The activities of the life sciences are essential to provide solutions for the future, for both individuals and society. Society has demanded growing accountability from the scientific community as implications of life science research rise in influence and there are concerns about the credibility, integrity and motives of science. While the scientific community has responded to concerns about its integrity in part by initiating training in research integrity and the responsible conduct of research, this approach is minimal. The scientific community (...) justifies itself by appealing to the ethos of science, claiming academic freedom, self-direction, and self-regulation, but no comprehensive codification of this foundational ethos has been forthcoming. A review of the professional norms of science and a prototype code of ethics for the life sciences provide a framework to spur discussions within the scientific community to define scientific professionalism. A formalization of implicit principles can provide guidance for recognizing divergence from the norms, place these norms within a context that would enhance education of trainees, and provide a framework for discussing externally and internally applied pressures that are influencing the practice of science. The prototype code articulates the goal for life sciences research and the responsibilities associated with the freedom of exploration, the principles for the practice of science, and the virtues of the scientists themselves. The time is ripe for scientific communities to reinvigorate professionalism and define the basis of their social contract. Codifying the basis of the social contract between science and society will sustain public trust in the scientific enterprise. (shrink)

Assessment of risk is one of the key issues in the field of responsible conduct of research which covers discourses of research ethics and research integrity. The principle of minimizing risks and balancing of risks and benefits is one of the main requirements of research ethics. In addition, the content of informed consent that is another fundamental principle of research ethics derives from the assessment of risks and benefits related to a particular research project. Risk assessment also plays a crucial (...) role in methodological design of the research project. This is an important point where research ethics and research integrity discourses overlap. Firstly, because the choice of a control group (e.g., placebo control) is a key ethical issue related to the protection of the research subjects’ interests. Secondly, because the quality of the research data, that is one of the key elements of research integrity, is closely connected to the choice of research methodology as well. The problem of biased interpretation or manipulation of risk related features of biomedical research should also be taken into account. Despite the importance of the concept of risk to the field of biomedical research, its relevance has not yet attracted a sufficient attention in the responsible conduct of research debate. (shrink)