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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.
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:
As a regulatory professional I aspire to:
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:
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:
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:
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:
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:
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:
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:
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: