Today I'm going to introduce a friend, a colleague, and a fellow Chicagoan who's going to talk today. So this is Sidney Halperin, who's a professor emeritus at the University of Illinois at Chicago, and a lecturer in the medical humanities and bioethics program at Northwestern. Sidney Halperin is a historical sociologist who has written extensively about 20th century American medical institutions and biomedical science. Currently she serves as professor emerita at the University of Illinois and lecturer in the program on medical humanities and bioethics that's out of the Feinberg School at Northwestern University. For some time, Dr. Halperin's focus had been the framing of moral issues in the conduct of human research. She earned her doctorate in sociology at University of California at Berkeley with a concentration in historical analysis and has served as a full professor at both Vanderbilt and the University of Illinois at Chicago. She has been a visiting scholar for the Center of Bioethics, University of Pennsylvania School of Medicine, the Institute for Government and Public Affairs, the American Bar Association, and the University of Illinois. Her funding awards include investigator in health policy research from the Robert Wood Johnson Foundation, and she has had major grants from university fellowships from the National Endowment of the Humanities. Today she's gonna talk about, the title of her talk today is Parsing Risks and Benefits. Why should we care about human experiments from medicines past? And that's in line with some of her books. She's published a book last year called Dangerous Medicine, The Story Behind Human Experiments with Hepatitis. And she's also published two other books, one from the University of Chicago Press called Lesser Harms, The Morality of Risk in Medical Research. And she also has a book in progress called American Pediatrics, The Social Dynamics of Professionalism. It's my pleasure to welcome Sydney Halperin for today's talk. Thank you for coming, Sydney. Thank you so much for having me. So I am going to share my screen. Okay. So my talk today addresses moral complexities and judgments about experimental risks and benefits. My focus is calculations surrounding non-therapeutic studies, experiments with healthy subjects that offer them no possible benefits. Researchers pursue these studies to benefit science and future patients. The comparisons made in risk benefit assessments for these studies are fundamentally non-commensurate. Risk to subjects are being weighed against benefits for medical knowledge. Complexities in making these assessments are often overlooked, but they're revealed in experiments from medicines past and they remain with us today. I'm going to be drawing on historical material from my recently published book that you can see here. A very, very briefly, a brief overview of the book. For a 30-year period during World War II and the early Cold War, 1942, scientists in the US conducted hundreds of experiments that involved deliberately infecting people with hepatitis. Their goals were to better understand the viruses and prevent a disease that was afflicting soldiers. Researchers had no animal model for hepatitis and they resorted to experimenting on people. A unit of the US military, the Army Epidemiology Board, or its post-war successor, the Armed Forces Epidemiology Board, sponsored the entire program. 10 groups of researchers involving 60 investigators conducted these viral transmission experiments. The lead scientists of these groups, held positions at prestigious universities and laboratories. The researchers enrolled more than 3,700 human subjects. Some were infected with hepatitis A, others received hepatitis B, and even inadvertently hepatitis C, a strain not identified until the program had ended. In the book, I drew on in-person interviews and a very large volume of archival and other historical materials to examine the full course of America's Hepatitis Infection Program. My account addresses how this troubling research program came into being, what sustained it over time, and how and why it came into an end in the 1970s. Here's the book's major themes. Again, this is gonna be brief. Hepatitis, the program was part of a very broad mobilization of science for the national defense during World War II and the early Cold War. This mobilization created a new constituency of science, what I call a military biomedical elite. It was composed of military medical officers, science scientists, and the National Institutes of Health and more broadly the Public Health Service and researchers at major universities and laboratories. So you're seeing here a picture of a meeting in 1942 of this newly consolidated elite. Its members approved, oversaw, and served as lead scientists for the Hepatitis Infection Program and its particular projects. During the war and a early aftermath, government-sponsored researchers also protrude human infection experiments with a variety of other pathogens. These include dengue, sandfly fever, atypical pneumonia. They also use this general protocol challenge trials now called challenge trials to test the efficacy of vaccines against influenza, measles and dysentery and test pharmacologicals used for treating malaria and a variety of sexually transmitted infections. The Hepatitis Program was distinctive in both its 30-year duration and the variety of human subjects that scientists enrolled. The research participants included, you can see here the numbers of institutions and the number of subjects in each category. They included conscientious objectors to the military draft, prison inmates, mental patients and adults and children in facilities for the developmentally disabled. All were from marginalized groups and all resided in institutional settings. The 1,200 disabled persons listed here in the image included 800 children at Willowbrook State School and it was there that the last of the human infection projects took place. And a good portion of the inmates were African-American. The information on the race of subjects was very difficult to get. It's really basically considered patient records. But occasionally I did find a revealing document and on that basis I estimate that depending on the prison between 25 and 45% of inmates enrolled at that location were African-American. I found very little information about the use of other minority groups. Scientists and their military sponsors put a great deal of effort into advancing narratives justifying their interventions. They gain access to custodial facilities for recruitment by appealing to the ethos and management concerns of institutional directors. So actually when they went into the mental hospitals and institutions for this disabled, they argued that the experiments were in the subject's best interest. And they secured sympathetic coverage for the overall program for the mainstream press by drawing on the wartime cultural ethos that emphasize patriotic contributions to the common good. What you're seeing here is an example of this lotatory press coverage. So this is a headline and a photo in an article in a Philadelphia newspaper that reports conscientious objectors serving voluntarily in these experiments. Elite scientists were able to establish a dominant moral framework in which for a quarter century dangerous experiments with marginalized persons were legitimate. In the prevailing narratives, experiments were either in the subject's best interest as I just noted, or participants were making voluntary sacrifices for science and country. And those are the arguments made for prison inmates in the conscientious objectors. But in the 1960s, the biomedical elite could no longer sustain the dominance of their narrative. Rights activism created pressures from outside the profession and even entered medicine itself. Progressively minded young physicians and even members of the biomedical elite repudiated risky experiments with members of vulnerable groups and objections to the troubling experiments including the Willowbrook studies spilled into the public arena. The image you're seeing here gives examples of the altered character of press coverage on the right as a leaflet from the medical committee on human rights announcing demonstrations against Saul Krugman, the lead investigator at Willowbrook. And this was one indicator of a growing divide within biomedicine itself. I argue that the biomedical elite lost control of the public narrative. And it was at that point that hepatitis infection experiments came to an end. I'd be happy to say more during discussion about this period because there's actually