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National Research Council (US) Board on Biology. Privacy Issues in Biomedical and Clinical Research. Washington (DC): National Academies Press (US); 1998.

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Privacy Issues in Biomedical and Clinical Research.

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What, if Anything, Should the Federal Government Do?

While the immediate impetus for the workshop was the worry that ill-considered federal legislation could harm genetic research, participants at the meeting were not necessarily asking that the federal government stay out of the issue altogether. Indeed, as Anne Phelps of the Senate Committee on Labor and Human Relations noted, "A lot of [Congress's involvement] has been at the request of the research community and the genetics community. They came to Congress and said, 'You need to act.'" But act how? Much of the discussion at the workshop centered on the question of what the federal role should be.

Some participants, particularly Paul Billings, thought that the federal government should play little if any role, given current conditions, in the areas of genetic privacy and genetic discrimination in health insurance. Because health insurance is primarily regulated at the state level, Billings argued, the individual states have more experience and are better equipped to legislate. "I would suggest that federal legislation should only be directed at reducing the stranglehold that the ERISA exemption has had on the states' ability to legislate in areas of genetic discrimination, and to ERISA, the Employees Retirement Income Security Act of 1974, imposed federal regulation on insurance plans offered by companies to their employees and thus preempted much of what states can do to oversee such medical coverage. Congress should return to the states much of their traditional ability to regulate health insurance, including issues of genetic discrimination, Billings said. Otherwise, it should stay out of the area for now, "except to rectify gross inequities of state legislation."

Billings said that if states were given this power they would be unlikely to pass legislation that would harm research. There has been no negative impact arising from the genetic discrimination legislation that was passed in California on the conduct of clinical or basic science in that state."

Other researchers disagreed, however. David Foster of Genzyme Corporation in Cambridge, Massachusetts, described how the Massachusetts legislature was close to passing a law that would have crippled certain types of research in the state. "They have been at this [writing genetic discrimination legislation] for two years, and now that some of our key research folks, like Massachusetts General Hospital, are starting to review legislation which is actually ready for passage, they have discovered that it would shut us down. When the research folks look at this and think it through, they are dumb founded. They cannot believe that state legislatures would pass certain things that would really prohibit a lot of the research that we take for granted today."

As observed by Eleanor Kerr of SmithKline Beecham, "it is a mixed bag out there." California legislators may have done their homework and produced a reasonable law, but other legislatures have not. "The danger here is that without federal legislation states are racing ahead. You saw a list of ten bills in Congress. There are literally hundreds on the state level. I think about twenty states have now passed statutes. There are states that have passed statutes, that have repealed them and passed new ones. We are not just dealing with California."

For that reason, many of the workshop participants seemed to want the federal government to step in. "I think one of the hopes of the research community," said Raymond White of the University of Utah, "is that reasoned legislation at the federal level might actually supersede a large number of local efforts which might not be so well thought through and might, in fact, be damaging to local groups."

A second argument for federal involvement was that even if all the states passed reasonable legislation, there would still be fifty different sets of regulations. "One of the concerns about approaching this state by state," noted Leo Whelan of the Mayo Clinic's legal department, "is that it is very easy to conceive of a situation where samples are collected in one state under full compliance with that state's laws and then the researcher later hopes to collaborate with a researcher in another state but is unable to do that because of differences in the two states' laws. That could be a very significant problem."

Or, White said, consider the nationwide cancer-genetics network that the National Cancer Institute is now planning. "Can you imagine trying to share records not only between states but to merge and provide access to records at the national level if each state, each community, each principality has its own set of regulations which you must satisfy in order to create a merger? I think that the effort would be effectively gutted were that to come to pass."

If the federal government is to get involved, what should it do? Perhaps the first and most important thing, some workshop participants said, was to keep the issues of genetic discrimination and access to health care separate from the policy issues surrounding genetic research. Because genetic research produces information that, if leaked, could lead to a research subject losing health insurance, there is a natural tendency to put genetic research and genetic discrimination into a single box. Then setting policy becomes a matter of weighing the benefits of genetic research against the costs to the people involved. That is the wrong way to go, Billings said. "I don't think we want to set up a situation where we are balancing people's access to health care—that is, research subjects' eventual access to health care—against scientific freedom and the conduct of scientific research." Instead, the two issues should be addressed separately.

National Health Care

When the discussion turned to protecting people from genetic discrimination in health insurance, several workshop participants suggested that the best solution would be to reform the entire national health-care system. "I urge that we not disintegrate this discussion of privacy and privacy law from the fact that health care financing is significantly broken in the United States," said Paul Billings of the Department of Veterans Affairs in Grand Prairie, Texas. "By fixing that, we would change this discussion enormously. The losses that research subjects might face as they enter into medical research would be changed if these willing individuals did not face the chance of losing their ability to finance health care."

