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The IRB at Central Michigan University revised its IRB application to make it more efficient and more closely aligned with federal regulations under 45 CFR § 46.111. (View the regulations at: http://bit.ly/2tIlxT9.)
The expedited review of new application worksheet includes checklist questions based on 111 criteria. In the IRB application, the cover page explains how each of the seven criteria under 45 CFR § 46.111 must be satisfied before the IRB will approve the research. The title page also asks investigators to list the project’s title, principal investigator’s name, department, college, mailing address, phone, and email. The form also asks investigators to checkmark which government agency funded or supported the work.
For each checklist item, there is a question of “Is Criterion met?” Options are “yes,” “conditional,” and “no.”
In using the “conditional” response, a reviewer would add a suggestion such as “insert the following language…,” according to explanatory comments by Robert S. Bienkowski, PhD, CIP, CHRC, director of the office of research compliance, Central Michigan University.
The following are some checklist items, shared by Central Michigan University IRB:
• Risks to subjects are minimized;
• Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;
• Selection of subjects is equitable;
• Informed consent will be sought from each prospective subject;
• Informed consent will be appropriately documented;
• When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects;
• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball is a consultant for Ethicon USA and Mobile Instrument Service and Repair.