Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell research -- International research.

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)

Although the terms mentor and thesis advisor (or research supervisor) are often used interchangeably, the responsibilities associated with these roles are distinct, even when they overlap. Neither are role models necessarily mentors, though mentors are role models: good examples are necessary but not sufficient. Mentorship is both a personal and a professional relationship. It has the potential for raising a number of ethical concerns, including issues of accuracy and reliability of the information conveyed, access, stereotyping and tracking of advisees, and (...) the abuse of power. Nevertheless, mentors can be critically important for professional success and are one of a number of elements that affect the responsible conduct of research. In addition, the community as a whole has a responsibility to mentor junior members. (shrink)

In little more than 30 years, China has recovered from the intellectual stagnation brought about by the Cultural Revolution to become a global leader in science and technology. Like other leading countries in science and technology, China has encountered some ethical problems related to the conduct of research. China 's leaders have taken some steps to respond to these problems, such as developing ethics policies and establishing oversight committees. To keep moving forward, China needs to continue to take effective action (...) to promote research integrity. Some of the challenges China faces include additional policy development, promoting education in responsible conduct of research, protecting whistle-blowers, and cultivating an ethical research environment. (shrink)

Ambiguity associated with everyday practice of science has made it difficult to reach a consensus on how to define misconduct in science. This essay outlines some of the important ambiguities of practice such as distinguishing data from noise, deciding whether results falsify a hypothesis, and converting research into research publications. The problem of ambiguity is further compounded by the prior intellectual commitments inherent in choosing problems and in dealing with the skepticism of one's colleagues. In preparing a draft code of (...) ethics for the American Society of Biochemistry and Molecular Biology (ASBMB), an attempt was made to take into account the ambiguities of practice. Also, the draft code adopted trust as its leading principle, specifically the importance of trust as a condition necessary for there to be science. During revision of the code, the focus on trust was changed. The new orientation was on trust as a consequence of carrying out science responsibly. By addressing the obligations necessary to engender trust, the ASBMB ethics code not only sets professional standards, but also makes a clear statement of public accountability. (shrink)

Research misconduct has been thoroughly discussed in the literature, but mainly in terms of definitions and prescriptions for proper conduct. Even when case studies are cited, they are generally used as a repository of “lessons learned.” What has been lacking from this conversation is how the lessons of responsible conduct of research are imparted in the first place to graduate students, especially those in technical fields such as engineering. Nor has there been much conversation about who is responsible for what (...) in training students in Responsible Conduct of Research or in allocating blame in cases of misconduct. This paper explores three seemingly disparate cases of misconduct—the 2004 plagiarism scandal at Ohio University; the famous Robert Millikan article of 1913, in which his reported data selection did not match his notebooks; and the 1990 fabrication scandal in Dr. Leroy Hood’s research lab. Comparing these cases provides a way to look at the relationship between the graduate student (or trainee) and his/her advisor (a relationship that has been shown to be the most influential one for the student) as well as at possibly differential treatment for established researchers and researchers-in-training, in cases of misconduct. This paper reflects on the rights and responsibilities of research advisers and their students and offers suggestions for clarifying both those responsibilities and the particularly murky areas of research-conduct guidelines. (shrink)

Responsible conduct of research courses are widely taught, but little is known about the purposes or effectiveness of such courses. As one way to assess the purposes of these courses, students were surveyed about their perspectives after recent completion of one of eleven different research ethics courses at ten different institutions. Participants enrolled in RCR courses in spring and fall of 2003 received a voluntary, anonymous survey from their instructors at the completion of the course. Responses were received from 268 (...) participants. Seventy-seven percent of open-ended responses listed specific kinds of information learned; only a few respondents talked about changes in skills or attitudes. The perception that courses did more to provide information than to foster skills or attitudes was verified in quantitative responses. Over 75% of the respondents specifically noted that courses were useful in preparing them to recognize, avoid, and respond to research misconduct. The two principal findings of this multi-institutional study are that respondents reported: a wide variety of positive outcomes for research ethics courses, but that the impact on knowledge was greater than that for changes in skills or attitudes. (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)

In this paper I shed light on the connection between respect, trust and patients’ satisfaction with their medical care. Using data collected in interviews with 49 women who had managed, or were in the process of managing, their risk of ovarian cancer using prophylactic surgery or ovarian screening, I examine their reported dissatisfaction with medical encounters. I argue that although many study participants appeared to mistrust their healthcare professionals’ (HCPs) motives or knowledge base, their dissatisfaction arose not from a lack (...) of trust, but from HCPs’ failure to treat them as persons or take their concerns seriously. I conclude by describing how respect, as evidenced by “being taken seriously”, is important for the development of trusting Patient–HCP relationships. (shrink)

In Nigeria, as in other developing countries, access to training in research ethics is limited, due to weak social, economic, and health infrastructure. The project described in this article was designed to develop the capacity of academic staff of the College of Medicine, University of Ibadan, Nigeria to conduct ethically acceptable research involving human participants.

Training in the responsible conduct of research (RCR) is required for many research trainees nationwide, but little is known about its effectiveness. For a preliminary assessment of the effectiveness of a short-term course in RCR, medical students participating in an NIH-funded summer research program at the University of California, San Diego (UCSD) were surveyed using an instrument developed through focus group discussions. In the summer of 2003, surveys were administered before and after a short-term RCR course, as well as to (...) alumni of the courses given in the summers of 2002 and 2001. Survey responses were analyzed in the areas of knowledge, ethical decision-making skills, attitudes about responsible conduct of research, and frequency of discussions about RCR outside of class. The only statistically significant improvement associated with the course was an increase in knowledge, while there was a non-significant tendency toward improvements in ethical decision-making skills and attitudes about the importance of RCR training. The nominal impact of a short-term training course should not be surprising, but it does raise the possibility that other options for delivering information only, such as an Internet-based tutorial, might be considered as comparable alternatives when longer courses are not possible. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each school (...) in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

This paper reports data and scholarly opinion that support the perception of systemic flaws in the management of scientific professions and the research enterprise; explores the responsibility that professional status places on the scientific professions, and elaborates the concept of the responsible conduct of research (RCR). Data are presented on research misconduct, availability of research guidelines, and perceived research quality.

The purpose of this paper is to provide a simple yet comprehensive organizing scheme for the responsible conduct of research (RCR). The heuristic offered here should prove helpful in research ethics education, where the many and heterogeneous elements of RCR can be bewildering, as well as research into research integrity and efforts to form RCR policy and regulations. The six domains are scientific integrity, collegiality, protection of human subjects, animal welfare, institutional integrity, and social responsibility.

This article reports on a method of group mentoring to strengthen responsible research conduct. A key feature of this approach is joint exploration of the issues by trainees and their faculty research supervisors. These interactions not only help participants learn about current ethical norms for research practice, but also draw on the accumulated experience of faculty and staff about practical problems of research conduct, and help to make faculty more articulate about responsible research conduct and so better able to guide (...) their trainees. By working with departments or laboratories as a whole the method facilitates the formulation of specific norms appropriate to particular research situations and to strengthen the group’s ability to support appropriate behavior and deal with new issues as they arise. It also gives students more ways to ask questions about research practice and to benefit from the experience of all members of their department or group as well as their own research supervisors. The method is well tested and has been well received by a wide variety of departments and research groups. It provides the means for a constructive and enjoyable response to the Public Health Service’s (PHS) new Policy on Instruction in the Responsible Conduct of Research (RCR) that requires education in the responsible conduct of research for all those funded by PHS funds, including faculty and staff as well as trainees. (shrink)