 Our first speaker for this afternoon, Tracey Cougler, an institution at the University of Chicago. She's the Assistant Director of the McLean Center, a Vice Chair on the Institutional Review Board and an Associate Professor of Pediatrics in the PICU, no less. Dr. Cougler is the Co-Director of the Clinical Ethics Consultation Service at the University and always gives me good months to be on service, so thank you very much. Hello. I am going to actually talk about a topic that may not actually come to pass. This is a talk about broad consent, and broad consent came up. The common rule for research in the United States has been under discussion for about three years now. The final recommendations came out this summer and we all believe that Obama was going to sign them. We thought he was waiting until after Tuesday, and now that Tuesday has occurred, I'm not sure he's going to sign them. So this may not come to pass, in which case I think this is still a topic worth discussing, and it was a little short notice to totally change my topic. So first of all, to understand where broad consent came from, we need to understand what these regulations are potentially going to change. And what they're going to change, the first thing they're going to change is what is a human subject. So the first two points are what has traditionally been considered a human subject by the federal regulations, and they're a living person about whom a researcher obtains data through intervention and interaction with the individual, or identifiable private information such as a medical record. They want to add a living individual about whom an investigator conducting research obtains uses, studies, or analyzes biospecimens. So what are biospecimens? It's essentially anything you collect and put in the lab, blood, urine, cheeks, wabs, biopsies, tissues. What have we used them for? Everything. We're looking for markers of disease. We're developing new tests for health conditions. We're understanding how people are going to respond to drugs. We're understanding how diseases change and progress. And we're trying to find the best treatments. So currently, we only consider biospecimens human research if they can be identified, which means that they have to be attached to the medical record for the most part. In those situations, in most cases, it's done as a retrospective study. We're going to look at the last five years of colon cancer specimens, and we're going to look at their medical records. The reality is that that's an expedited protocol, and we waive consent for looking at the medical record and looking at the biospecimen. However, if the pathologists or researchers just choose to look at the last five years of colon cancer specimens and not attach them to the medical record, currently, it's non-human subject research because it's completely unidentifiable, and it doesn't go to the IRB, and there's no consent required. So there have been several cases, but two really important cases that have come up that I think has sort of led to this possible change in the regulations. The first one is the Henrietta Lacks case. You're probably familiar with it. She was treated for cervical cancer at John Hopkins. Unfortunately, as part of that, during her radiation therapy, they also took additional biopsies of her tumor as well as her normal cervix without her knowledge for research. George Gay was the researcher who created the immortal cell line from her cancer cells that were called hella cells. Those of you that are basic science researchers have likely used these because they've been used for polio, vaccine, cancer, AIDS, gene mapping, apparently in numerous reasons. 20 tons of hella cells have been developed, and 11,000 patents have been made from these cells. In the second case, the Havasupi Indians versus Arizona State. This is the Indian tribe at the base of the Grand Canyon. They have very severe type 2 diabetes. They wanted to come up with a way to fix their type 2 diabetes because unfortunately as these people got worse and worse, they ended up needing dialysis and they couldn't get dialysis at the base of the Grand Canyon, and so they would actually have to leave their tribe in order to get dialysis. So they approached Dr. Martin, who's an anthropologist that was studying them. He found Dr. Mark Howe, and they began to collect DNA samples. And the Indians believed that they were doing it to find the genetic links to diabetes and a possible cure for their diabetes. Dr. Mark Howe was more interested in schizophrenia, which was also a disease process that this Indian population had. The consent, which was mostly oral, mostly with English as a second language, mostly in a non-high school educated population, stated that the causes of behavioral and medical disorders would be looked at, but did not specify diabetes or schizophrenia. ASU's IRB requested a letter from the tribal leadership to say that they supported it, and the letters clearly stated diabetes research. Her grant clearly stated schizophrenia. Most of the study was done on schizophrenia. There has never been a publication about diabetes, and when the tribe found out about it, there have been repercussions, and the tribe has been reimbursed. But the damage has been done. They were taken advantage of by our researchers. So what's the proposal that's out there? The proposal is that we don't have to get specific consent for each research project that we're using biospecimens for, but that at the time that the biospecimen is obtained, you would get a broad consent, and you would get a broad consent each time a biospecimen is obtained. So if you have a chronic disease and you're getting blood taken every three months for that disease, you would have to sign a broad consent each time. Or if you didn't sign it one month, that specimen couldn't be used, but if you'd signed the month before, that specimen could be used, and we'd have to keep track of that. This broad specimen consent would be using an approved template that the Health and Human Services Secretary would approve, and there would be a period for public comment. So even if this does get signed by Obama, the reality is it's going to be the next administration that goes through with this, which I think would lead to some other issues as well. And this broad consent would clearly state that there would be no return of individual results. So what's going to be in this consent that's supposed to be two pages long? A general description of the types of research that might be done. This is going to have to be really broad because we don't really know what's going to be done. A clear description of the types of biospecimens or information we think about medical records that are going to be collected. But the reality is, as we're learning about big data, they could be collecting our medical data, our insurance data, other outcomes data. The reality is that they theoretically could connect up to medical records at other institutions. And I don't know, could we foresee the day that things like even Facebook and Twitter accounts get attached? I don't know. Future specimens that are not obtained primarily for research can be kept for 10 years, unless you're a child, and then at the time of your 18th birthday you have to re-consent. But once the specimen is used up and the data collected from the specimen, i.e. the entire DNA genome from it, and it's all kept on a piece of paper or a disc or in a computer, that data, which is going to be