To ensure the ethical design and conduct of human subjects research, universities, professional societies, licensing bodies, and journals should adopt more effective ways of integrating a lively understanding of personal responsibility into professional research practice. Rigorous courses in bioethics and human subjects research at the undergraduate as well as graduate and professional levels should be developed and expanded to include ongoing engagement and case reviews for investigators at all levels of experience. Moral Science : Protecting Participants in Human Subjects Research
Physician-researchers should be competent in recognizing, analyzing, and addressing ethical issues that arise during human subjects research. Why is this important? Physician-researchers are responsible for the integrity of the evidence and knowledge they create. As stated in the American Board of Internal Medicine’s The Physician Charter , and endorsed by the American Board of Radiology, physicians are duty-bound “ to uphold scientific standards, to promote research, and to create new knowledge and ensure its appropriate use” . Self-regulation or self-correction by the medical profession has proven inconsistent, resulting in increased federal and state regulatory oversight . Unfortunately, the current emphasis on professionalism and ethics is driven in part by physician and researcher misconduct . Research misconduct, as defined by the Health and Human Services (HHS) Office of Research Integrity, means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results . Publicized instances of research misconduct in the United States appear to occur almost exclusively in academic medical centers (90%) during studies conducted with government funding (70%) . Publication of research results and authorship—the currency of academic advancement—has become debased through poor adherence to ethical practice . As medical educators, it is important to help restore confidence in the research enterprise by ensuring resident trainees are better prepared to conduct research ethically.
It cannot be assumed that trainees entering residency are competent in research ethics. Medical students in the United States receive instruction in medical ethics but not necessarily research ethics. Medical ethics is understood as applied, professional ethics that guide clinical practices and relationships between physicians and patients . In the academic year 2014–2015, almost all 141 medical schools then accredited through the Liaison Committee of Medical Education included a clinical medical ethics course in the curricula . There is considerable variability in those curricula . It was only recently that knowledge of principles of research ethics and regulation was added in the United States Medical Licensing Examination, STEP 3 .
Education in research integrity is an opportunity to foster moral development and ethical decision-making in postgraduate physicians. The Accreditation Council of Graduate Medical Education’s Common Core Competencies and Milestones oblige physicians-in-training to adhere to ethical principles, to promote the primacy of patient autonomy, social justice, and to be knowledgeable in research and quality improvement methodologies . The requirements incorporate the Belmont Report principles and are relevant to best practices in research integrity. The Belmont Report provides ethical principles and guidelines for the protection of human subjects of research: respect for persons, beneficence, and justice . These principles apply to, for instance, practice-based learning and improvement activities, quality improvement, and scholarly activities performed with faculty mentors. These types of resident activities lay the groundwork for scientific publications, grant applications, and research collaborations. The integrity of that foundational evidence is essential, particularly when subject to reexamination or replication as part of the research record .
Currently, biomedical researchers who receive public funding through federal agencies such as the National Science Foundation, National Institutes of Health (NIH), and the National Institute of Food and Agriculture must demonstrate completion of training in the Responsible Conduct of Research (RCR) or research ethics . This applies to undergraduate students, graduate students, and postdoctoral researchers. The RCR content areas include data acquisition, management, sharing, ownership, publication and authorship, mentorship, peer review, and collaborative science, research misconduct, conflict of interest, research involving animals, and human subjects research . Competence in the RCR content areas is not necessarily required of all researchers—specifically physician-researchers—who perform clinical research without external funding. A curricular requirement of research in t egrity education would help fill gaps in knowledge, regardless of research type or funding source.
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10. Physicians must consider the ethical , legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. 12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. 36. Researchers , authors, sponsors , editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research .
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Table 1
Public Resources for Research Integrity Training
Resource URL NIH Protecting Human Research Participants. Responsible Conduct of Research https://phrp.nihtraining.com/users/login.php Office of Research Integrity (ORI). General Resources http://ori.hhs.gov/general-resources-0 Collaborative Institutional Training Initiative at the University of Miami (CITI) https://www.citiprogram.org/index.cfm?pageID=265 National Center for Professional and Research Ethics https://nationalethicscenter.org/ Resources for Research Ethics Education http://research-ethics.net/
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