Frequently Asked Questions and Answers (updated June 2008)
The Research Program
What is the Kaiser Permanente Research Program on Genes, Environment and Health (RPGEH)?
It is an important new research project to identify genetic and environmental factors that can lead to disease or affect how a person reacts to medications. The goal is to help improve the health of Kaiser Permanente members and the general public through increased knowledge about the influence of genes and the environment on health.
Why is this research important?
When we understand how genes and the environment work together to affect people’s health, we will be able to use this information to help individual people improve their health. An 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.
What diseases and health conditions will be included in this research program?
The RPGEH 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 to find genetic and environmental factors that are related to improving overall health in old age.
What do you mean by "genes" and "environment"?
Your genes are inherited from your parents and influence things about you such as your hair and eye color. Everyone’s genes are slightly different. These small differences, in combination with other factors, may positively and negatively influence your health and reactions to medications. In this research program, environment refers to things other than your genes that can affect your health – like what you eat and drink, chemicals in the air, and water where you live and work and whether you smoke or exercise.
What does this research program involve?
The RPGEH is a long-term program that will consist of many separate studies over time. 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. More than 400,000 members participated. Researchers are combining responses from these health surveys into a new database with information from participants’ electronic health records.
We now are asking some members to give a 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 members to give a blood sample and perhaps complete other surveys.
Who oversees this research?
Kaiser Permanente has an Institutional Review Board (IRB) which is responsible for protecting the rights and welfare of all research participants. The IRB oversees all research and makes sure that we are in full compliance with Federal and State requirements at all times.
Does anyone else oversee this research?
The RPGEH has a 5-member Scientific Advisory Panel (SAP) and a 20-member Community Advisory Panel (CAP). The SAP gives scientific advice to the researchers on an as needed basis. The CAP meets quarterly and helps researchers identify any concerns that participants or the broader community may have about the RPGEH, and it makes recommendations on how we can address them.
How long will the RPGEH last?
All samples and data collected for the RPGEH databank will be used for research studies for an indefinite period of time. Unless you withdraw from the Research Program, your samples and data may continue to be used after you are no longer a Kaiser Permanente member and after you have died.
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 range of studies in this field. The Division of Research has been conducting medical and scientific studies since 1961. Many of these studies have resulted in our ability to detect diseases in earlier stages and develop improved treatments for common conditions, like diabetes and cancer.
How can I find out what kinds of studies are being done?
When study information becomes available, it will be posted on the RPGEH Web site. If you don’t have access to the Internet, call 866-369-2157 anytime, toll-free to request a printed copy.
Who is paying for this research?
The Research Program has received funding from Northern California and National Kaiser Permanente Community Benefit Funds and several private foundations. We are continuing to seek funds from private, not-for-profit and government sources.
The Consent Process and Collection of Saliva Samples
Why do I have to sign two different consent forms?
The purpose of the consent process is to make sure you know what you are volunteering for and how the research may affect you, and to give 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" 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." It gives researcher’s permission to access your personal health information and is required for all research that includes a consent form.
Why was I asked to give a saliva sample?
Your name was randomly picked from the Kaiser Permanente members who returned the RPGEH Health Survey. Eventually, we plan to invite all members who completed the survey to continue in the research, but for now we are contacting 100,000 survey respondents.
Why was I the only person in my household asked to give a saliva sample?
If other members of your household completed the Health Survey, we randomly chose one person to contact now. We did this to ensure that saliva kits for different household members don’t get mixed up. The only identifying information on the kits is a coded number; your name is not on it. Other members of your household may be contacted in the future.
What will you do with my saliva samples?
Research staff will separate the samples into smaller amounts and store them so they will be available for research. The samples will be labeled with a unique study identification number and kept in a secure Kaiser Permanente laboratory.
If I give a saliva sample now, will I be asked to give a blood sample later?
We may contact you in the future and ask you to give you a blood sample, but you will not have to give blood if you don’t want to.
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 used by you or your doctor or nurse practitioner 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 re-contact you and ask if you want to learn the results.
Privacy and Confidentiality
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 your medical record or shared with Kaiser Foundation Health Plan. We will also take the following IRB-approved steps to protect your 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 leave this secure environment.
- The computer system has electronic security measures to prevent attacks on the databank. The databank is protected by a “firewall” from unapproved entry (commonly called “hackers”).
- Access to the databank is limited to Kaiser Permanente Division of Research staff who have signed agreements pledging not to link participant data with any identifying information.
- Within the RPGEH databank, we will label your DNA samples, genetic information, survey answers, and medical record data with a unique study ID number only. Your study ID number will not be the same as your other personal numbers like your phone number, social security number, or medical record number. When scientists need to connect genetic information to survey or medical record data, they will do this with a code. Use of This code is limited to a very small number of Kaiser Permanente Division of Research scientists and staff members.
- Outside researchers working with Kaiser Permanente scientists will not be given data that includes individual identifiers.
What is a Certificate of Confidentiality?
We have applied for a Certificate of Confidentiality. Certificates are granted under a federal law, Section 301(d) of the Public Health Service Act. Under the law establishing the Certificate, researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative or other proceeding. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of the United States government that is being used for auditing or evaluating federally funded projects or for information that must be disclosed to meet the requirements of the Food and Drug Administration. You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about you or your involvement in this research.
Participation
Will participation in this project affect my medical treatment or insurance fees?
No. Your decision to participate or not participate in the research will not affect your health care, your membership in Kaiser Permanente, or the amount you pay for dues or your insurance record, either now or in the future. There will be no mention of whether or not you participated in any of your medical or insurance records, and you can drop out of the project at any time.
Does this research pose any risks for me?
There are no known risks from giving a saliva sample. If you are asked to give a blood sample, there are no major risks associated with drawing blood. Having your blood drawn can be uncomfortable and can sometimes cause a bruise. In rare cases, it can cause fainting. There is also a slight risk of infection at the site of the blood draw. If these things happen, they are usually minor and do not last long.
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 think the security measures we have put in place will make it unlikely that such an event would occur.
If I volunteer now but change my mind later, what will I have to do to withdraw from the RPGEH?
We will need to have your withdrawal in writing, so call 866-369-2157 anytime, toll-free and a staff person will assist you.
Why should I participate in this research?
We can’t do it without you. Voluntary participation in medical research is vital if we are to reduce the impacts of disease on future generations. If you agree to participate, you will help advance medical knowledge that may lead to improvements in the way we detect, treat and prevent disease for all people.
More General Information
Does this research involve cloning, or stem cells, or genetic engineering?
No. The Research Program is not using stem cells, and it does not involve research on embryos, cloning, or gene therapy.
Is a databank the same as a biobank?
Yes. The terms databank and biobank both refer to databases that store genetic information. We are using the term databank to emphasize the fact that our databank will contain other kinds of information, like medical, environmental and health survey information.
Do other large-scale genetics databanks currently exist?
Yes. The largest program is the UK Biobank in the United Kingdom. Programs in the US include the Marshfield Clinic Personalized Medicine Research Project and the NUgene Project (Northwestern University).
The content of this Web site has been reviewed and approved by the KPNC IRB.
