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J Med Ethics 30:308-310 doi:10.1136/jme.2002.002105
  • Brief report

The stipulations of one institutional review board: a five year review

  1. R A Sansone1,
  2. S McDonald2,
  3. P Hanley3,
  4. M Sellbom4,
  5. G A Gaither5
  1. 1Departments of Psychiatry and Internal Medicine at Wright State University School of Medicine in Dayton, Ohio and Director of Psychiatry Education at Kettering Medical Center in Kettering, Ohio, USA
  2. 2Department of Internal Medicine at Wright State University School of Medicine in Dayton, Ohio and Program Director for the Department of Internal Medicine at Kettering Medical Center in Kettering, Ohio, USA
  3. 3Department of Psychiatry at Wright State University School of Medicine in Dayton, Ohio, USA
  4. 4Department of Psychological Science at Ball State University in Muncie, Indiana, USA
  5. 5Department of Psychological Science at Ball State University in Muncie, Indiana, USA
  1. Correspondence to:
 Professor R A Sansone
 Sycamore Primary Care Center, 2115 Leiter Road, Miamisburg, OH, USA; randy.sansonekmcnetwork.org
  • Received 9 October 2002
  • Accepted 26 January 2003
  • Revised 13 December 2002

Abstract

Objectives: This study was designed to explore the prevalence and types of stipulations (such as clarifications or changes) required of investigators by the institutional review board (IRB) of one institution over a five year period.

Design: Stipulations to research proposals (n = 124) were documented from the minutes of the IRB meetings.

Setting: Community hospital.

Participants: IRB submissions.

Main measurements: Number and type of IRB stipulations.

Results: Nineteen research submissions (15.3%) were approved without any stipulations. For the remainder, the majority of stipulations related to consent forms (74.2%).

Conclusions: Consent forms appear to be at highest risk for IRB stipulations. Being aware of high risk areas before submission of research proposals may reduce the frequency of stipulations required of investigators.

Footnotes