From 1932 to 1972, there was allegedly the study of clinical evolution of syphilis for six hundred black men with untreated syphilis. There were some who claimed that the study was for the standardization of intervention for serological studies of syphilis. I think we need to understand the climate in which this occurred. The president of the American Medical Association at that time was Dr. Sims. He said physicians were to be allowed to profit from the products that they developed in human experimentation. Doctor Thomas Murrell said the future of the Negro lies more in the research laboratory than in the schools. The black man should be registered and forced to take treatment before they offer their disease to the minds and the bodies of other people. You have to know that Dr. Murrell was trained by Raymond Vonderlehr and Vonderlehr headed up the Tuskegee Syphilis Project. It was reported that in 1930 the Public Health Service promoted the statutes to give physicians jurisdiction regarding questions of property in the body of the people. The consent of research was governed by administrative law. There was a Chamberlain Kohn Act of 1918, which gave the public health service absolute power to take blood for testing of syphilis. The Supreme Court then in 1927 sanctioned the judgment of the government health agencies to decide who should have the right for appropriation so you see what the environment was with the American Medical Association, the Supreme Court, the Public Heath Service saying you have a right to what not. The environment was ready for the official thing. So before I go any further, let me tell you the official name. Now we often times say the Tuskegee Syphilis Project but the project is officially named the United States Public Health Service Syphilis Study Project. But when I found out that the injection that I was giving was not real medication, but there was something in that syringe that had a different color, I was angry and I was hostile. I had already graduated. I felt as a nursing student, I had been betrayed. And so I was angry, I was hostile. I felt I had been used and everything else. I didn’t know who to direct my anger towards because I don’t think the physician knew any more than I knew. It was all directed by a particular university that the grant had been given to and I have a gag rule on that I cannot name that university any longer neither can I name the principal investigator because the federal government has assumed the responsibility for the project.

Now I have been passing around, I have a picture of the last man of the Syphilis Study died in April of this year. And I have a picture of myself with him, but I was constantly getting letters from them asking me where can they go to get their Social Security increase, where can they go to get their rent paid, or where can they go to get food stamps. And the men really died in poverty. And when you consider each of those men got a lump sum, but the lawyer got eighty percent of all the money. Now that the last one is dead and there is some money that is left over, there is a big question as to what to do with this last money. Now my feeling is that this last money should go to the families who have been poverty-stricken all this time, by virtually the lawyer. But the lawyer, Fred Grace, has been putting into use of the money to a building that he wants to construct there at Tuskegee in their memory. Well, I think he has enough of their memory already. Somebody says what were the outcomes of the Tuskegee Syphilis Project and what were the consequences.

Well I think one of the consequences is that there was a lack of trust. And we created a culture of distrust and particularly for minorities who sometimes will not participate in clinical trials, who will not participate in any type of research because they have a historical memory of the Tuskegee Syphilis Project. And someone asked me do I think it is still ongoing. My answer is yes I think it is still ongoing. Not to the same extent that it was in the Tuskegee Syphilis Project. An M.D. called me where there were children, Head Start children, and they had collected the bottles and had the little Head Start kids to urinate in the bottles. And you know why they did that, don’t you? Because if cocaine is smoked in the house, that is in the system of that child. And what they do, if they find cocaine in that urine, they will go and arrest that mother or the head of that household. They will go and raid that particular household and the like.

Number one, these are Head Start children and nobody had permission to collect the urine. And my friend who is one of the M.D.s who is in charge of that clinic, they asked him if he would sign to cover them, and he said no I didn’t tell you to collect it and I am not going to sign for having collected it and the like, besides the fact that you decided that you were going to collect the urine so you’re going to have to try to do something about it. Now of course they immediately say the other doctors downstairs, they don’t mind signing it, he says well go and find them and let them sign it for you. But see that’s another misuse I think and that is another thing that is kind of like the Tuskegee Syphilis Project. We had another situation last year that you know about. The Office of the Inspector General closed down about seventeen research projects that were a violation of human subjects, in risk for human subjects. And another one of those was were teenagers were being interviewed for sexually transmitted diseases and all these teenagers, this was in Georgia, were under fourteen years of age but the interviews were telephone interviews without any consent. These teenagers are minors without any consent from the parents in terms of whether they can participate in this research. But without anything saying the safety of what you are going to do with the data when you collect the data. Are you going to turn it over to the Police Department? Are you going to turn it over to the Health Department? To whom are you going to do with it? That is complete disrespect for what you are going to do with the data. And I can go on and on and on and on and tell you examples like the Head Start and like the teenage program. There were seventeen such programs that were closed down last year. Now they finally got their acts together and they opened them back up, but they were closed and they were some of the big leading universities where the act occurred.

