“The Institutional Review Board (IRB) has the responsibility and authority directly to observe ongoing research projects and the consent process, as well as conduct continuing review of the project, including audits of research records. The IRB will audit research records randomly, for cause, and based on the compliance records of the investigators. Full cooperation by the Responsible Project Investigator and other members of the research team (if necessary) is expected. Research record audits are usually brief.” (Section 8-10: Project Audits, MSU Human Research Protection Manual)
On-site audits are conducted as part of the Human Research Protection Program’s (HRPP) continuing compliance oversight in accordance to federal regulations. “The purpose of the audit procedure is to ensure protection of the human subjects participating in research. The information gathered during the audit is for the IRB to use to monitor the implementation of approved protocols, identify areas that need improvement, correction or targeted education, and to gather information for continuous improvement on ways to improve the audit tool or the audit process.” (Section 8-10: Project Audits) Investigators are notified, generally by e-mail, at least 2-5 days prior to conducting the audit.
Federal agency overseeing the research (Food and Drug Administration, Office for Human Research Protection, etc.)
Research study sponsor (pharmaceutical company, funding agency, etc.)
Institutional Review Board (IRB Chair, IRB Member, IRB Staff, etc.)
You! The IRB recommends researchers perform in-house quality assurance checks
Helpful Tools/Forms/Documents
Short Audit Form for IRB Approved Projects: Word | PDF. This short form is used by MSU’s IRB audit team to conduct “spot checks.”
Self Assessment Audit Tool (For Expedited and Full Board Projects):Word | PDF. This tool is provided for researchers to conduct a self assessment on expedited or full board review projects.
Self Assessment Audit Tool (For Exempt Projects):Word | PDF. This tool is provided for researchers to conduct a self assessment on exempt review projects.
MSU Behavioral Study Audit Form:Word | PDF. This form is used by MSU’s IRB audit team when conducting an audit on research projects within the Behavioral Sciences.
Conducting a Site Visit - 4-20-05, L. Triemer:PDF. A presentation from the 2005 Spring IRB Conference on actions that may occur after an audit is conducted.
Questions?
For questions regarding IRB audits: Contact Judy McMillan, Director of the Human Research Protection Program at 517-432-4502 or via e-mail at irb@msu.edu.
Federal Oversight
Federal oversight agencies also conduct on-site compliance audits or inspections of institutions and universities.
The Food and Drug Administration also conducts inspections of IRBs and investigators. The FDA makes available warning letters sent from the FDA to inspected entities on their web site.
This information can be useful in evaluating specific protocols in terms of methodology or/and decision making, and to the IRB in determining and following policies and guidelines.
