Reported by Statewide correspondent, Mike Tobias.

[Dr. Byers Shaw, UNMC Chairman of Surgery] "The main workhorse part of it is this beast right here that looks like something out of science fiction."
Take a trip through the University of Nebraska Medical Center, and you'll find surgeons using state-of-the-art robotic equipment. Scientists using fetal cells to learn about the causes of Alzheimers. Transplant surgery that may someday use a pig liver instead of a human organ. Medical research centers are full of examples of how we're pushing the envelope of science. But how do researchers decide when, ethically, they've pushed too far? And what's in the patient's best interest?
It stpers with individual researchers like Dr. Beth Reed. She specializes in breast cancer research and bone marrow transplants. Most of her work is clinical. Reed spends her time with patients instead of in a lab. Reed's research usually involves testing new drugs for cancer treatment. These are typically phase 2 or 3 trials. That means earlier tests on animals and other studies have given doctors a pretty good idea of the drug's effectiveness and possible down sides. Reed then decides if she wants to conduct further research on the drug with human subjects - her patients.
[Dr. Beth Reed, UNMC Physician/Researcher] "I think it's sort of become second nature, but what I usually do when I see a new patient is I decide what I think is the best standard therapy for the patient, and then if there's a trial that offers that standard therapy vs. something that looks like might be better than that standard therapy, it's very easy for me to present that trial and be enthusiastic for the patient."
The final decision on any research involving human subjects doesn't lie in the hands of researchers like Beth Reed. It's in the hands of the Institutional Review Board, or I-R-B. Dr. Ernie Prentice has chaired the Med Center IRB for more than 20 years.
[Dr. Ernie Prentice, UNMC IRB Co- Chair] "The IRB is a federally-mandated review body whose charge it is to insure that the rights and welfare of research subjects are fully protected."
IRBs are required to evaluate any federally-funded research. This is the combined IRB for the Med Center and University of Nebraska at Omaha. It has 25 members. Most are doctors, researchers and Med Center faculty. Three members have no affiliation with the Med Center. They meet monthly. At a typical meeting they discuss hot topics in medical research ethics. In this case it's a revision of a World Medical Association document that's recognized as a cornerstone of research ethics.
Most of the meeting is spent reviewing research proposals. There are always about 50 new studies, or protocols, under review by the Med Center IRB. They also review ongoing protocols, another 40 or 50 each month.
[Dr. Bruce Gordon, UNMC IRB Co-Chair] "We don't get in the IRB a whole lot of protocols that we think are ethically questionable. I think most of those are weeded out early by the investigators."
[Gordon] "The things that come up that might be termed ethical issues are things like use of placebos, compensation of subjects for participation, we have a lot of ethical concerns when there are children involved in the research, we have a lot of ethical concerns when it seems like researchers are excluding children from research."
Conflict of interest is another problem. It concerns Dr. Judith Kissell, who studies and teaches medical ethics as part of Creighton's Center for Health Policy and Ethics. Kissell cites the 1999 case of 18-year- old Jessie Gelsinger. His liver disease was being successfully treated with medication. A University of Pennsylvania doctor talked him into stopping standard treatment, and being part of a gene therapy study. Gelsinger died, and the research was halted. The researcher was a stockholder in the company financing the study.
[Dr. Judith Kissell, Creighton Center for Health Policy and Ethics] "Right off the bat there is a conflict of interest for his making a profit. There's a conflict of interest for him being famous, because he's done gene research or the therapy."
There are also concerns about the growing amount of research being conducted or financed by private industry.
[Dr. Andrew Jameton, UNMC Ethicist] "So we're moving in a way, from an old notion of science in which honesty meant objectivity and we don't have an interest in a product, but now I think we're a little more focused on product, either because the funder is interested in that or because we ourselves as a university have an interest."
[Kissell] "That private research be subject be subject to the same oversight. I think that would be incredibly important. Secondly, that the commercial interests in research not override the interests of research subjects."
The modern-day IRB system and standards for evaluating the ethics of medical research developed 20 years ago. It evolved after a rash of incidents that shocked the public. One was the Tuskegee syphilis study, where black men from the rural south received useless treatment so researchers could study the long-term effect of the disease. A set of guidelines for protecting human subjects in research was also drafted. These include three basic principles: subjects must be able to give their informed consent to the research; the benefits of the research must outweigh the risks; and research subjects must be selected without any bias toward a specific group.
[Prentice] "The principles have stood the test of time. They're very hard to argue with. It's very hard to find fault with their relevance. And I think that any conscientious investigator would totally agree witth all of those principles."
[Jameton] "Gone are the days where someone could sort of quietly and secretly do some bizarre research and no one would know about it."
This doesn't mean there still aren't problems. In 1999, the government suspended federally-funded research involving humans at the Duke University Medical Center. Lack of documentation and tracking by the school's IRB were cited. Research at places like the University of Colorado and University of Illinois has also been shut down. IRBs also came under fire in a 1998 report from U.S. Department of Health and Human Services Inspector General June Gibbs Brown. She said IRBs are overworked - review too much, too quickly with too little expertise. The report didn't suggest there's widespread harm being done to research subjects. But it did say the effectiveness of IRBs is in jeopardy unless changes are made.
[Gordon] "They said that IRBs were overworked, we knew that. They said that IRBs were underfunded and undersupported, we knew that. They said there was the potential for problems, we knew that. What we hope is that university administrators, the people that hold the pocketbooks, that the people who fund and support IRBs also heard that."
[Kissell] "Medical schools are having a very hard time across the country financially, so they're trying to look for more research money. The more research money they get, the more it gets loaded onto the IRB. Yeh, that's a real serious problem."
Ernie Prentice says the Med Center IRB has been able to stay out of trouble. But he's seen problems elsewhere first- hand. He's inspected other IRBs as a consultant on site inspection teams. Prentice says lack of documentation is the biggest problem.
[Prentice] "With a few, glaring, inexcusable exceptions, by and large I truly believe that medical research is conducted in an ethical manner. That patients are treated appropriately, that their rights are not being transgressed."
[Reed] "There's no human system that is without error. And I think that there will be times where bad things can happen, even with a fairly good system in place. And when that happens you have to go back and look at your process and make adjustments."
Ethicists say the public should care more about what's happening in medical research. And be more involved in the process of deciding what's right and what's wrong.
[Kissell] "I like to think that science belongs to the public. I might get in trouble with people who would defend academic freedom. But I like to feel like, partly because its my tax dollars that are supporting it, partly because I think science and knowledge in general, being a philosopher I can think that if I want to, I like to think that science belongs to all of us."
[Jameton] "We can make kind of a good decision about consent for this patient today, but I think there's bigger decisions about the directions of health care service, of research, those really belong on the public sphere."
Because robots may be doing surgery, but human beings - emotional and flawed - still make the decisions that effect the patient.