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COVID-19 VACCINE TRIAL REGISTRY

The Kaiser Permanente Washington vaccine research group was the first in the
world to enroll people in a COVID-19 vaccine clinical trial. As we continue to
fight the pandemic, we are preparing to launch more COVID-19 vaccine trials.
Earlier this year, we started a registry of Seattle-area adults who wanted to be
contacted about COVID-19 vaccine trials.

With the success of COVID-19 vaccine trials in adults, trials of the vaccines in
children are now being started. We expect to be conducting COVID-19 vaccine
trials in children and so are now expanding the registry to allow parents and
guardians to add their children aged 17 years and younger to the registry if
they would like to be contacted about COVID-19 vaccine trials in children.



 * If you are a parent or guardian interested in having your child or children
   join the registry, please click here to learn more.
   
   
 * If you are 18 or older and interested in joining the registry, please read
   the information below to learn more.



 


COVID-19 VACCINE TRIAL REGISTRY CONSENT: ADULTS 18 OR OLDER

Kaiser Permanente Washington Health Research Institute (KPWHRI) has created a
registry for people who are interested in taking part in future clinical trials
of investigational vaccines for the 2019 novel coronavirus, SARS-CoV-2, which
causes COVID-19. To learn more about the registry, please read the information
below. Then, if you would like to join, click the link near the bottom of this
page to complete a survey.


WHAT IS THE PURPOSE OF THIS REGISTRY?

Upcoming investigational coronavirus vaccine trials will likely need to enroll
many people in a short period of time. To help with recruitment for these
trials, we are keeping a registry of people who live in the greater Seattle area
and are interested in taking part in an investigational vaccine trial.

Lisa Jackson, MD, MPH, a KPWHRI senior investigator, will be the lead researcher
for any upcoming vaccine trials.


WHO CAN BE IN THE REGISTRY?

 * People who are 18 years and older.
 * People in good health, or with stable medical conditions, who live in the
   greater Seattle area.
 * People who can travel to the KPWHRI research clinic in downtown Seattle for
   multiple study visits.




WHAT WILL HAPPEN IF I JOIN THE REGISTRY?

 * If you are interested in joining the registry after reading this page, please
   click the survey link below. The survey will ask for general information
   about you. It will also ask about your current and past health and
   medications and your line of work. The survey includes sensitive questions.
   * These questions will help us determine whether you are likely to be
     eligible for a clinical trial of an investigational vaccine.
   * Some of the questions ask for personal information. If you start filling
     out the survey and decide you want to stop, you do not have to submit your
     information.
 * We will keep your survey responses for up to 5 years. After a maximum of 5
   years, your responses will be deleted. We can also delete your responses
   anytime at your request.
 * We may contact you by phone or email and/or review your electronic medical
   record (if you are a Kaiser member) to clarify or gather more information
   about your survey answers.
   * If we review your medical record, we may look at your health information
     from the date you became a Kaiser member until 5 years from the date you
     join the registry.
   * Your health information is protected by a federal privacy law, called
     HIPAA, that we must follow. Information that we collect and review for the
     registry is part of that protected health information. By joining the
     registry, you are giving us permission to collect and review your health
     information as described above.
 * Records of your participation in the registry will be held confidential
   except when sharing the information as required by law. The investigator, and
   under certain circumstances, the United States Food and Drug Administration
   (FDA) and the Institutional Review Board (IRB), will be able to inspect and
   copy confidential registry-related records which identify you by name. This
   means that absolute confidentiality cannot be guaranteed.
 * If we begin a clinical trial of an investigational coronavirus vaccine while
   you are in the registry, we may contact you by phone or email to tell you
   more about that trial and see if you are interested in taking part. Please be
   aware:
   * Clinical trial visits will be held at the KPWHRI research clinic in the
     Metropolitan Park East building, near I-5 in downtown Seattle.
   * Vaccine clinical trials typically involve multiple blood draws.
   * Vaccine clinical trials typically involve a placebo (an inactive
     substance). Some people in the trial will receive the investigational
     vaccine, and others will receive a placebo.
 * Being in the registry does not mean you’ll be eligible to or committed to
   take part in any specific future trial.
 * You do not have to be a Kaiser Permanente member to participate in this
   registry, but if you are a member, participation will not affect your care or
   your benefits. You are free to say no now or to leave the registry at any
   time later. Either way, there will be no penalty. Your decision won’t affect
   the health care you receive or benefits that you are entitled to.
 * You will not benefit personally as a result of your participation in this
   registry.
 * There will be no costs or compensation if you choose to take part in this
   registry.
 * While you are in the registry, if you have questions, concerns, or complaints
   about the registry, please contact us at 206-287-2061. If you have questions
   about your rights as a research subject, and/or concerns or complaints
   regarding this registry, contact Advarra IRB at 877-992-4724 or by email at
   advisor@advarra.com.


WHAT SHOULD I DO IF I AM INTERESTED IN JOINING THE REGISTRY?

If you want to join the registry and agree to have your information stored as
described above, please click here to complete a survey.


WHERE CAN I FIND MORE INFORMATION ON THE SARS-COV-2, THE VIRUS THAT CAUSES
COVID-19?



 * Coronavirus (COVID-19) how to protect yourself, and what to do if you are
   sick:
   https://www.cdc.gov/coronavirus/2019-ncov/index.html
   
   
 * Coronavirus (COVID-19) pandemic public advice, and country and technical
   guidance: https://www.who.int/emergencies/diseases/novel-coronavirus-2019




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