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General

What types of samples are collected?

Participants provide a blood sample, complete a health survey, and grant researchers access to their past and future medical record. For your protection, all of this information will be stored using a special number assigned to you but not your name or medical record number.

What is the purpose of the Kaiser Permanente Research Bank?

It is a long-term research program designed to help scientists understand how people’s health is affected by their genes, behaviors, and the environment.

Genes are made of DNA. DNA provides the genetic information needed to build and work human bodies. DNA can be found inside blood; even small amounts of blood have enough DNA to do scientific research.

The Kaiser Permanente (KP) Research Bank will collect blood samples, answers from a health survey, and information from past and future medical records. To protect your privacy, all of this information will be stored using a special number assigned to you rather than your name or medical record number.

This collected information may help scientists, both inside and outside of KP, discover new ways to identify, treat, and maybe even prevent or cure health problems. Some of the studies may lead to new drugs or tests for diseases. Some studies may be about how genes and factors like the air we breathe, the water we drink, our lifestyles, and habits are linked to specific health issues.

What studies might be done?

The goal of the KP Research Bank is to provide samples for different types of studies. Many of the studies try to understand how a person’s DNA influences their health and wellness.

For example, researchers don’t understand what causes high blood pressure in most people. Some studies may explore if certain genes are a cause of high blood pressure.

Other studies may focus on identifying how a person’s genes might increase their risk of getting cancer, heart disease, diabetes, asthma, Alzheimer’s and many other common diseases.

Eligibility

How did you get my contact information and/or medical information?

Your Kaiser Permanente health plan membership agreement states that you may be contacted to participate in research. The KP Research Bank invites any member over age 18 to join. However, participation is your choice. If you do not want to be contacted for the KP Research Bank in the future, please email us at ResearchBank@kp.org or call at 844-268-2947.

 

This program is safe and does not put members like you at risk. Therefore the program received special permission to identify and contact members who might want to sign up. Some members are identified through information in their electronic medical record.

This study has been approved by an Institutional Review Board (IRB), a group that protects members like you.

Why are you asking me to participate?

The KP Research Bank is asking all adult members of Kaiser Permanente, who are 18 years of age or older, to participate.

It takes thousands of DNA samples to figure out what genes and environmental factors are involved in diseases. To understand disease and improve health care, researchers need to collect and study information of diverse people that represent the entire population, as well as people living with cancer and women who are pregnant, people who are healthy as well as those who are not.

Am I required to participate?

No. Participation is your choice. If you decide not to join now, or to withdraw your consent later, your decision will not affect your routine health care or health benefits.

How can I participate if I choose to?

Enroll now by clicking here.

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Expectations

What happens if I agree to participate?

Once you sign the consent form, these are the three steps to participate:

  1. Give a small blood sample (about two tablespoons). Once you have signed your consent, a lab order for the blood draw will be put in your medical record. You will be able to donate your blood sample the next time you visit your regular Kaiser Permanente clinic for medical care. You can also come in at a time that is easy for you. You will not be charged for the KP Research Bank sample. Please note that lab orders expire, so it’s important to have your sample drawn in a timely manner.
  2. Allow the KP Research Bank to collect information from your past and future health records at Kaiser Permanente. Information could include diagnoses, test results, vital signs, health procedures, images such as X-rays, or medicines you take.
  3. Complete a survey. The KP Research Bank will ask you to take a health survey that asks questions about your health and habits that may affect your health, such as exercise and diet. You can take the survey before or after you provide a sample.

Your personal information: name, member number, address, etc., will be removed from the samples and information and replaced with a study number to protect your confidentiality.

 

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Will the KP Research Bank give me results?

No. You should not expect to get personal results. The data from your individual information will be combined with thousands of other samples, so research scientists can discover patterns. The KP Research Bank results will not help you or your health care providers make decisions about your current care nor will results be added to your medical record.

Eventually, researchers may be able to use the discoveries made from your participation to change health care and help people who live with all sorts of common diseases.

Can I find out what research studies are using my information?

