Public Testimony: Dr. Ted Falk, Dr. Syd Glasser, Ms. Karen Hansen

DR. FALK: Thank you. Mr. Chairman and members of the Commission, I wanted to welcome you all to Oregon, the bioethics state. If you didn't see today's newspaper, the headline on it is, "Fitz Harbor Defends Suicide Law." And this is just really typical. For the last decade, I think probably once a week there is a front page article in the Oregonian about some bioethic issue. So, you've made an excellent choice of a place to conduct this meeting. I do have some written remarks, which I distributed to you, and they're short. But in lieu of the five minute rule, I will not even read through these. I have really only two points that I wanted to make, one about the report on mentally disordered subjects, and then a little discussion about Oregon's law of genetic privacy. On the report about mentally disordered subjects, I wanted to point out something to you, which is perhaps already crushingly obvious to you from your own work. But, of course, I didn't participate in the discussions, so I don't know about this. But, really, within your report on the mentally disordered subjects is the seed of a very powerful critique of the existing IRB system, very much along the lines of the recent OIG Reports. And so, I am hoping that you will extend your work on the rather special problems involving mental disorder subjects to return to a much more general features. Because as I read through your draft report, I actually found relatively little that I thought was all that specific to that population. Many of the points that were being made are general laws in the IRB process. And so, I'm hoping that you will be able to return to that in a future agenda item. And I gave a few bullet points in my testimony to illustrate why I think that's so. Turning now to the matter of genetic information, I don't know exactly where you're going with your report. But what I thought it might be useful for me to do would be to tell you a couple of things about Oregon's genetic privacy law. I was part of the group that wrote that law in 1985. And I've attached to my testimony a copy of the statute. And it's basically a law which establishes consent rights for individuals whose genetic information or DNA materials are going to be obtained, retained, or in the case of information, disposed. And what Trish Backlar, particularly, suggested would be useful for me to say a couple of words about is the property clause. Because this is something that's been very controversial in Oregon. Whether or not you agree with it, I at least wanted you to know that there was a rationale for it, and it was something that a great deal of thought was given to. The property clause, which is set forth in the statutes, but I've just cluttered it—the roman part in the memo declares in statute that, "An individual's genetic information and DNA sample are the property of the individual." The thing goes on to say, and most people don't read on, to say that, "The property clause is not to be used in determining whether an individual is entitled to compensation or royalties." So that was not the purpose of the property clause. What I suggest in my testimony was the purpose. It's a sort of metaphor, and you might ask why do you go to the trouble of enacting a statute or metaphor. And that is in response we are very rapidly changing biological fields. You want to have a coherent principle for dealing with a situation, which, at the time, a legislature is dealing with that, at one moment you have an only very imperfect glimpse of, especially in a very rapidly changing biological area, plus in a legal field in which there are practically no known issues about violation of genetic privacy that one points to. And by appealing to a word like "property," you establish a framework for evaluation of cases as they come up. And, of course, there may be very little genetic privacy law, but there is a great deal of property law. And so, what this law accomplishes suggests to a decisionmaker that the relationship of the individual to their DNA sample, or to their genetic information, is like the relationship of an individual to their property. It doesn't go beyond that. But that actually would be a big help to someone. They'd at least know which section of the law library to go to for analogies if they wanted to analyze a particular case. So, that was really the purpose of the property clause. Another approach that might be taken, and which is often taken in federal legislation, and which I feel is kind of unfortunate, to try to map out an extremely detailed scheme of rights and remedies. We actually looked at a very well written model statute, which attempted to do that. It's very difficult to do that in a fast changing area where the biological knowledge itself is so new. And, therefore, the understanding of the legal rights and relationships is so imperfect. And so, I guess I think there is something intelligent about trying to write a statute in what I call constitutional fashion, where you, a person, have a concept to deal with for future development, rather than trying to write every detail into the law as it exists. That's what I wanted to say to you, and if you have any questions, I'll be happy to respond.

DR. SHAPIRO: Thank you very much for being here. Alta.

