Attachment B. Informed Consent Forms

Attachment B: Informed Consent Forms

The informed consent forms for the random assignment and non-random assignment grantees are included here respectively.

OMB Control No. 0970-0462 OMB approval expires 8/31/2018 Abt Associates IRB Approval No. TBD Urban Institute IRB Approval No. xxxx

AGREEMENT TO TAKE PART IN THE
HEALTH PROFESSION OPPORTUNITY GRANT PROGRAM (HPOG)

RESEARCH STUDY—

FORM A: ADULT LOTTERY REQUIRED

+ PARENT PERMISSION BOX FOR MINORS

You are invited to take part in an important study of healthcare training programs. The study is funded by the U.S. Department of Health and Human Services. Several research organizations – including but not limited to, Abt Associates and its partners, MEF, the Urban Institute, Insight Policy Research, Abt SRBI and other researchers – are running the study for the U.S. Department of Health and Human Services. Your taking part in the study will help us learn more about how the HPOG program helps people improve their skills, find jobs, and advance in healthcare careers.

Over the next 10 years, researchers will use information about people in the program to do the study. This form: 1) describes the HPOG Impact study and 2) requests your participation in the study. We need to tell you about the study and what it means to be part of it. Only individuals who agree to participate in the study will be able to enroll in our [name of HPOG program].

What does it mean to be part of the impact study?

We expect a total of 43,000 people at up to 27 HPOG programs across the country to participate in this study. Entry into the HPOG program will be by computer lottery. Participation in the study is voluntary. You can choose not to be part of the study but that also means that you will not be part of the lottery and have a chance to be in the HPOG program. If you choose not to be part of the study you can, however, enroll in any other non-HPOG program or services in the community for which you are eligible.

1. If you agree to take part, staff at [NAME OF HPOG PROGRAM] will first see if you are eligible for the program. If you are eligible, then staff will explain that you must be in the lottery. The lottery will decide at random, whether or not you can take part in the [NAME OF HPOG PROGRAM]. If you are not selected, you will not be able to enroll in [NAME OF HPOG PROGRAM]. However, you can still enroll in any other service or program for which you are eligible.

2. The study team will collect data from all people who apply for HPOG and meet [NAME OF HPOG PROGRAM] eligibility requirements. This will happen when people first apply to the program and meet its eligibility rules.

3. The study team also plans to follow up with some of the people who participate in the study. The study team will keep track of people who participated in the lottery and were invited to enroll in the program. The study team also plans to follow-up with those who were not invited to enroll in the program. The study team will contact this group every three months to make sure that it has people’s current phone numbers and addresses. They will also have phone or in person interviews with this group approximately one and three years after they agreed to be in the study.

What type of information will the study collect?

If you agree to participate in the lottery, researchers would like to collect the following information about you:

4. Information you provide when you first apply to the program including:

   1. Current information about you, your family, your education, your income and your work history. This includes social security numbers.

   2. If you have children, researchers would like to request information about their birthdates and names. Researchers may contact you in the future about including your children in a related study. You can participate in this study even if you do not want your children to participate in a study in the future.

5. Information you or other organizations provide to the [NAME OF HPOG PROGRAM] staff about the training and services you get while you are in the program.

6. Information from follow-up surveys. Some of the people in the study will be asked to answer a 60-minute phone or in-person survey. You can choose whether you want to participate in the survey or not. If you decide to participate in the survey you can choose not to answer any question. Whether or not you choose to participate in the survey will never affect any benefits or services you receive now or in the future. If you are selected you will be asked for:

   1. Updated information about you, your family, your education, your income, and your work history;

   2. Information about the training and education or employment support services you have received;

   3. If you have children, updated information on your children including their educational experiences such as grades, socialization skills, goals and support system; their activities outside of school, family routines and other outcomes;

   4. Updated contact information every three months or so to make sure the study team knows the best way to reach you. The research study team (Abt Associates and Abt SRBI) may contact you via email, text or social media if you indicate it is okay to do so in your intake interview.

7. Information from government sources so researchers can learn more about your future employment, earnings, and post-secondary education over the next few years. Abt will use your name and social security number to get some of these data from the National Directory of New Hires and the National Student Clearinghouse. We will collect these data for you and up to 43,000 others study participants. The researchers will collect data for the 12 month period before you enrolled and up to five years after you enroll in the study.

Will my information be kept private?

The research organizations conducting this study will have access to the data being collected about you. These organizations are committed to keeping your personal information private. Any researchers using information to study the program must follow strict data security procedures and sign a privacy agreement. However, there is a small risk of a loss of privacy. We will take strong precautions to make sure this does not happen. Any piece of paper that includes your name or other identifying information will be kept in a locked storage area and will be destroyed after the study ends. Any computer files with your name or other identifying information will be protected by a password and will be stored on a secure network. Your personal information will be protected to the extent allowable by law. Our reports will combine your responses with responses from others. People who read the reports will not be able to identify responses you give. Any data sets that are developed for sharing with other researchers will be stripped of information that would make it easy to identify you.

Requesting Permission

Participation in this study is voluntary. If you participate, we will ask you to disclose your social security number. Abt will use your name and social security number to get some of these data from the National Directory of New Hires and the National Student Clearinghouse. This collection is part of research activities authorized by the Patient Protection and Affordable Care Act of 2010 (H.R. 3590, Title V, Subtitle F, Sec. 5507, sec. 2008, (a)(3)(B)).

This agreement is effective from the date you sign it (shown below) until the end of HHS’s research on HPOG grants, or when you choose to withdraw permission. You may choose to withdraw your participation in the study at any time. If you do withdraw, researchers will continue to use information collected during the time you consented. To withdraw from the study, please call toll-free at 844-717-4691 (the Abt help line).

