|I. Ethical Issues in Research: A Framework||II. Interpersonal Responsibility
||III. Institutional Responsibility|
|IV. Professional Responsibility||V. Animals in Research||VI. Human Participation in Research|
Welcome to the Online Research Ethics Course developed through the Practical Ethics Center at the University of Montana with Office of Research Integrity (ORI) support during the 2002-03 academic year.
This course is intended to provide a foundation for institutions that are working to promote Responsible Conduct of Research. Our hope is that web-based instruction like this will expose investigators and students to the kinds of ethical issues and federal requirements they encounter throughout their careers and prepare them to deal with those issues and requirements.
Each of the six sections of this course provide information on major issues and contain at least one case study that allow exploration of different options, as well as an assessment tool so you can test your knowledge of the area.
Read each section's Introduction and Major Issues for Discussion. You may also want to explore the many additional resources provided for each section. Next, select the Case Study link. Each Case Study provides different alternatives for you to explore. When you have finished all of the alternatives, click continue to test your understanding of the covered material.
Once you have successfully completed the Section Assessment, you will continue to the next section.
Federal funding agencies and research institutions are increasingly pro-active in insuring that researchers and graduate students in research disciplines learn about the ethics related to their work. In December 2000, the Office of Research Integrity (ORI) issued the Public Health Service (PHS) Policy on Instruction in the Responsible Conduct of Research (RCR). If the policy had been approved, ORI would require research institutions that are recipients of PHS funds to develop and require training in ethics for all research staff "who have direct and substantive involvement in proposing, performing, reviewing, or reporting research, or who receive research training, supported by PHS funds or who otherwise work on the PHS-supported research project even if the individual does not receive PHS support."/1 PHS research funding is provided by the Administration for Children and Families, Centers for Disease Control and Prevention, Indian Health Service, and National Institutes of Health.
The PHS policy requiring RCR training was suspended in February 2000, "pending review of its substance and whether the document should have been issued as a regulation rather than a policy," and, in more than three years has not been instituted. Nevertheless, ORI has continued to develop resources and to fund development to assist in educational planning for research institutions that are creating materials and processes for RCR.
In December 2000, the Office of Science and Technology Policy offered new definitions and procedures to standardize responses by federal funding agencies to allegations of research misconduct. The new definitions and procedures were meant to apply to all federal departments and agencies. That proposal defines misconduct as "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results." Under this proposal, research institutions would be responsible for the protection of those who make an accusation of misconduct and protection of those accused. Research institutions would also be required to separate investigations of misconduct into four different phases: inquiry, investigation, adjudication, and appeal.
As of early 2002, this proposal has still not been fully implemented, but federal agencies were seeking, individually, to adopt the standard definitions and procedures. For example, on January 25, 2002, The National Science Foundation (NSF) placed a notice in the Federal Register of its intention to revise its misconduct regulations to conform with the new federal policy./3
As will be explained more fully in the section on animals in research, there is an on-going battle at the federal level over whether birds, mice, and rats should be protected under the Federal Animal Welfare Act.
There are also some areas of agreement among federal agencies regarding research ethics. All researchers who use human participants in their research are required to have training on the topic, and research institutions must have committees to oversee the use of animals and human participation in research and documentation to show that the oversight is accomplished.
It is in this context that research institutions are working to develop research ethics education for investigators, students and lab personnel. This asynchronous online course provides such education. In anticipation of expected federal requirements, this online course covers the topics listed by PHS as core curriculum:
1). Data acquisition, management, sharing, and ownership;In addition, the course uses the partially implemented standardized federal definitions and procedures.
2). Mentor/trainee responsibilities;
3). Publication practices and responsible authorship;
4). Peer review;
5). Collaborative science;
6). Human subjects;
7). Research involving animals;
8). Research misconduct; and
9). Conflict of interest and commitment./4
This course also encourages investigators, and requires students enrolled in the course for credit, to think critically about what it means to be an ethical researcher. One may be in compliance, without being an ethical researcher. Being in compliance means following the rules; ethical research requires an understanding of the ethical imperatives behind the rules. The fundamental ethical imperative behind the rules is that researchers seek to do their jobs in a manner that will not cause unjustified harm to anyone. But, most researchers work toward acting in an ethically ideal way -- through their work and professional conduct, they seek to prevent harm and to promote the good. Throughout the course, investigators and students will be asked to think about the range of actions that count as responsible conduct for the ethical researcher as well as identifying the rules that researchers are expected to follow.
Some of the content for this course comes from work sponsored by NSF/5 and the Fund for the Improvement of Postsecondary Education (FIPSE)/6, conducted at Dartmouth College and the University of Montana from 1992-1995. Those projects resulted in three publications, Stern, Judy E. and Elliott, Deni, The Ethics of Scientific Research: A Guidebook for Course Development and Elliott, Deni and Stern, Judy E. (eds), Research Ethics: A Reader and a special issue of Professional Ethics Journal, Volume 4, Numbers 3 & 4. Both books were published by the University Press of New England in 1997 and material from both books is incorporated into this course. Copies of the journal may be ordered from Professional Ethics Journal at the Center for Applied Philosophy, University of Florida, Gainesville, Florida. This course was also enriched through a conversation the course authors had with Dartmouth, NSF and FIPSE in December 2000 and by the pilot testing of sections by colleagues around the country in March, 2002.
This course is divided into six sections that cover the major topics in research ethics. Each section includes an introduction that identifies learning goals, major issues for discussion, at least one case study, external links, and an examination on the concepts covered. The case studies are intended to be explored through an investigation of all the offered choices. Each of the six sections may be examined independently. Each section, not counting explorations into external links, will take between 30 and 45 minutes to complete.
