Statistical bias is known to affect the objectivity and integrity of data analyses and results, among other aspects of studies. Fundamentally, researchers have the primary responsibility to research subjects in that those tasked with conducting a study are required to recognize and adhere to the rights and interests of humans and any animal subject at all stages of their project. In the first study, the researchers did not inform the first group of participants that they were to receive a flu shot. Informed consent is an inalienable right that should be accorded to participants of a study ( American Statistical Association, 2018 ). Without informed consent, the reliability of the data was compromised. Informed consent aims to provide sufficient information to a potential participant to make a voluntary decision regarding or not to participate in a study. Fundamentally, the participants needed to understand the health risks that they were placing themselves in before participating in the actual research.
In removing the unethical element due to uninformed consent, the researchers must seek consent before the research. Informed consent also entails anticipating and soliciting approval for secondary and other indirect uses of data collected during the study, such as linkages to other data sets ( Nijhawan et al., 2013 ). The first stage of acquiring informed consent is giving information about the study to the participants. During this phase, the researcher will give a general description of the study and the projected end goals and uses of the data. The second phase is obtaining consent, whereby the researcher reiterates the terms and conditions of the study and allows each participant to agree or refuse to participate in the study. The researcher had an option of obtaining informed consent either orally or in a written form. However, for the written process of obtaining informed consent, the researchers must ensure that those involved can read and write. A rule of thumb for obtaining informed consent is that the researchers should not conceal any information from the participants.
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References
American Statistical Association. (2018). Ethical guidelines for statistical practice. Prepared by the Committee on Professional Ethics of the American Statistical Association . 57-70.
Nijhawan, L. P., Janodia, M. D., Muddukrishna, B. S., Bhat, K. M., Bairy, K. L., Udupa, N., & Musmade, P. B. (2013). Informed consent: Issues and challenges. Journal of advanced pharmaceutical technology & research , 4 (3), 134–140. https://doi.org/10.4103/2231-4040.116779
