Arts and Humanities Commons^™

A Comparison Of Journal Instructions Regarding Institutional Review Board Approval And Conflict-Of-Interest Disclosure Between 1995 And 2005, Anne Rowan-Legg, Charles Weijer, J. Gao, C. Fernandez

Charles Weijer

OBJECTIVES: To compare 2005 and 1995 ethics guidelines from journal editors to authors regarding requirements for institutional review board (IRB) approval and conflict-of-interest (COI) disclosure.

DESIGN: A descriptive study of the ethics guidelines published in 103 English-language biomedical journals listed in the Abridged Index Medicus in 1995 and 2005. Each journal was reviewed by the principal author and one of four independent reviewers.

RESULTS: During the period, the proportion of journals requiring IRB approval increased from 42% (95% CI 32.2% to 51.2%, p<0.001) to 76% (95% CI 66.4% to 83.1%, p<0.001). In 2005, an additional 9% referred to the Declaration of Helsinki or the International Committee of Medical Journal Editors' Uniform requirements for ethical guidelines; 15% (95% CI 8.5% to 22.5%, p<0.01) provided ambiguous or no requirements. The proportion of journals requiring COI disclosure increased from 75% (95% CI 66.6% to 83.3%, p<0.05) to 94% (95% CI 89.4% to 98.6%, p<0.05); 41% had comprehensive requirements, while some addressed only funding source (6%), were vague (10%) or both (14%). Criteria for authorship rose from 40% (95% CI 30.5% to 49.5%, p<0.05) to 72% (95% CI 63.3% to 80.7%, p<0.05). Journals with higher impact factors were more likely to require IRB approval (p<0.01). Journals in anaesthesia and radiology all required IRB approval; requirements in other disciplines varied.

CONCLUSIONS: Instructions to authors regarding ethical standards have improved. Some remain incomplete, especially regarding the scope of …

Structuring The Review Of Human Genetics Protocols Part-Iii: Gene Therapy Studies, Kathleen Glass, Charles Weijer, Denis Cournoyer, Trudo Lemmens, Roberta Palmour, Stanley Shapiro, Benjamin Freedman

Charles Weijer

No abstract provided.

Monitoring Informed Consent In An Oncology Study Posing Serious Risk To Subjects, Myrian Skrutkowski, Charles Weijer, Stan Shapiro, Abraham Fuks, Adrian Langleben, Benjamin Freedman

Charles Weijer

No abstract provided.

The Irb's Role In Assessing The Generalizability Of Non-Nih-Funded Clinical Trials, Charles Weijer

Charles Weijer

No abstract provided.

Structuring The Review Of Human Genetics Protocols: Gene Localization And Identification Studies, Kathleen Glass, Charles Weijer, Roberta Palmour, Stanley Shapiro, Trudo Lemmens, Karen Lebacqz

Charles Weijer

No abstract provided.