Episode Transcript
[00:00:00] Speaker A: Imagine a justice system built on rigorous evidence, not gut instincts or educated guesses about what works and what doesn't.
More people could access the civil justice they deserve.
The criminal justice system could be smaller, more effective and more humane.
The Access to Justice Lab here at Harvard Law School is producing that needed evidence. And this podcast is about the challenge of transforming law into an evidence based field.
I'm your host, Jim Griner, and this is Proof Over Precedent.
So welcome to another session of our podcast, the Access to Justice Labs podcast, Proof Over Precedent. And returning for now the fifth time is the incomparably wonderful Shannon Seward.
And I'm your host, Jim Greiner, the faculty director of the Access of Justice Lab. Shannon, you've appeared four previous times on our podcast. This is your fifth. But just in case listeners have picked out this podcast to listen to first or haven't seen, haven't, haven't experienced the previous four, why don't you remind everyone who you are and tell everyone a fun fact about you.
[00:01:09] Speaker B: Well, my name is Shannon Sewards. I'm a director of an IRB in New Hampshire and I've been doing IRB work for close to 25 years now.
It has afforded me to live in a lot of very interesting places across the country.
[00:01:25] Speaker A: So.
[00:01:25] Speaker B: So I think that's the fun fact.
IRB work can lead down many interesting paths.
[00:01:33] Speaker A: Terrific. And you just returned from a trip, is that right? Where was your trip?
[00:01:39] Speaker B: The trip was a cross country trip with two dogs at Yosemite national park and we camped all along the way. So we saw a lot of our country and met a lot of the people and ended up in a very beautiful national park in California.
[00:01:59] Speaker A: Terrific. A conversation for another time. We'd love to hear some more about that. But today I thought we could talk about the set of IRB regulations that universities try to comply with voluntarily that are not technically considered, if I'm right, part of the common rule. They are part of the subparts that follow subpart A of the common rule. And so in particular we're talking here about 45 CFR section 46, subpart C.
So 46, 301 to 40, 46. 301 to 46.306 and they are in the portions of subpart C is additional protections pertaining to biomedical and behavioral research involving prisoners as subjects.
And this is something that legal research or research by people in law schools or involving people in law schools and certainly the economics of crime people and sociology of crime people, criminology have been Focusing on, and with the increased interest in randomized control trials have had to encounter this portion of the regulations with increasing frequency and it has increasing salience. So maybe we could just walk through generally the structure of how the regulations work or actually, before we do that, actually, let's ask this question.
Why would there be a separate subpart for incarcerated individuals? Because as we'll find out, prisoners is defined very broadly. But why would the folks, the authors of the common rule and the pieces that follow the common rule feel like they needed to do something specific to incarcerated individuals?
[00:03:50] Speaker B: Yeah, and I think that's a really good point. And it really follows along with all of the subparts. So the, the subparts are additional protections.
And when the common rule, which is subpart A was written, they felt that there were specific populations that required additional protections. A lot of that came out of just excessive experimentation with folks that were, you know, either confined or they were in a position where they may have, you know, undue influence of some sort. And so, you know, there's not only for prisoners, but there's also for pregnant women, there's for, you know, children, those with diminished capacity, etc. So it's one of several subparts designed to really provide these additional protections.
There was a lot of research done on prisoners that very interestingly, former prisoner advocate that, you know, this is along with that, is that any research that is involving prisoners and that is federally funded, one must have a prisoner representative on their IRB panel in order to represent the views of, of prisoners.
So one prisoner representative that I worked with actually was incarcerated for quite some time and bring a very unique perspective. Most prisoner representatives are lawyers.
And so he brought a very interesting perspective, but he was saying that it was very common for there to be research and drug trials and things like that that did take place in the present setting. So I could see that the feds using this as a vehicle to ensure people are treated ethically, that people know that they do have rights as a research subject, even though they may not have many rights because they're a prisoner, but it creates those additional protections.
[00:06:01] Speaker A: Terrific. And you mentioned this. Let's actually start there.
