Genetic Privacy Guide

The Genetic Privacy guide is integrated with the Genetizen – a blog authored by experts in the field of bioethics, genetics, and healthcare who comment on and analyze current developments in the field.

A key feature of this guide is its peer-review capability i.e., the ability for visitors to contribute and interact with the content. Comments are enabled at the bottom of every page. However, if you'd like to submit your own story click Your Stories on the menu bar.

Action Alert Tell the Senate to take action on GINA!

Action Alert
Tell the Senate to take action on GINA NOW!

The Genetic Information Nondiscrimination Act, or GINA, (S.358) is on the verge of passing after 12 long years! The House bill (H.R.493) passed 420-3 on April 25 and the Senate bill has been reported out of committee. We just need the full Senate to vote on the bill to get it to the President’s desk!

Tell your senators to push for GINA to come to the floor for a vote! A list of senators and their contact information is below. Please take a few minutes to tailor the sample letter below on your letterhead and fax it to the Senate (or call, or email them - Feel free to insert personal reasons for your support of the bill into the text.

There is power in numbers! Tell your friends, family, coworkers, and other members of your organization to take action now. We must make a big impact on this issue, and if every senator is contacted multiple times, we can make it happen! [Coalition for Genetic Fairness can also hand deliver a big pile of letters if you want to also fax us a copy: 202.966.8553]

Sample Letter

Dear Senator ____,

I support the Genetic Information Nondiscrimination Act, or GINA, (S.358). I am writing to ask for your support for this legislation to come to the floor and pass.

It is astounding that this bill, which the Senate has passed unanimously in the 108th and 109th Congresses, has not passed in the 110th yet. The House passed it 420-3 on April 25, 2007. This bill protects all Americans from the misuse of genetic information in employment and health insurance decisions. With these protections in place, Americans will be able to use genetics in medicine without fear of misuse of their genetic information.

More than 140 national patient groups, academic institutions, research centers, companies, women’s organizations, labor organizations, and the millions of Americans endorse this legislation. We represent every sector of society in this nation, and we urge passage of GINA.

Thank you for your time.


