Code of Ethics & Professional Conduct
The Association of Clinical Research Professionals (ACRP) and the Academy of Physicians in Clinical Research (APCR) are global organizations committed to promoting excellence and professionalism in clinical research and pharmaceutical medicine. ACRP and APCR members are engaged in all aspects of discovery, testing, development and application of drugs, devices and biologics. The scope of their activities encompasses research and medical practice as well as diverse business activities, regulatory affairs, advocacy, education and other professional endeavors.
Members and certificants, those who receive certification from The Academy, affirm their commitment to upholding the highest standards of personal and professional behavior in the conduct of their endeavors. To file a complaint against a Member or certificant, please email firstname.lastname@example.org. Complaints will be addressed according to the Discipline and Complaints Policy developed by the ACRP Ethics Committee.
While pursuing their professional endeavors, all members and certificants shall:
- Be mindful and respectful of the important distinctions between medical practice and research.
- Accept ensuring the safety and welfare of human subjects and patients as their highest goal.
- Execute their work in accordance with standards of scientific objectivity, accountability and professionalism.
- Continue to advance their knowledge and understanding of the profession through education and training.
- Safeguard the quality and credibility of their professional judgment from inappropriate influence.
- Ensure that the principles of respect for persons and the practice of obtaining informed consent are honored at all times, both in spirit and in practice.
- Observe both in spirit and in practice all legal, ethical and regulatory requirements pertaining to confidentiality of identifiable personal information, relevant records and communications.
- Avoid conflicts of interest in their affairs and make full disclosure before undertaking any matter that may be perceived as a conflict of interest.
- Adhere to all relevant ethical standards and practices for responsible conduct of research and medical practice.
- Abide by all applicable laws, regulations and official directives applicable to their professional activities in the legal jurisdiction(s) in which they work and reside, and respect the prevailing ethical and community standards.
- Abide by the laws and ethical codes of their respective disciplines.
In observance of these principles, ACRP and APCR members and certificants shall be mindful of the following explanations and guidelines as may be applicable to specific circumstances and practices:
Distinctions between Medical Practice and Research
Medical practice seeks to benefit individual patients and public health through prevention, diagnosis and treatment of disease. Research seeks to advance knowledge through application of the tools of science and technology. Clinical research depends upon individuals who volunteer to participate as subjects of research studies. Society can benefit from both research and medical practice when conducted responsibly through the acquisition of knowledge and the testing and marketing of new as well as older products. Clinical research is an endeavor in which roles can be easily confused. Treatment is not the same as investigation. The relationship established between patients and those providing clinical care to them is distinct from that established between a research participant (or subject) and a member of the clinical research team. Accordingly, the terms patient and research participant should not be used indiscriminately or interchangeably. Similarly, steps shall be taken to ensure that the roles and responsibilities of physicians and investigators, especially when they may overlap, remain clear.
Beneficence and Nonmaleficence
Members and certificants shall strive to benefit those with, for and on whose behalf they work, and take care to do no harm. Members and certificants shall respect and safeguard the welfare and rights of all individuals with whom they interact professionally, including but not limited to research subjects. Members and certificants shall act in the best interest of research subjects, patients and society. When conducting research, members and certificants shall ensure that potential risks to research participants are minimized and that these risks are fully evaluated against potential benefits prior to and throughout the research. Members and certificants engaged in the practice of pharmaceutical medicine shall place the interests, safety and well-being of their patients above all other considerations.
Research Standards and Objectivity
Members and certificants shall educate themselves, their students and their colleagues about responsible research practices. Members and certificants shall apply sound ethical values, scientific principles and judgment in the design, conduct and analysis of clinical studies, and in interpretation of their results. Members and certificants shall report research findings accurately and shall not misrepresent, fabricate or falsify results. They shall conduct research in accordance with an approved research protocol. Members and certificants shall make all research data available for verification in accordance with established standards of the profession. Members and certificants shall ensure the dissemination only of scientifically sound information from clinical trials and other investigations, without regard to study outcomes, and shall not withhold information relevant to full evaluation of the safety, efficacy or utility of agents or devices under investigation for the benefit of medicine, patients, science and society.
Competence and Advancement of Knowledge
Clinical research professionals and pharmaceutical physicians are committed to being competent in all of their professional activities, and members and certificants shall strive to achieve the highest level of knowledge, skill and ability within their capacity. Members and certificants shall maintain knowledge of new developments in emerging areas of practice and ethical interpretations through professional education and training, including such activities as reading, courses, professional meetings, peer consultations, supervision and other continuing education opportunities.
Members and certificants shall exhibit the highest standards of integrity and be honest, open, objective and accurate in all of their professional activities. Members and certificants shall not lie, steal, cheat or engage in fraud, subterfuge, misrepresentation of fact, or partial or delayed disclosure of information in a misleading manner. Members and certificants shall act honestly and openly in all professional relationships and shall not participate in, condone or be associated with dishonesty, fraud or misrepresentation. Members and certificants shall accurately represent their own and their associates’ qualifications, education, experience, competence and affiliations in all spoken, written or printed communications. Members and certificants shall not fabricate data, withhold meaningful relevant data, leave significant errors in published data uncorrected, or present portions of others’ work or data as their own.