a lot more to say. But I wanna move on to my findings about experimental risks and benefits. First harms, and there's a great deal to say about risks and benefits. The hepatitis program involved a great deal more harm than researchers had anticipated. When assessing risks, researchers primary focus is on short-term risk of death. And researchers, the hepatitis researchers were quite accurate on the score. There were four deaths of prisoners from fulminate hepatitis B. A fifth prisoner spent a week in a coma with this condition that managed to recover. These numbers were consistent with the expectations of researchers. In 1942, there was a massive outbreak of hepatitis B in the military. It was this outbreak that triggered the first human experiments. The death rate among hospitalized cases during this outbreak was between one and two per 1,000 cases. What researchers greatly underestimated was the long-term harm, particularly harms associated with the creation of hepatitis carriers. So carriers are individuals who failed to clear the virus after initial infection. Researchers were aware of the existence of carriers because they were aware that the serum of some blood donors generated hepatitis in people receiving transfusions. But their concern about carriers was mostly disease transmission. They were unaware that hepatitis is also a risk for those who are carriers who may develop cirrhosis and or liver cancer two or more decades after initial infection or to put it more accurately. Researchers didn't have systematic data linking the carrier status to cirrhosis and liver cancer and that wouldn't be available to the late 70s and early 80s. Scientists were also unaware of the existence of hepatitis C, as I mentioned before. Originally it was called non-A, non-B, but it would become clear later that researchers had actually transmitted the strain inadvertently. One occasion when subjects were infected with hepatitis C was a project that researchers called the blood sterilization project. After the war, scientists discovered that the supply of blood and plasma was contaminated with hepatitis B. And in the early 50s, the Armed Forces Epidemiology Board launched a project aimed at inactivating the blood-borne pathogens. Researchers took serum known to contain the virus, applied irradiation or chemicals and then injected the treated serum into research subjects to see if they would be protected by the treatment of the serum. None of their interventions worked. During the 70s, after the hepatitis program had ended, researchers at NIH analyzed the blood samples from this experiment that had occurred 20 years earlier. And those researchers analyzed the samples from 65 subjects in that earlier study and concluded that 35 of the 65 had received non-A, non-B. This is significant because of the carrier rate of hepatitis C, which is much higher than for hepatitis B, as you can see on my slide. So on average among adults who are exposed or infected with B, about five to 10% become carriers, but among adults infected with hepatitis C, 75 to 85% become carriers. But most disheartening was the later discovery about the long-term harm to children, some of whom were used as human subjects in transmission of blood-borne specimens. Researchers at the time thought that hepatitis was mild in children. Indeed, the symptoms are typically mild, but it would turn out that child subjects, given hepatitis B, would be especially vulnerable to becoming long-term carriers. And the younger the child, the more likely that a carrier status will arise. So the image you're looking at includes my estimates of a number of subjects receiving blood-borne hepatitis B or C. So I estimate that more than a thousand subjects were injected with serum containing one of these viruses and at least 150 were children. I do not provide estimates on the number of carriers, but in order to do so, I'd have to know how many of those receiving tainted blood received hepatitis C, and I'd also have to know the age of the children, which the documents did not reveal. So the scientific benefits. There were benefits, particularly during the World War II period. Studies during these years confirm the existence of two distinct strains, A and B. It identified their routes of infection, their incubation periods, and researchers used a variety of liver function tests to follow the course of the illness. They also used successfully gamma-goblin during outbreaks of hepatitis A, and they found that it created temporary immunity, passive immunity, but delayed the spread of new cases during epidemics. But after the war, researchers shifted their focus to durable disease prevention. It was at this point that the Armed Forces Epidemiology Board initiated the blood sterilization project, which I've already referred to. And investigators also put a great deal of effort into developing vaccines. But for two decades, they made virtually no progress. And I noted earlier that this was a period where three of the four research deaths occurred. In 1957, John Rodman-Paul, a Yale researcher and head of the Army Epidemiology Board's Viral Commission, lamented the disappointing post-war trajectory. These are his words. After rapid growth of knowledge about hepatitis from research conducted during World War II, advances slowed down and it was almost seemed as if they ground to a temporary halt, leaving certain basic questions as unanswered as they were in 1942. Researchers had tried, but repeatedly failed to identify an animal model for hepatitis or its various strains to isolate the viruses, develop tests for the virus's presence, which could be used to test blood, for example, to inactivate the pathogens, to find a stable growth media, or to introduce an immunizing agent. Now, I want to point out that there was a breakthrough in the mid-1960s. At that time, a researcher by the name of Burro Flumber discovered a blood-borne particle, a blood-borne particle he called Australia antigen, and it turned out to be the hepatitis B surface antigen. Sol Krogman's team at Willowbrook was one of several groups that confirmed that this particle was part of the B virus. An identification of the B virus allowed researchers to screen blood donors, and it was also the basis for the development of the first hepatitis B vaccine. But the advance was not a result of human infection experiments. Blumberg wasn't even a virologist. His background was biochemistry and population genetics. Meanwhile, deaths and injuries to subjects were never compensated, and the long-term harms were never acknowledged. So what you're seeing here is an example of a waiver and release document and the statement releasing the researchers and sponsors from any liability for injury. And these were standard issue during this period. They were required by military sponsors, and indeed the wording was approved by Defense Department lawyers. Researchers did provide medical care for subjects while the experiments were ongoing. After that, subjects received no further treatment or medical follow-up. The Defense Department made no provisions for the care of continuing illnesses or delayed harm, and it consistently refused to provide compensation for research injuries. There was one exception to this pattern. It would pay for burial costs for subjects who died, so long as funds were taken out of the principal investigator's research account. Now, this situation actually became a source of tension between researchers and their military sponsors. From work during the war, hepatitis researchers discovered that or realized that some of the subjects weren't recovering after six months, and they requested that they be allowed to buy health or disability insurance for their subjects. The Defense Department refused. So the bottom line on risks and benefits was that during this 30-year period, there was a dramatic underestimation of risk to human subjects, particularly long-term risks, a marked overestimation of scientific benefits, and all this done without a safety net for human subjects. I'm gonna have to speed up here. So what can be learned from this historical case about the dynamics propelling misrepresent or misestimation of risks and benefits? And how does present-day research bioethics weigh in on these matters? I'm gonna start by making a distinction between addressing the misestimation of benefit, and I'm gonna distinguish between the likelihood or perceptions of the likelihood that a given experiment is gonna yield useful knowledge and perceptions of the importance of the problem. So I'm gonna start with expectations of scientific advance. And I'd like to suggest