I. Ethical Issues in Research: A Framework
A. Compliance and Ethics
B. Compliance Concepts
C. Ethics Concepts
II. Interpersonal Responsibility
A. Mentor/Trainee Responsibilities
B. Determining Publication Practices and Responsible Authorship
C. Collaborative Science/Competitive Science
III. Institutional Responsibility
A. The Institutional Process Regarding Allegations
B. Conflicts of Interest and Conflicts of Commitment
IV. Professional Responsibility
A. Proposing Research
B. Dissemination of Findings
C. Peer Review
V. Animals in Research
VI. Human Participation in Research
A Brief History of the Development of Research Ethics
Questions relating to the ethical practice of research have been around as long as research itself. However, until the late 20th Century, it was assumed that scientists were naturally conducting their research in a responsible way or that the profession could identify and weed out the few bad actors. One of the hallmarks of research in the hard sciences and social science is trust in its "self-correcting" nature.
Instances of intentional fraud were thought to be few. It was erroneously believed that well-intentioned researchers did not need clear statements of expectations or conventional norms. It was assumed that novice researchers learned the conventions and expectations of high quality research in the labs of their equally well-intentioned mentors. The individual nature of the instruction meant that what were perceived as "norms" were more often the individual mentor's own perspectives. "The absence of norms... was symptomatic of the neglect of research ethics in the decades leading to the 1980s," according to Caroline Whitbeck in her introduction to a collection of papers on Trustworthy Research./7 "During this period, hardly any universities or other research institutions established policies for investigating charges of wrongdoing."
The U.S. federal government, with its responsibility for overseeing the use of public funds, became actively involved in identifying and describing less-than-adequate research practices in the 1980s. Between 1980 and 1985, the federal focus and language changed from "research fraud" to "research misconduct." In Congressional subcommittee hearings in 1981 on biomedical fraud, led by Albert Gore, Jr., it became clear that the misdeeds being discussed were broader than what was previously thought to count as fraud. Through the work of this committee and subsequent work, the definition of misconduct evolved to include intentional acts of fabrication, falsification and plagiarism (FFP).
The inclusion of what has been referred to as FFP is generally not controversial, but FFP is not inclusive of all that can go wrong in research. Along with FFP, there are "other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research." Deviations from commonly accepted practices were thought by some to include behavior specific to the substance of the research, such as failing to report results that contradict one's hypothesis, and thought by others to include a wide range of unconventional behaviors on the part of the researcher, including sexual harassment or drug abuse.
Due to uncertainty as to what should count in the category of "practices that seriously deviate," that language was dropped out of the federal requirements proposed in December 2000. However, this category of problematic practices (in addition to FFP) has remained an important area for teaching responsible conduct of research. Responsible conduct of research includes avoidance of practices that seriously deviate from commonly accepted procedures as well as refraining from intentional fabrication, falsification, and plagiarism.
Since the 1980s, professional societies and federal agencies moved to describe research norms and to look for ways to educate young scientists. While not disputing the importance of informal mentoring in the teaching of students, the National Academy of Sciences explained that "[S]cience has become so complex and so closely intertwined with society's needs that a more formal introduction to research ethics and the responsibilities that these commitments imply is also needed - an introduction that can supplement the informal lessons provided by research supervisors and mentors." The Academy, in 1989, produced the first edition of "On Being A Scientist," to describe, for beginning scientists, the ethical foundations of scientific practice. More than 200,000 copies were distributed to graduate and undergraduate students./8
By the end of the 1980s, the Institute of Medicine recommended that students be provided formal instruction in research practice and PHS moved to make institutions of higher education more accountable for the conduct of their researchers. The 1989 misconduct regulations from the Public Health Service (PHS) (which includes some federal funding agencies) stated "Institutions should foster a research environment that discourages misconduct in all research and that deals forthrightly with possible misconduct associated with research for which PHS funds have been provided or requested."/9
Beginning in the mid 1980s the US Department of Education, the National Science Foundation (NSF), as well as the National Institutes of Health (NIH) began providing resources to encourage study and curricular development in research ethics itself. Among the important results of those efforts are the development of courses in research ethics that range from high school through senior investigator levels,/10 development of guidelines for practice,/11 study of the pressures that work against ethical research,/12 and the creation of an Online Ethics Center for Engineering and Science./13
The question remains about whether increased federal attention on standardizing definitions, procedures and training will encourage or inhibit the development of more ethical research behavior. Research institutions are increasingly encouraged to create and maintain an environment that supports the most ethical work. This supports the likelihood that researchers will become increasingly clear on their role-related responsibilities. However, the federal standards can alternatively be seen as encouraging a very minimalistic approach to ethics -- institutional attention to the development of minimal compliance.
One is ethically responsible for far more than for what one can be held legally accountable. This is true in general morality, just as it is true in research. It is wrong to lie in many more instances that the lies for which one can be prosecuted. In an analogous fashion, it is important that institutions and investigators keep in mind that requirements for compliance prescribe a minimal standard for research practice. It is important to know how to be compliant, just as it is important to know the laws for which one can be held accountable by society. But it is equally important that individuals think about how to best meet their role-related responsibilities in ways that go beyond mere compliance with rules and regulations. Institutions should consider how best to encourage research that is praiseworthy, rather than how to simply discourage research that is blameworthy.
3/Federal Register, pp. 76260-76264.
4/PHS Policy on Instruction in the Responsible Conduct of Research, December 1, 2000; www.ori.hhs.gov/html/programs/announcement.asp.
5/NSF #SBR 9496203.
6/FIPSE #P116 B960045.