Unrest about Research

An ongoing series of articles and essays in the Report have noted that human subjects research ethics, a sometimes intricate and arcane set of discussions that are virtually a discrete subfield within bioethics, is the site of growing and multiplying controversies. Some of the questions at the core of these debates: Does the protection of research subjects from the harms of research need to be relaxed to promote quick and fair access to the benefits? (See the May-June 2001 Report.) Has the protection of research subjects been undermined by pharmaceutical firms' interest in promoting their own benefit? (See September-October 2004.) What kind of benefits must be provided when the research is conducted in developing countries—must subjects be able to get access to the drug under investigation, or, if the drug is not likely to be available to them, might some other benefit be acceptable instead? (See May-June 2004.) Should human subjects research be seen as a purely scientific enterprise—in which case subjects might consent to be deprived of a known benefit—or is it a special version of the doctor-patient relationship—so that researchers should stop a trial early, for example, if early results show that the trial drug will be efficacious? (The lead article in this issue takes this one up.) Is human subjects research ethics only about what happens to individuals—what harms they will bear and what they consent to—or, when a population is under study, is it also about harms to and consent of communities? (The second article takes this one up.)

These questions go to the very core of research ethics. They are about how we evaluate research, whose opinion counts, how ethics is done, and what the core principles of research ethics are.

Some questions that have generated intense public discussion recently are touched on in this issue by Greg Koski, former head of the Office of Human Research Protections. Koski writes about OHRP's reaction to a John Hopkins University project aimed at determining whether doctors insert a central venous catheter more safely if they follow a checklist. The project quickly showed that they could, and that if widely instituted, thousands of lives and hundreds of millions of dollars could be saved. Johns Hopkins had determined that the project was a quality improvement program, not "research" as defined in the federal regulations, and so did not need any IRB review. OHRP said it was research and did need IRB review, forcing Johns Hopkins to halt the project pending that review. (OHRP's decision was the subject of a scathing New York Times op-ed by Atul Gawande and a detailed critique in the February 21 issue of the New England Journal of Medicine by Hastings scholar Mary Ann Baily.)

There are two sorts of questions here. One is about the nature of research ethics: Can we uphold the basic principles of research ethics rigorously yet apply them flexibly to different kinds of research conducted in different settings, with different risks to subjects and so on? Another question is about scope: What is research, anyway?

Koski's essay is part of a longer exchange in the Hastings Center Report. The relationship between quality improvement and research, and the reach of the federal regulations, was discussed in a July-August 2006 special report, "The Ethics of Using QI Methods to Improve Health Care Quality and Safety," which argued that collecting data about safety and efficacy—quality improvement—is an integral part of the good management of routine medical care, not "research." Koski holds that some QI is research. What the flap over the Johns Hopkins checklist makes clear is that the big questions at stake have a very significant impact on health care.