Now let me get into the protection of subjects from research risks. It is the law. The Public Health Service Act requires that each person, entity that applies for a grant, whether it is a contract or whether it is a cooperative agreement or whether it is some other formal mechanism, if there is funding from the federal government, they have to abide by the laws that govern the protection of human subject. The Code, and I won’t bother you too much with these codes, but the Code of the Regulation, Part 45 and Part 46 are the ones that govern protection of human subjects from research risks and the like. Now it is often times called the common law and the common law and the implementation that we use in Washington is pretty much governed by the Food and Drug Administration. When we had all the laws and all the control in Washington, D.C. I was one of the people who stood out and said but this has to be a local affair if you are going to have honesty. You cannot control morality and ethics from Washington. It has to be local affair. And I was a strong advocate for the Institutional Review Board, the IRB and I almost got myself out of a job because I went across the grain with NIH who thought there should be centralized control and I was steadfast and thought we should institutionalize this to the Institutional Review Board because I think that morals, and ethics, and civil rights, and whatnot are things that should be local and should not be national. Now the various tenants of the regulation and the protection of human subjects are in the Belmont Report. The Belmont Report is the report of the National Commission for the Protection of Human Subjects is an attempt to summarize the basic ethical principles for the conduct of biomedical and behavioral science research. There are three basic tenants: a respect for the individual, benevelatince, and justice. Let me just go over these. Treat the individual as an autonomous agent for ensured protection of human subjects. Benevelatince is secure wellbeing of the person and maximizing the possibility of the benefits that do no harm. Justice is the fairness in the distribution of the benefits and the burden that may not be distributed not on one person. The key features then that I just mentioned, the consent for participation. And consent should be voluntary. Consent should not be at all arbitrary.

The law says that consent has to be voluntary and you not only have to be told what is the procedure, but what are the side effects of the procedure, what are the alternatives of the procedure and that you have the right to refuse the procedure. And that is the law. And the fast selection of the research subjects is a part of the ethical conduct of research and that means that no undue call is on any particular person. Now informed consent is that the participation is willingly, is voluntary. Now participation means that the current subject has enough information to give the informed consent. They have a full knowledge of the risks that are involved and the benefits that are involved and the risks and discomfort that are involved. And they have to be told that they can, without malice, that they can have a right to refuse the treatment if they wish. Now one of the things that I like to say at this point, I think that is very important, that we who go to the hospital, how many of you have been to the hospital in the past five years? Now you know how they put the X in front of you and say just sign where the X line is? I hope you didn’t sign until you read it. I know that they are usually in such a big hurry that you are just going to sign the X.

Now you might have been saying that you can put on the radio, you can put on the television, any of my physical experience or you can release information to the newspaper, to a reliable source and a reliable resource is the newspaper and the like. So often the person who writes those informed consents are lawyers. And I just finished one, I am taking chemotherapy and I had my chemotherapy yesterday. Just before I had my chemotherapy I had to have an X-ray and I had fourteen forms to fill out. Fourteen X’s to make. And I wrote the same thing, scratching out the line and saying, I have not read the above but this is my signature. The lady says to me, Doctor Harper, I do not understand this, you have two PhD’s and it has taken you a whole hour to fill out those forms and the average person comes in here and in ten minutes, they have filled out those forms. And I said, “Simply because I am reading it, the other people simply sign where you put the X”. So I ask of you, please do not sign where the X is. The only thing you need to know that there is a penalty if you sign and do not know what you have read.

