Clinical Researcher—August 2025 (Volume 39, Issue 4)
ETHICS IN ACTION
Scott W. Ward, BS, CCRP, CT-C, ACRP-CP
Ethical compliance is the backbone of trustworthy clinical research. However, violations continue to occur, jeopardizing participant safety and data integrity. This article highlights key examples of ethical violations in clinical trials, outlines how clinical research professionals can detect them, and provides guidance on reporting procedures.
Clinical research depends on the integrity of its practitioners and the protection of human subjects. Despite rigorous oversight by institutional review boards (IRBs) and regulatory agencies like the U.S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP), ethical violations still emerge—often due to lack of awareness, pressure to produce results, or systemic oversight failures. It is essential for clinical research staff to remain vigilant and informed about common forms of misconduct and the appropriate steps for reporting concerns.
Examples of Ethical Violations
Informed Consent Failures
Case: In 1999, the death of Jesse Gelsinger in a gene therapy trial at the University of Pennsylvania was partly attributed to inadequate informed consent. He had not been fully apprised of the risks that might be faced by participants or the conflicts of interest involved on the part of the university and one of the study’s co-investigators.
Red Flags: Missing consent forms, signatures collected before subjects have adequate time to review materials, or participants unaware of key risks.
Data Fabrication or Falsification
Case: Dr. Scott Reuben fabricated data in at least 21 published studies related to pain management, leading to widespread retraction of papers and mistrust in published data.
Red Flags: Inconsistent data trends, identical patient data across different visits or studies, or unusual statistical outliers not addressed by study staff.
Undisclosed Conflicts of Interest
Case: Investigators with undisclosed financial ties to sponsors can bias trial design or interpretation. For example, failures to disclose payments from pharmaceutical companies have led to public scandals and loss of trust.
Red Flags: Resistance to disclose financial relationships, or sudden shifts in study design that favor sponsor interests.
Unreported Adverse Events
Case: In 2004, GlaxoSmithKline was criticized for failing to fully report suicide risk in children taking paroxetine (Paxil).
Red Flags: Participants dropping out without explanation, delays in adverse event reporting, or discrepancies between clinical notes and case report forms.
Enrolling Ineligible Participants
Case: Studies enrolling participants who don’t meet the inclusion/exclusion criteria can endanger participants and invalidate results.
Red Flags: Pressure to meet recruitment goals, incomplete medical histories, or intentional misclassification.
How Clinical Research Staff Can Spot Violations
- Routine Monitoring: Conduct regular audits of consent forms, data entries, and protocol adherence logs.
- Training and Education: Stay current with the Good Clinical Practice guideline from the International Council for Harmonization and participate in ethics training.
- Communication with Participants: Encourage open communication with subjects to uncover issues that may not be recorded.
- Team Culture: Promote a culture of transparency and safety within the research team.
Reporting Ethical Violations
Internal Reporting Channels
Start with your principal investigator or study coordinator, if they are not involved in the violation. Most institutions have a Research Compliance Officer or Institutional Official responsible for human subject research oversight.
Institutional Review Boards
IRBs are mandated to receive reports of noncompliance and are responsible for investigating human subject protection concerns.
Regulatory Agencies
- FDA Office of Scientific Investigations: For trials under FDA regulation.
- OHRP: For federally funded research (e.g., National Institutes of Health–sponsored studies).
- Whistleblower Protection Programs (e.g., U.S. Office of Special Counsel): Protect individuals who report ethical misconduct.
Anonymous Reporting Options
Some institutions provide hotlines or third-party compliance portals for anonymous reporting.
Conclusion
Clinical research professionals are on the frontlines of ethical decision-making. Recognizing the signs of ethical violations and knowing how to act is crucial not only for compliance but also for upholding the dignity and safety of research participants. By fostering a culture of integrity and vigilance, we strengthen the foundation of clinical research and public trust.
Resource
Emanuel EJ, Wendler D, Grady C. 2000. What Makes Clinical Research Ethical? JAMA 283(20):2701–11. https://jamanetwork.com/journals/jama/article-abstract/192740
Scott W. Ward, BS, CCRP, CT-C, ACRP-CP, is a Clinical Research Manager with Integrity Advanced Therapeutics in Houston, Texas. He serves on the ACRP Ethics Committee, the ACRP-CP Exam Committee, and the Job Analysis Committee, and has been certified through ACRP since 2020.