List of Senators

Senator Phone Fax
Daniel Akaka (D-HI) 202.224.6361 202.224.2126
Lamar Alexander (R-TN) 202.224.4944 202.228.3398
Wayne Allard (R-CO) 202.224.5941 202.224.6471
Max Baucus (D-MT) 202.224.2651 202.224.0515
Evan Bayh (D-IN) 202.224.5623 202.228.1377
Robert Bennett (R-UT) 202.224.5444 202.228.1168
Joseph Biden (D-DE) 202.224.5042 202.224.0139
Jeff Bingaman (D-NM) 202.224.5521 202.224.2852
Christopher Bond (R-MO) 202.224.5721 202.224.8149
Barbara Boxer (D-CA) 202.224.3553 202.956.6701
Sherrod Brown (D-OH) 202.224.2315 202.228.6321
Sam Brownback (R-KS) 202.224.6521 202.228.1265
Jim Bunning (R-KY) 202.224.4343 202.228.1373
Richard Burr (R-NC) 202.224.3154 202.228.2981
Robert Byrd (D-WV) 202.224.3954 202.228.0002
Maria Cantwell (D-WA) 202.224.3441 202.228.0514
Benjamin Cardin (D-MD) 202.224.4524 202.224.1651
Thomas Carper (D-DE) 202.224.2441 202.228.2190
Robert Casey (D-PA) 202.224.6324 202.228.0604
Saxby Chambliss (R-GA) 202.224.3521 202.224.0103
Hillary Rodham Clinton (D-NY) 202.224.4451 202.228.0282
Tom Coburn (R-OK) 202.224.5754 202.224.6008
Thad Cochran (R-MS) 202.224.5054 202.224.9450
Norm Coleman (R-MN) 202.224.5641 202.224.1152
Susan Collins (R-ME) 202.224.2523 202.224.2693
Kent Conrad (D-ND) 202.224.2043 202.224.7776
Bob Corker (R-TN) 202.224.3344 202.228.0566
John Cornyn (R-TX) 202.224.2934 202.228.2856
Larry Craig (R-ID) 202.224.2752 202.228.1067
Mike Crapo (R-ID) 202.224.6142 202.228.1375
Jim DeMint (R-SC) 202.224.6121 202.228.5143
Christopher Dodd (D-CT) 202.224.2823 202.224.1083
Elizabeth Dole (R-NC) 202.224.6342 202.224.1100
Pete Domenici (R-NM) 202.224.6621 202.228.3261
Byron Dorgan (D-ND) 202.224.2551 202.224.1193
Richard Durbin (D-IL) 202.224.2152 202.228.0400
John Ensign (R-NV) 202.224.6244 202.228.2193
Michael Enzi (R-WY) 202.224.3424 202.228.0359
Russ Feingold (D-WI) 202.224.5323 202.224.2725
Dianne Feinstein (D-CA) 202.224.3841 202.228.3954
Lindsey Graham (R-SC) 202.224.5972 202.224.3808
Charles Grassley (R-IA) 202.224.3744 202.224.6020
Judd Gregg (R-NH) 202.224.3324 202.224.4952
Chuck Hagel (R-NE) 202.224.4224 202.224.5213
Tom Harkin (D-IA) 202.224.3254 202.224.9369
Orrin Hatch (R-UT) 202.224.5251 202.224.6331
Kay Bailey Hutchison (R-TX) 202.224.5922 202.224.0776
James Inhofe (R-OK) 202.224.4721 202.228.0380
Daniel Inouye (D-HI) 202.224.3934 202.224.6747
Johnny Isakson (R-GA) 202.224.3643 202.228.0724
Tim Johnson (D-SD) 202.224.5842 202.228.5765
Edward Kennedy (D-MA) 202.224.4543 202.224.2417
John Kerry (D-MA) 202.224.2742 202.224.8525
Amy Klobuchar (D-MN) 202.224.3244 202.228.2186
Herbert Kohl (D-WI) 202.224.5653 202.224.9787
Jon Kyl (R-AZ) 202.224.4521 202.224.2207
Mary Landrieu (D-LA) 202.224.5824 202.224.9735
Frank Lautenberg (D-NJ) 202.224.3224 202.228.4054
Patrick Leahy (D-VT) 202.224.4242 202.224.3479
Carl Levin (D-MI) 202.224.6221 202.224.1388
Joseph Lieberman (D-CT) 202.224.4041 202.224.9750
Blanche Lincoln (D-AR) 202.224.4843 202.228.1371
Trent Lott (R-MS) 202.224.6253 202.224.2262
Richard Lugar (R-IN) 202.224.4814 202.228.0360
Mel Martinez (R-FL) 202.224.3041 202.228.5171
John McCain (R-AZ) 202.224.2235 202.228.2862
Claire McCaskill (D-MO) 202.224.6154 202.228.6326
Mitch McConnell (R-KY) 202.224.2541 202.224.2499
Robert Menendez (D-NJ) 202.224.4744 202.228.2197
Barbara Mikulski (D-MD) 202.224.4654 202.224.8858
Lisa Murkowski (R-AK) 202.224.6665 202.224.5301
Patty Murray (D-WA) 202.224.2621 202.224.0238
Ben Nelson (D-NE) 202.224.6551 202.228.0012
Bill Nelson (D-FL) 202.224.5274 202.228.2183
Barack Obama (D-IL) 202.224.2854 202.228.5417
Mark Pryor (D-AR) 202.224.2353 202.228.0908
Jack Reed (D-RI) 202.224.4642 202.224.4680
Harry Reid (D-NV) 202.224.3542 202.224.7327
Pat Roberts (R-KS) 202.224.4774 202.224.3514
John Rockefeller (D-WV) 202.224.6472 202.224.7665
Ken Salazar (D-CO) 202.224.5852 202.228.5036
Bernard Sanders (I-VT) 202.224.5141 202.228.0776
Charles Schumer (D-NY) 202.224.6542 202.228.3027
Jeff Sessions (R-AL) 202.224.4124 202.224.3149
Richard Shelby (R-AL) 202.224.5744 202.224.3416
Gordon Smith (R-OR) 202.224.3753 202.228.3997
Olympia Snowe (R-ME) 202.224.5344 202.224.1946
Arlen Specter (R-PA) 202.224.4254 202.228.1229
Debbie Stabenow (D-MI) 202.224.4822 202.228.0325
Ted Stevens (R-AK) 202.224.3004 202.224.2354
John Sununu (R-NH) 202.224.2841 202.228.4131
Jon Tester (D-MT) 202.224.2644 202.224.8594
Craig Thomas (R-WY) 202.224.6441 202.224.1724
John Thune (R-SD) 202.224.2321 202.228.5429
David Vitter (R-LA) 202.224.4623 202.228.5061
George Voinovich (R-OH) 202.224.3353 202.228.1382
John Warner (R-VA) 202.224.2023 202.224.6295
Jim Webb (D-VA) 202.224.4024 202.228.6363
Sheldon Whitehouse (D-RI) 202.224.2921 202.228.6362
Ron Wyden (D-OR) 202.224.5244 202.228.2717

Arguments against the genetic nondiscrimination bills

A new bill recently introduced in the U.S. House of Representatives would prohibit employers from making hiring/firing and promotional decisions based on genetic information showing a worker may contract a disease in the future, and would also prevent health plans from denying coverage or charging higher premiums using those same genetic tea leaves. (United Press International in today's online newspaper)

The article, in addition to providing reasons for the bill, supplies a good summary of the reasons some legislators are against the bill known as GINA (Genetic Information Nondiscrimination Act). Here are some of the statements in Laura Gilchrist's article, Analysis: Genes and job discrimination.

Some may think the bill is not strong enough:

The proposed legislation, co-sponsored by Reps. Louise Slaughter, D-N.Y., and Judy Biggert, R-Ill., would be limited to cases where an employer intentionally seeks out genetic information about a worker and misuses that information. The bill even carves out a so-called "water-cooler" exception to protect employers from liability under the law if they come across the sensitive data inadvertently.

The bill also requires that a worker first take his case to the Equal Employment Opportunity Commission before going to court, and damages caps are built into the law; for example, companies with fewer than 100 workers would pay no more than $50,000 in damages, while firms with more than 500 workers would have a damages limit of $300,000.

Others are concerned that the bill "recommends" genetic testing, while prohibiting discrimination based on test results.

"There is a clash between people who want to save money and those who say (a genetic-information non-discrimination law) will cause frivolous lawsuits," Biggert said.

Other policy experts said the bill should still allow companies to collect such data if they can show the genetic information is relevant to a specific job or to worker safety, and that the bill should make clear that it is not a ticket for workers to sue their employers for failing to provide coverage for certain medical conditions.