No. You will not be told which studies are using your samples and medical data. Not all participants’ samples are used for every study. However, you can find information about the studies that are being conducted by viewing our Updates page.

How long will my samples and health information be used?

Your samples and information can be used for research for an unlimited amount of time. The information can still be used if you are no longer a Kaiser Permanente member. If at some point you decide you don’t want to participate anymore, you can stop your participation.

If you wish to withdraw from your agreement, you must notify the KP Research Bank in writing at:
Michael Horberg, MD, MAS
Principal Investigator
Kaiser Permanente Research Bank
2101 East Jefferson Street, 3E, Rockville, MD 20852

Is there any cost?

No, participation is free. You will not be charged for procedures, such as the blood draw, related to collecting a sample.

Will I be paid to participate?

You will not be paid for participating.

Will the KP Research Bank contact me in the future?

Over time, stored samples may be used up or decrease in quality. The KP Research Bank will let you know if another sample is needed, and you can decide at that time if you want to participate further.

In the future, the KP Research Bank may invite you to take part in other research. Some studies may need extra information from you. For example, a scientist might ask you to give another sample or to fill out a different survey. The KP Research Bank will not contact you more than four times in a year. If you change your mind in the future about being a part of the KP Research Bank, you can ask to not be contacted again.

What if I decide I no longer want to participate?

If you wish to withdraw from your agreement, you must notify the KP Research Bank in writing at:
Michael Horberg, MD, MAS
Principal Investigator
Kaiser Permanente Research Bank
2101 East Jefferson Street, 3E, Rockville, MD 20852

Privacy and Security Questions

How can I trust the KP Research Bank to keep my information safe?

The KP Research Bank is serious about protecting your privacy and information. Samples are kept confidential. None of the samples you give to the KP Research Bank are stored with your name, address, birth date, medical record number, or Social Security number on them. A study number will be used to label samples and medical information instead.

The samples are kept in locked storage areas and buildings. Personal health information and data are stored on servers and computers that are protected through electronic security. Only certain staff will have access to this information.

There are also laws in place to protect you. A federal law, the Genetic Information Nondiscrimination Act, makes it illegal for employers and health insurers to use certain kinds of information about your genes to discriminate against you. Data from your sample will not go into your medical record.

More Questions

Are there any risks?

The physical risks are small. When you give your blood sample, you may feel brief pain or have some bruising from the needle. Infection, lightheadedness, and fainting are also possible, but not likely.

The biggest risk is that someone could get access to the data the KP Research Bank has stored about you, despite best efforts to keep the information safe. The KP Research Bank believes the chance that this will happen is very small, but there is no guarantee that there is no risk.

Protecting your privacy is very important to KP. The KP Research Bank will make every reasonable effort to protect it.

What are the benefits?

Your sample can be used along with those of other KP members to help scientists find new ways to prevent, discover, and treat health problems. The work researchers do could help improve health care and help many
others.

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What if I am injured as a result of participating in the KP Research Bank?

The KP Research Bank only involves collection of information and does not involve the use of any drugs, devices, or procedures. Therefore, it is not expected that you would experience any injury.

Can my participation affect my coverage or premiums?

No. The information and databases are used only for approved research and will never be used to set or increase health insurance premiums or make decisions on your health insurance coverage.

How will you protect me as a study participant?

At Kaiser Permanente, we believe that research has the possibility to improve care delivery, medications, and many other ways.  Research can help improve the health of our members and many others. Research is the key to learning how we can make health care more effective. However, when you participate in research, it is very important to us that we protect your information. We want to share some ways that we keep study participants safe.

Some people worry about participating in research. Often, it is because of bad things that have happened in the past.

In the past, some research was not ethical (not the right thing to do). Before rules and regulations were created and required for all researchers to understand and follow, some people hid the truth about research. Some people falsely believed that participants shouldn’t know everything about the research process. There were instances where people were misled about research and treated unethically. If you would like to know more about this harmful research please see the following link: http://www.cdc.gov/tuskegee/timeline.htm (CDC).

