INTRODUCTION & PURPOSE
Investigators in the Center for Health + Technology and the Department of Neurology at the University of Rochester have created a database (a list) of individuals who are interested in taking part in future neurology research studies. People included in the database will be contacted about future studies for which they might be eligible to see if they are interested in participating.
DESCRIPTION OF DATABASE
If you decide to be included, your contact information, demographic information, and any clinical information you elect to provide us will be placed in this list. The database will include information such as name, email address, phone number, date of birth and diagnosis. Researchers may then contact you in the future about potentially relevant neurology research opportunities, and/or to confirm that your contact information on file is still correct. You may be contacted by the researchers who run the database or by other qualified researchers at the University of Rochester. If you are contacted, you can decide at that time whether or not you are interested in participating in the study. Being included in the database does not mean you will be enrolled in any given study; rather, you are only agreeing to be contacted about future research studies in general. You may change your mind at any time, withdraw from the registry, and have your name and contact information tagged to preclude further contact by contacting the study team using the information on this form. Additionally, the principal investigators reserve the right to remove anyone from this registry if they become aware of any condition or circumstance that in their judgment would preclude participation in future research.
Besides neurology research studies, you may also opt in to three additional types of contact via this registry: (1) non-research contact – for example, educational content; (2) contact about studies or programs being run by our non-URMC collaborators; and (3) contact about research studies recruiting through URMC’s Health Research Participant Registry. More details about each of these three options can be found at the bottom of this form, where you select Yes or No for each.
If you opt in to components (1) or (2) above, your personal information will only be accessible to study team members within CHeT and the Department of Neurology. If you opt in to component (3) above, your information will be securely sent to URMC’s Health Research Participant Registry (maintained by the Clinical & Translational Science Institute), which may contact you about future studies related or unrelated to neurology. If you wish to change your mind and opt out of the Health Research Participant Registry at a later time, you may contact the Research Help Desk by phone (585-275-2107) or email (healthresearch@urmc.rochester.edu) and they will be able to remove you from their registry.
RISKS OF PARTICIPATION
Because this study involves collecting personal, identifiable information about you, there is a risk of invasion of privacy. To minimize this risk, all of the information we collect will be stored in a secure manner. None of your information will be used for research without your permission. Your personal/contact information will only be shared with qualified investigators at the University of Rochester and will not be shared outside of the University of Rochester.
BENEFITS OF PARTICIPATION
You will not benefit from being in this research database.
COSTS/PAYMENTS
There will be no cost to you to participate in this database. You will not be paid for participating in this database.
CONFIDENTIALITY OF RECORDS
The University of Rochester makes every effort to keep the information collected from you confidential. In order to do so, we will store your data in a HIPAA-compliant database and limit direct access to study personnel. Sometimes, however, researchers need to share information that may identify you with people that work for the University or regulators. If this does happen we will take precautions to protect the information you have provided. Aggregate characteristics of the database may be presented at meetings or in publications, but your name and individual information will not be used.
AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH PURPOSES
In order to collect your information, we have to get your permission to use and give out your personal health information. We will include all information you provide us in your database record, including contact information (name, email, phone number, address), demographic information (gender, date of birth, race, ethnicity), and clinical information (diagnosis, year of diagnosis, information on any medication taken, and other relevant condition-specific information). We may share the information you provide with other qualified researchers at the University of Rochester.
Your permission to use your health information for this study will not expire unless you tell us you want to cancel it. We will keep the information we collect about you indefinitely. If you cancel your permission, you will be removed from the study and your database record will be tagged to preclude further contact.
CONTACT PERSONS
For more information concerning this research or if you feel that your participation has resulted in any emotional or physical discomfort please contact Dr. Ray Dorsey at 585-275-0663.
Please contact the University of Rochester Research Subjects Review Board at 265 Crittenden Blvd., CU 420628, Rochester, NY 14642, Telephone (585) 276-0005 or (877) 449-4441 for the following reasons:
· You wish to talk to someone other than the research staff about your rights as a research subject;
· To voice concerns about the research;
· To provide input concerning the research process;
· In the event the study staff could not be reached.
VOLUNTARY PARTICIPATION
Taking part in this research database is voluntary. You are free not to take part or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefit to which you are entitled. In the event that you do withdraw from this registry, the information you have already provided will be tagged in our system to preclude further contact.
USE OF EMAIL FOR COMMUNICATION IN RESEARCH
When using e-mail to communicate with you for this registry, the researcher cannot guarantee, but will use reasonable means to maintain security and confidentiality of e-mail information sent and received. You and the researcher should understand the following conditions, instructions and risks of e-mail use:
Conditions for e-mail use:
· E-mail is not appropriate for urgent or emergency situations. The researcher cannot guarantee that any particular e-mail will be read and responded to.
· E-mail must be concise. You should schedule an appointment if the issue is too complex or sensitive to discuss via e-mail.
· E-mail communications between you and the researcher will be documented in your research record.
· Your messages may also be delegated to any member of the study team for response.
· The researcher will not forward subject-identifiable e-mails outside of URMC and Affiliates without your prior written consent, except as authorized or required by law.
· You should not use e-mail for communication regarding sensitive medical information.
· It is your responsibility to follow up and/or schedule an appointment if warranted.
Instructions for e-mail use:
· Avoid use of your employer’s computer.
· Put your name in the body of the e-mail.
· Put the topic (e.g., study question) in the subject line.
· Inform the researcher of changes in your e-mail address.
· Take precautions to preserve the confidentiality of e-mail.
· Contact the researcher’s office via conventional communication methods (phone, fax, etc.) if you do not receive a reply within a reasonable period of time.
Risks of e-mail use:
· Sending your information by e-mail has a number of risks that you should consider. These include, but are not limited to, the following:
· E-mail can be circulated, forwarded, stored electronically and on paper, and broadcast to unintended recipients.
· E-mail senders can easily misaddress an e-mail.
· Backup copies of e-mail may exist even after the sender or the recipient has deleted his or her copy.
· Employers and on-line services have a right to inspect e-mail transmitted through their systems.
· E-mail can be intercepted, altered, forwarded, or used without authorization or detection.
· E-mail can be used to introduce viruses into computer systems.
