Privacy & Confidentiality: Genetic Privacy

Abhishek Goyal, Aishwarya Kumar, Devansh Durgaraju Abstract: In this paper we present the issues related to genetic privacy. We deal with the nature of

genetic information and briefly describe the parties that have a stake in knowing or protecting that information. The issues that result due to the loss of genetic privacy are covered. Finally, the ideas and the issues related to genetic exceptionalism, consent, and information exchange are presented.

1. Introduction

“[Privacy] can be seen as the protector of reputations and sanities, a developer of intimate and personal relationships, and even a defender of hard-done-by individuals maltreated at the hands of overly bureaucratic governments departments [1].” “[Privacy] is seen as creating the context in which both deceit and hypocrisy may flourish: It provides cover under which most human wrongdoing takes place and then it protects the guilty from taking responsibility for their transgressions once committed . . . Concern for one's privacy maybe regarded as a sign of moral cowardice, an excuse not to state clearly one's position and accept whatever unpopularity may ensue. Privacy maybe seen as a culturally conditioned sensitivity that makes people more vulnerable than they would otherwise be to selective disclosures and to the sense of comparative inferiority and abject shame – a sense engendered by ignorance about the inner lives of others.[1]” The debate on privacy is at the heart of the debate between protecting private autonomy and furthering public interests, and in a democracy, the latter often comes at the cost of former. For example, the emerging genetic technology, though immensely useful for human race in general, comes at the cost of giving up personal information for some individuals. To look at the other side of coin, apart from adverse psychological effects on individuals, the need for protecting privacy also arises out of the fact that it is absolutely necessary for maintaining the social structure [2]. Thus it is necessary to protect privacy in public interest. This paradoxical observation leads to understandings of the long struggle in human society for defining privacy & confidentiality and the boundary between public and private spheres of life. As Stromholm explains, “Prevailing democratic ideologies stress the need for continuous debate on matters of public interest . . . the complexity of modern society and the subtle interwovenness of facts and interests within its framework have led to the feeling that almost everything concerns everyone in one sense or another. Thus, any unimportant event may touch upon matters in which the public may claim a legitimate interest.”[3] The contexts and situations in which concerns for privacy arise are so varied that it not feasible to work with any simple definitions of privacy. In any case two conceptions of privacy are useful: the state of non-access to and individual's physical or psychological self is spatial privacy and the state of non-access to an individual's personal information is informational privacy(where the word personal is can only be defined in social context). As we shall demonstrate, in some cases, for example genetic privacy, even this definition turns out to be too simplistic.

In the 20th century, the rise of technology added a whole new dimension to the privacy debate. From the dramatic increases in the ability to share and access information through the Internet to creation of new kinds of information due to the advent of advanced medical technologies, whether genetic or not, has spurred new debates among policy makers concerned with individual privacy. An intense focus has been on the protection of informational privacy of individuals. Out of a plethora of issues, this paper deals with the privacy problems caused by the creation of "new" kinds of information created by the emerging genetic technology, due the discovery of the "esoteric" DNA and its properties, which are grouped under the heading of Genetic Privacy. Though the information is arguably new, the issues do have a considerable overlap with the already existing problems in the area of health information privacy, which forms the basis for the view against genetic exceptionalism. The area of genetic privacy exemplifies the tension between public and private interests in the best possible way, with clearly visible benefits from genetic technology and harms of the loss of privacy. This was our primary motivation of choosing to work on this topic in the huge area of privacy and confidentiality, along with the fact that the issues that it raises are right at top of the pile of the debates at the interface of science, technology and society. Throughout the paper, we have assumed the need for protecting health information privacy and thus genetic privacy, on the basis that society places huge value in such information and attaches particular connotations to some information. The explicit justification of this fact would be out of the context of this paper. As Greenwalt puts it, “One reason why information control seems so important is precisely because society is as intolerant as it is, precisely because there are so many kinds of activity that are subject to overt government regulation or to the informal sanctions of loss of job or reputation." [4]

