The Ohio State University Consent to Participate in Research
Study Title: An Investigation of Patient Preferences of genetic testing result disclosure for Huntington’s Disease considering the 21st Century Cures Act
Protocol Number: 2023H0224
Researcher: Victoria Klee, MS GCG
Sponsor: The Ohio State University Genetic Counseling Graduate Program
This is a consent form for research participation. It contains important information about this study and what to expect if you decide to participate. Your participation is voluntary. Please consider the information carefully.
Feel free to ask questions before making your decision whether or not to participate.
Purpose: The goal of this study is to investigate individual’s opinions and preferences of how they receive genetic testing results for Huntington’s Disease considering the implementation of automatic result release mandated through the 21st Century Cures Act as well as to see if there is a correlation between preferred mode of result disclosure and type of result
Procedures/Tasks: The procedures and tasks of this study include reading through the consent form and signing, and then completing the survey.
Duration: The duration of this study is the time to complete the consent form and the survey, approximately 20 minutes total. You may leave the study at any time. If you decide to stop participating in the study, there will be no penalty to you, and you will not lose any benefits to which you are otherwise entitled. Your decision will not affect your future relationship with The Ohio State University.
Risks and Benefits: There are always risks associated with participating in research such as a breach of data confidentiality due to the study team accessing private health information to assess eligibility of patients, and that there may be feelings of discomfort experienced while completing the survey. There are no immediate benefits to participating in this study. There are possible benefits to this study such as revisiting HDSA (Huntington Disease Society of America) guidelines based on the preferences of patients in this population, and therefore improving patient care in the context of HD genetic testing result disclosure.
Confidentiality: We will work to make sure that no one sees your online responses without approval. But, because we are using the Internet, there is a chance that someone could access your online responses without permission. In some cases, this information could be used to identify you.
Also, there may be circumstances where this information must be released. For example, personal information regarding your participation in this study may be disclosed if required by state law. Also, your records may be reviewed by the following groups (as applicable to the research):
• Office for Human Research Protections or other federal, state, or international regulatory agencies;
• The Ohio State University Institutional Review Board or Office of Responsible Research Practices;
• Authorized Ohio State University staff not involved in the study may be aware that you are participating in a research study and have access to your information; and
• The sponsor, if any, or agency (including the Food and Drug Administration for FDA-regulated research) supporting the study.
Future Research: Your de-identified information may be used or shared with other researchers without your additional informed consent.
Incentives: You will receive a $5 Amazon Giftcard following completion of the survey.
Participant Rights: You may refuse to participate in this study without penalty or loss of benefits to which you are otherwise entitled. If you are a student or employee at Ohio State, your decision will not affect your grades or employment status. If you choose to participate in the study, you may discontinue participation at any time without penalty or loss of benefits.
By agreeing to participate, you do not give up any personal legal rights you may have as a participant in this study. An Institutional Review Board responsible for human subjects research at The Ohio State University reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of participants in research.
Contacts and Questions: For questions, concerns, or complaints about the study, or you feel you have been harmed as a result of study participation, you may contact Victoria Klee, MS CGC at Victoria.klee@osumc.edu. For questions about your rights as a participant in this study or to discuss other study-related concerns or complaints with someone who is not part of the research team, you may contact the Office of Responsible Research Practices at 1-800-678-6251 or hsconcerns@osu.edu.
Providing consent I have read (or someone has read to me) this page and I am aware that I am being asked to participate in a research study. I have had the opportunity to ask questions and have had them answered to my satisfaction. I voluntarily agree to participate in this study. I am not giving up any legal rights by agreeing to participate. To print or save a copy of this page, select the print button on your web browser.
Please click the button below to proceed and participate in this study.
If you do not wish to participate, please close out your browser window.
To access the survey please click the link below (DO NOT CLICK ARROW at the bottom of this page- ONLY CLICK THE SURVEY LINK):
https://osu.az1.qualtrics.com/jfe/form/SV_2n5LP1Yp6WMbZEW*Once in the survey, please ensure that you have selected answers to each question on the page, and then click the red arrow at the bottom of the page to proceed.