NURSING HOME RESEARCH: THE POSITIVE EFFECT OF INSTRUCTIONS FOR AUTHORS ON THE QUALITY OF REPORTED RESEARCH ETHICS
Jason HT Karlawish,1 Gavin W Hougham, Carol B Stocking, and Greg A Sachs
1Department of Medicine, Section of General Internal Medicine, University of Chicago, 5841 South Maryland Ave, MC 6098, Chicago, IL 60637, USA
Objective: To determine if an association exists between the quality of a published paper's reported human subjects research ethics and the research ethics requirements contained in journals' instructions for authors.
Design: Structured review of published papers identified by MEDLINE search (criteria: January 1992 through June 1996; clinical trial enrolling nursing home residents in the United States), and the instructions for authors of the journal that published the paper. The review instrument synthesized and operationalized published guidelines for research involving nursing home residents. A panel of knowledgable colleagues assessed the face validity of the instruments.
Results: We identified 45 papers and their corresponding instructions for authors from 22 journals. Quality measures of reported research ethics showed: justification of use of nursing home residents (45), informed consent obtained or waived (36), institutional review board review (18), nursing home committee review (6). Summed as a 4-point quality score: 6 papers scored 4; 12 scored 3; 18 scored 2; and 9 papers scored 1. The research ethics instructions of each paper's instructions for authors ranked into 1 of 4 categories: none; less than "Uniform Requirements for Manuscripts Submitted to Biomedical Journals "(7); the "Uniform Requirements" (24); the "Uniform Requirements" plus additional instructions (5). An association existed between research ethics instructions category and research ethics quality score (Kruskal-Wallis x2=12.38, P=.006). This association existed between categories of instructions(P<.03). That is, the more detailed the instructions, the greater the quality score.
Conclusions: Although basic elements of proposed guidelines for research involving nursing home residents are not routinely reported, the positive association between research ethics instructions category and research ethics quality score suggests that a journal's instructions for authors can affect the quality of reporting research ethics.
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