2. Genetic Information We have described that Genetic privacy issues are a subset of concerns related to informational privacy, but it is the perceived unique nature of the information which makes the issues important and thus debatable. Before the problems can be analyzed, the nature of the information needs to be defined clearly. Traditionally genetic information is considered as the information generated as the result of DNA analysis. Greely has mentioned that this information can “reveal” the future and the past *5+.The analysis also provides information about the current health condition and to some extent predicts the predisposition of person to develop diseases. The presence of BRCA1 gene in person to some extent increased the predisposition to developing cancer; the presence of chromosome 9 increases the risk for heart diseases from 1% to 1.6% [6]. Genetic information is more about possibilities than about certainties. It has been established that this information can be linked to a single person and thus it’s utility in forensics. The United Kingdom was the first country to establish a national DNA database for such purposes [7].It also reveals facts about family members, direct blood relatives and ethnic groups without their undergoing any kind of analysis. In Sweden government had requested the DNAs of prospective fathers to confirm heredity *8+. “Recently, two courts have held that physicians also have a duty to their patient’s family to warn of genetic risks. Indeed, one court saw “no essential difference between [a] genetic threat . . . and the menace of infection contagion or a threat of physical harm,” rejecting the defendant’s implicit genetics exceptionalism” *9+. A very small sample of the DNA is sufficient to conduct the DNA analysis. This information can be used to predict future risk in future persons. In 1994 Jones Institute for Reproductive Medicine at the Eastern Virginia Medical School in the United States successfully completed the testing of an embryo for Tay-Sachs disease [10]. The main difficulty which is faced here is in regards to using the definition of genetic information for the purpose of law and policy. This definition of genetic information excludes observable genetic information. Dutch insurers were accused of discrimination based on genetic information. The retort of the insurers was that no questions had been asked about hereditary conditions. They had simply asked if candidates had high cholesterol levels – classically a non-genetic question. But by asking this question they were able to find about inherited genetic disorder [11]. For example, a family history of Huntington’s Disease (“HD”), which indicates a 50% risk of the condition and is precisely the kind of predictive information that people want to protect, would not fall within the legislatively protected class of information [12]. The other common definition of genetic information is “Information about genes, gene products or inherited traits that may be derived from an individual or family member” *13+. This definition is over inclusive protecting information such height, sex which is primarily genetic trait. Not all genetic information concerns about the lack of control over one’s genes, the high level of predictiveness of genetic information, and its stigmatizing and hidden features. For instance information that “someone carries a single copy of a recessive gene may increase the chances of having an affected child, but it does not increase the risk of future disease in the carrier.” *14+ It is contested that genetic information is not in individual’s hand, but the other factors which can predict a future health condition like environment conditions or exposures are also not individuals hand. Non genetic health records contain information about an array of personal and social information with multiple uses like demographic information, financial information, medical information such as

diagnoses treatments and disease or family histories. This information provides a detailed medical and social profile of an individual and his family. There are many physical properties which have been traditionally used to uniquely identify a person. Some examples are fingerprint, hand and face geometry and human iris. Dental analysis is also used to identify corpses. These and other medically observable traits, challenge the reservation of genetic information as deserving special protection. “[i]n many– possibly even most – cases, great uncertainty still attaches to ascertaining whether or not a disease is hereditarily conditioned. A long string of illnesses such as cancer and cardiovascular disease cannot be categorically classified as being hereditarily or environmentally conditioned, but must be assumed to be due to the – as yet only partly clarified – interaction of hereditary and environmental factors.” *15+ Indeed it is virtually impossible fully to distinguish genetic information from other medical information [16]. One might argue that we can distinguish between the information based on the role played by genetics and environment. For like Huntington disease is markedly different from AIDS based on the role played by the genes. But the problem is that many conditions fall in the middle. [17] “Although directly obtained DNA-based genetic information may in many circumstances be more predictive than indirectly obtained information for the inherited genetic disorders, the converse is likely to be true for common complex diseases. It is a matter of consensus, for example, that information about smoking, family history, blood pressure and cholesterol levels are together likely to be significantly more accurate in assessing cardiovascular risk than a knowledge of the genetic sequences and mutations in the relevant genes. *18+”

3. Concerned Parties

In this section we bring out the issues that arise due to the very existence of genetic information and the loss of genetic privacy by discussing the interest of various stakeholders in the information. These stakeholders are: Individuals, their families and the groups they belong to; the state; researchers and private organizations like insures and employer.

