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Human Subjects in Research

The Institutional Review Board's (IRB) mission is to protect the rights, dignity, and welfare of all human subjects who participate in research programs at Lehigh University. The IRB's authority extends to all human subjects research conducted using any property or facility of Lehigh University, and under the direction of any employee, student, faculty member, or agent of the University. The IRB supports Lehigh University's dedication to excellence in research by promoting the ethical principles of respect for persons, beneficence, and justice as discussed in the Belmont Report.

Human Subjects Federal Wide Assurance (expires 04/17/2020) FWA00003041
IRB Number (www.hhs.gov/ohrp/) (expires 04/20/2018) IRB00002553

Lehigh University Human Subjects Research Policy

IRB Committee Meeting Schedule: The IRB committee meets on the 2nd Tuesday of every month (except when the date falls on a break scheduled on the academic calendar).

Submitting Applications: Protocol applications must be submitted through IRBNet.org. IRBNet is secure, web-based, and easy to use and accessible from virtually any computer. Applications are accepted on a rolling basis. The IRB recommends submitting applications at least six weeks in advance of the anticipated research start date. Applications requiring full board review must be submitted at least four weeks in advance of the meeting date. Research with human subjects may not be conducted without the advanced approval of the IRB.
 
IRBNet Log-in and Training Materials:

Protecting Human Research Participants Training: All faculty, staff, and students conducting research are required to complete the NIH's online tutorial, "Protecting Human Research Participants".

Sample Informed Consent Documents:

Regulations, Guidance, and Educational Materials: For regulations, guidance and excellent educational materials on the protection of human subjects in research go to the Office of Human Research Protections.

Frequently Asked Questions: Click here for a list of FAQs about the IRB and conducting human subjects research at Lehigh University.
 
Request for a Waiver of IRB Review for Class Projects form:  Please see the "Class-Related and Student Conducted-Research" section of the Lehigh University Human Subjects Policy for information on activities that may qualify for IRB review through the submission of the Request for a Waiver of IRB Review for Class Projects form.
Email completed Request for a Waiver of IRB Review for Class Projects forms to inors@lehigh.edu.
 
Guidance: IRB Authorization Agreements for Human Subjects Research: Guidance for Lehigh University researchers who wish to enter into a joint review arrangement where one IRB relies upon the review of another qualified IRB to avoid duplication of effort in collaborative or multi-site human subjects research projects.
 
IRB Contacts: 
Naomi E. Coll, MPH, CPH, CIP - (82985) or nac314@lehigh.edu
Susan Disidore - (83020) or sus5@lehigh.edu

Office of Vice President and Associate Provost for Research and Graduate Studies • Lehigh University • 7 Asa Drive, Bethlehem, PA 18015 • (610) 758-2585