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Frequently Asked Questions

1. What is the purpose of the Research Program on Genes, Environment, and Health (RPGEH)?

2. Why are you asking me to participate in the RPGEH?

3. How many people will participate in the RPGEH?

4. If I agree to participate, how long will I be in the RPGEH?

5. What will happen if I agree to participate in the RPGEH?

6. What is the National Institutes of Health (NIH) research database?

7. What are the risks of participating in the RPGEH?

8. What are the benefits of participating in the RPGEH?

9. Will the RPGEH return results to me?

10.What are my choices if I do not want to enroll in the RPGEH?

11. What if I am injured as a result of participating in the RPGEH?

12. Am I required to participate in the RPGEH?

13. Will it cost anything to participate in the RPGEH?

14. Will I be paid to participate in the RPGEH?

15. Will my information be kept confidential?

16. Does the RPGEH have other protections for my privacy?

17. Can my participation in the RPGEH affect my Kaiser Permanente membership, coverages, or premiums?

18. Does Kaiser Permanente participate in commercial research?

19. If I participate in the RPGEH, will you contact me again?

20. Why am I being asked to sign a new consent form?

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

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

23. What if I have questions?

24. I’m no longer a member of Kaiser Permanente. Can I still participate in the RPGEH?

1. What is the purpose of the Research Program on Genes, Environment, and Health (RPGEH)?

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

Most common diseases are complex, and a person's risk for getting a disease depends on many factors. Your risk includes the genes you inherit from your parents as well as environmental factors. Environmental factors mean just about everything you are exposed to in your daily life - what you eat and drink, chemicals in the air and water, where you live and work, and whether you smoke or exercise. Scientists believe that even small differences in genes or environmental factors can affect whether you get a disease or a medical condition, or whether you lead a long and healthy life.

Over the long term, the RPGEH may help scientists discover new ways to diagnose, treat, and even prevent some common health conditions, such as diabetes, cardiovascular disease, asthma, cancer, and many others.

2. Why are you asking me to participate in the RPGEH?

In order to understand how genes and environmental factors interact and affect health, scientists need to study medical, behavioral, environmental, and genetic information from large numbers of people. They need information from people who are representative of the entire population, including people who are healthy as well as those who are not.

3. How many people will participate in the RPGEH?

We plan for 500,000 Kaiser Permanente members from Northern and Southern California to participate in the RPGEH.

4. If I agree to participate, how long will I be in the RPGEH?

If you agree to participate in the RPGEH, information about you may be used for research studies for an indefinite period of time. You may withdraw from the research program at any time. Unless you withdraw, your samples and data may be used by researchers even after you are no longer a Kaiser Permanente member and after you have died.

5. What will happen if I agree to participate in the RPGEH?

If you agree to participate in the RPGEH and sign the consent form, this is what will happen:

Giving Saliva and/or Blood Samples: We will ask you to give a small sample (less than two tablespoons) of your saliva and/or blood. If we ask you to give a blood sample, you will be able to give the sample when you visit your regular Kaiser Permanente clinic for medical care, or you can come in at another time if that is more convenient for you. If we ask you to give a saliva sample, we will send you a kit in the mail that will include instructions on how to use it. We will ask you to return the kit in a postage-paid envelope.

The RPGEH will use saliva samples to get DNA for research. The RPGEH will use blood samples to get DNA for research and also study environmental exposures and contaminants.

We will keep your blood and/or saliva sample in a secure laboratory. Research staff will separate the samples into smaller amounts and freeze them so they will be available for research for an indefinite period of time. The samples will be labeled with a unique study identification number. More information about how we protect your samples is given in the answer to question 14, "Will My Information Be Kept Confidential?" in this FAQ.

Taking a Health Survey: If you have not already done so, we will ask you to take a health survey that will provide information about your family history, your health, and behaviors that may affect your health, such as exercise and diet.