3.1 Individual, relatives and groups Genetic data, DNA sample is regarded as unique to a person and can be used to trace back to a single person. Gostin puts this as following: “Genomic data are qualitatively different from other health data because they are inherently linked to one person. While non-genetic descriptions of any given patient’s disease and treatment could apply to many other individuals, genomic data are unique. But, although the ability to identify a named individual in a large population simply from genetic material is unlikely, the capacity of computers to search multiple data bases provides a potential for linking genomic information to that person. It follows that non-linked genomic data do not assure anonymity and that privacy and security safeguards must attach to any form of genetic material” Moreover the genetic tests like non-genetic reveals information about current health conditions and treatable maladies. But these tests can also predict a person’s disposition to developing certain health condition or un-treatable disease. One issue which arises from knowing this information is the interpretation of this information. While some individuals who have tendency to develop certain health condition may take certain precautionary care by changing their environment and behavior to compensate for the genetic tendency, others may feel a sense of hopelessness and increase unhealthy behavior [19].So genetic counseling after genetic testing could provide a mechanism not to misinterpret the results. There exists genetic testing for Huntington’s diseases for which no effective treatment exists. Studies of individuals who have undergone testing in clinical settings show the changes in self-perception caused by positive, as well as negative, test results [20,21].Adjustments seem to have been particularly difficult for those who have already made reproductive decisions based on the presumption that they were at high risk for developing a disease[22].And in the interests of protecting the privacy of children and adolescents, some institutions have also adopted a policy of refusing parental requests to test children for late-onset diseases when no medical intervention is available to prevent or alleviate the genetic condition [23]. Moreover the information relating to the development or predisposition to a disease can also be linked with direct blood relatives, members of the group. The effect of such information on them would be similar and they should have control over what they want to know about themselves. This information can be used by untrustworthy parties to hurt individuals. Like by accessing the genetic information we can tamper with crime scene, so as to acquit an innocent. In Norman-Bloodsaw vs Lawrence Berkeley Laboratory, employees of a research facility owned and operated by state and federal agencies alleged that non-consensual genetic testing by their employers violated their rights to privacy. Holding that the right to privacy protects against the collection of information by illicit means, as well as unauthorized disclosures to third parties, the court stated “One can think of few subject areas more personal and more likely to implicate privacy interests than that of one’s health or genetic make-

up” *24]. “These data can intrude on privacy interests exposing deeply personal attributes of individual’s life. Alter a person’s sense of self and family identity. Adversely affect opportunities in education employment and insurance [25]”. For example genetic testing may reveal unanticipated instances of non-paternity. Banking and storage of this vast amount of information, along with personal identifiers, provides unique challenges to existing privacy protections. “An individual has very strong claims to determine what happens to such information [26]”. Genetic information has been used to discriminate against individuals and groups [28], particularly Jewish persons and other minorities [29]. In recent past eugenics based on genetic information was widely accepted, spread in different states and it was even legislated at places. “Supreme Court, in the now notorious opinion, Buck v. Bell, promoted the virtues of eugenics when Justice Holmes upheld such a statute on the grounds that three generations of imbeciles are enough” *30]. In the early 1900s, bolstered by a popular eugenics movement supported by prominent intellectuals, politicians, and scientists [31], such discriminatory practices were common in the United States. In the case of a group, as genetic information can reveal the information about the group, we need to address the question about who in the group is authorized to take a decision regarding the participation in the research. Research can help the group identify the potential risks. Some groups which have taken part are Amish, Ashkenazi Jews, Mormons and Native Americans [32]. “The effect of these considerations is that the number of people who undergo clinical genetic testing is much below the estimates of physicians and companies [27+”.

