One of a growing, if unknown, number of normal, healthy research volunteers, Marc had offered up his body, brain, and bloodstream to science—for a fee. He was rewarded with an array of experimental assaults: nasal flushes for bacteria and viruses, blood draws, injections with weakened or modified versions (or pieces) of organisms responsible for tularemia, hepatitis, canary pox, and AIDS. In a study of malaria, he contracted the disease, requiring a course of quinolone therapy.
The cadre of healthy volunteers, many of whom sign on for multiple medical and psychological experiments, often simultaneously, are responding to a legitimate social need. They are among the estimated 20 million Americans recruited into clinical trials annually by universities, medical centers, drug and biotech companies, and a host of clinical-research organizing companies that receive some $10 billion a year from pharmaceutical and medical device companies to conduct trials.
The contributions of normal healthy research volunteers, or NHRVs, are vital to the advancement of medical and psychological knowledge, and many treatments would not exist without them. The National Institutes of Health alone enrolls 3,500 to 5,500 of them each year for phase-1 trials that determine drug safety and absorption, or for "challenge" studies that temporarily create or mimic asthma, infections, allergic reactions, addictive behaviors, hallucinations, or pain in order to then attempt to treat them. Scores of thousands more volunteers, mostly college students, spend weeks in confinement to test diets or the effects of sleep deprivation—or of isolation itself.
Many come back repeatedly. One study of 440 NHRVs found that 44 percent of them had enrolled in two to five studies per year. Among another group of NHRVs, 14 percent had enrolled in at least 18 studies over the prior three-year period.
The bad old days of tricking or blatantly coercing prisoners and the illiterate into studies are over. Nonetheless, a few highly publicized deaths among NHRVs, sometimes for no clear reason, have amplified a chorus of concern among ethicists, psychologists, and medical professionals about what motivates this group of "repeat professional volunteers" for whom participation in research is close to a way of life and, for some, a living. Notably, there is no potential medical payoff for these healthy volunteers, unlike for participants in the estimated 80,000 U.S. clinical trials each year who are selected because they have specific illnesses or disease risk factors.
Are they subtly coerced by financial incentives? Paying volunteers to play with their health is nothing new; U.S. Army surgeon Walter Reed gave his 19th century volunteers $100 in gold to contract yellow fever. Yet the law puts no limit on how much privately funded researchers can pay study recruits, and some studies offer enrollees thousands of dollars. For federally funded research, the National Institutes of Health has only vague guidelines that the amount of money not be an "undue inducement."
Are they thrill seekers, or somehow "addicted" to being "used"? Are they hypochondriacs reveling in the extensive checkups that accompany such studies? In the absence of clear national standards and channels of oversight, experts say, who knows whether the volunteers are really as healthy—psychologically or physically—as they tell the experimenters they are.
Ask the volunteers themselves why they do it and the answers are almost always some combination of altruism, curiosity, excitement, and self or family interest. "It's my way of giving my body to science," says Bob Peer, a 70-year-old retired Michigan real estate appraiser, who estimates he's been in more than 100 sociological, psychological, and medical studies since 1985. "There isn't a square inch of my fanny that has its original skin," which he let doctors razor off for 40 dermatologic tests of sunscreens at $65 per half inch, leaving raw wounds that felt like "burns." Bird-flu vaccine tests? "Sure, and I didn't grow any feathers," he chirps, having enjoyed that trial a lot more than the nine years he volunteered to pose as a patient for medical students learning to do prostate exams. Peer counts MRIs, X-rays, PET scans, lung studies, and treadmill tests as "no big deal."
But the response among the "repeaters" seems also to reflect big-business marketing, a sense of indebtedness to investigators they've come to know and like, and financial rewards as high as $10,000 that may skew decision making and cloud motivation, although most payments hover at a few hundred dollars. Given the various inducements involved, and the squeamishness non-volunteers can feel about submitting their bodies to science, it's legitimate to ask why volunteers do it, says Suzanne Bartholomae, an Ohio State University scientist. She questions whether all of the individuals are "normal," "healthy," or even really "volunteers."