Speaking in opposition to the bill,

Mohit Gose, spokesman for the trade group America's Health Insurance Plans, told United Press International that his group generally supports the new legislation's goal of prohibiting genetic information-based discrimination in coverage and premium policies, but said insurers should still be able to use the information for "improving the quality of healthcare being provided."

"We continue to work with the House and the Senate to ensure that (its passage) has no inadvertent consequences that could impede (health) quality improvement activities," he said.

Others argue that genetic testing is so new that discrimination isn't occurring yet and we're wasting time passing unneeded legislation.

"Trying to stay ahead of the curve through legislation is a recipe for unintended consequences," Jack Calfee, resident scholar with the free market-oriented think tank American Enterprise Institute, told UPI. "These bans have a way of expanding through legislation and regulatory proceedings and become much broader than contemplated when they were written," he said. "Let's see if it's a problem for employers and employees before we legislate."

Committee Ranking Member Rep. John Kline, R-Minn., also noted the apparent lack of evidence as yet that genetic data are being misused by companies and insurers. "We don't necessarily need a broad, federal mandate," he said. "If legislation is needed -- and the jury is still out -- we should target the solution to the problem, rather than going after a mosquito with a machine gun."

While there have been few discrimination cases stemming from the testing so far, employees of Burlington Northern Railroad did bring a successful case against their former company.

Geneforum's policy is to address issues in their early stages, before great damage has occurred. People in a number of surveys have indicated that they value their genetic privacy. I think this value, and the right to work and to have health insurance regardless regardless of genetic "predisposition", should be addressed while genetic testing is still in its infancy.

Marie Godfrey, PhD



Could you face genetic discrimination?

Tomorrow (January 30), at 10:30 am EST, the House Subcommittee on Health, Employment, Labor, and Pensions will hold a hearing on The Genetic Information and Nondiscrimination Act (GINA). If your Representative is not yet a sponsor of the bill--as mine is not--you may want to join me and encourage that person to sign on.

The list of sponsors can be found at This particular bill is even supported by President Bush. Details are available at

You can call (best option) or send an e-mail to your Representative. The time it takes is well worth it. Here are some details of interest--taken directly from the information provided by the Coalition for Genetic Fairness:

Why We Need GINA

1) We are all affected.

  • Each of us carries a handful of genetic anomalies. Some of those might cause us to be affected by genetic conditions. Some of those will not affect our health, but may affect the health of our children.
  • Currently, 1200 genetic tests exist which can diagnose thousands of health conditions. This number has grown from just 100 genetic tests 10 years ago. With more genetic tests in the pipeline, increased genetic information will become accessible through testing.
  • Genetic information is invaluable. It provides a key to our makeup that we can use to proactively manage our health. However, this same information may also be misused and put us at risk for genetic discrimination. Cases of genetic discrimination have already been documented in the United States, and without laws to address the issue adequately, such cases will likely continue.
  • We need legal protection so that all Americans are free to put their health concerns first without fear of discrimination.

2) Current laws do not adequately protect us from genetic discrimination.

  • The current patchwork of state laws leaves individuals vulnerable. A few states have strict protections against genetic discrimination, but most states have little to no protection. This leaves individuals with little knowledge about how much their genetic information is protected from state to state. In addition, companies who deal in any kind of health information are left with no national framework to guide how they handle genetic test results and genetic information privacy.
  • Genetic information is not properly covered under HIPAA privacy guidelines. Current HIPAA guidelines do not prohibit insurers from requiring genetic testing or from denying coverage based on genetic information. Genetic information is becoming increasingly more ingrained in medicine, and as such, will serve to complicate privacy law if steps are not taken now to close gaps in policy.

3) We all lose under current guidelines.

  • Fear of misuse of genetic information is preventing people from getting genetic tests done. Refusal to utilize effective genetic tests hurts individuals, researchers, doctors, and companies. Individuals’ lack of testing denies them important medical information that they could otherwise use to proactively manage their health. The information garnered by genetic tests also helps doctors to prescribe treatments and lifestyle changes with increased success. The same information can be used by researchers to effectively create targeted drugs and develop treatments. In addition, companies developing these important tests cannot recoup research costs, and therefore, are unable to invest in further development.
  • Fear of discrimination is also causing a large number of people to opt out of clinical trials. Fewer participants in clinical trials leads to slower development of treatments and beneficial drugs. With the exponential increase in genetic tests being developed, lack of participation in trials will most likely prove to be a severe limiting factor. In addition, clinical trials provide patients in late stages of disease with access to breakthrough treatments that would normally be unavailable.

4) We can all benefit from protections offered in the Genetic Information Nondiscrimination Act.

The Genetic Information Nondiscrimination Act protects all Americans by:
  • Prohibiting insurers in both the group and individual health insurance market from 1) “requesting or requiring” genetic testing of an individual or his family or 2) using genetic information to determine eligibility or establish premiums.
  • Prohibiting employers, including employment agencies and labor organizations, from 1) “requesting or requiring” genetic testing of an individual or his family or 2) using genetic information to make hiring or promotional decisions, or when determining eligibility for training programs.
Americans support the Genetic Information Nondiscrimination Act. An overwhelming majority of Americans (85%) believe that if someone has a genetic test, their employer should not have the right to know the results. Republicans, Democrats, and individuals from all racial and ethnic groups, religions, and income and education levels share this opinion. [Survey conducted in 2002 by the Genetics and Public Policy Center, Johns Hopkins University.]

