Toxic tort litigation involves judgments about an actor`s duty of care that creates risks for those who may be harmed by those risks. Toxicogenomic data could influence or modify these due diligence judgments in a number of contexts. For example, finding that certain members of the population may have a genetic susceptibility that makes them particularly sensitive to a product may impose new obligations on the manufacturer of the product with respect to testing, labelling and selling that product. Some people claiming to have been harmed by the Lyme disease vaccine Lymerix have sued, claiming that the vaccine manufacturer was required by law to warn vaccine users to obtain genetic testing for polymorphism, which would have affected the user`s propensity to develop serious side effects of the vaccine (Noble 2000). However, the lawsuit, which was settled before a judgment was rendered, likely contributed, at least indirectly, to the vaccine`s withdrawal from the market, and was the first of what is likely to be a new trend for plaintiffs who claim that a product manufacturer has additional obligations to protect people who are genetically sensitive to their products. Alternatively, under the «idiosyncratic defense doctrine,» defendants may argue in some cases that they have no obligation to protect people with rare genetic susceptibility to a product. In this series of cases, the courts have held that a product manufacturer can reasonably be expected to ensure the safety of «normal» members of the public and not persons with unusual sensitivity to the active ingredient in question (Cavallo v. Star Enterprise, 1996; Marching, 2000). Address privacy, confidentiality and security issues that affect the use of toxicogenomic data and the collection of data and samples required for toxicogenomic research. The fact is that technology has made our information available to businesses – takeaway and, in some cases, sell.
Is it ethical for a company to collect data about one person and then sell that information to another company? Many organizations collect data for their own purposes, but they also recognize that your data is valuable to others. As a result, selling data has become a source of revenue for many businesses. If you didn`t know that your data was collected by Company A, it`s even less likely that you would know it was being sold to Company B. A related issue concerns cases where research on biodeposit samples has led to commercially valuable discoveries: are sample donors entitled to a share of the proceeds (see Greenberg v. Miami Children`s Hospital Research Institute, Inc., 264 F. Supp. 2d 1064 [S.D. Fla. 2003]; Moore v. Regents of Univ. of Cal., 793 p.2d 479 (Cal. 1990)? There have been documented cases where an individual`s sample has been extremely useful for the development of cell lines or other investigational products (Moore v.
Regents of Univ. of Cal., 793 p.2d 479 [Cal. 1990]; Washington, D.C., 1994). However, it is much more likely that analyses of many samples will be required to obtain a commercially viable result. Whether it is ethically justifiable for individual research subjects to relinquish all their interests in the products of discovery is unclear, although it is common for consent documents to provide for this. Regardless of the wording of informed consent, the principle of benefit-sharing would be respected if researchers stated in advance that they would allocate a small percentage of commercialization revenues to donations to a not-for-profit organization that, for example, provides medical care to poor people with the disease that is the purpose of the research (HUGO 2000; Knoppers, 2005). Wise, I.J. and P. Borry. 2022. An ethical review of CRISPR-based elimination of Anopheles gambiae to fight malaria. Journal of Bioethical Inquiry 19(3): doi:doi.org/10.1007/s11673-022-10172-0 To what extent should individuals have responsibility for knowing whether they are at increased risk from certain exposures, avoiding those exposures, and coping with the consequences of diseases caused by those exposures? To what extent does society have a duty to respect the autonomy of the individual, to refuse to be aware of possible increases in risk, or to accept those risks? To what extent is society obliged to protect these individuals and health care when they become ill? The development, exploitation and protection of intellectual property are important elements of contemporary research strategies.
Many of the contentious IP issues, such as publication, time of application, ownership and licensing, arise «downstream» after a patentable invention is discovered. These questions are not limited to toxicogenomic and pharmacogenomics research. However, since many toxicogenomic applications involve assays that produce large amounts of data, often with a large number of genes or proteins, obtaining intellectual property rights over all materials used in an assay could be particularly burdensome and problematic for researchers and platform makers in the field of toxicogenomics (NRC 2005b). The introduction of new technologies can have a profound impact on human behaviour. New technologies give us capabilities that we didn`t have before, creating environments and situations that weren`t specifically addressed in ethical terms. Those who master new technologies acquire new power; Those who can`t or won`t control it can lose power. In 1913, Henry Ford set up the first mobile assembly line to create his Model T cars. While this is a huge technological (and economic) step forward, the assembly line has reduced the value of humans in the production process. The development of the atomic bomb concentrated unimaginable power in the hands of a government that then had to struggle with the decision to use it. Today`s digital technologies have created new categories of ethical dilemmas. The rise of patents has led to a new form of greed for profit called patent trolling. A patent hunter is a person or organization that acquires the rights to a patent, but does not actually manufacture the invention that protects the patent.
Instead, the patent hunter looks for those who use the invention illegally in any way and prosecutes them. In many cases, the alleged infringement is questionable at best. For example, companies have been sued for using Wi-Fi or digitizing documents, technologies that have been on the market for many years. While pharmacogenomics holds promise for increasing drug effectiveness and reducing drug-related adverse events, there is a risk of «racialization» of medicine. It`s easy to rely on race as a surrogate for genotype, but the social cost of doing so can be high. «By carelessly equating race with genetic variation and genetic variation with genotype-based drugs, we risk developing an oversimplified view of race-specific drugs and a misleading view of the scientific importance of race» (Rothstein 2003, pp. 330). The controversy surrounding the FDA`s approval of the drug BiDil in 2005 for self-identified African Americans shows the timeliness of the problem (Saul 2005). See Box 11-3. Health behaviour and health education researchers and practitioners can play a critical role in integrating toxicogenomics into practice to improve public health (e.g., Sorenson & Cheuvront, 1993; C.
Wang et al., 2005). Priority areas ripe for further research, understanding, and applications include: (1) public and provider education on genetic information, (2) risk communication and behavior change interventions, (3) sociological consequences of genetic testing, and (4) public health insurance and advocacy. An environmental perspective should be considered when considering education and communication issues associated with the application of toxicogenomics to reduce health risks. Many types of stakeholders and practitioners should be considered and, therefore, many levels of intervention and analysis should be sought. In the ACM Code of Conduct, you will find many simple ethical instructions, such as the exhortation to be honest and trustworthy. But because it is also an organization of IT-focused professionals, there are more specific caveats that relate directly to information technology: There are many dimensions to translating toxicogenomic and pharmacogenetic knowledge into health benefits. Research should focus on individual and demographic educational aspects and on risk communication of application to medical practice and public health (Kardia and Wang 2005). For example, critical research questions at an individualized level are illustrated by research on genetic risk communication (Hopwood et al., 2003), formed consent processes (Geller et al., 1997), decision-making (Shiloh, 1996), and provider knowledge and awareness of genetics (Suchard et al., 1999). These areas of research have a direct impact on genetic training and genetic counseling (C. Wang et al.
2004), interventions with genetic information (Lerman et al. 1997), patient adherence to screening recommendations (Hadley et al. 2004), effectiveness of decision support tools (Green et al. 2004), and training of health care providers (Burke et al. 2002). A socially disadvantaged population may also be based on common somatic mutations. For example, workers with an acquired mutation or biomarker based on a particular occupational exposure, or residents of a particular area with toxic exposure who have demonstrated the subclinical effects of a particular exposure, may also be referred to as socially vulnerable populations. These polymorphisms may not be phenotypically evident and often are not correlated with race, ethnicity and other traditional social categories.