There are a series of regulations about what topics the research can legally address. If the, if the, if the, if say, universities who are not federally funded are going to voluntarily try to follow these regulations, and then certainly if they're going to be implementing federally funded or they're going to receive federal funding for a research project, there's a series of topics that are permissible there. And Others that are not. There are a series of requirements within permissible topics, things that IRB has to certify as true. And then in addition to that, and this is in my view somewhat unusual, there's a series of structural protections. And you mentioned one of them about the IRB composition, in other words, the board itself. So for example, you mentioned that there needs to be a prison representative on the IRB that approves a study involving prisoners as participants.
And then can the IRB hire, excuse me, can the prison system for example have its own IRB made up of prison employees? Is that permissible under the regulation or the regulation regulations regulate who can be on the irb?
[00:07:22] Speaker B: Well, you know, I think that for any IRB panel that has to involve those that are not affiliated with any particular institution.
So while a prison might constitute an IRB panel, not everyone that is on that that panel can be affiliated with the prison. There would have to be some non affiliated individuals. And then also you have the mix of, you know, you have to have scientist and non scientist designations, not all one gender, etc. So you know, the, the real purpose of the composition of the IRB is to give this 360 degree view of, of the research taking place and to get different opinions and perspectives. So I don't know if you do did have a prisoner Irby and they were all from the prison, how they might accurately give that more holistic viewpoint of research taking place.
[00:08:26] Speaker A: Yeah, and I think actually if I'm right, section 304A says that a majority of the board, exclusive of prisoner members, shall have no association with the prison involved apart from their membership on the board. In other words, they can't be the prison, you know, the prison administrator, the warden or whatever it is.
And then you mentioned the prison representative. There has to be at least one prison representative.
Where do those folks come from? You know, you've worked with many before.
What's a typical background? You said many are lawyers.
[00:09:02] Speaker B: Yep. Many are, you know, individuals that defend these folks in court.
So that that's the most common prisoner representative, as I mentioned, did work with, with one individual that was a former prisoner.
And I think they bring a very good perspective about, you know, the conditions and so forth.
I think, you know, having a warden might not be the best choice for a prisoner representative. Not that they're doing anything, you know, you know, wrong or untoward toward these individuals, but it's really looking to, you know, have that unbiased perspective as well and really looking at the rights and welfare of the individuals.
[00:09:52] Speaker A: Terrific. Terrific. Let's then move on to the topics that are permitted and thereby the topics that are not permitted.
Because I'm looking specifically now at section 46.306, which says that the research can occur only if in the judgment of the Secretary. Meaning in other words, this is what the research has to involve. The proposed research involves solely the following. So these are the only permissible topics.
And generally what are those topics? I mean, we don't need to read through, you know, all four, but there's four categories that are listed there generally. What are they?
[00:10:43] Speaker B: So, you know, they're very specific. And this does apply to federally funded research.
Just of note that even though some institutions may choose to require this applicability regardless of funding, so that's where you're going to find some variability in IRBs as well.
But really looking at, you know, what are the causes, the effects of incarceration or on criminal behavior, and that is also tethered to risk, so that one can involve no greater than minimal risk. And they also indicate inconvenience to those that take part. So that's a very unique aspect that you don't necessarily see in the other subparts.
[00:11:33] Speaker A: I've seen it nowhere else, by the way, where it says. It says that comparing no more than minimal risk and no more than inconvenience to the subjects.
[00:11:42] Speaker B: Yep, exactly. Exactly. The other is looking at studying prisons as institutional structures.
It's individual that that one as well is tethered to risk such that it can include no more than minimal risk or inconvenience as well.
The, the third one is really looking at individuals as prisoners, as a class.
This one has more of a biomedical point of view and, you know, probably came out of vaccine trials and the like that that took part in.
Also they put into this bucket looking at, you know, social issues such as alcoholism, drug addiction, sexual assaults and like that.
Section three requires an okay by the Secretary in order for that to take place after notice too.
[00:12:42] Speaker A: And interestingly enough, you have to publish it in the Federal Register that you're thinking that you're thinking you'll do this. Is that right?
