penalty. If you choose to withdraw early from the study without finishing the survey, you are encouraged to contact the researcher or study staff.
Information that was recorded before you withdrew will be used by the researcher for this study, but no additional information will be collected after you withdraw your permission.
You can request withdrawal of your information (ie, age range) until submission of your survey results. It won’t be possible to eliminate your data after that time, as they will be anonymously pooled with other participants data in our server.
WHAT ARE THE RISKS/DISCOMFORTS OF PARTICIPATING IN THIS STUDY?
We believe there are minimal risks helping with this study. If you would like to talk with someone about how the questionnaire has made you feel, please tell the research assistant or your nurse or doctor. You can also contact any of the investigators in this study listed on the previous page.
WHAT ARE THE POTENTIAL BENEFITS OF PARTICIPATING IN THIS STUDY?
The expected benefit in participating in this study is the opportunity to gain access to evidence-based, high quality educational resources about breast reconstruction. The information we collect from these surveys and from assessing the usage of these educational tools will help us finalize a tool that will be used by many patients going forward. It is hoped that in the long-term, our approach to patient care and education can be improved.
HOW WILL MY PERSONAL INFORMATION BE KEPT PRIVATE?
If you decide to participate, the researcher and study staff will only collect information they need for this study. No personal identifying data will be collected. The data from the survey is completely anonymous, and saved on a secure, encrypted server. No data relating to this study will be released outside of the study site nor will it be published by the researcher. However, every effort will be made to make sure that your information is kept confidential.
Any patient information will be kept in a locked filing cabinet or on a password-protected computer. Your name will not be used in any publications. Only the researcher in charge and her research assistant will see your information. The data will be used in a pooled analysis with other patient data to assess the patient satisfaction with the education resources provided. At the end of the study, your data will be destroyed.
Data collected using the web-based application (accessible on phone, tablet or computer) resides on the secure servers, and is firewall protected.
A copy of the consent form that you electronically sign to enter this study may be included in your medical record/hospital chart.
WILL THERE BE COSTS INVOLVED WITH PARTICIPATING IN THIS STUDY?
There is no cost to you to participate in the study.
WILL I BE COMPENSATED FOR PARTICIPATING IN THIS STUDY?
You will not be paid for taking part in this study.
WHAT ARE MY RIGHTS AS A PARTICIPANT IN THIS STUDY?
You will be told, in a timely manner, about new information that may be relevant to your willingness to stay in this study.
You have the right to be informed of the results of this study once the entire study is complete. If you would like to be informed of these results, please contact the primary investigator.
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected.
By signing this form you do not give up any of your legal rights against the hospital, researchers, sponsor, institutions or their agents involved for compensation, nor does this form relieve these parties from their legal and professional responsibilities.
IS THERE ANY CONFLICT OF INTEREST RELATED TO THIS STUDY?
There are no conflicts of interest declared between the researcher and funder(s) or sponsor of this study.
WHO DO I CONTACT FOR QUESTIONS RELATED TO THIS STUDY?
If you have questions about taking part in this study you should talk to the researcher, co-investigator or study coordinator. These person(s) are:
Dr. Jennifer Matthews 403-474-0113
Dr. Claire Temple-Oberle 403-521-3012
Dr. Anna Todd, Resident archmid@ucalgary.ca
If you have questions about your rights as a participant or about ethical issues related to this study and you would like to talk to someone who is not involved in the conduct of the study, please contact the Office of the Health Research Ethics Board of Alberta.
Telephone: 780-423-5727
Toll Free: 1-877-423-5727