that researchers have a highly skewed view about the pace of science. The histories of research that appear in publications highlight disparate contributions that seem to culminate in medical achievements. In these accounts, contributions that culminate in these accounts, scientists remember successes and they forget failures. I'm certainly not the first to point out that these histories of medical progress are a far cry from what actually happened in the past, but I wanna emphasize the implications for risk assessment because I think it basically results and researchers overestimating the likelihood of scientific benefit. Scientists can get enthralled by powerful ideas, and ideas sometimes are really powerful in biomedicine, and they can also get captivated by ideas that seem eminently workable. This leads, I think, to an overestimation of benefits and overconfidence about auspicious outcomes. Hepatitis strains have been damnably difficult viruses to study. Today, 80 years after laboratory and human experiments began in earnest, there's a cure for hepatitis C carriers, but there's no vaccine. There's a vaccine for hepatitis B, but no cure for carriers. Mid-century hepatitis researchers tried numerous techniques used successfully with other viruses. They tried cultivating hepatitis in chick embryos that work for influenza and measles, didn't work for hepatitis. They tried animal-based tissue cultures, worked for polio, didn't work for hepatitis. They even tried a medium derived from human cancer cells, which may very well have contained unrecognized cancer-causing viruses, but this didn't work either. Yet expectations of promising outcomes were repeatedly thwarted, and yet with one exception, scientists' belief in the scientific value of these hazardous human experiments didn't waver. The exception was a very brief period in which hepatitis infection experiments were halted following the death of the three subjects in the blood sterilization project. That moratorium lasted only 18 months, and after that, that Willowbrook study started. I noted earlier that comparisons between in non-therapeut experiments are fundamentally non-commensurate. So moving on now to perceptions of the importance of the problem. In these types of experiments, there's no grounding in expectation for benefits for subjects. And I'd like to suggest in these situations, it's inevitable that zeitgeist, the value of the time, the historical context, will powerfully influence assessments. And this is certainly played out in the history of hepatitis infection experiments. The wartime military medical office considered hepatitis among soldiers a major problem in national security. During the Korean War, the problem of hepatitis in the blood supply affected 20% of service personnel who received plasma, they contracted jaundice. And obviously the contamination of blood supply was also a problem for civilian healthcare. But narratives surrounding the blood sterilization project focus on nuclear preparedness. The Soviet Union had tested an atom bomb. The Truman administration was making plans for responding to a nuclear attack on the continental US. Cold war planners determined that a vast supply of blood would be needed and hepatitis contamination threatened the entire blood program. According to defense officials, the seriousness of the problem was such that research injuries could be tolerated. Unfortunately, I've seen a similar dynamic or a comparable, maybe analogous dynamic play out beginning two years ago, shortly after COVID-19 hit us. Again, some argue that the disease was such a serious problem. And it was so dangerous that very dangerous human infection experiments with this virus were justifiable. In addition to the pandemic, there were several other contextual factors operated. The use of the human challenge model had become mainstream and institutionalized in the infectious disease research world. Pathogens had been used in these types of experiments included Dengue, dysentery, typhoid, cholera, influenza, malaria, cholera, tuberculosis, neuroviruses, retroviruses and E. coli. And I think they were widespread in part because they could be done quickly and at relatively lower costs than doing large field trials. Meanwhile, there was an emergence of a new field of public health ethics along with an effort to revitalize a cultural emphasis on contributions to the common good. I'd just like to comment that there are two human challenge trials with SARS-CoV-2 currently ongoing in Britain. They began in the spring of 2021. But the point I wanna emphasize here, also in the slide you see that some things I think that advocates for this course are willfully ignoring to start off with the existence of long COVID and the availability of susceptible animals to conduct basic research. But the point I wanna emphasize here is the evaluation of benefits now referred to in among public health ethicists as social value is powerfully affected by social conduct, social context and assessments of the importance of the problem. I wanna move now on to the issue of underestimation of harm. Should mid-century hepatitis researchers have known better? I've said that they lack systematic information about the delayed consequences of the carrier status. But they encountered accumulating evidence of disease sequela, case reports of cirrhosis following hepatitis, subjects who didn't fully recover or subjects who recovered and then only to relapse. The original principal investigator of the blood sterilization project told prospective subjects, and this was in a recruitment pitch, that the chance of disability or a disabling injury from the experiment was one or two per 100, which is fairly high. Should researchers have a frame from human infection experiments because of growing evidence of disabling injuries? Should they have gone back to the laboratory and worked on developing animal models which were developed later, although for hepatitis A it's a pretty good one for B the available ones are less good. I'm gonna leave these questions on the table as open questions, but I'd also like to introduce a quite different line of argument. I'd like to point to the difficulty of making good judgments about risks when scientists are working at the boundaries of medical knowledge. Shouldn't we assume that when researchers go about studying a very poorly understood disease that human harm is a possible outcome? Or for that matter, that bad outcomes are gonna arise when investigators are testing really poorly understood pharmaceuticals or biologicals. Researchers have been testing antivirals for hepatitis B for years, and many of them have turned out to be highly toxic. In 1993, NIH investigators conducted a clinical trial, a field loridine FIAU for treatment of hepatitis B carriers. Among 15 subjects, there were five deaths and two other subjects survived as a result of liver transplants. I think we need to assume that when research takes place at the boundaries of medical knowledge, risk may be underestimated, and that we need to plan for how to handle these consequences. US does not have, and I feel very badly needs an organized system for caring for injured human subjects and for compensating research injury. I think it's a moral imperative to have such a system, particularly for subjects who have nothing to gain, who are healthy, have nothing to gain, and were asked to contribute to the greater good. But what do we have? Well, since the 1970s, some ethicist and policy analysts have been championing the introduction of a no fault compensation program for medical research injuries. But what we've had on this front is periodic advocacy and no meaningful action. Finally, I'd like to, before closing, raise another issue. And that is, who are the subjects in today's non-therapeutic experiments? And here I'm thinking about not only human challenge trials, but also non-therapeutic studies more generally, including phase one clinical trials. There's a growing literature revealing that commercialization of human research through contract research organizations points to the use of an economic underclass. Even where investigators are doing their own recruiting, subjects are drawn from the bottom of the economic hierarchy.  