MS. CHARO: Yes, thank you, Dr. Falk. And thank you for providing a copy of the statute. I was just last night asking somebody if I could see it. If I'm reading it correctly, and I ask you that as a question, this statute would preclude what is permitted under the federal regulations; that is, the use of stored samples, where their use represents a minimal risk to the source of the sample, and where contact to obtain permission is considered impractical. This statute, as I'm reading it, it would preclude that, assuming that the samples are identifiable through coding or whatever. Am I reading it correctly?

DR. FALK: Well, first of all your attention to an exception which is built in, and I do mention this in my testimony, and then you can track through the statute. There is an exception for anonymous research. The sample is not identifiable as belonging to a particular individual. And I think we assume that reverse DNA engineering would not mean that a subject was identifiable.

MS. CHARO: Right, but the more common situation, the one that we've been struggling with here, is where a coding system has been used, so that it's not obvious what the person's name and address is, but the code can be broken. And that would appear under your definitions, if I'm reading them correctly, to meet the standard for identifiable. So, this seems to be a quite typical scenario, look one state to the south in California, you've got people that are working coded samples. They're using the codes in order to allow for periodic updating for the medical records that are being abstracted. And it's been determined by the IRB at UCSF, this is minimal risk and it's impractical to re-contact people for consent. And so, under the federal regulations the research is permitted to go forward. Do I understand correctly that in Oregon that research could not go forward because of the statute?

DR. FALK: I think you'd have to deal with some legal technicalities about effective dates, about when the sample is collected and so forth, because I don't think the statute probably has a retroactive effect on samples that have been collected prior to the enactment of the law. But with that caveat, I would agree with your interpretation.

MS. CHARO: So, I'm sorry. I'm just trying to get to—the law was enacted a couple of years ago. I'm curious. What has been the experience now in Oregon? How much have you been following the experience in the research community, as to the effect it's had on what can and cannot be done and—

DR. FALK: Well, I know a lot of people are anxious about what cannot be done, although probably should have asked Dr. Kolar at the reception last night, but I do not believe that biomedical research in Oregon has ground to a halt. And whether people are puzzling over what this law means, I don't know. And I actually cannot tell you how it's being applied in the field in Oregon. But I think that your interpretation is correct; that there would not be, on the fact of the statute, any sort of exception for minimal risk research, as opposed to substantial risk. That's correct. And, of course, the federal law doesn't have any preemptive effect. I agree with that. And I guess I would put back to you that I'm not sure that there is anything wrong with that result.

MS. CHARO: I'm not sure. I just want to know, but we can't answer it.

DR. FALK: I think it was the drafters of this statute, that I was a part of, felt that the use of stored sample bank was entirely too casual, that—and an individual had a right to consent before their information will be put into historical sample bank. That's correct.

DR. LO: I want to again thank you for preparing all of this for us, which I think is very helpful. We probably don't have enough time to do it now, but if you could also provide some sort of information of specific examples of how the property clause in the statute has helped? And what are the sorts of situations in which that sort of guidepost has been, or is thought to be, useful for winding one's way through disputes? That would be helpful, as well.

DR. FALK: There is actually a sort of coalition at OHSU that whose job it is to monitor this statute, and furnish advice, and I'll suggest to them that they see if there is any further information they could furnish on that.

DR. SHAPIRO: That would be very helpful. We'd appreciate that very much, if that's not too much effort. Any other questions?

DR. FALK: Thank you very much.

DR. SHAPIRO: Thank you very much. We very much appreciate you being here today. Is Dr. Sid Glasser here? Thank you. Dr. Glasser is from San Francisco.