[00:12:50] Speaker B: So, yes. So it's a very prescriptive process in order to get the prisoner certification from ohrp.
I'm not sure who is still there to provide ohrp.
[00:13:03] Speaker A: Again, just in case. This is the first one that folks.
[00:13:05] Speaker B: Have listened to is Office for Human Research Protections. It falls under Health and Human Services.
So that is the.
The overseer of the common rule in the subparts. And so they recently had quite A bit of staff turnover, let's just say.
[00:13:23] Speaker A: Right.
[00:13:25] Speaker B: So that is a very interesting category as well, is that it's, it's very protected and monitored.
The fourth again requires that, that Secretary consultation and publication in the Federal Register, looking at on practices they mentioned innovative and accepted which can improve the health or well being of the individual.
This can include randomization, but it is, you don't really see this a lot. And in fact, I would say that 3 and 4 aren't commonly seen, I think because they're seen as prohibitive just through the hoops that one must go through in order to do the research.
[00:14:17] Speaker A: So that's what's there. And I want to ask one or two questions more about what exactly minimal risk means, because interestingly, minimal risk is defined here in these regulations. But before we get to that, this seems like it could include a fair amount of what people would be interested in if they were going to involve incarcerated individuals as participants. But what is, what is this list designed to exclude?
What is it basically designed to say, no, we're not going to allow you to do this?
[00:14:50] Speaker B: I think just basically targeting this population as a matter of convenience and that the study itself must really have a distinct purpose of benefit to this population.
[00:15:07] Speaker A: So, for example, if I just want to know whether my drug prevents a lung disease or something, and it just happens to be that, because I know that where prisoners are and where they may be for three or four years, so they won't have trouble tracking them and I go to that population and say, I'll run it with them. It's not like they can say, no, we want to prevent that.
[00:15:31] Speaker B: Exactly.
[00:15:32] Speaker A: Yeah.
[00:15:32] Speaker B: Recidivism is probably pretty low in regard to any particular study enrollment with those in this population. So I, I think that, and that has a different. I know. Meaning in criminal.
[00:15:45] Speaker A: It does, it does not say. That's an unusual word to use in our career setting. But anyway, go ahead. Yep.
[00:15:51] Speaker B: Yes. Yes.
You know, I think it's, it's exactly that, you know, you know, and that's really also in the Belmont Report. Justice is that, you know, should any one population have to really bear the burden of the entirety of the risks when the benefit is for all?
And so that's really what is trying to be prevented here with this additional subpart.
[00:16:17] Speaker A: And then there is subpart B. There is just basically a very broad prohibition sort of reiterating the only part of what we read earlier.
Biomedical behavior research supported by DHHS Department of Health and Human Services shall not involve prisoners except according to some various things.
Is there anything particular we should know about those various things, or is the basic idea here that we just generally are not going to let you do research on prisoners except as provided previously and the stuff that we just went over.
[00:16:53] Speaker B: Exactly. And I think that's really the intent. And as I mentioned, it really depends on the institution where the research is taking place as well.
You know, some state penitentiaries require additional approval above and beyond the local institutions. Irb, there may be a specific panel that it needs to go through, et cetera.
This is really sort of the floor in regard to the additional reviews that might be needed.
Like, as I mentioned, there's some institutions that feel that this subpart is only applicable when it's federally funded.
Some others may use a spirit or something akin to this, but not the actual subpart when they're doing their review.
I know that previous institutions that I've been at just for a matter of ensuring equal protections will apply this subpart. However, they will not apply the aspect in regard to the certification piece or the Federal Register piece because it wouldn't be required. But they're still looking at it through the lens of the subpart, regardless of funding.
[00:18:07] Speaker A: Oh, go ahead. Sorry, Go ahead.
[00:18:08] Speaker B: Oh, I was going to say there was a little bit of a loosening of this subpart with the 2018 revisions that took place that it really looked at prisoners as. Are they the focus of your study? Or let's say you just might incidentally enroll someone.
