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Informed Consent – Ellen Roche, Asthma Study Essay

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Updated: May 7th, 2022

Review of historical perspective of informed consent

Scientific discoveries of the 20th centuries also led to developments in the field of medicine. Researchers have used such knowledge to develop drugs and vaccines that protect people from diseases. However, some of these drugs have resulted from research atrocities involving human subjects. Subjects in such studies rarely get any information about clinical trials. Thus, they do not give informed consents to the studies.

Horror cases from the World War II by Nazis, atrocities of the United States Public Health Service (USPHS), and other medical trials made the public demand for ethical procedures and practices in medical studies. This was the beginning of bioethics and the emergence of Institutional Review Boards (IRBs).

Informed consent aimed at protecting the research participants. People interested in taking part in research trials have the right to know risks, benefits, procedures, the aim of the study, and protection of identity (confidentiality). Thus, participants can give their consents through signing consent forms. However, subjects retain the right to withdraw from the study when they want (Aschengrau and Seage, 2007).

A serious case involving human subjects was Tuskegee experiment, which showed that withholding treatment from the research subjects was unethical. The USPHS conducted the study from 1932 to 1972 using 600 subjects who never consented to the study. This violation of subjects’ right led to the formation of the National Research Act of 1974. Before this Act, there was also the Declaration of Helsinki in 1964. This declaration became the foundation of protecting all humanities from unethical research studies. Since then, the UN has revised the document on several occasions (Pelias, 2006).

However, the introduction of IRBs, Acts, Declaration of Helsinki and other measures to protect subjects have not been effective as research standards still fail to meet ethical requirements. In some cases, subjects have lost their lives. This was the case of Ellen Roche in 2001 Asthma Study.

The role of the case of Ellen Roche (Asthma Study) in developing ethical research practices

The Office for Human Research Protections (OHRP) provides clear and detailed procedures of obtaining informed consent (Office for Human Research Protections, 1993). However, some researchers and subjects fail to adhere to such requirements leading to severe ethical issues and legal consequences.

Roche was a healthy research subject. However, the subject inhaled hexamethonium and became ill. Hexamethonium causes lung damages. This explains why researchers administered the drug in extraordinarily large amounts. Roche succumbed to lung damages in less than a month after inhaling hexamethonium.

The OHRP investigated the incident and found several violations of the subject’s rights (Savulescu and Spriggs, 2002). The IRB of Hopkins did not take precautions to protect the subjects. First, board did not review the toxic effects of inhaling drug since its ban in 1970s by FDA. These data were readily available in medical journals. Second, the IRB did not consider additional materials on safety beyond what it had. Third, the researcher failed to warn subjects about effects of inhaling the drug. Instead, he withheld information from subjects by failing to inform them that hexamethonium was under experiment (Savulescu and Spriggs, 2002). Fourth, subjects did not give informed consent due to inadequate information provided. After the experiment, the researcher failed to report emerging conditions and concluded that subjects were reacting to cold due to changes in temperatures.

The case of Roche shows flawed and ineffective systems of protecting human subjects in research. It also shows that institutions’ IRBs may have vested interest in the study. This makes them lack a true independent review of the study.

References

Aschengrau, A. and Seage, G. (2007). Essentials of Epidemiology in Public Health (2nd ed.). Burlington, MA: Jones & Bartlett Learning.

Office for Human Research Protections (OHRP). (1993). Web.

Pelias, M. K. (2006). Human Subjects, Third Parties, and Informed Consent: A Brief Historical Perspective of Developments in the United States. Community Genet, 9(2), 73-77.

Savulescu, J. and Spriggs, M. (2002). The hexamethonium asthma study and the death of a normal volunteer in research. J Med Ethics, 28(1), 3-4.

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