3.2 State

The governments have realized the applications of genetics to improve public health, enforce law and in cases of inheritance disputes. Genetic data can help track the incidence, patterns and trends of genetic carrier states or diseases in populations [33]. The availability of genetic information can arguably lead to enhanced patient choices in terms of lifestyle, procreation etc. The disclosure of genetic information might lead to prevention of spread of the disease in future generations, but the availability of genetic information might not lead to change in choice in terms of reproduction. Arguably, this also infringes the right to not knowing. “A particular instance is during the French Glaucoma studies, where in the investigators were able to trace the antecedents of three families who were known to be suffering from glaucoma back to 15 generations to a blind couple who lived in the region in sixteenth century. The INED decided to consult the National Data Protection Agency to determine the correct procedure to be followed in order to inform the individuals at high risk. The Agency responded that the Institute should not, in any circumstances, take steps to inform these people of what they had discovered. To do so, it was said, would be a breach of their privacy.” [34] This is an example where the research output is conflicting with the public health. For applications in law enforcement, it is required that huge databanks be maintained. The state thus takes active interest in encouraging genetic tests and gathering of genetic information. Concerns can be raised about the security of such information. Failing to protect the privacy of individuals may make people reluctant to share information with doctors or researchers, leading to the failure of public health system. There can be several other ethical issues that have been raised, for example the difference between choice and coercion, the societal judgment of choices and genetic determinism related to

tendency to being predisposed to commit a crime. But these issues are more due to the nature of genetic information rather than due to the lack of genetic privacy.

3.3 Researchers

Modern medical research is one of the pillars of modern scientific thinking. Crucial to this process is the participation of volunteers. In order to gain these volunteers, researchers need to win their trust. With the rise of the private sector in the medical research industry, the public perception has been declining over the years with fears about safety and privacy being paramount. Still, there is no denying that the majority of the public still feel medical research to be worthwhile. It is also true that the collection of genetic data or tissue data into genetic databases will help in improving diagnosis and treatment of various diseases. With the advancement of modern data storage capabilities, huge amounts of data can now be accrued and stored in genetic databases. These databases are present in both public as well as private sectors for clinical and research purposes. The use of genetic data in research has many causes for concern. A prime concern among these is ‘How much control does the donor hold over third parties wanting to use their DNA information??’ *35] These stored samples are subject to initial informed consent of the donors but when these are held perpetually and a new way of using this information turns up after the death of the donor, the question of informed consent cannot be fully satisfied. As mentioned in individual an issue regarding genetic data is that unlike health data, genetic data has the possibility traceability of the donor, which nullifies the concept of anonymous donors. The problem is also with the deteriorating public perception, which is a consequence of misconceptions about genetics and its research methodology. The public perceive that genetic science and more importantly the information that comes from it has deterministic consequences, i.e. they think the accuracy and veracity of the prediction made form genetic science and its information is unchallenged and absolutely certain. This perception makes it easy for people to use this data for the purposes of discrimination. Hence, there is fear in undergoing any form of genetic testing and thus fear in undergoing voluntary research activities, which are in fact key to the development of science, more so in the case of genetic science.

3.4 Insurance and Employment Not all parties interested in genetic information are those that are directly affected by it. The foremost among these are insurers and employers. The reason why these parties would be interested in accessing the genetic information of prospective insurers and employers is because of the possible future ill health which is detrimental financially to the insurers and employers.

3.4.1 Insurers The types of insurance that genetic information is most relevant to are Life and Health insurance [36]. The assessment of risk to estimate the premiums for insurance are issues that insurers are concerned with and genetic information is seen as vital indicator of health risks that can be associated to a person. This can result in the insurance firms discriminating on the basis of genetic information. Anderlik and Rothstein mention two types of discrimination: Rational and Irrational. Irrational discrimination is discrimination that is based on ‘misunderstandings’ and ‘misreading’ of genetic test results and the information they give [37]. Most genetic tests are still not 100% confirmatory tests and thus their predictions are just those, prediction. Thus, a positive test doesn’t mean a confirmation of the

occurrence of the disease and neither does a negative test exempt a person from the risk of the disease [38]. It is a common practice for insurance firms to take into account the age, family health history, occupation, personal habits into account to determine the level of risk that a person who has a positive test is susceptible to [39]. In effect, this is an effort by the insurers to achieve fairness in levels of premium rates among different insurers depending on the various factors mentioned above.

