Thursday, May 19, 2011

Ethics Experts Stupefied by a "Nitpicking Monster", the official blog of the Presidential Commission for the Study of Bioethical Issues, reports on two experts' frustration with the gap between the good intentions behind the IRB system and the depressing reality faced by researchers. Describing the 18 May 2011 Commission meeting in New York City, the blog explains:

One of the themes in the discussion today at the Presidential Commission for the Study of Bioethical Issues: Why did proper concerns for protecting human subjects in trials lead to the creation of a regulatory structure that makes so many researchers cringe?

Researchers equate dealing with Institutional Review Boards (IRBs) as like "going before a (New York City) co-op board or before an IRS auditor," said Ronald Bayer, professor and co-chair of the Center for the History of Ethics of Public Health at the Mailman School of Public Health at Columbia University.

Bayer said he hears endless grumbling about IRB's "picayune questions." "I am concerned," he said. "Is the structure we created something very different than what we wanted it to be?"

He said the the challenge to this commission is "to revisit in a fundamental way the institutions we have created. Something is off when people see the entire process as something we are not proud of, but as a process they find, well, stupefying."

Commission member Dr. John D. Arras, a professor of biomedical ethics and philosophy at the University of Virginia, said he wondered whether the concern about protecting vulnerable populations in medical trials had "given rise to a backlash."

"We pushed for an ethical reform of system, real oversight, and now we are left with this bureaucratic system, really a nitpicking monster," Arras said, addressing Bayer. "And I am as stupefied as you are."

Their concerns ranged from overzealous IRB oversight to requirements of taking standardized tests on ethics.

So, you want to understand change over time? Summon the historians!


Anonymous said...

I used to have a position in which I prepared clinical research studies for IRB review. Regarding IRB bureaucracy, I've seen IRB members make comments that I found less than rational. But people who are interested in seeing their studies pass can attend the meetings and discuss the issues with the board members (at least where I worked). Many wanted someone to get their worked passed through the board and didn't bother to even attend the meetings. Their schedules might be busy, but certainly an appearance of one of the PIs to defend the study and answer questions always helps.

I have also had the misfortune of witnessing doctors trying to get around IRB issues, reporting things to the IRB and FDA when really there would have been few repercussions for the researcher since many of the patients were terminal. When research interests trump patient rights the system has a big problem. When there is financial incentive for the research (as in payment from pharmaceutical companies for each patient enrolled), then the problem might be financial greed rather than bureaucratic IRBs. Separating the financial system from research would be impossible at this point, but I think people really have to question what's going on with the research. When something that is almost standard care but still in "experimental" phases is blocked by absurd regulation that's one thing. When
there is money on the table for what truly is experimental and might shorten a patient's life, that is something totally different.

Having read through some of your other posts, I have to say that I think that all nonconsensual experimentation (biomedical, behavioral, social science, experimental psychology) that intends to harm the subject should be banned across the board. That type of legislation should have been in place years ago and the fact that it is not is IMO indicative of something quite serious. Not only should it be banned, but it should be criminalized and prosecuted. I don't like to see the issue of "harm" be reduced to philosophy. There are studies that involve intentional harms to innocent persons who did not volunteer. The "benefits to society" do not matter if the research is involuntary and harmful.

Zachary M. Schrag said...

Thanks for these comments.

I wonder what kinds of research you have in mind when you propose to criminalize "all nonconsensual experimentation (biomedical, behavioral, social science, experimental psychology) that intends to harm the subject." Most of my posts on beneficence and nonmaleficence concern consensual interaction, as when a researcher gives a suspected wrongdoer the chance to defend his or her actions in an interview.

An exception is my discussion of the effort to investigate the sale of loose cigarettes in San Francisco. The storekeepers willingly sold the cigarettes, but perhaps you consider their participation nonconsensual, since they were not informed that they were being researched. If so, then under your proposal, citizens would face jail for exposing such criminal behavior in their community.

Anonymous said...

In reply to your response, I am trying to address things that haven't been exposed yet as well as some that were exposed and there were no repercussions for the experimenters.

The US has conducted experiments in the past that would not have passed through a review board based on both their potential (and real) harm to subjects as well as the ambiguous sense of benefience to society. The exposure of some of this experimentation in the 1970s lead to the adoption of the Common Rule by some but not all Federal agencies.

The exposure of the radiation experiments in the 1990s under Clinton led to no changes in regulation and oversight that I'm aware of; though the DOE has a complicated "roadmap" to the experiments. Would someone deem those experiments to have been worth the health risk to subjects less important that societal benefits? Who has the right to make that decision when the outcome of experimentation can be costly, harmful or deadly to the subject? In my opinion, no one - no group, individual, agency, or country - has the right to make that determination. And if other laws are being broken to carry out the research, then there should be full execution of those laws. Otherwise the whole system is a hypocrisy.

In the US, there is no one place for oversight of human experimentation. IRBs are generally attached to institutions but there is no federal law that all institutions that conduct research must have an IRB. Generally institutions that receive Federal funding have IRBs but where is there both oversight of review boards and assurances that all human subjects research that involves more than minimal risks actually passes through a review board?

Several states have specific laws dealing with clinical and/or nonclinical research and their own consent requirements, but most states have nothing to this end. In addition, the language covering medical experimentation lags far behind the technologies used in medical research. Examples of this are "non invasive" techniques used for both imaging and effects on the human body. Who has the right to use these and under what conditions?

If these laws don't exist does that mean that no unethical experimentation is going on? Why have previous attempts in Congress (in the 90s Senator Glenn, in the 2000s Representative DeGette) to pass stricter legislation on human research been tabled?

I speak as a victim of both nonconsensual biomedical and experimental psychology experimentation that has caused severe harm. I think if others are really concerned about the possibility of harmful research then they should investigate why there isn't better legislation in the US. For a victim the only option at the moment is to save up to move to a country with better laws that are actually enforced.

Zachary M. Schrag said...

Thanks for these comments.

Though you are correct that the work of the Advisory Committee on Human Radiation Experiments (ACHRE) in the 1990s did not lead to new legislation, it did lead to greater oversight, much to the dismay of many researchers. Among the eventual changes was the replacement of the Office for Protection from Research Risks with the Office for Human Research Protections. (See Ethical Imperialism, chapter 6.)

The debate over the radiation experiments also led to the formation of the National Bioethics Advisory Commission (NBAC), which in 1999 offered recommendations much like your own. But NBAC also conceded that "the current Federal regulations have served to prevent most recurrences of the gross abuses associated with biomedical research in the earlier part of this century," which may explain the lack of interest in Glenn and DeGette's efforts.

Professor Bayer's point (which led to my original post) was that "what began as a venture in confronting abuse -- the misuse and abuse of research subjects -- has become something very different. And that is a beaurocraticized [sic] system of regulation that often misses the core of what the mission had began to do, and that actually has turned itself into an object of ridicule and sometimes contempt in a way that I think is dangerous to those who believe in the ethical conduct of research.." Other critics have noted that IRBs approve studies of dubious ethics.

Thus, the kind of legislation proposed by Glenn and DeGette could prove counterproductive unless accompanied by a more rigorous rethinking of the IRB system.