Focus group consent

Provider Focus Group

Participant Informed Consent

Study Title: Medication-Assisted Treatment for Opioid Use Disorders (MAT Study)

Study #: N/A

Sponsor: Centers for Disease Control and Prevention (CDC)

Principal Investigator:

Laura Dunlap

RTI

3040 E. Cornwallis Rd. Durham, NC 27709

Telephone Number: (800) 957-6483

After Office Hours: (919) 599-9771

Introduction

You are being asked to participate in a research study. Before you decide if you want to take

part in this study, you need to read this Informed Consent Form so that you understand what the

study is about and what you will be asked to do. This form also tells you who can be in the

study, the risks and benefits of the study, how we will protect your information, and who you can

call if you have questions.

You are encouraged to ask the Principal Investigator or study team to explain anything you don’t

understand before you make your decision.

Purpose

The Medication Assisted Treatment (MAT) Study is a research study funded by the sponsor, the

Centers for Disease Control and Prevention (CDC). The study is being conducted by RTI

International, a research organization located in Research Triangle Park, North Carolina. The

purpose of this study is to aid the CDC in assessing the comparative effectiveness of the

different medication assistant therapies (MAT) and non-MAT counselling for opioid use disorder

treatment. You are one of about 81 people selected from among over 40 medical/counseling

facilities that are participating in the MAT Study.

Procedures

If you agree to participate, you will be asked to take part in a telephone conference call with

seven to nine of your colleagues from medical/counseling facilities that are participating in the

MAT Study. Participants in the focus group will only be identified by first name or other label of

their choice. The group will discuss:

• experiences and challenges in providing MAT for opioid use disorder (OUD),

• practice environment and organizational structure, and

• barriers and facilitators to treating OUD clients.

Your participation in the focus group discussion will take about 90 minutes. All your responses

will be held confidentially and used only for research purposes. Your responses will be audio

recorded if all the participants in the group agree to allow audio recording. You can still take

part in the focus group even if you do not want the discussion to be recorded. You will be able to

indicate your choice regarding audio recording of the focus group at the end of this form.

Alternatives

Your alternative is to not participate in this focus group discussion.

Possible Risks or Discomforts

Your participation is voluntary. You may contribute to the discussion or not at your choice. While

we will keep all the conversations as confidential as possible, it is possible that other

participants in the group will reveal information that you gave during the focus group discussion.

Please keep this mind during the discussion. If the discussion is recorded, it is also possible that

people who hear the recording will recognize your voice.

We are required to disclose suspected child abuse and neglect or threats of harm to self

or others.

You will be informed in a timely manner if new information becomes available that may be

relevant to your willingness to continue participation in the focus group discussion.

Your Benefits

There are no direct benefits to you for participating in this focus group discussion. We hope that

information from this study will help those suffering from opioid dependence by creating new

and additional opportunities for opioid treatment in the future.

Incentives

You will be given $150 for your participation in this group.

Costs

Taking part in this focus group discussion will not involve any costs to you.

Confidentiality

Many precautions have been taken to protect your privacy and keep the information you provide

(including the audio recordings, if applicable) as confidential as possible. The study team uses

computer security measures to protect your data. Your data are encrypted and stored on

password-protected systems. Generally, only study team members may access your data.

Personal information like your name, address, telephone number, email address, and social

security number, will be stored separately from the information you provide. No one at your

facility will be told what you say. Your name will be replaced with a number when we transcribe

the data from our interview. If the results of this study are presented in reports, at scientific

meetings, or published in scientific journals, no information will be included that could identify

you or your answers personally.

In addition, we are seeking a Certificate of Confidentiality from the United States

Government. Certificates are issued by the Department of Health and Human Services (HHS) to

researchers to help protect the privacy of people enrolled in sensitive, health-related research.

With this Certificate we cannot be forced to release information that may identify you, even by

court subpoena, in any federal, state or local civil, criminal, administrative, legislative, or other

proceeding. The Certificate allows us to refuse to release any information that may identify you,

with the following exceptions:

This Certificate cannot be used to turn down a demand for information from the United States

Government for the purpose of auditing or evaluating federally funded projects. A Certificate

does not prevent you or a member of your family from voluntarily releasing information about

yourself or your involvement in this project. If you provide written permission for release of

research information to an insurer, employer, or other person, the study team cannot use the

Certificate to withhold your information.

The certificate will NOT be used to prevent disclosure of suspected child abuse and

neglect or threats of harm to self or others.

To learn more, please see this website: http://grants.nih.gov/grants/policy/coc/index.htm

Your Rights

Your decision to take part in this research study is completely voluntary. You do not have to

take part in this focus group discussion. You can also refuse any part of the study and you can

stop participating at any time. There will be no penalty or loss of benefits that you are otherwise

entitled to. You can refuse to answer any question.

