By Jim Stommen

Executive Editor

SAN FRANCISCO - Money may or may not be the root of all evil, but as far as Arthur Caplan is concerned, it's certainly a major factor in what ails human-subject medical research these days.

Caplan told a plenary session audience during the 52nd annual meeting of the American Association for Clinical Chemistry last week at the Moscone Convention Center that the greater availability of research funds and the growing pressure on researchers to get their hands on those funds is negatively impacting the ethical standards that are supposed to guide such research.

The director of the Center for Bioethics at the University of Pennsylvania - itself one of the dozen or so institutions slapped by the federal government over the past year for lapses while conducting human research - said that such research "is not in a good place" in the U.S. at present.

Having earlier outlined a three-pronged set of ethical principles involving informed consent, peer review of research protocols and privacy of information gathered in such research efforts, Caplan wondered rhetorically: "What's going on? Have we really given up on our old principles?"

He pointed to the availability of more and more research monies as the key culprit in what he referred to as the crisis in human experimentation ethics. "The whole pot of money available for biomedical research has gone up disproportionately to the number of researchers available," Caplan lamented. The reality in the research business these days, he said, "is that people are starting to succumb to the lure of this money . . . the potential for cutting corners to move things forward is there."

Noting that a University of Oklahoma research program has just been shut down because of problems with research subjects in a Phase I cancer vaccine study, Caplan made clear for his AACC audience of several hundred laboratorians and diagnostic industry representatives where he stands on such trials. "If a [human] subject got better in a Phase I study," he said, "we should publish a paper in a religious journal, because it's a miracle!"

As for human research overall, Caplan got "too" the point on what's wrong with the system: "There's too much research, too much money and too little review."

Noting that Institutional Review Boards (IRBs), of which he is a frequent member, are swamped with research proposals to the point that the system is capsizing, he predicted several developments:

¿ The IRB system is going to have to be given more money and more support staff.

¿ Those who serve on IRBs are going to have to be certified in human-subject experimentation.

¿ Researchers also are going to have to be certified in human-subject research.

¿ There will be more demographic information gathered on those who are research subjects.

¿ The federal government will start to randomly audit institutions doing human-subject research. He said he anticipates that beginning to happen in about a year.

Caplan said some "simple principles" will emerge from the chaos surrounding the research community at present. The key one, he said, "is that you don't study anything with human subjects where you have a financial interest." The problem of researchers having financing interests in companies for whom they are conducting research is so rampant, he said, that "the footnotes on disclosure of financial interests accompanying some journal articles are longer than the articles themselves."

He sees such conflicts - or the potential for such conflicts - changing. "We're going down the road very fast to the point where there will be a firewall between the research subject and those with a financial stake in the outcome of a human subject trial."

Caplan said that the third principle in the triad governing human research - that of privacy - is "the battleground where the action is going to be." He cited the movement toward a private company analyzing the data from the monumental Framingham Heart Study and then selling the results of that analysis to biotech and pharmaceutical firms. "The public is getting wary of this," he said. "Some participants are saying, 'If that's case, then my involvement in the Framingham Heart Study is over." Such a result would be nothing short of calamitous, Caplan said.

What's needed in all human research, he said, "are protections that show we will do all we can to protect the privacy" of those involved as research subjects.

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