Clinical trial: NCT02485561
Section: Confidentiality
Subsections: How Will You Keep My Information Confidential?|Are There Additional Protections For My Health Information?

We will keep your participation in this research study confidential to the extent permitted by law. However, it is possible that other people such as those indicated below may become aware of your participation in this study and may inspect and copy records pertaining to this research. Some of these records could contain information that personally identifies you.  
Government representatives, (including the Office for Human Research Protections) to complete federal or state responsibilities NIH
University representatives, to complete University responsibilities Washington University's Institutional Review Board (a committee that oversees the conduct of research involving human participants) and the Human Research Protection Office. The Institutional Review Board has reviewed and approved this study.
The Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital is supported by funding from the National Cancer Institute (NCI). To meet NCI requirements, your protected health information relating to your participation in this study will be stored in a secure database at the Siteman Cancer Center. This database may be reviewed by Siteman Cancer Center personnel. All information will be securely and confidentially maintained. To help protect your confidentiality, we will use study identification numbers to identify your data and we will store your name and contact information separate from your data; both pieces of information will be kept in password protected computer files and/or under lock-and-key. Once the study is completed, all personally identifying information will be destroyed and only the de-identified data will be used for analysis. If we write a report or article about this study or share the study dataset with others, we will do so in such a way that you cannot be directly identified.

Protected Health Information (PHI) is health information that identifies you. PHI is protected by federal law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this research, you must give the research team permission to use and disclose (share) your PHI for the study as explained in this consent form. The research team will follow state and federal laws and may share your health information with the agencies and people listed under the previous section titled, "How will you keep my information confidential?".  
  
  
Once your health information is shared with someone outside of the research team, it may no longer be protected by HIPAA. The research team will only use and share your information as talked about in this form or as permitted or required by law. When possible, the research team will make sure information cannot be linked to you (de-identified). Once information is de-identified, it may be used and shared for other purposes not discussed in this consent form. If you have questions or concerns about your privacy and the use of your PHI, please contact the University's Privacy Officer at 866-747-4975. Although you will not be allowed to see the study information, you may be given access to your health care records by contacting your health care provider.
Clinical trial: NCT02485561
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?

If you agree to take part in this study, your involvement will include an online session about 30 minutes long and a one-month follow-up survey about 15 minutes long. You may be asked to complete a brief survey six and twelve months after the first survey.
Clinical trial: NCT02485561
Section: Participant Responsibilities
Subsections: If You Decide To Participate:

You authorize the use of your PHI for this research This authorization does not expire.  
You may later change your mind and not let the research team use or share your information
(you may revoke your authorization).  
To revoke your authorization, complete the withdrawal letter, found in the Participant section of the Human Research Protection Office website at http://hrpo.wustl.edu (or use the direct link: http://hrpo.wustl.edu/participants//withdrawing-from-a-study/) or you may request that the investigator send you a copy of the letter.  
o **If you revoke your authorization:**
The research team may only use and share information already collected for the study.  
Your information may still be used and shared as necessary to maintain the integrity of the research, for example, to account for a participant's withdrawal from the research study or for safety reasons.  
You will not be allowed to continue to participate in the study.
Clinical trial: NCT02485561
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of This Study?

You may experience one or more of the risks indicated below from being in this study. In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this study. Some of the questions may make you uncomfortable. If you are not comfortable answering any questions, you may choose not to answer it. One risk of participating in this study is that confidential information about you may be accidentally disclosed. We will use our best efforts to keep the information about you secure. Please see the section in this consent form titled *"How will you keep* my information confidential?" for more information
Clinical trial: NCT02485561
Section: Procedures
Subsections: What Will Happen During This Study?

You will be asked to 1) complete an online survey about your health and thoughts about colorectal cancer screening 2) read information about colorectal cancer screening, 3) complete another survey about your opinions and reactions to the information, 4) one month later you will be asked to complete a follow-up survey. You may also be asked to complete a brief survey six and twelve months after the first survey. Any information about your current or past health conditions you disclose will remain confidential. Your answers will be identified with your study identification number, not your name. At any time, you may skip any questions you do not wish to answer.
Clinical trial: NCT02485561
Section: Purpose of Research
Subsections: What Is The Purpose Of This Study?

This is a research study. We invite you to participate in this research study because you are 50-75 years old and eligible for colon cancer screening. The purpose of this research study is to examine thoughts and reactions to screening information. We value your opinion and reaction to patient education materials being developed to educate and motivate adults to get screened for colon cancer.
Clinical trial: NCT02485561
Section: Voluntary Participation
Subsections: How Many People Will Participate?|Is Being In This Study Voluntary?

Approximately 400 people will take part in this study conducted by investigators at Washington University.  
 APPROVAL DATE: 08/21/18 RELEASED DATE: 08/21/18 EXPIRATION DATE: 08/20/19

Taking part in this research study is completely voluntary. You may choose not to take part at all. If you decide to be in this study, you may stop participating at any time. Any data that was collected as part of your participation in the study will remain as part of the study records and cannot be removed. If you decide not to be in this study, or if you stop participating at any time, you won't be penalized or lose any benefits for which you otherwise qualify. APPROVAL DATE: 08/21/18 RELEASED DATE: 08/21/18 EXPIRATION DATE: 08/20/19
Clinical trial: NCT02485561
Section: Withdrawal from Study
Subsections: If You Decide Not To Participate, It Will Not Affect

your treatment or the care given by your health provider. your insurance payment or enrollment in any health plans.  
any benefits to which you are entitled.  
However, it will not be possible for you to take part in the study.