Ms. Maggie Scheie-Lurie?

Is she here?

You are representing the National Alliance of Mentally Ill, is that correct?

MS. SCHEIE-LURIE: That is correct.

Dr. Childress and members of the subcommittee, my name is Maggie Scheie-Lurie and I am the consumer outreach coordinator for the National Alliance for the Mentally Ill. NAMI is the nation's largest grassroots organization representing persons with severe mental illnesses and their families.

Research represents the best hope we have for alleviating the suffering caused by severe mental illnesses such as schizophrenia, depression, bipolar disorder, obsessive compulsive disorder, and anxiety disorder.

Remarkable advances, which have already occurred in treating these disorders, would not have happened without the participation of people with these brain disorders as human research -- human subjects in research.

I appear before you today as someone who has participated for many years as an outpatient human subject in a longitudinal clinical protocol on clinical depression at the National Institute of Mental Health. My experience in this protocol has generally been quite positive. Throughout my participation I have had access to medication and clinical treatments which have for the most part been successful in controlling the worst symptoms of my illness. Additionally, I have usually been treated in a respectful and dignified manner by the research investigators and staff persons.

These people have communicated to me the nature, goals, risks and benefits of the research in an understandable manner so that I have been able to consent in an informed manner to participate in specific aspects of the study.

But I am aware that there are many individuals who participate in research who do not benefit directly from their participation. Some research protocols are not designed to benefit individual participants. Even potentially beneficial research designs sometimes involve procedures which are painful or risky for individuals participating as human subjects.

Some research participants may actually experience psychiatric relapse or deterioration, particularly those studies involving relapse study, drug washout procedures or placebo controls.

At the same time some individuals with severe mental illnesses who participate in research may lack capacity at times to understand research and to consent to their participation.

While it is vital for people with severe mental illnesses to participate in research clearly procedures must be established to protect the well-being of these vulnerable consumers.

In February of 1995 the NAMI board of directors adopted policies which contain specific recommendations of this nature. These recommendations were developed through a sensitive consultation with consumers, family members, researchers and other experts. NAMI's recommendations attempt to strike a balance between the importance of research with the equal importance of protecting the well-being of people who participate in the research.

In the short time remaining I will focus briefly on four aspects of these recommendations. Our complete NAMI policy is attached to our written testimony.

Number 1: "Informed consent." Informed consent should be an ongoing process designed to ensure that consumers who participate as human subjects in research understand as much as possible the objectives, procedures, risks and benefits of the research. Researchers must be particularly sensitive to changes in functioning and comprehension which may occur during the course of a research protocol and must make special efforts to provide information to consumers and their families during periods when symptoms may be exacerbated. Researchers should also be sure to inform subjects and their families of potential alternatives to research.

Number 2: "Assessing capacity." Some important research, particularly research on experimental medications, may require the participation of individuals whose symptoms are quite severe. In research of this nature it is important to carefully evaluate the capacity of these individuals to comprehend the research and to provide informed consent to participate in the research. We strongly believe that responsibility for assessing capacity should be vested with a qualified individual who is not directly involved with the research.

If it is determined that a person lacks capacity to provide informed consent substitute consent should be sought from a family member or others who are legally entrusted to act on behalf of the incapacitated individual. The responsibility of research to provide clear and comprehensive information to research participants exists even when these individuals lack capacity to provide informed consent. Research investigators should make all efforts to inform these individuals that they are participating in research and to ensure that these individuals agree to such participation.

Number 3: "The important role of IRB's." IRB's have very broad responsibilities to evaluate and provide oversight over research protocols. However, there are no requirements that IRB's monitoring research on severe mental illnesses include members with direct and personal experience with these disorders. There are also no requirements that members of the IRB make themselves known or are available to the individual research participants. We have three recommendations to remedy these problems.

First, all IRB's evaluating research using human subjects with severe mental illnesses should include consumers and family members.

Second, IRB's should receive specialized training about severe mental illnesses and the needs of people who suffer from these disorders.

Finally, IRB's should designate at least one person who will function as a point of contact for individual research subjects and should be sure to inform research participants about this person.

Four, research using placebo controls. The administration of placebo to individuals with severe mental illnesses participating as human subjects research on experimental treatments can cause relapse and immense suffering. Consequently we hope that the day will soon come when valid research can be done without the use of placebo controls. In the mean time we strongly believe that all individuals should be given trials on experimental occasions even if they are initially included in the group which is administered placebo.

