Study participants baseline interview

Supportive Housing & Individual Placement and Support (SHIPS) Study

ICAP SHIPS consent form IRB 053024

Study participants baseline interview

OMB: 0960-0840

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Supportive Housing and Individual Westat, Inc.

Placement and Support (SHIPS) Study University of

Consent to Participate in Research Southern California



CONSENT TO PARTICIPATE IN RESEARCH

Supportive Housing & Individual Placement and Support (SHIPS) Study

PATH, University of Southern California, and Westat, Inc.


Sites: PATH supportive housing residences in the Greater Los Angeles region


Principal Investigators: Justin Metcalfe Ph.D. and Debra Rog Ph.D.


Key Information


Introduction

You are invited to be part of a research study. Participation is voluntary. You do not have to take part in the study if you do not want to. You are invited because you live in PATH supportive housing services and have said you want to find a job. PATH is working with Westat, the University of Southern California (USC), and the Social Security Administration (SSA) to conduct this study. This means they will provide some extra services, collect data, and analyze the data they collect. Westat is a private scientific research company that is funded by the United States government to help on this research study.

  • Your decision to join or not join the study will not change the supportive housing services you receive at PATH.

  • SSA is helping to pay for this study. If you consent to be in the study, SSA will also give Westat some information about you. For example, SSA will tell whether you apply for or receive any benefits from SSA. There is a detailed description of this information under “What information will SSA share with researchers if you provide consent.”

  • If you consent to be in the study, you will receive a copy of this informed consent form.

The document below will refer to PATH, USC, and Westat as “the researchers” or “research staff.”


What is the purpose of this study?

The SHIPS study will see which of two ways of helping people in supportive housing find jobs is better. We do not know the answer to this question.


What does this study involve?

  • If you join the study, you will participate in services designed to help you find a job.

  • You will participate in this study for about 2 years (24 months).

  • Researchers will split the study participants into two equal size groups. Researchers will assign you by chance (like flipping a coin) to one of those groups:

    • One group will participate in employment services from local Worksource Centers. This is how PATH usually helps people in supportive housing find jobs.

  • The other group will participate in Individual Placement and Support (IPS) employment services. IPS includes support from a team of people. This team includes your PATH case manager, someone who works at PATH and is familiar with your mental health, and an IPS employment specialist. They will work together to help you find a job.

At the end of the study, the researchers will compare how well people in each group find and keep jobs. They will also compare where participants live and their total income. Total income includes money earned from jobs and from different benefits that study participants receive.

  • Interviews.

    • Research staff will ask to interview you nine times during the study:

      • Two 60-minute interviews will be at the beginning and end of the study.

      • Seven 10-minute interviews will be during the two-years that you participate.

    • Researchers may ask to interview you about your experiences during the study. This would happen during the study.

    • Researchers may recontact you for up to five years after the study ends and ask to interview you.

    • You can skip any questions that researchers ask if you do not want to answer them.

    • You can stop any meeting with research staff at any time.

    • After each interview, research staff will give you a gift card in return for your time. You can find more information about gift cards under “How much will you be paid to participate?”

  • If you consent, Westat will share your consent form with SSA. This will let SSA know that:

    • You are participating in this study.

    • SSA can share information about you with Westat. There is a detailed description of this information in the document below. SSA will be able to share information about disability benefits that you apply for or receive for up to five years after the study ends.

  • You can leave the study at any time. If you leave the study, you take back permission for PATH, USC, Westat, or SSA to share information about you. This is called withdrawing consent. To withdraw consent, tell your case manager that you want to stop being in the study.


What are the risks involved with being in this study?

  • Some interview questions may make you feel uncomfortable. You may not want to answer those questions. If you feel uncomfortable:

    • You can take a break and continue later.

    • You can skip any question you do not want to answer.

    • You can stop any meeting with research staff.

  • Some interview questions may make you feel distress. If you feel distress:

    • Interviewers will know how to help you.

    • They will provide any support you need. This support may include contacting case managers, clinicians, and emergency services. Interviewers will also have a list of people you can contact if you need more help.

    • Interviewers will not leave you in distress without finding help.

  • You may decide to leave the study at any time. The employment services you are receiving during the study may change after you leave the study:

    • If you are receiving the local services that PATH typically provides to help residents find jobs, then there will be no change. You can continue to receive these services.

    • If you are receiving IPS, then your employment services will change. If you leave the study, then you can no longer receive IPS from PATH. Instead, you will be able to receive the local services that PATH typically provides to help residents find jobs.