Marie Godfrey, PhD

Faces of Genetic Discrimination

See the attached article (28 pages long) for stories on people who have faced genetic discrimination.

Marie Godfrey, PhD

Genetic discrimination bill active again

The following comes from a bulletin I received a few minutes ago from the Genetic Alliance. If you are concerned about the potential effects of genetic testing--whether for privacy or insurance coverage--you will want to check this out and make your opinion known.

Genetic Information Nondiscrimination Act Introduced in House!

The Genetic Information Nondiscrimination Act (GINA) was introduced in the House of Representatives as H.R. 493 on January 16. Over 140 original cosponsors joined sponsors Rep. Slaughter (NY-28), Rep. Biggert (IL-13), Rep. Eshoo (CA-14), and Rep. Walden (OR-2) in supporting GINA's introduction. House and Senate bill sponsors will build stronger support in their chambers with your grassroots help. Genetic Alliance is collecting letters of support from our community and to present GINA's House and Senate sponsors. You can simply customize a template letter and send it to us to deliver with all of the other letters. Please join us in this effort and take a few minutes to make your voice heard!

Click here to learn more about the GINA letter drive

Click here to help build cosponsors for GINA

Click here to learn more about GINA

Join the Genetic Alliance push if you are in favor of the bill, or write a letter of your own. Equally important: if you have doubts, questions, reservations about the substance of the bill (you'll have to read it of course), say or do something. We at geneforum bring you information like this so that you can voice YOUR opinions. If you want more information on genetic discrimination, ask a question here, or consult other Genetizen blogs about the subject.

Marie Godfrey, PhD


GINA passes in the House

Today, the Genetic Information Nondiscrimination Act (H.R.493) passed the House of Representatives. Representative Slaughter (D-NY) and Representative Biggert (R-IL), GINA’s lead sponsors, spoke to the need for protections against genetic discrimination and thanked the House chairs of the committees of jurisdiction for their work to move the bill. Members of the House from both sides of the aisle stood in support of GINA and called for a favorable vote on the legislation. The bill was passed with a 420-3 vote under the suspension of the rules.

Thanks for all your help.

Marie Godfrey, PhD

Senate committee to review genetic nondiscrimination

Tomorrow (January 31) at 10 am EST, the Senate committee on Health, Education, Labor, and Pensions will "mark-up" the Senate version of the genetic nondiscrimination bill discussed today by a House committee. Word from the rumor mill is that the meeting will be open to the public. I don't know whether it will be broadcast on t.v.

You can check out the text of each of the bills by going to and searching for H. R. 493 for the House and S. 358 for the Senate.

I wrote to my Utah Representative, Rob Bishop, about the bill in the House and he called me tonight with some questions. I hope my answers were helpful to him.

Marie Godfrey, PhD

Ways to protect people from discrimination based on genetic information

Michael Hill, in a recently released story in the Baltimore Sun, provides a series of questions and answers about genetic discrimination. The answers come from Karen Rothenberg, dean of the University of Maryland's School of Law and founding director of the school's Law and Health Care program. Last week, she testified in Washington before a House subcommittee considering a bill designed to protect workers from discrimination by employers and insurers on the basis of genetic information.

Here are some of the questions and her answers:

If potential discrimination has been an issue for such a long time, why is it just getting written into a federal law?

Early on, I was part of a series of working groups that put together a framework for a legislative approach to the issue because I had researched early state legislative approaches. When it appeared that we were not going to get it through initially on the federal level, we adopted a two-stage approach -- state-by-state efforts and continuing work on the federal level -- going back as early as 1995. Maryland is one of a number of states that took action on this, though it is impossible for any single state to cover all the issues.
In Washington, on and off, we have made some progress. We would get something watered down through the Senate and not through the House. It looks possible that this year something could happen.

As a matter of social policy, this issue is extremely important. What we are saying is that we should not allow discrimination because somebody gets genetic information that tells them that something in their genetic code says they have a predisposition to heart disease or cancer or whatever.

I think what we as a society have to say is, "Look, we all have a number of mutations in our genetic makeup that predispose us to diseases or conditions."

The people and the genetic predictors that get singled out are the ones that researchers happen to have looked at. . . We should not discriminate against somebody because we have identified some predictor in their genetic code. That is important in every state, and it is important nationwide.

Why would people want to get genetic information about themselves if they are worried about discrimination? Doesn't testing usually just tell you something you can't do anything about?

Remember, there is a wide range of genetic information. Some can paralyze you and there is nothing you can do about it. But others can mean you can make a change in your lifestyle or medical choices.
Let's say a disease, colon cancer, has already been diagnosed, then, for example, a genetic test might say something about what sort of treatment you should get, what kind of drugs, whether it should be chemotherapy or radiation or radical surgery. At that point, you may make a risk/benefit analysis, weighing privacy and discrimination concerns against medical decisions.

What you have to remember is that most people who get colon cancer do not have a genetic explanation, at least at this point. Then there are people in the same family, and one gets it and the other doesn't. They grew up in same environment, ate the same food, breathed the same air and for some reason one gets sick and the other doesn't. They may or may not have the genetic predisposition. Even if someone does have that predisposition, it interacts with the environment in a way that we do not understand. So it really makes no sense to use these genetic markers for employment or insurance or any other reason like that. Even if we knew for sure, this is a civil rights issue. People should not fear discrimination based on their genetic code.