Financial concerns This ‘actuarial fairness’ is accompanied by concerns regarding the finances of the insurers because of suppression of information [40]. When there is suppression of information and insurers are forced to charge the same rate to insured persons who have different expected costs, then the insurance pricing might not only be viewed as unfairly discriminatory to the group of lower expected cost persons, but will also encourage moral hazard and adverse selection against the insurer. The financial effects of these adverse incentives ultimately drive rates upward and may even threaten the solvency of insurers [41]. The financial interest of an insurer are making money and spreading the cost of insurance as widely as possible [42]. Genetic information when used for assistance in determination of premiums can also cause a lot of people to refuse genetic testing causing damage to the industry’s long term interests. The risk of these refusals is significant as is shown by a 1995 survey where 85% of respondents were concerned about access to their genetic information [43+. The ‘house of commons’ Science and Technology committee commented that: “We accept that the insurance industry has collectively tried to deal with genetics in a responsible way; nonetheless we are concerned there is a real danger that people could decide to decline testing, even when such testing would be advantageous to them, because of the possible insurance implications” [44].

A possible solution to the above problem would be to impose a moratorium on the use of genetic information [45+. But a severe downside to this solution is the phenomenon of ‘Adverse Selection’ [46]. Adverse selection is a situation where an individual with knowledge of his heightened risk of being affected by a disease takes out insurance of high sums. This has the potential to create huge losses for the industry as a whole.

3.4.2 Employment The issues regarding employment are similar to those in the insurance industry. The interests of the employer include adverse financial consequences when an employee is prone to ill-heath and in fatal cases a frequent turnover of employees leading to dip in efficient working of the company. Simply put: “Healthy workers cost less they are less often absent through illness, there are lower costs for hiring temporary replacements, and there are fewer precautions which would need to be taken to deal with health and safety risks.”[47] To reduce costs due to such inefficiencies the employer request for genetic information before the employment of the employee. It is effective because of low expenditure to the employer and also because the employer’s training and benefits expenditure on the potential employee is low. Once,

the employee has been appointed, the employer is obliged to conform to certain health and safety standards at work and must bear the cost of all work related accidents. For instance a worker who has genetic predisposition to heart attacks is working on heavy machinery, which increases is chances of getting the heart attack, then it is the responsibility of the employer to ensure the worker is set to work on something less risky [48]. It is also argued that employer access to genetic information is beneficial to the prospective employee as well. For instance, screening of people and these test results would provide the individual with an idea of the ‘desirability’ of a certain employment. Thus, employees would work in conditions which are less risky and thus more suitable to them. An important issue arises when the accuracy of genetic information is questioned. The discrimination occurring is thus based on shaky grounds. This sensitive but inaccurate information can be unintentionally misused to eliminate people who only have a probability of being affected by a certain ailment. The Clinical Molecular Genetics Society along with the House of Commons Science and technology committee have sent a clear message saying that decisions of employment should be based on current ability to do the job at hand. It also added that genetic screening could be done in cases where: 1) there is strong evidence of a connection between the working environment and the genetic disease predisposition. And 2) the condition of the employee is too serious [49+. Also, the committee decries that ‘employees should have the right to decide whether or not to participate in such screening’ *50].Rothstein has criticized the above recommendations of the council as being ‘not strong enough’ *51]. But his stricter restrictions on genetic testing leave very few instances where genetic testing is permitted.

