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Privacy and Confidentiality

Kaiser Permanente Northern California's Institutional Review Board

All research conducted by the Research Program on Genes, Environment, and Health is designed to ensure participants' privacy and confidentiality. As with all research conducted at hospitals and universities throughout the United States, research conducted at Kaiser Permanente is reviewed by our organization's institutional review board (IRB) to ensure that all research is conducted with the utmost respect for individuals' safety, welfare, and rights as research participants.

What is an institutional review board (IRB)?

An IRB is a formal committee that reviews research proposals within a health care organization or university. The role of the IRB is to assure protection of the rights, safety, privacy, and dignity of all human research subjects. The IRB has the authority to approve, disapprove, or require modifications of research taking place within its organization. Federal regulations require the Kaiser Permanente IRB to review and monitor all research that involves Kaiser Foundation Health Plan members and patients, their medical records, and biological specimens. The IRB reviews such materials to ensure that patients' rights are protected and also for appropriateness, clarity, and accuracy.

Who are the members of the IRB?

The Kaiser Permanente Northern California IRB consists of 15 members from various backgrounds, including physicians, lawyers, scientists, and other community members. Their experience positions them to provide appropriate scientific and ethical review of research projects. An IRB must have at least one scientist member and at least one member whose primary concerns are nonscientific. Additionally, there must be one member who is not otherwise affiliated with the institution (a community representative). The Kaiser Permanente Northern California IRB also strives for appropriate diversity in gender and racial and cultural backgrounds of its members.

Using health information from electronic health records

People who participate in the RPGEH by completing a survey and/or giving a saliva sample are asked to give their written permission for the Research Program to use information from their electronic health records for research projects that are part of the RPGEH. The information from electronic health records has been de-identified and every precaution is taken to maintain the confidentiality of the information. These precautions are described below. The RPGEH database will be regularly updated with de-identified information from electronic health records. This enables researchers to study many health conditions and study factors that affect the course of disease and response to medications.

How we protect member information

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.

  1. 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.

  2. The computer system has electronic security measures to prevent attacks on the databank. The databank is protected from unapproved entry by a computer "firewall."

  3. Access to the databank is limited to authorized Kaiser Permanente Research staff. All Research staff have signed agreements promising to safeguard participant data and use it only for approved purposes.

  4. 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 Research scientists and staff members.

  5. No identifiable participant information may be kept on a portable device that could be stolen, such as a laptop, a flash drive or a PDA (for example, a Blackberry).

  6. 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.

Additional protection of your confidentiality and privacy - Certificate of Confidentiality

To help us protect participants' privacy, we have received 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 participants, 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 demand for information that would identify participants, except that permitted under the law.

The certificate permits child abuse reporting as authorized by law. Also, 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. At the same time, a certificate of confidentiality does not prevent participants or a participant's family member from voluntarily releasing information about themselves or their involvement in this research.