ETHICAL STANDARDS IN REPORTING RESEARCH FROM RETROSPECTIVE OBSERVATIONAL STUDIES BASED ON DATABASES USING ANONYMOUS AND PERSONALLY UNIDENTIFIABLE
Author(s)
Hiroi S1, Uda A1, Tokaji A2, Takeshima T3, Iwasaki K3, Mishiro I1
1Takeda Pharmaceutical Company Ltd., Tokyo, Japan, 2MDS-CMG Inc., Tokyo, Japan, 3Milliman, Tokyo, Japan
OBJECTIVES: Ethical practice is now required for conducting medical research. Various types of ethical guidance are available for interventional clinical trials; however, none is yet to be established for retrospective observational studies based on databases using unlinkable anonymized data. We aimed to review ethical considerations and reporting standards (such as STROBE and RECORD) required to publish database study reports in peer reviewed medical journals. METHODS: We conducted a review of ethical considerations (e.g., IRB/EC reviews and approvals) and endorsed statements for retrospective observational studies using unlinkable anonymized data in submission (authorship) guidelines of peer reviewed medical journals. The journals with impact factors of 10 or more in general medicine and major therapeutic areas oncology, endocrinology, cardiology, and gastroenterology and hepatology were targeted in this study. We searched publically available information from the journals, their publishers, and publicationrelated websites. RESULTS: We surveyed the publication policies of journals meeting our selection criteria. Among the preliminary studied 25 journals five endorse STROBE statement and one of them indicates the needs for both STROBE checklist and IRB/EC review and approval. A total of 6 journals mentioned IRB/EC review and approval on the journal websites. One journal encourages registering the systematic reviews and metaanalysis on PROSPERO, and asks for detailed explanations if IRB/EC approval was not obtained. CONCLUSIONS:
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PRM61
Topic
Real World Data & Information Systems
Topic Subcategory
Reproducibility & Replicability
Disease
Multiple Diseases
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