Can E.T. phone home?: The brave new world of university surveillance

Academe, Sep/Oct 2003 by Nelson, Cary

Once confined largely to the sciences, institutional review boards have begun to broaden their purview. The consequences for other disciplines could be serious.

"Hey, Frank, you forgot to put the gonad shield on this guy." Frank was a medical technician at the National Institutes of Health (NIH) in Bethesda, Maryland. The time was winter 1964. The "guy" vvho'd just had an X ray without proper shielding was me. I was a first-year college student employed in a dual role that winter, as a normal control in a cystic fibrosis study and as a laboratory assistant. I was also a student at the most progressive institution of higher education in the country, Antioch College, in Yellow Springs, Ohio, which had a work-study requirement. Antioch typically placed about two dozen students a year in NIH jobs.

My lab job was fairly straightforward. It began by my processing tissue samples from children who had died of cystic fibrosis. But these were the days when neither family nor employee sensitivities were elaborately protected. I would receive a beaker with, say, a little human heart inside it. The label was never "Subject C-33" but rather "Tim" or "Sally." Tim or Sally was typically a child I had known on the ward the week before. I pulverized the samples and put them through a centrifuge. No better preparation could be imagined for a lifetime as a literary critic.

But the NIH as a whole taught me many lessons about institutions and about academic researchers. It was a thirteen-story research hospital, full not only of patients but also of M.D.'s, Ph.D.'s, and federal bureaucrats. It was an airless world unto itself and in some fundamental ways a madhouse. One of the Ph.D.'s in my lab sometimes began his day by killing experimental mice so they could be analyzed. Dissatisfied with mass execution, he acquired a little guillotine that enabled him to behead his research subjects one by one. It was his collaborators, alas, who had charge of me.

The main consent form that I signed to participate in the experimental program was my weekly salary check, $35, minus taxes, plus room and board. In other words, I was an employee and employees were expected to do what they were told. Officially, I was being paid only for the lab job, but the main reason I was brought there was to participate in the cystic fibrosis study.

One of my regular duties was to have an intestinal biopsy. And it was at one of those biopsies that Frank, as I am calling him, forgot the lead apron. The biopsy was performed by inserting a long metal tube down my throat, through my stomach, and into my intestine. The X ray machine was kept on to guide the tube along its way. When the sample site was reached, a wire inside the tube was pushed forward. This opened a little metal claw at the end. A yank on the wire then made the claw tear off a piece of intestine, \vhich was then pulled up all the way through my gut while I retched on the table. Still retching, I was wheeled back to my room.

Things became still more interesting when the researchers learned from my medical history form that I had no sense of smell; so far as I knew, I had been born without one. There was no question of a cure, but if they could find out why I had no sense of smell, they might have another publication. This angle of research was not part of their cystic fibrosis study, just an unexpected target of opportunity. They asked me if I would agree to a brain X ray preceded by removal of a small quantity of spinal fluid and injection of an equivalent quantity of air. Because of the very small chance of introducing impurities with the air, and the possibilities of resultant paralysis, they asked me to sign a form absolving both them and the federal government of any liability. I refused. Then the pressure began.

It was not until two years later, in 1966, that the NIH-under orders from the U.S. Surgeon General-introduced a committee system to evaluate the ethics of human subject research. In 1964, the hospital had a preliminary system to review general plans for research with normal controls, but no full-scale ethical oversight. Suffice it to say that it would have been nice to have had more formal regulations in place in 1964.

But that would have to wait for later. Despite the indictment of Nazi physicians at the Nuremberg Tribunals, Americans showed little concern about medical experimentation in their own country; indeed, Nuremberg may have helped assure Americans that such outrages occur only in exceptional elsewheres. Government regulation in the United States is almost always scandal driven, so it took incidents like the 1972 revelation of the forty-year-long Tuskegee experiments-in which researchers withheld treatment from a group of African American men infected with syphilis-to generate congressional pressure to turn the surgeon general's policy into a formal regulation.

Even then, the standards applied only to federally funded projects. Not until 1981 did a national commission recommend that the review policy be extended to all human-participant research in the United States. In 1991, some seventeen federal agencies adopted a uniform policy, "widely known as the "Common Rule," which established the principles that research institutions receiving federal funds have to follow. The key element of the policy is the institutional review board (IRB), \vhich has authority to approve, require modification of, or disapprove research subject to the Common Rule. As of 2000, roughly 4,000 IRBs were operating in the United States, primarily at universities, hospitals, and private research facilities.