Then there is the impact on the future of genetic research. People should not be afraid to participate in big clinical trials that can advance our knowledge of dealing with diseases, afraid that the information the researchers find out about them can be used against them. Some people will want their individual results if available, some will not. Again it is a risk/benefit analysis, deciding if the results are of value to them. But what will they do the next time they are filling out a form that asks about medical tests? Does this include genetic information? When you don't get the results, you don't have any of those issues.

My bottom line is that if we as a society choose to invest in this research, it should not be to penalize or hurt people; it should be to empower them.

In the end, can we pass laws to address all of these problems? Is it really possible to legislate such discrimination out of existence?

You can never guarantee legislation will eliminate hate or fear, but we can try. This is particularly important post-9/11 when the government is looking into so many aspects of people's private lives. What I worry about is that your genetic code, as opposed to your race or your gender, is invisible. If you make a claim of discrimination based on race or gender, you are not revealing any secrets. But that might be the case for a healthy person who is claiming discrimination because of some genetic predisposition. So they risk their loss of privacy and, unless they are protected, they have no discrimination claim.
It is one thing, as we have done in many states, to tell insurance companies that they cannot discriminate, cannot refuse to issue policies, based on genetic information. But the fact is that in our society, most insurance comes through employers. So if an employer denies you a job because of what that company knows about your DNA, it is in effect denying you insurance.

And remember, many of these employers are self-insured so they are essentially directly denying you the insurance they underwrite.

One thing you have to realize is that there are ways for employers to get such information that legislation will never deal with. An interviewer doesn't have to ask if you have a lot of breast cancer in your family. Say I call a reference you give me and that reference says, "She's a fantastic worker, such a hard worker that she never missed a beat even over the last few years when three or four members of her family got breast cancer."

There is not going to be anything illegal about that. But try proving discrimination if you don't get the job. It will be difficult.

I don't think any legislation can do all that. But legislation can send a strong message about social policy. People should be respected for who they are, not denigrated because of some difference in their genetic makeup.

The full article is available at


Marie Godfrey, PhD

Everyone wants your DNA--whose is it anyway?

In contrast to Kaiser Permanente's recent acknowledgement that they are planning to use tissues, including DNA, from their patients for unspecified resarch unless individuals opt-out by submitting a letter to them, the Ministry of Health in New Zealand announced today that residents of that country are being asked to comment on proposed guidelines for such unspecified research. In an article, the ministry's chief clinical adviser, Sandy Dawson, stated:

New Zealand already has clear guidelines on the ethical collection, use and disposal of tissues for research which is specified at the time that consent is given. These proposed guidelines provide additional guidance for ethics committees and researchers to cover situations where tissues can be stored and used for to find answers to research questions that arise in future.

According to the article, "human tissue is defined as any material that is, or includes, human cells. It includes all or any part of a body, a foetus or the body of a still-born child, human stem cells, other human cells and blood."

New Zealand research groups are among those who want to bank human tissue for future, unspecified research. Kaiser Permanente, deCODE genetics (Iceland), biobank of the UK, and many other groups are already building or working with their "biobanks". Several days ago you had an invitation to give comment on a US genetic advisory committee proposal for a biobank--at the same time NIH has already begun initial work on such a project. Hmmm, should we wonder whether the branches of our government are not talking to each other?

What's happening? Are the decisions being made for us? Do we have any say in the matter?

Becoming informed--even realizing that these things are happening around us--is a good first step. Reading and commenting on notices for public input are other ways. If you want to read what New Zealand proposes, go to and download a copy of the proposed guidelines.

For the US proposals (for what they're worth), check out the blog entry YOUR comments needed on whether NIH should start a population study on Genes, Environment, and Disease.

Marie Godfrey, PhD

Geneforum Interview with George Annas: Genetic Turf Wars: Whose DNA is it anyway?

An Interview with George J. Annas
Professor & Chair of the Health Law Department
Boston University School of Public Health

by Mark Compton, November 2000

Over the past decade, George Annas has come to be considered one of the nation's foremost experts on genetic privacy. That's largely because in 1995 he was the principal author of a model designed to serve as the basis for federal gene privacy legislation. Although Congress has since remained divided over the issue, the Annas model has been adopted - to greater or lesser degrees - by a number of states that have passed genetic privacy acts of their own.

George J. AnnasThe first state to take action was Oregon. But now Oregon's Genetic Privacy Act is being reviewed, largely at the urging of biotechnology industry leaders who believe the law inhibits their ability to collect the massive amounts of data required for disease association studies. Of particular interest to industry lobbyists is a clause in the statute which establishes that each individual owns his or her own DNA and thus is entitled to exercise autonomy over its use. Researchers would like to strike that clause. Annas wonders at their motivations.

[Mark Compton]: At present, Oregon's Genetic Privacy Act explicitly defines a DNA sample as being the property of the person from whom the sample was harvested. But various researchers, pharmaceutical companies and biotechnology organizations have objected to this provision, arguing that it unduly interferes with their ability to collect disease association data. Having heard these complaints, the Oregon legislature is currently considering removal of the property clause, substituting in its place some as-yet-unspecified legal remedies. If the legislators decide individuals should not be permitted to assert property rights over their own DNA samples, what implications would you expect?

