Research Participants
"My sister has cancer right now. So anything done in the past that can help her along today, I certainly appreciate. I know she does, too".
- Member from Sunnyvale
Volunteer recruitment
We began recruiting volunteers by contacting most adult Kaiser Permanente Northern California members, by mail, inviting them to participate in the Research Program, and asking those who agreed to complete a survey that solicits background, health, and lifestyle information. So far, we have received nearly 400,000 completed surveys.
We are continuing to recruit volunteers.
What new volunteers are being asked to do now
Northern California members who agree to participate in the Research Program can complete the Health Survey online. The survey asks for health, environmental, and demographic information, all of which are factors that may affect a person’s physical well-being.
Where you live and work, what you eat and drink, and your exercise habits are the “environmental factors” that researchers will be studying to determine which, if any, affect a particular disease, either positively or negatively. The survey also asks questions about family members. This information is important because a history of disease among family members can be an indicator that a condition is influenced by genetic background.
What volunteers may be asked to do in the future
In the future, some participants in the Research Program will be contacted again, and they may be asked to complete additional questionnaires. Some may be asked to give a sample of their saliva and/or blood for DNA analysis. If they agree, they will be asked to sign a Consent Form first, granting permission to let their biological sample be used in the study.
Volunteers can drop out at any time
Even if you take part in this first phase of the Research Program, participants are free to say "no" and opt out at any time.
About blood and saliva samples
Participants who are asked and agree to give a saliva sample will receive a kit in the mail that includes instructions on how to use it and how to return it to us in a pre-paid envelope. More information on saliva collection can be found in the section on "Research Participants." Information on blood samples will be available later in 2008.
New Survey Respondents
Who Can Participate
Participation in the Research Program is open to all adult members (age 18 and over) of Kaiser Permanente Northern California (KPNC).
Saliva Sample Collection
Who is being asked to give a saliva sample?
We are currently contacting 100,000 members whose names were randomly picked from the Kaiser Permanente members who returned the RPGEH Health Survey and asking them to give a 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.
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 does giving a saliva sample involve?
If you are willing to give a saliva sample, you will have to sign two different consent forms and mail them back to us, and then we will mail you a saliva kit with instructions on how to use it and how to mail it back in a pre-paid envelope.
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" 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.
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. More information about how we protect your samples is given in the section on cPrivacy and Confidentiality."
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 and after you have died.
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 be from just 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.
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.
Are there any major risks associated with giving a saliva sample?
There are no health risks associated with collecting saliva. If the saliva sample was analyzed for genetic information and an unauthorized person gained access to that information, then 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. Information about our security measures is described in the "Confidentiality"section.
It is possible that scientists will discover that people of a particular race, ethnicity, sexual orientation or some other characteristic may be at higher risk of developing certain conditions than people without those characteristics. If this happens, and if the information is made public, it may cause you to be labeled or treated differently if you are in a group that is considered to be higher risk for a condition This may happen whether you participate in the research or not.
Will I receive any benefits from giving a saliva sample?
No. This research is not intended to directly benefit individual participants. However, we hope that results from the research will improve how doctors prevent, diagnose and treat major illnesses in the future.
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.
If I change my mind about being in the Research Program, how can I withdraw?
We will need to have your withdrawal in writing, so call 866-369-2157 or 510-891-3400 and a staff person will assist you.
If I withdraw from the Research Program, what will happen to my saliva sample?
If you withdraw, we will destroy your samples and any unpublished data from these samples.
Saliva Sample Kit Instructions (IRB approved)
- Pending
The content of this Web site has been reviewed and approved by the KPNC IRB.
