TakePART-NW

TakePART-NW (Patients and Research Together-Northwest) is a research program. TakePART-NW aims to improve human health by developing better methods to prevent, diagnose and treat diseases such as cancer and heart disease, mental health and other conditions. We will collect your biological samples and de-identified health information. De-identified health information means that your personally identifiable information has been removed or hidden from researchers. Your samples will be stored according to strict rules. Researchers may use your samples and health information to study how and why diseases occur, why they vary from person-to-person and how to improve the prevention and treatment of health problems. TakePART-NW aims to enroll approximately 200,000 participants. 

Biological samples include blood, urine, saliva and tissue obtained during a surgery, biopsy, or other clinical tests. They are collected during your regular clinical care appointments. 

We are asking you to give us permission to collect and store your excess biological samples from a blood test, biopsy or surgery. You can say yes or no. 

We are also asking you for an extra tube of blood and/or a saliva sample to be collected during an existing visit for a routine blood draw. You can say yes or no. You can say no to this additional sample, even if you say yes to letting the TakePART-NW team use your excess samples for research. 

Your medical care will be the same, whether you agree to participate or not.

Your participation may help researchers better understand how to prevent and treat different diseases, such as cancer, in the future.

Collection of excess samples, and all sample storage will continue indefinitely throughout the lifespan of TakePART-NW. The principal investigator of TakePART-NW may remove you from the study at any time. TakePART-NW is not intended for treatment of disease. The TakePART-NW program team will work to provide awareness of sample availability to the research community to ensure as many as possible are utilized in approved research studies. 

You can sign up in your MyChart portal. You will see a banner under your MyChart Announcements section that will ask you to “Join Today” to start the TakePART-NW consent process. You can access the TakePART-NW consent form in the Questionnaire tab of your MyChart portal at any time.

You can change your consent at any time by logging into your MyChart portal and selecting the TakePART-NW (Patients and Research Together) consent form in the Questionnaires tab, or by contacting the TakePART-NW team at (206) 606-6045 or takepartnw@fredhutch.org. The TakePART-NW team will assist you in navigating back to the TakePART-NW consent in MyChart so you can update your responses.

You can change your mind at any time. If you choose to withdraw, your samples will not be used for any future research. Samples that have already been used for research cannot be withdrawn. Choosing to withdraw your consent will not affect your health care now or in the future. 

An independent ethics board consisting of physicians, researchers, and volunteer members of our communities may review, and approve the requests from researchers before the health information, blood, or samples you provide to TakePART-NW can be used. The ethics review board protects people who are participating in research. Your information and samples may be used for many types of health-related research. Researchers from Fred Hutch, University of Washington and other institutions, including for-profit organizations, such as pharmaceutical and biotechnology companies, will be able to make requests which will be evaluated by the ethics review board. Examples of research at for-profit organizations include new drug discovery and clinical trials. Your information will not be made public. It will not be shared outside of the approved research teams. Fred Hutch has access to research participants' records. 

Your information and samples may be used for many types of health-related research such as studies of cancer and heart disease. Researchers will not have access to identifiable private information about you. Some types of research may not have been invented yet. Some examples are:

1. Genetic Research - Your samples contain DNA. DNA makes up the genes that serve as the "instruction book" for the cells in our bodies. By studying genes, researchers can learn more about diseases such as cancer. There are many different types of genetic tests. The testing on your samples might include genetic testing called whole genome sequencing. Whole genome sequencing looks at all the genetic information in your cells. As technology advances, researchers may test your DNA samples in the future in a way that does not exist today. 
2. Cell Lines – A cell line is made by growing your cells in a lab. Cells are alive, and can be grown for a long time, even forever. Researchers can use cell lines to study different diseases, including cancer. Cell lines can be used to test the possible benefits of new treatments before they are used in a person. 
3. Scientific and Future Genetic Research Databases – Researchers may place information from their research studies into a scientific database. This may include non-identifiable information about you and your health conditions. This can help speed up future research discoveries. 

