Does a surgeon’s complication rate in a randomized controlled trial constitute a “significant new finding” that must be reported to patients during the consent process?
As courts continue to define the balance between a First Amendment right of free speech, the public's right to know, and protection of the private, physicians must take care to protect patient privacy in any publishing endeavor.
Writing a case study of a psychiatric patient may change the patient-physician dynamic even if the patient consents to be written about. And when the patient is a minor and consent must involve her parents, the process becomes even more complicated.
Primary materials including interviews with some of the volunteer subjects provide information on the experiments into the pathogenic mechanism of yellow fever.
Institutional review boards (IRBs) have the responsibility to ensure the protection of human-research subjects and are legally liable if they fail to do so.