Introduction
The ethical issue that is the focus of the current study is the use of patient DNA for research by a company without their knowledge and consent. In the context of this ethical issue, the main concern pertains to the absence of informed consent acquired from an individual whose DNA material was used. Through evidence-based research, it is necessary to identify best practices for addressing ethical concerns in the healthcare industry. Besides, it is necessary to compare and contrast the studies and projects on informed consent practices. External factors that affect the issue in the current case may include organizational, and socio-demographic, as well as the extent of patients’ knowledge about the informed consent process.
Informed Consent
Informed consent represents a crucial ethical conduct aspect of research involving humans who can make autonomous decisions regarding their participation. The goal of informed consent is to ensure that subjects know and understand the potential risks of research (Lee, 2018). The agreement to participate is made voluntarily, without coercion or manipulation to guarantee that bias does not affect the outcomes of the study. In addition, an ongoing consent process shows that participants stay up-to-date regarding what is occurring during research. Depending on the procedures and other factors, consent can be documented in different forms, which illustrates the flexibility of the process.
Informed Consent in Genetic Testing
Informed consent is foundational to the principle that patients and research participants can make autonomous decisions regarding undergoing genetic testing. In order to make such decisions, individuals must receive and comprehend information for making decisions about their participation. Currently, there is no unified approach to informed consent in genetic testing as there is a variability in standards in determining which information should be provided. An example of the available standards is the ‘medical providers standard,’ which represents professional guidelines that identify local and national standards of what information to include as a part of the informed consent process.
Ethical Issue – Use of DNA Without Client Consent
The core ethical issue applied to the case being discussed is the use of DNA for research without the consent of a client. This is problematic because the company should have engaged in a dialogue with its clients and informed them about the purposes of using DNA data, the process in which the data will be used, and that genomic data may be stored and used indefinitely. Regarding any risks, the company should communicate that it would address them and that any concerns about privacy would be handled effectively.
Evidence-Based Research to Eliminate the Ethical Concerns
Evidence-based research entails using prior findings systematically to address newly arising challenges. EBP can help reform existing standards and norms regarding DNA use for research purposes, allow giving patients notice of medical records review and use, show that acquiring consent is not possible in all instances, and help wider audiences understand the importance of DNA data in research. Prior research could illustrate the application of the Privacy Rule and Common Rule.
The application of evidence-based research is necessary for distinguishing between instances where consent must be obtained and where it is not required and creating step-by-step guidelines that patients can reference. It is necessary to create a formal review process to determine whether organizations adhere to the ethical standards of DNA use in research and develop methods for safeguarding information through DNA data encryption. Besides, it is necessary to set clear expectations on disclosure and transparency in relationships between organizations and clients.
Comparison of Studies and Quality Management Projects
Research on the matter of informed consent in DNA testing agrees that research in this area entails high requirements for quality and often raises ethical, legal, and social concerns. The use of DNA data has significant implications not only for patients but also for their families. This is why is necessary to address any issues with adequate information disclosure and implement change management methods for quality assurance. Because key elements of information are often missing in informed consent forms, it is necessary to carry out workshops to strengthen the ethics of the use of DNA for research.
A contrasting perspective to Berwouts et al. (2010) and Al-Riyami et al. (2011) was provided in the study by Samuel et al. (2017) who proposed to focus on a relational approach to obtaining informed consent in DNA testing. This approach entails more collaboration between patients and practitioners because the informational aspect of genetic testing may not always facilitate effective decision-making. Therefore, effective standards for obtaining informed consent should rely on virtue ethics – when clients trust their providers, they are more willing to give consent to DNA testing for research.
EBP Quality Management Recommendations
Based on available EBP research, recommendations for quality management are made. Specifically, there is a need for stricter regulatory oversight procedures and specifically designed regulations for organizations that conduct genetic testing. There should be no differences in the use of licensing, certification, and accreditation procedures while increasing standardization in test performance and the reporting of results. In addition, it is necessary to establish certainty in terminology and the choice of appropriate quality systems.
External Factors Affecting the Ethical Concern
Organizational factors represent the most impactful category of external factors affecting the ethical concern in the discussed case. They include the lack of a standardized consent form that the company can give to its clients, the absence of employee training on obtaining informed consent, and constraints in time linked to obtaining consent from clients. In addition, there may be limited administrative support for obtaining informed consent, the lack of policy at the institution, as well as everyday challenges of assigning responsibilities for informed consent taking.
Other external factors affecting the ethical concern include healthcare worker-related factors and policy and regulatory factors that influence the lack of adherence of an organization to the standards of informed consent. Healthcare worker-related challenges include the lack of knowledge about the need to obtain informed consent and potentially negative attitudes toward the procedure. As policy and regulatory factors, they include the absence of a clearly defined policy to which organizations must adhere when collecting and using DNA for research. Besides, there is a great degree of flexibility in how organizations approach consent in DNA testing.
Conclusion
To conclude, the ethical issue of a company using client DNA data for research without their consent may occur without malice on the organization’s end. While DNA used for research entails high standards, there is variability in policies and procedures, which causes further issues with informed consent. Therefore, because organizations can approach informed consent collection in different ways, it is necessary to establish a formal review system for informed consent in DNA research. Besides, there is a need for educating healthcare workers about how they can obtain consent from clients.
References
Al-Riyami, A., Jaju, D., Jaju, S., & Silverman, H. (2011). The adequacy of informed consent forms in genetic research in Oman: A pilot study. Developing World Bioethics, 11(2), 57-62.
Berwouts, S., Morris, M. & Dequeker, E. (201). Approaches to quality management and accreditation in a genetic testing laboratory. European Journal of Human Genetics, 18(Suppl 1), 1-19. Web.
Lee S. W. (2018). Ethical implications of clinical genomic information, records research, and informed consent. The Ochsner Journal, 18(3), 196-198. Web.
Negash, W., Assefa, N., Baraki, N., & Wilfong, T. (2021). Practice and factors associated with informed consenting process for major surgical procedures among health-care workers, South Eastern Ethiopia. International Journal of General Medicine, 14, 7807-7817. Web.
Samuel, G. N., Dheensa, S., Farsides, B., Fenwick, A., & Lucassen, A. (2017). Healthcare professionals’ and patients’ perspectives on consent to clinical genetic testing: moving towards a more relational approach. BMC Medical Ethics, 18(47). Web.