Several genetic databases are available to help researchers understand different diseases. These databases contain DNA information and other data helpful for studying diseases. DNA comes from cells in your body and contains all your genetic information. As part of this study, we will only put your genetic information and information about your medical condition into these databases. Your information may benefit future research. All your personal information will be removed. Your name and address, etc. will not be in the database. Only genetic information and information about your condition will be sent to the database. There is a small risk that your genetic information could be matched against other genetic databases to get your name. Once we release your data to the central database, we are no longer in control of the information. The information from this study may be stored in a public unrestricted data bank that anyone can use. This public information will not include your name or other information that could identify you.

Although the study may not benefit you directly, your participation may help researchers better understand how to prevent and treat different diseases, such as cancer, in the future. For most participants there is not a direct clinical benefit anticipated by participating. You can decide whether you would like to be contacted about results as part of TakePART-NW. If you decide you would like to be contacted about results, and a specific research study identifies a finding on your sample used for research, clinical care team members will be available to talk to you about what those results mean. It is important to note that it may be a long time before results about you are available, or they may never be available.

There are some risks associated with having a blood draw. They may include brief discomfort and or/bruising; infection; excess bleeding; clotting. Fainting is a rare side effect.  

For questions about injuries related to participation in TakePART-NW, please contact:  

• Peter Nelson, MD
  Fred Hutch Cancer Center/University of Washington
  825 Eastlake Ave. E., Seattle, WA 98109 
  (206) 606-6045
• TakePART-NW study team at (206) 606-6045 or takepartnw@fredhutch.org.

There are no funds to pay you for a research-related injury. State or national law may give you the right to seek payment for some of these expenses. You do not waive any right to seek payment by consenting to participate in TakePART-NW. You or your insurer will be billed for standard clinical care. You would not lose any legal right to seek payment for treatment by joining TakePART-NW.

Since the researchers evaluating your samples do not know who you are, it is extremly unlikely that anyone could connect information about your genes back to you. For more information about genetic testing on your samples, see the section earlier on this page called "What types of research will my samples be used for?".

There is a small risk that results of genetic tests might be released by accident or theft. This risk is very low because personal information is kept private and data security measures are in place.

In the unlikely event that your genetic information is connected to your name, a federal law called the Genetic Information Nondiscrimination Act (GINA) helps protect you.

GINA restricts access to your genetic information so that it cannot be used for health insurance coverage decisions. GINA will not allow health insurance companies or group health plans to: 

• Ask for genetic information you have provided in research studies.
• Use your genetic information when making decisions regarding your eligibility or premiums.

However, GINA does not help or protect you against discrimination by companies that sell life, disability or long-term care insurance. If the genetic results become known, there could be harms from others knowing about your test results. For example, the results could cause stress or anxiety in family members who learn about their own risk of developing disease. There is a risk that these test results could be combined with other information to identify you, and your information could become known to the public, employers, or law enforcement agencies. There is a risk that negative stereotypes of individuals, groups or communities may occur if information is disclosed inappropriately. There may be other risks from re-identification that are not yet known.

Your privacy is very important to us. We will:

• Follow all federal, state and local laws and rules for keeping data safe
• Continue to evaluate the security of where we store data
• Tell you if there is a risk to your privacy because of a data or accidental breach
• Ensure only people with approval can see your health information

If you join this study, some people and organizations might need to look at your medical or research records for quality assurance or data analysis. They include:

• Institutional Review Boards (IRB), including the Fred Hutch Cancer Center IRB. An IRB is a group that reviews the study to protect your rights as a research participant.
• Fred Hutch Cancer Center and the University of Washington.

Researchers will be able to make requests to use your information and samples, but they will not have access to identifiable private information about you. (For more detail see the section ‘What types of research will my samples be used for?’ and ‘Who can use my samples for research?’)

