Numbers indicate misconduct rising

But they don’t tell the whole story

Research misconduct activity reported by institutions in 2002 reached the highest levels since 1997, according to a report in the quarterly newsletter from the Department of Health and Human Services’ Office of Research Integrity (ORI).

In their 2002 Annual Report on Possible Research Misconduct, 107 institutions reported misconduct activity stemming from allegations received during or before 2002 — the previous high number of institutions reporting was 82. Seventy-one institutions, compared to the existing high of 61, received new allegations. At those institutions, the 83 new cases topped the previous high of 72 cases.

Although the reports do indicate an increase, they do not necessarily indicate a wave of misconduct sweeping through institutions receiving funding through the National Institutes of Health (NIH) — the research that ORI is charged with overseeing, says ORI director Chris Pascal, JD.

"In terms of actual numbers, the increase is not very large," he points out. "We have approximately 4,000 institutions that report information to us and, of that number, we have about 100 institutions in any given year reporting activity to us. More than 90% of our institutions report no activity at all."

Institutions receiving NIH funding are required by the ORI to file annual reports of allegations of research misconduct, Pascal says. That report is simply numbers — how many allegations, of what type, which allegations led to further inquiry, and how many were deemed unfounded, etc.

If an individual allegation progresses, at any point during the year, to the point the institution launches an investigation, a separate, more detailed, report to ORI is required.

"The annual report gives us a chance to make sure we are getting the required information. Occasionally, they forget to send us stuff and we see a disconnect between sthe cases we have reported to us and those that should have been reported," Pascal says. "In that case, we follow up with the institution."

Since 1989, the ORI has had a compliance assurance program in place that requires institutions that receive funding to develop a clear policy for managing reports of research misconduct.

The office develops and distributes model policies and guidance for developing policies and then uses the annual reports of research misconduct as a means of ensuring that institutions have appropriate policies in place.

"If the institution doesn’t have a road map on how to process an allegation and investigate it, it is much less likely that they will do so," Pascal says. "They are more likely to make mistakes, and the employees and the staff at the institution that have a concern, the potential whistle-blowers, won’t know how the process works and who to go to, etc."

In recent years, ORI has shifted from a strictly enforcement role to sponsor more educational efforts, offering conferences, seminars, and publications to help institutions and researchers understand what research misconduct is, how to avoid it, and how misconduct allegations should be managed.

"Partly as a result of that, I think the institutions have gotten a little more adept at identifying substantial allegations up front and taking them through the whole process, and maybe dropping those where there seems to be nothing wrong," notes Pascal. "Many institutions also now have more experience in doing an investigation so that they can determine whether misconduct actually occurred."

The office also has seen a slight increase in the number of investigations of misconduct that it pursues, Pascal says.

If an institution has a substantial allegation that leads to a full-scale investigation, it files a detailed report with ORI. In some cases, ORI reviews the institutional documentation and finds reason to visit the institution to conduct an oversight review, possibly asking additional questions and reopening parts of the investigation if it feels the institution missed something, he explains.

Recently, the office has averaged about 12-14 official findings of research misconduct per year, about 30% of all of the allegations of misconduct. In the past two years, the numbers, and therefore the percentage, has gotten higher, but the actual numbers are not that different.

With only about 100 institutions reporting allegations, and only 30%-40% leading to official investigations of misconduct, the percentage of research affected is small.

"Most of the activity comes from the larger institutions with the most grants," he notes. "We did a comparison of that at one point, you could see the number of cases that come from the institutions with the most funds."

Mark Brenner , PhD, vice chancellor for research and graduate education at Indiana University in Bloomington, also thinks the recent statistics are not representative of a growing problem.

"I am not aware of, among the people I interact with, a huge wave or change or surge [in misconduct allegations]," he says. "I think institutions are becoming more informed on how to deal with allegations, and I suspect that, in general, the education programs are touching more people. To some degree, that awareness does bring out more allegations. People find out about the policies and the processes."

More and different education for research investigators and other personnel about responsible research standards still is needed, however, he adds.

With more private sponsorship of research and increased federal attention to the integrity of information gained from studies and the conduct of researchers, institutions need to be explicit about what they expect and what they will require from students, faculty and others who participate.

"I certainly don’t want to be lurking in the corridors looking for instances of misconduct, interviewing students and staff, asking, Is there something going on here I need to know about?’" he says. " I am much more interested in having us engaged in promoting education programs. And my position is that this isn’t just for graduate students, we need to have programs that touch all people engaged in research."

In recent years, it’s not even been clear what different entities mean when they talk about misconduct.

In 2000, the federal Office of Science and Technology (OSTP) issued a standard Federal Policy on Research Misconduct, which was designed as the single federal standard, defining research misconduct.

Prior to that, different federal agencies and different institutions had widely varying definitions and policies.

The final policy adopted by OSTP defines research misconduct as the, "fabrication, falsification or plagiarism in proposing, performing or reviewing research, or in reporting research results." The policy further clarifies that:

Fabrication is making up data or results and recording or reporting them.

Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

• Research misconduct does not include honest error or differences of opinion.

This is the definition that ORI and other federal agencies use to define misconduct and breaches of conduct that fall under these categories are the allegations and investigations that should be reported to them, Brenner says.

However, investigators and research coordinators should be aware that individual institutions might have policies that include broader definitions of misconduct, he adds.

"For example, at my campus as we are going forward, without question we use include the fabrication, falsification and plagiarism in our definition, and that would be reported to federal agencies, but we continue to have in our definition the failure to comply with federal regulations,’ which means then that if you failed in a reckless and intentional way to comply with the regulations governing human subjects research or animal subjects as an animal, we could consider that misconduct on our campus," Brenner explains.

Investigators who are found to be violating federal standards for protecting human subjects can have their research suspended by the institutional review board, and may lose research privileges, Brenner notes. But, at Indiana, and other institutions with similar policies, they would also be subject to disciplinary action for misconduct.

"The IRBs do not dispense disciplinary action, they can suspend or halt studies, take away research privileges, but that is about protecting the subject, not the researchers themselves," he says. "That is why we’ve chosen to leave the other available as a tool in our toolbox."

Researchers need to be aware both of the federal definitions of research misconduct and those used by their sponsoring institutions.