DR. GLASSER: Okay. Thank you for the opportunity to speak here. First, several people have given public testimony at earlier sessions on being preyed upon by government agencies or their contractors. Some of what has been relayed may seem fanciful and unbelievable. It's not the inability to correctly interpret the means by which such abuses have been carried out that's important, but that they have been subject to psychological and other tests of a sadistic nature without their approval. Understanding may be lacking, but the reality of the abuse is real. I'm here today—excuse me. One more private citizen, whose life has been—whose life has been severely damaged by the domestic covert activities of the U.S. government. Next, intrusion on the privacy and intended abuse of ordinary citizens have used means which are essentially those mentioned previously, subliminal for the individual signals, drugging, microwaves, etc. An indication of the indifference of government is suggested by the two House bills, H.R. 3946, of 104th Congress, which was shelved, and a modified bill, H.R. Bill 3946, of the 105th Congress. The former is for the protection, or was for the protection of humans from government-sponsored research or abuse, and means for compensation. The new bill, which is the modified version, protects only animals. The statement of each bill is enclosed with the other materials. Number two, protection of humans from exposure to behavior control methods. (A) The agencies and the contractors we're dealing with are distinctly different from those discussed heretofore. We are dealing with agencies who have never had much constraint placed on any of their activities. Traditionally, Congress has been loath to study the details of their operation. Results and deniability have been the only goals bringing them advancement. History has proved again and again the need for tight oversight control. Next, few programs such as psychological warfare evolve and seldom end. The one in which I had been a participant started in 1952 for me, and became more expensive as applications were conjured up. They appeared from years of no restriction to those of improving—for improved technology, and limited controls. And, finally, to—when the President says to stop, "We're working on it, just give us a little more time." Finally, the intelligence agencies are trained to be deceitful. They are essentially on their own among the public. They get higher ratings when reporting having pressed the right button without revealing exactly what citizens they choose to bother. Okay. Constraining the agencies. The robust discussions at previous meetings have some good ideas relevant to constraints. There should be a ban on invasion of privacy, including eavesdropping for test profiling, or related reasons, and/or the use of private citizens without their written consent, no exceptions, just plain and simple. Now, one idea which may have been missed, probably was from the past transcripts, is having an Office of Consumer Affairs. That is a citizen's police review board, Office of Citizens Spared, or complaints and retribution or compensation, whatever you want to call it. Any citizen who has some concern goes to the citizen's council, which then has the agency in question respond directly to the complaint. And the resolution watched over by calling in experts, such as yourselves. If we're going to have a future of ongoing, closer government surveillance, which certainly looks like the case, then we need such a council for it. And this idea is likely to be more effective and necessary than some of the earlier ones given, because of all of the attending intramural and intermural bureaucratic turf battles. Okay. I have one last thing to say. The rest is several references which sum up my own ordeal, and that of some of the other thousand pledge victims, which are mostly connected through the Internet. Many individuals and organizations assisting one another, as is telebiostimulation, the woman spoke last time, and those listed in the packet given you today. Now, the rest are references, dementia in family, which covers a lot, and subliminal stimulation. There is one that I'd like to point out, which is a little different. It's called the Control of Candy Jones, being a book written by Donald Bain, who is a friend of the family. Candy Jones was a famous model. She offered office space to an FBI agent and some other individual, ended up being drugged and involved in some sort of spy-related episodes over a couple of years. Now, when the doctor in charge was told to end it, end all of the experiments, or whatever, he then tried to have her commit suicide through drugging and hypnosis. Anyway, the rest are references that have been distributed. Thank you.

DR. SHAPIRO: Thank you very much, both for the material you provided, and for the trouble you've taken to come up and speak to us here in Portland. We very much appreciate it. Any questions from members of the Commission? Once again, thank you very much. Next, is Ms. Karen Hansen. Karen Hansen here is representing Public Responsibility in Medicine and Research, which is to speak to us on the issue of the Inspector General's Report on the IRB. Thank you very much for being here.

