Activity 3
Ethics in Research
- View Human Subjects Research Training: “Protecting Human Subjects” (https://www.youtube.com/watch?v=174SkSszRVg)
- PDF titled PHRP. Reflect on History, Codes and Regulations, Respect for Persons, Beneficence and Justice.
- Explore theResearch Clinic https://ori.hhs.gov/TheResearchClinic
Choose a vulnerable population and describe the ethical issues surrounding this population. What is the role of the Institutional Review Board (IRB) in protecting vulnerable populations? Should the population be considered for research? Why is it important to have diverse populations sampled in research?
Resources
National Institute of Health (2008). Protecting Human research participants. Retrieved from https://learn.americansentinel.edu/pluginfile.php/709455/course/section/110371/PHRP%20%282%29.pdf
Additional Instructions:
- All submissions should have a title page and reference page.
- Utilize a minimum of two scholarly resources.
- Adhere to grammar, spelling and punctuation criteria.
- Adhere to APA compliance guidelines.
- Adhere to the chosen Submission Option for Delivery of Activity guidelines.
| Submission Options | |
| Choose One: | Instructions: |
| Paper |
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| Microsoft PowerPoint Presentation |
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| Other media (Prezi, etc.) presentation |
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| Video Presentation |
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| Table |
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| Graphs or other illustrations |
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| Poster |
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| Note: Title and reference pages/slides do not count towards the count requirements. | |
Ethics in Research
Student Name
University
Course
Professor Name
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Ethics in Research
The use of human subjects in research made it necessary to develop methods that would prevent participants from being harmed. In medical research, there is a history of harm of human subjects especially before 1946 when there was no global code for the protection of human subjects. Prisoners were used as human cultures for testing vaccines and were also exposed to harmful physical conditions. Most of them died in the course of research and as a result, the Nuremberg code, the first international code that described ethics in medical research, was developed. The code clarified integrity standards for research including informed consent and non-maleficence although it was a guide not a law. The development of legal considerations followed several studies that failed to respect human subjects. The first legal policy on ethics in research required all studies funded by the government to be reviewed by institutional associates of the researcher as a way of protecting participants from harm. In 1974, the U.S. congress passed the National Research Act that led to the establishment of the Institutional Review Boards (IRBs). The Belmont report was also issued in 1978 and it described the ethical principles to be followed in research (Health Resources and Services Administration, 2012). The purpose of this paper is to describe legal and ethical considerations in research involving human subjects and to identify a specific vulnerable population, the role of IRB in protecting the population, and the importance of diversity in research.
Ethical and Legal Considerations
Ethical considerations refer to the ethical principles that researchers must adhere to when working with human subjects. Ethical concerns in research are based on the principle of non-maleficence which states that one should engage in actions that do not harm others. Another important principle followed in research ethics is respect for persons which focuses on voluntary participation and freedom from undue influence and coercion to engage in a study. The autonomy and dignity of human subjects must be protected and respected. Human beings are regarded as autonomous persons with the ability to make choices about actions that affect themselves or others. In cases where participants do not have the ability to engage in autonomous decision making, appropriate steps must be taken to protect them from any harm. Research ethics also follows the beneficence principle which states that researchers must only engage in actions that benefit their subjects. Notably, some benefits may expose participants to risks which must be evaluated before conduction the research. Participants should be informed about the research topic and potential risks and benefits before they provide informed consent. Justice and confidentiality are also important ethical considerations. Justice entails equal treatment of all participants regardless of their backgrounds. Confidentiality entails respecting the anonymity of participants (Sng et al., 2016).
Legal considerations are laws that researchers must follow to prevent legal liability. Current laws are mostly based on ethical considerations and include informed consent, equal treatment of participants, maintaining confidentiality, and minimizing harm (Sng et al., 2016). The main role of IRBs is to protect participants; welfare, privacy, and rights since they have the authority to monitor, approve, and disapprove research studies conducted within their jurisdiction (Gordon, 2020).
Vulnerable Population
The selected vulnerable population is the African American population which as a minority population, has been affected by unethical research. As per Health Resources and Services Administration (2012), an example is the Tuskegee study whose aim was to examine the natural course of syphilis although the participants were not informed that they had syphilis and that they were taking part in research. The participants were not treated even after penicillin was discovered as effective treatment for the disease. The study also went on for 40 years even though it was initially meant to last for a few months. As per George et al. (2014), African Americans have an understandable distrust for researchers hence it is important to focus on building a positive relationship with participants from this community before conducting any form of research. According to Gordon (2020), federal law requires that all IRBs engage in actions that protect the wellbeing of vulnerable research subjects including educationally and economically disadvantaged people. Racial minorities experience higher rates of poverty hence they are more likely to be take advantage of especially by being offered financial incentives.
Involvement of diverse populations is highly encouraged in all research, especially medical and behavioral research which focuses on developing knowledge on interventions for promoting physical and mental health. People from different racial backgrounds, ethnic backgrounds, gender, and age react differently to healthcare interventions hence diversity in research ensures that medical interventions incorporate cultural, genetic, and social factors in treatment development (George et al., 2014).
Conclusion
Ethical and legal considerations in research studies were developed to protect human participants from harm. The considerations mainly include justice, respect of persons, beneficence, non-maleficence, and autonomy principles. The role of IRBs is to ensure that all studies follow ethical and legal considerations.
References
George, S., Duran, N., & Norris, K. (2014). A Systematic Review of Barriers and Facilitators to Minority Research Participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. American Journal of Public Health, 104(2), e16-e31. https://doi.org/10.2105/ajph.2013.301706
Gordon, B. (2020). Vulnerability in Research: Basic Ethical Concepts and General Approach to Review. Ochsner Journal, 20(1), 34-38. https://doi.org/10.31486/toj.19.0079
Health Resources and Services Administration. (2012). Human Subjects Research Training: “Protecting Human Subjects” – Module 1. https://www.youtube.com/watch?v=174SkSszRVg.
Sng, B., Yip, C., & Han, N. (2016). Legal and ethical issues in research. Indian Journal Of Anaesthesia, 60(9), 684. https://doi.org/10.4103/0019-5049.190627