As a researcher and institutional research board (IRB) member, I read the article, “Protecting Patients During Clinical Research” (February 2004:53–59), with great interest, and I am appreciative of the exemplars the author gives as potential pitfalls in the clinical setting. However, I disagree that the IRB is the first level of protection of a patient’s rights during clinical research.

The IRB is only one of the safeguards (albeit one of the most important institutional safeguards) for protection of patient rights. The first, and most important, safeguard is the ethics of the researcher. A researcher’s ethics carry a project from identification of the topic to publication of the study.11 In addition, researchers with high ethical standards do not view the IRB in an adversarial context, but rather as a double check for the protection of human subjects. I...

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