hinckley first operation ether webWhen well-known ethicists such as Ruth Faden, Tom Beauchamp, and Nancy Kass, call for an end to informed consent for certain clinical research trials one has to wonder what’s going on behind the scenes. In the February 20, 2014 issue of the New England Journal of Medicine they state, “Interest in learning healthcare systems and in comparative-effectiveness research (CER) is expanding. One major question is whether informed consent should always be required for randomized comparative–effectiveness studies, particularly studies conducted in a learning healthcare system. Our answer to this question is no.”(1)

Our question is why now?

The requirement for informed consent was decades in the making and is fundamental to all international ethical guidelines for research in humans. It was a result of some of the most egregious abuses of research in humans who were either not informed or misinformed about the research that was being performed on them (see A Cautionary Reminder. Nuremberg Revisited). Faden and associates argue that certain comparative studies may not require informing the patient that they are participating in a research study. This is a step backward and one susceptible to abuse and fostering distrust of the medical community. Basically they are suggesting that the academic establishment be trusted to determine whether an individual should be informed that they are participating in a research study.

In an accompanying article, Kim and Miller consider Faden’s proposal as “paternalistic” countering that individuals have the right to determine whether they participate in research regardless of the investigators viewpoint.(2) They add an additional concern—physicians would be engaging in deception, actively concealing the patient’s inclusion in a research study.

Faden and collaborators overstate the benefit of CER to patients. “Some research, including some CER, pose only minimal risks, yet the potential effect on patients welfare of answering the core question of CER—which standard interventions work best for whom—is immense.” In reality CER, as emphasized by Kim and Miller, is of little direct benefit to the patient but of “immense” benefit to healthcare providers. While CER refers to comparative-effectiveness research it is in reality a euphemism for cost-effective research. One has to dig deeper to determine why cost-effective research has become so popular and ask, what’s really behind the push for CER, who really benefits, who determines which treatment is best and on what basis?

Faden et al. provide a seemingly innocuous example of where CER could be conducted without informed consent—that of comparing two different treatments for hypertension. The authors, none of whom are physicians and care for patients, propose an example of a study that in their view would not require consent, “… a pragmatic, randomized clinical trial that compares two widely used hypertension medications, perhaps two diuretics, and in which there are no delineated clinical characteristics that would favor one drug over another for many patients.” There are in fact no drugs that are likely fit those characteristics and if there were, why would they need to be compared?

In reality, different treatments for hypertension exist because the mechanism of action, the side effect profiles and the interaction with other drugs are important factors that individual physicians must evaluate together with their patients. Why then would a patient not be informed that they are being placed on the treatment which may not fully control their hypertension or which may produce undesirable side effects that, unless they are fully informed, could disrupt their health?

Current informed consents require that research subjects be informed of the purpose of the study, who is conducting the study, how the study is financed and what benefits may be derived, not just to research study participants, but also to individuals who conduct the study. Should not therefore CER follow the same rules indicating the purpose of the study? I for one, if involve as research study participant, would want to know why the study is being conducted, is there any benefit to me as an individual and to the investigators and the universities that they represent? And if I found out after the fact that I was enrolled in a research study without knowing it, why I was not told about it?

Of course there’s a nagging question that arouses suspicion as to why informed consent should be eliminated in the first place —with the proliferation of CER is the time and cost of obtaining human research subject committee approval considered an unnecessary obstacle for the researchers? Couldn’t they conduct more studies and implement them more efficiently if they could bypass the constraints of ethical guidelines?

The suggestion that informed consent should be eliminated for certain research studies runs contrary to the ethical obligation of physicians to fully inform their patients of any intervention. Physicians are not only obligated to inform patients of the research but also to obtain permission from the patient before engaging in the research. This is no different than the obligation of physicians to inform their patients and obtain their permission prior to performing diagnostic procedures, surgery, medical treatments etc. The inconsistency of exempting informed consent for any research should be obvious to all.

References

1- N Engl J Med. 2014 Feb 20;370(8):766-8. doi: 10.1056/NEJMhle1313674.
Informed consent, comparative effectiveness, and learning health care.
Faden RR, Beauchamp TL, Kass NE.

2- N Engl J Med. 2014 Feb 20;370(8):769-72. doi: 10.1056/NEJMhle1312508.
Informed consent for pragmatic trials–the integrated consent model.
Kim SY, Miller FG.