The Research Program on Genes, Environment, and Health (RPGEH) is a developing resource for scientific research. The RPGEH is designed to help researchers study genetic and environmental influences on common health conditions, such as heart disease, diabetes, cancer, asthma, mental health disorders and many others. The goal of the program is to improve the health of Kaiser Permanente members and the general public through increased knowledge about the influence of genes and other factors on health, disease, and aging. The building blocks of the RPGEH are: - Genetic information from blood or saliva samples provided by RPGEH participants in Northern California; - Data collected from RPGEH participants through self-reported health surveys; - Historical and ongoing clinical data on RPGEH participants from the Kaiser Permanente electronic health record; and - New environmental databases that will allow researchers to study the health effects of environmental factors such as air pollution and water quality, as well as neighborhood characteristics, such as proximity to parks, grocery stores, and healthy foods.

2. Why is this research important?

When we understand how genes and the environment interact to affect people's health, we will be able to use this information to help individual people improve their health. One example of how this research might be used in the future is that a person's genetic information could be used by his or her doctor to prescribe the medication that is the most effective for that person and that causes the fewest side effects.

3. What diseases and health conditions will be included in this research program?

The research program will include many diseases that affect people at different ages, including heart disease and stroke, cancer, diabetes, asthma and lung diseases, autoimmune disorders, Alzheimer's disease and other neurological disorders, mental health problems and chemical dependency, pregnancy and reproductive disorders, and infectious diseases such as hepatitis. The research program will also study aging in order to find genetic and environmental factors that are related to improving overall health in old age.

4. What do you mean by "genes" and "environment"?

Genes are inherited from one's parents and influence things such as hair and eye color. Everyone's genes are slightly different, and these small differences, in combination with other factors, may influence health and reactions to medications both positively and negatively. In this research program, environment refers to things other than one's genes that have potential to affect health - like where one lives and one's background, chemicals in the air and water, lifestyle and health habits.

5. What will this research program involve?

The RPGEH is a long-term program that will consist of many separate studies over time. The first steps in this program involve building a databank of information from volunteers that can be used in research studies. In the first phase, we contacted most Northern California adult members of Kaiser Permanente and asked them to take part in the RPGEH and complete a health survey. Nearly 400,000 members participated. Researchers are combining responses from these health surveys into a new database with information from participants' electronic health records. New volunteers can complete the survey on-line. Now, we are asking some members who have completed the survey to give a blood or saliva sample for use in genetic and environmental analyses. Those who agree must sign a written consent form, and the results of these analyses will be entered into the database for use in future studies along with their other background and health information. Having all of this information together in a database is called a "databank." In the future, we also may ask some participants to give a blood sample and perhaps complete other surveys. In 2009, RPGEH researchers began work on several research studies that use information in the databank to examine genetic and environmental factors that affect specific health conditions.

6. Why is Kaiser Permanente doing this kind of research?

Kaiser Permanente is one of few organizations in the United States with both the scientific expertise and a membership that is large and diverse enough to be useful for a broad array of studies in this field. The Division of Research has been conducting medical and scientific studies since 1961, many of which have resulted in our ability to detect diseases in earlier stages and new treatments for common conditions, like diabetes and cancer.

7. How many Kaiser Permanente members have joined the research program?

As of November 2009, almost 400,000 Kaiser Permanente members in Northern California have completed our health survey, and more than 120,000 of these members have also provided saliva samples.

8. Who is eligible to join the research program?

All adult members (18 years of age and older) of Kaiser Permanente in Northern California are eligible to join the RPGEH.

9. Who is paying for this research?

The research program has received funding from Northern California and National Kaiser Permanente Community Benefit Programs, private foundations, and the National Institutes of Health. We are continuing to seek funds from private, not-for-profit, and government sources. Research projects that use the information in the RPGEH databank will be supported by grants from the government, private foundations, and other funders of biomedical research.

