1. Tilden, Virginia DNSc, RN, FAAN, Associate Editor

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Squeezing myself in a middle seat of an over-booked flight, my eyes land on a headline of my neighbor's newspaper: "Federal Rules for Research on People Often Fail: Two Former Patients Sue Eye Surgeon in Florida Over an 'Experimental' Device" (USA Today). Apparently, a Florida ophthalmologist, in a rush to market, applied his experimental corneal transplant technique to more than 60 patients without their informed consent for research. The technique had been approved for animal research; without telling the institutional review board (IRB), the investigator applied the technique to human patients. The article accused the university, which stood to profit from the ophthalmologist's invention, of failing to monitor his work or to intervene appropriately until after patients had been injured. The somber conclusion was that there are serious flaws in the nation's system for protecting humans in medical experiments.


Researchers, nursing and otherwise, don't need reminding that the screws are tightening on human subjects protection. Across the country, IRBs are implementing policies that would have nipped the Florida case in the bud. And, universities are ratcheting up their scientific misconduct policies, since a strong culture of scientific integrity makes it unlikely that any investigator could shift from animal to human model without an outcry from project staff and colleagues. At the first sign of trouble, IRB protocol violation procedures, had they been used in Florida, would have suspended the study during an investigation and, if substantiated, would have immediately ended the study and sanctioned the investigators.


Meanwhile, new NIH application procedures related to human subjects have become effective. Grant writers provide detailed information on human subjects protection on: (a) human subjects involvement and characteristics, (b) sources of material, (c) recruitment and informed consent, (d) potential risks, (e) protection against risks, and (f) benefits. For a clinical trial, a plan must be described for data and safety monitoring by a standing monitoring committee. Scientific reviewers must determine that all of these points have been fully addressed. If the Human Subjects section is missing, the reviewer notifies the NIH Scientific Review Administrator and the application is returned without review.


Does this add up to more safety and protection for human subjects? Probably, yes. Does it add up to extra headaches and slower progress for researchers? Definitely, yes. Does it prevent human subjects violations? Definitely, not. Cases will still occur, because the volume of human subjects research is high, because a few investigator-bad-apples put their interests ahead of subjects, and because regulations can never be fail-safe. Even as I finish writing this, there is another prominent headline: "Uninformed Consent: Patients Never Knew the Full Danger of Trials They Staked Their Lives On" (Seattle Times). These issues are here to stay.




1. USA Today, February 26, 2001.


2. Seattle Times, March 13, 2001.