UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
| Study Title | Progressive Supranuclear Palsy (PSP) Trials Prescreening Survey |
| Principal Investigator (Person in charge of this study) | Adam Boxer, MD, PhD UCSF Department of Neurology |
| Study Contact Information | PSP Trials Prescreening Survey Team (email: pspprescreen@ucsf.edu, phone: 415-514-9420) |
In this consent the word "you" refers to the person being considered for inclusion in the study described. This may be you as the reader of this document, and/or a person about whom you are providing information.
1. Why have I been given this document?
To see if you are interested in taking part in a research study. A research study is a planned project done to learn more about a topic.
2. Do I need to take part in this research study?
No. Taking part in research is voluntary. If you don't want to take part there will be no penalty and you will not lose your current benefits. The Principal Investigator, or another member of the study team, will explain the study to you. Please ask questions. Take your time deciding if you want to be in this study. You can talk with your health care team, your family, and friends before deciding.
3. This section describes key information to consider about this study
3.1 Why is this study being done?
We are asking you to take part in a research study being done by Dr. Adam Boxer at the University of California, San Francisco to gauge interest in and feasibility of participation in current and future clinical trials.
3.2 How long would I be in this study? How many study visits are there?
If you choose to be in this study, you will complete a survey. It will take about 10-15 minutes to complete.
3.3 What are the procedures with the most risk in this study?
The procedures with the most risk in this study are:
- Survey questions about sensitive topics
- Loss of confidentiality
3.4 What risks and discomforts are most severe? What risks and discomforts are most common?
Possible risks and discomforts of this study that are the most severe and most common are:
- Survey questions about sensitive topics
- Loss of confidentiality
We will tell you more about risks and discomforts later in this form.
3.5 Are there benefits to taking part in this study?
You may or may not benefit from participating in the study. The information learned from this study may help others in the future.
3.6 What are my other options if I don't want to take part in this study?
You may be able to take part in another study if one is available.
4. How many people will take part in this study?
About 2000 people will take part in this study.
5. Who is paying for this study?
This study is being paid for by the National Institute on Aging.
6. Do any UCSF researchers of this study have financial interests that I should know about?
No.
7. What are the research procedures of this study?
In this quick survey, we will ask you to give us some basic information about you (or your family member or friend) including diagnosis and some other medical information to see if you may be a good fit for current and future PSP Clinical Trials. It may be helpful to have information about your (or your family member or friend's) doctor and medical conditions easily accessible before you start this survey. If you are filling out this survey on behalf of someone with a PSP diagnosis, and if you would also like to be involved as that person's study partner in future trials, you will be asked to provide the following: name, email address, phone number, relationship to the person with PSP, how frequently you see the person with PSP, and general information about your situation.
Contact information and survey responses will be used to see if a person might be eligible for current or future PSP trials, and they may be contacted by a member of the UCSF PSP Trials Prescreening research team for a given study for recruitment purposes via their preferred contact method. You will also be given the option to indicate if we have your permission to share your contact information with other clinical sites for outreach purposes; we will not share your information without your consent. If you agree to be contacted, these sites may contact you directly via their preferred contact method.
7.1 Where do the procedures happen?
This study can be completed on a device with a reliable internet connection at a location of the participants' choosing. Should participants contact the study staff with questions about the survey or if staff reach out to participants to discuss their answers to the survey, those staff will be located the UCSF Mission Bay campus.
8. What are the risks of this study?
Risks and side effects related to this study include
- Emotional discomfort: Some of the survey questions may make you feel uncomfortable or raise unpleasant memories. You are free to skip these questions.
- Loss of confidentiality: There is a risk of a loss of confidentiality of your information collected in the study. For more information about how confidentiality will be protected, please see below.
9. Will I be paid if I take part in this study?
You will not be paid for taking part in this study.
10. Will I be reimbursed for expenses if I take part in this study?
This study does not involve any expenses to research participants.
11. How will my information be used?
Researchers will use your information to do this study. Once the study is done, we may use your information for other research studies in the future. We may share it with other researchers to be used in their studies. We will share your name, contact information, and survey answers with other researchers only if you have given us permission to do so.
12. How will information about me be kept confidential?
If you take part in this study, there may be some loss of privacy. We will do our best to make sure information about you is kept confidential. But we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.
12.1 Who may review my research information?
Authorized representatives from the following organizations may review your research data for the purpose of monitoring or managing the conduct of this study:
- Representatives of the University of California
- Representatives of the National Institutes of Health
- Representatives of the Office of Human Research Protections (OHRP)
12.2 Certificate of Confidentiality
This study has something called a Certificate of Confidentiality. This helps keep your information private. Researchers can't be forced to share your information with others like courts or law enforcement.
There are some things that the certificate does not stop:
- Reporting abuse of children or elders, or if you or someone else is in danger.
- Reporting of certain diseases.
- Groups (like those listed in 12.1) from checking the research records to make sure the study is going okay.
- Agencies from getting information if they need it for safety reasons.
- Your information from being used in other research if it follows the rules.
The certificate doesn't stop you from:
- Talking about being in this research study.
- Looking at your own medical records.
13. Does this study involve testing of diseases and conditions that must be reported to the public health department?
No, this study does not involve testing for reportable diseases and conditions.
14. What happens if I am injured or feel harmed because I took part in this study?
It is important to tell the Principal Investigator if you feel you have been injured or harmed because you took part in this study. The contact information for this person is on the first page of this form.
15. Are there any costs to me for taking part in this study?
No. There is no cost to you or your insurer if you take part in this study.
16. Can I stop being in the study if I want to?
Yes. You can decide to stop at any time.
17. Can I be removed from the study by the Principal Investigator?
Yes. The Principal Investigator may stop you from taking part in this study at any time. This could happen without your permission. It could be because it is in your best interest., if you did not follow the study rules, or the study has been stopped.
18. What are my rights if I take part in this study?
You may choose to take part or not to take part in this study. It's your choice. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you. Leaving the study will not affect your medical care. You can still get your medical care from our institution.
We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.
19. Who can answer my questions about this study?
You can contact the study team with any questions, concerns, or complaints you have about this study. The contact information is on the first page of this form.
UCSF has an office that can answer questions about your rights as a research participant. This office is called the Institutional Review Board (IRB). The IRB is available to talk about any problems or concerns you have about the study. The UCSF IRB's phone number is 415-476-1814.
20. Consent
You will be emailed a copy of the PSP Trials Prescreening Survey consent form to keep upon completion of your survey.
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to say "No" to this study now or at any point without penalty.
If you wish to take part in this study, click the "Start Survey" button below.