[George J. Annas]: That property notion was developed on the basis of the common-sense notion that no one should have greater authority over your own body and DNA than you. The other underlying premise is that the simplest way to protect that autonomy is to say simply that you own your DNA and if anybody else wants to use it, they can only do so with your authorization. The idea that anyone else can own your DNA - like the biotech companies or the researchers - while you can't strikes me as nonsense. It can't possibly be that everyone else in the world can own my DNA, but I can't. So when researchers at biotech companies complain about the property notion potentially interfering with what they're doing, what they're really balking at is having to go to the trouble of getting explicit authorization from individuals before using their DNA for commercial or research purposes. But that's something they should be doing anyway. So basically what they're arguing is that they should be allowed to take DNA without consent. And I just don't find that persuasive and I hope that ultimately the Oregon legislature doesn't either.

Should researchers get out of line somehow, would you think they'd have less to fear if the only recourse was state-imposed "legal remedies" as opposed to the current property clause?

Well, without knowing what the legal remedies are, it's hard to say. But again, I think it's likely that someone who can assert ownership, especially in the US, will have a stronger claim than someone who cannot assert ownership to an asset that's been misused or exploited for commercial gain.

Since Oregon's Genetic Privacy Act currently includes no enforcement provisions, might it be argued that the substitution of legal remedies for property rights actually puts some teeth into the statute?

It's possible. But again, that depends on what the remedies are. Ultimately, what you want to protect is genetic privacy - to protect individuals from having their DNA taken without their consent and then used without their authorization. So if we can achieve that end through criminal penalties, that would be fine.

Of course, generally in such cases, industry can be expected to have a hand in helping the legislators define appropriate remedies.

I certainly would not be surprised at that - in which case, I think it's unlikely criminal penalties will be seriously considered.

To get closer to some of the implications, there's a topical issue I'd like to explore. Just recently, a California startup called DNA Sciences mounted a splashy, nationwide public relations campaign announcing its goal to seek out as many as 100,000 DNA donors for a so-called Gene Trust. Billing its effort as a search for knowledge with the potential to change medicine forever, DNA Sciences is directing its appeal entirely to altruism, promising no compensation apart from free diagnostic tests for contributors (assuming, of course, that any such tests are ever developed). To your way of thinking, does this sort of appeal rise to the level of informed consent?

It certainly does not rise to the level of informed consent and I would be surprised, actually, if very many people end up taking them up on this offer based on their vague promise to protect privacy even as they go about collecting personal information about each donor. This is the very type of thing that demonstrates the need for state and federal legislation to protect individuals. Because there is no enforcement whatsoever behind these promises. People are being asked to act strictly on faith. And what do we actually know about this "Gene Trust"? Who's the trustee? For whose benefit is this being done? And if DNA Sciences chooses not to live up to their promises, what can be done about it? The answer is: nothing.

Also, although DNA Sciences and other groups like it routinely promise to preserve donor anonymity, is that even possible in an Internet-powered culture where we're repeatedly reminded that information wants to be free?

I don't think the assurances are worth much so long as it's possible to link the DNA sample with identifiable information about the donor. But generally when people talk about anonymous use of DNA, what they really mean is that it's going to be coded. And my argument is that the person who has that code can break that code. So that's not good enough. I think if you're going to use anonymous DNA, you have to have DNA that's not linkable, which is to say there's no possibility of somebody going back through the records later to find that individual.

But of course, from the researchers' perspective, maintaining that all-important context is vital if they're trying to develop disease association data.

Well, some have certainly made that argument. And, in some studies, identifiable DNA is undeniably important. But if that's the case, they should just go ahead and get the individual's authorization before moving forward. And that's not really all that hard to do.

So long as the authorization rises to the level of informed consent.

Exactly right. If the researchers decide to do a new project, they should be required to go back and get additional consent. But again, that shouldn't be hard because the only reason for keeping an identifier in the first place is to allow them to go back to the donor. So the argument that it's impossible to go back or cumbersome to do so is not particularly compelling - especially when they're arguing at the same time that they need to keep the identifier so they can go back and learn more whenever they feel the need to do so.

So let's say a donor's privacy actually is broached. What potential implications might that individual face?

It depends on what's in their DNA. Suppose there's an indication that they're at higher risk for a form of cancer or for early Alzheimers disease. If their employer finds out about that, they might not get promoted or they may even lose their job. If a life insurer finds out, they may not be able to get life insurance. Or they may only be able to obtain health insurance policies at prohibitively high rates. More important to me, the subjects themselves may end up finding out something about themselves they really don't want to know. For example, we haven't found the early Alzheimers gene yet, but assuming we do, researchers might find that a person is at a higher risk for getting early Alzheimers, and learning this may discourage that person from getting advanced training or going to medical school or doing any number of other things they might otherwise do - thinking they're not going to live all that long anyway. Or their spouse might start to think differently of them. Or their children might think differently of them.

So there's an element of self-fulfilling prophecy here?

No question about it. We know how much people agonize already over their health and get screened all the time for various forms of cancer, high blood pressure, cholesterol … you name it. You can magnify that 100 times with genes because we think of them as being that much more predictive. They're not really as deterministic as all that, but we tend to treat them almost as if they were magic. And in this case, perception is reality since there's a distinct possibility we would discriminate against ourselves should we suddenly learn we're at extremely high risk for various lethal disorders.

And might not the anxiety thus engendered be sufficient in and of itself to induce various adverse health effects?