I'm drawing here on the excellent work of Jill Fisher, for example, in a recent book, Adverse Events. I'm also drawing my own reading of publications from small scale human challenge trials that I referred to before with a variety of other pathogens. I think on this matter, we need a norm of greater transparency in reporting recruitment practices for all non-therapeutic studies. But I'd like to suggest that current bioethic literatures see no fundamental problem in paying people for participation in non-therapeutic studies, so long as the wage is not an undue inducement. But of course it's an inducement. People without economic resources enroll in non-therapeutic experiments for the money. I think on this score, research ethics has been hampered by narrow frameworks that are half a century old. Since the designation of vulnerable groups for human research during the 1970s and 80s, social inequalities have become immensely steeper. And as of now, the field of research ethics has been toned to economic and social inequalities in the recruitment of human subjects. I think the field can and should do better. Finally, a question I've been asked a lot is what would have happened if scientists hadn't done or had stopped doing the hepatitis infection experiments? It's not really feasible to rearrange history or to tell an alternative history. But I do think scientists could have figured out, would have figured out through other means what they figured out with the human infection experiments, although probably not in the same timeframe. But maybe we should be posing other questions. For example, will experimental outcomes actually prevent any illness or help any patients? And are there other ways to answer questions, to find answers to pressing questions that don't put human subjects in danger? I wanna thank you for your attention. I've been poking the bear a bit and I look forward to a lively discussion. I'm gonna stop share. Great, well, thank you so much, Sidney. So your lecture was very interesting and really raised a whole bunch of fascinating questions that are really analogous to modern times. I'm gonna let Peggy start off with her question. Thank you so much. That was absolutely wonderful. I'm curious if you have any comments on research into orphan, what are often called orphan or let me rephrase that as rare diseases. And the economic incentives are not really what it's about, but it's society. And if in the cases where the orphan disease is inheritable, it also can have some impact on other family members that might- Different category. And I think that in those arenas too that there are dynamics going on between the subject groups and families and researchers that I think are really good. And that is, and I think this is one of the things I think we need more of in other arenas. And that is that subjects and researchers feel they're part of a common enterprise. And I think that's a way of undoing a lot of the problems we have in non-therapeutic human experiments. I also don't see these... Well, I'd have to think about particular experiments, but I don't think a lot of those I don't imagine are non-therapeutic. And if they are, they're really toward a common enterprise in which the families and the patients are part of and included. And I think that's one way of really improving the research process. Yeah, I agree. And I also think that there is a sense where these individuals with these rare disorders want to be understood and want to be... They want to understand themselves. They want other people to understand them. They want to be seen even medically, even scientifically. Yeah. Okay, thanks. And this is one of the ways to... I think we need broader participation in non-therapeutic trials. And I think one of the ways to do that is to really promote the idea that this can be a common enterprise. And also promote the idea that maybe we want to reward, socially reward contributions to the common good that people who aren't poor might want to be part of this or more people who don't need the money might want to do... I mean, we used to have a Peace Corps. Maybe we need a research corps, just some ideas that we don't have to pursue this the way we've been doing it. And just the other thing that's interesting to remember about this discussion is that some of this stuff was driven like the hepatitis experiments or things like that may have been driven by a desire to ultimately avoid having people get sick and not be able to work or not be in the military. So there's another agenda as opposed to what Peggy was talking about when you have family members or people who are really interested in some unusual situation. You know, it's interesting when Caleb Alexander came and spoke about like drug development because he does a lot of that stuff. He said one of the interesting things was these, not only these clinical trials, but the advocacy on the part of patients and their families. And you know, we've watched that grow up that started with breast cancer and AIDS, this old patient activism and activation. So that's another interesting piece, you know. Carolyn, you wanna take it away? Sure, thank you. Thanks for this talk. I was curious if you could speak at all about the geography of these kinds of studies. I mean, when we're thinking about equity and sort of the balance of participation it seems like the fact that it requires so much infrastructure to recruit patients and then keep up with them that, you know it sort of forces some of these studies to take place in more urban environments where the kind of disparity between available populations to test is maybe more pronounced. And I wonder if you have any ideas about moving these kinds of studies into other, what I'm calling geographies to sort of alleviate some of those challenges. Interesting, you know, I haven't done primary research on the contract research industry. So apparently it is all over the US. And although apparently recruitment methods and also who's serving as subjects varies when they're in different parts of the country. So I don't, I mean, what's happening for the human challenge trials, this, what I'm suggesting, there are a lot of them going on or have been they're usually small scale. And from what I can tell, mostly it's the university or laboratory that's handling the recruitment. They're not contracting these out. And usually it's the community around the institution say it's a university or a laboratory. So it's usually local recruitment. Yeah, so I don't really have any particular insights other than that. I mean, what happened with the hepatitis experiments in the mid-century was that researchers tried to find locations, institutions within proximity. The blood sterilization project was actually a collaboration of the Defense Department, the National Institutes of Health and PHS and also the Bureau of Prisons. And so the Bureau of Prisons designated three prisons around the country. And so one was off the coast of Washington, one was in Kentucky and another in rural Pennsylvania. And that actually ended up being a problem because the researchers were in Washington and when there were adverse events at the study sites it was hard for the researchers to get there to find out what was going on. So I think part of the problem is who are the responsible PIs and where is the study site? And that can be an issue. So equity in geographical locations may be hampered by the need for a responsible investigator to be in proximity to figure out what the heck's going on, if that makes sense. And the bigger question is, how do you get away from the fact that when people are really desperate, they will do a lot of things that other people who have more money will not do?   