Members and certificants shall, as appropriate for the approved research, obtain informed consent from individuals who are research subjects using language that is reasonably understandable and clear, informing research subjects of the purpose of the research, risks and discomforts related to the research, potential benefits of the research to the subject and/or society, the subjects’ right to refuse or withdraw consent, the duration of participation and any other information relevant to making an informed decision regarding participation in a study. Members and certificants also shall provide subjects with an opportunity to ask questions, which shall be answered completely and truthfully. When potential subjects are not literate or have difficulty understanding the primary language used, members and certificants shall take steps to ensure subjects’ comprehension, such as providing subjects with a detailed verbal explanation or arranging for a qualified interpreter or translator. Individuals who do not comprehend the information provided and voluntarily agree to participation shall not be enrolled in a study. For persons who are legally incapable of giving informed consent, members and certificants shall nevertheless provide an appropriate explanation, obtain the individual’s assent, and obtain appropriate permission from a legally authorized person. When a physician is both researcher and clinician, he/she shall ensure that any patient understands this dual role and is free from coercion or other undue pressure to participate in the research endeavors. Consent must be not only fully informed, but also freely given without restriction.
Privacy and Confidentiality
Members and certificants shall not solicit private information from research participants or patients unless justifiable and appropriate. Members and certificants engaged in the practice of medicine shall recognize that information obtained by caregivers from patients is privileged and they shall respect the privacy of their patients. In medical practice research and business activities, if private information is shared, standards of confidentiality apply. Members and certificants must take reasonable precautions to protect confidential information obtained through or stored in any medium, recognizing that the extent of limits of confidentiality may be regulated by law or established by institutional rules or professional or scientific relationship. Members and certificants may disclose confidential information, when appropriate, only with valid consent or authorization, or if otherwise required by law. In all instances, members and certificants shall disclose the least amount of confidential information necessary to achieve the desired purpose. To the extent that confidential information is disclosed inappropriate scientific or professional circumstances, it shall be disclosed with appropriate protections and only to persons clearly concerned with such matters. Written and electronic records and other sensitive information shall be stored in secure locations and shall not be made available to those who are not authorized to have access.
Conflicts of Interest
At all times, members and certificants shall safeguard the quality and credibility of their professional judgment from inappropriate influence. Members and certificants shall not exploit any professional relationship to further personal, political or business interest at the expense of the best interest of clients, research participants, employers, patients or others. Members and certificants shall avoid dual relationships that could impair professional judgment or increase the risk of harm to others, such as relationships that are familial, social, financial, business or close personal relationships with employees, supervisees, students or research assistants. Members and certificants shall take precautions to avoid conflicts of interests and, when a conflict of interest or the perception of a conflict cannot be eliminated or avoided, take further steps to protect the affected individuals and the clinical research enterprise.
Ethics and Responsible Conduct
Members and certificants are committed to involvement in professional endeavors that enhance knowledge, skill, judgment and intellectual development for the benefit of society. Members and certificants shall be personally committed to and encourage others to engage in safe, sound research practices consistent with the relevant ethical and scientific standards. Members and certificants shall cooperate with other professionals as appropriate and ethical. Members and certificants should consult and advise each other regarding medical, scientific and ethical concerns, and seek external opinions, as appropriate, in the best interests of clinical study participants and patients. Members and certificants shall assist those who enter the profession by helping them to acquire a full understanding of the ethics, responsibilities and needed competencies of their chosen area of research and practice.
Duties to Society and Compliance with the Law
Clinical research professionals and pharmaceutical physicians have a duty to society as a whole. Members and certificants should be aware of their place in society and develop ways to help the profession contribute to the betterment of society. ACRP members and certificants must uphold the profession’s responsibility to society by promoting the highest ethical and practice standards in the profession and by supporting measures to maintain accountability. Members and certificants should strive to understand and respect differences in values across cultures and to appropriately adapt behaviors while maintaining ethical principles. Members and certificants shall not participate in criminal or fraudulent activities. If faced with an apparent conflict between abiding by a law or regulation and following an ethical principle, unless in an emergency, members and certificants shall consult with colleagues and seek consensus as to the most ethical course of action in the most responsible, knowledgeable, effective and respectful way to carry it out. Members and certificants shall not advocate, sanction, participate in or cause to be accomplished, or condone any act that is prohibited by this Code of Ethics, unless doing so would be seriously detrimental to the rights and well-being of others.
Duties to Professional Discipline and Beneficiaries of Practice
Whenever members and certificants maintain a medical or clinical license, or otherwise participate in clinical practice, additional laws and ethics that do not pertain to research apply. Members and certificants shall, in addition to adhering to this Code of Ethics, abide by their respective discipline’s laws and ethical standards pertaining to their practice so that first priority is always given to the well-being of patients or other beneficiaries who use pharmaceutical products or medical devices, or who receive any other clinical services in a practice setting. Additionally, members and certificants whose efforts indirectly aid the practice of medicine shall ensure that all contributory information is fair, balanced, accurate, comprehensive and easily accessible to all so that well-informed decisions about the use of pharmaceuticals, medical devices or other clinical services can be made by their beneficiaries and their providers.
©2012 Association of Clinical Research Professionals and the Academy of Physicians in Clinical Research