Key Information:
The following is a short summary of this study to help you decide whether or not to be a part of this study. More detailed information is listed later on in this form.

Why am I being invited to take part in a research study?
We invite you to take part in a research study because you are a physician working with this disease or are a patient with ANCA-associated vasculitis.

What should I know about a research study?

  • Whether or not you take part is up to you.
  • You can choose not to take part.
  • You can agree to take part and later change your mind.
  • Your decision will not be held against you.
  • You can ask all the questions you want before you decide.

 

Why is this research being done?
The purpose of this research project is to gather more information about this disease to develop response criteria for ANCA-associated vasculitis for use in clinical studies/trials.

How long will the research last and what will I need to do?
We anticipate this survey taking approximately 20 minutes to complete. There will be 4 rounds of this survey. You will be asked to answer approximately 50 questions about your disease and a few basic demographic questions.

What happens if I say yes, I want to be in this research? Is there any way being in this study could be bad for me?
For patients participating in this study you may be identified as a patient with ANCA-associated vasculitis if you choose to be listed by name in the published study as a contributor. This is an optional portion of the study and it is a decision that will be made by you before completion of the survey.

Will being in this study help me anyway?
There are no direct benefits to you from your taking part in this research. We cannot promise any benefits to others from your taking part in this research. However, possible benefits include improved testing of treatment for ANCA-associated vasculitis in the future.

What happens if I do not want to be in this research?
Participation in research is completely voluntary. You can decide to participate or not to participate.

Detailed Information: The following is more detailed information about this study in addition to the information listed above.

Who can I talk to?
If you have questions, concerns, or complaints, please contact the research team at Georgetown University Division of Rheumatology. Please email Dr. Kaitlin Quinn at [email protected].
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to them at (202) 687-1506 or [email protected] if:

  • Your questions, concerns, or complaints are not being answered by the research team.
  • You cannot reach the research team.
  • You want to talk to someone besides the research team.
  • You have questions about your rights as a research subject.
  • You want to get information or provide input about this research.

 

How many people will be studied?
We anticipate approximately 50 experienced physicians and 50 patients in the study.

What happens if I say yes, I want to be in this research?
If you choose to participate in this research, at the bottom of this web page you will click on a link that will take you to the survey. This study will consist of four rounds of questionnaires through a system called DelphiManager. You will provide your email in the initial round and be contacted by email to participate in future rounds. These surveys will ask you about your disease and/or your participation and extent of work with this disease. They will also ask you if you wish to be acknowledged in any publications. This is optional and regardless of your answer, you can continue to participate in this trial.

What happens if I say yes, but I change my mind later?
You can leave the research at any time and it will not be held against you. If you choose to continue past this consent form into the survey and then wish to discontinue or end your participation, do not press submit at the end of the survey and your information will not be collected.

Policy/Procedures or Research Related Injuries
The Policy and Procedure for Georgetown University Medical Center are as follows:

If you are injured or become ill while you are in the study and the illness or injury is due to your participation in this study, you will receive necessary medical care. The costs of this care will be charged to you or your third party payor (e.g., your health insurer) in the usual manner and consistent with applicable laws. No funds have been set aside by Georgetown University, Georgetown University Hospital, MedStar Health Research Institute, or their affiliates, to repay you or compensate you for a study related injury or illness.

What happens to the information collected for the research?
Efforts will be made to protect any personal information to the extent allowed by law. However, we cannot guarantee absolute confidentiality. Records of research study participants are stored and kept electronically with the Principle Investigator, Dr. Kaitlin Quinn. Records will be kept without any identifying information to ensure confidentiality in a password protected file. You will not be identified in any reports or publications resulting from this study unless you answer ‘YES’ to the final question asking if you would like to be listed. Your information that is collected as part of this research will not be used or distributed for future research studies, even if all of your identifiers are removed. The only reason your identifiable information will be shared is if you authorize mentioning of your name as a participant in this trial in publications.

New Findings
At the end of the study, we plan to present findings in a peer-reviewed publication for the academic and clinical community. The findings will also be summarized for patient groups in the Vasculitis Network.

Consent Documentation
By clicking on the consent box on the registration page, you are consenting to participate in this survey. This will act as a waiver of documentation of consent.