Supporting Statement for OMB Clearance Request
Appendix H: Informed Consent
Pathways for Advancing Careers and Education (PACE) – Follow-up Data Collection
OMB No. 0970-0397
November 2014
Submitted by:
Brendan Kelly
Office of Planning,
Research
and Evaluation
Administration for
Children
and Families
U.S. Department of Health and Human Services
Note: There are two versions of the informed consent being used in PACE. The first form presented is the informed consent being used in the three PACE sites that are also HPOG recipients. The second form presented is the informed consent being used in all the other PACE sites. Random assignment (RA) for the study is concluding in December 2014. Because RA is over for all but a small number of study participants at one of the nine PACE sites, the consent forms are not updated and reference the original study name, Innovative Strategies for Increasing Self-Sufficiency.
Agreement
to Take Part in the
Innovative Strategies for Increasing
Self-Sufficiency (ISIS) and
Health Profession Opportunity Grant
(HPOG) Studies
ISIS and HPOG are two important studies of services that may help people improve their skills, find a job, and advance in their careers. Both studies are funded by the U.S. Department of Health and Human Services.
ISIS is a study looking at the effectiveness of career pathways programs designed to help people improve their careers in a number of occupations. A research organization called Abt Associates is conducting the ISIS study. ISIS expects to recruit 10,800 people across 9 different programs to be in the study.
HPOG is a study of programs training people for jobs in health care. Abt Associates and The Urban Institute are conducting the HPOG study. HPOG expects to recruit over 30,000 people to be in the study.
[Name of site] is trying innovative approaches to help individuals improve their education and employment outcomes. To learn about how well the program is working, researchers will compare participants who receive the innovative program services to those who receive other services. Other researchers may engage in future studies. Your participation in the studies is voluntary. You can end your participation at any time. There are no penalties for declining to participate. We hope you will agree to be in these studies. It will help us learn how well the program is working and how to improve services for future participants.
What Does Participation Mean?
If you agree to be in the study, we will assign you to one of two groups. One group will be able to participate in [Program Name]. The other group will not be able to participate in this program but may be eligible for other services in the community. We will use a lottery-like procedure to determine which group you will be in. This procedure makes sure that assignments are fair. Everyone who agrees to join the study has the same chance of receiving [Program Name] services. People who are not selected for this program can re-apply after a period of 48 months. If you decide not to participate in the study, you will not be able to get these services at [name of site]. If you are not selected for the program or decline to participate, you will be given a list of other resources available in the community.
If you agree to be in the study, ISIS and HPOG researchers and program staff will collect information from you to help understand how well the services you receive are working. We will ask you to fill out two forms today. They will take about 38 minutes to complete. They will ask about your educational background, family structure, work history, and other experiences. You may feel that some questions are personal or sensitive. The information will help us to understand what contributes to people’s success, and we encourage you to provide it. You may refuse to answer any question. Your answers will not affect your placement into the program or non-program group. In exchange for your time, we will provide you with a $25 gift card before you leave today.
ISIS and HPOG researchers will collect additional information about you in the future, regardless of which group you are in. This information will help us understand how well the program is working.
1) We will ask you to participate in one or more additional surveys sometime in the next few years. You will receive a payment for your time completing each additional survey. You can refuse to participate in the interviews or answer any of the questions.
2) We will collect information about you, including data maintained by this program, other schools, your employer, and government agencies. This information may include information about government services you have received, such as TANF or SNAP (food stamps) and employment records. We will collect records from schools you have attended including but not limited to grades and test scores, coursework, support services, and financial aid. To do this, we need to collect your Social Security Number.
3) We are interested if programs like [name of site] benefit children. If you have children, we may collect information about them from school records and other agencies. We also may ask your permission to talk with or observe your children. Your participation in these activities is voluntary. You or your children can choose to stop participating at any time.
If you withdraw, researchers may continue to use information that was collected about you during the period that you did give permission for research.
Potential Risks
We are committed to keeping your personal information private. All information you provide will be protected under the federal Privacy Act of 1974. Only the interviewer and authorized project staff and researchers evaluating the new programs will see your survey responses. However, there is a small risk of a breach of privacy. We will take strong precautions to make sure this does not happen. We will keep any paper that includes your name and other personal information in a locked storage area and destroy the files after the study ends. We will password protect any computer files with personal information and store them on a secure network.
We will give the Department of Health and Human Services a dataset with your answers but not your name or anything that might identify you such as date of birth, Social Security Number, address, or phone number. The information we give to the Department of Health and Human Services will not be available to the public. Your personally identifiable information, like your name or the names of your children, will not appear in any public document produced as part of the study. Your information will be used only for the purpose of the study and will be kept private to the extent allowed by law.
Questions about participation
If you have any questions about the study, contact Karen Gardiner, ISIS Project Director, at ISIS@abtassoc.com (email) or 301-634-1700 (phone). If you have any questions about your rights as a study participant, contact Teresa Doksum with the Abt Associates Institutional Review Board at IRB@abtassoc.com (email) or 877-520-6835 (toll-free).
