Policy And Ethics: How Likely Are Ethical Violations ✓ Solved

Policy and Ethics: How likely is it that ethical violations

Policy and Ethics: How likely is it that ethical violations of research could happen in the United States? In your opinion, what is the probability that an event, such as the Tuskegee incident, could reoccur? How does policy development impact these types of events? Lastly, provide two reasons why it is important for epidemiologic researchers to conform to high ethical standards and discuss one current ethical violation that has occurred in the last five years and what could have prevented the incident. Discuss how policy development relates to public health.

Paper For Above Instructions

Introduction

Ethical violations in research have profound consequences for individuals, communities, and public trust. In the United States, a combination of regulatory frameworks, institutional oversight, and professional norms reduces but does not eliminate the possibility of unethical research. This paper evaluates the likelihood that research ethical violations could occur in the U.S., estimates the probability of a Tuskegee-like event reoccurring, explains how policy development affects such events, provides two reasons epidemiologic researchers must adhere to high ethical standards, discusses a recent ethical violation, and connects policy development to public health outcomes.

How likely are ethical violations in U.S. research?

Despite comprehensive protections such as the Common Rule (45 C.F.R. 46) and institutional review boards (IRBs), ethical violations remain possible. Misconduct categories—fabrication, falsification, and plagiarism—are documented annually by agencies such as the Office of Research Integrity (ORI) (ORI, 2021). Additionally, privacy breaches, inadequate informed consent, and conflicts of interest continue to arise, especially in large-scale data-driven studies (WHO, 2017). The presence of federal regulation, institutional compliance offices, mandatory training, and research audits makes systemic, prolonged abuses less likely than in the early- to mid-20th century; however, isolated violations or lapses in oversight are plausible (HHS OHRP, 2018). Thus, I assess the likelihood of some form of ethical violation occurring in U.S. research as moderate—rare at the level of mass exploitation but not negligible for individual studies or projects (Emanuel, Wendler, & Grady, 2000).

Probability of a Tuskegee-like event reoccurring

The Tuskegee Syphilis Study (1932–1972) represented prolonged, systemic ethical failure: deception, withholding of care, and racial exploitation (CDC, n.d.). Modern safeguards—IRBs, informed consent requirements, whistleblower protections, patient privacy laws (HIPAA), and heightened public scrutiny—make an exact reprise unlikely. I would estimate the probability of a direct analogue (government- or institution-sanctioned, decades-long, racially targeted denial of standard care) occurring in the U.S. today as low (closer to 0–5%). However, conditional probability rises when considering more subtle or shorter-term abuses—such as exploiting vulnerable populations via inadequate consent or insufficient risk disclosure—where the risk might be moderate (10–25%) without strong oversight (Belmont Report, 1979; HHS OHRP, 2018).

How policy development impacts these events

Policy development both prevents and shapes responses to ethical breaches. Federal regulations like the Common Rule codify consent, IRB review, and protections for vulnerable populations; revisions and enforcement influence institutional behavior (HHS OHRP, 2018). Policies enforce mandatory training, conflict-of-interest disclosures, data-sharing standards, and penalties for misconduct (ORI, 2021). Well-crafted policies prompt institutions to implement compliance infrastructure, while weak or poorly enforced policies create gaps that malicious actors or negligent researchers can exploit. Furthermore, policy development is iterative: high-profile violations often trigger reforms, as seen historically when Tuskegee catalyzed the Belmont Report and subsequent regulations (Belmont Report, 1979; CDC, n.d.).

Two reasons epidemiologic researchers must conform to high ethical standards

1) Protecting participants and communities: Epidemiologic work often involves vulnerable populations and community-level data; ethical practice preserves physical safety, psychological well-being, and privacy (WHO, 2017). Breaches can cause direct harm—denial of care, stigmatization, or reidentification of personal data.

2) Preserving public trust and scientific validity: High ethical standards sustain public willingness to participate in studies and accept public health recommendations. Unethical behavior undermines confidence, reduces participation, and can invalidate research findings through biased recruitment or compromised data integrity (Emanuel et al., 2000; Beauchamp & Childress, 2013).

Recent ethical violation and prevention

One prominent recent example—illustrating the consequences of weak data governance—was the 2020 Surgisphere controversy in which high-profile COVID-19 observational studies were retracted due to unverifiable and inconsistent data (Mehra, Ruschitzka, & Patel, retraction notice, 2020; Retraction Watch, 2020). Although outside the strict five-year window used by some assessments, it highlights systemic vulnerabilities relevant today: reliance on third-party datasets without adequate validation, rapid publication pressures, and insufficient data-sharing for peer review. Preventive measures include mandatory data audit trails, requirements for independent data access by peer reviewers, robust institutional data governance policies, and enforced penalties for failure to provide underlying data (Lancet retraction editorial, 2020; Retraction Watch, 2020). Applied broadly, these governance improvements would reduce risks of similar violations in future fast-moving public health crises.

Policy development and public health

Policy development shapes public health by setting ethical baselines for research that inform practice, surveillance, and interventions. Ethical policy ensures that data used for public health decision-making are reliable, that communities are treated fairly, and that interventions do not exacerbate inequities. When policies are reactive—developed only after scandals—damage to trust can persist; conversely, proactive, transparent, and enforceable policies help prevent harm and enable equitable public health responses (National Academies, 2017; WHO, 2017).

Conclusion

While modern U.S. research governance makes a repetition of an event identical to Tuskegee unlikely, ethical violations still occur at the project or investigator level. Continued policy refinement—focused on data governance, enforcement, transparency, and protections for vulnerable populations—reduces risk and strengthens public health. Epidemiologic researchers must adhere to ethical norms to protect participants and sustain public trust, which are both essential to effective public health practice and scientific validity.

References

  • Beauchamp, T. L., & Childress, J. F. (2013). Principles of biomedical ethics (7th ed.). Oxford University Press.
  • Belmont Report. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health, Education, and Welfare. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
  • Centers for Disease Control and Prevention. (n.d.). Tuskegee Study - Timeline and facts. https://www.cdc.gov/tuskegee/index.html
  • Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? JAMA, 283(20), 2701–2711. https://doi.org/10.1001/jama.283.20.2701
  • HHS Office for Human Research Protections. (2018). Federal policy for the protection of human subjects ('Common Rule') — revisions and guidance. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp
  • Lancet Editors. (2020). Expression of concern and retraction notices related to registry-based COVID-19 treatments research. The Lancet. https://www.thelancet.com
  • Mehra, M. R., Ruschitzka, F., & Patel, A. N. (2020). Retraction — Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. The Lancet. Retraction notice.
  • National Academies of Sciences, Engineering, and Medicine. (2017). Using population-based administrative data for research: Ethics and governance. National Academies Press.
  • Office of Research Integrity. (2021). Research misconduct: Findings and case summaries. U.S. Department of Health and Human Services. https://ori.hhs.gov
  • Retraction Watch. (2020). The Surgisphere scandal and retractions: lessons for data transparency. Retraction Watch. https://retractionwatch.com
  • World Health Organization. (2017). Guidance on ethical issues in public health surveillance. WHO. https://www.who.int

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