Vital Signs Blog

Bioethicists say patient consent not needed in all comparative-effectiveness studies

Under the right circumstances, informed consent may not always be required for randomized comparative-effectiveness studies, and many pose no, or only minimal, risk to patients, write bioethicists from two leading universities. Patient-advocate groups warn, however, that any weakening of informed consent requirements would be troubling and counterproductive to patient safety and quality efforts.

The requirement for researchers to obtain informed consent is one of the central protections provided to human research subjects by HHS, but the bioethicists say the same stringent protections need not apply across the board.

“Current consent and oversight practices too often overprotect patients from research that has little effect on what matters to patients, whereas in other cases oversight practices under-protect patients from medical errors and inappropriate medical management,” wrote Ruth Faden and Nancy Kass of the Berman Institute of Bioethics at Johns Hopkins University, and Tom Beauchamp of the Kennedy Institute of Ethics at Georgetown University. Their commentary is posted Feb. 20 in the New England Journal of Medicine.

“In a mature learning healthcare system with ethically robust oversight policies and practices, some randomized CER studies may justifiably proceed with a streamlined consent process and others may not require patient consent at all,” they said in the commentary, which outlines what this type of process could look like.

They suggest that fully developed ethical safeguards, including patient engagement, the use of ethics-oversight panels and transparency mechanisms to ensure involved parties are aware of what studies are being conducted, would make it ethically acceptable for randomized CER studies, having no, or only minor effects on patient interests, to proceed without consent.

"I absolutely concur with their article and their point of view on CER studies,” said noted bioethicist Arthur Caplan, director of NYU Lagone Medical Center's division of medical ethics. “If there is no increased risk or burden on patient and if doctors genuinely donšt know if drug A is better than drug B but both are in use and either might be given depending on who the doctor is, where they trained or other random factors, then I don't think full informed consent is needed or warranted."

Patient advocates disagree, however. They argue that this type of framework could take their efforts several steps backward.

“Weakening any requirements for informed consent is counterproductive to patient safety and quality efforts,” said Julia Hallisy, founder and president of the Empowered Patient Coalition, a not-for-profit consumer advocacy group based in California. It could result in the return to the “old paternalistic model of healthcare,” she said, where providers make the decisions and patients are unable to fully participate.

One issue she raises objections to is that researchers would make determinations about what matters to patients, something she said is more difficult than the article suggests. “Patients may not even know themselves at first what matters, or it could change several times during the study.” She also said, at this point in the game, even patients may be beyond the suggested approach.

“Truly engaged patients will likely find this unacceptable and it could lead to distrust and suspicion,” she said.

Hallisy did agree with the NEJM authors on two points, however—that a one-size-fits-all approach will not address the many concerns over informed consent, and that more focus needs to be placed on the issue going forward.

Suzanne Henry, policy analyst at Consumers Union's Safe Patient Project and Hospital Infections Campaign, also disagrees with the authors.

"Patients should be informed when they are a part of a comparative effectiveness study,” she said. “Even if a patient representative approves a study that does not include informed consent, the overall ethical issues should err on the side of disclosure and transparency.”

Follow Sabriya Rice on Twitter: @MHSRice


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