Medical research on prisoners

You know what prisoners need? More medical experiments, says the Institute of Medicine.

A new report by the Institute of Medicine of the National Academies of Science recommends relaxing the rules for medical research on prisoners--allegedly for the prisoners' own good. [NYT]

Currently, researchers may only experiment on prisoners if those studies pose "minimal risk" to the inmates.

The IOM report contains some sound recommendations: Protection for parolees and probationers as well as inmates, uniform ethical standards for all prison research, and, a public database of research in prisons.

To discourage the exploitation of prisoners as an accessible population, the report suggests that prisoners should be allowed to comprise no more than half of the subjects in any given study. This recommendation strikes me as well-intentioned, but unlikely to be effective. In this era of mega-trials, there would still be a strong temptation to exploit prisoners as an easy way to double one's sample size.

The most disturbing recommendation of the report is to shift from "category-based" ethical rules to a "cost-benefit" standard. The current regulations only allow experiments with minimal risk to prisoners. The IOM report recommends changing the standard to allow riskier experiments if the benefits outweigh the risks.

The report notes that research on children uses a cost-benefit standard. The authors argue that similar standards should apply to prisoners. The cost-benefit standard allows experimenters to seek parental consent for experiments where the potential benefit for the child subjects outweighs the potential risk.

Prisoners are in a fundamentally different position from children whose parents are making medical decisions for them.

The IOM suggests that an ethics review board should weigh costs and benefits for prisoners. Presumably, the board would first decide whether the potential benefits of a proposed project outweighed the risks, and then individual inmates would be given the option of enrolling in the approved trial. (Only the summary version of the report is publicly available for free. Maybe the full-text version offers more details about the ethics approval and informed consent process.)

It is unclear whether prisoners can give informed consent to participate in potentially risky research. They are, after all, under the control of the penal system. Even if there are no explicit incentives to participate, inmates may still interpret a request to participate as an implied order. It is unethical to create a situation in which prisoners may sign on to a risky research project out of fear of reprisal (well-founded, or not). Prisoners often lack access to basic medical care and may be pressured into accepting experimental treatments because they can't obtain standard medical care.

Then there's the thorny issue of payment. On the one hand, free research subjects are frequently paid for their participation. If free subjects are getting paid, prisoners deserve the going rate. However, paying prisoners raises its own ethical complications. Risky medical experiments might be disproportionately attractive to people who have no other opportunities to make money.

Unlike children, prisoners are social outcasts. The institutional review board is not a loving parent who weighs the costs and benefits for individuals. Even the most thorough and conscientious committee would be making calculations on behalf large numbers of strangers from a marginalized group. The decisions of the review boards may be colored by society's disdain for prisoners. I doubt these committees will be as solicitous of the well-being of inmates as individual parents are about the welfare of their sick children.

Perhaps even more alarming is the redefinition of "benefit" in the proposed cost-benefit analysis. The IM recommends that review boards take into account not only potential benefits for the people being studied, but also prisoners as a class:

To provide extra protections in the area of biomedical research, which likely carries the greatest risks for subjects, the only benefits that should be considered are the benefits to the subjects themselves. There may be social/behavioral and epidemiological studies, however, that carry very low risks for the prisoner subjects but little or no personal benefit. In this case, if risks are very low and important knowledge or benefits may accrue for prisoners as a class, the research may be considered ethically acceptable if all of the ethical safeguards recommended by the Committee are in place. (p3)

By expanding the concept of "benefit" to include prisoners as a class, the proposed guidelines undercut the ethical rationale of the cost-benefit analysis. Virtually any research program on prisoners' health is a potential benefit to prisoners at large. Morally, the important question is whether the benefits to the particular prisoner offset the risks that he or she is taking on.*

[Update: Jeralyn has more on the IOM's guinea pig iniative.]

*[Update 2: Reader Andy posted a link to the 43-page summary of the IOM's report, which, unlike the 4-page summary that I cited earlier, proposes different standards for high-risk and low-risk research. High-risk studies, such as those involving drugs, surgery, or psychotherapy would base the cost-benefit analysis solely on the likely outcomes for the (average?) individual. Whereas, very low-risk studies, such as epidemiological research, would only have to establish a likely benefit for prisoners as a group. (p11)

Even if the cost-benefit analysis is conducted entirely on the individual level, there are huge ethical problems with shifting the standard from minimal risk to cost-benefit analysis. As I understand the plan, review boards decide whether a particular intervention is sufficiently beneficial for the average individual participant, and then prisoners are asked if they want to participate.

