What is the quality of the reporting of research ethics in publications ofnursing home research?

OBJECTIVE: To assess the quality of reporting of research ethics in publish ed clinical. research that involves a particularly vulnerable population: n ursing home residents. DESIGN: A structured review of publications researched from 1992 to 1996 th at involve nursing home residents. The review instrument assessed each publ ication's compliance with four common standards for research that involves nursing home residents or the cognitively impaired: justification of the us e of nursing home residents, Institutional Review Board (IRB) review, nursi ng home committee review, and informed consent. For each publication, these results were summed into a quality score. The research ethics requirements contained in the journals' instructions for authors that corresponded with each publication were categorized in order to compare whether an associati on exists between the average quality score for each category and the detai l of its research ethics instructions. RESULTS: Forty-five publications were identified. The four quality measures of research ethics showed that (1) all 45 publications reported justificat ion of use of nursing home residents, (2) 36 publications reported that inf ormed consent was obtained or waived, (3) 18 publications reported IRE revi ew, and (4) six publications reported nursing home committee review. Of the 35 publications reporting informed consent was obtained, 16 reported asses sing subjects' decisional capacity, and 24 reported whether cognitively imp aired subjects were included (19) or excluded (5). The research ethics requ irements of each publication's instructions for authors ranked it in one of four categories: (A) None (9); (B) Less than "Uniform Requirements (UR) fo r Manuscripts Submitted to Biomedical Journals" (7); (C) UR (24); (D) UR pl us Additional Instructions (5). A positive association exists between the d etail of a research ethics instructions category and the average research e thics quality score for each category (Kruskal-Wallis chi(2) = 11.2, P =.01 ). That is, the more detailed the instructions, the greater the quality sco re. CONCLUSION: In publications of research that involves nursing home resident s, basic standards of research ethics are not typically reported. However, the positive association between research ethics instructions category and research ethics quality score suggests that a journal's instructions for au thors or other features of peer review and editing can affect the quality o f reporting research ethics.