At Kaiser Permanente, we take the rights and the protection of our members very seriously.

We want you to know how we protect our study participants’ rights, welfare, and well-being. We have many ways to help ensure that the highest ethical standards are used in our research.

Safeguards

Institutional Review Board

A Kaiser Permanente Institutional Review Board (IRB) reviews all research studies before they start. Members of the IRB include health care providers, researchers, and community members. The IRB makes sure that your rights, safety, privacy, and dignity are protected.

The IRB has many purposes

  • The IRB makes sure that the rights, safety, privacy, and dignity of all participants (human research subjects) are protected.
  • The IRB makes sure that the benefits of the research outweigh the risks.
  • The IRB makes sure that the risks to people who participate are as low as possible.
  • The IRB reviews all research activities to make sure that all regulations are followed.
  • The IRB also reviews all research activities to makes sure all ethical principles are met.
  • The IRBs include people who bring many different views to the review of research.

KP Research Bank goes to great lengths to reduce risks of harm for all its participants. Involvement might be as simple as completing a health survey and donating a small sample of your blood. There is also a very small risk that someone could get access to the data we have stored about you. We work hard to make sure this does not happen. Your privacy is very important, and we make every effort to protect it.

Certificate of Confidentiality

The KP Research Bank has a Certificate of Confidentiality from the federal government (through the National Institutes of Health). Having the certificate means:

  • No one can force the KP Research Bank to release information that may link to you. This includes a court subpoena by federal, state, or local civil, criminal, administrative, legislative, or other proceedings.

Advisory Boards

The Kaiser Permanente Research Bank has three Advisory Boards that offer guidance. These are the:

  • Community Advisory Board,
  • Scientific Advisory Board, and
  • Bioethics Advisory Board

Some Board members are experts in research and ethics. Other Board members are leaders in the community, or KP members. These Advisory Boards provide feedback about:

  • The design of the KP Research Bank program
  • How to protect members’ data and privacy
  • KP Research Bank recruitment and informational materials
  • Ideas on how to engage KP members  and recruit participants

Human Subjects Training and Informed Consent

All Kaiser Permanente research staff must complete special training called Human Subjects Training. ‘Human Subject’ is another word for ‘participant.’ In this training, research staff learns about ethical research and how to protect participant rights.

Learning about ‘informed consent’ is an important part of staff training. Before a person participates in research, they should understand what they are being asked to do, and why. With this information, a person can make an informed decision about if they want to participate. This process is called ‘informed consent.’ Informed consent is required for most types of research.

To obtain ‘informed consent’ these things must happen:

  • Researchers must tell participants what they will be asked to do if they sign up for research.
  • A person must be told the benefits and risks of participating in the research project.
  • A person must be told they will not personally benefit from the research.
  • A person must be told how they can withdraw from (leave) the project, if they change their mind.

This information is found on a consent form. You will need to sign a consent form online or on paper to participate in the KP Research Bank.

Protecting Privacy

Another concern people have is about privacy. Especially today when we hear in the news about people’s personal information being released publicly or people having their electronic identity stolen. In addition to protecting our members’ rights, we are also very serious about protecting information about you. Kaiser has strict processes in place to ensure your data is kept safe.

  • Kaiser uses strong electronic security to protect your health information and research data.
  • Your samples will be labeled with special numbers and kept in locked storage areas.
  • The KP Research Bank staff often reviews and updates our security steps.

Using Your Information in Research

If you agree to participate in research, it is important to know that all research being done using your information is ethical and that we will keep your information private and safe.

  • Only qualified and trained researchers can conduct studies using your information.
  • Only research that has been approved by a KP Research Bank Review Committee can be done.
  • Only research that has been approved by the IRB can be done.
  • Additionally, many research studies are reviewed by funding agencies, such as the National Institutes of Health. Projects are only funded if they are ethical and protect patient safety and privacy.

I am no longer a member of Kaiser Permanente. Can I still participate?

Not at this time.

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