Participating in Research Studies: Scientists will select RPGEH participants for use in research studies based on various criteria, such as a participant's health conditions, age, race/ethnicity, or other factors. If researchers decide to use information about you from your health survey, genetic sample, or Kaiser Permanente medical record for research studies, the RPGEH will probably not contact you about these studies You will not need to sign additional consent forms or participate in additional lab tests or interviews, unless the scientists would like to ask for additional information about you for their studies. As new information is added to your Kaiser Permanente medical record, this information will also be available to scientists if it is applicable to their studies.

Studying DNA: 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.

Sharing Research Data: The RPGEH may share some genetic and health data about you with other researchers whose studies are approved by the RPGEH Access Review Committee and the Kaiser Permanente Institutional Review Board, which is responsible for protecting the rights and welfare of all Kaiser Permanente research participants. The RPGEH may also share some genetic and health data about you with the National Institutes of Health (NIH) for its national research database, which other scientists may use for additional research.

6. What is the National Institutes of Health (NIH) research database?

To support more research, scientists sometimes share information from research studies. If you agree to participate in the RPGEH, we may place some of your genetic and health information in a national, research-only database for other scientists to use for additional research studies approved by the NIH.

The purpose of this national research database is to enable a broad range of researchers to study health and disease and enable analysis of a much larger collection of data than is available in a single study. This national research database is managed by the NIH, which is part of the U.S. Department of Health and Human Services. NIH is the primary federal agency for supporting medical research in the U.S.

The data provided to the national research database will not include identifying information such as your name, address, social security number, or medical record number. However, because your information is unique to you, there is a small chance that someone could trace it back to you. The risk of this happening is very small but may grow in the future. Researchers will always have a duty to protect your privacy and keep your information confidential.

7. What are the risks of participating in the RPGEH?

There are no major risks associated with collecting saliva or 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 would be loss of privacy or confidentiality if unauthorized people got access to study records. 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 answer to question 14, "Will My Information Be Kept Confidential?"

A federal law called the Genetic Information Nondiscrimination Act (GINA) makes it illegal for employers, health insurers and group health plans to discriminate against individuals based on their genetic information. GINA does not protect individuals against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. The genetic information we collect or obtain through research will not affect your eligibility for future medical care, membership in Kaiser Foundation Health Plan, or cost of your premiums or benefits.

8. What are the benefits of participating in the RPGEH?

This research is not intended to benefit individual participants. However, we hope that results from the research will improve how doctors prevent, diagnose, and treat major illnesses in the future. 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 you or your health care providers would use 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 will re-contact you and ask if you want to learn the results.

9. Will the RPGEH return results to me?

No. 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 you or your health care providers would use 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 will re-contact you and ask if you want to learn the results.

10. What are my choices if I do not want to enroll in the RPGEH?

You are free to choose not to participate in the RPGEH without any negative consequences.

11. What if I am injured as a result of participating in the RPGEH?

The RPGEH only involves collection of information and does not involve the use of any drugs, devices, or procedures. Therefore, we do not expect that you would experience any injury.

12. Am I required to participate in the RPGEH?

Your participation in the RPGEH is voluntary. You are free to refuse to participate in the RPGEH. Your decision will not affect your medical care. If you decide to participate, you can change your mind at any time without any effect on your medical care or eligibility for future care or membership in Kaiser Foundation Health Plan. If you withdraw from the RPGEH, we will stop using your samples for research. Data from your samples may continue to be used in ongoing studies, but will not be used for any new studies.

13. Will it cost anything to participate in the RPGEH?

No, there are no costs to you for participation in the RPGEH.

14. Will I be paid to participate in the RPGEH?

No, you will not be paid for your participation in the RPGEH.

15. Will my information be kept confidential?

All research conducted by RPGEH is designed to maintain the privacy and confidentiality of participants' personal information. Consistent with federal standards for human subjects research conducted at hospitals and universities throughout the United States, research conducted at Kaiser Permanente is reviewed and approved by our organization's institutional review board to assure that it is designed to maintain the appropriate respect for individuals' safety, welfare, and rights as research participants.

No information from the RPGEH including information derived from testing of your DNA samples provided for research will be placed in your medical record or shared with the Kaiser Foundation Health Plan. We will also take the following steps to keep information about you confidential.