4. Genetic Exceptionalism “Genetic Exceptionalism is the societal practice of treating genetic data as different from other types of health data for the purpose of assessing privacy and security concerns” * 52]. In this section we discuss the various steps taken by the government to protect the privacy and prevent discrimination based on genetic information. The current obsession with genetic information means that it is more likely to be taken seriously [53, 54]. Genetic researchers including Francis Collins have suggested not concentrating on privacy rules, but rather concentrating on anti-discrimination as the basis of genetic information [55]. Here it is important to note that there is difference between privacy and non-discrimination. Roche suggests a federal policy which provides individual with control over their identifiable DNA, by giving them property interest in their own DNA. There is a voice that the current laws are only a patch work, and there are gaps and inconsistencies in them. Never the less this could act as a foundation for the future policies. These legislations can cause serious inequities. Consider two persons Roy and Kate both have an increased risk to develop cancer, based on environmental and genetic reasons respectively. The genetic legislations cover Kate, and so the health insurance companies would have to provide a cover without charging higher premium. Roy may pay higher premiums along or be denied a cover. The result is unjust because some increased risks are covered while others are not. The health insurance Portability and Accountability Act(HIPAA), prohibits employer sponsored d group health plans from charging individuals higher rates or excluding certain medical conditions from coverage based on an individual’s current health or “genetic information.” Thus the only concern is about the individual groups who are not covered by either the genetic legislations (Genetic indiscrimination Act) or HIPAA. [56] “Can passing antidiscrimination laws ever a bad idea? Yes, if broad policy reform is abandoned in favor of genetic specific legislation. But in spite of the serious flaws, genetic specific legislations are sometimes worth passing.”*57] Another concept which has been put forward is of defense of incrementalism. These genetic legislations can form the basis for extending the laws to other health information. There two main explanations for this firstly, “the protections created by genetics legislation will eventually apply to all medical information because genetic analysis will be so integral to every aspect of future medical records”. The next approach is that once genetic legislations are successful, then the goal is to convince legislators that the distinction between the genetic and non-genetic information is very narrow, and for greater equality we need to extend the laws [58]. There is also a concern that this process may not follow through as the legislators may think that they have solved the real issue that is at hand, thus bringing complacency in the process of legislate evolution [59]. Another suggestion to tackle the issue of genetic exceptionalism is to form legislation which is more related to privacy and discrimination. These would more generic laws will deal with discrimination based on health and genetic information rather than only on genetic information. The legislations would be based on features of genetic information rather specifically on genetic information. HIPAA is said to be a good step in this direction which aims to protect all the individually identifiable health information [60].

5. Consent and Information Exchange

Laws make consent for research a legal issue. The Nuremberg code endorses the principles of informed consent and describes consent as an affirmative decision by the experimental subject [61]. In this way the participants are informed about the possible breaches to their privacy, the purpose of research and the potential use of their data. Written consent is required by New York even on certain genetic tests performed on clinical samples [62]. In the case of un-identifiable information consent is not required by the participants. The question of who has the authority to give consent for his/her genetic material? An interesting case is of Iceland where the government had created a database of genetic information, which was then used by deCODE to conduct research and the benefits were reaped by Icelanders. This was a great success with very high acceptance among the people. This was based on an Opt out method, by which every citizen is already a part of the database, and if some does not want to be part of the research then he would have to opt out, his data would be deleted from the database, but the research that had already been conducted would not be affected. There is a lot of criticism of this method; Greely calls this as a form of compulsory enrollment and a violation of the respect for autonomy. He believes that autonomy could be retained by using an opt-in structure [63]. Another reason for the success of this program was that it was made as law in Iceland thus ensuring high degree of public scrutiny and acceptance. Though it might seem like the practice of informed consent is an answer to most of the privacy issues, it raises several ethical and practical issues and it can be argues that it is wrong to consider it a panacea for genetic privacy problems. A major problem is regarding the power distribution between the two groups involved in consent, due to the very nature of it, especially in insurance and employment. The group being asked for consent is already at a disadvantage as this leads to coercion, by demanding the access to genetic information in exchange of goods. The other problems are related to the degree of consent required for future work and advisability of mandating destruction of samples or data at the end of a specified period or upon completion of the purpose for which samples or data were collected [64]. To protect the loss of the information it is also suggested that fair information practices be employed. Mary J Culnan has hypothesized two main ideas [65]: “When people are not explicitly told that fair procedures will be employed for managing their personal information, people with a greater concern for privacy will be less willing to have their personal information used for profiling.” “When people are explicitly told that fair procedures will be employed for managing their personal information, privacy concerns will not distinguish people who are unwilling to be profiled from those who are willing to have their personal information used for profiling.” Legislators realized that fair information practice should be followed and so the Privacy Act of 1974 came into being. By following these practices, the customer trust would increase and they would be more willing to share their information. Gostin has presented the following as an important part of the fair information practices: Substantive review of the research, procedural review, control of personal health data, right to review and correct personal data, use of data for intended purposes. He believes that by following these practices some of the privacy issues would be addressed.

