Information Sheet

The information below provides a brief description of the research study. After reading this description, you will be asked whether or not you agree to participate in the survey.

Protocol Title: Employer perspectives on the need for resources to address opioid use in the workplace

Study No: HP-00096979

Principal Investigator: Marianne Cloeren, MD, MPH, FACOEM, FACP

Co-Investigator: Jodi Jacobson Frey, PhD, LCSW-C, CEAP

Sponsor: Maryland Department of Health (MDH) Occupational Health and Safety Surveillance project (CDC Cooperative Agreement 5 U60OH011154) and Overdose Data to Action project (CDC Cooperative Agreement NU17CE924961)

You are invited to take part in a research study. Taking part in this research study is voluntary. This information sheet describes the research and your part in it. Please read this sheet carefully.

The University of Maryland, Baltimore in collaboration with the Maryland Department of Health is developing an online toolkit that will include resources for employees and employers related to opioid use and recovery in the workplace. The project is called Workplace PROSPER and our goals are to help improve workplace safety, prevent opioid overdoses, increase access to treatment for Opioid Use Disorder (OUD), and promote non-discriminatory work practices for employees recovering from OUD. To create this toolkit, we need your help. Your opinion is critical to the success of the project, and we are asking Maryland employers with a broad perspective of their employees' needs to either complete an online, and anonymous survey or participate in an interview via videoconferencing software (Zoom or WebEx).

There are no direct benefits for participating in this study. However, your responses to the survey and/or interview will inform researchers about employer needs related to supporting individuals in recovery who are looking to get or maintain a job. Any discomfort you might feel when answering questions should be no more than you would experience in your daily life.

If you are interested in learning more about this study, please continue to read below.

This study is being conducted to help create an online toolkit that can be used by employers and employees. The toolkit will include resources to address opioid use and recovery in the workplace. We are asking employers who are at least 18-years-of-age, who have employees working within Maryland, and who have a broad perspective of their employees' needs and workplace programs and policies, to either complete a brief, online, and anonymous survey, which will immediately be provided after you read this information sheet and provide your consent or participate in an interview. If you complete the online survey for this study, it will take about 15 minutes to complete. If you complete the interview, it should last for about 30-45 minutes, and a member from the research team will contact you to schedule this to take place
within about 2-3 weeks.

The survey and interview questions will ask similar:

• demographic questions specific to the respondent's workplace;
• questions related to the presence of or need for specific employer policies;
• questions related to the availability of or need for educational resources; and
• questions specific to the presence of, need for, and interest in employee peer support.

Participation in this research study is voluntary; you do not have to participate if you do not want to. If you agree to participate, you will be asked to either complete one online survey today or one interview in the next 2-3 weeks. If you decide to complete the survey, it will take you approximately 15 minutes to complete. Please complete the survey all at once as you will not have an option to save and come back to complete it at a later time. If you are asked to do the interview, we will schedule a time to talk with you in the next 2-3 weeks. The interview should last about 30-45 minutes. It will be conducted over Zoom or WebEx and recorded and transcribed word-for-word. Questions will ask about opioid use in the workplace, from your perspective as an employer. We encourage you to find a comfortable and private location to complete the survey or interview.

If you know that someone from your work organization has already completed the survey or interview, we ask that you discontinue participation. If you would like to recommend a potential project participant from another work organization, please contact the research team at prosper@ssw.umaryland.edu and share the name, email, and work organization in your email. At the end of the survey/interview, you may be given the option of being contacted in the future about another related research study. Consent for that study will be done separately.

If you take part in this research, you will either complete one survey today that will take approximately 15 minutes or one interview (Zoom/WebEx) that should take about 30-45 minutes. The interview will be scheduled in the next 2-3 weeks.

There are no expected physical or psychological risks associated with participation in this study. Any discomfort you might feel when answering questions should be no more than you would experience in your daily life. Your response to survey items and interview questions will not affect your current or future relationship with your employer or the University of Maryland, Baltimore.