10. Who has oversight responsibilities for this research?

Kaiser Permanente has an institutional review board (IRB) that is responsible for protecting the rights and welfare of all research participants. The IRB oversees all research and makes sure that that research program remains in full compliance with federal and state requirements at all times.

Questions and Answers for Participants and Potential Participants

11. Why are you asking me to be a part of this research program?

Most adult members of Kaiser Permanente in Northern California are being asked to participate. It is important that people with different backgrounds and medical histories - including those with no health problems - participate so the results can be applied to as many people as possible.

12. How will you protect my privacy and confidentiality?

Privacy protection is an essential component of this research. No results from the RPGEH will be placed in participants' medical records or shared with Kaiser Foundation Health Plan. We will also take the following IRB-approved steps to protect participants' privacy and keep this information confidential.

All RPGEH information will be kept in a computer databank that is only for research. The computer system that holds the entire databank, including the genetic records, is located in a locked and physically secure facility. The data can never be placed on a laptop computer or portable storage device that could be removed from this secure environment.
The computer system has electronic security measures to prevent attacks on the databank. The databank is protected from unapproved entry by a computer "firewall."
Access to the databank is limited to authorized Kaiser Permanente Division of Research staff. All Division of Research staff have signed agreements promising to safeguard participant data and use it only for approved purposes.
Within the RPGEH databank, we will label participants' DNA samples, genetic information, survey answers, and medical record data with a unique study ID number only. Participants' study ID numbers will not be the same as their other personal numbers, such as phone numbers, social security numbers, or medical record numbers. The link between your medical record number and the study ID will be kept secure, with access restricted to a very small number of Kaiser Permanente Division of Research scientists and staff members.
No identifiable participant information may be kept on a portable device that could be stolen, such as a laptop or a PDA (for example, a Blackberry).
Outside researchers working with Kaiser Permanente scientists will not be given data that includes individual identifiers. Outside researchers will be required to maintain the confidentiality of the data by written agreements, and they will be required to use similar methods to safeguard the privacy and confidentiality of any information they are provided for research purposes.

13. Will anyone ever be able to identify me as a research participant?

Yes. A limited number of trained employees will have access to the list that links the deidentified information to member names. This is necessary to enable researchers to contact participants for new phases of the study, and to update health information in the new database.

14.Who will have access to the new database?

Only scientific and medical researchers that have been trained and signed confidentiality agreements will have access to the data. Data may be made available to researchers outside of Kaiser Permanente working in collaboration with Kaiser Permanente researchers, but they will not be provided with any identifying information about individual participants and they will be required by written agreement to maintain the confidentiality of all information.

15. Will participation in this project affect my medical treatment or insurance fees?

No. Your participation in the research will not affect your health care, your membership in Kaiser Permanente, the amount you pay for dues or your insurance record, now or in the future. There will be no mention of your participation in any of your medical or insurance records, and you can drop out of the project at any time.

16. Does this research pose any risks for me?

One potential risk of participating would be loss of privacy or confidentiality if unauthorized people got access to study records and information about you was made public. We believe the security measures we have put in place will make it unlikely that such an event would occur.

17. I completed a survey for another study at the Division of Research. Why am I being asked to give a saliva or blood sample to the RPGEH?

The next step in researching many diseases and conditions is to better understand the genetic and environmental factors that affect health. The scientists who direct the research project you participated in are joining with Kaiser Permanente's Research Program on Genes, Environment and Health to investigate the genetic and environmental factors involved in your condition or illness. If you choose to give a saliva or blood sample to the RPGEH, scientists will study the genetic and environmental information from your blood or saliva along with the survey information you already have provided, with that of thousands of other volunteer participants. With this overall information about many people's background, scientists will be able to better understand the genetic and environmental factors that affect various diseases and conditions.

18. Why are you asking pregnant women for special blood samples for the RPGEH?

Pregnant women's blood is an especially rich source of genetic and environmental information that could help scientists better understand both common and unusual diseases and health conditions of women, infants, and children.

