Ethics reporting in publications about research with Alzheimer's disease patients.

Persons with impaired decision-making capacity require special ethical protections during recruitment for and participation in research. To assess how fully basic protections for these persons were reported in the literature, the first structured review of a sample of reports of trials including Alzheimer's subjects was performed in 62 journals between January 1992 and December 1998. Neither institutional review board review nor informed consent was mentioned in 28% of the studies. In 48% of the studies, there was no mention of subject involvement in the consent process or that any potential subjects refused or withdrew. Protections may have been offered and simply not reported in the journal articles. The critical importance of these protections would be demonstrated if editors required that authors provide full documentation of ethical protections when submitting an article for review. These might be briefly reported in the articles but be made available electronically to interested readers. Authors could then specify in detail how they conducted their research involving persons with diminished decision-making capacity.