Well, the literature on repeat, there are a lot of repeat human subjects today, serial human subjects. And they do it as a kind of, they do it as an informal labor market, basically. And, you know, the bioethics literature says, well, you know, we're not paying them more than they could get in another kind of job like this, but there are a lot of advantages for these, for enrolling. And one is that the subjects get lump payments. They can also spread out their participation when it's convenient. And also some people have trouble getting jobs because either their job record or quite honestly, their criminal justice record. And this is not a problem for signing up for any of these contract research organizations. In fact, they recruit people who are likely to have problems getting other kinds of jobs. So. That is really, that's absolutely fascinating. Peggy. Yeah, I really think we need more information on where the research organization, like the University of Laboratories during the recruitment. So I'm reading this literature and there's some investigators who are really responsible. They're saying like, here's who we recruited. Here many, here, this is many people who were minority, but most of them don't do that. Most of them say, well, we use community volunteers. It's completely unclear who these people are. It's completely unclear how they were recruited. So I think we need a norm. I'm not suggesting we want more regulation, but I think we need a norm. When you publish this kind of work, you need to say something, a paragraph on how you've got human subjects for non-therapeutic trials. Why, I think that's, I think that's a great way to end about non-humans. Can I just ask one more question? Sure, go ahead. Yeah. So, I mean, it's interesting what you just said and I just want to comment on that before I ask my question, which is, you know, if you knew how many subjects were in this or that demographic I still not sure quite what that would tell you. Because you want the demographic to reflect the population. You don't want it to be coerced, but you do want them reflected and seen. So I'm not quite sure where that's taking you. Okay, so I think with therapeutic trials we really want full participation of everybody. But non-therapeutic trials, I think we need more participation of more different segments of society. Let's put it that way. I'm not worried about representation on non-therapeutic trials. I'm worried about that for therapeutic trials. Does that make any sense? Non-therapeutic trials are fundamentally, I don't think they're good for human subjects. I mean, we do it for what? For the money or for altruism? I'd like more of it done for altruism. Let's put it that way. So, well, maybe that connects to my question, which is we look back on what happened at Willowbrook and other places, and we look back and say that was horrible and that's not occurring today, in that exact format at least. And in the equivalent amount of time, which is I guess 100 years, do we look back, will people look back on phase one trials and what else and say that was horrific, we're not doing that anymore? I think the answer is yes. And what beyond phase one would you group in that? I think the willingness to not raise questions about social equity and social inequality, okay, let me put it up more starkly. I think given that our society in recent decades has moved to escalating social inequalities, I think people at the bottom end of the socioeconomic strata are doing dirty work for all of us. And that includes dirty work in taking risks for human experiments that we all benefit from. And I think that's basically exploitative and that we're so inured to it because it's so widespread that we don't think that, we don't think there's anything wrong with it because we're like blind to it, and we're impervious to it, how's that? And I hope in 50 years we'll be at a place where we don't see that as okay, how's that? And I do think there are ways of approaching it differently. I hope there are ways of approaching it differently. I mean, some of the human subjects I look at were conscientious objectors to the draft. These were young men who were pacifists and didn't believe, they didn't believe in bearing arms, but they wanted to do good. And they were, I would say that they were genuine volunteers. And they understood, well, as much as a young person of 20 can understand that they could die from an experiment because I think young people think they're immortal. They understood what the risks were by making sense. And they wanted to do it because they wanted to show that they could make a contribution to the war effort without bearing arms. So maybe we need a little bit more of that. I'm not suggesting I wanna be a pacifist because I'm not a pacifist, but anyway, I just think there are other ways we can approach this. Caroline, you wanted to continue the conversation? Sure, just one follow-up on that point is you may not know some of some of this or you may not work with this literature, but it just strikes me that there might be relevant parallels with the literature on the ethics of organ donation and the ethics of like surrogacy and egg donation that there might be legal protections in place for some of those kind of participants in this larger kind of altruistic system that are not in place for participants in experiments, maybe a parallel. Thank you. Thank you. So anyway, I think it might be a natural place to take a break because I know Sydney will be back this afternoon and I really wanna thank you for a really interesting and thought provoking talk. It really made, I just, as we round this out, I think about the different topics that we've explored as part of like this ethics piece. We talked about Tuskegee in Guatemala. We talked about what to do if the president is incapacitated. We talked about radiation therapy. We got in a couple of weeks, we got to talk in the Nazis. And it's just really interesting to see these ethical problems in a historical context and realize that to get it really clearly and I think it's really useful. So Dr. Bob said, I wonder if they could have been given more rights like sex worker than other countries. So I'm gonna leave that for the afternoon and we'll continue the conversation. But Sydney, we'll give you a little time before the 130 session and on behalf of the McLean Lecture Series, that was really, really interesting and thank you for coming and I'm definitely gonna read that book. Thank you so much.


You have seven minutes or thereby, Ms Graham. Thank you, and a much-cammer Christine Graham on a cammer debate than in the last one. On 26 September, I attended the launch of a capital credit union outpost at Penicook Northcourt Church. It sounds like something from the wild west, but it is a partnership with a capital credit union in Edinburgh and other local denominations such as St Mungos and St James the Les. It is volunteers drained by capital credit union who helped run the operation and some meme have made it through the storms to be in the gallery tonight. The church provides the premises free of charge and low the impresbytery, the furniture. As you all know because you are all informed in here, credit unions, and I am a member of the capital credit union, should have declared this sooner, is a financial cooperative that provides savings, loans and a range of services to its member and, very importantly, it is non-profit making. It is owned and controlled by the members, a bit like the old trustee savings bank, Deputy Presiding Officer, which I think you might remember. Each member has one vote and volunteer directors are elected from the membership by the membership for the membership. Membership of a credit union is based on a common bond. That can be working for a particular employer in a particular industry or simply living or working in a specified geographical area, which could be as small as a village or as large as several local authority areas or, in this case, the size of Penicook. Credit unions encourage all their members to save. This is the key, save. Members can pay in directly by payroll, deduction or through benefit direct accounts, through retail payment networks such as Paypoint or Payzone, by standing order, direct debit or in cash at local offices and collection points. The credit union offers an affordable source of credit to their members and there is the word affordable, another key word, not loans that lead the borrower into personal financial crisis. In fact, they are more responsible than the so-called responsible banks, where or indeed perhaps still are. They are prepared to make the small sum, the shorter term loan, which most banks and building societies do not offer. Yet interest in credit union loans is always much lower than that charged by doorstep lenders and payday lenders. For example, home credit companies such as Provident openly advertise a typical APR of 399.7 per cent, while paydaylenders such as wonga.com can charge rates in the order of 5,853 APRs too. Lawn charts can charge even more outrageous interest rates and, incidentally, interest for savers isn't that bad either. At the north cut, there was already established a food bank and this is a further practical church initiative, introducing people to that old-fashioned way of saving and responsible borrowing, and again, as I say, in a not-for-profit organisation. The borrowing that is offered, the loans that are offered are on the basis of what the person can afford, a proper look at what they can afford so that they don't get into trouble. This initiative follows a special commission undertaken by the Church of Scotland in 2012, which called on the Kirk society and our Governments to take action on four priorities, reducing inequality, ending poverty, ensuring sustainability and promoting mutuality. The important report encouraged the use of credit unions, commenting that, with