Attachment MICS-5_Extended MICS Informed Consent_Revised_11-29-22_Clean

RTI International / Protocol Number STUDY00022143 / 0218596

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Extended Consent to Participate in a Research Study

Sponsor / Study Title:	RTI International / “Mental Illness Calibration Study (MICS)”
Protocol Number:	STUDY00022143 / 0218596
Principal Investigator:	Leyla Stambaugh, PhD
Telephone:	1-919-485-2618 (direct line) 1-800-848-4079 (project line)
Address:	RTI, International 3040 E Cornwallis Rd, PO Box 12194 Research Triangle Park, NC 27709

KEY INFORMATION

You have been selected for a follow-up study to the National Survey on Drug Use and Health. This study, sponsored by the U.S. Department of Health and Human Services, will ask questions about mental health, and consists of one interview.

If you decide to participate in the follow-up interview, your first name, telephone number, and email address will be collected so we can contact you about your interview. To schedule an interview appointment, you can either select a date and time through the study’s online scheduling system or when speaking to the interviewer who contacts you.

The interview should take about 60 minutes to complete. Your participation is voluntary, you can refuse to answer any questions you do not want to answer, and you can stop the interview at any time. The interview will be conducted using Zoom. You can be in your home, office, or another private location when you complete the interview. You will be asked for permission to record the interview to ensure the interviewer administered the interview properly. You can still be interviewed even if you do not allow the interview to be recorded. Your interview recording may be used for quality or training purposes. If you agree to complete the interview, you will receive a $30.

Federal law requires us to keep all of your answers private and confidential. Any data you provide will only be accessed by authorized personnel for statistical purposes according to the Confidential Information Protection and Statistical Efficiency Act of 2002. The only exceptions to this promise of confidentiality are if you tell the interviewer that you intend to seriously harm yourself or someone else, or if a child has been or will be seriously harmed. In this situation, the interviewer may need to notify a mental health professional or other authorities.

The following information is meant to help you decide whether you want to participate in this study.

WHO IS LEADING THE STUDY?

The person in charge of this study is the Principal Investigator from RTI International, a non-profit research organization in North Carolina. The study is sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency in the U.S. Department of Health and Human Services (DHHS).

WHAT IS THIS STUDY ABOUT?

The study will look at how many people in the United States have experienced mental health conditions like depression, anxiety, and post-traumatic stress disorder. We are asking people who take part in the study to answer questions about these conditions.

For the study to be successful, we need to hear from people who have had these experiences and from people who have never had these experiences.

Your name will not be linked to your answers. Your answers will be combined with answers from the other study participants and will be used to understand how many people experience mental health conditions, and how these conditions impact their quality of life. Also, this information may be used by local, state, and federal agencies to support education, treatment, and prevention programs.

DO I HAVE TO TAKE PART IN THIS INTERVIEW?

No – your participation is voluntary, and you can refuse to answer any questions. Even if you decide to start the interview, you may change your mind and stop at any time. If you decide to stop the interview before finishing it, let the interviewer know. The only alternative is to not participate in the study. If you decide not to take part in, or stop, the interview, there will not be any penalty, and you will not lose any benefits or rights you would normally receive.

WHAT ARE THE POSSIBLE RISKS OR DISCOMFORTS?

The length of the interview might cause you to feel tired or stressed. You may find some of the questions we ask to be upsetting or stressful. If this happens, you can take a short break, or stop the interview, and finish later or on another day.

WHAT ARE THE POSSIBLE BENEFITS?

This study is for research purposes only. There is no direct benefit to you from your participation in the study. Information learned from the study may help other people in the future.

WILL THERE BE ANY COSTS ASSOCIATED WITH MY PARTICIPATION?

There will be no charge to you for your participation in this study, other than your normal phone, internet, or data plan charges if applicable.

WILL I RECEIVE ANY PAYMENT FOR TAKING PART IN THIS STUDY?

Yes, you have received $30 in advance of your participation.

WILL MY RESPONSES BE KEPT CONFIDENTIAL?

You cannot be identified through any information you give us. Your name and address will never be connected to your answers. Your answers will be combined with those from the other study participants. The results of the study will come from the combined answers, and it won’t be possible to identify you. In addition, federal law requires us to keep all your answers confidential. Any information you give us will only be used by authorized personnel for statistical purposes.

Federal law requires us to keep all of your answers private and confidential. Any data you provide will only be accessed by authorized personnel for statistical purposes according to the Confidential Information Protection and Statistical Efficiency Act of 2002. The only exceptions to this promise of confidentiality are if you tell the interviewer that you intend to seriously harm yourself or someone else, or if a child has been or will be seriously harmed. In this situation, the interviewer may need to notify a mental health professional or other authorities.

WHOM TO CONTACT ABOUT THIS STUDY

During your interview, if you have questions, concerns, or complaints about the study, please contact the Principal Investigator at the telephone number listed on the first page of this consent document.

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, and/or concerns or complaints regarding this research study, please contact RTI International’s Office of Research Protection at 1-866-214-2043 (a toll-free number). You are not giving up any of your legal rights by agreeing to be in this study.

Leyla Stambaugh, PhD

RTI International IRB Approved Version 1 June 2022