Informed Consent

Before you sign up for the SUN project, you must fill an Informed Consent form.

IRB STUDY # 1708832784

INDIANA UNIVERSITY INFORMED CONSENT STATEMENT

Implementing SUN – A Multimedia Education and Health Tracking Application

You are invited to participate in a research study to assess how to design the content and format of a multimedia application educating college students about Substance Use Disorder (SUD) science and evidence-based treatment methods.  You were selected as a possible subject because you are a college student and are 18 years of age or older, and either saw a flyer describing SUN or may have sought assistance with health concerns at the IU Health Center.  We ask that you read this form and ask any questions you may have before agreeing to be in the study.

The study is being conducted by Dr. Jody Madeira, Associate Professor of Law, Indiana University Bloomington Maurer School of Law, and Basia Andraka-Christou, Postdoctoral Fellow, Fairbanks School of Public Health, Indiana University – Indianapolis.

STUDY PURPOSE

The purpose of this study is to assess the effects of implementing a) a multimedia application about Substance Use Disorder (SUD) science and evidence-based treatment methods and b) a health tracking application where students can track answers to brief questions about their health on a daily basis.

PROCEDURES FOR THE STUDY

This multimedia application is divided into four video modules on the science of and evidence-based treatment for alcohol use disorder, marijuana, opioids, and stimulants.  Each video module consists of 2 or 3 videos that are approximately 3.5 to 5 minutes and include pre- and post-surveys.  Modules with two videos should take approximately 20 - 30 minutes to complete, and those with three videos should take approximately 30- 40 minutes to complete. The health tracking application contains five short questions which students answer at a chosen time each day, relating to how students are doing, how each day is progressing, how strong cravings are, how confident students are that they won’t use, and what good things students did for themselves that day. These questions should take about 5 minutes each day to complete. A short use questionnaire asking how you like the application may appear on the health tracking application after you use the app for five days in a row. This should take 5 minutes to complete, and will be the same every time.
You may currently be obtaining counseling services from IU CAPS and OASIS, or may obtain such services in the future. If you are currently doing so, a health professional may have invited you to use SUN. It is your choice whether or not to share your responses to the health tracking application questions with a particular counselor. Choosing not to participate will not affect provision of any counseling or health services.

To enroll in the program, you will have to complete informed consent online form and answer a series of setup questions about your demographics and preferences, such as when you would like to answer the daily health journal questions. There are no right or wrong answers to health journal questions. This setup process should take about 15 minutes.

You are free to withdraw from the study at any time by notifying Dr. Madeira or Dr. Andraka-Christou.

CONFIDENTIALITY

Efforts will be made to keep your personal information confidential.  If you are assigned to a health provider at CAPS or OASIS, you can choose whether or not to share your responses to the health tracking application, your video completion rate, and your answers to video pre-post survey questions with that health provider.  Your identity will be held in confidence in reports in which the study may be published.

We cannot guarantee absolute confidentiality.  Your personal information may be disclosed if required by law.  Organizations that may inspect and/or copy your research records for quality assurance and data analysis include groups such as the study investigator and his/her research associates, the Indiana University Institutional Review Board or its designees], and (as allowed by law) state or federal agencies, specifically the Office for Human Research Protections (OHRP) who may need to access your research records.

PAYMENT 

If you are one of the first 100 students to complete the following tasks, you will receive a $20 Amazon gift card: 1) register for the SUN program; 2) download the mobile application; 3) answer mobile application questions daily for two weeks; 4) watch at least one complete module of videos; and 5) answer pre-post questions associated with that video module.

After that time period, you are invited to continue using the mobile application and video modules.

CONTACTS FOR QUESTIONS OR PROBLEMS

For questions about the study, contact the researcher, Dr. Jody Madeira, at 8128561082 or jmadeira@indiana.edu.

For questions about your rights as a research participant or to discuss problems, complaints or concerns about a research study, or to obtain information, or offer input, contact the IU Human Subjects Office at (317) 278-3458 or (800) 696-2949.

VOLUNTARY NATURE OF STUDY

Taking part in this study is voluntary.  You may choose not to take part or may leave the study at any time.  Leaving the study will not result in any penalty or loss of benefits to which you are entitled.  Your decision whether or not to participate in this study will not affect your current or future relations with Indiana University.

SUBJECT’S CONSENT

In consideration of all of the above, I give my consent to participate in this research study.

I have printed off a copy of this informed consent document to keep for my records. I agree to take part in this study.

[E-signature]


If you are invited by a counselor to use the SUN system, or begin seeing a counselor while using the SUN system, you may choose whether or not to share your data with the counselor. You can later decide to not share your data in settings in the mobile application or student portal.

The ONLY information that will be shared with your counselor are your answers to the daily health tracking questions.  The information in the Gratitude List, Goal Tracker, and Journal WILL NOT be shared with your counselor.

SUN is not a substitute for a counseling relationship.  If you are in a counseling relationship and choose to share your daily health tracking trends with your counselor, your counselor does not have a duty to check this application regularly to see if information has been shared, and will review any shared data for analytics purposes only. 

If you need help for a mental health emergency, please contact IU CAPS Monday through Friday during business hours at (812) 855-5711, or contact IU CAPS Crisis Hotline afterhours at (812) 855-5711.