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Institutional Review Board

When is IRB Review Required?

IRB review is required for research involving human subjects.

What is a Human subject?

A living individual about whom an investigator (whether professional or student) conducting research obtains                                                                                                                                             (1) data through intervention or interaction with the individual, or                                                       (2) identifiable private information (45 CFR 46)

What is Research?

Research is defined by the U.S. Department Health and Human Services as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46)

When in doubt, contact the IRB Manager to help determine whether a particular project is “research” as defined by the University of Maryland and by federal regulations.

Please note: Research that is limited to the collection of private information on individuals requires prior approval.  If the research is exempt, the application must be approved by the IRB Manager or the IRB Co-Chair before data collection begins.  If the research is non-exempt, the application must be approved by the IRB before data collection for exempt research begins.

The Request for Determination of Non-Human Subject or Non-Research Form may be used by faculty, staff and students who are not sure whether their activity requires IRB review. You may mail the form to the IRB Office via campus mail or bring the form to the IRB office which is located in 2100 Lee Building. Faculty and staff who submit a completed Request for Determination of Non-Human Subject or Non-Research Form to the IRB will receive written documentation on whether the activity requires IRB review. If you have any questions regarding this form, please contact Roslyn Edson, the IRB Manager, at 301-405-0678.

IRB Staff Contact Information

When is IRB Review Required?

IRB Policies and Procedures

IRB Meeting Dates

IRB Membership Roster

IRB Applications, Consent Forms and Addendum Requests

Student Research Projects

FAQs

HIPAA Information

NIH Certification

IRB Training

Federal Wide Assurance

Federal Regulations and Codes and Requirements for International Research

Information Resources

This page is maintained by the UM Division of Research and Graduate Studies. 

Questions, comments, and/or suggestions should be directed to IRB@deans.umd.edu

Institutional Review Board, 2100 Lee Building, University of Maryland, College Park, MD 20742 USA

This page last modified 31 March 2006
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