Agreement to Participate
By signing this participation agreement, I confirm that I have read and understand the description of the ISIS and HPOG studies. I have had the opportunity to ask questions. I understand I will be put into one of two groups at random. One group will get the innovative program services. The other group will have access to other services. I understand that my participation is voluntary. I understand that I can refuse to answer any questions or stop being in the study at any time without penalty. I understand that I will be given a copy of this consent form to keep. I understand that Abt Associates and The Urban Institute will get information about me as described above. I understand that researchers may ask me for permission to talk with or observe my children. I understand that participation in these activities is voluntary. I understand this information will be used only for the purpose of the study and will be kept private to the extent allowed by law.
Participant:
______________________________________ ____________________________________
Name of Participant (Printed) Signature of Participant Date
Agreement to Take Part in the Innovative Strategies for
Increasing Self-Sufficiency (ISIS) Study
We invite you to take part in an important study of services that may help people improve their skills, find a job, and advance in their careers. The study is the Innovative Strategies for Increasing Self-Sufficiency (ISIS) project. The U.S. Department of Health and Human Services is funding the project. A research company called Abt Associates is conducting the study.
«Site_Name_1» is trying innovative approaches to help individuals improve their education and employment outcomes. To learn about how well the program is working, we will compare participants who receive the innovative program services to those who receive other services. Your participation in ISIS is voluntary. You can end your participation at any time. There are no penalties for declining to participate. We hope you will agree to be in this study. It will help us learn how well the program is working and how to improve services for future participants.
What Does Participation Mean?
If you agree to be in the study, we will assign you to one of two groups. One group will be able to participate in «Program_Name». The other group will not be able to participate in this program but may be eligible for other services «Services_2» in the community. We will use a lottery-like procedure to determine which group you will be in. This procedure makes sure that assignments are fair. Everyone who agrees to join the study has the same chance of receiving «Program_Name» services. People who are not selected for this program can re-apply after a period of «Embargo_Period» months. If you decide not to participate in the study, you will not be able to get «Services_1» services «Site_Name_2». If you are not selected for the program or decline to participate, you will be given a list of other opportunities available «Services_2» in the community. We expect to recruit 10,800 participants across several programs to be in this study.
If you agree to be in the study, ISIS and program staff will collect information from you to help understand how well the services you receive are working. We will ask you to fill out two forms today. They will take about 38 minutes to complete. They will ask about your educational background, family structure, work history, and other experiences. You may feel that some questions are personal or sensitive. The information will help us to understand what contributes to people’s success, and we encourage you to provide it. You may refuse to answer any question. Your answers will not affect your placement into the program or non-program group.
The ISIS team will collect additional information about you in the future, regardless of which group you are in. This information will help us understand how well the program is working.
1) We will ask you to participate in one or more additional surveys sometime in the next few years. You can refuse to participate in the interviews or answer any of the questions.
2) We will collect information about you, including data maintained by this program, other schools, your employer, and government agencies. This information may include information about government services you have received, such as TANF or SNAP (food stamps) and employment records. We will collect records from schools you have attended including but not limited to grades and test scores, coursework, support services, and financial aid. To do this, we need to collect your Social Security Number.
3) We are interested if programs like «Program_Name» benefit children. If you have children, we may collect information about them from school records and other agencies. We also may ask your permission to talk with or observe your children. Your participation in these activities is voluntary. You or your children can choose to stop participating at any time.
If you withdraw, researchers may continue to use information that was collected about you during the period that you did give permission for research.
Potential Risks
We are committed to keeping your personal information private. All information you provide will be protected under the federal Privacy Act of 1974. Only the interviewer and authorized project staff and researchers evaluating the new programs will see your survey responses. However, there is a small risk of a breach of privacy. We will take strong precautions to make sure this does not happen. We will keep any paper that includes your name and other personal information in a locked storage area and destroy the files after the study ends. We will password protect any computer files with personal information and store them on a secure network.
We will give the Department of Health and Human Services a dataset with your answers but not your name or anything that might identify you such as date of birth, Social Security Number, address, or phone number. The information we give to the Department of Health and Human Services will not be available to the public. Your personally identifiable information, like your name, will not appear in any public document produced as part of the study. Your information will be used only for the purpose of the study and will be kept private to the extent allowed by law.
Questions about participation
If you have any questions about the study, contact Karen Gardiner, ISIS Project Director, at ISIS@abtassoc.com (email) or 301-634-1700 (phone). If you have any questions about your rights as a study participant, contact «IRB_Contact_Info».
Agreement to Participate
By signing this participation agreement, I confirm that I have read and understand the description of the ISIS study. I have had the opportunity to ask questions. I understand I will be put into one of two groups at random. One group will get the innovative program services. The other group will have access to other services. I understand that my participation is voluntary. I understand that I can refuse to answer any questions or stop being in the study at any time without penalty. I understand that I will be given a copy of this consent form to keep. I understand that Abt Associates will get information about me as described above. I understand that researchers may ask me for permission to talk with or observe my children. I understand that participation in these activities is voluntary. I understand this information will be used only for the purpose of the study and will be kept private to the extent allowed by law.
Participant:
______________________________________ ____________________________________
Name of Participant (Printed) Signature of Participant Date
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Abt Single-Sided Body Template |
| Author | Missy Robinson |
| File Modified | 0000-00-00 |
| File Created | 2021-01-24 |