They also, in regard to expedited studies, that's that other, you know, review level to permit the inclusion of those in those categories again to the institution more than likely pull in that prisoner representative to ensure that there's equal protections. And the real spirit of the subpart, even though it's not necessarily required.
[00:18:52] Speaker A: Got it. Got it.
And this is a preview for something that I think we'll talk about in just a couple of minutes in terms of.
For institutions that make the choice not to apply all aspects of this regulation to research that is funded by a source other than federal funding, it may be just simply because the regulation is extremely difficult to apply the way it's written. It may not always stem from a desire to just avoid oversight or to avoid ethical principles. It may actually be quite difficult the way some of these regulations are written. And I think we'll talk about an example of that coming up. Just as a preview before we get there, though, there's the phrase that at least a couple of these categories of Research can go forward only if they involve no more than minimal risk and then can't involve greater than inconvenience. We talked about the inconvenience before, but minimal risk is actually defined in section 46.303 D.
And I have a question about it. It says if minimal risk is the probability or magnitude of physical or psychological harm normally encountered in the daily lives or in routine examination of healthy persons.
And I guess my question is, is that a healthy incarcerated person?
Is that a healthy person suffering from the condition that say one is attempting to investigate the efficacy of a intervention that's designed to address, or is that, you know, in other words, what you know, this is, we run into this all the time in law. What is a reasonable person here? What is a healthy person or what is a person?
[00:20:35] Speaker B: For these purposes, I would say your standard Joe on the street, just the healthy person and what they encounter. But this, this definition is, is different than, than what you would find. And I think it, it speaks to how this population was previously targeted for a lot of medical, dental or psychological research, that it shouldn't be above and beyond what any person might encounter. You, me, someone else, not necessarily someone that's incarcerated.
[00:21:13] Speaker A: I think that's the key. Because you said the healthy Joe on the street, which actually is usually just the throwaway term, but here that's actually the most important part is you're saying that ordinarily that folks are considering this by reference to people who are not incarcerated.
[00:21:30] Speaker B: That's been my understanding.
If you look at any one population, is that what I think about is, you know, if you look at miners and you're studying like people that are, you know, go into a coal mine and so forth, and what their daily experience is and what they're breathing in, etc. Etc. That daily experience is much different than my daily experience.
[00:21:55] Speaker A: Right.
[00:21:56] Speaker B: And so I think they're trying to level set here in regard to it should be no different than what anyone encounters.
[00:22:07] Speaker A: Terrific. Okay, so then they use the regulations, use the term prisoner throughout. While we're on definitions, let's look at another part of the definitions. They use the term prisoner throughout. And here, at least for folks trained in law, this is an odd use of term.
And so, but the definition is long and it does encompass a lot of things, but a lot of things that lawyers and judges say in the legal system wouldn't use the term prisoner for. So let's go over that quickly so we can understand the scope of the regulations. So clearly people who are in prisons, as you Know, in other words, people who have been sentenced usually for something longer than a year or longer than six months, they're included. But someone who say is detained, predisposition, pretrial detention, is that person included as a prisoner under the definitions?
[00:23:05] Speaker B: It is. I mean, and that's the last part of the definition is that it also includes individuals detained pending arraignment, trial or sentencing.
[00:23:15] Speaker A: So, so predisposition folks are included. What about someone who is, say, civilly committed? So someone who doesn't go through because there's all this language in the definition says confined or detained in a penal institution.
Right, but and so that would not ordinarily be include, say someone detained, predisposition, except for the fact that later in the definition clearly does say those folks are included because one wouldn't consider, put it this way, predisposition, incarceration is not supposed to be punitive. It's not supposed to be penal.
That said, again, clearly in the definition, just by virtue of the last clause, what about someone civilly detained? So someone who say, has to go through a legal proceeding in order to be declared and there's a declaration from the court that they're a danger to themselves or others, and that finding is made by clear and convincing evidence, not by beyond a reasonable doubt. Is that person a prisoner within the meaning of the regulations?
[00:24:17] Speaker B: So, you know, and this has been A challenge for IRBs is like, are they a prisoner? Are they not a prisoner?
