-
-
-
Genomic Data and the Research Enterprise
QUESTION
In the 1940s, researchers recruited over 5,000 people from the town of Framingham, Massachusetts to participate in a study to discover the causes of heart disease. Over 60 years later, the children and grandchildren of the original cohort are also enrolled in the study, in addition to new cohorts with diverse racial and ethnic backgrounds (Framingham Heart Study, n.d.).
The Framingham Heart Study is one of the largest and longest running research projects in the United States. Over the life of the study, researchers have added new objectives and new tools and tests in response to advancing science and technology, which have given rise to new ethical considerations. One new objective is to discover associations between genetic mutations and disease, leading researchers to begin conducting genetic testing. This fictionalized deliberative scenario is loosely based on an ethical issue encountered by the study.
You are a member of the study’s ethics board. The investigators have decided to embark on genetic research to better understand the genetic risk factors for certain diseases. It has always been common practice in the study to inform participants about concerning results, but genetic information can be different—it can reveal a wider array of information than other tests, the meaning of which can be uncertain. In addition, it can reveal information about biological relatives, who have not consented to be in the study, and put participants in the position of having to decide whether to disclose genetic information to them. Many of the participants are likely to have one or several genetic mutations—some of which might lead to cancer, others of which have unknown effects.
As a member of the ethics board, you are tasked with recommending policies for dealing with the results of these genetic tests, based on the information in the fictional memo below.
-
-
| Subject | Nursing | Pages | 4 | Style | APA |
|---|
Answer
Genomic Data and Research Enterprise
The ethical implications of research form one of the issues affecting outcomes and the development of clinical interventions in medicine. Evaluating historical and current clinical research events indicates increased awareness and emphasis on the protection of participant information. Genome research continues to define approaches of ethics in clinical studies, and it is crucial that current and future policy focus on alleviating the negative implications of issues such as publicly accessible data. The question of ethics relative to genomic data and research enterprise is multidimensional, implying that it can increase the risks of discrimination in health insurance and false alarm if giving research participants invalidated findings (Das et al., 2020). This paper provides a recommendation statement based on the case study regarding genomic data and enterprise research from a research participant's perspective.
The imperatives of sustaining the value and interests of participants in genomic data and research are pegged on how enterprises only focus on the validity of unintended findings but also confidentiality and security. In general, the ethics of the study underpins the importance of clinical practices to ensure that participant data is secured. Whereas genomic data provide critical information on health development, it should be understood that individual genetic and genomic data represent the most private information about the past, present, and future (Bonomi et al., 2020). Enterprise policy should focus on keeping the information package safe and confidential. The mantra needs to establish a firm policy around data security and management practices, especially from those having access to participant data.
Secondly, clinical research enterprises need to establish coherence in defining the purpose of collecting genome data. The pragmatism lies in recognizing that a research participant is the primary beneficiary of a clinical trial; therefore, all decisions are supposed to affirm that fact. It is an issue of ethics defined on-premise of right and necessity when disclosing information not initially under investigation to a subject (Oliver et al., 2012). Under such circumstances, the proposition needs to look at the validity of new genetic findings and how they will impact a subject's psychological and physical. The primary benefit component associated with the subject's expectations should inform decisions for disclosure. For instance, disclosure of genetic mutations that cause malignant conditions can fast-track early intervention and mitigate risk factors, which overrides the psychological impact associated with information acquisition (Hartz et al., 2015). Therefore, a necessity rather than ethical considerations must inform disclosure of genetic data to patients.
One of the issues raised concerning genetic data and disclosure to patients revolves around validity. Whereas ethical considerations provide buffers against access to unauthorized information in clinical trials, it is the mandate of research to lay the ground bare and allow consolidation of genomic data based on sufficient evidence (Hartz et al., 2015). Research participants may be aware of the possibilities of findings recording other underlying conditions based on the quality of information and clarity provided at the beginning of trials. Validation of comorbidities results not initially on the scope of trials can be achieved with transparency and seeking participant consent, a direction that genomic data research needs to adopt (Sankar and Parker, 2017). Participant consent to review unsubstantiated claims and findings will reduce incidences of dramatic follow-up care and procedures based on questionable validity. The proposition aims to expand clinical trials' scope based on genomic data and improve the extension of response.
In conclusion, the benefits of genomic data and research lie in balancing ethical research components and promoting the benefits accrued by participants. All decisions and tasks must be informed and built with the consensus that a participant must receive the best possible disclosure to information based on validity. Genomic data policies should extend investigations into initially unintended comorbidities as part increasing the scope of benefits for participants, their generations, and the public.
References
|
Bonomi, L., Huang, Y., & Ohno-Machado, L. (2020). Privacy challenges and research opportunities for genomic data sharing. Nature Genetics, 1-9. Caulfield, T., McGuire, A. L., Cho, M., Buchanan, J. A., Burgess, M. M., Danilczyk, U., ... & Juengst, E. T. (2008). Research ethics recommendations for whole-genome research: a consensus statement. PLoS Biol, 6(3), e73. Das, S., McClain, C. J., & Rai, S. N. (2020). Fifteen Years of Gene Set Analysis for High-Throughput Genomic Data: A Review of Statistical Approaches and Future Challenges. Entropy, 22(4), 427. Hartz, S. M., Olfson, E., Culverhouse, R., Cavazos-Rehg, P., Chen, L. S., DuBois, J... & Ramnarine, S. (2015). Return of individual genetic results in a high-risk sample: enthusiasm and positive behavioral change. Genetics in Medicine, 17(5), 374-379. Oliver, J. M., Slashinski, M. J., Wang, T., Kelly, P. A., Hilsenbeck, S. G., & McGuire, A. L. (2012). Balancing the risks and benefits of genomic data sharing: genome research participants’ perspectives. Public health genomics, 15(2), 106-114. Sankar, P. L., & Parker, L. S. (2017). The Precision Medicine Initiative’s All of Us Research Program: an agenda for research on its ethical, legal, and social issues. Genetics in Medicine, 19(7), 743-750.
Wagner, W. E. (2016). Using IBM® SPSS® statistics for research methods and social science statistics (6th ed.). Thousand Oaks, CA: Sage Publications.
|