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Institutional Review Board and Research Ethics

Institutional Review Board and Research Ethics

Part 1: Institutional Review Board (IRB)

The term research resonates well with knowledge creation. Research refers to the systematic process of generating newer understandings, concepts, or methodologies by using readily available knowledge or new knowledge. The research process is elaborate, often using a multi-step approach to generating newer generalizable knowledge and consequently sharing the information identified therein. Lehane et al. (2019) note that the purpose of healthcare research studies is to disseminate the findings or derive conclusions from the research findings to inform specific aspects of clinical practice. In this respect, research should be based on an identifiable concept and done purposefully to disseminate the findings to where they will be used clinically. Dissemination of research findings can be attained through publication in a journal or through a presentation.

My research study will involve human subjects. The research process interrogates aspects of mental healthcare, including perceptions and behaviors of people with mental health illnesses on their illness. Involvement of human subjects per the federal regulations encompasses all procedures that allow data collection on humans, including direct or indirect communications between the principal investigator and the research participants. The research may involve direct human-to-human interactions, thus meeting the federal criteria for classifying research involving human subjects.

Part 2: Research Ethics

The Tuskegee syphilis study is one of the historical atrocities that prompted the implementation of ethical standards in research. Tuskegee syphilis study was a research process that began in 1932. In this research process, black men of low-income status were used as test subjects to observe the manifestations of syphilis. Six hundred black men aged 25 and above were enrolled in the study and told they were being treated for bad blood (a term used to describe syphilis and other health issues). In the study, 399 of the participants had syphilis, and 201 participants did not have the disease. The participants were promised free meals, transportation, medical exams, and even burial insurance as a persuasion to join the study. While some of the men were given the then-available treatment for the disease, other men did not receive any treatment. Even with the discovery of penicillin 15 years into the study, the participants were not offered the medication for the entirety of the study duration.

The apparent issue of concern in the Tuskegee study is the unethical investigative practice of ethnic minority groups. The study violated the normative ethical principles of autonomy, beneficence, and non-maleficence. Notably, autonomy requires that research participants are informed of the study and its possible impacts on their health and that informed consent is sought before being enrolled in the study (Bitter et al., 2020). The Tuskegee study did not seek informed consent from the participants, nor did it give the participants adequate information about the research. Beneficence and non-maleficence require that research processes do good and not bring harm to the participants. The Tuskegee study, contrarily, resulted in at least 28-100 direct deaths. The principle of justice was also contravened as the research participants were predominantly from the black community. This historical atrocity informed the development of the protective Belmont Report in 1978, which underlined the principle of Respect for Persons.

References

Bitter, C. C., Ngabirano, A. A., Simon, E. L., & Taylor, D. McD. (2020). Principles of research ethics: A research primer for low- and middle-income countries. African Journal of Emergency Medicine10. https://doi.org/10.1016/j.afjem.2020.07.006

Lehane, E., Leahy-Warren, P., O’Riordan, C., Savage, E., Drennan, J., O’Tuathaigh, C., O’Connor, M., Corrigan, M., Burke, F., Hayes, M., Lynch, H., Sahm, L., Heffernan, E., O’Keeffe, E., Blake, C., Horgan, F., & Hegarty, J. (2019). Evidence-based practice education for healthcare professions: An expert view. BMJ Evidence-Based Medicine24(3), 103–108. https://doi.org/10.1136/bmjebm-2018-111019

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Question 


As the first part of your response, describe in your own words (approximately 150–200 words) what research is and explain if your study will involve human subjects.

Part 2: Research Ethics

The development of the field of ethics in research includes numerous historical atrocities and egregious breaches of humane ethical values.

Institutional Review Board and Research Ethics

For the second part of your response, research “historical atrocities and research ethics” and share one historical violation that prompted the implementation of ethical standards in research (approximately 150-200 words).

Include your own experience as well as 2 citations from peer-reviewed academic journals, industry publications, books, and/or other sources that align with or contradict your comments. Cite your sources according to APA guidelines. If you found information that contradicts your experience, explain why you agree or disagree with the information.

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