Patient Tools® - Research

A Research Study
Online Consent Form

You are being asked to participate in a research study. Your participation in this study is voluntary. You may decide not to participate or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled.

What is the purpose of this study?
The purpose of this research study is to evaluate CHAT-III for the diagnosis of cluster headache and related headaches.

Many individuals suffer with cluster headache for years before the correct diagnosis is made. It is hoped that CHAT-III will make a diagnosis of cluster headache available in a more timely manner.

What does the study involve?
If you participate in this study, you will be asked questions about the features of your headache. It takes most individuals less than 10 minutes to complete the survey. At the end, you will be shown a potential diagnosis. If this diagnosis is a new diagnosis for you, or different from the diagnosis you have been given, you will be asked to participate in a telephone interview to review your diagnosis. The telephone interview may take 15 – 30 minutes.

No medical treatment or recommendations will be offered as part of this study. Any diagnoses generated from this study should be reviewed with your usual health-care provider.

Risks and Benefits.
The risks of participating in the study include the time involved. There is the potential risk of a loss of confidentiality of your research-related information.

Possible benefits of participating: you might receive a diagnosis that leads to specific therapy that may help control your headaches. However, we cannot promise any benefits. Your participation might also help others in the future receive a more accurate headache diagnosis.

What are my alternatives to participating?
You may choose not to participate in this study. You may also choose to take the survey, see the computer-generated diagnosis, and not participate in the follow up telephone interview.

Privacy
Your information will be shared with individuals and organizations that conduct or watch over this study, including:
  • The sponsor
  • People who work with the sponsor
  • Government agencies, such as the Food and Drug Administration
  • The Institutional Review Board (IRB) that reviewed this study
We protect your information from disclosure to others to the extent required by law. We cannot promise complete secrecy. If the results from this use are published, your identity will remain confidential.

Who can answer my questions about this research study?
If you have questions, concerns, or complaints, or feel you have suffered a research related injury talk to the Principal Investigator (PI), Morris Maizels MD, at 425.261.4940.

This research is being overseen by an Institutional Review Board (“IRB”). An IRB is a group of people who perform independent review of research studies. You may talk to them at (800) 562-4789, help@wirb.com if you have questions, concerns, or complaints that are not being answered by the Principal Investigator, or for information about your rights in as a research subject.

You will not be paid for being in this study.
Please check each box to indicate your understanding.
   I1 - If you choose to participate in this research study, you will be asked questions about the frequency, severity, and nature of your headache symptoms. Information entered into this survey will be stored in a database for analysis. Your participation is strictly voluntary, and your answers are completely confidential.

   I2 – At the end of the survey, you may choose to participate in a diagnostic telephone interview. The diagnostic interview will be compared to the results of your online survey. If you agree to participate in the diagnostic interview, you will be asked to provide your contact information at the end of this online survey. The interview is expected to last 15 to 30 minutes.

You do not have to participate in the diagnostic interview to be part of the study.

   I3 – A small number of headaches have serious underlying causes. This survey is not a substitute for medical care. Patients with new or recent onset of headaches, a recent change in their headaches, poorly controlled headaches, or daily headaches should have a medical evaluation to be sure there are no "worrisome" features of their headaches.

   By clicking Next and taking this online survey, you are agreeing to participate in this research study.

-   You may withdraw from the study at any time and no further data will be collected. However, data already collected will remain part of the study.


   Please check the box if you have read and understand the statements above.