A number of forum participants felt we would be facing fewer issues in genetic research if our health care system wasn't based on a system of voluntary private optional health care.

Even if the country does not move to such a system in the short run, advances in genetic research and medicine may leave it no choice in the long run, argued Frederick Anderson, an attorney with Cadwalader, Wickersham & Taft in Washington, D.C. In the future, he predicted, people will be able to foresee quite accurately, through genetic tests, what their life expectancy and health problems are likely to be. On the other hand, given if it is possible for people to keep that genetic information to themselves, it will put insurance companies at a huge disadvantage. "As a cynical lawyer," he said, "I predict individuals will choose their life insurance and health insurance in such a way as to deal with one's condition, which twenty years from now they will know quite accurately, so that the insurers will be bankrupt and will have to spread risk over the largest possible pool, and that will be a national health insurance scheme.''

Billings, citing a study from the University of Utah that found people with genes predisposing them to breast cancer did not modify their insurance choices, thought Anderson was being too pessimistic. ''There isn't much evidence that adverse selection will occur in pools with this [genetic] information. There are lots of other factors that go into why people buy insurance and how much they buy."

"If I were 40 years old," Anderson replied, "with three kids, and in receipt of a genetic profile that says that I am at a 75 to 80 percent chance of being very ill and dying between fifty and sixty years of age, I think it would be irresponsible of me not to take that information into account in the health care that I purchase and the life insurance that I purchase. I would be astonished if, as studies come out over the years, people in resounding numbers insist on ignoring this information."

Although the first of those two issues—how to prevent genetic discrimination, particularly against the subjects in genetic research—was not officially on the workshop's agenda, the participants did discuss it and offer suggestions. Some argued that the best solution was a national health care system. [See box, page 24.] Others thought that since national health care is such a controversial topic, it makes more sense to look for solutions that fall short of that. Cynthia Kenyon, a researcher at the University of California, San Francisco, offered one possibility: "Since the primary risk that the individual volunteers face is loss of health insurance, why not have the government guarantee to provide health insurance to every individual that is subject to genetic testing?" Since genetic research is for the common good, she said, it makes sense that the country protect those people who might be hurt financially by participating in genetic research.

Or the risk to research subjects might be dealt with by laws preventing discrimination on the basis of genetic testing. "The health insurance law that passed last year does prohibit genetic discrimination in health insurance in certain instances," said Phelps, the Senate staffer. It also set a precedent for the proper way to think of a genetic predisposition, she said. "There is social significance and awareness attached to the legislation as well. One of the key elements was the language saying that a genetic predisposition to a disease is not a diagnosis of a disease. It is not a pre-existing condition, and that is as much a social statement as it is a legal one."

Many workshop participants did not believe that concerns about genetic discrimination could be dealt with by trying to establish some sort of right to genetic privacy. Too much genetic information is already in people's medical records, and the amount of such information will increase dramatically in coming years. Yet people's medical records are not private now, at least not in any practical sense, and that isn't likely to change soon. "I truly do not believe that we have the political capacity in this country in the short term to secure medical information to the point where people who worry about privacy will ever be comfortable," said David Korn of the American Association of Medical Colleges. "There are too many necessary folks rummaging through the files."

"The key question," Whelan said, "is whether you have information generated by the research getting into the medical record. If it does go into the medical record, then the privacy risk really becomes significant because the medical record—for all the protections afforded it—is often shared with health insurers, life insurers, and employer owned benefit plans. If the person ever becomes party to litigation, it is often disclosed, and there are a number of other means for disclosure of the medical record."

But, Korn said, if genetic information generated in research is never passed along to a subject's medical record or to the subject, it should be possible to keep it private. "I really do believe that we could secure the research database," he said. "There is no reason why any external entity should be entitled to forcibly get into a research database and poke around in it." And this, most workshop participants agreed, is a step that the federal government should take, and take quickly.

Current Genetic Discrimination and Privacy Legislation in the 105th Congress

Irene Stith-Coleman of the Congressional Research Service reviewed the current legislation (Fall 1997) pending in Congress which had the potential to affect biomedical and clinical research. This legislation can be grouped into 3 area's: legislation devoted to the privacy of medical records, legislation devoted to the prevention of discrimination from the use of information in medical records, and legislation devoted to the more specific regulation of how to perform genetic research (see Table 1). According to Stith-Coleman, "Three bills are more generic in terms of medical information privacy, 9 bills are more specific to disclosure, use and protection of genetic information, and one bill, Domenici, which is quite comprehensive in addressing specific considerations while doing genetic research."

