Patient Informed Consent to Participate in Research
Investigating Problem-Solving in Diabetes Management
Mobile Diabetes Detective (MoDD) Project
Patient Informed Consent to Participate in Research
You are being asked to participate in a research project. This page will give you information about the project and will describe the project to you. Please read the information on this page carefully before deciding whether or not you wish to participate in the study. If you have any questions or would like to receive more information, please contact the investigators at Columbia University; their contact information is provided on the bottom of this page. Please remember, it is your choice whether or not to take part in the study. Your ability to participate in TuDiabetes community will not change because of your decision.
What is the purpose of this project?
Many people have hard time managing their diabetes, including maintaining a healthy diet, exercising, and dealing with stress. The purpose of this project is to learn about ways to help people manage their diabetes better. We hope this project will result in better-controlled diabetes by helping people solve diabetes-related problems they face every day. This project will focus on people with diabetes who are members of TuDiabetes community. We plan to recruit a total of 300 persons in the project.
How does this project work?
If you agree to take part in the project, we will ask you to test a computerized web application called the Mobile Diabetes Detective (MoDD), that has been developed to help patients manage their diabetes and aid them with problem solving. We will ask you to test the application for four week. At the end of these four weeks, we might contact you and ask you to participant in a 30-minute interview conducted over the phone or skype, where we will ask you to provide more feedback on your experience using MoDD.
What risks do you face if you decide to take part in this project?
Some of the questions ask you to share personal information, which may make you feel uncomfortable, stressed, or upset. You may choose not to answer any question or stop participating in the project at any time without giving a reason. Doing the finger prick to measure your blood sugar can hurt where the prick is done. You could also get a small bruise at the place of the prick. This is not serious and the mark will go away within a few days. In this study, you will have a chance to send your blood glucose readings using voice or text messaging services on your phone. When you use text messaging or telephone voice services, you are using commercial providers, which can lead to some risks to the privacy of your data. Your messages will be sent via cell phone company networks. There is a chance that your data could be accessed by other individuals, if someone breaks into the cell phone company’s data network. Also, you may accidentally send your data to a wrong number and make it available to individuals not involved with the study. Finally, if your cell phone keeps a history of text messages and is not password protected, if you lose your phone, other individuals may be able to view your messages. We will protect your privacy to the extent possible. We will also suggest ways for you to protect your privacy when you are using the text messaging technology.
What are the possible benefits to you for taking part in this project?
You may not benefit from being in this project. Your diabetes may or may not be better controlled by participating in the project. You may find the MoDD website helpful in managing your diabetes. You may feel good from knowing that what you tell us may help to help more patients manage their diabetes.
What will happen if you do not take part in this project?
You will not be affected in any way if you decide not to take part in this project. Your choice whether or not to participate will not change the relationship with TuDiabetes community and your ability to participate as a member. Even if you decide to begin the project, you may stop at any time. If you decide to stop being part of the project, your standing with the TuDiabetes community will not be affected.
Should you wish to withdraw (revoke your authorization to participate in the research) from the study at any time, you may contact the Principal Investigator, Dr. Lena Mamykina, at: (212) 305-3923 or via email: email@example.com . However, if you revoke this Authorization, you will not be allowed to continue taking part in the Research. Also, even if you revoke this Authorization, the Researchers and the Sponsor may continue to use and disclose the information they have already collected as permitted by the Informed Consent and HIPAA Authorization form.
While the Research is in progress, you may not be allowed to see your health information that is created or collected by Columbia University in the course of the Research. After the Research is finished, however, you may be allowed to see this information.
Once your health information has been disclosed to a third party (e.g., a pharmaceutical company participating in this Study), federal privacy laws may no longer protect it from further disclosure.
The authorization that you provide today will expire seven years after the end of the study (2023)
How will the privacy and the confidentiality of your records be protected?
