Introduction
A potential study enrollee indicates that she wants to participate in the study on the safety of a new medical device to be used on human beings but does not wish to read the materials, including the consent form. The paper discusses the further actions of a researcher and the ethical principles involved.
Ethical Challenges to Address
In this case study, some of the ethical challenges that must be addressed include obtaining informed consent from study participants, respecting autonomy and decision-making, protecting the safety of participants, communicating effectively, and ensuring transparency. Potential study participants must understand the risks and benefits of the study and any available alternatives before deciding to participate (McGuire et al., 2020). Hence, allowing a potential enrollee to ask, “where do I sign” without understanding the information provided is unethical. It is important to explain the study and its associated risks to potential study enrollees and any available alternatives.
Furthermore, it is important to ensure that potential participants can make an informed decision and that they have sufficient time to make a timely decision. It is important to respect the autonomy of potential study participants and ensure they understand their decisions’ implications. Beneficence is concerned with the potential benefits of the study to the participants and society. For instance, the study of a new medical device might be beneficial to society. Non-maleficence requires that potential study enrollees are not exposed to unnecessary risks like harm or abuse. Justice ensures that all potential study participants have equal access to the study and its associated benefits and that no one is disadvantaged or favored (Molina-Mula & Gallo-Estrada, 2020). Transparency requires that potential study enrollees are informed of all relevant information clearly and understandably.
In this situation, it is important to follow the ethical principles of research. For instance, ensuring all research participants are safe from harm (McGuire et al., 2020). You are responsible for ensuring that the potential study enrollee has all the information to make an informed decision about participating. It would help if you did not allow the potential study enrollee to sign the consent form without providing them with a detailed explanation of the study, the risks and benefits associated with taking part, and any available alternatives to using the new medical device. If the potential study enrollee still wishes to participate, provide them with the materials to read and allow them to ask questions. As a researcher and team leader, answer all questions from the enrollee and act as an example. Provide an opportunity for the potential study enrollee to discuss their decision with someone independent of the research team, such as a family member or healthcare professional. It is important to be respectful of the potential study enrollee’s wishes and not pressure them into participating. Suppose the potential study enrollee insists on signing the consent form without providing informed consent. In that case, it is important to document the situation in the study records and explain why it was necessary to proceed with the enrolment.
In this situation, as a team leader and researcher should not proceed with obtaining the informed consent of the potential study enrollee. Obtaining informed consent is an important ethical principle in research involving human subjects (Biros, 2018). It is the researcher’s responsibility to ensure that the potential study enrollee is provided with all relevant information about the study and is fully aware of its risks and benefits. In addition, the potential study enrollee must be allowed to ask questions and receive answers. In this case, the potential study enrollee needs to be adequately informed and aware of the study’s risks and benefits. The ethical principles involved in this situation are autonomy, respect for persons, and beneficence (Biros, 2018). Autonomy is the principle that individuals should be free to make their own decisions and should not be coerced into making a decision they are not comfortable with. Respect for persons is the principle that individuals should be treated with respect and dignity and that their decisions and preferences should be respected. Beneficence is the principle that the research should benefit the participant and not cause harm (Biros, 2018). It is the responsibility of the researcher to ensure that all of these ethical principles are upheld.
In addition, it is important to adhere to the ethical principles of HIPAA (Health Insurance Portability and Accountability Act). HIPAA requires that all health information must be kept confidential and secure (Krzyzanowski & Manson, 2022). This means that any health information obtained during the consent process must be kept secure and only shared with those who need to know, such as the research team. This ensures that the potential study enrollee privacy is respected and that their health information is kept secure (Krzyzanowski & Manson, 2022). Furthermore, HIPAA also requires that any data collected during the study be kept secure and that any personal health information not be shared without the express permission of the potential study enrollee.
Informed consent is an ethical principle in medical research requiring researchers to provide participants with all the information they need to make an informed decision about whether or not to participate in the study. For instance, in the case under study, it is the role of the researcher to provide the enrollee with all information about the study (Biros, 2018). This includes information about the purpose of the study, the procedures to be used, the risks and benefits, and any alternatives to the study.