All ethical human research requires true informed consent--even when third parties expect the intervention to be overwhelmingly beneficial. Prisoners simply can't give informed consent in the same sense as free citizens. Simply being locked up and isolated makes a person less able to make informed choices. Therefore, I find that the IOM's recommendations are dubious at best. Prisoners should not be presented with the "decision" to participate in potentially risky experiments. The potential for coercion and abuse is simply too high.]

Comments

[Alan Bostick]

Imagine the benefits to society as a whole of the gathering of data on, say, the effects of hypothermia.

[MikeEss]

Since we're on the path to Fascism, we're making sure we hit all of the moral "highpoints" along the way. We are becoming one sick society...

[The Heretik]

Benefit means different things to different people. Follow the money to see who benefits most.

[Barbara]

The only reason to use prisoners is because they can't fight back -- no one cares if they are injured and it's almost impossible for them to sue if they are, not to mention, that most juries won't find the loss of their life or physical abilities to be worth compensating.

Prisoners are completely helpless. Children and animals have more sympathy not to mention many more advocates and defenders.

The IOM is either out of its mind or has seriously lost its moral compass.

I'm just going to go into a corner and cry for my country. The IOM is an organization that I actually respected.

[Barbara]

P.S. I wonder if this proposal is suggestive that testing drugs in third world populations is encountering more and more resistance?

[Lindsay Beyerstein]

Barbara, I was also shocked to read that the IOM was championing the human guinea pig initiative. The IOM always struck me as a decent and reputable organization.

[bob koepp]

I haven't had a chance to study the IOM report in detail, but from Lindsay's summary I think there might be real cause for concern here. Nonetheless, I think prisoners should be able to volunteer as research subjects. Because of their circumstances, society has a responsibility to be _extra_ vigilant in protecting prisoners' already limited rights. If that means a cumbersome and inefficient system of heightened review on a case by case basis, so be it. Of course, that might make the whole business very unattractive to business.

[Andy]

The full version of the report is also available for free online, ; you can read it by going to http://www.nap.edu/catalog/11692.html#toc and clicking on the sections you want to read--if you start at the beginning, you can read the report in its entirety. The interface is (probably purposefully) a little clunky, but you can use it to read the entire report. The executive summary is drawn from the beginning of the report and is much more detailed than the summary you linked to, and it can be found at http://newton.nap.edu/execsumm_pdf/11692 (or by going to the first URL and scrolling up a bit).

You can read all of the IOM's (or the other National Academies') reports the same way--you can get to that first page that I linked to by clicking 'read and purchase' at the page that you linked, and then clicking 'read online for free' or scrolling down a bit.

I think the IOM's proposals sound pretty good, from an ethical standpoint--part of our difference of opinions might stem from the different summaries that we read (and that I have a very favorable opinion of the IOM). While I only skimmed the executive summary, they emphasize that in cases where prisoners/research subjects would face anything more than a small risk, the risk-benefit analysis can be applied only to the prisoners themselves, and not to prisoners as a group. I was also impressed by their emphasis on obtaining truly voluntary consent, and the proposal for the creation of national oversight systems for research on prisoners, including a central registry of all projects involving prisoners. To my mind, the potential for trouble doesn't come from the report itself, but rather from the possibility of half-way or selective implementations of its recommendations that leave out the kind of safeguards that it recommends.

[Lindsay Beyerstein]

Bob, I agree. I have no objection to research on prisoners, per se. I just think they need extra-stringent protections because of their vulnerable situation.

Andy, I'll check out the full report. Thanks very much for the link.

[Nicholas Alexander]

Is it a question of human rights vs human progress? We do not hear of the many less than harmful experiments on volunteers, and without them and the risk taken by volunteers we risk too much to bring out new drugs. It seems unwise to always experiment on an artificially controlled society and for that reason exampansion of the use of prisoners is morally and scientifically suspect.

[Martin Wisse]

Y'all might want to read Jessica Mitford's The American Prison System; in it she describes what happened when this sort of medical experiment was commonplace in US prisons...

[Jodie]

The rules are so tight now that a prisoner can't participate in a trial EVEN IF IT IS HELPFUL TO THE PRISONER.

I had a patient in one of my trials whose condition was improving with the study medication.

Unfortunately, this person shoplifted $50 of stuff from a grocery store; the store chose to prosecute. The patient had two felonies for marijuana possession more than 20 years previous, so the "3 strikes law" kicked in, and she went to jail.

The jail folks decided that because this person was now incarcerated, the study could not continue even though the medication was helpful, the patient wanted to continue, the sponsor was willing to continue, and my research group was willing to work with her in jail.

Yes, it was more than minimal risk because it involved a medication, but since she'd already been on it for six months prior to incarceration, I can't see anyone making a case for coertion.