Those researchers will make these requests directly through the TakePART-NW honest broker process. The Fred Hutch Specimen and Data Access Network (SAN) will act as the honest broker for samples, and the Fred Hutch Data Science Lab (DaSL) will act as the honest broker for de-identified health information. An honest broker is a team that retains private information but ensures no identifiable information is given to researchers.

Information that can identify you, like your name and date of birth, will only be shared with a limited number of authorized people on the TakePART-NW program team.

By agreeing to participate in TakePART-NW, you permit your medical information to be shared with the TakePART-NW program team at Fred Hutch Cancer Center and others who work with them. Federal and state laws require that you give your permission for this team to see and use your patient information.  A federal law known as the Health Insurance Portability and Accountability Act (also called “HIPAA”) protects the confidentiality of patient information created and used by your health care providers.  Once this information is disclosed to the team, it will no longer be protected by HIPAA and could be re-disclosed. However, other laws do apply to the TakePART-NW program team that require them to protect the confidentiality of your information. The program team will use your information only for the purposes named in this consent. Your information may be used for research studies or shared with other researchers who are conducting research studies. 

The TakePART-NW program team may collect your medical record information. This may include information that can identify you, such as your name, contact information, and medical record number. If applicable, this may include information about mental health, alcohol or substance abuse, HIV/AIDS, sexually transmitted diseases, and/or results of genetic testing. However, only the TakePART-NW program team will have access to information that can identify you.  Any future use of the biorepository information will not be identifiable by other researchers.  If you agree to participate, you authorize your healthcare providers to disclose your medical record information and the TakePART-NW program team to receive and use your identifiable information as necessary to maintain the integrity of the biorepository. 

Your authorization to use and disclose your identifiable health information will continue until the TakePART-NW research program ends.

If you choose to withdraw your authorization for use and disclosure of your identifiable health information, you must do so in writing by notifying the TakePART-NW program team at takepartnw@fredhutch.org. If you change your mind, the TakePART-NW team may still use your information that was collected as part of the research project between the date the authorization was signed and the date the authorization was cancelled.

You will not be paid or charged for participating in TakePART-NW. Your samples might help researchers develop new products. Some research could be done by for-profit companies. You will not be paid if any new tests, products or discoveries result from any research involving your health information or samples. If you have any questions about your costs, financial responsibilities and/or medical insurance coverage for this activity, please contact the Fred Hutch Patient Financial Services team at (206) 606-6226 or the University of Washington Billing and Insurance Department at (206) 520-0400.

TakePART-NW is one of several research programs at Fred Hutch that asks patients for consent to use their biological samples for health research. TakePART-NW is unique in asking for an extra tube of blood and/or a saliva sample collected at the same time as one of your clinical lab collection appointments. This is a one-time request and collection. There is no need to come in for separate, research-related appointments.

Each of the research programs at Fred Hutch has a separate consent form for patients to fill out and sign. The consent form you sign for TakePART-NW will not replace existing consents that you may have signed.

Because each study has slightly different criteria that samples must meet to qualify for use in research, you may also be approached to participate in other research studies in the future. Some of these studies will be able to apply your consent from TakePART-NW and some will require you to sign an additional consent form.

Newsletters and regular updates about the types of research happening in TakePART-NW studies will be available on the TakePART-NW website. It will not be possible to identify you from the newsletters or website posts. You will not get any results back unless you let us know that you want to receive results about you. It is important to know that you may never receive results about you.

For questions prior to consenting or questions that arise during your participation in TakePART-NW, you can contact:

• Peter Nelson, MD
  Fred Hutch Cancer Center/University of Washington
  825 Eastlake Ave. E.
  Seattle, WA 98109
  (206) 606-6045
• A member of the TakePART-NW team by emailing takepartnw@fredhutch.org or calling (206) 606-6045.

To learn more about your rights as a research participant contact:

• Fred Hutch Institutional Review Office at (206) 667-5900 or email irodirector@fredhutch.org
• Human Subjects Division at University of Washington at (206) 543-0098