There's a lot of question about whether someone on probation is a prisoner. I don't think it meets this definition, but, you know, very loosely it's been interpreted as someone that is held against their will, wherever that might be.
[00:24:37] Speaker A: And again, there's all sorts of challenges edge cases. So halfway house is designed to be halfway.
[00:24:45] Speaker B: Exactly, exactly. And it's been interesting too, because that the regulators haven't really given those nice guardrails for a definition. So a lot of IRBs will operationalize the definition of what they consider a prisoner according to the regulatory definition to help present some of that gray area and make a more consistent application.
So depending on the IRB you're working with, some have considered a halfway house to be, it's a prisoner, people that are on probation, a prisoner, etc. So, you know, I think a really good thing to do is before you go down the road of having research that might involve prisoners to consult with your IRB on how they are interpreting this subpart and where your research might fall.
[00:25:45] Speaker A: And we've mentioned that theme before, but it bears repeating as Often as possible that early cooperation in the planning stages of research can save not just an enormous amount of heartache and work later, but actually save the study.
And so this is one of the things I've been so grateful to you for when you were in Harvard's office, Shannon, is your willingness to do that and teaching me about how important that can be.
[00:26:13] Speaker B: Yeah, I mean, it can make a big difference in how your research is conducted and what you can and can't do.
So it's really important to discuss what is the real world scenario in which you want to conduct your research, who will it involve? What will it entail, and actually run that by your IRB of record first.
So just always a good idea.
[00:26:38] Speaker A: Terrific.
There's one other sort of section we should discuss here which actually is quite loaded in the sense of quite difficult to apply in certain settings. So this is section 46.305.
It's entitled Additional Duties of IRBs When Prisoners Are Involved. In fact, it doesn't so much as give duties to IRBs as opposed to make substantive regulations over things that have to be found to be true. In other words, it isn't, you know, irb, you must, you know, you must file these reports or something. It says basically research has to, has to meet the following conditions in order to be permissible.
And there, there are some real bombs for us. So let's, let's, let's step on them here just to make sure that. And explode them. Explode some of them here so people know that they're out there.
Let's focus, for example, on subsection A2, which is that this is basically saying that the risks and the benefits, in particular the incentives to participate in studies are not of such of a magnitude that the incarcerated individual's ability to weigh the risks of research in the context of the limited environment is impaired. And again, this one has always struck me as a bit of a head scratcher. Basically, as I understand it, the compensation cannot be too good.
And I guess I get the idea that if the compensation is too good, it seems like in some sense you're taking away choice. But it seems like not allowing people to get too good of a deal also takes away their choice.
So can you unpackage that one for me a little bit?
[00:28:32] Speaker B: Oh, my goodness, Jim, I hear you. And I can only guess here that the writers of this saw that people are there against their will. These are the conditions.
They really shouldn't be too great of a condition because they're in prison.
[00:28:52] Speaker A: You mean an incentive? An incentive to Participate in the research.
[00:28:56] Speaker B: Exactly, exactly.
You know, to give you one example. So there was a research study that wanted to look at whether, you know, providing better quality bedding, improved sleep.
And there was a, this was a discussion that we had with a researcher and they were going to randomize individuals to take part. And it was this lengthy study. It not only involved, you know, like giving them better bedding and better pillows, you know, but, but also of surveys. And it was just wrought with issues, but one could see it was like, well, sure, I want a better bed. Sure I want a better pillow.
And, you know, could, could one individual weigh the risk or benefit along with that? You know, is it going to end up in a knife fight in the yard or you got the better bed and I didn't get a better bed. There's, there's a lot of, a lot of things about this, but I think that, you know, it's, it's hard to look at this from the per. From the point of, you know, giving people compensation for their time. I think maybe adjusting that according to what is the typical standard in, in that environment, or maybe what are the typical benefits that one can get.
You know, it's, it's, it's hard.
