Make sure the choice is yours, not the insurance company's

Kaiser Permanente, a major health insurer in Oregon, has sent letters to its participants informing them that they may "opt out" of Kaiser's plan to use tissue and genetic samples from its participants for research and database construction.

In part, here's what the letter says:

The State of Oregon has passed laws about anonymous and coded genetic research. These laws give you certain rights. You may decide if you want your health information or biological samples to be available for use in future anonymous and coded genetic research. You also have the right to tell us not to use this information or these samples in research. It's your choice.

To participate
If you make this choice, you don't have to do anything.
Your health information or biological samples may be used for anonymous or coded genetic research at any time without further notice.

To decline participation
If you do not want to participate, you must tell us. By declining, your health information and biological samples will not be available for use in anonymous or coded genetic research. If this is your decision, please fill out the enclosed form. Then, mail . . .

As a non-directive parent, I discussed benefits and risks with my children and their spouses, but did not tell them what to do. Frankly, I'm not sure what I would do in the same situation.

Here are some of the things we discussed:

  1. Kaiser could use the information against them and deny insurance. The letter responds by stating: "Your decision will not affect the care you receive from Kaiser Permanente. It will also not affect your health insurance coverage." This statement is consistent with Oregon law; the US non-discrimination law is still in Congress.
  2. In anonymous research there are no links (presumably) between you and your sample (or data from your sample), In coded research, personal information used to identify you is kept separate from health information and the biological sample. In coded research, a link could be made to you if conditions justified making that connection (perhaps if they wish to notify you that you have a gene for a fatal condition). Or, a computer could be stolen (as in the VA Administration case) and your information would then no longer be secure. According to information I received, Institutional Review Boards (who must give permission for human research) no longer allow Informed Consent statements to say things like "We guarantee your privacy." since guarantees are no longer possible.
  3. According to the form, you choose to opt out of both anonymous and coded research. You cannot opt out of one and allow the other. So you cannot allow anonymous research for the benefit of others without allowing coded research (where your personal information is available, but separate).
  4. The decision is made individually, by name, for each member of the insured family. In one daughter's case, this involves making the decision for their 3-yr-old daughter as well as themselves. If they choose to opt out the daughter, they will also have to decide, when the next child is born, what to do with that child's information and samples.
  5. The decision is not irreversible. You can change your mind later by notifying the address given. However, if you do not opt out before July 1, 2006, any work or information already used in research before you opt out will not be removed from the research database.

We discussed other items, I believe, but this gives you the general idea.

If you live in Oregon and are insured by Kaiser Permanente, you have a decision to make. If you've already discarded the letter, thinking it junk mail, and you wish to read it in full and consider opting out, contact them for a new copy. I've also posted copies of the three pages in our resources/articles section.

If you live in California, and are insured by Kaiser Permanente, be aware that your time is coming. The process is in the works and Kaiser has requested approval from the appropriate IRBs for similar action in your state. I haven't checked on other states.

Marie Godfrey, PhD

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