  • You may not find a job. This may make you feel disappointed and frustrated.

    • Participating in the study does not guarantee you will find a job.

    • Interviewers and PATH staff will be aware of this possibility. They will be ready to provide support if you feel frustrated or distressed.


Are there any benefits from being in this study?

If you choose to participate in this study:

  • You will receive help finding and keeping a job. People have successfully used both local services and IPS to help them find jobs.

  • You will be helping the researchers learn if IPS or local services are better. This will help people who make decisions about policies, funding, and programs. It will help them identify the best ways to support people in supportive housing and help them have more control over their lives.


How is being in this study different from what will happen if you are not in this study?

  • If you decide to join this study:

    • You will receive help finding a job.

    • You will meet regularly with research staff.

    • Researchers will track your work activity and housing. They will also receive information from SSA about you.

    • You will continue to receive other supportive housing services from PATH as you are now.

  • If you decide NOT to join this study:

    • You can still receive the help finding a job that PATH typically provides. This includes support from your case manager and a referral to a Worksource Center. This help does not include IPS. IPS is only available to study participants randomly selected to be in the IPS group.

    • You will not meet regularly with research staff.

    • Researchers will not track your work activity and housing. They will not receive information from SSA about you.

    • You will continue to receive supportive housing services from PATH as you are now.


Detailed Information


Leaving the study:

You can choose to leave the study at any time. If this is your decision:

  • Please tell your case manager. They will ask you to sign a brief letter. This letter will be an official notice that you will stop being in the study. This is called “withdrawing consent.”

  • If you do not have a case manager then you can call Justin Metcalfe and tell him. He is the Principal Investigator for this project. His phone number is 603-583-4708.

  • It will take up to 10 business days for Westat to officially remove you from the study.

After you have left the study:

  • No new information will be collected about you .

  • SSA will not release any data about you.

  • However, researchers may continue to use any information collected or received before you officially stopped being in the study.

The type of employment services you receive will change if you were in the IPS group. The quality of other services you receive from PATH will not change.


How many people will participate in the study?

We expect 200 people who receive services from PATH to participate in this study.


What kinds of questions will interviewers ask you?

  • The first interview will happen after you sign this consent form. The researcher will ask you about yourself. They will ask about things like:

  • Age

  • Military experience

  • Disabilities and health status

  • Language

  • Race and ethnicity

  • Sex and gender

  • Education

  • Finances

  • Income

  • Marital status

  • Social networks

  • Satisfaction with supportive housing services

  • Histories of housing, justice system involvement, and employment

  • The final interview will ask you similar questions as the first interview.

  • The 10-minute interviews that will occur every three months after the first interview will include questions about your housing and employment.


What information will SSA share with researchers if you provide consent?

  • If you consent, SSA will give research staff information about you. It will tell researchers about benefits you apply for or receive from the SSA for up to five years after the study ends. This will include some Personally Identifiable Information (PII). PII is private information that SHIPS researchers will carefully protect. The PII that SSA will give research staff will describe:

    • Dates of any applications you may have made for Social Security Disability Insurance (SSDI) and Supplemental Security Income (SSI) disability benefits.

    • The type of diagnoses or impairments used to determine your eligibility for benefits (This will not include any specific diagnosis, only broad categories.)

    • The outcomes of those applications. This includes any appeals and outcomes of those appeals (decision types, dates of decisions and appeals, and reasons for denials)

    • Payments made by the Social Security Administration to you for up to five years after the study ends, and

    • Any dates and reasons for termination of benefits.

This information will help researchers understand how different types of services can affect your employment and self-sufficiency during and after the study.


How will your privacy be protected?

Westat, USC, and PATH will make every effort to protect your privacy:

  • Research staff will protect your name and Social Security number (SSN).

    • Research staff will not link your name, SSN, or date of birth to any other information. This includes information you provide in interviews and information collected from PATH or SSA.

    • Research staff will identify your information by a random number created just for this study.

    • Research staff will not use your name or identifying information in any publications.

  • Research staff will:

    • keep all data on secure servers.

    • enter all data directly into secure systems.

    • store data collected on paper in locked cabinets.

    • store data collected electronically on secure and password-protected computers. They will then transfer it to a secure server.

    • not store data on personal computers.

    • keep all data collected during interviews secure until destroying it within five years of the end of the study.

  • Research staff will only use the information collected for this study to fulfill the goals of the study.