considered secondary research, can be kept indefinitely. And then a statement that participation is voluntary. And then these are if applicable, but I would argue that any academic medical center is going to put all of these in. A statement stating the subject will not be informed about specific research studies, because they're not. A statement notifying the subject that the biospecimen may go anywhere in the world to be looked at, because it is. And you can decline, and then the other thing that they would like to do is have some of these biospecimens put in a publicly accessible database, and you will have an opt out for that. So I go back to what we've all, several of us have been talking about, is we go back to our basic tenets of research ethics, and are we meeting them by setting these things up? So the first is respect for persons. So I fear that broad consent's going to give a false sense of security about the types of research. We can still do the schizophrenia research on the biospecimen that maybe the patient just thought was for diabetes. And the other piece about this is by signing the broad consent, all the studies that are done with the broad consent biospecimens don't have to come back to an IRB. So we have to depend on the researcher to do the ethically right thing. It's not going to come back to an IRB ever. The consent's necessary. How are institutions going to do this? How are we going to make this work? It's going to be, and if we do it, we're going to do it so it's identifiable, right? Because we're going to want the medical record. We're going to want as much data as we can get. That's what the researcher's going to want, and that's what most academic medical centers are going to put in those consents. Currently, it's not always connected, and it doesn't always need to be connected. But now every researcher is fundamentally going to get access to everything because that's what they're going to do, because they can do it now if we have the broad consent. And how is this going to be implemented? Who's going to explain this to the patient? When you go get your blood drawn, is the person drawing your blood going to do it? Is this going to get added to what has to be taken care of in the 15-minute appointment with the physician? Is it going to be the man or woman at the front desk that checks you in? I will tell you from personal experience, there's one institution in the city that in one of their clinics is essentially already doing this, and it is the person at the front desk. I thought about asking her some questions, but I didn't. Even though I signed the consent. But I thought about it just to see what she would do if I asked, other than think I'm just a pain. So how are we really going to consent these patients? And the reality is that for many diagnoses, we originally get diagnosed at a community hospital if we don't work at an academic medical center. We may get transferred to the academic medical center, or our biopsy may go to the academic medical center for additional diagnosis. But is that community hospital going to get that broad consent? And if they don't get that broad consent, even if it is at the academic medical center, the academic medical center can't use it for research. So we may actually be denying people the right to have their samples used. And maybe that's okay, but maybe if you've got a disease that actually you can pass on to your family, maybe you really would like if your specimen is helpful to have it be used. Beneficence. The federal government states in the 400-page regulations that's currently on Obama's desk that they really didn't see any real harms with the current standards. But they wanted to change them because there were some public outcry that they didn't want specimens used without their consent, even though I'm not sure everybody really understands what that means. And as I said, the current standards require IRB review for individual studies, and the new guidelines won't require that. And I think individual IRB review can be quite helpful sitting on an IRB to sort of say, it's not quite what you should be doing or looking at specific populations when we're studying specific populations. And then I'm not sure what we're really doing for the advancement of research, because a lot of research has been done. I thought about making this personal and decided I just couldn't. But I looked up some studies related to EGFR lung cancer. And one study out of Sloan Kettering used 1,500 lung samples over a two-year period. Now, maybe Sloan Kettering actually saw 1,500 patients with lung cancer in a two-year period. But my guess is they didn't, but they got those specimens from community hospitals from other academic medical centers. And they're not going to be able to use those the way that they use those then. And I think being able for major academic centers to use those is important. And I'm not sure those 1,500 people care if they signed a consent or not. Maybe they did, but I just can't believe that they really would. Justice. Again, patients still aren't going to know that specific studies are completed with their cells. It's the same now. So I'm not sure what we're doing with a broad consent because it's not like they're going to really know anything more than they know now. I've talked about denied the right to use their samples. Research that can harm individual communities can still happen. And IRVs aren't going to know about it until it gets published and then gets on the front page of the New York Times. Cell lines without a subject or family's permission can still occur because you're donating as a broad consent and that doesn't mean that you can't create hella cells out of it. And subjects aren't going to have access to the results. And this is an area of discussion and there's people on both sides of the argument. But there are some researchers in genetic research that strongly believe that if they find a strong link between a gene and a family has it and it's in their research database that they want to be able to contact that family. Others are going to say no to that but there are some researchers that really have strong opinions about this and I think this is going to be an area that's going to continue to be discussed in the future. And this way the consent says you're not going to hear that. So I really am not convinced I'm really not convinced that passing these regulations are going to preserve the rights of patients or improve them from where they are now and I think the abuses that have occurred in the past can still happen in the future with these new regulations if they're signed in. If they are signed in research institutions have got the duty to educate beyond the paper consent. We have to go out into communities we have to give talks we have to have real education about what's going on so we're not the black box. I have been working with PCORI and that has been my argument there as well they're using big data from the entire city and I wanted ads on CTA buses and CTA trains to say your data is being used your data is being used ask your doctor about it and it didn't happen but I think if we start doing this we absolutely have to make this an educational issue and it has to be public and not private just within our institutional laws and if they're not enacted I think we need to look at how biospecimens are used and continue to look at what rules should be used in the future and how we really need to do that and I'll end it there.