PSU Magazine Fall 2000

experts from throughout the United States helping to form policy on a full range of bioethical issues. Like Everett, her connection with bioethics is personal. Her 38-year-old son, David, has schizophrenia, and much of her career developed from the issues she faced as his mother. She has written widely on psychiatric and biomedical research practices and is the author of The Family Face of Schizophrenia (Putnam, 1994, and paperback, 1995). In addi– tion, she serves as assistant director for the Center for Ethics in Health Care at Oregon Health Sciences University. She was well-suited to the task President Bill Clinton put before the NBAC when he created the commission in 1997. The group was to come up with recommendations on both the rights and the welfare of human research subjects, and the use of genetic information in enterprises such as human gene patenting. The NBAC has written reports on this huge scope of sensitive issues, all of which can be viewed on the Web at www.bioethics.gov/pubs. html. In 1999 the NBAC produced "Research Involving Human Biological Materials: Ethical Issues and Policy Guidance." It recognized that 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. "The informed consent process is the linchpin that keeps in place a cluster of protections necessary for the safety of partici– pants in human subject research," says Backlar. "Consent that is freely made, while truly infonned and understood is at the heart of the matter." The report suggests interpretations and clarifying language for current federal regulations that can protect subjects' rights and interests and at the same time permit well-designed research to go forward using biological material already in storage as well as specimens newly collected. The NBAC esti– mates there are more than 282 million tissue samples stored in labs throughout the country. The commission, which gathers public input for its reports through meetings every month or so, will be dissecting bioethical dilemmas well into 2001. T he point of these commissions, public meetings, reports, and Web sites is that they help to form the policies that eventually find their way into our laws, our courts, and the labs where research is taking place. It is a sometimes slow, but ultimately crucial soul-searching that trickles down to real life. Just this past August, President Clinton, at the urging of the medical establishment and the public, announced new, more stringent rules to protect the privacy of medical records-in part because of genetic infor– mation they may reveal. The implications of science's unlocking of the human genome are just beginning. They will become increasingly prevalent in the decades to come as we all learn to speak what President Clinton called "the language in which God created life." D (John Kirkland, a Portland freelance writer, wrote the article "Going to Extremes," in the spring 2000 PSU Magazine.) 10 PSU MAGAZINE FALL 2000 'v / .j ...... ·1' r ' r' r I ~ ' r I r ,., r r j I r 'J -~-- ....... ~ J ~ ...,_,, ... The following question and c:hoic:es were condensed from the genejorum.c:om Web site. Completing this survey online provides Gene/arum with input that c:ould affec:t public: polic:y. You go to your doctor's office for a routine checkup. Your doctor suspects that you might be at risk of colon cancer and wants you to have a sigmoidoscopy. In the course of that pro– cedure, the physician is likely to take a biopsy of any suspi– cious 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. Which choice(s) are you most comfortable with? 1. I grant permission for my tissue to be used for genetic research, without any restrictions. Benefits: This may help researchers develop ways to prevent, detect, and treat genetically-influenced diseases such as colon cancer, cardiovascular disease, diabetes, high blood pressure, breast cancer, and prostate cancer. Risks: There could be harmful consequences if your informa– tion got into the wrong hands. For this reason, in federally funded research, precautions are taken to keep your identity confidential. Although there is a risk of loss of confidential– ity, the risk is very small. 2. I grant permission for my tissue to be used for genetic research so long as no information that identifies me or is obtained from my medical records is forwarded with the sample. Benefits: Your identity and medical records will be confidential. Risks: Your tissue may not be useful since your medical his– tory will not be available. If many people made this choice, it could take scientists longer to develop ways to prevent, detect, and treat genetically influenced diseases. 3. I grant permission for my tissue to be used for genetic research so long as I am given any information that could affect my health or that of my children. Benefits: You would be informed by your physician if the research generated information on factors that increase your risk of getting a serious disease. And, if this is inherited, you could inform your children. Risks: Complying with your request for information may not be reasonable for a researcher who must balance time avail– able, cost, ethical issues, and uncertain medical significance. As a result, your sample might not be used. Even if your tis– sue is used, information that would be useful to you may not be available for many years. Or, you could be misinformed based on preliminary information that turns out later to be inaccurate. 4. I refuse permission for my tissue to be used for genetic research under any conditions, and I request that my tissue be destroyed after the test is completed. Benefits: Your identity and medical records would be confi– dential. Risks: Because your tissue has been destroyed, you cannot benefit from any research results which might come from a re-examination of your tissue. New discoveries that may save lives in the future often come from research on stored tissue samples. •