Appendix H - PACT HM Consent Program Participants 10

O MB No.: 0970-0430

Expiration Date: July 31, 2016

[PROGRAM NAME]

Parents and Children Together (PACT) Study of

Healthy Marriage Programs

[PROGRAM NAME] IS PART OF A NATIONAL STUDY

The [PROGRAM NAME] is part of the Parents and Children Together (PACT) 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 couples build better relationships and be better parents, 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 couples build better relationships, have healthy interactions with their children, and get and keep good jobs. This 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.

The [PROGRAM NAME] program is for couples. 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 as a couple and work together as a couple to solve problems and have a healthy relationship. 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 PACT study. If you and your partner decide 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.

If you decide to be in the [PROGRAM NAME] program and the study, and you are eligible for the study, we will ask you to answer some questions today on the telephone with the researchers in New Jersey. They will ask you questions about yourself, your partner, and your child or children. This will take about 30 minutes. A staff member from the [PROGRAM NAME] program will give you a phone and a private space to use to answer the questions. You will receive $10 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 with your partner, your interactions with your child or children, your relationship with other family members, your employment, and services you receive. At that time, you may also be asked to participate in focus groups and in-person interviews. We will provide more information about these activities later and your participation is voluntary.

The decision to participate in the survey in 12 months and the interviews is voluntary and will have no effect on your participation in the program, and you can decide in 12 months whether to participate in the survey and interviews.

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, and child support agreements. We will ask you for your social security number.  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 child support agreements and may be used to locate you more easily for the interview in a year’s time.  

HOW WILL PROGRAM PARTICIPANTS BE CHOSEN?

This study will look at two groups of couples: those who receive [PROGRAM NAME] 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 the [PROGRAM NAME] program services at no cost to them. The other group will be able to receive referrals to other organizations for services, but not the [PROGRAM NAME] program 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 [PROGRAM NAME] will let you know which group you are assigned to after you and your partner complete today’s interview.

If you are not randomly assigned to participate in the [PROGRAM NAME] program, 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.

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.

WILL YOUR 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.

WHAT ARE THE RISKS OF PARTICIPATING IN THE STUDY?

Your participation in the study could help in providing services in the future to other couples like you. You may feel uncomfortable answering some questions in interviews. 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, and child support agreements. In addition, representatives from the Department of Health and Human Services and 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.

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, or local civil, criminal, administrative, legislative, 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 the interviewers 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 yourself 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.

WHAT ARE THE BENEFITS OF PARTICIPATING IN THE STUDY?

You may or may not benefit from participating in this study.

IS YOUR PARTICIPATION VOLUNTARY?

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.

Consent to Participate in Parents and Children Together

I have read the information on the previous pages.

• I have been informed about the services offered by [PROGRAM NAME], and I want to participate in those services.

• I agree to answer a set of questions now. I can choose to participate in later study activities when the researchers contact me in 12 months. I understand that I may be asked some questions about personal things, but I will not have to answer any questions that make me feel uncomfortable. I can change my mind about participating at a later time, and this will not affect my participation in the program.

• I give permission for the study team to collect information on [PROGRAM NAME] services I receive. I give permission for [PROGRAM NAME] staff to release information to the study team about me and my participation in the program.

• I give permission for the researchers to access information about me from federal, state and local agencies about my employment and earnings, and child support arrangements and payments.

• I understand that all information will be protected. However, I do understand that if a person on the study team observes child abuse, it must be reported.

• I can call Sheena McConnell, Principal Investigator for the PACT study, at 202-484-4518 or Shawn Marsh, Survey Director for the PACT study, at 609-936-2781 or toll-free at 855-398-3304 at Mathematica Policy Research to get an answer about any questions I may have.

• If I have questions about my rights as a research volunteer, or feel that I have been harmed in any way by participating in the study, I can call the New England Institutional Review Board, at 1-800-232-9570.