Introduction
Several ethical principles need to be considered when conducting research. At the core of the code of ethics, researchers are expected to do good (beneficence) without causing harm (maleficence). This paper highlights the importance of institutional approval, informed consent, and sharing research data for verification. The essay also discusses how the standards would apply in research of interest and how to ensure the safety of human subjects during the research.
Institutional Approval
The institutional review board (IRB) is responsible for approving, rejecting, and monitoring all research activities within its jurisdiction. IRB uses a group process to assess the research protocols and materials concerning their impacts on participants. The board ensures that the research subject’s welfare, safety, rights, and privacy in a given survey are protected. The IRB also guarantees that only scientifically valid studies are conducted, and the survey adheres to the core ethical values and principles (Parker, 2016). Institutional approval is an ethics clearance or statement of compliance that shows a research project meets the minimum approved research standards and guidelines, including the study’s ethicality and validity (Parker, 2016). In case a study does not meet the minimum requirements, the board can recommend modifications to the research processes.
Informed Consent
Informed consent is a core legal and ethical requirement for any study involving human subjects. It entails giving participants complete information about all aspects of the research activities and allowing them to make voluntary decisions to participate in the study. For informed consent to be ethically valid, the research information provided to participants must contain vital elements, including a detailed description of the procedures that will be undertaken, and the possible risks and benefits. Other details incorporated in the informed consent form include the study duration, medical coverage in case of injuries, and the extent to which the study will protect participants’ identifiable and demographic data (Manti & Licari, 2018). The researcher must provide the subjects with the opportunity to withdraw from the study at any time without any consequences.
The goal of providing this information to participants is to allow them to make informed decisions on whether they want to participate in the study. Valid informed consent requires respondents to have the legal capacity to decide and exercise the freedom of choice, without coercion, force, fraud, duress, deceit, or any other ulterior motive of constraint or undue influence (Manti & Licari, 2018). This way, it is difficult for a researcher to conduct research deceitfully. Without informed consent, study subjects would risk being exploited and abused to the investigator’s benefit.
Sharing Research Data for Verification
Free and open data sharing in research can foster scientific discovery, accountability, knowledge synthesis, and decision-making. Investigators are expected to ensure data confidentiality and privacy during the handling, sharing, and storage of personal information and any incidental research findings. The National Health Act states that personal and confidential information (‘restricted’ and ‘sensitive’ data) cannot be released without consent (Kaewkungwal et al., 2020).
Failure to comply with this provision risks causing damage to a person’s character and privacy, which could lead to fines or six-month imprisonment (Kaewkungwal et al., 2020). According to Kaewkungwal et al. (2020), ethical data sharing can minimize harm and promote trust, fairness, and reciprocity. Knowing that a survey will protect and safeguard the individual’s privacy entitlements enhances trust and perceptions of fairness which, in turn, promotes reciprocity.
Sharing data within the legal framework can also safeguard intellectual property rights. The APA Board of Scientific Affairs states that researchers should freely share data with competent peers to allow for the reanalysis and verification of claims and findings (Sloan & Alper, 2018).
Unfortunately, abuse of intellectual rights during data transfers is common. According to Kaewkungwal et al. (2020), researchers tend to lose control of how their data is used after sharing. Obscure ownership rights make it difficult to determine a study’s authorship, limiting research accountability. When a survey’s author(s) is unknown, data misuse, intentional abuse, and misinterpretation are possible. Therefore, honoring the ethical and legal data-sharing guidelines will protect the subjects’ and researchers’ interests and rights and promote accountability.
Application of these Sub-Standards
The impact of human genomics on health outcomes has attracted a lot of attention in the medical field. Scholars suggest that medical practitioners could transform the healthcare system by developing personalized treatments based on patients’ genetic information. Extensive research is needed to stimulate the knowledge base for the human genome among healthcare providers as well as obtain evidence on the efficacy and effectiveness of this treatment approach. Such research will need institutional approval because it involves genetic testing on priority populations, including several family members. In the absence of IRB, an independent committee will be established to oversee the research process. The committee will periodically review the research activities until the study is completed.
A subject’s consent to participate in the study will be obtained before initiating the project. The researcher should disclose complete information about the research activities and ensure the participant is competent to make decisions and voluntarily expresses (oral or written) their consent. Consent to use and share the genetics data should also be obtained if the research requires collaboration with third parties. According to McCormick and Calzone (2016), a single genetic study on a single patient can generate up to 1 terabyte of data since it includes data on clinical observations, lab, tissue biopsy, morphologic data, imaging, etc. Due to the data volume, cooperation with third parties is inevitable.
I would protect and uphold participants’ privacy by de-identifying personal and confidential data before sharing it with third parties. Two legislative articles govern research data management – one of the stipulations states that consent for sharing personal data must be clear, affirmative, and explicit (Sloan & Alper, 2018). Therefore, participants simply checking a box as a form of consent is no longer practical. To this end, I would provide the participants with comprehensive information, written in a language they are familiar with, on how their data will be managed after collection. I will conduct quality assurance by monitoring service outcomes, assessing performance, and setting safety standards to ensure participants’ safety during the study.
Conclusion
Institutional approval, informed consent, and privacy in sharing research data are all crucial in protecting the safety and welfare of research subjects. They prevent exploitation, deception, and potential harm to participants during research. Institutional approval safeguards subjects’ welfare by ensuring that the study is conducted within the established safety standards and ethical guidelines. Informed consent and privacy in sharing research data protect participants’ right to privacy and discrimination. Consent for participation and the consent to use and share research data should always be obtained from the participants before research initiation.
References
Kaewkungwal, J., Adams, P., Sattabongkot, J., Lie, R. K., & Wendler, D. (2020). Issues and challenges associated with data-sharing in LMICs: Perspectives of researchers in Thailand. The American Journal of Tropical Medicine and Hygiene, 103(1), 528–536. Web.
Manti, S., & Licari, A. (2018). How to obtain informed consent for research. Breathe, 14(2), 145–152. Web.
McCormick, K. A., & Calzone, K. A. (2016). The impact of genomics on health outcomes, quality, and safety. Nursing Management (Springhouse), 47(4), 23–26. Web.
Parker, G. E. (2016). A framework for navigating institutional review board (IRB) oversight in the complicated zone of research. Cureus, 8(10), 1–12. Web.
Sloan, S. S., & Alper, J. (2018). Data matters: Ethics, data, and international research collaboration in a changing world: Proceedings of a workshop. The National Academies Press.