In conclusion, NAMI supports the critical need for biomedical research on severe mental illnesses. At the same time we recognize the importance of establishing strengthened procedures for protecting the health and welfare of vulnerable individuals participating as human subjects in this research. Through open dialogue and willing consumers, families, members of the scientific community and others, we believe that consensus can be reached on how this balance can best be achieved.

I greatly appreciate this opportunity to testify before you.

Thank you.

DR. CHILDRESS: Thank you. Thank you for strictly respecting the five minute limit.

Trish?

DR. BACKLAR: I am interested in the remark that you made in research using placebo controls in which you say in the meantime we strongly believe that all individuals should be given trials on it, et cetera, et cetera.

Could you talk a little bit more about this? Do you really mean all individuals?

MS. SCHEIE-LURIE: What I am saying is what the policy means to say is that individuals who have been in a research study in which they were given a placebo and were not given the benefit of the medication being studied should be allowed to have access that medication following the study if they choose.

DR. BACKLAR: I think that we both read this quite differently. I thought that you were saying that all individuals should be included in a trial in which there was a placebo arm.

MS. SCHEIE-LURIE: Well, again -- well, I believe this is saying that many individuals, I believe, go into research believing that they will personally benefit. If they, in fact, end up in a placebo group instead of the group that receives the medication being studied they are not having the opportunity to receive a benefit of that research medication. I think what this is saying is that they should be given the opportunity following the study to perhaps benefit from that medication.

DR. CHILDRESS: Alex?

MR. CAPRON: Two things. One is to follow up on your exchange.

Trish, if you look at point nine in their recommendations I think it is stated a little more clearly. It is right after the testimony.

DR. BACKLAR: Oh, yes.

MR. CAPRON: The question I had was about your second suggestion for IRB's that they should receive specialized training about severe mental illnesses and the needs of people who suffer from these disorders. Do you have in mind a model in which this has been done where you would be able or we would be able to see what such education or training consisted of and what effects it had on the IRB's functioning?

MS. SCHEIE-LURIE: I am not aware that we have a model at this point that has been used but I am sure we would be more than happy to be involved in the development of such a model.

MR. CAPRON: Without the existing model can you enumerate some of the sorts of things that such training would address?

MS. SCHEIE-LURIE: Well, I would think the basic nature of these disorders, the typical kinds of treatments that people receive, the difficulties that people may inherently experience in the course of treatment and in the course of attempting to recover these disorders. I am obviously talking off the top of my head but I think part of the problem is that the nature of what these illnesses are like is not necessarily understood by people involved in evaluating whether particular research protocols are appropriate.

Mental illnesses are not like other illnesses and I think it is really important that people involved in determining whether research protocols are appropriate know what the severe -- for instance, the ideas of washout periods. People knowledgeable about mental illness will know how devastating that kind of a period would be. So I think if an IRB was knowledgeable of the devastation that can occur and how someone's whole life can be destroyed in the course of a washout period it would be much more sensitive to the appropriateness of that kind of research protocol.

DR. CHILDRESS: We will take one more question.

DR. BRITO: Earlier this morning I kept hearing a recurrent theme and in a lot of the reading that we have received that keeps coming up about the suggestion to have an autonomous doctor or someone outside of the research, whatever research protocol, to help that patient.

I was curious given your positive experience how did you get involved in research in the first place? Were you referred by someone? Did you have someone guiding you through that that was not involved in the research?

MS. SCHEIE-LURIE: I initially became involved in this research because I was seeking treatment. I sought treatment at a local community health center which was not able to serve my needs and they said, "We cannot do this but it is possible that you will fit the protocol in this particular study at the NIMH," and I was evaluated and I did fit.

I have been fortunate that the people I have been involved with all along have been sensitive and responsive to my questions about what is going on, why are you doing this, what can I expect to learn from this, what can you expect to learn from this, how can I benefit. I have been very fortunate. I have been unusual, I believe, especially in the course of hearing what we have heard today and what I have known from talking with people outside of this hearing, that many people do not experience that. I consider myself something of an anomaly.

DR. BRITO: But when you say the people that you have been involved you are talking about certain people in the research program. Once you were referred you had no further contact with another physician outside of that program?

MS. SCHEIE-LURIE: No, I did not.

DR. BRITO: Okay.

DR. CHILDRESS: Thank you again.

MS. SCHEIE-LURIE: Thank you.