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07/30/2010 - 8:05am
Renowned academic David Harvey looks at the roots of capitalism’s current troubles. Can we envision a new social order that would be responsible, just, and humane?
07/29/2010 - 7:42pm

After getting beat up by the Dartmouth Atlas, by the press, and by me for its comparatively more aggressive approach to end-of-life treatment, I was happy to see that New Jersey is now looking to establish an Advisory Council on End-of-Life Care in its Department of Health and Senior Services.  Last week, Senator Teresa Ruiz introduced S.B. 2199.  (Notably, she is also the primary sponsor for New Jersey's POLST bill., S.B. 2197.)  

07/29/2010 - 7:32pm

In a soon-to-be-published article in the Journal of General Internal Medicine, nephrologist Ezra Gabbay and Tufts colleagues examine the empirical basis for determinations of medical futility.  Not surprisingly, after an extensive literature review to support Schneiderman's "1 in 100" threshold rule, they find that there is no such basis.  

07/29/2010 - 8:49am

Recently I was contacted by a reporter for a major newspaper and asked to answer a few questions about “future trends in emerging technologies.” Here is what I said.

Generally, what trends/innovations will there be in nanotechnology in the next 10 to 20 years?...

07/29/2010 - 8:49am

Recently I was contacted by a reporter for a major newspaper and asked to answer a few questions about “future trends in emerging technologies.” Here is what I said.

Generally, what trends/innovations will there be in nanotechnology in the next 10 to 20 years?...

07/29/2010 - 2:52am

Apparently Facebook isn't just for playing MafiaWars anymore. It's also for finding living unrelated donors to give you their organs. Seriously. The six degrees of separation that we all experience via Facebook makes those who have long been waiting on...

07/28/2010 - 12:00pm

Given the current state of technology, reproductive cloning is not a safe and effective means of human reproduction. Cloning reduces genetic diversity, is beneficial neither for the child nor the parent, and without restrictions could create many legal and social problems.

While I strongly support therapeutic cloning and have no reservations about using embryonic stem cells for research, I think there are serious issues to consider with regards to human reproductive cloning. At present, given the current state of technology, I do not believe it is safe enough to be attempted. Furthermore, if done in the future it should only be with certain limitations, which I will address below. ...

07/28/2010 - 11:11am

The Yale Interdisciplinary Center for Bioethics offers an interview project as one of its Cases in Research Ethics, which describe choices faced by hospital IRBs in Connecticut.

Case 3 concerns a nurse who was also a divinity school student, and who gained approval from her hospital's IRB to interview fifteen "hospital patients who were suffering from a progressive and/or life-threatening disease such as cancer" about their religious beliefs and practices and the role of religion in their feelings about their illnesses. Patients agreed to participate after "a thorough review of the purpose of the study, the nature of the questions and the time involved for participation."

Eleven interviews went fine. Then the twelfth patient "became agitated and demanded the researcher leave immediately. The researcher spoke with the hospital nurses and was informed that this subject had 'fallen away' from her prior religious involvement and had wondered if her malignancy was divine retribution for her lapse."

The researcher dutifully reported this as an adverse event. The IRB then reconsidered the project and voted 10 to 1 to forbid the researcher from interviewing the three additional patients.

As described in the case study, the IRB recognized that, collectively, it knew little about this kind of research. "While this IRB was routinely accustomed to addressing the standard types of adverse medical events seen in oncology drug trials, it did not consider the possibly significant adverse psychological consequences of asking these same subjects about their religious and spiritual beliefs vis-à-vis their disease."

Yet the IRB's awareness of its ignorance did not prevent it from stopping the research project. The case study does not give the reason for this decision.

Was the IRB constrained by federal regulations? No, 45 CFR 46 exempts interview research unless it "could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation." There is nothing in the case study to indicate that was a concern.

Did the IRB conclude that any study that might agitate a patient is unethical? One hopes not, for such a decision would prevent just about any discussion with any patient, particularly seriously ill ones.

Did the IRB decide that such research is permissible, but only if the researcher takes specific measures to avoid upsetting an interview participant? This seems not to be the case, for the IRB did realize that no protocol can predict who will become upset by a question. According to the report, the IRB "concluded it was highly unlikely for the researcher to reliably have screened and thus excluded subjects who may have been troubled by this line of questioning or to have predicted which subjects might have been at highest risk of experiencing such reactions. In addition, screening and thus excluding such patients from study participation might seriously have undermined the scientific validity of the study." Moreover, if the IRB had thought of some additional measures the researcher could have taken, it could have allowed the remaining three interviews under those conditions.

Perhaps the IRB decided that because "the researcher did not precisely delineate a research hypothesis," her research was not valuable enough to risk upsetting another patient. But how can an IRB that has admitted its own unfamiliarity with social research judge the value of such research?

There may be additional details, not included in the case study, to explain the IRB's decision. But I fear that this IRB shut down the research not because it had upset a patient, but because it had upset the IRB. The IRB system is premised on the idea that risks and benefits are predictable. By challenging that premise, this project forced the IRB to face its own limits. And while the IRB reacted by pledging "to seek consultative advice in the future when faced with certain types of socio-behavioral studies," it apparently stopped the project without such consultation.

This decision to block future interviews punished not only the researcher but also the three patients denied a chance to talk to her. By forbidding these adults from deciding for themselves whether they wished to speak with someone about their disease and their beliefs, even if it upset them, the hospital failed to treat its patients with the respect they deserve.

Forbidding consenting adults from talking with each other is a grave act. While there may be occasions when it is necessary to shield patients from an incompetent or unethical researcher, this case study does not provide the justification for this measure.

NOTE: Another case in the series, "An ethnographic study of homeless adolescents, describes an IRB with a much better sense of what prospective review of a protocol can and cannot do. Through careful reading of the federal regulations, it was able to approve a plan for a challenging ethnography with no major modifications.

07/28/2010 - 4:13am
Atul Gawande has a predictably eloquent and insightful article at the New Yorker: "Letting Go: What Should Medicine Do When It Can't Save Your Life?"  Comments later. 
07/27/2010 - 4:02pm

Arthur Caplan in his MSNBC column discusses over a confessed killer receiving a liver transplant. How could someone who himself admitted killing his wife jump to the head of the queue to receive one of the scarcest resources in the...