Thursday, March 5, 2009 | San Diego is fortunate to be an international leader among centers of science and technology. This is no accident. We have an array of outstanding universities with global reputations, including U.C. San Diego, San Diego State University, and the University of San Diego. These institutions, as well as other local universities and colleges, have provided the work force and the ideas to conduct superlative basic research and to translate it into applied research, which in turn generates an extraordinary range of products that serve the world.

This is all good news for the state of science, technology, and health in our community as we enter 2009. However, this success will not last if we aren’t proactive in identifying and addressing its associated challenges.

One area in particular to watch for is the ethical repercussions of science and technology, particularly in biology and medicine.

Although biomedical research and development are among San Diego’s greatest strengths, such work requires that we begin by testing new products that may turn out to be neither safe nor effective. Scientists know that they have a special ethical obligation to think through the risks posed by such research. Three of these risks are both timely and noteworthy.

Stem Cells

The development of promising new interventions that might prevent or treat medical problems requires clinical trials of course, but there are reasons to tread more cautiously than we might have in the past. We are on the threshold of new therapies that would place living cells into research subjects and, potentially, patients.

Stem cells are the best known and newest example of this type of research. The first Food and Drug Administration approval for clinical trials involving stem cells was announced in January of this year.

The vast majority of clinical researchers have always been appropriately cautious before testing in humans, but cell-based interventions are different from those involving drugs and devices. Precisely because the implantation of cells is a new line of research, failures in initial trials could adversely affect the entire field, which might otherwise generate safe and effective cell-based therapies. Potential research subjects, researchers, regulators, and the public are all likely to be more wary of future trials if significant problems occur in a trial that was attempted prematurely. This wouldn’t be just a loss of one trial; it would be an impediment to an entire field of research.

Another reason to be cautious about cell-based interventions is that living cells are very different from the model that we know best: drugs. Even the most long-lived drug will eventually be metabolized or excreted from the human body.

However, there is generally no turning back once living cells have been inserted into the body. Under that circumstance, it will be important to help potential research subjects to understand that, unlike other clinical trials, there may be no option to change one’s mind once the trial starts. This isn’t to say that those cells will not be safe or effective, but until we conduct the necessary clinical trials we won’t be able to answer either question.

Human Research Subjects

A second risk associated with clinical trials has been developing over a number of years. The problem is that to test new therapies, clinical investigators need human volunteers. However, while the number of potential treatments continues to increase, the number of potential research subjects is not always sufficient.

One example of a clinical research field that potentially affects many patients but which may suffer from insufficient numbers of research subjects is spinal cord injury. Because clinical trials need to be conducted on participants who meet certain criteria, potential subjects rarely can participate in more than one trial. In short, the decision to conduct a trial with product A may mean that we will have to wait much longer before a trial can be conducted to test product B.

If all potential treatments were equally likely to be effective, then the challenge here would be easily solved by the current model: first come, first served. On the other hand, a case can be made that government regulators and the research community might do well to find a way to decide which new interventions should have the highest priority to be tested.

Financial Conflicts of Interest

A third risk in the domain of clinical trials is also not new, but is likely to be of increasing concern as the impact of the economic downturn increases. For the most part, researchers, clinicians, and the general public are highly motivated to find the best solutions to treat the pain and suffering caused by diseases and disorders.

However, even the most dedicated in our society can become victims of unintentional bias. With sometimes significant sums of money involved, it is now more important than ever that we develop strategies that will minimize if not eliminate the bias that might creep in because of financial conflicts of interest.

Financial conflicts can occur at many different levels. Clinicians, as well as clinical researchers, might underestimate the risks of participation of their own patients in a clinical trial because of their hope that this new treatment might work or because the income for recruiting research subjects is needed in order for them to continue their work. Researchers might pursue one direction over another, or fail to evaluate their data objectively, if continued funding of their research project is at stake.

This is not to suggest that anyone is deliberately abusing the clinical trial system, but the most well-meaning individuals can be unaware of their own biases. For this reason, the roles of the FDA and local human subjects committees are vital to the ethical conduct of clinical trials.

Undue financial pressure might also be exerted inadvertently on prospective trial subjects. In our current economic downturn, members of the public are increasingly turning to clinical trial participation, sometimes for very substantial sums of money. These potential research subjects are certainly entitled to decide for themselves whether or not the financial rewards outweigh the risks of participation. However, the worry that should be on the minds of researchers and research review committees is whether the financial benefits of research participation are sometimes so large that the potential subjects will not truly appreciate the risks that they might face. In short, their consent might be voluntary, but it is not informed.

The examples cited here are obviously rooted in the biomedical sciences; but this should not be taken to mean that our only challenges are in the conduct of clinical trials.

San Diego scientists are major contributors to a wide array of new technologies including, but not limited to, healthcare, biofuels, robotics, information technology, nanotechnology, communications, surveillance, and weapons development. It is not difficult to recognize that each of these lines of research is associated with a variety of challenging questions such as: Should we do this? Is the work feasible?

What will we gain and what will it cost, and who decides? To some degree, these are scientific and public policy questions, but they are all ethical questions.

These questions of ethics cannot and should not be answered solely by scientists. Both the scientists doing this research and the public which might either benefit from or be harmed by that research, have an obligation to come together to find the best solutions to the ethical challenges we face. The result may not be perfect, but it is our best chance to achieve the progress we seek through science and technology.

Michael Kalichman is a founding co-director of the Center for Ethics in Science and Technology, dedicated “to increasing awareness, understanding and discussion of the ethical implications of new developments in science and technology.” He is also director of the Research Ethics Program (http://ethics.ucsd.edu) and professor of pathology in the UCSD School of Medicine.

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