The researcher must explain the potential consequences of not participating, such as being denied access to the medical care or treatment being studied. Participants must also have the right to withdraw from the study at any time (McGuire et al., 2020). Informed consent is critical to any ethical research study, ensuring that participants understand their rights and make an informed decision about their participation (Biros, 2018). Therefore, the enrollee should be guaranteed to make her decision concerning participation. The researcher should answer all inquiries of the enrollee, which is essential for protecting the rights and well-being of research participants. By requiring researchers to clearly explain the risks and benefits of participating in a study, informed consent helps to ensure that participants enter into a study willingly and with full knowledge of the potential risks and benefits. It also aids in guaranteeing that study participants have the freedom to leave at any moment. Giving their informed consent helps to guarantee that study participants are shielded from any possible risks.
The role of an Institutional Review Board (IRB)’s is to protect human research subjects’ rights and welfare. IRBs review research protocols to ensure they comply with applicable federal regulations and institutional policy (Lapid et al., 2019). Therefore, all research team members must understand the ethical role and protocols that ensure the required standards have been followed. Having the opportunity to obtain the consent form, it is appropriate to ensure the right ethics and safety standards (McGuire et al., 2020). For example, all information obtained from participants should be kept confidential and secure. It is the role of IRBs to also provide oversight of research activities throughout the study, including monitoring of adverse events. For instance, they explained to the enrollee the potential risks and available alternatives to using new medical devices. IRBs ensure that all research activities comply with applicable laws, regulations, and institutional policies (Lapid et al., 2019). Hence, the researcher can ensure that the enrollee participates fully in the research and reads all necessary materials like the consent form, study descriptions, and all other relevant materials of the field research. It is the role of the researcher to explain to the enrollee the importance of observing the research protocol. Thus, the role of an IRB is to protect the rights and welfare of human research subjects by providing oversight of research activities and ensuring compliance with applicable laws, regulations, and institutional policies.
Conclusion
In conclusion, research ethics in any field are important in determining the research outcome. Various protocols are observed during research, and rules must be followed to ensure all ethics are observed. For example, it is the right of participants to be protected from any form of abuse and harm. Research in the medical field requires an ethical code of conduct that ensures safety and respect for all participants. This includes the principles of respect for persons, beneficence, justice, and non-maleficence. Respect for persons requires that research participants give informed consent and that their autonomy be respected. Beneficence requires that potential risks to participants be minimized, that potential benefits be maximized, and that the research should be conducted in the best interest of the participants. Justice requires that research participants be treated fairly, including that any potential risks or benefits be distributed fairly. Non-maleficence requires that potential risks to the participants be minimized and that no harm can come to them due to the research. Adhering to these ethical principles allows medical research to be conducted safely and with the utmost respect for the participants.
References
Biros, M. (2018). Capacity, vulnerability, and informed consent for research. The Journal of Law, Medicine & Ethics, 46(1), 72–78. Web.
Lapid, M. I., Clarke, B. L., & Wright, R. S. (2019). Institutional review boards: What clinician researchers need to know. In Mayo Clinic Proceedings (Vol. 94, No. 3, pp. 515–525). Elsevier. Web.
McGuire, A. L., Aulisio, M. P., Davis, F. D., Erwin, C., Harter, T. D., Jagsi, R., Klitzman, R., Macauley, R., Racine, E., Wolf, S. M., Wynia, M., & Wolpe, P. R. (2020). Ethical challenges arising in the COVID-19 pandemic: An overview from the association of bioethics program directors (ABPD) task force. The American Journal of Bioethics, 20(7), 1–13. Web.
Molina-Mula, J., & Gallo-Estrada, J. (2020). Impact of nurse-patient relationship on quality of care and patient autonomy in decision-making. International journal of environmental research and public health, 17(3), 835. Web.
Krzyzanowski, B., & Manson, S. M. (2022). Twenty years of the Health Insurance Portability and Accountability Act Safe Harbor Provision: Unsolved challenges and ways forward. JMIR Medical Informatics, 10(8), e37756. Web.
