Guinea pigs

What does "informed consent" mean in a sleep deprivation experiment?

Testing by Ellen Barry

He had been thinking about taking off for three days already, but Paul Anderson wasn't sure he was going to do it until he had already ripped the electrodes off his scalp and stepped out of the room where he had spent the last 45 days. As Anderson remembers it, the technician on duty stood stock-still. All she could say was, "I am not standing here looking at you."

Fifteen minutes later, Anderson was walking down the street at Roxbury Crossing -- blinking and disoriented, unaware that it was three in the morning -- when he realized that he was being tailed by a white security van. A man got out.

"He says, 'Were you in a study?' And I was like, 'Actually, yes,' and he calls in and he's just hanging around and he's looking at me like, 'What do I do with this guy?' and he goes, 'They want you back,' and I go, 'I have rights,' " recalls the 39-year-old Anderson. "At this point, rights are a big thing."

Indeed. The man explained that Anderson's doctors were simply worried about releasing him in such a compromised state, but Anderson kept walking. Three white security vans followed him slowly in a long white trail to the police station, where he called for ride home. Anderson may not have been the first person to be surprised by the hardships of a prolonged sleep study, but that night he felt completely alone. And almost two months later, he still has a strong desire to talk about the "metamorphosis" he experienced as a test subject.

As sleep studies go, it was a pretty high-profile one. Anderson's participation, which was slated to last for 55 days, was part of a physiological study headed by Brigham and Women's researcher Charles Czeisler, who has been carrying out sleep research since 1973. In an attempt to determine how the hormone melatonin affects sleeping patterns, Czeisler has been testing sleepers both in space -- John Glenn will be a subject when he boards the space shuttle in October -- and on the ground. Although Czeisler would not comment on Anderson's case, because of confidentiality guidelines, he says that out of the roughly 150 subjects who participate in experiments every year, several typically withdraw because they are unhappy with the experience -- and, he adds, researchers encourage them to do it. "People are very different in how they respond to checking into a hospital to participate in one of these studies," he says. "It's difficult to predict what particular element might be something that someone will find unpleasant."

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The words human research subject evoke terrible images from history -- Nazi doctors, Tuskeegee, blind LSD trials, and so on -- but the fact is, voluntary human testing is still used to great social benefit, and every year hundreds of thousands of adults respond to calls for subjects. Since the mid-1940s, when medical ethicists wrote up the Nuremberg Code, society has held human research to increasingly strict ethical standards. Chief among those principles are the idea of informed consent -- researchers don't do anything they don't warn subjects about -- and the ability of subjects to withdraw from a study at will without great financial penalties.

Anderson is not claiming that Brigham and Women's violated the contract he signed when he was selected for the experiment, but his lonely, distressed walk away from the dark room does raise the question of whether it is always possible to warn participants adequately about what they will undergo as test subjects.

"You can tell people exactly what to expect over and over again, but until they actually experience it, they have no idea," says Donno Layton, 26, who wrote about his own experiences in a NASA-sponsored sleep-deprivation study for Guinea Pig Zero, a 'zine devoted to human-subject research.

During experiments in which he had to stay up for as long as 88 hours at a time, Layton had hallucinations involving spider legs, and one extended episode in which he imagined he was Dick Cavett. Sleep deprivation "is definitely like a truth serum," adds Layton, who plans to participate in more sleep studies in the future. Layton and hospital technicians "got into very, very serious conversations about all aspects of our lives. And I can see that after [several weeks in the lab], I could have been saying a lot of things I wouldn't want to say."

That's what happened to Paul Anderson, anyway. After 45 days in a dimly lit room, without any clues to the time or date, Anderson says his relationships with hospital staff turned, from his perspective, into a Kafkaesque drama of surveillance and groupthink. During "constant routines," in which he stayed awake for upward of 50 hours, Anderson says, he confided very personal information to the technicians assigned to keep him up; he also learned that other technicians were sometimes listening on monitors in another room. Czeisler says conversations may be overheard by technicians assigned to make sure subjects aren't falling asleep, but that they are never recorded, and that the consent form clearly states that subjects will be under surveillance at all times. Still, when it became clear that third parties had heard one of his conversations, Anderson was outraged. He decided to demand the log that the technicians were keeping and to withdraw from the study.

"I almost didn't want the money by that time," he says. "It was like blood money -- that's the cost of my soul. The money became tainted."

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In the end, Anderson was paid at least $5000 of the $6000-plus originally promised him, so he didn't lose much as the result of the decision. Brigham and Women's lost a good deal more -- typically, costs to the researcher run $2000 a day, Czeisler says. In the end, Anderson's case is a study in the limits of informed consent and the flexibility required to release subjects who develop qualms. Both these issues are vital, since human-subject studies often involve particularly vulnerable populations.

One person with a close eye on patients' rights is Robert Helms, the Philadelphia-based publisher of Guinea Pig Zero. Helms has been agitating to improve conditions for human-research subjects, who he says are underpaid (the rates range from $40 a day for some government studies to $300 a day from private pharmaceutical companies). But when there isn't a breach of contract -- and there does not appear to be one in Anderson's case -- Helms says a subject's only recourse is to walk out.

That's not very useful advice for someone who's already gone through a bad experience and is still reeling from the effects. Looking back, Anderson is aware that he was warned -- for instance, when he asked the technicians whether they would agree to be subjects, they all said no. At that point, though, he was a long way from seeing the full picture.

"They're aware of this," he says. "A couple of people over there were saying, 'We hate to see what happens to you guys.' At that point, I was sort of like, 'What the hell can happen? What can they do? I'm watching movies, I'm having a good time, it's no big deal.' But psychologically, things start happening."

Ellen Barry can be reached at ebarry[a]phx.com.