Informed Consent Form
Sponsor / Study Title:
Geneoscopy Inc. / “Longitudinal assessment of adherence to the multi-target stool RNA test (ColoSense)”
Protocol Number:
CT-PRT-0005
Principal Investigator:(Study Doctor)
Erica Barnell, MD/PhD
Address:
Geneoscopy2220 Welsch Industrial CourtSaint Louis, MO 63146
Telephone:
(314) 887-7777 (24 Hours)
We invite you to participate in this research study being conducted by investigators from Geneoscopy. This study aims to determine patient adherence to colon cancer screening guidelines. About 500,000 participants will participate in this study.
Subjects are provided a link to a secure electronic survey through the provided email address or telephone number. Prior to submitting the survey to our secure database, the following questions must be answered:
By completing this survey, you agree to allow your responses to be collected and analyzed for research and quality improvement purposes. You also consent for your medical records to be collected and analyzed for research and quality improvement purposes. Further, you agree to being contacted approximately 30, 60 and 90 days following ColoSense result and release of medical records.*
*Survey entry will be time stamped to document time and date of signature.
Essential things you should know are:
- This research requires completing a survey and potentially providing medical records information related to follow-up care. Participants will also be contacted after the date of colonoscopy, 30 days, 60 days, and/or 90 days after a ColoSense result was generated to confirm if the colonoscopy was completed, where the colonoscopy was completed, and results of the colonoscopy. This can be confirmed via survey, email, phone call, text, or other method of contact.
- You also may permit Geneoscopy to retrieve medical records related to your medical history and related procedures, including a follow-up colonoscopy if you have a positive noninvasive test result.
- An investigator on this study has an ownership interest in Geneoscopy Inc, the company sponsoring this research study. As a result, the investigator may benefit financially from a successful study. Please speak with the study investigator if you have questions about this.
- Your participation is completely voluntary. The survey can be discontinued at any time. You may choose to not participate or you may withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care. If you are an employee associated with this research, it will not have any effect on your performance appraisal or employment at this clinical research center. However, please note that any information collected up to the point of your withdrawal cannot be removed from the study. The Investigator or the sponsor can stop your participation at any time without your consent.
- Your information will be kept confidential. The Investigator, the sponsor or persons working on behalf of the sponsor, and the Institutional Review Board (IRB) will be able to inspect and copy confidential study-related records which identify you by name. This means that absolute confidentiality cannot be guaranteed. If the results of this study are published or presented at meetings, you will not be identified.
- While every effort will be made to safeguard your personal information, there is a small risk that your information may be inappropriately disclosed. For this reason, absolute confidentiality cannot be guaranteed. The questionnaires used in this study may be upsetting. You do not need to answer any questions that you are not comfortable with. There may be other risks that are unknown.
- You will not benefit from being in this study, however, you may experience indirect benefit from Geneoscopy’s patient navigation services for CRC screening adherence and compliance. Information learned from the study may help other people in the future.
- This survey is for research purposes only. The only alternative is to not participate.
- Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you.
- There will be no costs associated with completing this survey.
- Participants who complete surveys will be entered into a raffle to win a $200 Amazon Gift Card. For every 10,000 participants who complete a survey, a gift card recipient will be randomly selected.
By completing the survey, subjects consent to being contacted in the future. Contact may be made through survey, email, phone call, text message, or other communication methods, and will focus on recommended follow-up care. Subjects will always have the option to decline further contact at any time.
WHOM TO CONTACT ABOUT THIS STUDY
During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:
- Whom to contact in the case of a research-related injury or illness;
- Payment or compensation for being in the study, if any;
- Your responsibilities as a research participant;
- Eligibility to participate in the study;
- The Investigator’s or study site’s decision to withdraw you from participation;
- Results of tests and/or procedures;
Please contact the Investigator at the telephone number listed on the first page of this consent document.
If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.
An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, contact:
By mail:
Study Subject Adviser
Advarra IRB
6100 Merriweather Dr., Suite 600
Columbia, MD 21044
Phone (toll free): 877-992-4724
Email: adviser@advarra.com
Please reference the following number when contacting the Study Subject Adviser: Pro00087917.
Data obtained through these surveys, medical records, and subsequent follow-up can be used in a de-identified way to assess research objectives.