MR. ALLER: My name is Robert Aller. Can you hear me okay? And my son, Gregory, actually was a participant in a schizophrenia research project at UCLA. And at the time I had actually personally seen the benefits of human subjects research prior to my son entering the project. Between the years of 1964 and 1988 I had been employed to document on film a UCLA Department of Psychology research project to develop new teaching techniques for autistic children. I found because I was working with the researchers all the time that they demonstrated extraordinary care and concern for the children and their families and the families were always fully informed of what was happening.

When our son was diagnosed and joined the UCLA research, the Schizophrenia Research Program, I had anticipated experiencing the same kind of researcher concern for the welfare of human subjects that my wife and I had seen in the autism project for a period of almost 25 years. However, what we found was something very different.

By 1989 at UCLA Greg was taking antipsychotic medication and he was actually earning a 3.8 in college and working 15 hours a week so he was really doing quite well. And at that time we thought that the experimental aspects of the research were benign from the informed consents and fliers that they gave us.

The researchers told us at that time that Greg might not even have to take antipsychotic medication and it was recommended that he participate in the crossover and withdrawal protocol. While the consent form stated with equal emphasis that he may get better, stay the same or get worse, the researchers did not reveal to us that in a previous year over 92 percent of the subjects got worse.

After the medication withdrawal Greg suffered a lost of intellectual functioning. He became violent and our family was devastated in the process. After remedication he failed to return to his previous level of functioning and after waiting six months my wife and I decided to go see the UCLA Vice Chancellor of Research and discuss the issues that we had been confronted with.

In that tense meeting with the Vice Chancellor and the Chair of the Human Subjects Protection Committee and the Administration we told them that we thought that a murder or suicide could occur in this research based on our experience, and we also asked for Greg's records at the time so that they could be evaluated.

In response, only a few of Greg's records were made available and about two weeks later at 8:30 in the morning as students were on their way to their classes another human subject in this research, Tony LaMadrid, jumped off the engineering building committing suicide.

At that point we, of course, were quite, quite concerned and the LaMadrid family and two more families were joined with us in filing complaints with OPRR and I think we may have been the first group of families to speak out about abuse in the schizophrenia research.

OPRR conducted an investigation and determined that the consents were deficient and that Tony LaMadrid had been in a monitoring phase of the research that did not even have a protocol.

We found NIMH was vigorously defending the research conducted without proper informed consents and it reminded us of the U.S. Public Health Service's defense of Tuskegee.

But a public debate ensued in professional journals and the researchers seemed to be claiming -- and these are journals that are even published just up to now -- claiming that schizophrenic patients are able to comprehend consent. There was no proof that anyone had been hurt and that everything in psychiatric research is really all right.

We are here today to say that everything is not all right from what we have observed. Administrators at NIMH have been authorizing protocols that inflict unnecessary harm on vulnerable people. We believe that there is a serious imbalance that favors the researcher and leaves the human subjects inadequately protected in the process and that imbalance should really be corrected.

Consent forms are often ambiguous and misleading either by omission or vague language. To strengthen the system of protection of human subjects we have several suggestions in this time limited period here.

Medical doctors not connected to the research should represent the best medical interests of the human subjects. Nonhuman primates already have that protection. We think humans should also have that protection.

Informed consent documents should no longer be blanket forms but instead should reflect the medical history of the individual human subject.

Alternative treatments should accurately reflect the alternative treatments that are actually available for that individual human subject.

Risks should be put in rank order of probability. Something that people have avoided doing.

Consents should be truthful and forthcoming and even blunt.

The risks are too great to camouflage the foreseeable outcomes.

The vulnerable populations that we are concerned about cannot be compared to football players out on the field who when injured can have a knee operation.

Researchers have reported that following psychotic relapse some patients never return to their former level of functioning. No operation is possible to correct that kind of harm.

I, for one, do not believe that researchers should conduct protocols that cause harm by design. Vulnerable patient populations already have a high rate of suicide. How many are we going to knowingly harm?

"There was nothing in the experiment that was unethical or unscientific." Of course that is Dr. John Heller speaking, a former director of Tuskegee.

We found that that same defense was offered for research that has harmed those who are decisionally impaired. Some of the cases presented today will hopefully represent properly conducted research and researchers should be applauded when that happens. We know that happens all over the country. However, some of the cases presented today will raise some troubling ethical and scientific questions.

Thank you.

DR. CHILDRESS: Thank you. And thank you for sticking pretty close to the time limit.

Questions for Mr. Aller?

DR. BRITO: I have a question, Mr. Aller. Thank you for your presentation.

Just out of curiosity do you know what the findings of the study your son was involved in? What the end result -- what was found or were you informed of that?

DR. ALLER: Yes. I would not want to summarize it. I think they did find that everybody needed medication or that is what they said.

DR. BRITO: My understanding is that what bothered you most is that you were not informed of the previous year's findings. How much time was taken with the informed consent?

DR. ALLER: Well, actually they omitted a couple of crucial things and what we find in informed consents that is omitted that I think is most egregious is the alternative treatments because very often the alternative treatments would be a better choice. So they omitted alternative treatments and risks when they knew what the probabilities were.

DR. BACKLAR: Thank you, Mr. Aller, for coming to testify before us.

Could you tell us a little bit about when your son agreed to be in this trial as I believe there was some connection to clinical treatment as well as being in a research protocol? Were you or your son confused by this?

DR. ALLER: Well, it was called the After Care Clinic and so what was not clear in the presentation -- what was clear from the brochure is that you are going to get the best treatment available. That is what the claim was. And there was no up front claim that you are probably going to have a relapse. There is some dispute. The researchers claim they did everything orally and, therefore, it is okay. But we feel that the federal regulation should be complied with and these things should be spelled out in a written form.

DR. BACKLAR: But I want to ask this question again. Did you believe that your son was going to be in treatment, getting clinical treatment?

DR. ALLER: Well, we were aware that they were making observations and collecting data. We thought he was getting the best clinical treatment, absolutely.

DR. CHILDRESS: The last question from Eric.

DR. CASSELL: Do you think that you would have benefitted from a summary of the findings of the study thus far, that is your son entered at your point and another person entered at this point, that you should have known the findings thus far?

DR. ALLER: Very definitely. That should have been in the consent forms that the data that they had collected should have said that on average 88 percent or 75 percent or whatever percentage had adverse reactions to this experience. Yes.

DR. CASSELL: And then a subject entering in the beginning of the study would be somewhat different than a subject entering halfway through, and then so forth?

DR. ALLER: Well, not really. They already had data from other studies that they could have shared with us. I think the idea of full disclosure is a real problem for researchers when you are in high risk research. They could have disclosed that in other research there were no relapses while on medication and there was a high rate of relapse off medication.

DR. CHILDRESS: Thank you again for sharing this with us.