RAPS Code of Ethics

As regulatory professionals, we have the responsibility to maintain particularly high standards of professional conduct while exercising professional requirements and duties in upholding and clarifying the applicable laws and regulations. We strive to make a positive contribution to public health by using this code of ethics in our workplace(s). This is the RAPS Code of Ethics; regulatory professionals understand that their employers and others may have other codes of ethics that they may need to acknowledge, understand, and follow.
Our Code of Ethics was first initiated in 2003 and has been updated twice since then. We vow to regularly assess its applicability and refresh its content as the regulatory profession grows and evolves.

Fundamental Principles

As a regulatory professional I aspire to:

• Provide my employer with the complete regulatory requirements to ensure their activities are conducted in compliance with the laws and regulations of the respective authorities.
• Be competent in performing my duties as a regulatory professional.
• Base decisions on factual, up-to-date information and clearly communicate competing or conflicting concerns, as necessary. Have integrity. Be consistent in making decisions and be trustworthy.
• Be honest with employers and team members to ensure all information and communications are accurate and complete.
• Have the courage to make difficult decisions. Present all relevant information to my organization to promote decisions. Be able to withstand challenges to my views and be accountable for my errors.
• Be fair in my dealings with all stakeholders. Apply regulatory standards equitably. Consider all interests of all parties in the decision processes.
• Be respectful of others. Treat all individuals with dignity and courtesy.

RAPS members perceive eight core values that regulatory professionals use in conducting their professional responsibilities.

Duty

Our role is defined by our responsibility to advise individuals, team members and organizations regarding the appropriate regulatory context for actions they may want to take. We also must heed our obligations as employees, consultants, and contractors for making products for patients; as members of teams conducting clinical & nonclinical studies; as regulators; and as members of our profession. Regulatory professionals have a duty to:

• Disseminate and interpret applicable government laws and regulations, industry standards and good practice guidelines without bias.
• Provide healthcare professionals (HCPs) with accurate and relevant information regarding the safety and effectiveness of products.
• Maintain the integrity of our profession and strive to preserve the public’s trust.

Competence

Competence means the regulatory professional has the knowledge, experience, ability, and skill sets to effectively identify, analyze, solve, or recommend solutions for regulatory challenges. We must be dedicated, yet flexible to adapt to the constantly changing requirements.
The diversity of individuals and organizations within the profession necessitates a commitment to evolve by a variety of options: continuing education, work experience, professional training, and certifications.
Maintaining regulatory competence is a continual learning process. Regulatory professionals develop competence by:

• Being knowledgeable about current and future trends.
• Encouraging and supporting professional growth and development among peers and colleagues so all can gain and demonstrate competence in the profession.
• Participating in continuing education opportunities related to regulatory laws, guidance, standards, and other updates.

Objectivity

Regulatory professionals display objectivity by:

• Responding carefully to issues and recognizing other points of views and striving to offer an unbiased expression of facts.
• Presenting regulatory opinions, options and associated risks when developing regulatory strategies.
• Clearly delineating regulatory requirements, internal requirements, and personal preferences.
• Appropriately disclosing new information.

Integrity

Regulatory professionals should not compromise their values or trustworthiness for personal gain or professional enhancement. Regulatory professionals shall develop and maintain integrity by:

• Keeping their commitments
• Giving credit for the work of others
• Maintaining confidentiality
• Seeking advice when uncertain
• Maintaining integrity without compromise
• Avoiding situations that put integrity at risk
• Accepting that best option may not be in their employer’s short-term interest
• Avoiding conflicts of interest
• Adhering to their employer’s Ethics and Compliance Standards

Honesty

Regulatory professionals shall exhibit honesty in all activities. Honesty requires acting free from deceit or deception, including dishonesty by omission or failing to provide comment when ethically required. Regulatory professionals shall build honesty and trust by:

• Ensuring information is accurate and complete.
• Protecting against omission of information or creation of false impressions.
• Resisting pressures to relax standards of honesty to achieve expediency.
• Providing a complete profile of a product under review in all regulatory submissions.

Courage

Regulatory professionals must have courage to evaluate, conclude, and provide consistent and accurate advice. Regulatory professionals develop courage by:

• Encouraging an open exchange of all views, even if they challenge regulatory advice.
• Admitting mistakes, accepting accountability, and promptly correcting any errors, miscommunications, or misperceptions.
• Delivering bad news quickly to management when necessary.
• Providing information to all stakeholders regarding risks and consequences if regulatory advice is overruled or ignored.

Fairness

Regulatory professionals strive to treat all persons fairly, equitably, and equally to create and maintain a healthy workplace, so that all people can thrive both personally and professionally. Regulatory professionals demonstrate fairness by:

• Respecting the letter and spirit of laws and regulations.
• Applying the appropriate regulatory standards to all cases.
• Considering cultural and regional differences and local requirements.
• Presenting the facts and objective analysis of scientific information using sound statistical interpretation to minimize bias while clarifying uncertainty.
• Ensuring all interests, public and private, are appropriately considered in the regulatory decision processes.

Respect

Regulatory professionals must respect the roles of their colleagues, and both recognize and acknowledge all. Regulatory professionals develop respect by:

• Listening.
• Treating all parties with dignity and courtesy.
• Accepting personal differences.
• Creating a positive environment where diversity, equity and inclusion thrive.
• Creating an environment where there is zero tolerance for harassment of any kind towards others.
• Finding creative ways to resolve conflict.
• Being patient and forgiving when others make mistakes and not assign blame.

Effective September 2022