[00:30:26] Speaker A: It seems quite odd to me, for example, that if you were going to try to compensate people for their time at the rates that you would use for non incarcerated individuals, then that might be, that might be deemed to be, for example, to answer a survey, to respond to a survey that might be deemed to be coercive because in fact, in the prison system, you earn might, you might earn 15 cents an hour for working.
Whereas, you know, in the IRB, in the non incarcerated IRB world, it would be standard, say, to give somebody $50 for an hour of their time doing an interview or something like that. And so, you know, $50 versus 15 cents seems a bizarre difference.
And yet, as you'll see in the next subsection we're going to talk about, there appears also to be a desire to equalize the treatment of prisoners versus non prisoners. And so again, I'm a little puzzled.
[00:31:23] Speaker B: No, I, and I completely see the point because, I mean, if you can conduct a survey with 50 people and it costs, you know, your study $10 versus $5,000, you know, what a magnet to do research imprisonments.
[00:31:39] Speaker A: Right, right. And, you know, well, anyway, so then the next one, which is what I alluded to, and for, for me, this is the poster child of how the regulations as written may in certain circumstances simply be impossible to apply to certain categories. Of research.
So it's not a matter of trying to evade them. It actually is a matter of impossibility.
This one reads, this is subsection A3. I believe it is, yes. 305A3. It says that in order for research to go forward, here's the quote. The risks involved in the research are commensurate with the risks that be accepted by non prisoner volunteers, unquote. And so, you know, one can see how that might work if the research is biomedical. You know, you're basically taking some potentially risky drug and you know, would somebody that's not a prisoner agree to take the non, the risky drug?
That said, if we're investigating, as we often are in law and in economics and in criminology, decarceral remedies, remedies that are designed to remove people from incarceration, they're in and we're going to let them out.
It's very difficult, I would say impossible, to see how you could have or measure the risks for a study like that to non prisoners. In other words, how do you let somebody out who isn't in and think about those risks? So what am I missing?
[00:33:11] Speaker B: You're not missing anything.
[00:33:13] Speaker A: That's depressing. I was hoping you could correct me here.
[00:33:17] Speaker B: I, I think that, you know, this subpart, they're trying to equate participation with what a person that is not incarcerated would experience.
And you see that consistently throughout this subpart. You know, what, what would I consider normal, regardless if I'm incarcerated or not?
Right. And I think that's a way that they're trying to equalize between these two populations.
In that example.
I don't think the people, the individuals that were writing this subpart were thinking of that particular example. And that's really the inherent challenges with this, with the regulations overall, is that these regulations are static and research is constantly evolving. There are new questions, new ways to really test do these regulations work.
And I think that the subparts, maybe they need to be reexamined.
[00:34:26] Speaker A: I would certainly advocate for that.
And again, research is of course designed to be new and so it's designed to tackle new problems, as you point out.
[00:34:38] Speaker B: Yeah. And the real challenge is, and you know, I think for the IRB office and the IRB members, going through any of these subparts, especially when you're focusing in on social and behavioral research, is a challenge.
And just the federal regulations overall are a challenge for social behavioral research because it's really speak, speaking to, you know, testing out a new drug device or biologic Right. You know, not, not looking at a social impact or social change.
So even during an IRB meeting, having to go through this list of requirements is, you know, a lot of the members are like, how do, how do I approach this, how do I satisfy this criterion when it may not be applicable to the specific research?
[00:35:33] Speaker A: Super. And again, this is where we get tension with the desire to adapt to the prison environment in the sense of making sure that incentives are not too high so as to preserve prisoner choice versus equalize the research as between prisoners and non prisoners. At some point those two have to collide.
Those two, those two desires are going to be inconsistent.
And you can see that how that can happen.
Moving on, we have that the procedures is a subpart 4. The procedures have to be fair in the selection of who could participate.
And as I take it, this is in reaction to the idea that sometimes participation in a study can be something that prisoners very much want to do.
You brought up the idea of, you know, giving people randomly selected people better betting, for example. There might be in some sense competition for participation in this. In the, in the sub. In the, in the study. Is that correct?
