This Course Is Designed To Prepare Investigators Involved In ✓ Solved

This course is designed to prepare investigators involved in

This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants. Evidence based research involving human subjects requires that researchers be cognizant of and adhere to the important tenets necessary to protect subjects from abuse, harm, injury, and/or other undesirable outcomes resulting from the research process.

Based on this fact, write a minimum of 2 pages (Title page and Reference not included in page count) of an APA formatted paper answering the following questions:

  1. Historical background of human subjects protection?
  2. Find and discuss at least one historical incident of human subjects abuse in research and what human right was violated.
  3. What steps will you take to minimize risks on human subjects?
  4. What populations are considered vulnerable populations and why?
  5. What are appropriate ways to recruit subjects?
  6. How would you properly obtain consent?
  7. What are the elements of a properly executed consent?
  8. What committees are responsible for monitoring the protection of human subjects?

Paper For Above Instructions

Title: Understanding Human Subject Protections in Research

Research involving human subjects has a complex and often troubling historical context that necessitates stringent protections to maintain ethical integrity and respect for human rights. Understanding this history is vital for modern researchers who must ensure the welfare and rights of participants in research studies.

Historical Background of Human Subjects Protection

The history of human subjects protections can be traced back to World War II and the unethical experiments conducted by Nazi physicians. The Nuremberg Trials brought to light the atrocities committed during these experiments and led to the development of the Nuremberg Code in 1947, which established a set of ethical principles for the conduct of research involving human subjects (Weindling, 2015). This code laid the groundwork for later ethical guidelines including the Declaration of Helsinki, which provided further clarity on the rights of research participants (World Medical Association, 2013).

In the United States, the Belmont Report of 1979 identified three core principles of ethical research: respect for persons, beneficence, and justice (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). These principles serve as a guide for researchers to protect the dignity, rights, and welfare of participants, reflecting a collective commitment to ethical accountability in research involving human subjects.

Historical Incident of Human Subjects Abuse

One significant incident of human subjects abuse in research is the Tuskegee Syphilis Study, which began in 1932 and continued until 1972. In this study, African American men diagnosed with syphilis were deliberately misled and denied treatment to study the natural progression of the disease (Gamble, 1997). This blatant disregard for informed consent violated the basic human right to information and personal autonomy, highlighting racial disparities in medical treatment and ethical violations within research settings.

Minimizing Risks on Human Subjects

To minimize risks to human subjects, researchers should conduct thorough risk assessments prior to beginning any study. This includes identifying potential physical, psychological, and social risks, and implementing strong mitigation strategies. Researchers should also ensure that ethical review boards assess the study protocols for compliance with ethical standards (Faden et al., 2015). Informed consent processes must clearly outline potential risks, ensuring participants can make educated decisions about their involvement.

Vulnerable Populations

Vulnerable populations can include children, prisoners, pregnant women, and individuals with mental disabilities, among others. These groups may be at increased risk for coercion or undue influence, and therefore require additional protections when involved in research (U.S. Department of Health and Human Services, 2018). Being cognizant of the unique challenges and risks faced by these populations is essential for ethical research practices.

Recruiting Subjects

Appropriate ways to recruit subjects include advertising through community organizations, educational institutions, and ethical online platforms. All recruitment methods should prioritize transparency about the study's purpose, procedures, and any potential risks involved (Friedman et al., 2010). Researchers should also avoid any incentives that may unduly influence a potential participant's decision-making process.

Obtaining Informed Consent

Informed consent should be obtained through a clear, understandable process. Researchers must provide potential participants with detailed information about the study, the nature of the participation, any risks involved, and their right to withdraw at any time without penalty (Beauchamp & Childress, 2013). This dialogue ensures participants have the opportunity to ask questions and express concerns before agreeing to partake in a study.

Elements of a Properly Executed Consent

A properly executed consent form must include several key elements: a clear explanation of the purpose of the research, detailed procedures involved, potential risks and benefits, confidentiality assurances, and contact information for researchers (National Institutes of Health, 2016). The language used must be accessible, and participants should be encouraged to discuss the consent form with family or trusted advisors before making their decision.

Committees Monitoring Human Subjects Protection

Institutional Review Boards (IRBs) are responsible for monitoring the ethical conduct of research involving human subjects. These committees ensure that research proposals comply with ethical standards, assess risks, and review informed consent processes to protect participants throughout the research process (U.S. Department of Health and Human Services, 2009).

Conclusion

In conclusion, understanding the historical context, ethical considerations, and regulatory frameworks surrounding human subjects research is imperative for all investigators. By implementing best practices in recruiting, consent, and risk management while being vigilant about the treatment of vulnerable populations, researchers can uphold the rights and welfare of participants, fostering trust and integrity in the research community.

References

  • Beauchamp, T. L., & Childress, J. F. (2013). Principles of biomedical ethics. Oxford University Press.
  • Faden, R. R., Beauchamp, T. L., & Kass, N. E. (2015). Informed consent, comparative effectiveness, and the ethics of research with human subjects. New England Journal of Medicine, 372(7), 555-558.
  • Friedman, L. M., Furberg, C. D., & DeMets, D. L. (2010). Fundamentals of clinical trials. Springer Science & Business Media.
  • Gamble, V. N. (1997). Under the shadow of Tuskegee: African Americans and health care. American Journal of Public Health, 87(11), 1773-1778.
  • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research.
  • National Institutes of Health. (2016). Informed consent and parental permission: A quick guide for researchers.
  • U.S. Department of Health and Human Services. (2009). Institutional review boards (IRBs) and human research protection programs (HRPPs).
  • U.S. Department of Health and Human Services. (2018). Regulations for the protection of human subjects.
  • Weindling, P. (2015). The origins of consent: The paternalism of an international code. In Medical ethics (pp. 41-54). Routledge.
  • World Medical Association. (2013). Declaration of Helsinki: Ethical principles for medical research involving human subjects.

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