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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 05/09/2022) FWA00003041
IRB Organization (IORG) registration (expires 07/10/2020) IORG0002036
 
IRB Standard Operating Procedures and Policies:
 
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. The IRB receives a high volume of applications, and most need adjustments before they are considered review-ready. Please plan accordingly. 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:
Tutorial: New User Registration - self-registering online; managing training and credentials.
Tutorial: New Project Submission - designing, sharing, signing, submitting new projects. Managing approval documents and automatic expiration alerts.
Tutorial: Submitting Subsequent Packages and other Advanced Topics - update and revise project documents for resubmission, submit subsequent packages, manage continuing reviews, review and manage messages, alerts, and reminders.
 
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".

Federal OHRP 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.

Revised Common Rule: Ending five and a half years of rulemaking and speculation, the US Department of Health and Human Services (HHS) and 15 other Federal Agencies released a final revision of the Federal Policy for the Protection of Human Subjects, or “Common Rule,” on January 19, 2017. These are the first revisions to the Common Rule since it was promulgated in 1991. Click here for a helpful summary of the revisions provided by PRIM&R.

 
IRB Forms:
Request for a Waiver of IRB Review for Class Projects Form (must be completed and submitted by faculty)
 
IRB Guidance:
 
IRB Worksheets:
Human Subjects Research Determination *Note: the information on this worksheet may not apply to student-conducted or class-related human subjects research activities. Please see page 3 of the Lehigh University Human Subjects Research Policy for more information on the types of student-conducted or class-related activity that may require IRB review.
Approval Criteria (non-exempt research)
 

Contact Us

 

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