The thing is, there are lots of studies out there. I can see limiting trials in which the only requirement is a healthy human, and the only reward is extra privileges or cash. However, those trials which target an actual illness perhaps should be considered separately; a prisoner with terminal cancer should not be prevented from trying a last-ditch oncology trial after traditional avenues have failed if that is what the person wants.

[B-money]

"Because of their circumstances, society has a responsibility to be _extra_ vigilant in protecting prisoners' already limited rights."

"Bob, I agree. I have no objection to research on prisoners, per se. I just think they need extra-stringent protections because of their vulnerable situation."

Vulnerable situation??? Society has a responsibility?? These people in prison are there because they lack the basic moral compass to function within our society. The "vulnerable position" you speak of is a result of their own doing. These losers decided to exploit the "vulnerable position" of others. They deserve no sympathy and very little protecting. They lost their rights when they violated the law. We owe them nothing more that a 8 x 10 cell and some food, which should be the most basic we can provide.

That being said, I certainly do not support any type of medical testing on prisoners that is unvoluntary. While I feel that these monsters are lower than dog crap, they are still technically human beings. And we are not Nazis the last time I checked. Although, some here and many around the world want to make us out to be Nazi-esque. (there is even a reference to our moving towards a facist state in this blog.)

The only medical procedure that should be mandatory on a prisoner is to nueter rapists and other sex offenders.

[B-money]

"Because of their circumstances, society has a responsibility to be _extra_ vigilant in protecting prisoners' already limited rights."

"Bob, I agree. I have no objection to research on prisoners, per se. I just think they need extra-stringent protections because of their vulnerable situation."

Vulnerable situation??? Society has a responsibility?? These people in prison are there because they lack the basic moral compass to function within our society. The "vulnerable position" you speak of is a result of their own doing. These losers decided to exploit the "vulnerable position" of others. They deserve no sympathy and very little protecting. They lost their rights when they violated the law. We owe them nothing more that a 8 x 10 cell and some food, which should be the most basic we can provide.

That being said, I certainly do not support any type of medical testing on prisoners that is unvoluntary. While I feel that these monsters are lower than dog crap, they are still technically human beings. And we are not Nazis the last time I checked. Although, some here and many around the world want to make us out to be Nazi-esque. (there is even a reference to our moving towards a facist state in this blog.)

The only medical procedure that should be mandatory on a prisoner is to nueter rapists and other sex offenders.

[bob koepp]

B-money -
You might think that someone incarcerated for possessing a small amount of an illegal substance used recreationally should forfeit _all_ rights and protections enjoyed by those of us who have managed not to get "caught." Well, you'll need to change the law of the land before there's any legal standing for your benighted vision. In the meantime, such people do have rights, and its up to society to protect them, whatever it takes.

[B-money]

See, I know I would get the dopers throwing in the weed isn't so bad that I should get 5 years in a maximum security prison post. And I do agree.

But let's also recognize that we are not truly talking about low level narco offenders who got busted with a dime bag of pot or a ball of coke. No, we are talking about the major offenders, the maximum security shitbags in places like Chino, San Quentin, Sing Sing, Angola, Attica, etc. Those murderers and rapists and habitual assault and batterers do not deserve much more than basic human dignity rights. That being the right to eat, sleep and not have to piss or shit yourself. Other than that, they are worthless drains on the ecomony.

FYI: I agreed with the central tenor of the post, that we should not allow inmates to be treated as lab rats. I just think they are scum as well. Pardon me for not wanting to stand up for assholes that murder people, rape women and children and would rob you blind if they could.

[bob koepp]

B-Money, again - Well, I didn't say doping isn't bad, though I did insinuate that it shouldn't result in the forfeiture of all rights. I also mentioned it because it's the "crime" that puts a huge number of people into the penal system. I'm glad to know that you don't think scum should be treated like lab rats. Do you also think that the few rights retained by scum should be ignored? Just asking.

[B-money]

To first answer your question: No I do not think the few, limited rights inmates have should be ingnored. While I detest these people (again, the aforementioned worst of the worst) I would not want to see them deprived of basic human rights, i.e. food, a shower, the right not to be tortured and/or abused by prison officials, etc.

Yes, drugs does result in many becoming incarcerated. But their actions while on drugs is what is the true problem. And again, these are the morally bereft of our society. But I do think there are instances where drug crimes are worthy of harsh punishment. Remember, drug use never remains the victimless crime that it is purported to be. Murder, assault, rape, theft and numerous other crimes result from drug use. But I am definitely with you on the fact that recreational users caught with a dime bag should get a fine, not a prison term.