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Protecting Your Data

 

The below outlines the information that you will agree to share, if you choose to participate in the study, and how it will be protected.

This is for your reference only as part of the study enrollment process will require you to read and agree to the HIPAA Authorization to Use and Disclose Your PHI for We The Village Family Support Study in order to participate.

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What is PHI?

Some of the information we are asking to get, use, and share is called “Protected Health Information” (PHI).  PHI is health information that can identify you.
•    PHI is protected by a law called “The Health Insurance Portability and Accountability Act of 1996” (HIPAA).  This means we need to follow certain rules to use or share PHI.
•    Information about you and your health is personal and private, so we cannot use or share this information without your permission.
•    We are asking you to give us permission to use and share your PHI for this study.

What PHI will be used and shared for this study?  How will PHMC get my PHI?
 

We will ask you to share the following PHI in surveys: 

•    Name and date of birth
•    Type and frequency of counseling for being a relative of someone with a problem using opioids
•    Type and frequency of counseling for your own substance use disorder/mental health needs
•    If you were ever diagnosed with a substance use disorder and length of recovery, if applicable
•    Type and frequency of your loved one’s substance use disorder treatment, including medication assisted treatment
•    Recent physical and mental health problems and impact on quality of your life

The below PHI will be obtained from website data:

•    Number of times you attended an online session
•    Number of times you logged onto the WTV forum
•    Number of times you completed homework assignments (if any)
•    Length of time you participated in an online session or forum

 

There will not be any highly sensitive PHI data.

We will use and share your PHI to learn if:  

•    Some of the information we are asking to get, use, and share is called “Protected Health Information” (PHI).  PHI is health information that can identify you.
•    PHI is protected by a law called “The Health Insurance Portability and Accountability Act of 1996” (HIPAA).  This means we need to follow certain rules to use or share PHI.
•    Information about you and your health is personal and private, so we cannot use or share this information without your permission.
•    We are asking you to give us permission to use and share your PHI for this study.

Will my information be kept confidential?
Yes, we will do our best to keep your personal information confidential. We cannot promise total confidentiality. It is possible that others may learn that you are in this study or learn information you tell us.

 

Protecting your information:
•    All research surveys will be stored in a secure password-protected computer system. Only select research staff will have access this information.
•    Some participants will receive online coaching sessions using Zoom, a secure video conferencing/chat platform. Some of the Zoom sessions will be recorded so that we can check on the quality of the coaching participants are receiving. These recordings will be seen only by trained quality control staff and your coach.
•    All participants will be instructed not to use last names for their username. Usernames will never be shared with anyone outside of the study.
•    All participants will agree not to disclose any information shared during discussions in coaching sessions or forum.
•    We instruct participants to be in a private location for coaching sessions because participants are visible to coaches and other participants during Zoom coaching sessions (in Program A).
•    We will only share your information with the research study staff.
•    Any information kept on a computer will be in a password-protected file. Only research staff on this study will know the password.
•    Any paper information will be kept in a locked filing cabinet. Only research staff on this study will have access to this cabinet.
•    Your research records will not have your name on them. We will use a code number instead. The code number will be kept secure and separate from your name and user name. Only research staff on this study will have access to the document linking code numbers to names.
•    We will also protect your privacy when we try to contact you. We may contact you
to confirm your enrollment, for missed sessions and to send reminders to complete surveys. We will only contact you using information you have agreed to share with the research team.
•    We will not share that you are in the study, but you can still share information about yourself or tell others that you are in this study, if you choose.

Exceptions to confidentiality: 

There are times when we will break this confidentiality agreement with you: 
•    Any information about child or elder abuse or intent to harm self or others will be reported to authorities, as required by law.
•    We will also break this agreement to get you help if you are having a medical emergency or if your safety is at risk.

Will my research information be used or shared for future research studies?
We will keep information that can identify you (like your name and date of birth) secure and separate from your research information. We may use or share your de-identified research information for future research studies without asking for your consent again.

 

Steps taken to ensure confidentiality:

•    The surveys you complete for this study will not have your name on them.
•    We will keep your personal information separate from your study information.
•    All paper information will be kept in a locked filing cabinet at We The Village and PHMC. Only research staff on this study will have access to this cabinet.
•    All electronic information will be kept in password-protected computer and website systems. Only research staff on this study will know the password.
•    We will use a more secure Zoom account that is HIPAA compliant.   Recorded Zoom sessions will be stored in password protected files on secure servers.
•    We will ask everyone involved in group activities not to use last names of participants or to discuss other participants outside of the group. We also will provide a brief training on the importance of respecting confidentiality when participating in groups.
•    Participants create their own user names and can change them at any time during the study.
•    When we try to contact you, we will only use the information you agreed to share. If we call you or send you a direct message, we will say it is about a health survey.

How long will my PHI be used?

We will get, use, and share your PHI from now until the study ends, unless you change your mind.  After the study is done, we will stop getting, using, and sharing your PHI with one exception: 

If you agreed in the WTV Family Support Study consent form that we may contact you in the future to provide additional research information. Of course, you can always let us know that you changed your mind about contacting you at any time.

We will destroy all PHI five years after the study ends as required by the funder. 

What happens if I give you permission to use my PHI, but change my mind later?

You can change your mind at any time.  You will not be treated differently.  If you change your mind, send a letter to Calum Handley saying you do not want us to use your PHI anymore.  You should send letters to this address: 

Calum Handley 

10 Saint Paul's Place

Brooklyn, New York, 11226

Who can I call about my rights as a participant in this research study?
If you have questions about the research study and program activities, you can contact Calum Handley, Principal Investigator, at 413.438.4673 or at calum@wethevillage.co


If you have questions related to screening and data collection, you can contact Jaime Metzger, Research Coordinator at PHMC, at 267.353.4762 or at jmetzger@phmc.org.
In addition to the above people, you can also contact the study’s Institutional Review Board (IRB). The IRB makes sure that this study is being done right.

 

You can call the PHMC IRB at 1-800-335-9874 or email ResearchCompliance@phmc.org if:
•    You have questions about your rights as a study participant.
•    You want to make a complaint about this study.
•    You get an injury from being in this study.