New Federal Regulations Issued on Ethics Training

National Institutes of Health (NIH)-funded graduate students and postdocs, look out: Your ethics classes may soon be getting a bit more crowded! Why? Because on 1 December, the Office of Research Integrity (ORI) published new federal regulations that greatly expand the definition of who must undergo instruction on the responsible conduct of research (RCR).

Already, all NIH-funded trainees--graduate students supported by NIH training grants and postdocs with National Research Service Awards--must be trained in scientific ethics. But, says ORI director Chris Pascal, because the new rules apply to all research staff working on projects funded by the Public Health Service (PHS), they will affect "thousands not currently covered." According to Pascal, only a "couple of hundred institutions" have NIH training awards, but when all PHS-funded institutions--including businesses--are counted, that number soars to approximately four thousand! So, if you or your PI receive funding from the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, or the Health Resources and Services Administration (a few of the component agencies of the PHS), you'd better sharpen your pencils!

What will the training involve? ORI has developed nine broad "core areas" for ethics curricula (see sidebar). But the policy stops short of requiring that all staff be exposed to all nine areas of instruction, instead stating that "the institution may exercise reasonable discretion" when deciding which areas to cover for different groups of researchers. Pascal explains that institutions could suggest that all staff be exposed to each core area, but "if it does not apply, then it's not required." Some institutions already cover topics similar to those recommended by ORI. Harvard Medical School, for example, touches on all of the core issues in their Program in the Practice of Scientific Investigations (PPSI), except for human subjects, which is the focus of a different ethics series.

Ethics Training: Nine Core Areas

  • Data acquisition, management, sharing, and ownership

  • Mentor/trainee responsibilities

  • Publication practices and responsible authorship

  • Peer review

  • Collaborative science

  • Human subjects

  • Research involving animals

  • Research misconduct

  • Conflict of interest and commitment

Also left up to each institution is the extent of training and the method of evaluating staff. RCR education does not have to get in the way of research--hours and hours of instruction are not necessary. In fact, ORI's own booklet/Web-based instruction resource, which is expected to be available in May of 2001, may only take 3 hours to get through.

Another responsibility ascribed to institutions in the ORI recommendations is deciding just who fits the definition of "research staff." Clearly, PIs are not necessarily exempt. In fact, unless they are involved in teaching an ethics class or have recently taken an ethics class themselves, ORI's regulations stipulate that PIs must receive RCR training right along with their students and postdocs.

This is not a bad thing, points out Adam Fagen, a graduate student at Harvard. "There are [some PIs] who have not set such a good example and might benefit from the program," he explains. Krista Cunningham, a postdoc at Harvard, states that "it is important that all scientists, including professors, should be required to take the courses. The problem is trying to ensure that everyone attends."

Linda Sweeting, professor of chemistry and ethics at Towson University in Maryland, is developing a faculty training program in ethics with a colleague and agrees that PIs should be involved in RCR education. "The policy suggests that the principal investigators will be given a major role in implementation, and I believe they must be educated first," she says. But she realizes that this is easier said than done: "Teaching them is going to be like herding cats."

Harvard, too, has recognized the need to instruct PIs and is also initiating a separate program for them, according to PPSI director Walter Robinson. More than a matter of pride for the PIs, the real problem at Harvard is the sheer numbers of scientists who attend the ethics sessions already. Robinson says, "We have more people [attending the meetings] than we can handle!" He added that institutions will be surprised at the enthusiasm of their research staff when they finally do implement their programs; in fact, Robinson notes, once the discussions get going in the PPSI sessions, it's hard to stop them!

The teeth that ORI has put into the regulations may help coax institutions into making sure that those researchers who are not so enthusiastic about ethics training actually attend. Although it is unclear what the repercussions would be if an individual research staff member refused to attend RCR training, institutions that do not implement a sufficiently robust RCR program could be denied PHS funds, as stated in the "Frequently Asked Questions" document accompanying the regulations. Such a drastic measure, however, would only be taken if a noncomplying institution failed to establish an ethics training program after being notified of their deficiency by ORI. Moreover, institutions cannot plead a lack of resources as a reason for not providing an adequate program--along with composing the booklet/Web module, ORI is teaming up with other PHS agencies to provide additional instructional resources (see the ORI Resource page for more details).

And there's plenty of time to comply with the regulations. Institutions will have until 1 October 2003 to train all current staff. Thereafter, all incoming researchers must be instructed in RCR concepts no later than 1 year after starting work on PHS-funded projects. ORI also suggests that continuing education in the topic be provided from time to time to remind researchers of the principles of RCR.

As Next Wave previously reported, the draft policy was posted for public comment in July 2000, and ORI made a number of changes based on the comments it received. On the whole, the final regulations appear to be more flexible than the original draft report. But are they too flexible? Fagen says that the document is "broad and nonspecific in its requirements ... the lack of specificity certainly leaves open the opportunity for institutions to water down the purpose of the policy." ORI's Pascal disagrees: "It is not as vague as it may look to some; it just provides flexibility to the institutions in some areas," he says.

Robinson welcomes the new regulations, saying that "they are a wonderful idea--they've hit the nail on the head ... they're a step in the right direction." The document issued by ORI has set the stage for a new way of thinking about the practice of scientific research, but it will probably not be the last word on the subject. Says Pascal, "We're at a starting point, not an end."

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