MS. HANSEN: Yes, I have a letter that I'd like to share, that was written by public responsibility in medicine and research. "Dear Chairman Shapiro and Distinguished Members of NBAC: The House Committee on Government Reform and Oversight recently held a hearing on Institutional Review Boards, using the Inspector General's Report as a base. It is imperative that others associated with IRBs comment both on the misinterpretations of this report in the national media, and the worthwhile substance of the OIG report itself. PRIM&R, Public Responsibility in Medicine and Research, has been active in the education and promulgation of policy for IRBs for the past 25 years. The problems enunciated in the OIG report are those that PRIM&R has described many times in regularly scheduled conferences, and has even proposed solutions. With all of the negative remarks in the press directed to the unsatisfactory manner in which we in the IRB community protect human subjects of research, it is imperative to remember that the OIG report looked for but found no widespread or substantial violation of subject/patients' rights. What it did find, however, was the potential for problems to both the changes in the system to protect human subjects, and to lack of ongoing assessment of outcomes by that system of protection. One problem noted was that the meaningful work of IRBs is being subsumed with ever increasing amounts of paperwork, most having little to do with actually protecting subjects. At a time of exponential growth of biomedical research, as well as seeing increasing complexity of that biomedical research, IRBs have been stressed by inadequate resources. It is also increasingly difficult to recruit senior medical faculty to IRB membership. The demands on their time have also increased, and there is little recognition of the significant amount of time that is necessary to devote to this work. PRIM&R welcomes to OIG report for two reasons: First, it significantly documents this lack of resources; second, the report acts as a wake-up call to institutions, sponsors, and our regulators about the potential for problems and the system of protection. Without assessment of outcomes, we cannot be certain how well the entire system of protection is working. One type of outcome assessment is performance-based evaluation. It is possible and probable that with a concentrated effort on the part of regulators working together with IRBs, we can develop performance-based evaluations for IRBs. NIH has called a panel together, which meets the end of this month, to deal with this very issue. There is no one who will deny the variability of IRB review. Performance-based evaluation should be a considerable aid to all IRBs, as they seek improvement. IRBs cannot function effectively, efficiently, nor provide the appropriate educational opportunities for investigators without sufficient staff and administrative support. We must find better mechanisms to fund our IRBs, than the traditional indirect cost method. All regulators need to reconsider much of their paperwork requirement, scale them back, and make them more meaningful. Regulators and institutional administrators must also provide the resources for the development of educational programs for investigators, IRB members, and potential subjects, in order to make the mandates given to IRBs take their proper form. Until all of the players in the research enterprise are sensitive to the fundamental ethical principles when involving human beings in research, we have not accomplished much more than paper checks and balances. Education will play a significant role in helping to internalize those ethical principles. In summary, we must make sure that we understand the nature of all of the major problems and come up with solutions that do not have perverse, unintended consequences. The next PRIM&R meeting about IRBs in November 1998 will devote considerable time to the OIG's report and its implications. PRIM&R hopes that NBAC will help the process of full identification of problems, and development of truly effective solutions. Sincerely, Sanford Trodoch, M.D., President, Board of Directors, Public Responsibility in Medicine and Research. Thank you.

MALE VOICE: Thank you. And, once again, thank you very much for being here. Let me see if there are any questions from members of the Commission. Alta, then Bernie.

MS. CHARO: You spoke about one specific suggestion with regard to improving the quality of the IRBs, and that's the performance standard. It's kind of a CLIA model, based on the laboratory certification model we have. There are two other cogs in the system, and I wonder if your organization has thought about some very concrete suggestions. One is with regard to individual investigators, with whom everything really starts, since they are the ones who have to approach the IRBs. IRBs can't review things that are not brought to their attention. Have you thought about specific ways in which to enhance the understanding of their obligations under the regulations and the way in which they need to interact with the IRBs? The second, you mentioned the problem of the paper flow to track the activities of the IRB. I think everybody is sympathetic with that, and I wonder if your organization had any specific suggestions about where that could be, either cut back or altered in a way to make the process more streamlined.

MS. HANSEN: Since I'm not on the Board of Directors of PRIM&R, any comments that I might make really represent my own, and can't fully represent PRIM&R. So, first of all, though, as far as investigator obligations, I think a lot of that, through the training programs, both that the NIH has in regional workshops with OPRR and FDA, as well as what PRIM&R and ARENA both offer, as far as educational outreach. There is always a continued emphasis, unless you really get in touch with our investigators, what kind of training programs do you have. And I know, for example, this coming November at the ARENA program that we're planning, there is again a whole panel that's devoted to education. And I think that is where the emphasis lies in really getting the word out to investigators, and making sure they understand what anonymous means, or what, for example, coded information means. And when it comes to the paper flow, and I take it that you're talking about increased—the increased paperwork and how might we gear back a little bit. Just, again, this is personally, I think in the area of annual progress reports and review, that there are situations potentially where some of the volume of activity for the full IRB can be presented in more of an expedited review fashion, based on the status of the research at the time of annual review by the IRB. So, there are some areas where things could be cut back. And, again, I think, too, that with multi-site trials, where there are so many adverse events report, that if there was really terrific collation of offense reports, so that they came to the IRB Board Review in a meaningful fashion on an annual basis. And, certainly, at times, immediately if there is an immediate adverse event to report. But in the annual assessment process again, where we look at studies every year, it would be really helpful to have some collated, really useful information that enables the IRB then to do their job of reassessing risks and benefits of a study. So, those are two suggestions I have. And those are my personal suggestions.