That's very possible as well and there are many respected professionals who believe that's the case. Certainly, before we get into using DNA for clinical diagnostics, we need to have at least a couple hundred thousand genetic counselors who are able to talk to people intelligently about what genetics means. Because, at this point, it's certainly clear that very few people understand anything at all about the field - including physicians.

And apart from that education, is there some special informed consent that should accompany those kinds of diagnostics?

Absolutely. And we're just in the infancy of trying to figure out how to get informed consent prior to applying a wide panel of genetic tests, for example. It's one thing to get informed consent prior to a very narrow test, say, for the cystic fibrosis gene or even the breast cancer gene, but it's quite another thing to get informed consent prior to administering a battery of 1000 tests. And there are DNA chips being developed even now that will be capable of doing just that. In the future, it's conceivable that 10,000 - or even 100,000 - genetic tests could be run at the same time. I personally don't think it's possible to give informed consent to any and all DNA-based tests a researcher might ever choose to run. That would require something more like a waiver of consent, saying you really don't care what the researchers do. But I think that with genetic tests, which are potentially so life-changing, you'd be well advised to be quite specific with your consents.

Because once the veil of privacy has been pierced, is there really anything that can be done to make a person whole?

I think not, which is one reason why I've suggested that parents should not be allowed to test their children for diseases that aren't going to manifest until adulthood unless there's some way the disease can be prevented or mitigated during childhood. Otherwise, you take away the child's right not to know about their genetic predispositions. It's very important that decisions about testing be left for the individual to make once they're able to grasp all the implications.

And if the privacy of family members of a DNA donor should be compromised, what sort of recourse would currently be available to them? Perhaps more tellingly, what sort of recourse should be available to them, given the assumption that they provided no consent whatsoever - either informed or otherwise - to have their genetic material examined?

Right. It would be difficult under current law for them to show that they've been harmed. Usually, in malpractice law, we talk about specific harms - for example, a physical harm, medical bills or loss of earnings. So unless you can demonstrate that you were fired because somebody else in your family notified your employer of a genetic concern, it would be very difficult to get any satisfaction whatsoever under current law. The physician could always say he passed word to other family members about the genetic predisposition because he thought they might be in danger. And that's exactly why I think we need specific legislation that says doctors can never tell relatives about what they've found - only you can. And that, in turn, would protect doctors from malpractice actions for keeping those secrets. Because if we had a federal privacy law, everybody would know exactly what the rules were and would be able to act accordingly.

As for protecting individuals from unwanted information divulged by family members, I don't suppose we can really write legislation for that.

No, I don't think we can. That's part of being in a family. We often disclose and know a lot more about our family members than we may really want to know. But that's all part of the deal. Still, that can present problems. Take the example of twins who are both at risk for Huntington's Disease. If they're identical twins, that means either they both have the Huntington's gene or neither one of them has it. So if one wants to get tested and the other one doesn't, who should win in that case? Historically, the policy has been that a geneticist shouldn't test one unless both want to know. Personally, I think that's wrong. I think the right to know probably should trump the right not to know. So, in that case, the other one who doesn't want to know is probably going to have to move and not come in contact with their sibling. But I think the people who want to be tested should have a right to that information.

Another property consideration we haven't touched on yet has to do with the matter of compensation. Some believe DNA donors should be compensated in some way if lucrative discoveries are made on the basis of their DNA material. But without provisions that recognize a property right to one's own genetic material, are claims of that sort likely to gain any traction?

It's hard to see on what basis people could be compensated if the law doesn't believe they own the DNA in the first place. I guess if the researchers had some sort of agreement with the donors from the outset, then there might be a basis. But those kinds of agreements are all very problematic. It's unlikely in any event that any one individual's DNA is going to be all that valuable. Most studies are going to involve DNA from tens of thousands of people. But in the rare case where one person's DNA turns out to be valuable - like the John Moore case - yes, I think those individuals should be compensated.

John Moore?

Yes. There's a celebrated California case in which a man named John Moore had been diagnosed as having hairy cell leukemia. His spleen was subsequently removed, but the doctors didn't tell him they were going to give the spleen to a biotech company, which in turn used the tissue to develop an immortal cell line that could be used for therapeutic purposes. The patent for that cell line turned out to be worth a lot of money. And when John Moore finally found out what had happened a couple of years later, he sued to try and get some of the proceeds. Ultimately, the California Supreme Court held that the biotech company owned the patent, along with Mr. Moore's cell line, which led to the conclusion that he had no rights to it himself. That meant the only person he could sue was his physician for not explaining that his spleen might be used commercially. And today biotech companies continue to rely very heavily on that case [John Moore v. The Regents of the University of California]. That's exactly the sort of arrangement they want, because that case essentially says everybody can own your DNA except for you.

Also, above and beyond property protections, doesn't it make sense to have precautions in place that preclude employers and insurance providers from essentially implementing red-lining policies?

Yes, absolutely. That's what I call a fifth-line issue. The first issue for legislation is to prevent people from taking any tissues or samples or blood from you for the purpose of doing DNA analysis without your consent. The second level is to prohibit people from performing DNA tests using tissue or blood samples they already have without first obtaining informed consent. The third level is to prevent people from storing your DNA samples without your consent. The fourth level is to prevent people who have obtained results from disclosing them to third parties, such as employers, without your authorization. And the fifth level - the anti-discrimination level - prevents people who get information about you from using it against you. So you're exactly right. You need both privacy legislation and anti-discrimination legislation.

