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Research Compliance
Compliance and Ethics in the Laboratory
Often it is helpful important to get an outside opinion when faced with complex research compliance issues or perceived ethical questions . The Kelly Group’s consultants and subject matter experts have experience and expertise in multiple aspects of research oversight and compliance including:
- Animal Welfare
- Biosafety
- Conflicts of Interest (COI)
- Research Misconduct
- Compliance Assessments/Audits
We can help you design, implement, and improve your ethics and compliance programs, as well as create sustainable processes to communicate expectations and monitor compliance.
Your laboratory or company's reputation and the trust of your staff, partners and customers are your biggest assets. You can protect your reputation and increase the likelihood that your research results will not be tainted by compliance issues or misconduct by creating an environment where ethical conduct is the norm in both the laboratory and the office.
Ethical conduct and regulatory compliance depend on integration into the organizations culture and a robust implementation that includes:
- Positive, consistent examples by leadership
- Written standards of conduct
- Effective training
- Reporting mechanisms
- Fair and transparent consequences for violations.
Even in organizations with strong ethics and compliance programs, there are occasions when compliance standards have not been met or ethical lapses are suspected.
When issues arise, the first step is to assemble an appropriate response team, usually for minor infractions the response team is the lab manger and the organization’s individual responsible for quality control. For more serious issues, you may need to engage an outside expert who can bring an unbiased approach to identify root causes and appropriate corrective action.The response team’s responsibilities are to:
- Determine what happened;
- Why it happened;
- Is the issue a symptom of a systemic failure or an isolated incident?
- Provide options to management to mitigate the current issue and prevent a repeat.
- And finally, to lead the stakeholders in a lessons-learned exercise afterward to institutionalize the agreed upon corrective actions.
When compliance questions arise our solutions and services to meet these challenges are always customized to best meet the needs of our individual clients, please contact us so that we can discuss your needs.