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Ethics of Human Subjects
Apr 7, 2007, 10:39p - Ethics

As I've been considering grad school, I've gotten curious about the rules that regulate experiments involving humans. Specifically, I've been concerned that Institutional Review Boards (IRBs) (a) unnecessarily slow-down the pace of research and (b) prevent reasonable experiments from occurring at all. I've heard numerous horror-stories (one detailed below), and though I don't know exactly what research I want to do, I want to make sure that I don't fall prey to similar bureaucracy.

IRBs exist to protect humans from dangerous experiments, typified by the Tuskegee Syphilis study. That study, lasting from 1932-1972 and involving syphilitic black men from Alabama, is the epitome of the unethical experiment. The researchers repeatedly abused their patients, most notably witholding a new treatment (penicillin) so that they could continue to study how syphilis spread, all without the consent of the patients involved.

Such experiments are clearly unethical. Not only did the costs (of human suffering) overwhelmingly outweigh the benefits (of greater understanding of syphilis), the patients did not give informed, non-coerced consent, as they were never provided with the information that better treatment had become available. In cases like these there is a strong argument that the individual alone cannot protect himself and broad social (read legal) intervention is necessary.

Given the long history of unethical experiments on humans, the federal government requires that all federally-funded research be reviewed by IRBs. However, this particular requirement has led to a dramatic slow-down in the speed of some experiments. For example, the American Association of University Professors cites the following from a group who sought to conduct a multiorganization study of medical treatment for substance abuse:
Nearly eighteen months and 17 percent of the total research budget had to be spent on obtaining the nine IRB approvals that were required for the study to be undertaken. The IRBs demanded many changes in the formatting and wording of the consent and survey forms, and each change demanded by one IRB had to be approved by all the others. The researchers claim that by the end of the process, no substantial change had been made in the protocol, and that the changes demanded had no discernible impact on the protection of human subjects.
As with all things, there is a cost associated with the legal protection that the IRB law provides. In my opinion, the IRB requirement is overly broad, so broad that it significantly reduces the speed at which relatively harmless experiments are conducted. Of course, one could argue that the cost of slowing everything down is worth the benefit of preventing great human suffering and loss of life, but that doesn't appear to be true here, to me.

Ultimately, though, I'm most disturbed by the hard paternalism of the IRBs. What right do they have to tell others what risks are worth taking and what risks aren't? As long as the researchers inform the participants of the known risks involved, why should the participants be forbidden from participating? The reasonable counter-argument is that this would cause poorer people to unfairly bear the burden of risky research, as their desperation for cash would increase their willingness to take undue risks. This objection has a simple solution: don't pay participants for participating. That way, if one guy chooses to take a risk that someone else wouldn't take, he isn't doing it under unreasonable duress. For example, experiments such as the Prison Experiment and Milgram's shock experiment would never get past IRBs today. But understanding what I know now about the psychological risks, I would be willing to participate for free. There's a whole world full of derivative experiments that could be as informative as the originals, yet they aren't done because of IRBs. One can argue that researchers can revise their experiments to reduce the risks, and this does in fact happen, but the bottom line is that not all experiments have low-risk alternatives.

There's a simple analogy. It's wrong and illegal to sell your kidney, because as a society we believe it inhumane to sell body parts for cash. But you can donate your kidney for free, even though organ donation can put your health at great risk. Why not have a similar policy for research participation?

Changing policies, especially those that are ratified into law, is no trivial matter, and is highly unlikely given our current culture of caution. Ultimately though, if IRBs are blocking truly ground-breaking research, we'll see such research diverted outside of federal funds. More research will be funded by private organizations (both for-profit and non-profit) as well as non-US nations, and in the long run, this could put the US at an economic disadvantage. I care less about such narrow nationalistic interests, but if you care more, this could be important to you. So for the sake of your country, or for the sake of free will and individual responsibiltiy, vote NO on IRBs! We should just require researchers to get the informed, non-coerced consent of their participants by making it illegal not to. Of course, the definition of "non-coerced" is tricky, and is probably best left to the courts or to a future blog post :)

Resources consulted in writing this essay:
- Federal law: Title 45, Part 46 - Protection of Human Subjects
- California state law: CA Committee for the Protection of Human Subjects
- Critique of IRBs by the American Association of University Professors
- Review of National Organ Transplant Act of 1984

Read comments (3) - Comment

omar - Apr 8, 2007, 11:31a
nikhil, two things. first, why do some societies forbid prostitution, and not others? while this may be seen as a somewhat extreme example, i think you can connect this idea with what's happening with IRBs. there's a combination of two things: what is believed to be reprehensible, and what is believed to negatively effect both the participants and the society at large.

on the level of the participants, IRBs are supposed to be advocates and protectors of the people who are participating in the experiment. you say that an experimenter should explain everything to the participant, give them all the information, and make sure they are adequately, and hopefully completely, informed.. but how do we know that the participant can adequately gauge the risk? sometimes people need help at this, and i don't see the experimenters as necessarily having the best interests of the participants in mind. that's why they need a special advocate. i think the restrictiveness of the rules is partly pragmatic: can they really ensure that every participant is adequately informed and understands their rights? probably not, so restrict experiments to such a degree that even if the participant agrees to something that they don't fully understand, the potential risk is still quite low.

hmm, that's likely the goal, but as you point out, the implementation seems to be lacking. part of being a participant advocate is putting the experimenter through all the required hoops to make sure they are, as much as is reasonable, considering the participant and the possible effects on the participant. but it certainly sounds like in some instances the IRBs do nothing for either the participants or the experimenters. and that's unfortunate.

jessica - Apr 9, 2007, 9:38p
sounding more libertarian every day...

nikhil - Apr 23, 2007, 5:26p
Just to be clear - I'm advocating that there be 2 routes to research approval:

1) If you're going to pay your participants, use the IRB process

2) If you aren't going to pay your participants, you're approved!

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