RAC Code of Ethics

As the international leader for the healthcare regulatory profession, RAPS has initiated and supported the development of this code of ethics for the profession. The principles embodied by these core values are outlined in the section (below) entitled “Fundamental Principles.” Following that, each core value is presented with suggested behaviors that should be encouraged or discouraged.

RAPS believes that this is a living document and encourages your feedback. Use this code of conduct in your work and share it with your colleagues and employer.

Statement of Personal Responsibility

Regulatory professionals have the professional and ethical responsibility to maintain the highest standards of professional conduct as they exercise their professional duties of upholding and clarifying the laws and regulations of the authorities under which we operate.

As individual regulatory professionals, we are making a positive contribution to public health and we aspire to embody this code of ethics in our words, actions and deeds.

As regulatory professionals, we play a pivotal role in ensuring compliance with applicable laws and regulations in the development and commercialization of healthcare products. We are a diverse profession: we work in healthcare companies, for government regulatory agencies, for contract research organizations and as independent consultants around the world. Our profession includes attorneys, engineers, managers, nurses, pharmacists, physicians and scientists, among others. We are a growing profession and we are developing and continually exploring our core values in an increasing complex global regulatory environment. We do this in the hope that everyone who practices in this field will aspire to these principles. We do this also in the hope that those whom we serve will hold these principles as inviolable.

The following eight core values defined below are maintained from the original code:

  • Regulatory Compliance
  • Competency
  • Objectivity
  • Integrity
  • Honesty/Credibility
  • Accountability
  • Equitability
  • Dignity and Respect

Fundamental Principles

As a regulatory professional I aspire to:

  • To ensure my employer’s activities are conducted in compliance with the laws and regulations of the authorities under which we operate, consistent with advancing, preserving and protecting public health.
  • Be competent to perform the services I have been hired or retained to perform. As a regulatory professional, I hereby commit myself to continual learning while being able to acknowledge areas outside my expertise.
  • Act in an objective manner. As a regulatory professional, I will base decisions on factual information. I will not be unduly influenced by competing or conflicting interests and I will clearly communicate competing or conflicting interests when appropriate.
  • Have integrity. As a regulatory professional, I must be principled and consistent in applying my views. I must live up to my commitments, and be trustworthy and scrupulous at all times.
  • Be honest in all dealings with my employers and others with whom I interact. As a regulatory professional, I must ensure all information and communications, whether oral or written, are accurate and complete. I acknowledge and affirm personal and institutional credibility is crucial to my success.
  • Have the courage to make difficult decisions. As a regulatory professional, I will present all relevant information to my organization to promote wise decisions. I must be able to withstand challenges to my views, while at the same time being accountable for my mistakes.
  • Be fair in my dealings with all parties. As a regulatory professional, I must apply legal and regulatory standards equitably. I must be just in considering the interests of all parties in decision processes.
  • Be respectful of others. I must treat all individuals with dignity and courtesy.