Theory Research and Practice Applied to Human Research Protection Foundational Certificates

Research using human subjects is complicated due to the physical, psychological, social, economic, and legal risks associated with such research. These make it important to protect human subjects in any research and pass such responsibility to the researchers (White, 2020). There is a clear conflict between ethical principles and human rights in research involving human subjects, especially in times of how both can be enforced, and researchers obligate tooth during research (Constantin, 2018). This paper analyzes the Tuskegee Syphilis scenario and how that relates to theory, research, and practice in evidence-based research and its relationship to informed consent and concepts in the Human Research Protection Foundational Certificates.

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Researchers need to understand the ethics of research involving human subjects to ensure the risks involved are mitigated and kept at a minimum. The Office of Human Research Protections (OHRP) offers researchers comprehensive training on human research protections as per related laws and requirements. This training and certification assist researchers who want to use human subjects in their research by teaching them how to combine theory, research findings, and their practice experience in order to develop ethical, evidence-based interventions. Theory creates the conceptual foundations for research and helps understand the phenomena the research seeks to explore. Previous research findings can help nurses identify gaps in previous research as well as easily translate previous research findings into evidence-based clinical research and practice. On the other hand, practice helps translate research findings to evidence-based practice and identify nursing gaps in practical nursing settings. Integrating theory, research findings, and practice can ensure that the nurse as a researcher upholds ethical standards and protects their human subjects from harm as per their OHRP certifications.

The Tuskegee Syphilis Study is a perfect example of ethical misconduct in research involving human subjects. In the study conducted from 1932 to 1972, a study sample of 399 African American men diagnosed with syphilis were misled and denied proper treatment to study the natural progression of the disease (Rose et al., 2022). The Tuskegee Syphilis study violated ethical principles considered during research, including informed consent, beneficence, and justice. It clearly identifies the need for a clear understanding of the relationship between ethics of research and human rights in research involving human subjects. An example of a study that shows how the aspects of theory support evidence-based research, including obtaining informed consent and meeting other aspects of ethical research, is the article by Peters et al. (2019). In the cross-sectional postal survey study, Peters et al. (2019) examine how self-efficacy relates to quality of life in primary care patients with multi-morbidity. In the article, the authors clearly explain the process of participant recruitment and the process of the study, including providing the study participants with information on the aims of the study and other ethical considerations. The study was also reviewed by England’s National Research Ethics Service Committee East Midlands-Derby and provides its reference number, 15/EM/0414, and the ethical approvals it was granted by the Health Research Authority of England’s National Health Service (NHS), and other health care organizations during the recruitment of its participant. The Tuskegee Syphilis cannot present any of these as it did not apply any theoretical framework nor consider any ethical guidelines during the time it was conducted. The Theory of Unitary Human Beings by Martha E. Rogers can be a perfect nursing conceptual model for research to relate research and practice in meeting the ethics of informed consent, beneficence, and justice. The Theory of Unitary Human Beings is based on humanistic and humanitarian nursing concepts. Therefore, the theory can guide research involving human subjects, help adhere to ethical guidelines, and consider possible human rights in research regardless of their racial or socioeconomic background.

 References

Constantin, A. (2018). Human Subject Research: International and Regional Human Rights Standards. Health and Human Rights, 20(2), 137. /PMC/articles/PMC6293356/

Peters, M., Potter, C. M., Kelly, L., & Fitzpatrick, R. (2019). Self-efficacy and health-related quality of life: A cross-sectional study of primary care patients with multi-morbidity. Health and Quality of Life Outcomes, 17(1), 1–11. https://doi.org/10.1186/S12955-019-1103-3/T