We will do everything in our power to protect your privacy. Your confidentiality will be protected by assigning a code to your study records. All of your answers from the interviews will be coded and stored in a secure, password protected and encrypted database at Columbia University. The audio-recordings will be stored on a password-protected computer at Columbia University and only project staff will have access to the recordings. The audio-recordings will be destroyed within one year of the date of the interview. A separate master list of names, addresses, and telephone numbers, along with the code numbers will be stored in a secure, password protected electronic file. Only research staff involved with the project will have access to information you share or information taken from your medical record during the project. The master list of names will be destroyed at the end of the project in 2016.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Institutional Review Boards may access your data for monitoring purposes. They will also keep all information private.
The results of this project will be published; however, your name will not appear in any publications or presentations about the results of the project and no one will be able to identify you. At the end of the project, Columbia University may display the results of the project on its website: www.dbmi.columbia.edu
You will have a chance to send your blood glucose readings using voice or text messaging services on your phone in this study. We will do everything we can to protect the privacy and security of the data you send us. However, we cannot guarantee that your privacy will be protected completely because we do not have control over commercial text messaging and telephone service. We will protect your privacy to the extent possible. We will also suggest ways for you to protect your privacy when you are using the text messaging technology. As a reminder, when you use text messaging or telephone voice services, you are using commercial providers, which can lead to some risks to the privacy of your data. Your messages will be sent via cell phone company networks. There is a chance that your data could be accessed by other individuals, if someone breaks into the cell phone company’s data network. Also, you may accidentally send your data to a wrong number and make it available to individuals not involved with the study. Finally, if your cell phone keeps a history of text messages and is not password protected, if you lose your phone, other individuals may be able to view your messages.
In order to reduce these risks, we suggest that you do the following:
- Add the MoDD phone number to your address book (and also to the list of your favorite numbers) using MoDD as a name. This way, when you dial the number, or receive messages from the number, it will be easier to see that they are coming from the right number.
- Put a password on your cell phone so that no one can access your phone.
- Never send us any of your private information. Do not send us or put on the website your social security number or your credit card numbers.
What are your privacy rights?
The health-related information that we will receive about you in this study, for example, your daily blood glucose readings, is personal. The research team is required by law to protect the privacy of information called “protected health information” or PHI. We will make every effort to protect the confidentiality of your PHI, which may be shared with others to support this research, to conduct public health reporting, and to comply with the law as required.
By agreeing with this Informed Consent form and HIPAA Authorization, you give permission for the researchers at Columbia University to use health information collected during this study. Your information will also be shared with the members of the research team at Columbia University, Clinical Directors Network, and Georgia Institute of Technology. However, before sharing your information outside of Columbia, we will remove everything that discloses your identity (such as your name or address). Also, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the funder of this project will have access to study information.
Representatives of government agencies, review boards, and other persons who watch over the safety, effectiveness, and conduct of the research may also review study information.
You have a right to refuse to agree with this Informed Consent and HIPAA Authorization form. Your standing with the TuDiabetes community and your ability to participate in the community as a member will not be affected if you do not sign this form, however if you do not ”agree” to participate at the end of this document, you will not be able to be part of this research study.
What are the costs of being in this project?
The only cost to you for taking part in this study is the time you spend answering the questions during the interview, the time you spend on the MoDD website, and sending your blood glucose readings.
Will I be paid to participate in this project?
There is no reimbursement for participation in the study. However, if you are invited and choose to participate in an interview, you will be reimbursed $10.
Whom can I call when I have questions about this project?
Please feel free to ask any questions. Think about this project and the consent being asked of you carefully. If you have further questions about this project or if you have a research-related problem, you may contact the Principal Investigator,
Lena Mamykina, Ph.D at (212) 305-3923 or firstname.lastname@example.org
If you have any questions concerning your rights as a research participant, you may contact the Columbia University Institutional Review Board by phone at (212)305-5883 or by email at email@example.com.
Consent to Participate in Investigating Problem-Solving in Diabetes Management /Mobile Diabetes Detective (MoDD) Project
I have read the above information about the Investigating Problem-Solving in Diabetes Management /Mobile Diabetes Detective (MoDD) Project. I have asked all of the questions that I have today and they have been answered. I have been told that I can ask other questions at any time. I agree to take part in this project. I have been given a copy of this paper for my own records. I understand that agreeing with this form does not take away any of my legal rights.