DR. LO: Thank you for coming and presenting to us. I have a question and a request. The question has to do with finances and dollars. We have spent some time this morning trying to figure out how much recommendations cost. And I was wondering if your organization has figures on how much would—how much additional extra support it would take for a good-sized IRB to do all of the things that have been suggested over and beyond the term of funding. And my request is that if you could convey back to PRIM&R, and I guess the individual members that we—I think we would very much like their input on the drafts of these two reports that have been up on the Web in one case, and going up on the Web. We are making a lot of recommendations that call on IRBs to take an even greater role in areas that up to now they really have not played as large a role. Whether this seems practical, feasible, desirable, etc., from the point of view of members of IRBs, I think would be very, very helpful, too.

MS. HANSEN: I don't know exactly what's in the pipeline with PRIM&R. But I do know that there is a lot of attention currently being taken to assess what's the level of salary support for people that are running IRBs, and they're doing salary surveys, and, so on. And along with that I think we'll be sure to mention back to the PRIM&R Board, as well as the ARENA Council that this is an area of interest that will be real useful, both to the NBAC, as well as the IRB community.

DR. SHAPIRO: You should also—and we'll turn to Bette in a moment—but point out that we are looking at the broader review of federal oversight, a report that we issue next year, in which we'll be directly dealing with these issues. We are indirectly dealing with some of them in the two reports that are—will be issued hopefully soon. And so, we do have some time, and any feedback you could give us in that area would be very much appreciated. Bette, I'm sorry.

MS. KRAMER: Thank you very much for your presentation. I'm curious: does your organization, or is anybody tabulating the numbers, the percentages of IRB members who actually avail themselves of these educational programs? I gather these programs are not compulsory for IRB members.

MS. HANSEN: The educational conferences that PRIM&R and ARENA put on are not compulsory. It's primary if the institution is going to support attendance of their members, chairs, and administrators to attend them. They're open to the public, as well.

MS. CHARO: One of the areas in which I've heard and noticed a lot of complaints is in the area of collaborative research with multiple IRB reviews from multiple institutions. It's not simply that you need to have five different reviews, it's that the five reviews rarely come out exactly the same, so that they then all need to be coordinated. And so, in the end, five investigators at institutions may wind up with easily 15 to 25 interactions with their IRBs while they make things uniform. The current regulations, however, seem to require this, because they require local IRB review for each investigator. Has PRIM&R as an organization ever had an occasion to look closely at this phenomenon and investigate the advantages of local IRB review and measure them against the burdens that this lack of centrality has caused? And have any suggestions ever emerged?

MS. HANSEN: Timely question, they're actually having a conference on central IRB process. That will be late October, and they are having a workshop to evaluate central IRB process. And I have not received the agenda outline yet, so I can't comment on it any further. But if you were interested, certainly we could arrange to have NBAC provided with the information about that conference, because it sounds like that might be useful.

MS. CHARO: It would be very useful. Thank you very much for the offering.

DR. SHAPIRO: It would be helpful, and I do want to send a little gratitude, for not only your presence, but the work that this group has done over a long period of time now. I might point out to the Commission there is a Web page for this organization's support, which will probably give us a clue to a lot of these resources and we ought to take advantage of them. Thank you very much. Thank you very much. Okay. Let me see. I have one other person, whom I'm not sure is here. Is Ms. Sarah Hardstat here? If not, then let me suggest that we decided yesterday, we would work through lunch. But let's take a ten-minute break now, and then reassemble. There will be some provision for getting our lunches in front of us, and then we'll begin work. Thank you very much.