Addressing the Opioid Crisis in Communities of Color

OMB Control Number 0990-0421

Expires October 12, 2020

Attachment C. Script for Verbal Informed Consent

TITLE OF STUDY:	Addressing the Opioid Crisis in Communities of Color
INVESTIGATOR:	The Urban Institute
PHONE NUMBER:
SPONSOR:	U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the Office of Minority Health (OMH)

[DIRECTIONS FOR INTERVIEWERS: Read the below information to the participant(s) and ask each participant to respond to the two consent questions: (1) for study participation and (2) for permission to record the discussion. Do not record the process of obtaining consent. Do not record the interview if the respondent declines consent to record.]

Thank you for taking the time to meet with us today. The Urban Institute is being contracted by the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the Office of Minority Health (OMH) to conduct a study of the communities’ response to the substance use, particularly opioid use disorder, among racial and ethnic minorities.

You are being asked to participate in this research study. Before we begin we want to obtain your verbal consent to participate in the study. As part of obtaining your consent we will share information about the study’s purpose, procedures, and any benefits or risks of the study. Once we review these aspects of the study and you’ve had a chance to ask any questions, we will ask if you consent to participate in the study.

The purpose of the study is to learn from state and local administrators and practitioners about the local efforts to address substance use and opioid use disorder among racial and ethnic minority populations, specifically focusing on models and initiatives that integrate human services programs.

We are asking for your participation in this [interview/small discussion group] to hear about your professional perspective on and experiences with [insert name of the site]’s response to the opioid crisis among [insert minority population of focus].

For this study, Urban researchers will be interviewing up to 144 individuals from 8 sites across the country. The selection criteria ASPE and OMH used to identify sites ensured geographic diversity. The site selection criteria also took into consideration whether a site had a promising treatment model or strategy for integrating human services with SUD treatment, concentration of two or more racial/ethnic minority groups, and high SUD prevalence and overdose mortality rates among minority population. [Site name] was selected as one of the 8 sites for this study.

During the [interview/small discussion group] will we ask you to discuss your professional perspective of how substance use disorder, and particularly opioid use disorder, may have impacted minority populations in your community and how health care and other systems have responded to substance use in the community, including substance use treatment and human services agencies and providers.

The information that we collect as part of this study will be analyzed and shared in a summary report for ASPE and OMH. The report will not identify you by name or specific job title, but will summarize all the information we learned about [insert site name].

We will also ask for your consent to record the discussion for transcription purposes. As part of Urban’s study contract, we will provide transcripts to ASPE and OMH, but we will redact all identifying information from the transcripts. Specifically, Urban researchers will remove any identifying information, such as names or job titles, before sharing transcripts with ASPE and OMH.

There are no known risks to this study. Participating in the study may not provide a direct benefit to you, but information from the study will be helpful to inform federal and state administrators’ practices and policies regarding how to better meet the needs of minority populations with substance use disorder.

Participation in the study is completely voluntary and you may end participation at any time. Your refusal to participate or withdraw from the study will not result in any penalty. There is no compensation for participating in the study.

Do you have any questions for me about the study before we get started?

If you have any additional questions about the study, you may contact me [interviewer/site liaison] at [contact email and phone number] or Lisa Clemans-Cope, the study’s lead researcher at Urban, at 202-261-5580.

[Consent Question 1] Do you consent to participate in the study? [yes/no]

[If yes, Consent Question 2] Do you consent to allow us to record the discussion? [yes/no]