On the whole, does it seem to you that we're plunging headlong into the collection and analysis of personal DNA samples without having paid adequate attention to the rules, ethics and social norms that come into play?

I think the answer to that is "yes". It's all happening very quickly now. Just in the last year there've been dozens of little biotech companies that have started to go around collecting all the DNA samples they can get their hands on. And I've talked to a lot of representatives from these companies and they all say, "Gee, we don't know what the rules are. We're trying to kind of make them up as we go along." And there's some truth to that, although there has been work on these rules. There are published guidelines and things people can look at. But as a general matter, there's certainly no national standards, no federal legislation. Even our institutional review board's guidelines don't deal very well with stored tissue samples.

So from the biotech industry's perspective, it's better to ask forgiveness than permission?

That's where we are right now.

And who should be party to shaping public policy? Should that be left to government-commissioned panels of worthies or should these be matters that are thrown open to general dialogue?

I think they should be open to general dialogue. After all, what we're doing is asking average citizens to contribute their DNA or get involved in efforts to help biotech companies find something that may cure diseases. Ultimately, if any of this pans out, we're going to get more diagnostic tests and hopefully some effective treatments - all of which are going to be used by the public, so it makes no sense not to have the public involved in setting policies right from the start.

And there's also the possibility of backlash, isn't there, if the public is kept out of the discussion? Witness the current brouhaha over genetically modified foods.

Very true. There are people who are very worried that even the word "gene" is going to become like the word "nuclear". I don't want that. And certainly the example of genetically modified food is shaking up a lot of people in the biotech industry.

As a practical matter, what can be done to facilitate public dialogue? Eric Lander, Director of the Whitehead MIT Center for Genome Research, has been quoted as saying the public is "deeply, deeply uneducated" about the issues pertaining to biotechnology. If that's true, is there a way the public can ever be drawn into meaningful dialogue?

I think it's difficult, but the real question is: Do you try? I think most of the industry is looking for excuses not to even try. But the idea that these concepts can't be explained to the public strikes me as nonsense. It may be that researchers don't want to get informed consent because they don't think they can come up with palatable explanations for the research they're doing. But, believe me, once they're been required to obtain informed consent, they'll figure out how to do it somehow.

Editorial Note: Geneforum has come to understand that at the time of this interview with George Annas, DNA Sciences, Inc. had already adopted and implemented an independent IRB-approved consent process, applicable to all participants in the company's "Gene Trust" research project. According to DNA Sciences, their privacy policy and terms and conditions constitute legally binding contracts enforceable in a court of law.

About the Interviewer

Mark Compton monitors trends in information technology and biotechnology from a comfortable perch midway between the Silicon Valley and Oregon's Silicon Forest.

Kaiser Permanete letter to participants June, 2006

The pages in the three attachments are photographic copies of the letter sent to those insured by Kaiser Permanente in Oregon.

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

Medical family histories are powerful tools

Today's online edition of the TimesDispatch from Richmond, Virginia sums up the benefits and drawbacks of medical family histories in a very readable way. Here's some of what the author Betty Booker has to say:

If Daddy died of a heart attack and Mommy had a stroke, you ought to keep yourself fit and lean. . . But, you knew that already, right? If Grandma had a stroke and Grandpop died at the office in a gray flannel suit, then you have more reason to get serious. And if your great-grandmother had a stroke cooking at the wood stove and your great-grandfather dropped dead plowing the north 40, you really do have a genetic inheritance demanding attention.

Here are some of the author's reasons for compiling histories and for genetic testing:

If you can piece together your health history, you can track disease and health patterns that could make a huge difference in your life and those of future generations. Knowing what diseases your kin had, and their causes of death, can help your doctor understand your own health problems--and better yet, teach you how to prevent them.

Preventing--or delaying--the onset of serious health problems by what you do to improve your health may prolong independence. And taking responsibility for your health based on your family history can save you a lot of pain, disability, surgeries, medicines and high medical bills.

Elders with serious health problems sometimes will get genetic testing as part of their legacy.

Some seniors elect to store DNA material to be used when more advanced tests are developed in order to help their children and grandchildren. [This is what I recently did with my husband's DNA.]

The "most common, costly and preventable" chronic health problems are heart disease; stroke; diabetes; and colon, breast, and ovarian cancer, according to
the U.S. Surgeon General. Knowing whether any of our ancestors had these problems, and making full use of
the scientific information available about how to avoid these diseases or detect them early could significantly influence or own health future.

So, what are the potential problems?

Key people in our families may have already died without leaving details of their medical history. Collecting information isn't easy if your older relatives have memory problems.

The information that we collect generally is incomplete and it may not always be accurate.

The information is highly personal--"and not all of it is yours. If your history includes an aunt's breast cancer and a brother's depression, for instance, their private information should be protected."

There's always a chance your information can get into the wrong hands--especially if you complete personal family history forms online. However, online forms that are connected to databases of information can give you predictions about how your family's health history may affect your own future--if you understand what the "predictions" mean.

The author concludes: "Family health histories are part of a larger trend of data-rich medicine. . . Instead of working on a lot of hunches about how a patient should be treated--which is still pretty much how medicine works today, doctors in the future will have huge population databases to guide their decision-making about individuals based on evidence of their genes and other factors."

The steps are straightforward--if you can get the medical information you need. To start, prepare for your next family gathering--large or small--by checking out one or more of the following websites:

Enjoy! Creating your family's medical history is not only worthwhile, it's fun.

Marie Godfrey, PhD