There are no direct benefits for participating in this study. However, your participation in this study will inform researchers about employer needs related to supporting individuals in recovery in obtaining or maintaining employment.

You may choose not to participate at any time without penalty. If you choose to leave the survey prior to completion, your partial response(s) will be recorded. We are not able to identify your individual responses within the database. If you choose to leave the interview prior to completion, your partial response(s) will be recorded and transcribed.

It will not cost you anything to take part in this study.

All responses to the survey and interview will be stored in a password-protected electronic database. Only members of the research study team will have access to your survey and interview responses. Additionally, there is no way for the researchers (or anyone who may have shared this survey link with you) to know if you responded or to link answers to individuals or workplaces. The survey includes questions that allow for a free text response; however, you should not include personal details such as your name, the name of coworkers, or your company or work organization name. Similarly, we will not ask for information that may identify you during the interview. You will decide if you want to participate on camera and/or with your name showing, or not. If any identifying information is provided by accident, either in the free text response or the interview, it will be removed from the final dataset and transcripts. Original transcripts and recordings with identifying information will be deleted and the transcript deidentified. Only trained research staff at the University of Maryland Baltimore will know that you are participating in this project.

When the study ends, research results may be shared in the aggregate (i.e., as a whole) within professional presentations or research publications. Study results will not include any information that could identify you or your employer.

Quotations will be extracted from the transcripts and assigned a pseudonym without any identifying information. This information will also be shared in written reports for funding entities, professional presentations, and any publications authored by the research team.

Your decision to be in this study is voluntary. You do not have to take part in this research. You are free to withdraw your consent at any time. If you withdraw, already collected data will remain in the study database. If you refuse to take part or if you stop taking part in this study, you will experience no penalty or loss of benefits to which you are entitled. Please contact the principal investigator, Marianne Cloeren, MD, MPH, FACOEM, FACP at (410) 328-2637 or mcloeren@som.umaryland.edu if any of the following occur:

• You decide to stop taking part in the research.
• You have questions, concerns, or complaints about the research.
• You need to report a medical injury related to the research.

You may also contact the University of Maryland, Human Research Protections Office. Contact information is listed below. You will be told of any significant new findings that develop during the study. Such findings may affect your choice to take part in the study.

The principal investigator does not foresee any reason for removing you from the research study.

The University is committed to providing participants in its research all rights due them under state and federal law. You give up none of your legal rights by participating in the research project. Please call the Institutional Review Board (IRB) if you have questions about your rights as a research participant.

The research described in this consent form has been classified as minimal risk by the IRB of the University of Maryland, Baltimore (UMB). The IRB is a group of scientists, physicians, experts, and other persons. The IRB’s membership includes persons who are not affiliated with UMB and persons who do not conduct research projects. The IRB’s decision that the research is minimal risk does not mean that the research is risk-free. You are assuming risks of injury as a result of research participation, as discussed in the consent letter. If you are harmed as a result of the negligence of a researcher, you can make a claim for compensation. If you have questions, concerns, complaints, or believe you have been harmed through participation in this research study as a result of researcher negligence, you can contact members of the IRB or the staff of the Human Research Protections Office (HRPO) to ask questions, discuss problems or concerns, obtain information, or offer input about your rights as a research participant. The contact information for the IRB and the HRPO is:

University of Maryland Baltimore

Human Research Protections Office

620 W. Lexington Street, Second Floor

Baltimore, MD 21201

410-706-5037

Thank you for reading this information sheet.

If you voluntarily agree to participate in this research study, please select from one of the buttons below
• "Yes, I agree to participate. I will complete the survey now." to be directed to the first survey question.
• "Yes, I agree to participate. I will provide my name and contact information so that a researcher can call me to discuss the interview." to be directed to a contact form (name, email address, phone number).

If you do not want to participate, please click on the button below labeled, "No, I do not want to participate" and you will be exited from the survey.

Do you want to participate in this study?

Yes, I agree to participate. I will complete the survey now.

Yes, I agree to participate. I will provide my name and contact information so that a researcher can call me to discuss the interview.

No, I do not want to participate.

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