You will receive a copy of this form for your records. An agency may not collect information and a person is not required to respond to an information collection request unless it displays a currently valid OMB control number.

For questions or concerns about the research, call Abt Associates toll-free at 844-717-4691. For questions or concerns about your rights as a research participant, call Teresa Doksum at the Abt Associates Institutional Review Board at toll-free 877-520-6835.

Statement

“I have read this form and agree to participate in the Health Profession Opportunity Grant Program research study.

• I know that I must agree to be in the research study before I can enroll in the [NAME OF HPOG PROGRAM].

• I know if I agree to be in the research study, I will be selected by the lottery to be in the HPOG program. I understand that even if I am not selected to be in the program, I will still be in the research study.”

PRINT YOUR NAME ABOVE DATE

I AGREE to be in the research STUDY, SIGN ABOVE

Parent or Guardian for HPOG applicants under the age of 18, your parent or legal guardian also must sign below:

By signing this participation agreement, I confirm that I have read and understood the description of the HPOG Research Study. I agree to the participation of my child in this study.

______________________________________ ___________________________________

NAME OF PARENT/GUARDIAN (Printed) SIGNATURE OF PARENT/GUARDIAN

_________________________________

DATE

ADD IRB STAMP

According to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. The valid OMB control number for this information collection is 0970-0462. The described information collection is voluntary. If you have comments or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer.

OMB Control No. 0970-0462 OMB approval expires 8/31/2018 Abt Associates IRB Approval No. TBD Urban Institute IRB Approval No. xxxx

AGREEMENT TO TAKE PART IN THE
HEALTH PROFESSION OPPORTUNITY GRANT PROGRAM (HPOG)

OUTCOME STUDY—

FORM B: ADULT LOTTERY NOT REQUIRED

+ PARENT PERMISSION BOX FOR MINORS

You are invited to take part in an important study of healthcare training programs. The study is funded by the U.S. Department of Health and Human Services. Several research organizations – including MEF, the Urban Institute, and Insight Policy Research and other researchers – are running the study for the U.S. Department of Health and Human Services. Your taking part in the study will help us learn more about how the HPOG program helps people improve their skills, find jobs, and advance in healthcare careers.

Over the next 10 years, researchers will use information about people in the program to do the study. This form: 1) describes the HPOG Outcome study and 2) requests your participation in the study. We need to tell you about the study and what it means to be part of it.

What does it mean to be part of the Outcomes study?

We expect a total of 43,000 people at up to 27 HPOG programs across the country to participate in this study. Participation in the HPOG Outcome study is voluntary. You can choose not to be part of the study and still receive HPOG services.

The study team will collect data from all people who apply for HPOG and meet [NAME OF HPOG PROGRAM] eligibility requirements. This will happen when people first apply to the program and meet its eligibility rules.

What type of information will the study collect?

If you agree to participate in the study, researchers would like to collect the following information about you:

1. Information you provide when you first apply to the program including: current information about you, your family, your education, your income and your work history. This includes social security numbers.

2. Information you or other organizations provide to the [NAME OF HPOG PROGRAM] staff about the training and services you get while you are in the program.

3. Information from government sources so researchers can learn more about your future employment, earnings, and post-secondary education over the next few years. Abt will use your name and social security number to get some of these data from the National Directory of New Hires and the National Student Clearinghouse.

Will my information be kept private?

The research organizations conducting this study will have access to the data being collected about you. These organizations are committed to keeping your personal information private. Any researchers using information to study the program must follow strict data security procedures and sign a privacy agreement. However, there is a small risk of a loss of privacy. We will take strong precautions to make sure this does not happen. Any piece of paper that includes your name or other identifying information will be kept in a locked storage area and will be destroyed after the study ends. Any computer files with your name or other identifying information will be protected by a password and will be stored on a secure network. Your personal information will be protected to the extent allowable by law. Our reports will combine your responses with responses from others. People who read the reports will not be able to identify responses you give. Any data sets that are developed for sharing with other researchers will be stripped of information that would make it easy to identify you.

Requesting Permission

Participation in this study is voluntary. If you participate, we will ask you to disclose your social security number. Abt will use your name and social security number to get some of these data from the National Directory of New Hires and the National Student Clearinghouse. This collection is part of research activities authorized by the Patient Protection and Affordable Care Act of 2010 (H.R. 3590, Title V, Subtitle F, Sec. 5507, sec. 2008, (a)(3)(B)).

This agreement is effective from the date you sign it (shown below) until the end of HHS’s research on HPOG grants, or when you choose to withdraw permission. You may choose to withdraw your participation in the study at any time. If you do withdraw, researchers will continue to use information collected during the time you consented. To withdraw from the study, please call toll-free at 844-717-4691 (the Abt help line).

You will receive a copy of this form for your records. An agency may not conduct and a person is not required to respond to an information collection request unless it displays a currently valid OMB control number.

For questions or concerns about the research, call Abt Associates toll-free at 844-717-4691

For questions or concerns about your rights as a research participant, call Teresa Doksum at the Abt Associates Institutional Review Board at toll-free 877-520-6835.

Statement

“I have read this form and I know that my participation in the study is voluntary and I still may receive HPOG services if I choose not to participate.

• I agree to be in the research study

• I do not agree to be in the research study

PRINT YOUR NAME ABOVE

DATE

Parent or Guardian for HPOG applicants under the age of 18, your parent or legal guardian also must sign below:

Print Name of Parent/Guardian

If you agree to let researchers use your Child’s information, sign above date

If You Do Not Agree to Let Researchers Use Your Child’s Information, Sign Above Date

ADD IRB STAMP

According to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. The valid OMB control number for this information collection is 0970 0462. The described information collection is voluntary. If you have comments or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer.

Attachment B: Informed Consent Forms  ▌pg. 1