Task Force IV: Scientific responsibility and integrity in medical research

Abstract Ethical standards are a set of affirmative responsibilities to which the investigator must subscribe; behavior that is incompatible with these responsibilities should be presumed unethical, whether or not it is explicitly proscribed. This Task Force sought to present these standards as principles or guidelines. In undertaking research an investigator must accept that publicly funded or supported research is intended to yield public benefit; personal gain should be only incidental to and not at the expense of the public benefit. The responsibilities of the investigator are summarized as follows: Design of Research • • To develop a research design that effectively and efficiently addresses the scientific question while minimizing the likelihood of incorrect or misleading results. • • To protect the rights and welfare of human subjects, assure the humane use of laboratory animals and protect the safety of laboratory workers and the environment. Conduct of Research • • To ensure that accepted laboratory and research practices are followed and that all data are accurately collected and properly recorded; the investigator must participate in the review of original data. • • To carry out research in accordance with that approved by the institutional review board and ensure that fully informed consent is obtained, that the welfare of human subjects is protected and that animal welfare and laboratory safety procedures are carried out. • • To provide effective ongoing supervision of research trainees and technicians. • • In multidisciplinary collaborative research, to have at least an overview familiarity with the work outside his or her areas of expertise. In fixed protocol, multicenter collaborative research the investigator must be satisfied with the adequacy of the collaborative activities. p] Reporting Research • • To report on research clearly, accurately, completely, honestly and in a manner that is likely to be interpreted correctly. • • To analyze and report data that reject the hypothesis being tested, as well as to those that support it. • • To report findings promptly and in the formal literature of science, but not at the expense of careful preparation and review or through multiple fragmentary publications. • • To ensure that any previously published data are clearly identified to editor and reader. • • To offer and accept authorship of scientific papers only when there is substantial participation in at least two of the three phases of research—concept or design, execution, and data analysis and report preparation—and every author must participate in the review of the manuscript. • • To make prompt, accurate and public correction of any significant errors in his or her publications. p] Research Objectivity, Credibility and Conflicts of Interest • • To try to avoid side interests and activities that may provoke plausible questions about his or her goals, or about the accuracy and objectivity of results. Concerns may arise particularly when an investigator has a financial interest in the outcome of research, is dependent on or indebted to someone with a financial interest in the outcome of research or has roles with conflicting responsibilities. • • If a potential conflict of interest cannot be totally avoided, the investigator must consult and obtain the concurrence of institutional officials. • • To indicate the existence and nature of any real or apparent conflict of interest in publications, presentations and reviews. p] Maintenance of Research Records and Data • • To work with his or her institution to maintain research records upon which reports are based for a reasonable time, such as at least 5 years following publication. p] Access to Data • • To work with his or her institution to make available within a reasonable period of time the data on which published reports are based. p] Access to Research Products and Reagents • • When published research involves reagents or yields products that cannot be replicated based on their published description, to make these available to the scientific community for research purposes but not for commercial exploitation. Mentorship and Education • • To serve as a mentor for indoctrinating junior scientists into the purposes, values and methods of science, both through teaching and example. p] Scientific Citizenship • • To contribute to the well-being of the scientific community through service on committees, and in referee and advisory capacities; these responsibilities must be discharged with the same standards of accuracy, objectivity, balance and avoidance of conflicts of interests as the investigator's personal research. • • To maintain the confidentiality of privileged nonpublic information with which he or she is entrusted. • • To call to the attention of editors information that suggests or establishes serious errors published in their journal. • • To call to the attention of appropriate institutional or other officials scientific misconduct of which he or she becomes aware.