If you decide to participate and later change your mind, you will not be contacted again or asked

for further information.

If you stop participating in this study, the Principal Investigator and study team will still be able to

use your information that they have already collected.

Your Questions

You can ask questions about the study at any time. You can call the Principal Investigator or

study team at any time if you have any concerns or complaints. You should call the Principal

Investigator or study team at the phone number listed on page 1 of this form if you have

questions about the study procedures, study costs (if any), or study payment (if any).

Quorum Review reviewed this study. Quorum Review is a group of people who review research

studies to protect the rights and welfare of research participants. Review by Quorum Review

does not mean that the study is without risks. If you have questions about your rights as a

research participant, if you are not able to resolve your concerns with the Principal Investigator

or study team, if you have a complaint, or if you have general questions about what it means to

be in a research study, you can call Quorum Review or visit the Quorum Review website at

www.quorumreview.com.

Quorum Review is located in Seattle, Washington.

Office hours are 8:00 AM to 5:00 PM Pacific Time, Monday through Friday.

Ask to speak with a Research Participant Liaison at 888-776-9115 (toll free).

Are You Willing to Participate?

If you agree to participate in the MAT Study as a provider focus group participant, please sign at

the end of this form.

If you agree, we may contact you in the future for additional studies. You do not have to agree

to being contacted in the future to take part in this study, and you may withdraw your permission

for future contact at any time. If you do not want to participate in this study, we thank you for

considering being a participant.

HIPAA AUTHORIZATION

This section explains who will use and share your health information if you agree to take part in this focus group discussion. You must authorize this use and sharing of your information by signing this form or you cannot be in

this study. You can still be in the main part of the study even if you do not authorize the use and sharing of your information for the optional future contact part of the study. The Principal Investigator and study staff will collect, use, and share health information about you, including any information needed to do this study, as described in this form, and other identifying information about you, such as your name, address, phone number, or social security number.

Your information may be used and shared with these people for the following purposes:

• The Principal Investigator and study staff to conduct this research.

• The sponsor, The Centers for Disease Control and Prevention (CDC); people who work with or for the sponsor; and other researchers involved in this study. These people will use your information to review the study, and to check the results of the study.

• Others required by law to review the quality and safety of research, including the U.S. Food and Drug Administration (FDA), Department of Health and Human Services, Office for Human Research Protections, other government agencies in the United States and other countries, and Quorum Review.

After your information is shared with the people and groups listed above, the law may not require them to protect the privacy of your information. To maintain the integrity of this research, you might not have access to any health information developed as part of this study until it is completed. At

that point, you generally would have access to your health information. This authorization to use and share your information expires in 50 years. You may withdraw your authorization at any time but you must let the

Principal Investigator know in writing. You should send your written withdrawal notice to the address on page 1 of this form. If you withdraw your authorization, your participation in this study will end and the study personnel will stop collecting information from you for the focus group. You can cancel your authorization for the optional future contact part of the study and remain in the main study. Information about you collected before you cancel this authorization may continue to be used and shared by the CDC following your cancellation of this Authorization.

_____________________________________ _________

Signature of Participant Date

Your Statement

I have read the above information. I have been given the opportunity to ask questions, and my

questions have been answered to my satisfaction. By signing this form, I voluntarily consent to

participate in the research study. I understand that I may withdraw from this study at any time

without penalty or loss of benefits to which I am otherwise entitled. I am also authorizing the

collection, use, and disclosure of my personal health information as described above. I

understand that I will not lose any of my legal rights as a research subject by signing this

consent form. I will be given a copy of this signed consent form. I hereby elect to participate in

this research study.

Please keep a copy of this form in a safe place in case you need to refer to it later concerning

your rights and responsibilities as a research participant.

Optional Future Contact

I read earlier that if I agree, I may be contacted in the future regarding additional studies. I

understand that this future contact is optional. My decision regarding the optional

activity will not affect my participation in the main study.

I have decided that (please initial one line):

______ Yes, I agree to be contacted in the future regarding additional studies.

______ No, I do not agree to this future contact. I may still be in the main study.

Audio Recordings

Do you wish the focus group discussion to be recorded? You can say no and still participate in

the discussion. The discussion will only be recorded if all participants agree to allow audio

recording.

Initial below beside only one option:

______Yes, I agree that the focus group discussion may be recorded.

______No, I do not agree to the focus group discussion being recorded.

_________________________________________________

Printed Name of Participant

_________________________________________________ _________

Signature of Participant Date

YOU WILL BE GIVEN A COPY OF THIS CONSENT FORM TO KEEP.

I attest that the individual providing consent had enough time to consider this information, had

an opportunity to ask questions, and voluntarily agreed to participation in this study.

_________________________________________________

Printed Name of Person Explaining Consent

_________________________________________________ ________

Signature of Person Explaining Consent Date