by Gregory Fowler and Barry Anderson

Greg Fowler is an Associate Clinical Professor of Public Health, Oregon Health Sciences University, Portland, Oregon and Executive Director of Geneforum.org (www.geneforum.org). Barry Anderson is Emeritus Professor of Psychology, Department of Psychology, Portland State University, Portland, Oregon.

The genomics revolution rolls on, promising tremendous improvements in our ability to secure a new level of physical well-being, yet, at the same time, creating a sense of unease about some of its possible consequences. With the growing power to obtain accurate genetic information about individuals the question we need to ask ourselves is: Who should have access to this information? And under what conditions?

Genetic privacy and research have been considered in every legislative session in Oregon since 1993. The issues are technical and complex and the ramifications are wide ranging.

Does such a landscape call for a new level of public education and public dialogue about the scientific, ethical and social issues raised by genome science? Based on a survey of lay citizens, a gubinatorially-appointed legislative body of experts in Oregon thinks so.

For the past year, the Genetic Research Advisory Committee (GRAC), a group of health care professionals, business and industry leaders, and policy makers, has been deliberating on the use and disclosure of genetic information, that is, knowledge about an individual or family obtained through DNA testing of tissue samples. Oregon's 1995 genetic privacy act, the first in the nation, says that a person's DNA is his or her own personal property and cannot be used for any purpose, including research, without that person's informed consent.

Throughout its deliberations, the GRAC had the benefit of input from Oregonians around the state generated from focus groups and an Internet Web site (http://www.geneforum.org) organized by Geneforum.org, a Portland based nonprofit, nonpartisan organization seeking to educate and inform citizens about the societal implications stemming from the new genetics.

The input we received reflects a citizenry generally supportive of genetic research but equally concerned about the protection of their privacy. In addition, Geneforum.org's preliminary findings show that Oregonians share with citizens throughout the country a high degree of confusion, misunderstanding and misinformation about all aspects of genetic research and genetic privacy.

The Method

An interactive scenario, "The Office Visit," was used by Geneforum.org to elicit citizen response. It begins with the following Web site instructions (the italicized words are defined in linked hypertext):

You go to your doctor's office for a routine check-up. Your doctor suspects that you might be at risk of colon cancer and wants you to have a sigmoidoscopy. In the course of that procedure, the physician is likely to take a biopsy of any suspicious polyps.

When you go for the test, you are given a form that asks you to decide how your tissue may be used in the future.

Check the choice(s) you are most comfortable with.

Respondents were asked to make several choices. Hypertext descriptions of benefits and risks were provided at each choice point in an attempt to ensure that choice was fully informed. Respondents were asked for the reasons for their choices.

In addition, four offline focus group discussions were convened around the state. Participants in each group were presented the office visit scenario from the Web site and then asked a series of questions to probe their views in greater depth.

Following is a categorization of the views that were expressed. Redundant quotations have been eliminated. The analysis is strictly qualitative, since the methodology provides little reason to believe that any frequency counts would be representative. What is presented below is classification of the most articulate statements of the various points of view expressed at the Web site and in the focus groups.

The Responses

Releasing Tissue

Tissue can be considered as material or as information. The following statements comment on tissue as material:

"Common law requires consideration be paid in order for any object to become one's property. Consideration was paid by us or someone else for the tissue(s) by supplying the body with food. Therefore, it is perfectly legal to sell your blood."

"Although I'd like to profit from the results, I think that it would be an administrative nightmare and would limit research."

Tissue as information is information about the donor's body (e.g., what diseases the donor may be prone to) or about the human body, in general, and not information about the donor's identity (e.g., the donor's name and Social Security number).

"The DNA that defines and shapes me floats on a slow-moving stream of life. The "I" that takes shape with this DNA is a wonderful gift. I don't think I own it. It came as a gift, a wonderful surprise. The secrets of DNA just seem to belong to all of us."

"Common law requires consideration be paid in order for any object to become one's property. None of us paid for the information encoded by our DNA. The information contained in the cells is public domain. I wouldn't want to profit from the research, but if they found something that could save lives, I would want it to be common knowledge for anyone who needs it."

"I would want to know if risks are present in future family offspring."

"I would want to know if there are reasons not to have children."

"Some women will abort a fetus based on their genetic test. This is a very disturbing scenario for me."

"Just as if a limb were to be amputated, any and all uses of that limb by the hospital would be my choice. This is no different."

"I feel that I own my DNA, and I am not comfortable that it could take on a life of its own, outside of my knowledge and control."

"I really wouldn't someone making another me without my knowing it."

"First, let's look at the ethical issue and develop a standard of where this is going to go."

"The assurance by the researchers of what the tissue will be used for [is necessary] so that there is no conflict with the donor's ethics."