[00:36:41] Speaker B: That is correct. And so, you know, again, this is just. We want to make sure that people that want to participate can. And those that don't want to feel that they have a voluntary decision not to.
So that research, whether you want to take part, is a choice.
[00:36:58] Speaker A: Right. And so here, there's going to have to be. There. There are certain, there are certain things governing selection into. And then we get to the final one. There's also then a subpart about, about information presented in language understandable the subject population that we should just apply everywhere. Honestly, I'm not sure why that's there and limited just to prisoners. It isn't actually. There are other requirements, let's say that has to be done pretty much for everybody. But then the last one, that's another head scratcher is adequate assurance that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole. And each prisoner has to be clearly informed of that fact ahead of time.
But what if the research is designed specifically to try to make it more likely that a prisoner will be paroled?
In other words, it's a training program, for example, that we're going to give you job training so that you can be employed afterwards and you can only be employed afterwards if there isn't afterwards, which means parole courts by the parole you. So how do we apply it to that which is an increasingly common area of research. Right. Is reentry. Right. This whole, the whole idea of reentry, in other words, all reentry research, it would seem like, is in tension with this, with this subpart. How do we deal with that?
[00:38:18] Speaker B: You know, what this, what this is basically stating is, is what you are indicating is that even though they're gaining the skill set, Right.
If it's part of research, parole board can't take that into account, which seems.
[00:38:36] Speaker A: I mean, I hate to say it, but it seems perfectly ridiculous.
[00:38:40] Speaker B: Well, it's going back to the point of is this. Is it undue influence for someone to take part in the research?
[00:38:48] Speaker A: Right.
Yeah. Okay. I mean, again, so this is. This is. Again, these are. These are some of the. The most difficult.
[00:38:57] Speaker B: It truly is challenges. It is. And I think that when these were written, they weren't really contemplating the type of research that we're now seeing.
They're looking at more of the, you know, big drug trials, vaccine trials, things like that, to help protect prisoners.
Not from a social perspective, but from a medical perspective.
And, you know, the research that you're doing, Jim, is, you know, as, you know, is really challenging these regulatory standards.
And it doesn't make sense.
[00:39:40] Speaker A: It doesn't. And again, I think I'd like to take as much credit as anyone wants to give me for being innovative here, but I don't think it's actually me. I think the entire area of social determinants of health is. And then obviously the behavioralists and psychologies, colonization of economics, et cetera, are all bringing this all to the forefront, so.
[00:40:05] Speaker B: Exactly.
[00:40:06] Speaker A: Well, with that in mind, Shannon, we're going to leave it there, I think. But. But thank you so much again for walking us through these intensely complicated set of regulations and demonstrating and at least that I'm not as crazy as I thought I was. And when I first read these and actually threw up my hands and said, I'm actually not sure how there's anything at all I can do to share, you know, not just, you know, can I. How is it going to fit? You know, there's a little bit of tension. There's absolutely nothing I can do in some of these situations.
[00:40:38] Speaker B: And it's hard for IRBs as well to ensure compliance when even IRB staff and members are scratching their heads about, oh, wow.
[00:40:51] Speaker A: Really not sure what we could do there. So, as always, Shannon, thank you so much for spending your time and for. And for clearing things up for us for the exam. For the extent they can be cleared up, we're so grateful.
[00:41:03] Speaker B: My pleasure, Jim. Anytime.
[00:41:05] Speaker A: Proof Over Precedent is a production of the Access to Justice Lab at Harvard Law School.
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[00:41:31] Speaker B: So we studied expungement in Michigan, which is basically in Michigan. What we mean by that is sealing of records. They're not eliminated for all purposes, but it makes it so that you can say no if asked on an application about a record and it won't show up in a background check.
And we studied both the effects of expungement on people who received it, which were very positive. We found increases in in wages and employment levels, and although we couldn't study this causally, we found quite low crime levels, in fact lower than the general population for people who received expungements. However, the bad news of our study was that under Michigan's old regime, in which you had to jump through a bunch of hoops to achieve an expungement, very few people who were legally eligible got them.