"There is a continuing debate as to the most appropriate strategy in dealing with the issue of genetic discrimination or issues of medical record privacy." According to Stith-Coleman, "a hearing by the Senate Labor Resources Committee was supposed to be focused on general medical privacy, but the discussion evolved into something that focused on genetics, much like today's deliberations. So the verdict is still out as to which strategy will be used to address this issue"

"Domenici's bill is quite comprehensive in addressing research considerations, so I will spend most of this time highlighting some of the provisions pertaining to this bill," said Stith-Coleman. The bill has provisions that would require anybody who would be collecting tissue to provide so-called ''vital'' information, as well as provide certain rights to the test subjects. The tissue collector must inform the subject what the expectations and implications are for the genetic tests. The individual has rights to rescind consent anytime before the analysis is initiated, and this would include the right to order the destruction of any identifiable DNA sample as well as the right to examine clinical records. "In addition," said Stith-Coleman, "there are provisions for civil penalty if these rights are violated."

There are "re-transfer" controls which would apply in cases of discontinuation of the activities pertaining to the protocol under which the tissue was obtained. "If a researcher is planning to transfer the tissue, or if the services for which the tissue was obtained are ceasing for some reason, information would have to be provided to the subject. The subject would have to give the consent for the tissue to be transferred, or if he or she elects to have the tissue destroyed, the researcher would have to honor this decision. If the researcher holding the sample attempts to locate the 'donor' and doesn't get a response, the tissue may be destroyed, placed in a 'tissue-archive' or transferred to another facility."

"Also within the Domenici bill," said Stith-Coleman, "there are provisions for defining the responsibility of the IRB or similar Board that is overseeing genetic research. The IRB or Board must determine whether or not the sample is essential to the project, and balance the benefits to society versus the risk to the subject from which the tissue is being obtained. The protocol must contain adequate safeguards to protect the subject, though those safeguards are not specified. The protocol must also require informed consent as well as written authorization from the subject from which the tissue is being obtained."

"In addition, there is a prohibition of including genetic information in the clinical record unless the subject authorizes it. One additional provision that the protocol must have is the person obtaining the tissue must provide a reasonable method of disclosing to the family of the subject information pertaining to the risks associated to the genetic information."

There are other bills in addition to Domenici which concern genetic research. "The Stearns bill provides for the requirement of a report to be submitted to Congress by the National Bioethics Advisory Commission" said Stith-Coleman. "The report should set standards with respect to the acquisition and retention of genetic information, how it would be obtained and stored, and the report must be submitted within 1 year after the enactment of the legislation."

TABLE 1. Genetic Discrimination and Privacy Legislation in the 105th Congress.


Genetic Discrimination and Privacy Legislation in the 105th Congress.

"I'm certainly not a legal scholar," said Eugene Carstea of the Saccomanno Research Institute in Grand Junction, Colorado, "but it seems that trouble arises when research information is added to a patient-participant's medical record.

Such a policy could protect the subjects of genetic research, thus making the public more comfortable with such research and allowing researchers to recruit the large numbers of volunteers they need. "Any institution doing human subjects research should have a stiff confidentiality policy in place," Korn said. "Public flogging might be a good thing for violators, and I would say that I think the Feds have to oversee this. I don't think anybody else has the credibility to at least try to assuage some of the public anxiety.

"I am not a big government person philosophically, but I don't know who else can do this. In return for a policy that met standards, the Feds could give to the institution—not the individual, not the project, but the institution conducting human subjects research—a blanket protection of its human subjects research database modeled on the certificate of confidentiality."

The certificate of confidentiality is a federal credential designed to let researchers keep information about their human subjects secret from people outside the lab. "It was enacted back in the 1970s to permit studies of drug abuse in returning Vietnam veterans, who clearly weren't going to play if they figured they were going to get arrested for talking to the researcher, and was subsequently broadened in the late 1980s to include any biomedical or behavioral research that might generate sensitive information about individuals." In theory, Korn noted, the certificate of confidentiality may not be a perfect safeguard. "I know that people will say that if a court wants information and a judge issues a subpoena, nothing will stand in the way." But, he added, "it has been twenty-two years or more that the certificate has been used, created for studies of a criminal activity, and to my knowledge it has never once been challenged successfully. I am not sure anybody has even tried to challenge it."

If institutions doing genetic research could be given such protection, it would guarantee a near-absolute privacy of genetic research data. "Now, nothing will work perfectly, and you can never prevent an individual scientist from acting like a jackass," Korn said, but "the system should work very hard through education and reinforcement to try to prevent such behavior." Then people could volunteer for genetic experiments confident that their genes would not be used against them, and medical research could continue providing the rapid advances that people have come to expect.

Copyright © 1998, National Academy of Sciences.
Bookshelf ID: NBK45158


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