Twice a week, in the name of science, Suzette Garcia enters a small conference room at the California Regional Primate Center where nurse Susan Moser draws four tablespoons of blood from her right arm. Daily, Garcia collects a urine sample and gives it to Moser at the end of the week.
Garcia, a human resources assistant at the center, is not sick; she's participating in a study testing the effects of the menstrual cycle on the immune system.
"I knew that it wouldn't be easy to find people," said Garcia, who, at 34, met the age and medical requirements of the study. "I would be the perfect person, and there would likely be no risk to me."
David Fisher, 58, traded muscle soreness, a weakened immune system and still lingering nerve damage in his hands to participate in a cancer drug trial last year. After several months of taking tirapazamine, a drug in its second phase of testing, the North Highlands resident's inoperable lung cancer went into remission.
Research like that conducted on Garcia and Fisher is essential to the advancement of medicine, said Don Hilty, an assistant professor of clinical psychiatry at UC Davis and the vice-chair of a university committee that reviews human subject research proposals.
The challenge for top research centers like UC Davis - which approves about 1,200 human trials a year - is to conduct their studies safely, with the benefits to human subjects outweighing the risks.
"If you put (a medication) out there and you don't know its effects, you could wipe out scores of people," Hilty said. "The safest way to find treatments and help people who are ill is to carefully test it in small numbers of normal volunteers, and, if all goes well, in a small number of patients with an illness."
Fisher gladly participated in the trial and has become an outspoken advocate for experimental drug trials.
"I thank the Lord that it helped me, and I hope I am able to help others as well," he said.
Recently, however, medical research using human subjects has been closely scrutinized at universities from UC San Diego to the University of Pennsylvania, and most recently, Johns Hopkins, because of what federal regulators say was researchers' inability to effectively screen and carry out studies using human volunteers.
Universities probed
Two years ago human subject research at the University of Pennsylvania was briefly suspended after a teenager participating in a gene therapy experiment died. In June, UC San Diego and the U.S. Department of Veterans Affairs asked a top liver specialist at the university to suspend a drug-company-sponsored study when a patient fell ill after overdosing on medication.
And in July, after the death of a 24-year-old woman participating in an asthma medication study, federal officials briefly shut down human subjects studies at Johns Hopkins Regulators have accepted Hopkins' plan to improve safeguards for research volunteers, but they are requiring that its research review boards reconsider many of the university's 4,200 federally funded studies on humans.
The key to safe, rewarding research using human subjects is to carefully scrutinize each proposal a university investigator proposes, say campus research officers and faculty members.
Review boards investigate
Last year the National Institutes of Health began requiring all researchers using human subjects to take an online course on the topic. But universities also need a more objective group to evaluate the safety and scientific merit of each study or trial.
That task falls to institutional review boards, composed of UC Davis faculty members as well as community members.
"We rely on them to give us a perspective that we might not otherwise have," Hilty said.
Issues of volunteer consent, research protocol and the benefit and risks of the study are addressed in the review board meetings. Review board approval is required for social science research, in which volunteers are interviewed or surveyed, as well.
"(In all cases) we look at the proposed research and ask, 'Are we doing enough to protect the person, and are we doing enough to inform the person?' " said Ahmad Hakim-Elahi, director of sponsored programs at the UC Davis Office of Research. "Anytime a researcher wants to touch a human body these questions come to mind."
Garcia, the human resources assistant says she was pleased with the detailed study information she received, which let her know possible side effects and how scientists would use her results.
"I'm really interested in the outcome," she said. "There is a lot of time (when menstruating) that I feel tired," she said. "It will be interesting to see whether your immune system is weaker."
Need for ongoing caution, study
Hilty said Johns Hopkins faltered when they had some researchers "pre-review" some study proposals, rather than bringing it before the full board. The consent forms for the asthma study also failed to acknowledge past problems of the medication and its worst possible side effects.
UC Davis, said Hakim-Elahi, is known for its careful approach to approving studies.
"In recent years the (review boards) have been much more careful," he said. "They ask more questions. We have been accused of being overly cautious."
To keep up to date on the issues, David Holt, director of the UC Davis Office of Human Research Protection, and other campus research officers attend biannual meetings with the UC Office of the President. The group has discussed how to keep review boards well-staffed and informed about the newest medical technology, new concerns about researchers' financial interests and ongoing patient consent issues.
Fisher, the cancer patient, says he supports UC Davis conducting as many drug trials as it safely can, to help people like him.
"If the cancer returns, I'll make myself eligible for another study," Fisher said. "For me, there is no other alternative."