Bulger defines informed consent as the process by which “a fully informed patient or participant can participate in a research project after being informed of its procedures, risks, and benefits” (Bulger, 2002). Informed consent is a part of ethical and legal rights that research participants or patients have.
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It remains a critical procedure for any research project. Research subjects or patients must understand all issues about the research or procedure before giving their full and conscious consent to the researcher or physician to proceed with the procedure. It is necessary to understand the history of informed consent in research in order to appreciate its importance.
One significant case that influenced the issue of informed consent was “the aftermath of the Tuskegee Syphilis Study” (Deria, 2006). Between 1932 and 1972, the United States Public Health Service conducted a study in order to understand prolonged effects of syphilis among blacks (Deria, 2006).
The subjects had syphilis but were not aware of their conditions. Moreover, researchers withheld important information from them. In the 1950s, those physicians discovered that penicillin effectively treated syphilis. However, the researchers did not reveal the information to the patient about the penicillin cure.
Further, they also prevented research subjects from getting treatment. As a result, many participants “died from syphilis related complications” (Deria, 2006). However, one researcher who worked at the project revealed the procedure in a newspaper article, which shocked the public.
There were also other cases of unethical practices, which involved “the Nazi Germany doctors and their horror experiments on prisoners in concentration camps” (Deria, 2006). In addition, there were also cases of unethical studies in the US and the UK after the WW II. Since then, the issue of informed consent has become critical for researchers, legislators, institutions, and the research subjects.
The aim of the informed consent is to ensure that research subjects understand the process, benefits, and risks associated with the study. However, the process has serious challenges in its application. Researchers have failed to obtain a fully informed consent from their subjects. The requirement to obtain informed consent is critical for protecting marginalized groups from taking part in procedures they do not understand.
The informed consent has remained significant in research. It has originated from several laws and declarations like the Nuremberg Code, the Belmont Report, and the Declaration of Helsinki. These documents strive to ensure that researchers and doctors behave ethically throughout their procedures.
The informed consent guarantees and promotes the rights of the subjects as autonomous participants who deserve respect, benefits, and justice and can withdraw from the study at any time. Therefore, participants must understand implications of the study in order to make such informed choices. In most cases, researchers and participants have approached the procedure casually.
However, a well-founded consent requires the subjects to understand the significance of the process. In some cases, negligence of informed consent has led to unethical procedures, loss of subjects’ rights, and even deaths (see the case of Ellen Roche in the Asthma Study).
The process is prone to misunderstanding between the subject and the researcher. Misunderstandings in obtaining an informed consent may result from both the researcher and the subject. Such barriers contribute to unethical practices or negative outcomes in research procedures. It is the responsibility of the researcher to inform research subjects about the purpose, benefits, and risks of any procedure before such subjects take part in a procedure.
Bulger, R. (2002). Research with Human Being. In R. H. Bulger, I. Heitman and J. Reiser (Eds.), The Ethical Dimensions of the Biological and Health Sciences (pp. 117-12). New York: Cambridge University Press.
Deria, M. (2006). Protecting the Vulnerable: The Tuskegee Syphilis Study and the Evolution of Informed Consent in the Twentieth Century. Retrieved from https://med.uottawa.ca/department-innovation/medicine-humanities/history-medicine#04