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
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
Statement of Personal Responsibility
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.
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.
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
- Dignity and Respect
As a regulatory professional I aspire to:
ensure my employer’s activities are conduct-ed in compliance with the
laws and regulations of the authorities under which we operate,
consistent with advancing, preserving and protecting public health
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 out-side my
- 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
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
- 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
- Be respectful of others. I must treat all individuals with dignity and courtesy.
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
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.
to the extent possible, the benefits justify the risks for those who
participate in clinical studies and who use regulated products
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.
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.
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.
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.
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:
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.
professionals with integrity will not com-promise 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.
confidentiality of information and never disclosing information
concerning the business or technical affairs of others without their
- Seeking advice from others when uncertain.
their obligations and the long-term consequences of their actions when
asked to com-promise 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.
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.
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.
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
Regulatory professionals develop courage by:
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.
mistakes, accepting accountability and taking appropriate measures to
promptly correct any errors, miscommunications or misperceptions.
- Delivering bad news quickly to management when necessary.
information to stakeholders about regulatory risks and describing
consequences if regulatory advice is overruled or ignored.
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.
the facts and objective analysis of scientific information using sound
statistical interpretation to minimize bias while clarifying
- Ensuring all interests, public and private, are appropriately considered in the regulatory decision processes.
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
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.
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.
patient and forgiving when others make mistakes and working to prevent
mistakes from recurring rather than assigning blame.