Identify two issues you have seen undermine these rights in your clinical setting.
DNP 810 Topic 8 Discussion Question Two
There are several issues that undermine client rights to make genetic and genomic-related decisions and act. Identify two issues you have seen undermine these rights in your clinical setting. What are potential solutions for each? What is your role as the patient advocate with each issue? Explain. Support your rationale with a minimum of two scholarly sources.
Paramount in the conduct of genetic studies is concern about protecting the privacy of potentially sensitive genetic information generated about research participants. A number of groups have offered recommendations for protecting the privacy of study
DNP 810 Topic 8 Discussion Question Two
DNP 810 Topic 8 Discussion Question Two
participants’ genetic information (for example, Annas et al., 1995; Fuller et al., 1999; NBAC, 1999). Privacy concerns arise because many individuals, institutions, and/or organizations may have an interest in knowing a person’s genetic status, and such knowledge has the potential to result in stigmatization, discrimination, and other adverse effects.
Potential Societal Stigmatization and Discrimination
Examples of insurance (e.g., auto, health, and life) and employment discrimination related to genetic information have been reported by consumers and by genetic counselors and nurses in genetics (U.S. Congress, Office of Technology Assessment, 1992; Geller et al., 1996; Lapham et al., 1996). These cases also reveal that difficulties with other societal agencies and institutions such as blood banks, adoption agencies, the military, and schools may be possible (Geller et al., 1996). It has been suggested that educational and legal institutions may have an interest in genetic status for identifying learning problems (Geller et al., 1996; Fuller et al., 1999) and deciding custody and paternity disputes (Fuller et al., 1999). Medical benefits reportedly have been denied to retirees with illnesses determined to have a known genetic basis (Fuller et al., 1999), an issue that may be particularly relevant to incorporating genetic sampling and studies into demographic studies of aging populations.
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Despite these studies, the extent of the risk of genetic discrimination in health insurance and other societal institutions has been difficult to pin down. Examples of genetic discrimination, such as those included in the studies referred to above, resulted in legislation in many states and at the federal level, through the Health Insurance and Portability and Accountability Act (HIPAA) (for overviews see Fuller et al., 1999; Hall and Rich, 2000). However, current policies and existing laws to protect the privacy of genetic information are limited in number and nature and vary according to state, while comprehensive federal protections do not exist. A recent study aimed to assess the effectiveness of laws prohibiting health insurers’ use of presymptomatic genetic information (Hall and Rich, 2000). The study used a variety of approaches to collect information from representatives of various groups, including genetic counselors, state departments of insurance, and health insurers. Similar data were collected from seven different states with and without laws prohibiting health insurers’ use of presymptomatic genetic information. After a lengthy analysis, researchers were unable to document any substantial degree of genetic discrimination by health insurers. They were also unable to document a difference in insurers’ actions between states with and without genetic-specific laws or before and after enactment of state laws in a particular state. However, they did discover that insurers were well aware of the existence and content of such laws, and suggest that the existence of such laws has served to heighten insurers’ awareness of the “social legitimacy” of using presymptomatic genetic information.
In addition to genetic-specific laws and regulations, protection of participants in federally funded research is addressed by a two-pronged approach, that is, review by an institutional review board (IRB) and execution of an informed consent process. Most institutions that receive some federal funds require that nonfederally funded projects be reviewed by their IRB as well. The critical importance of the informed consent process in describing the privacy-associated risks of genetic research studies and the mechanisms in place to protect participants is discussed in detail by Botkin in this volume, as well as elsewhere (Institute of Medicine, 1994; Clayton et al., 1995; American Society of Human Genetics, 1996). For federally sponsored research, the IRB is responsible for ensuring that participants’ risks are minimized, their rights and welfare are protected, and their consent to the research protocol is informed and voluntarily given (Fuller et al., 1999; Department of Health and Human Services, 1991). IRBs also consider issues related to the confidentiality of research records and how these protections are communicated to study participants. Specific suggestions about considering these issues within the context of genetic research studies are offered in the IRB Guidebook (OPRR, 1993). However, as noted elsewhere, research on current practices to protect confidentiality of research data, including genetic data, is limited, and best practices have not yet been developed (Fuller et al., 1999).
One option that may be available to genetic researchers is to obtain a federal Certificate of Confidentiality. Certificates of Confidentiality may apply to certain types of genetic research (see Earley and Strong, 1995; Fuller et al., 1999). Originally developed to provide protections for research into illegal or very sensitive activities, such as illegal behavior, sexual practices, and alcohol or drug use, Certificates of Confidentiality protect federally and privately funded institutions from being compelled to reveal identifying information about participants in a research study (OPRR, 1993). However, as noted by Fuller et al., these Certificates do not protect research participants from being compelled to reveal research data or information.
Another option available to investigators is to work with anonymous or unlinked samples, i.e., samples that cannot be linked to any identifying information. It is often difficult in genetic studies to work with unlinked samples, since matching DNA sequences with medical histories or pedigree information is integral to the research process. In addition, it may still be desirable for individuals to be able to exert some control over how their samples are used, even if the samples have had all identifying information removed (see below; Clayton et al., 1995; Botkin, this volume). However, if unlinked samples can be used, this affords protection from many privacy concerns.
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