The National Institutes of Health has issued a Certificate of Confidentiality (CoC) for the SHIPS study. The CoC limits how research staff can use and release your information.

  • The CoC protects your information. Researchers cannot release or use information, documents, or samples created or compiled for the purposes of this study that may identify you in any action or suit. They can only do this if you say it is okay. The researchers also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.

  •  There are some important things that you need to know about the Certificate of Confidentiality:

    • It DOES NOT stop reporting that federal, state, or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others.

    • It CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs.

    • It DOES NOT prevent your information from being used for other research if allowed by federal regulations.

  • You can still willingly release information about your involvement in this research. This means that the researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers or any other persons not connected with the research.

  • You still have access to your own information.


How much will you be paid to participate in this study?

Researchers will provide a gift card after every interview. This adds up to a total of $240 over 24 months. Payments include:


Gift Card Value

Payment for:

$50

one 60-minute at the beginning of the study.

$20/interview

(up to $140 for all seven 10-minute interviews)

each of the seven brief, 10-minute interviews conducted once every three months during the study.

$50

one 60-minute interview at the end of the study.

$240

TOTAL


Researchers may ask for additional interviews. These are also optional.

Gift Card Value

Payment for:

$50

  • a possible 60-minute interview when research staff ask you about your experiences during the study.


  • additional optional interviews after the 2-year study period.


Whom should you call with questions about this study?

If you have questions about this study, please call Justin Metcalfe. He is the Principal Investigator for this project. His phone number is 603-583-4708.


If you have questions about your rights and welfare as a research participant, please call the Westat Human Subjects Protections office at 1-888-920-7631. Please leave a message with your first name, the name of the research study that you are calling about SHIPS, and a phone number beginning with the area code. Someone will return your call as soon as possible.

Consent

Participation in the study

I have read the above information about the Supportive Housing & Individual Placement and Support Study and have met with research staff at least two times to discuss my participation in the study. I had the chance to ask questions during each meeting. I understand:

  • what this study is about and what I am being asked to do.

  • that I am agreeing to be contacted by research staff for two years to complete interviews.

  • that I am agreeing the research staff may approach me for additional interviews after the end of the study.

  • that SSA will share data regarding any disability benefits for up to five years after the study ends.

  • the risks and benefits of being part of this study.

I volunteer to take part in the study as described above. I make this choice freely.


Release of data

I agree to allow the Social Security Administration (SSA) to provide the following information to Westat for this research study:

  1. Dates and outcomes of any application for disability benefits (SSI or SSDI). This applies to applications made before the study period, during the study period, and for up to five years after the study ends. Data includes the categories of diagnoses or impairments used to determine eligibility for benefits, whether an application was approved or denied, reasons for denial, and the date of this decision.

  2. Dates and outcomes of any appeals of denied applications for disability benefits made during the study period and for up to five years after the study ends. This includes whether an appeal was approved or denied, reasons for denial, and the dates of these decisions.

  3. The benefit amounts I received during the study period and for up to five years after the study ends.


SSA will send this information electronically to Westat. I agree to allow researchers to share my consent form, my name, my date of birth, and my Social Security number with SSA to help locate this information.


I also agree to allow PATH to share information collected during interviews with researchers at Westat.


Westat is located at the following address:

Westat

1600 Research Blvd.

Rockville, MD 20850


I understand that I will receive a copy of this consent for my records that does not include the final page.

Consent Summary

I agree to take part in the research study as described above. I also agree to allow SSA to release the data described above to Westat on an ongoing basis until December 31, 2032. That is the end date for this consent.


_______________________________________ _______________________________

Phone Number Participant’s DOB


_______________________________________ ______________________________

Email Address Participant’s SSN


_______________________________________ ______________________________

Participant’s Signature Date


_______________________________________

Print Name

I have fully explained this research study to the participant. I have answered any questions he/she has asked. I believe the participant understands the study. I believe the participant is capable of giving voluntary consent.


_______________________________________ ______________________________

Researcher Signature Date


_______________________________________

Print Researcher Name


If a research participant chooses to sign this document with an “X” or similar sign, two witness signatures are required.


I do not stand to gain anything from the disclosure of the information described above.


_______________________________________ ______________________________

Witness Signature Date


_______________________________________ ______________________________

Print Witness Name Witness Address


I do not stand to gain anything from the disclosure of the information described above.


_______________________________________ ______________________________

Witness Signature Date


_______________________________________ ______________________________

Print Witness Name Witness Address

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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorJustin Metcalfe
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File Created2024-07-20

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