Recruitment Survey

The purpose of this study is to see if we can use wearable motion sensors for measuring arm and hand recovery during outpatient rehabilitation or in controls.  

The study involves 3 visits with a research team member. This includes a Baseline visit and two follow up visits.  Visits will last 15-60 minutes, depending on the visit.  Visits will occur at Washington University, remotely via virtual or phone call, or a research member can travel to your home. Each visit will require you to answer questionnaires and then to wear movement sensors on each wrist. Eligible participants will receive $25 per visit.  This will be reimbursed at the end of each study visit.  The National Institutes of Health is funding this research study. 

In order to determine if you are eligible for this research study we need to ask you a few questions.  This is called a screen.  The  screen is for research purposes and will last about 5 minutes. Below are some questions about your age, your arm and hand, and your health.  If you prefer to do this at a more convenient time you are welcome to. 

A risk of participating in this screen is that confidential information about you may be accidentally disclosed.  You will not benefit from participating in the screen.

We will keep the information you provide confidential by storing it in a password protected file only accessible to the research team.  Any report or article that we write will not include information that can directly identify you. However, federal regulatory agencies and Washington University, including the Washington University Institutional Review Board (a committee that reviews and approves research studies) and the Human Research Protection Office may inspect and copy records pertaining to this research activity. To further protect your privacy, this research is covered by a Certificate of Confidentiality from the federal government. This means that the researchers can refuse to disclose information that may identify you in any legal or court proceeding or to anyone who is not connected with the research except if:

• there is a law that requires disclosure, such as to report child abuse and neglect, or harm to self or others;
• you gave permission to disclose your information, including as described in this consent form;
• or it is used for other scientific research allowed by federal law.

This Certificate may not be effective for information held in foreign countries.

You have the right to share your information or involvement in this study with anyone at any time. You may also give the research team permission to disclose your information to a third party or any other person not connected with the research.  Your participation in this  screen is completely voluntary.  You may choose not to take part at all.  If you decide to participate in the screen you may stop participating at any time. Any data that was collected as part of this screen will remain as part of the study records and cannot be removed.  If you decide not to take part in the screen, or if you stop participating at any time, you won’t be penalized or lose any benefits for which you otherwise qualify. 

If, after completing this screen, you are eligible for the research study you will be asked at a later date to sign a separate consent form that includes more detailed information about the study. Before you complete the screening questions, we would like to tell you about what we will be doing with the information you give us.   

Your answers to the screening questions will create Protected Health Information (PHI) that identifies you. Your health information is protected by law under HIPAA (the Health Insurance Portability and Accountability Act). Because of this law, you will need to give the research team permission to use and share your protected health information from the phone screen for this research. 

When possible, the research team will make sure information cannot be linked to you.  Once information doesn’t identify you, it may be used and shared for other purposes not discussed during this screen. The information collected today during the screen may be seen by people making sure the research is being done right. This may be people at Washington University, from the federal Office for Human Research Protections, the Food and Drug Administration, or the National Institutes of Health.

• If you agree, you are giving permission for us to use of your PHI for this research, and your permission will not expire. 
• If you do not agree to allow us to use your PHI it will not affect your treatment or the care given by your health provider, insurance payments or enrollment in any health plans, or any benefits to which you are entitled.  However, it will not be possible for you to take part in the screen for this study.
• Once your health information is shared with someone outside of the research team, it may no longer be protected by HIPAA.
• If you change your mind and do not want the research team use or share your information, you will need to provide a written letter to the research team cancelling your permission. Please contact the Human Research Protection Office for more information on how to revoke your authorization or contact the research team to request the withdrawal letter.  If you do this, the research team may only use and share information already collected for the study. You will not be allowed to continue to participate in the study.
• If you have questions or concerns about your privacy and the use of your protected health information, please contact the University’s Privacy Officer at 866-747-4975.
• You will not be able to see the research information, but you may be given access to your health care records by contacting your health care provider.

We encourage you to ask questions.  If you have any questions about the research study itself, please contact: Christine Gordon at 314-273-5661. If you have questions, concerns, or complaints about your rights as a research participant, please contact the Human Research Protection Office at 1-(800)-438-0445 or email hrpo@wustl.edu.   General information about being a research participant can be found on the Human Research Protection Office web site, http://hrpo.wustl.edu.  To offer input about your experiences as a research participant or to speak to someone other than the research staff, call the Human Research Protection Office at the number above.

By filling out the information below you agree to participate in the screen.