Of course. But . . . you know . . . eggs – omelette.
“We can't eliminate risk, but we can make sure the patients in the study are properly informed.”
That seems to be the issue at dispute.
"Study proposals are also not approved by the boards unless the value of the knowledge that stands to be gained outweighs the risk of the study.
How would you know that is the case here? You haven't read the protocol and consent forms (and have little desire to). Also keep in mind that medical ethics is “a subject of great debate.”
“I suspect the action being taken against the EPA is more politically motivated than anything else, and has more to do with the EPA's policy regarding particulate matter.”
Wherever there is government money to be spent, there will be politics. To bemoan that dynamic is to betray either an ignorance of how government works, or to betray an annoyance that the resources of others can’t be spent without their oopposition.
I know that's the case here because, although I haven't read that specific protocol and consent form, I have read many other protocols and consent forms, and have taken the training to sit on an Independent Review Board. Plus, I have sat in on quite a number of IRB meetings. The laws regarding medical research ethics are quite clear.
No researcher is allowed to sit in on a board regarding his/her own research project, or a project in which he/she has some professional interest (for instance, a physician trying to recruit subjects for a study, but who isn't doing the study himself would not be allowed to sit on the board).
Here is a link to the website of a company that does IRB reviews. It does a pretty good job of explaining what the IRB process is all about.
And I said that there is still quite a bit of debate over medical research ethics because it is possible to recognize that there are many areas where there is not broad agreement on what, exactly, is ethical while still agreeing that it is necessary to be as ethical as possible in conducting research.
It is generally agreed that patients considering whether to participate in a study should be given full disclosure. However, in some studies (especially psychological studies), giving full disclosure to the patient would skew the results of the study. So the study author wants to deceive the patients about the purpose of the study--for instance, they might be told that the study is about how package design affects their decision to purchase a product, but in reality, the researcher is testing the type of person they are most likely to buy from (someone who looks and talks a lot like them, someone who is drastically different, someone they see as a peer, or someone they see as an authority, for example). If the researcher tells them the real point of the study, they will try to guess the researcher's expectations, and act accordingly. But if they think they are just judging the package, the researcher can gather unbiased data. They are only told after the conclusion of the study what the real purpose was. The ethical discussion is on whether it is okay to lie about the purpose of the study, when telling the truth would change the results.
Other ethical discussions involve whether it is acceptable to exclude pregnant women from studies, or to require that women use some form of contraceptive during the study (since the researcher doesn't want to be responsible for harming a fetus)--do such requirements restrict a woman's autonomy? I could go on; the point I was trying to make is that another Tuskegee isn't going to happen, but there are still many grey areas.
Wherever there is government money to be spent, there will be politics. To bemoan that dynamic is to betray either an ignorance of how government works, or to betray an annoyance that the resources of others can’t be spent without their oopposition.
Given that I've been associated with the military during my whole adult life, I think I have a fairly good idea of how the government and politics work. Besides that, my PhD--like that of most people in my field--was mostly paid for by the government (state and federal). In my assessment of this particular case, I assigned the political motives to Steve Milloy--along with the physician who wrote that letter--because I believe they are trying to point out a perceived inconsistency in EPA policy.
The reality is that, at the upper levels, the EPA operates politically--political appointees with little to no scientific background run it according to the politicians' whims. And, clearly, the politicians do try to accrue political power by using the EPA. But the scientists at the EPA are not politicians; they are trying to do the research that they believe has value (because of questions raised about particulate pollution, it *is* important to determine what, if any, effect that has on human health). They will conduct the research according to their understanding of the risks, not according to the EPA's politically motivated policies. And that is what Steve Milloy is using to make some political points. Don't get me wrong--I respect Steve Milloy, and I find his Junk Science website very interesting, even if I disagree with him on this point.