  1. All RPGEH information will be kept in a secured computer system that is only for research. The computer system is located in a locked and physically secure facility. RPGEH data will not be placed on a laptop computer or portable storage device that could leave this secure environment.
  2. The computer system has electronic security measures to prevent attacks and is protected by a firewall.
  3. Access to RPGEH information about participants is limited to Kaiser Permanente Division of Research staff who have signed agreements promising to safeguard participant data and use it only for approved scientific purposes.
  4. 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 other personal numbers such as your phone number, social security number, or medical record number. The link between your medical record number and the study ID number will be kept secure, with access restricted to a very small number of Kaiser Permanente Division of Research scientists and staff.
  5. Outside researchers may be given information about you, including genetic information. However, this information will be de-identified. This means that information such as your name, address, phone, date of birth, and any other information that could be used to identify you will not be included.

16. Does the RPGEH have other protections for my privacy?

To help us protect your privacy, the RPGEH has a Certificate of Confidentiality from the National Institutes of Health. Certificates of Confidentiality are granted under a federal law, Section 301(d) of the Public Health Service Act. Under the laws 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; however, the certificate permits child abuse reporting as authorized by law. 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 evaluation of federally funded projects or for information that must be disclosed in order 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.

17. Can my participation in the RPGEH affect my Kaiser Permanente membership, coverages, or premiums?

No. RPGEH 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 a member's health insurance coverage.

18. Does Kaiser Permanente participate in commercial research?

From time to time Kaiser Permanente participates in research projects with commercial companies. Kaiser Permanente does not sell or trade any genetic material or data gathered for the RPGEH for profit. However, research results may lead to the development of a medical or genetic test. They may also be used in research projects conducted with commercial companies. You will not receive any personal financial benefit from any kind of commercialization effort. Kaiser Permanente employees will not benefit financially from any commercialization efforts. Any royalties or similar financial benefits received by Kaiser Permanente will be used for research or other non-profit public benefit purposes of Kaiser Permanente.

19. If I participate in the RPGEH, will you contact me again?

At some time in the future, we may want to get in touch with you to ask if you would like to take part in other RPGEH studies. In these studies, we might ask you to fill out other surveys, complete an interview, or give new samples. If asked, you will be free to refuse to participate in these activities.

20. Why am I being asked to sign a new consent form?

For some of the early RPGEH participants, the consent form you reviewed and signed previously did not include information about the National Institutes of Health (NIH) research-only database. This information is included in the program's new consent forms. See answers to questions 5 and 6 for more information about this NIH database.

With your consent - and only with your consent - we would like to provide the NIH with some of your genetic and health information for this national research database. All the data we send to the NIH will be "de-identified," meaning that it will not include identifying information such as participants' names, addresses, phone numbers, social security numbers, or Kaiser Permanente medical record numbers.

The NIH and Kaiser Permanente want you to be fully informed about your options for participating in research and controlling how your data are used. If you received a revised consent form and letter from us, please review the material, and contact us if you have questions.

If you would like to give your permission to have your de-identified data sent to the NIH, please sign and date the new consent form and return it to us in the enclosed postage-paid envelope. If you do not wish to sign the revised consent form, you will remain a participant in the RPGEH, but your data will not be transferred to the NIH database. This means that your data will be used by scientists at Kaiser Permanente and other scientists they work with to study genetic and environmental effects on health and disease, as described in the consent form that you signed when you provided a saliva sample. However, your data will not be sent to the NIH.

21. 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.

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 if I have questions?

If you have any questions, you may call the RPGEH toll-free any time at 1-866-369-2157. A trained member of the staff will return your call.

24. I’m no longer a member of Kaiser Permanente. Can I still participate in the RPGEH?

Yes. Please call us toll-free at 1-866-369-2157 so we can confirm the details of a non-KP member blood draw with you.

If you have questions or complaints about how we treat you as a research participant, please contact the Institutional Review Board for the Protection of Human Subjects at the Kaiser Foundation Research Institute, 1800 Harrison Street, Oakland, CA 94612-3433. The toll-free telephone number is 1-866-241-0690.