6. Open Consent: Paradigm Shift?

Lunshof[66] argues that the even though most of the research promises the protection of an individual’s private information, since the complete confidentiality can never be guaranteed in practical circumstances, the whole notion of informed consent is rendered invalid and fair information practices are thereby violated. On these grounds she asserts her support for an “open consent” model which is based on veracity rather than assurances of genetic data secrecy. The model has been successfully implemented in the Personal Genome Project. Open consent as part of the Personal Genome Project implies that research participants accept that:

Their data could be included in an open-access public database.

No guarantees are given regarding anonymity, privacy and confidentiality.

Participation involves a certain risk of harm to themselves and their relatives.

Participation does not benefit the participants in any tangible way.

Compliance with monitoring of their well-being through quarterly questionnaires is required.

Withdrawal from the study is possible at any time.

Complete removal of data that have been available in the public domain may not be possible.

“The moral goal of open consent is to obtain valid consent by effectuating veracity as a precondition for valid consent and effectuating voluntariness through strict eligibility criteria, as a precondition for substantial informed consent.” It remains to be seen whether the open consent model can work as a feasible solution or is just too idealized for the real world

7. Conclusion

The developments in genetic technology have led to creation of a new kind of “personal” information which is seemingly indefinable; and it has been established that this information needs to be protected under current societal norms. The divulgence of such information can lead to a vast array of undesired consequences, from psychological effects on individuals to serious ramifications for groups, including discrimination in employment, for insurance and in society in general. This has resulted in serious attention by policy makers, bioethics groups etc. to the notion of genetic privacy. The resulting struggle is a classic example of the effort to maximize public good while protecting private interests and societal structure itself. The public interest lies in the research being conducted in which vast amounts of genetic data is required, law enforcement, public health and welfare etc. There have been several approaches that have led to current policies. On one hand there are policies to curb genetic discrimination in society, which may or may not employ the principle of genetic exceptionalism and on the other, the policies to protect the information itself, which can be imposed on the research organizations in form of law and provide guidelines for consent and information exchange. For a formal classification, the legislations to protect the privacy can be classified into three main categories: Front Loading, Information management and Harm Avoidance. The government has made laws in each of these areas. Front loading- under this approach the state impedes the ability to generate informed consent on testing. Information management- Government tries to manage the storage, sharing and the usage of

the information. Finally in the harm avoidance, it tries to minimize the extent of harm to individuals by making laws that prevent discrimination based on genetic information. There are several ethical issues that we have not touched upon in this paper due the limitations space ad context. These issues concern themselves more with the nature of the information rather than the privacy issues. For example, is a doctor obligated to inform an individual’s relatives about a genetic condition? Finally, we have commented on the inadequacy of informed consent and introduced the open consent model. Another question that can be raised is that is such a model possible if there is a societal acceptance of the true nature of genetic information (in light of the success of Iceland bio-bank and decode)? And can such acceptance be motivated by active involvement of public in the framing of problems and solutions (Beck)?

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49. Nuffield Council, ‘Genetic Screening’, para. 10.13.

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59. Id. 6

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