the new breed of pawn shops, payday loans, check caching and so on, and instant internet loans, it's easy for the unwary to fall into a debt trap. In 2014, the Church of Scotland General Assembly took up this theme and encouraged all members of the church to save and to borrow with a credit union, and I encourage all members here and outside to do just that. That is what Penicook, through its churches, is doing. The facility is open 10 to 12 noon on Mondays and 2 pm to 4 pm on Fridays. The target was to sign up two new members to the capital credit union each week. In the first few weeks of operation, with the team of trained volunteers, they have signed up 28 new members exceeding that target. Each of those people will have opened a savings account with capital credit, and in addition, they have even had one loan taken at that time. Quotes, joining a credit union is a great way to support ethical banking. Credit unions are responsible lenders and offer affordable credit. They also encourage us to save as well as borrow, and, as I said before, not for profit. That can be a real benefit to all the people of Penicook, and the more people who join, the greater that benefit will be. I have already joined, and I hope that everyone who lives or works here will join to close quotes. As I have said, I encourage all members who are not yet a member of a credit union to do so. The interest is quite good in savings, and it is an ethical way to save and allow others to borrow responsibly. There is a good return and interest that I have said, and, better still, you have got this mutual funding for people who may not be able to access banks otherwise. I very much congratulate on the church. I am not a member of a church myself, I am actually an atheist, but I have to say that this is where I like to see churches doing and putting their money where their mouth is. I commend the churches of Penicook who are doing just that practical work in the community, firstly through the food banks, now through having the capital credit union outposts, encouraging people within the community, and helping those who maybe need a little bit more help. So I wish the pilot well, and I look forward to localising credit union facilities being extended following in Penicook's footsteps. Thank you very much. I now call on Malcolm Chisholm to be followed by Kenny MacAskill, four minutes of thereby, please, Mr Chisholm. Presiding Officer, this time of year is a time for celebration, for being with family and friends and reflecting on the year gone by. It is also a time of increasing pressure to give gifts to spend, to splash out on treats for those who care about. For many, it is a time of real stress as parents buckle under the weight of expectation and advertising to spend. For some, this time of year is no different to the rest of the year, a constant struggle to make ends meet. This is often the time when we see many people in Scotland turn to payday lenders and short-term solutions. That is why Christine Grahame's motion today is so welcome. Credit unions provide saving accounts and a range of services, including a safe, reliable alternative to payday loans and their accompanying high-sky interest rates, something that my colleague Kezia Dugdale has done so much to highlight over recent years, and I'm sure all in the chamber would commend this work. It helped to make a greater number of people aware not only of the danger of loan sharks, but also of the existing alternatives. Therefore, the piloting and possible expansion of capital credit unions through the work of dedicated church volunteers is a very welcome development indeed, and the more awareness that we as a Parliament can raise to this alternative, the better. Volunteers, as Christine Grahame has outlined at Penicure North Church, give their time to run a satellite office for capital credit union, where local people can find out about saving and borrowing with capital credit union and also apply to join. The credit union office is staffed by volunteers from Penicure North Kirk, St Mungos and St James The Less, all of whom have been fully trained by capital, in a joint endeavour to offer fair and affordable savings and loans to church members and others in the community. Traditionally, credit unions have been small, non-profit financial organisations set up by members with something in common to benefit their community. That common factor may be living in the same town, working in the same industry or belonging to a particular trade union. Can I mention here the local North Edinburgh credit union, which serves the North Edinburgh part of my constituency, but clearly the capital credit union serves my constituents and people in a much wider area? Of course, the advantage of a larger credit union such as capital is that it is more able to give the kind of loans that are an alternative to payday loans. For example, it can give fast-track loans of £500 to anyone who joins the credit union. Of course, that is at a rate of interest, which is considerably less than even the capped payday loans that have been announced recently. The most extensive credit union loan will still charge eight times less interest than payday loans at their new cap. I hope that that cap will be considerably reduced, because, while it was a step forward, it is clear that there is a long way to go. Generally, to be part of a credit union, as we have heard, you need to share a common bond with other members. Those common bonds mean that those who pay in also have a say in the running of the credit union, so it is genuinely rooted in shared interest and community. It is part of the philosophy of credit unions. Everyone pays a small amount in to save for a rainy day, and everyone in the community gets the safety net that they need in the full knowledge that they have a major role in the functioning of the union. The more people who start to use credit unions, the better. Credit unions continue to call for measures to boost membership. I welcome any policies that the Government can bring forward to promote credit union membership. For example, the credit unions are saying that they would like the public sector to encourage all employees to join a credit union, and there are various ways that they could do that. Another demand from the credit union movement is that there should be a guaranteed loan fund for the purposes of lending by credit unions. Again, I welcome the minister's comments on that. It would be a form of preventative spend in terms of stopping people getting into the kinds of difficulties they get with payday loans. Credit unions are an absolutely great institution that I have admired for a long time and a time of immense distress in the integrity of those who guide our financial systems. Credit unions, I believe, offer an ethical breath of fresh air. I thank both Christine Grahame for raising the issue. It has been raised in Parliament before, but it is right, not just because of the time of year, as Malcolm Chisholm has said, but because the issue itself is important and we should continue to drive that home, and that the Government will respond and show what further commitment it is making to what has already been given. It is important that we should recall both the general and the specific matters here that are important to pay tribute to the local credit union that Christine Grahame has been referring to, to those who work within it and those who volunteer to it, but indeed the specific issue that both Christine Grahame and Malcolm Chisholm commented on. I should declare a member of a credit union, the castle credit union, that was originally Craig Miller. It serves both its area and now the enlarged area, as it has seen the benefit of getting in a greater share and greater capital and membership. Again, I think that there is thanks owed to two aspects and two sections there. First of all, there is the thanks that go to those involved in credit unions, per se, but equally to those who volunteer and the specific mention made towards the churches. Sometimes, in debates in this chamber, people can view with some skepticism those who volunteer from the faith communities. I share with Christine Grahame's view that whether people volunteer from the secular or indeed the faith aspects of our society, we should welcome those who give and those who contribute. Indeed, as we face another swath of churches and closing in my constituency and elsewhere, we may very well rue the day that the opportunities that were offered in various communities, not simply by the church building but by the church hall and those who participated in