As a biomedical engineer, I have always been excited about doing research that might have an impact on health care.

My first research experience was in computer simulation of eye movements. Later research focussed on the subcortical control of eye movements and visual functions, studied by single unit recording in anesthetized eats and monkeys. By the time of my Ph.D. thesis, I was working in human motor control, using healthy human subjects for various noninvasive experimental procedures.

In all of this work, the researcher was not required to pay very much attention to the experimental subjects. Someone else cared for the animals and computers, and the healthy human subjects cared for themselves. The institutional review hoards easily passed many innocuous protocols.

Following my Ph.D. work, I continued to work in the area of human motor control, but my interests shifted to pathological motor control. These new interests were particularly concerned with restoration of functional movement following spinal cord injury. I soon found myself ready to perform experiments with human research subjects who were spinal cord injured. Suddenly, experiments were no longer as easy to perform as before, and many ethical questions arose in my mind that had not arisen before.

A short review of spinal cord injury and the experimental techniques involved in this type of research may assist the reader in understanding the nature of the ethical problems involved here. Spinal cord injury is one of the most devastating and frustrating injuries that the human nervous system can sustain. The muscles below the level of the injury no longer move upon voluntary command.

In my work I have been concerned with paraplegia-paralysis of the lower extremities. Typically, a sudden and irreversible change occurs in the life of the injured person and the family. The injured person and family are rightly told by the medical staff at most trauma units and rehabilitation centers that nothing can be done to cure the injury, and that anew lifestyle which takes the injury into account must begin. This new lifestyle revolves around the wheelchair or long leg braces for mobility. Yet in most cases, the injured person and family nurture hopes that someday everything will return to normal-that "someday I will walk again."

In many cases of paraplegia, it has long been known that electrical stimulation of paralyzed muscle can cause it to contract. There have been a number of demonstrations in laboratories around the world since 1960 which have shown that this technique might be feasible to restore standing or walking.
In my studies, surface electrodes are placed over the belly of the muscles in the front part of the thigh. When pulses of electric current are passed through these electrodes, the thigh muscles contract to stabilize the knee, and the person can now stand.

The postural stability when standing by electrical stimulation is not as good as the stability of a neurologically intact person. It is also not yet as good as the postural stability achieved while wearing long leg braces. Some advantages of standing by electrical stimulation are that it is less cumbersome to use than braces and more cosmetic. Despite the feasibility demonstrations 1 have performed and those performed at other laboratories (Rancho Los Amigos Hospital, Case Western Reserve University, Rehabilitation Engineering Center of Ljubljana, Yugoslavia, and others), most researchers agree that it will still be many years before this technology is clinically available.

As a researcher, I have hope that the projects I am working on will benefit mankind. Yet, in reality, a given project may not really result in any benefit to mankind. If no benefits occur, I am not disturbed, because I have many projects; perhaps one of the others will be successful.

The ethical question here is whether I have the right to project my hope for a single project to an individual research subject who may be very desperate for something to hope for. In this case, if the project is not successful, the individual typically has few other places to turn for hope. The research described earlier is a perfect illustration of this dilemma. Generally, the spinal cord injured individual has been rightly told by the medical profession that the likelihood of standing or walking is remote. Psychological professionals agree that this news is devastating to an individual. When the "carrot" of a research project is dangled that might imply some hope that the medical predictions were somewhat pessimistic, the injured individual is highly likely to chase it. It is useful to recall a quote from the late Dr. Morris Fishbein:
"In times of great stress, of pain or of sorrow the human being recants all that he may have learned of science and truth and resorts to incantation and to prayer. He is ready to leap at any cure or suggestion that may be offered to him for the alleviation of his travail, never stopping to inquire as to the motives of those who would heal him or as to the basis on which their claims may rest."

This dilemma must be resolved. On the one hand, if no research is done with human subjects, the likelihood that advances will be made is diminished; on the other hand, if research is conducted with human subjects, there is the potential for psychological trauma to the individuals participating as human subjects in the research. Obviously, taking either extreme position (that the research should be conducted no matter what harm comes to the subjects or that the research should not be done at all) is indefensible. We must thus address the nature of the compromise to be made in this case.

In the research program at ITT, we have had the cooperation of rehabilitation psychologists. We try very early on to make sure the prospective research participant understands the difference between treatment (which we do not do) and research (which we do). We further screen participants for expectations, try to identify them, and manage them. We want to make the best possible effort to help the research participant understand that he or she is really a co-investigator of sorts, and that the only benefits that might accrue are the satisfaction of having contributed to scientific knowledge in this field.
Despite this ethical wrangling, I , as a researcher, am left with a bitter taste in my mouth. Why not return to research in areas that do not have these problems?

One answer to this question may lie in the observation that research in bioengineering has to a large extent not been as effective as it might be, since not enough research feasibility studies that have been successful have been brought to the point where they directly benefit people and improve the quality of health care. If more researchers do not attempt to see their results move beyond publication in a journal, and into the mainstream of health care, then these research efforts will ultimately be curtailed.

A second answer lies in the ability of the researchers to feel that they have done their best, in spite of the many difficulties working against them, to bring their ideas to help mankind to fruition.