INFORMED CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Full Study Title: International practice patterns for radiation planning and treatment of limited stage small cell lung cancer (LS-SCLC)

Principal Investigator: Dr. Alexander Louie MD, M.Sc., PHD, FRCPC,
Radiation Oncologist, Odette Cancer Centre – Sunnybrook Health Sciences Centre
Associate Professor, department of radiation oncology, University of Toronto
Contact: Alexander.Louie@sunnybrook.ca

Sponsor: This study has no funding source or sponsor
INFORMED CONSENT

You are being asked to consider participating in a research study. A research study is a way of gathering information on a treatment, procedure or medical device or to answer a question about something that is not well understood.

This form explains the purpose of this research study, provides information about the study, the tests and procedures involved, possible risks and benefits, and the rights of participants.

Please ask the study staff or one of the investigator(s) to clarify anything you do not understand or would like to know more about. Make sure all your questions are answered to your satisfaction before deciding whether to participate in this research study.

The survey itself has been crafted as multiple choice answers to minimize time burden. We estimate that the survey may take anywhere from 15-20 minutes to answer. There are a total of appoximately 40 questions. They must be answered in 1 sitting as responses cannot be partially saved.

Participating in this study is your choice (voluntary). You have the right to choose not to participate, or to stop participating in this study at any time.
INTRODUCTION

Due to your experience, perspectives, and involvement in thoracic radiation oncology, you have been invited to take part in an international consensus-building survey. The goal of this effort is to help develop a guideline that will support standardization and best practices in radiation planning and treatment for limited-stage small cell lung cancer. We value your insights and appreciate your participation.
WHY IS THIS STUDY BEING DONE?

The purpose of this study is to develop global consensus statements to guide treatment decision making in the setting of LS-SCLC. There have been isolated attempts in the last decade to analyze national trends in treating LS-SCLC, however no surveys have been conducted recently to encompass the recent positive trials reporting increases in overall survival (OS) in the domains of BID dose escalation and the addition of immunotherapy in the adjuvant setting. We aim to understand current global trends in decision making in the field of LS-SCLC.

WHAT ARE THE RISKS OR HARMS OF PARTICIPATING IN THIS STUDY?

There are no anticipated risks or harms to participating in the study. Participants will remain anonymous from each other. We do not expect participants to incur costs, aside from the time required to complete the surveys.

CAN PARTICIPATION IN THIS STUDY END EARLY?

You can also choose to end your participation at any time without having to provide a reason. Simply reply back to the invite email to do so.

WHAT ARE THE COSTS OF PARTICIPATING IN THIS STUDY?

There are no expected costs to participate in the study, outside of your time. By signing this consent form, you do not give up any of your legal rights.

ARE STUDY PARTICIPANTS PAID TO PARTICIPATE IN THIS STUDY?

You will not be paid to participate in this study.

HOW WILL MY INFORMATION BE KEPT CONFIDENTIAL?

You have the right to have any information about you that is collected, used or disclosed for this study to be handled in a confidential manner.

If you decide to participate in this study, the investigator(s) and study staff will look at your survey responses. Responses will be kept anonymous from other participants.

Collecting data using technology over the internet or using apps/tools/devices can increase potential risks to privacy and confidentiality. This study will be using Google Forms to collect data for this study. The data will reside on an external server and no assurance can be made about its confidentiality or that it will only be used for this research purpose. Please read the terms and agreement of the service provider for further information regarding data security and confidentiality of the technology being used.

This study will be using U.S. based internet service providers which means that the electronic data will be stored and accessed in the U.S. and is therefore subject to U.S. laws including the U.S Freedom Act. The Freedom Act allows authorities access to the records of internet service providers. It is therefore possible that this information could be disclosed to U.S. federal officials.

When the results of this study are published, your identity will not be disclosed.

You have the right to be informed of the results of this study once the entire study is complete
ARE THERE ANY CONFLICTS OF INTEREST/RELATIONSHIPS?

The investigators and their institution have no relevant conflict of interests to declare.

WHAT ARE THE RIGHTS OF PARTICIPANTS IN A RESEARCH STUDY?

You have the right to ask questions and to receive answers throughout this study. Please feel free to email the PI of this study Dr. Alexander Louie (alexander.louie@sunnybook.ca).

The Sunnybrook Research Ethics Board has reviewed this study. If you have questions about your rights as a research participant or any ethical issues related to this study that you wish to discuss with someone not directly involved with the study, you may call the Chair of the Sunnybrook Research Ethics Board at (416) 480-6100 ext. 688144.

DOCUMENTATION OF INFORMED CONSENT

Full Study Title: International consensus recommendations for radiation planning and treatment of limited stage small cell lung cancer

Participant:
By filling and submitting this survey, I confirm that:
· This research study has been fully explained to me and all my questions answered to my satisfaction
· I understand the requirements of participating in this research study
· I have been informed of the risks and benefits, if any, of participating in this research study
· I have been informed of any alternatives to participating in this research study
· I have been informed of the rights of research participants
· I have read each page of this form
· I have agreed, or agree to allow the person I am responsible for, to participate in this research study
We appreciate your time and contribution. Please click next to start the survey. Thank you.
 
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