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. Following a series of surveys and focus groups held over two years, a task force of volunteers was convened in February 2003. Their work, reviewed and shaped by many regulatory professionals, forms this code.

The task force identified eight core values that regulatory professionals embrace. 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.

Duty

Our role as regulatory professionals is defined by our duty to advise individuals and organizations regarding the appropriate regulatory context for actions they may want to take.

Our role is further defined by our obligations as employees of companies making important medical products for patients, as members of teams conducting nonclinical and clinical studies, as regulators and as members of our profession.

Regulatory professionals have a duty to:

• Disseminate and interpret relevant governmental regulations, industry standards and good practice guidelines without bias.
• Ensure products are safe and beneficial to patients, while maintaining the long-term interests of our employers.
• Ensure, to the extent possible, the benefits justify the risks for those who participate in clinical studies and who use regulated products.
• Provide physicians and other healthcare professionals with accurate and complete information about the safety and effectiveness of products.
• Maintain the long-term integrity of our profession and strive to deserve the public’s confidence and respect.

Competence

Competence means a regulatory professional has the knowledge, experience, ability and skill necessary to effectively identify, analyze and solve or recommend solutions to regulatory challenges. Regulatory professionals must be dedicated and flexible enough to adapt to the ever-changing realm of the regulatory profession.

The diversity of individuals and organizational contexts within the regulatory profession necessitates commitment to continually develop competence by a variety of means: seeking continuing education, work experience, professional training and certification.

Just as the regulatory profession continues to evolve, maintaining competence within the field is a continual learning process.

Regulatory professionals develop competence by:

• Being informed and knowledgeable about cur-rent and future trends.
• Claiming competence only in areas where they have a thorough understanding.
• Encouraging and supporting professional growth and development among peers and subordinates so all who work in the field can gain and demonstrate competence in the profession.

Objectivity

Regulatory professionals must be objective and must display their objectivity by representing facts without distortion by personal feelings or biases. The regulatory professional must understand the facts and must evaluate information from several points of view.

Regulatory professionals must understand their decisions may affect the interests of many parties including companies, regulators, healthcare professionals, patients and shareholders. Regulatory professionals must be aware of these differing interests without letting them influence their final regulatory interpretations and actions.

Regulatory professionals develop objectivity by:

• Responding carefully to opinions and issues and recognizing a single right or wrong answer is rare. Opinions can often take on a partisan perspective. The regulatory professional should always strive to offer an unbiased expression of facts.
• Presenting reasonable regulatory opinions, options and associated risks when developing regulatory strategies.
• Clearly differentiating among regulatory requirements, internal requirements and personal preferences.
• Disclosing new information appropriately within the proper context.

Integrity

Regulatory professionals with integrity will not compromise their values or trustworthiness for personal gain or professional enhancement. Individuals with integrity are principled, scrupulous and trustworthy. Having integrity suggests that one is “whole,” and one’s beliefs, words and actions are congruent and consistent.

Regulatory professionals develop and maintain integrity by:

• Keeping commitments.
• Giving credit for the work of others.
• Maintaining confidentiality of information and never disclosing information concerning the business or technical affairs of others without their consent.
• Seeking advice from others when uncertain.
• Considering their obligations and the long-term consequences of their actions when asked to compromise integrity for the sake of one party over another.
• Avoiding situations that put their integrity at risk.
• Recognizing the best course of action may not be in the short-term interest of their employer.
• Accepting compensation only when earned.
• Avoiding conflicts of interest or making conflicts known when they are unavoidable.

Honesty

Regulatory professionals must exhibit honesty in all of their activities. Honesty is truthfulness, candor and sincerity. Honesty requires a regulatory professional to act in ways free from deceit or deception, including dishonesty by omission or failing to say something when comment is ethically required. Honesty requires candid and forthcoming actions, not simply refraining from false statements.

Regulatory professionals build honesty and trust, which is absolutely essential to fostering effective working relationships, by:

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

Courage

Regulatory professionals demonstrate courage by choosing the right thing even when doing so is difficult. Regulatory professionals must have the courage to evaluate, conclude and provide consistent and accurate regulatory advice while accepting the consequences of their actions. They must gain access to information required to do their jobs as completely as possible.

Regulatory professionals develop courage by:

• Reviewing and reiterating their advice and strategy when necessary or when challenged and changing their advice when appropriate.
• Asking for help when needed.
• Encouraging an open exchange of views even if those views challenge their regulatory advice.
• Admitting mistakes, accepting accountability and taking appropriate measures to promptly correct any errors, miscommunications or misperceptions.
• Delivering bad news quickly to management when necessary.
• Providing information to stakeholders about regulatory risks and describing consequences if regulatory advice is overruled or ignored.

Fairness

Regulatory professionals strive to treat all persons fairly, equitably and equally in accordance with the law by holding all those with common responsibilities to a common standard. Regulatory professionals should consider the rights and needs of all parties in the context of all applicable laws, regulations and scientific and societal norms.

Regulatory professionals demonstrate fairness by:

• Respecting the letter and spirit of laws and regulations.
• Applying the appropriate legal and regulatory standards to all cases.
• Taking into account 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 demonstrate respect by appreciating the worth or value of people and things. Regulatory professionals must respect the roles of their colleagues and should recognize and acknowledge the worth of all parties.

Regulatory professionals develop respect by:

• Listening to what others have to say.
• Treating all parties, regardless of level or position, with dignity, civility and courtesy.
• Accepting personal differences but working diligently toward accommodating those differences where ever possible.
• Creating a positive environment encouraging participation of all parties without embarrassment, ridicule or hurtful actions or inactions.
• Sharing what they know in a nonintimidating way.
• Tolerating and encouraging those who do not initially understand.
• Avoiding conflict where possible and finding creative ways to resolve conflict quickly.
• Being patient and forgiving when others make mistakes and working to prevent mistakes from recurring rather than assigning blame.