Attachment G_STREAMS_Consent statement for adult participants

ATtachment g

consent statement for adult participants

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CONSENT STATEMENT FOR ADULT PARTICIPANTS

[PROGRAM NAME] IS PART OF A NATIONAL STUDY

[PROGRAM NAME] is part of the STREAMS study, a national study being conducted by the U.S. Department of Health and Human Services. The study is being done to learn more about which services help people improve their relationships, as well as improve their economic stability. The Department of Health and Human Services asked researchers from an organization called Mathematica to assist with the study. We invite you to be a part of the study.

WHAT IS THE STUDY ABOUT?

The study is being done to learn how well programs like [PROGRAM NAME] work. This program aims to help people improve their relationships (and get and keep good jobs). The study will determine whether the program achieves those aims, and will help us learn whether there are ways these kinds of programs can be improved.

HOW WILL PROGRAM PARTICIPANTS BE CHOSEN?

If you participate in the program you (and your partner) can attend a series of group workshops where you can learn how to communicate better and improve your relationship skills. (You can also get help with employment problems you might be facing.)

If you want to be in the program, you (and your partner) have to agree to be a part of the STREAMS study. If you (and your partner) decide that you do not want to be a part of the study, you will not be able to participate in the [PROGRAM NAME] program. You will be given information about other services that you can receive in the community. You will be free to participate in any of these other services provided by other organizations to get help with your relationship or employment issues.

WHAT DOES PARTICIPATION INVOLVE?

If you decide to be in the [PROGRAM NAME] program and the study and you are eligible for the study, I will ask you to complete a short survey on the telephone with me today. This will take about 30 minutes. You will receive $10 once you complete the survey in appreciation of your time.

In about 12 months, the researchers will contact you again by phone and ask you about topics such as your relationships, your employment, and services you receive. The decision to participate in the survey is voluntary and will have no effect on your participation in the program. We will provide more information about this survey later, and you can decide in 12 months whether to participate.

You may also be asked to participate in focus groups. We will provide more information about these activities later, and your participation is voluntary.

If you agree to be part of the study, it means you are giving permission for the [PROGRAM NAME] program to share information with the researchers about the services you receive from the program. The research team may also contact federal and state agencies for information about your employment and earnings. We will ask you for your social security number. You can decide whether or not to give it to us. We want to assure you that it will be kept private and will only be used for research purposes. It may be used in requests to federal and state agencies for more information about your employment and earnings and may be used to locate you more easily for the interview in a year’s time.

This study will look at two groups: those who receive [PROGRAM NAME]’s services, and those who receive referrals to other existing services in the community. The study will compare outcomes for the two groups. A computer will randomly select which group you will be in. One of the groups will receive [PROGRAM NAME] services at no cost to them. The other group will be able to receive referrals to other organizations for services, but not [PROGRAM NAME] services.

The computer works like a flip of a coin; assignment to a group is completely random. This procedure makes sure that assignments to the groups are fair. Everyone who agrees to join the study has the same chance of being placed into either group. The chance of being able to receive services is not influenced by what you say to program staff or your answers to the questions on the telephone. A staff member from [PROGRAM NAME] will let you know which group you are assigned to after you (and your partner) complete today’s interview.

At any time, after you have been randomly assigned, you can call Mathematica’s help line to say that you no longer want the program to share information about you with the Mathematica researchers, and that will have no effect on the services available to you.

WHAT HAPPENS IF I AM NOT SELECTED TO RECEIVE [PROGRAM NAME] SERVICES?

If you are not randomly assigned to participate in [PROGRAM NAME], you will be provided with information about other services available to you in the community, and you will be able to talk to a staff person about those other services.

WILL MY PRIVACY BE PROTECTED?

Everything you tell the researchers will be used for research purposes only, unless we are required by law to release it for some other purpose. The Department of Health and Human Services may allow other researchers to use the information that you provide, and researchers may use your name and contact information to get in touch with you in the future for research purposes. Nobody will ever publish your name in connection with the information you provide. Instead, information about you will be combined with information about other people in the study, so researchers can describe the overall program effects and participants’ experiences.

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, local, civil, criminal, legislative, administrative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, with one exception. The Certificate of Confidentiality does not prevent the researchers from disclosing information that would identify you as a participant in the research project if you tell me anything that suggests you are very likely to harm yourself, that you are planning to hurt another person or child, or that someone is likely to harm you.

You should understand that a Certificate of Confidentiality does not prevent you, or a member of your family, from voluntarily releasing information about you or your involvement in this research. If an insurer, employer or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.

We hope you will want to be in the study but your participation is strictly voluntary. However, if you do not want to be in the study, you cannot be entered into the computer system to see if you can receive services from [PROGRAM NAME]. If you agree to be in the study and later decide you do not want to answer some or all study questions or have information from the program shared with researchers, you may decline at any time. By agreeing now to be in the study, even if later you tell us you want to withdraw from the study, you are authorizing researchers to use information that was collected about you before you withdrew.

WHAT ARE THE BENEFITS OF PARTICIPATING IN THE STUDY?

Your participation in the study could help in providing services in the future to other people like you.

WHAT ARE THE RISKS OF PARTICIPATING IN THE STUDY?

You may feel uncomfortable answering some questions in the interview. You can refuse to answer those questions if you wish, and it will not change your participation in the program. Although researchers will take many steps to protect all study information, there is a small risk that non-researchers could see it, including information about your employment and earnings. In addition, representatives from the Department of Health and Human Services and the New England Institutional Review Board (IRB) may inspect and have access to confidential information as they ensure your rights as a study participant are protected.

WILL I BE COMPENSATED FOR MY PARTICIPATION?

The Paperwork Reduction Act Statement: This collection of information is voluntary and will be used to examine the effectiveness of healthy marriage and relationship education programs designed to improve intimate relationships. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this collection is XXXX-XXXX and it expires on XX/XX/XXXX.

You will receive $10 once you complete the survey in appreciation of your time.

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