Understanding Risk Factors for Stomach Cancer in People with Inherited Genetic Mutations |
Consent Form
Title of Study: Understanding Risk Factors for Stomach Cancer in People with Inherited Genetic Mutations
Investigator: Dr. Sue Friedman (FORCE), Diane Rose (FORCE) & Dr. Luis Carvajal Carmona, (University of California, Davis)
Introduction and Purpose: You are invited to join a research study conducted by FORCE and researchers from the University of California, Davis. The purpose of this study is to understand gastric (stomach) cancer risk among people known to carry a hereditary (germline) mutation(s) in genes that are linked to an increased risk of certain cancers, including ATM, BRCA1, BRCA2, CHEK2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM) and other genes linked to increased cancer risk.
You will be asked questions about demographic information, genetic mutation(s), personal and family history of cancer, gastric cancer risk factors, and whether genetic testing was received. It should take no more than 15 minutes to complete the survey. There is no direct benefit to you from taking part in this survey. We will use your information to conduct this study and the data collected for this research may also be used for future research studies. We hope that the research will lead to improved prevention and screening efforts for gastric cancer, particularly for high-risk populations, including carriers of genetic mutation. We will not share any personally identifiable information. Our goal is to make more research possible. These studies may be done by researchers at this institution or other institutions, including commercial entities. Data may be placed in one or more external scientific databases for access and use. We will not ask you for additional permission to share de-identified (anonymous) information. The risks of this research survey are minimal. Some of the questions might make you feel uncomfortable or upset. You do not have to answer any of the questions you do not want to answer.
Confidentiality: If you agree to participate, you will be asked to complete an anonymous survey. We will not be able to identify who you are by your replies, and we will not be able to link your survey responses to any information that identifies you.
As with all research, there is a chance that confidentiality could be compromised; however, we are taking precautions to minimize this risk. Your responses to the survey will not include information that identifies you. Additionally, and to minimize the risks of breach of confidentiality, we will store all survey responses in a password-protected server.
Compensation: You will not be paid for taking part in this study.
Rights: Taking part in research is completely voluntary. You are free to decline to take part in the survey. You can decline to answer any questions and you can stop taking part in the survey at any time. Whether or not you choose to take part, or answer any question, or stop taking part in the project, there will be no penalty to you or loss of benefits to which you are otherwise entitled.
Questions: If you have any questions about this research, please contact Diane Rose (FORCE) at (866) 288-7475 x 712 or dianer@facingourrisk.org, or Luis Carvajal-Carmona, PhD, (UC Davis) at (530) 752-5301 or lgcarvajal@ucdavis.edu. If you have any questions about your rights or treatment as a research participant in this study, please contact the UC Davis, Institutional Review Board by phone: (916)-703-9158 or by email: HS-IRBEducation@ucdavis.edu.