Leadership in Research Compliance: Human Subjects, Animal Care, and EH&S

Overview

In the world of research compliance, leadership is far more than managing tasks or coordinating teams, it is the backbone of sustainable, ethical, safe, and high-quality work necessary to transform a compliance burden into a strategic advantage for organizational resilience and efficiency. Whether supporting human subjects protections, overseeing animal care and use, coordinating clinical research activities, or maintaining environmental health and safety (EH&S) programs, leaders develop systems that support teams through complex regulations, high-stakes decisions, and cross-functional collaboration.

Yet many professionals in these fields transition into leadership roles because of their technical or scientific expertise, not because they received formal leadership training. As a result, teams may struggle with communication breakdowns, inconsistent adherence to procedures, unresolved conflict, or resistance to change. These challenges increase organizational risk and can compromise participant protections, animal welfare, data quality, or worker safety.

CITI Program’s Becoming an Effective Leader course closes this gap by equipping professionals with practical, research-relevant leadership skills, including communication, team building, conflict resolution, coaching, problem‑solving, ethical decision-making, and change leadership. These competencies strengthen not just individuals, but the compliance programs they support.

Below are the core leadership competencies featured in the course, and why they are essential for human subjects research, animal care and use, and environmental health and safety.

Leadership Essentials: Creating Vision, Alignment, and Integrity in Compliance Programs

Compliance-based organizations require leaders who can interpret complex regulations, set a clear direction, and maintain a culture of ethical conduct. The Leadership Essentials module emphasizes:

• Understanding the role and influence of a leader
• Gaining the commitment of diverse teams
• Identifying leadership strengths and improvement areas
• Aligning team goals with institutional mission

In Institutional Review Boards (IRBs), Institutional Animal Care and Use Committees (IACUCs), clinical research, and EH&S programs, these skills enhance:

• Ethical deliberation
• Consistency of oversight
• Interpretation of regulatory expectations
• Alignment between scientific goals and compliance requirements
• Robustness, recovery, and flexibility to manage the unexpected

Effective leadership improves research integrity, participant protections, animal welfare, and organizational safety.

Communication: Preventing Errors and Strengthening Oversight Across Research Settings

Communication breakdowns are one of the most common causes of compliance lapses. In both human and animal research, unclear directions can lead to:

• Protocol deviations
• Incomplete or inaccurate documentation
• Inadequate procedural training
• Misunderstandings around responsibilities
• Breakdowns in IACUC or IRB expectations

Leaders must demonstrate:

• Strong verbal and written communication skills
• Clear and direct expectations
• Consistent communication across different teams (such as IRB with researchers, IACUC with facility researchers, and EH&S with labs)
• Attentive listening and thoughtful, constructive feedback

Better communication means better compliance, whether implementing a new protocol amendment, onboarding a new staff member, or ensuring a lab implements a revised safety standard operating procedure.

Relationship Building & Conflict Management: Navigating Tension Without Compromising Compliance

Compliance roles often involve balancing competing priorities while providing a sufficient capacity to address mistakes and prevent them from cascading into a complete failure:

• Scientific goals versus regulatory requirements
• Operational constraints versus ethical expectations
• Protocol timelines versus safety considerations
• Investigator preferences versus institutional policies

Leaders must manage these tensions constructively. Developing conflict management tools provides leaders with the ability to:

• Identify the root causes of conflict
• Navigate emotionally charged situations
• Mediate between stakeholders with different priorities
• Maintain professionalism during audits or inspections

In IACUC contexts, for example, conflict may arise over protocol requirements or institutional guidance. In human research, conflict might center on informed consent expectations, protocol adherence, or workload distribution.

Leaders who can address conflict early reduce risk and help teams remain focused on compliance and quality. Developing conflict management skills is an integral aspect of leadership development.

Coaching and Staff Development: Building Competent, Confident Compliance Teams

Coaching is essential in environments where errors can jeopardize participant safety, animal welfare, or worker health.

The Coaching module supports leaders in:

• Selecting the right coaching style
• Reinforcing correct procedures
• Providing actionable, constructive feedback
• Encouraging accountability and growth

Consider how coaching impacts compliance programs:

• A principal investigator coaching staff through protocol procedures
• A clinical research manager guiding clinical research coordinators on documentation accuracy
• An EH&S leader coaching labs on building capacity for success in an unpredictable setting by encouraging proactive learning through better hazard identification and risk assessment
• An IRB administrator helping investigators navigate regulatory requirements

Strong leaders elevate the capabilities and confidence of the entire team, which directly strengthens compliance outcomes.

Problem‑Solving & Decision-Making: Responding Effectively to Unexpected Challenges

Human subjects research, animal research, and EH&S operations often face unplanned situations, such as:

• Adverse events
• Protocol deviations
• Animal health or welfare concerns
• Safety incidents or near misses
• Equipment failures
• Facility emergencies

The Problem-Solving and Decision-Making module provides leaders with structured approaches to:

• Analyze issues objectively
• Consider ethical and safety implications
• Evaluate alternatives
• Implement effective solutions
• Document decisions transparently

In regulated environments, good decisions protect participants, animals, staff, and the institution.

Ethical Leadership: Setting the Tone for Compliance and Integrity

Ethical leadership is critical in:

• Protecting human participants
• Upholding animal welfare standards
• Ensuring worker safety
• Maintaining transparent communication
• Fostering responsible data management
• Supporting a “speak up” culture

Ethical leadership emphasizes fairness, trustworthiness, and accountability. These are qualities leaders must embody in IRB, IACUC, and EH&S environments.

Ethical leadership ensures that policies aren’t followed merely because they’re required, but because they represent shared values.

Change Management: Guiding Teams Through Regulatory and Operational Transitions

Human subjects research programs, animal care programs, and EH&S units face constant change:

• Revised federal guidance
• New Hazards are introduced into the research, which in turn impacts the exposure risks
• New institutional policies
• Updated standard operating procedures
• System migrations (IACUC/IRB platforms, research systems)
• Facility renovations or expansions
• Implementation of new safety controls

Effective change management reduces confusion, enhances adoption, and maintains compliance throughout transitions.

Leaders must learn to:

• Communicate changes early and clearly
• Engage and support affected staff
• Anticipate barriers
• Reinforce training and expectations
• Build in sustainability and resilience.

This prevents processes from becoming inconsistent during periods of transition.

Leadership Is Central to Ethical and Compliant Research

When research and safety programs are led well:

• Participants are safer
• Animals receive higher-quality care
• Labs operate more safely
• Documentation is more accurate and complete
• Audit readiness improves
• Teams collaborate more effectively
• Staff feel supported and valued

Leadership skills are not supplemental, they are core operational competencies.

Conclusion

Effective leadership is essential in compliance-driven research environments, including human subjects research, animal care and use, and EH&S. These areas depend on leaders who can guide teams through complex regulations, ethical expectations, and operational challenges.

Whether you’re a principal investigator, IACUC professional, laboratory supervisor, clinical research coordinator, IRB administrator, attending veterinarian, research facility manager, biosafety professional, or EH&S specialist, the CITI Program’s Becoming an Effective Leader course equips you with leadership skills you can apply immediately.