Releasing Information about One's Identity

A person can give up tissue with or without information about his or her identity. There are both benefits and risks associated with letting others know what tissue is yours. Coding systems have been devised in an attempt to secure the benefits without incurring the risks. Benefits relate to the coordination of data for research purposes. Risks focus on the misuse of information about the donor by HMOs, insurance companies, employers, and data brokers.

"Genetic diseases are the product of random processes over which the individual has no control. Legislatures will eventually pass laws against such discrimination. Until they do, I want my identity kept confidential."

"I feel, perhaps naively, that the safeguards outlined in the scenario would guarantee sufficient, protection from misuse."

"I would prefer that no identifying data was forwarded with the sample but rather that information was kept for the pool of individuals who donated who would then be compensated as a group if any profit was made from their tissue sample."

As for the benefits of maintaining at least a coded link from the tissue to the identity of the donor, raw genetic data by itself without any knowledge of the other health or physiological condition of the donor is not nearly as useful as when that information is linked to it.

"There isn't a safe way to ensure privacy of genetic privacy, even with codes."

Concerns were voiced on the risks of genetic information being linked to the donor and getting to the donor's HMO, insurance company, employers or data brokers:

"I would not want anyone else to know the results because of the possibility, nay the certainty, that certain insurance companies/HMOs would use this as discriminating and incriminating reasons for rejection."

"I wouldn't want any employer being able to find out any possible defects about myself."

Research and Profit

The two reasons people want tissue are for research and for profit. The following statements comment on the research motive:

"I want to support research."

"I believe that the study of genetics is terrific, especially in the fight and prevention of many diseases. However, I do not see the need to clone a human being. I just don't think that we should be [messing] up the human gene pool. It's great that we are making better vegetables, but let's keep genetic mutations to food only and not people."

"I choose for my tissue to be used for other research, not genetic."

"There is no guarantee as to what purpose this will be used."

The following statements comment on the profit motive:

"Decreasing the potential for monetary gain will decrease the amount of research in the future."

"I believe that the profit motive and the free market need to be regulated. I look to legislative and other public bodies (such as the FDA) to be the vehicles (with public input) for regulations that constrain the profit motive to contribute to the general well being of society. I am greatly concerned that this DNA-focused research will lose sight of the human condition generally and collapse into a costly focus on the wealthy elite."

"I think the BIG problem with the power of genetics in biomedicine and agriculture is fear over what corporations will do with this power, given their penchant for [putting their own] profits above all other considerations. With our patent and regulatory laws virtually restricting the commercial domain to multinationals who can afford the horrendous expenses and risks of working in this area, it means what happens with the technology will be determined by a very few, very large global corporations. Until these corporations can demonstrate that they are far better global citizens than they have, as a community, so far or that government regulatory bodies are truly competent and in control people will be very hesitant to allow genetic technology to be widely employed."

The Significance

Observations from the Geneforum.org Web site and the statewide focus groups present a consistent qualitative picture of the values and beliefs of a sample of Oregonians regarding the decision to allow their tissue to be used in genetic research. On the one hand, there appears to be considerable willingness to support genetic research by donating tissue. On the other, Oregonians have concerns about confidentiality and informed consent. In general, then, responses suggest more willingness to release tissue than to release information about personal identity.

Even from these early attempts by Geneforum.org to assess public values and beliefs among Oregonians, it is clear that much needs to be done in the way of informing and educating the public about the realities and possibilities of genetic research.

GRAC agrees. In its final report to the state legislature the committee recommends the creation of a new, and ongoing, advisory committee established to monitor genetic research and privacy in the state. The following statutory language reflects the proposed role of the public in that process:

As part of its regular activities, the Advisory Committee on Genetic Privacy and Research shall create opportunities for public education on the scientific, legal, and ethical development within the fields of genetic privacy and research.

The committee shall also elicit public input on these matters. The committee's recommendations shall take into consideration public concerns and values related to these matters. The committee should make reasonable efforts to insure that this public input is representative of the diversity of opinion in the Oregon population.

So, where do we go from here? The fact that the GRAC committee recognizes the importance of public perspectives on genetic research is no guarantee that the Oregon legislature will feel the same way. However, the perception that informed public opinion is an endangered species has been seriously challenged by the activities of Geneforum.org reported here. The upcoming challenge is to create more opportunities for public education and intelligent public opinion polling. In 2001, Geneforum.org will continue its effort toward this end by administering a statewide survey on genetic privacy designed to collect perspectives from a broad spectrum of Oregon stakeholders and the general public.

The use of human biological material by researchers is vital to the advancement of human health, but the rights and welfare of those who provide the specimens should never be compromised.