To the Editor: A few years ago Greg Koski, then-director of the Office of Human Research Protections, and I sipped a glass of wine in the Delta Crown Room at the Cincinnati airport after we'd each presented a talk at a conference on research ethics. I peered at Greg and mused, "Ten years ago, who'da thunk that research ethics would one day become the sex kitten of bioethics?" We agreed it was a somewhat remarkable turn of events.
The Hastings Center Report's collection of articles on human subjects research protection in the March-April 2008 issue confirms that the literature in this important field has indeed come of age. Collectively, these pieces represent a remarkably comprehensive state-of-the field overview. At the same time, they continue some important, uncompleted conversations and identify an array of emerging issues.
Some of those issues are fundamental to the entire research enterprise. As Joffe and Miller point out in "Bench to Bedside: Mapping the Moral Terrain of Clinical Research," much of the traditional thinking about investigators' ethical obligations, from Freedman's seminal paper on clinical equipoise and on, assumes that research ethics is just another genre of clinical practice ethics. This, they argue, is profoundly misguided. Their article launches from the platform of their earlier work challenging that assumption, now finally addressing the question, "If investigators should not simply extend clinical ethics to the research setting, then what sort of ethics should they bring?" It is a contribution not to be missed, even if its views may not elicit universal consensus.
But even this fine collection leaves plenty of room for further discussion--particularly regarding the "ground level" of what actually happens during clinical trials, as opposed to the "upper level" reflection on expansive issues and principles.
I am reminded of an experience from about a year ago. Just out of curiosity, I thought I'd maybe sign up for a clinical trial--just a benign-looking drug trial--so that I could see what things looked like "from the inside." I phoned in a response to a TV ad, then got in touch with the local office for the trial and went for a visit. The research coordinator, a nurse, was very cordial and informative. She told me what the trial was about and provided some written material, including the consent form, to take home and read. Needless to say, although I didn't deceive her about anything, I didn't volunteer information about my occupation or what motivated me to come.
But I noticed a couple of things. As she described the various tests they would perform prior to beginning the drug (or placebo), she said they'd then repeat the whole series at the end, "just to make sure you're still okay." At no point did she actually say anything about gathering data. Zip. Nada.
At another point, as she described the series of tests, she said "we'll be doing the little ones first, then work on up to the bigger ones." It seemed an effort to reassure. She resumed. "So ... we'll do the endometrial biopsy first."
"Isn't that a bit 'bigger' than, say, the blood tests, or even the mammogram?" I asked.
"Well, yes, I guess so." She went on to explain that if people weren't willing to undergo the biopsy, then the researchers didn't want to go through the expense of doing all the other tests first. The answer was perfectly reasonable, but I wondered, why offer the misleading "reassurance" earlier?
I didn't sign up for the trial.
I also recall another episode. I'd gone to a conference to present a talk. Mine was in the afternoon, so at my table at lunch, it was a group of friendly strangers, not speaker-and-audience-after-the-talk. One young woman had recently begun her job as research coordinator for a group of pediatric neurologists in private practice. They were practicing clinicians who also did a lot of research trials. …