Questions and Answers About Saliva and Blood Samples

19. Who is being asked to give a blood or saliva sample?

We are currently contacting Kaiser Permanente members who returned the RPGEH Health Survey and asking them to give a blood or saliva sample. Eventually, we plan to invite all members who completed the survey to continue in the research and give a saliva and/or blood sample.

20. What does giving a blood or saliva sample involve?

First, willing participants will need to sign BOTH a consent form and a form that authorizes use of health information, which they will receive in the mail, and mail them back to the RPGEH. Participants will then receive instructions on providing a blood or saliva sample. For blood samples, participants will receive information about how to go to their local Kaiser Permanente laboratory to provide a blood sample. If participants prefer to provide a saliva sample rather than a blood sample, we will send them a saliva kit with instructions.

21. Why do you prefer to get a blood sample rather than saliva sample?

Blood samples provide more information for future research than saliva samples, and it has always been our goal to collect and store blood components for research. While saliva is a good source of DNA, it does not provide information about environmental exposures, which blood samples can provide.

22. Why do I have to sign two different forms?

The purpose of the consent process is to ensure that you understand what the Research Program is about and how participation in the program may affect you. It also gives you an opportunity to ask questions. Federal laws require that volunteers sign consent forms before they can participate in medical research projects.

The "Consent to Participate in a Medical Research Program" form gives you information about the RPGEH. It explains the purpose of the study, number of participants, procedures, potential benefits and risks and possible alternatives. It also tells you what is expected of research participants.

For this phase of the research program, the law also requires that you sign the "Authorization to Use and Disclose Protected Health Information" which is required by the Health Information Portability and Accountability Act (HIPAA). It gives researchers permission to access your personal health information and is required for all research that includes a consent form.

23. What will you do with my blood or saliva samples?

Research staff will label them with a unique study identification number and store them in a secure laboratory facility. When needed for a research project on a specific disease or health condition, DNA will be extracted from the blood or saliva, and some of the DNA will be analyzed for genetic information.

24. How long will you keep my samples?

All samples and data collected for the RPGEH will be used for research studies for many years. Unless you withdraw from the research program, your samples and data may continue to be used even after you are no longer a Kaiser Permanente member.

25. What will you do with my DNA sample?

Since this is a new area of science that changes quickly, we don't know now which genes scientists will study. We also don't know how many genes your DNA may be tested for. The number of tests will range from a few to possibly hundreds of thousands. It will depend on what researchers study and what they discover. It may also be years before your blood and/or saliva samples are analyzed for research purposes.

26. If I have provided a saliva sample, will I be asked to give a blood sample later?

We may contact you in the future and ask you to volunteer to give a blood sample.

27. Are there any major risks associated with giving a blood or saliva sample?

There are no health risks associated with providing a blood or saliva sample. If the blood or saliva sample were analyzed for genetic information and an unauthorized person gained access to that information, there would be a potential risk of loss of privacy or confidentiality. We believe the security measures we have put in place will make it highly unlikely that such an event would occur.

28. Will I receive any personal benefit from giving a blood or saliva sample that may impact or improve my own health?

This research is not intended to benefit individual participants directly. However, we hope that results from the research will improve how clinicians diagnose, treat, and maybe even prevent major illnesses in the future.

29. Will I be getting any test results?

You will not receive personal health or medical results from taking part in the RPGEH. We do not expect that results from the RPGEH will be the kind of information that can be used by you or your health care provider to make decisions about your current health care. However, if scientists discover information as a result of RPGEH research that we believe is of substantial medical importance to you, we may contact you and ask if you want to learn the results.

30. If I change my mind about being in the research program, how can I withdraw?

You will need to withdraw in writing. You can contact the RPGEH and/or Dr. Schaefer at the address on your consent form, or you can call 866-369-2157 or 510-891-3400 and a staff person will assist you.

31. If I withdraw from the research program, what will happen to my blood or saliva sample?

If you withdraw, we will destroy your samples and any unpublished data from these samples.

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