Will scientific ethics classes become mandatory for all trainees? Who will teach the old guard--the established principal investigators (PIs) who are by no means immune from ethical lapses? Should the government force institutions to implement scientific ethics instruction?
These were just a few of the questions raised in an open meeting on 10 October 2002 in Washington, D.C. Within the ornate halls of the National Academy of Sciences building, members of the scientific and legal communities, ethicists, and representatives from funding agencies and professional societies discussed a recent Institute of Medicine (IOM) report, Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct .
In a twist on the typical scientific ethics discussion, the IOM report and companion meeting shifted the spotlight from a negative perspective--preventing scientific misconduct--to the more positive one of encouraging ethical research practices. Specifically, the IOM committee was charged by the Office of Research Integrity (ORI) in January 2001 to define "integrity in research" and to find ways to promote and assess integrity among researchers.
Ironically, although it adopted a positive outlook, the IOM committee itself was formed in the midst of a heated debate about government regulation of responsible conduct of research (RCR) education. On 1 December 2000, ORI published regulations requiring all research staff working on Public Health Service-funded projects to get formal ethics training--not just NIH trainees as was previously the case. (See New Federal Regulations Issued on Ethics Training ).
Almost immediately, institutions balked at the new directive, citing the heavy financial and human resource burden it would place on them to educate nearly all of their PIs, graduate students, postdocs, and technicians. By 5 February 2001, the debate had escalated to the point of congressional involvement--on that date, Representative W. J. "Billy" Tauzin (R-LA) wrote a letter to Chris Pascal, director of the ORI, criticizing the process ORI followed to make the regulation public. On 20 February 2001, ORI suspended the regulation. (See Ethics Training Rules Put on Hold.)
Although the IOM report was not touted as a direct response to these events, and in fact it never mentions them, a major theme of both the report and the subsequent meeting was the ethics education of scientists--and that the government should not regulate it.
According to the report, the responsibility for integrity in research rests with both individuals and institutions. More specifically, " For a scientist, integrity embodies above all the individual's commitment to intellectual honesty and personal responsibility. For an institution, it is a commitment to creating an environment that promotes responsible conduct by embracing standards of excellence, trustworthiness, and lawfulness and then assessing whether researchers and administrators perceive that an environment with high levels of integrity has been created."
Institute of Medicine Committee Recommendations
- Funding agencies should establish research grant programs to identify, measure, and assess those factors that influence integrity in research.
- Each research institution should develop and implement a comprehensive program designed to promote integrity in research, using multiple approaches adapted to the specific environments within each institution.
- Institutions should implement effective educational programs that enhance the responsible conduct of research.
- Research institutions should evaluate and enhance the integrity of their research environments using a process of self-assessment and external peer review in an ongoing process that provides input for continuous quality improvement.
- Institutional self-assessment of integrity in research should be part of existing accreditation processes wherever possible.
- The Office of Research Integrity should establish and maintain a public database of institutions that are actively pursuing or employing institutional self-assessment and external peer review of integrity in research.
Michael Zigmond, professor of neurology and psychiatry at the University of Pittsburgh and a member of the IOM committee, presented the report's conclusions on RCR education. According to Zigmond, the committee decided that institutions should be "aiming for impact rather than a 'check-off.' " RCR training should "prepare individuals for the future," he said, and be integrated into the professional development of scientists, much like critical reading of the scientific literature is an integral part of every researcher's training.
Which begs the $64,000 question--how should integrity be taught? For this, the committee turned to principles of adult learning. Based on this body of literature, Zigmond reported that effective adult learning occurs when practitioners themselves are involved, which means that PIs should teach trainees and "not turn it over to the philosophy department," he said. The training should take place over some time, not simply over a few days or hours. Active participation should be encouraged, and individualized programs offered for different groups of researchers, accounting for varying learning styles and past experiences.
The committee examined a variety of methods for teaching RCR, including learning from one's own research adviser, formal RCR courses, the integration of RCR within core courses, and Web-based instruction. Of those methods, only learning from an adviser fit all the principles, but it was also the only one deemed virtually impossible to standardize. As Zigmond said, "some [PIs] do a good job; some do a poor job or ignore it all together."
In a later session featuring talks by professional society representatives, Stephen Teitelbaum, president of the Federation of American Societies of Experimental Biology, also emphasized the importance of an adviser in modeling appropriate ethical behavior. In his presentation, RI [Research Integrity] is a Mentoring Issue, Not a Lecture Course, Teitelbaum warned that if the number of ethics courses increase and start to demand more time from trainees, that time will have to come "at the expense of other course subjects."
So who will teach the teachers? Throughout several question-and-answer sessions, participants raised concerns that the report focused too much on teaching the trainees and not on teaching the old guard already ensconced in the scientific research establishment. Some committee members, like Zigmond, asserted that integrity concepts would filter back to PIs from their students. Others, such as Stephanie Bird, special assistant to the provost at the Massachusetts Institute of Technology, championed formal training for faculty. She said that faculty can be trained in the process of "training them to teach others."
As is the case for many other facets of integrity that the committee examined, studies on how best to teach RCR do not exist. This lack of scientifically rigorous studies on teaching and monitoring integrity was a common refrain at the meeting and in the report. Committee members and Pascal reminded attendees that for the past 2 years ORI has attempted to rectify the situation by awarding grants for "Research on Research Integrity," as well as grants to help defray the costs of implementing RCR courses at institutions. But it is still too early to glean useful information from the ongoing ORI-funded studies and courses.
Despite the lack of facts about successfully promoting research integrity, IOM and the meeting participants were certain of one thing--the federal government should not mandate RCR education. Speaking for the committee, Robert Rich, executive associate dean at the Emory University School of Medicine in Atlanta, said that institutional self-assessment is the way to go. Rich said that external accreditation criteria should assess and monitor institution practices governing research integrity. "Internal peer review" should evaluate the research integrity practices of individual lab environments. Rich said that each faculty member could be evaluated "as part of faculty review" where trainees are asked, "what is the climate in this lab?"
In summing up the reaction of his office to the recommendations of the report (see sidebar), Pascal told the audience that ORI "is trying to engage on all six recommendations," and that it is a "process." ORI plans to "continue the dialogue with the community" and will search for practical ways to follow through with the committee's suggestions. Pascal told Next Wave he was "not prepared to say anything" regarding whether or not ORI plans another attempt at mandating RCR education in light of the IOM committee's strong aversion to governmental interference. He did say, though, that he "hope[s] to announce something by the end of the year."
So stay tuned!