Now not only do we have the Belmont Report, we have the Data Safety Monitoring Plan. And we call it the DSMP. Each investigator has to have a plan for how they are going to have the safety and the confidentiality of the data that is coming up from the research of the clinical trials and that can be biomedical or behavioral and social science kind of trials. NIH specifically are required that we establish a Data Safety Monitoring Board for multi-site clinical trials that are being held and whatnot. The DSMB monitoring experts, they are an independent group, and someone asked me what we expect of that board. We ask that it be number one, that it be an independent committee and that the membership of that committee include clinical trial exerts, not people involved in any of the research. Bio-staticians, bioethics, staticians, and clinicians. The objectives of the DSM3L3, the risks that are associated with the participation are minimized to the extent possible. The second one is the integrity of the data. And the third is the ethics and the clinical trials. In addition, the DSM3L3 has the responsibility to stop the clinical trial if the data does not seem to be administered safely. Now I don’t know how many of you know about the clinical trials, but do you know that there are three phases of the clinical trials? For the most part, when we talk about clinical trials, the federal government has defined what is clinical trials and defined the phases and we have defined what is clinical research and the like. If they violate the grant and what is in the grant in the protocol, we can close the project down. And that’s what that data-monitoring group can do, they can recommend to the secretary of HHS that the project be closed. The FDA is under the secretary also so they can see that it be closed down. Now we have another program to safeguard the research integrity. And that program is called Recruitment Retention, which includes women and minorities in clinical research and clinical trials.

We have a system in Washington under Doctor Vivian Pinn where we can track all research that is done and we do track all research that is done seeing about to what extent have you included women and to what extent have you included minorities. For the most part, they do not want to include women because they say number one, women take more medicine than men do and women have more diseases. And my conscience is more so they should be involved in research and more so should they should be involved in clinical trials. This same thing is true with the elderly. They do not want to involve the elderly because they have too many diagnosis and they are also on too many medication. But I was saying after all, they are the ones keeping it going and therefore, they should be the person that is involved in that.

Many of you know Dr. Bob Temple. Dr. Bob Temple is the head of clinical trials for FDA. He was coming down the hall and my mind is programmed every time I see Bob, “What are you going to do about include including women and elderly in clinical trials?”. And he says, “But Mary I encourage it all the time.” I said, “Encouragement does not help that pharmaceutical companies at all, they need a mandate.” So finally he is coming down the hall; we are on the same floor incidentally. So he was coming down the hall, he knew I was going to ask him he dotted into the men’s room and I stood right outside of the men’s room until he came out. And I said, “Bob, the question is the same before you went into the men’s room and after the men’s room. “What do you plan to do?” He said, “Mary I am going to be sending out a white paper”. I said, “A white paper and a blue paper and a yellow paper are not going to do the manufactures any good unless you mandate that they include women and minorities and the elderly, they are not going to volunteeringly do it, I don’t care what color the paper is and the like”. So finally I got him to call a press of the manufactures, one hundred of them together. And guess where they met? In January in Florida. Now can you imagine what happened in January in Florida. How many meetings did they go to?

One of the consequences of the Tuskegee Syphilis Project was the mistrust that the minority people have involving clinical trials and I think that it has very well been decided that the preferences, the hopes, the distrust, how that affects treatment outcomes. And I personally say to people, it is more detrimental for you not to participate in a clinical trial than for you to do so. You should participate in a clinical trial because as it is now, when we look at former kinetics of aspirin, we know very little about the former kinetics of aspirin for minority people and low-income people in Baltimore population. So it is very important that they get involved in the clinical trials. You see, I think that a great deal of the not participating in the clinical trials and not participating in the clinical research has created some disparities because if you don’t participate in the research, we don’t know what findings, we don’t know what medicine is effective, then we don’t know what diagnostic treatment to use. Then when we use diagnostic treatment, then we say there are disparities in the treatment so it is a no-win situation that we have and therefore I think a great deal of our disparities are created in that particular area. The NIH has a book on inclusion and exclusion; you can get a copy of that free. It gives hundreds of suggestions in terms of inclusion and exclusion of minorities in research and clinical trials.