APPENDIX E: MUSE-STC Consent Form

Consent Form

Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.

COMIRB No: 22-0595

Version Date: Version #: 1

Study Title: Multi-Site Study of State-Tribal Collaboration in Home Visiting (MUSE-STC)

You are being asked to be in a research study. This form provides you with information about the study. A member of the research team will describe this study to you and answer all of your questions. Please read the information below and ask questions about anything you don’t understand before deciding whether or not to take part.

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Why is this study being done?

This study examines collaboration between state awardees that receive Maternal, Infant, and Early Childhood Home Visiting (MIECHV) funding and organizations serving tribal communities with MIECHV funds. The goal of the study is to learn more about how state agencies and local organizations work together to provide home visiting services to American Indian and Alaska Native (AIAN) families. The study will describe how collaboration influences planning and implementation of these home visiting services.

This study will attempt to identify strategies that support successful collaboration between states and local/tribal agencies providing MIECHV funded services. This information may help MIECHV programs better serve AIAN families. The study may help federal funding agencies provide better support to states and local organizations serving AIAN families.

You are being asked to be in this research study because you are currently employed by [AGENCY/ORGANIZATION] and you have been identified as someone who is knowledgeable about the partnership between [STATE AWARDEE] and [AGENCY SERVING TRIBAL COMMUNITY]. We want to know about your experience with this work.

The study includes up to 6 state-tribal partnerships. We will ask up to 42 staff from state awardee agencies and local organizations to participate in this study.

What happens if I join this study?

If you join the study, you will participate in an interview about your role in the agency or organization where you work and your experience partnering to provide home visiting services to AIAN families with [PARTNERING AGENCY].

You will be interviewed over a private telephone or video conference call. To keep the interview private, we will work with you to ensure that only you and the interviewer will be able to hear your conversation. We are asking that you let us record the interview (audio only). If you agree, we will later transcribe the recording and remove any names you mention.

The research team will then share some of what they learn from these interviews in presentations, or written reports, or articles in professional journals. Anything shared from the interviews will be written or presented in a way that does not identify you, anyone you discuss in the interview, your agency, or your community.

You are asked to help the research team maintain your own privacy and that of others in your community by not disclosing your participation in this study or sharing what you discuss with the research team.

You will be asked to participate in one interview that will last between up to90 minutes.

You may be asked to participate in a brief follow up phone call if there are remaining questions or clarifications needed after the interview.

What are the possible discomforts or risks?

The interview asks about your experiences as a part of collaboration to provide home visiting to AIAN families and will include questions about work with [STATE OR LOCAL AGENCY] and collaboration with [STATE OR LOCAL AGENCY]. Some of these questions may be difficult or uncomfortable for you to answer.

There is a small risk that your personal information will accidentally become known. We take steps to make this unlikely. We will assign you an ID number and use this ID instead of your name on your interview transcript to keep your information private.

There is a risk that your information will become known if you disclose your participation or information shared with others outside the research team.

There are some times when we cannot keep your information private because we want to make sure people are safe. If you tell us about child, spousal, or elder abuse or neglect, we have to report that to Social Services or the appropriate authority, as per tribal and state legal codes. If you tell us that you are going to physically hurt yourself or someone else, we have to report that to the police.

What are the possible benefits of the study?

This study is designed for the researcher to learn more about collaboration between state MIECHV awardees and local agencies serving AIAN families. You will not benefit directly from being in this study.

Who is paying for this study?

This research is being paid for by the Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services. ACF has funded James Bell Associates and the University of Colorado’s Anschutz Medical Campus, Centers for American Indian and Alaska Native Health to conduct this research.

Will I be paid for being in the study? Will I have to pay for anything?

If allowable by the terms of your employment, you will be paid $75 for participation in the interview.

It will not cost you anything to be in the study.

Is my participation voluntary?

Taking part in this study is voluntary. You have the right to choose not to take part in this study. If you choose to take part, you have the right to stop at any time and to decline answering any questions. If you refuse or decide to withdraw later, you will not lose any benefits or rights to which you are entitled.

Who do I call if I have questions?

The lead researcher responsible for this study is Dr. Nancy Rumbaugh Whitesell. You may ask any questions you have now. If you have questions later, you may call Dr. Whitesell at 303-724-1456.

You may have questions about your rights as someone in this study. You can call Dr. Whitesell with questions. You can also call the Colorado Multiple Institutional Review Board (IRB). You can call them at 303-724-1055.

Who will see my research information?

We will do everything we can to keep the information you share during the study secret. It cannot be guaranteed.

Both the records that identify you and the consent form signed by you may be looked at by others including:

• Federal agencies that monitor human subjects research

• People at the Colorado Multiple Institutional Review Board (COMIRB)

• Researchers working on this study from the University of Colorado and James Bell Associates

• The Administration for Children and Families, the agency paying for this research study

• Regulatory officials from the institution where the research is being conducted who want to make sure the research is safe

The results from the research may be shared at a meeting. The results from the research may be in published reports and articles. Researchers will keep your name private when information is presented and will remove or alter details in what you share that identify you, your agency, or your location.

If you consent to participate in the interview, your conversation with the study team member will be audio-recorded using a secure web-based platform. We will protect the audio-recordings by:

• Using only password protected audio-recording platforms;

• Transferring and storing audio-recordings and interview transcripts using secure data storage platforms accessible to research team members only;

• De-identifying transcripts during the transcription process;

• Audio-recordings will be erased after the transcript is verified and interview transcripts will be kept for 5 years after the study is complete and then erased.

Agreement to be in this study

I have read this paper about the study or it was read to me. I understand the possible risks and benefits of this study. I know that being in this study is voluntary. I choose to be in this study. I will get a copy of this consent form.

Signature: Date:

Print Name:

Consent form explained by: Date:

Print Name:

Consent Template Social and Behavioral

CF-156, Effective 10-24-18

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