it, will be lost to our communities. However, there are two particular aspects that I want to comment on. First of all, the good work that is done by credit unions operates often in areas where there are no banking opportunities. Craig Miller is a clear example. It is not the size that the community once was. To be fair, there once was a TSB bank located there, but now there are no banking opportunities. The same applies in many peripheral and sometimes urban areas in Scotland. Banks go through a raft of closures, as they see. Understandably, people such as myself do internet banking, but the issue of access to funds and access to banks in many areas of deprivation was and remains a significant problem and a significant challenge. It appears to me that the solution is through the use of credit unions, both in Craig Miller and the outreach work that was done and testified to by Christine Grahame and Malcolm Chisholm, seen in places such as Gilmot and myself in my constituency, where access to France is difficult. However, it is also the opportunity that credit unions offer, not simply to deal with austerity and those who are in deprivation and face challenges and cannot get access to finance, because credit unions are not simply for those who are in deprivation or perhaps they lower less well-off aspects of our society. They offer opportunities, which I and others have mentioned, to take up. However, in particular, I would like to put on record the good work that is done by the police credit union, which touches on the points made by Malcolm Chisholm. Credit unions are there for all if it can be done when people sign up for the police and this is what happens. Members are encouraged when they join the police service to join the police credit union. It can be of benefit to them. Young men or women may find themselves posted to a police station that is distant from where they live. They may have to buy a car. It may be that the best way to obtain that vehicle to be able to carry out their service and their work would be through the police credit union, so, yes, it is an opportunity to address austerity. However, it is also something that should be done as a matter of course. Whether you are on MSP, whether you are in the public sector or whether you are in the private sector, credit unions have so much to offer, not simply in Pennycook but throughout the whole of Scotland. Thank you very much, and I now call on Cameron Buchanan to be followed by John Wilson. Thank you, Presiding Officer. I would like to start by saying that I too commend Capital Credit Union of starting an outpost in Pennycook, North Kirk, and welcome Ms Graham's motion, particularly as I'm for once agreeing with her. Access to credit at reasonable rates can be so important to many people and responsible provision of it can make such a difference. I know that it's particularly true where credit unions have local communities' interests at heart, and at risk of repeating everybody what everybody else has said, we've all heard the horror stories about payday lenders and the huge rates that they can charge. Now, people get trapped into this. Credit unions send out a much-needed message that this is not the only option. Furthermore, I hope we can all applaud the efforts of the Church of Scotland and the Episcopalian Church in working to make this outpost a reality. Credit unions, such as the new branch at Pennycook, North Kirk, pay an important role in Scotland with over 300,000 members nationwide. This large figure translates into about one in every 20 Scots. As well as in Pennycook, credit unions exist across the countries you've heard in North Edinburgh Credit Union and the first Scottish University Credit Union. There are many others. The importance of their role is actually magnified considerably by the comparison with payday lenders. These companies, which have been known to charge over 5,000% APR, have led many people into financial difficulties unwittingly and unwillingly, and they're very, very difficult to get out of. Indeed, the Citizens Advice Bureau in Scotland report that they deal with over 100 cases involving payday loans every single week. A crucial point here, I feel, is that it is far better and easier to deal with financial difficulties by avoiding escalating debt in the first place. However, the solution there is not simply to ban loans, but rather to make them more affordable. An outright ban on payday lending would not be a useful intervention, rather overcoming them competitively by undercutting them on interest rates that is practical and a sustainable solution. This, thankfully, is where the credit unions have stepped in and encouraging people to save, which is the key word, as has already been mentioned. With credit unions restricted by law to lend at a maximum of 26.8% APR, they do indeed undercut payday lenders by some considerable and significant margin. They are beating them in fact at their own game. This, I think, is all good news from members of the public, but it doesn't come easily and relies on volunteers to do an awful lot of the work. We should, of course, all recognise the amount of effort and time invested by various people in credit unions, both specifically at Penicook North Kirk and in the wider sector. In Penicook, the new branch will be located at Rent Free in Penicook North Kirk, furnished by the Lothian Presbytery and staffed by Church volunteers from the Church, St Mungos and St James Aless, all of whom have been fully trained by capital. This shows just how much has been freely given in order to operate the credit union and all involved should be applauded loudly. It appears that without this level of voluntary contribution such credit unions would not be able to offer the relatively low rates of interest that they can at the moment. Since being able to undercut payday lenders on interest rates is central to outmoving them as lenders, we cannot overstate the importance of these voluntary contributors. It would appear that there's a lesson here when we have faced with some operators, in this case payday lenders of course, that they are not acting in the consumer's best interests. The solution in these cases, in this case, may not be a severe government legislation against them, but rather a private or third sector initiatives to outcompete them. The demand of supply can be moved to responsible suppliers rather than outlawed altogether. According to Presiding Officer, I hope that the launching of a capital credit union outpost at Pennycourt North Kirk can be commended by us all. The huge amount of time and effort put in by the local volunteers will enable the outpost to compete with payday lenders and in doing so provide a great service to local community. Their example is one that has demonstrated how communities can work together to deliver local services, as well as highlighting how the problems arising from questionable lenders can be overcome by outcompeting rather than outlawing them. Thank you. Thank you very much. I now call on John Wilson after which he will move to the closing speech from the minister. Thank you, Deputy Presiding Officer. Can I get off my congratulations to Christine Grahame for moving this member's debate tonight? I think that, as others have said, it's a very timely debate in relation to the credit union movement, as well as the time of year coming up to Christmas, which I'll expand on later. We almost forget the role that Church of Scotland played at the General Assembly in 2010 when it actually established the special commission on the purpose of economic activity, which resulted in the report that was produced in 2012, commissioned by Professor Charles Munn, who clearly identified that the Church could play a role in promoting greater economic activity within communities. Some of the suggestions made by Professor Munn we clearly see in the motion tonight, because it's quite clearly outlined that the Church had resources, both in people and facilities, that it should be offering to credit unions and other community organisations to ensure that it could promote the credit union movement and greater economic activity in the areas in which it had a presence. I'm glad to see that, in terms of the Penicook area, the Church members and the Churches have taken that on board and taken that to heart. Hopefully, we will see that type of development taking place throughout Scotland, that other Churches will get involved and will carry out the good work that was suggested firstly by Professor Munn. The examples that I wanted to allude to, Presiding Officer, is that we talk about payday lenders, and we talk about online payday lenders where the 278 per cent APR, or as Christine Grahame mentioned herself, longer, which promotes one at 1,538 per cent APR. What we forget is some of the high street stores that offer goods at double the value. I took two examples this afternoon. A Playstation 4 in one high street store, if you buy it on an average store you'd get it for £400, and a particular high street store is £636, and they claim an APR of 94.7 per cent, but the total price paid for something that you could buy for £400 is £1,300. That's three times more than what you could purchase if you were buying it cash. A Xbox One console with a game, approximately £370, the same high street store selling at £738.87, with the 94.7 per cent APR total payable £1,508. Those are the types of things that are happening in many communities throughout Scotland where parents are under pressure to buy the latest games or the latest consoles and people are feeding off that deprivation. They are feeding off those individuals that are trying to deliver and they are making profit out of that. The issue for us all we have to bear in mind is that we want to see a fairer society. Credit unions aren't, as many have described, the poor man's bank. I think that Kenny McCaskill quite rightly outlined that some of the most successful credit unions are the ones that can draw down the salaries that the staff contribute to those who are now offering mortgages to their members. The reality is that we need to make sure that credit unions have a balance of those who are involved and that they can actually get people actively involved across society. The only dissenting note that I would make is that, while I welcome capital credit unions move out to peripheral areas and expanding, I wish that they would speak to the existing credit unions in those areas that they are expanding to. I received an email two weeks ago from a credit union who had more or less raised a concern that the capital credit union because of the size and the savings that it has can actually undercut some of the smaller existing credit unions. I would make the plea speak to the existing credit unions in an area. If there is no existing credit union there, by all means, go on and establish a credit union outpost, but clearly consult with, discuss with and involve existing credit unions in areas. Lastly, I welcome the work that has been done by the Scottish Government in the past, particularly 12 days of debt mis-campaign, this time last year. I look forward to the work that is going to be taken forward by the Scottish Government in the future to not only promote but to enhance the role of credit unions in society today. I would also like to thank Christine Grahame for securing the debate on this issue of credit unions, which is something that we all agree is very important. I would also like to express my thanks and congratulations to everyone who has invested their time and energy in making the new capital credit union outpost in Penicook a reality. I am delighted to see how actively engaged the church is with the credit union movement and to see that they are working together like this to help their communities. I am sure that I speak for everyone in the chamber when I say that I hope that the Penicook pilot will be a resounding success and that we will see similar partnerships rolled out elsewhere. All across the country there are people interested in working together to bring ethical, affordable financial services and products into the heart of their communities. We should all do what we can to bring people together and support them in their endeavours. It does not need to be churches. Any organisation or group with space and a willing group of volunteers could develop similar partnerships. The Scottish Government's support for the Penicook pilot forms part of our wider work to promote credit unions. That work recognises the significant contribution that credit unions make to the financial landscape in Scotland, providing financial services and products to a wide range of customers, often the most financially vulnerable or excluded. I think that Malcolm Chisholm and Kenny MacAskill and now John Wilson have made the point that credit unions are not just and exclusively for those on low incomes. They absolutely understand that they need to have people from across society in their membership. Very often it is the people on the low income who are bearing the brunt of changes to the welfare system and no increase in their income. Credit unions can play a role here too. Some credit unions are actively delivering new services to help those affected by welfare changes and I welcome that. In my own area I know that the First Alliance credit union has a relationship with the six housing associations in the area and those in the housing association have been encouraged to join the local credit union, and that is a very good move. As part of the Scottish Government's support, we have been working with the private and public sector to raise awareness of the benefits of credit union membership. We have heard very much from all of the speakers tonight just how the benefits are of being the member of a credit union. In particular, we have been encouraging the take-up of payroll deduction schemes, which Malcolm Chisholm talked about, including for Scottish Government and Scottish Parliament employees. We have also been working closely with schools to improve financial education and to promote credit unions as a vital means to save. There has been significant activity to promote credit unions such as was mentioned by John Wilson, the accountant in bankruptcy's 12 days of debt mass campaign last year. I am sure that we all share the concern and reports of spiralling personal debt as a result of high-cost loans. The Scottish Government does not have the power to regulate in this area, which is something that I would very much like to see change. Until that day comes, I want to assure you that we are doing everything that we can to bring about the changes that we can so far as devolved legislation allows. The Scottish Government has been pressing for a cap in payday loans. I was thinking about preparing for this debate tonight. My first member's debate in this chamber as a backbencher in March 2012 was about payday loans, and one of the things that I called for then was to cap the interest in payday loans. We now see a cap being introduced in January, but I think that the action is too little and too late. Like Malcolm Chisholm, I agree that the proposed cap is still too high. Fergus Ewing, the Minister for Energy, Enterprise and Tourism, will continue to urge the financial services to look at this again. We are pleased to see that the payday lending industry has been subjected to better and greater regulation, but more work is needed. Link to our work to promote credit unions last week, my colleague Fergus Ewing launched the new financial health service for Scotland website. The website aims to help people to build their financial resilience and to help to prevent repeated debt problems. It brings together information, including debt advice, employability and access to ethical and affordable lending such as credit unions. The aim is to provide a central hub that allows people to find trustworthy organisations in one place to help them with their financial queries or difficulties. To discuss what more we can do to promote credit unions, the Scottish Government has set up a credit union working group chaired by Fergus Ewing. The group is looking at ways to ensure that we have a secure, thriving and sustainable credit union sector in Scotland, that credit unions have a wide and varied customer base and that financial vulnerable are supported by having alternatives to high-cost lending. Again, I was looking back at what I said in 2012 and at that time I said that I would like to see credit unions as being the first resort on the high street for saving and affordable borrowing. That is what we should be aiming for, the first port of call. The working group's first meeting was held on 9 October and the group will meet again early in the new year and has already highlighted a range of areas that we can take forward. For example, encouraging employers to link with credit unions and to encourage save as you earn, and I think that all members ask for that. Today's debate has highlighted the vital role that credit unions can play and do play and that the PENICUT outpost is a great example that shows the desire within our communities for people to come together, work together and make a difference to people and their communities.