Human Subjects in Research

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The revised Common Rule took effect on January 21, 2019. For more information on how these changes to the Federal Regulations impact human subjects research at Lehigh, please see our Revised Common Rule Update page.

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 Lehigh University IRB reviews, approves, exempts, and monitors activity that meets the definition of human subjects research and is conducted by Lehigh University faculty, staff, or students. See What Types of Activities Require IRB Review for more information. 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.

IRB Standard Operating Procedures and Policies

Lehigh University Policy on the Protection of Human Subjects in Research
Composition and Membership of the IRB
End Approval Dates
Exempt Determinations
Expedited Reviews
Human Subjects Research Principal Investigator
Reporting Unanticipated Problems/Adverse Events to the IRB
Additional Requirements for Research Supported by Other Federal Agencies
IRB Conflict of Interest
Researcher Training
Children as Research Subjects
Research Involving Fetuses, Pregnant Women or Human In-Vitro Fertilization
Research Involving Cognitively Impaired Participants
Research Involving Prisoners as Research Subjects
Use of Lotteries, Raffles, and/or Drawings in Research
Informed Consent / Waiver of Informed Consent
Documentation of Informed Consent / Waiver of Documentation of Informed Consent
Suspension / Termination / Expiration of IRB Approval

IRB Guidance

What Types of Activities Require IRB Review
Ethical Issues in Research
Research Design Guidance
Student Investigators' Guide
IRB Authorization Agreements for Human Subjects Research
Assessing Risk Level Using Magnitude of Harm
Human Subjects Research Engagement
Suggested Best Practices for Gender & Sexuality Demographic Questions - from the LU Pride Center for Sexual Orientation and Gender Diversity
International Research and Research with Non-English Speaking Populations - guidance and forms
Family Educational Rights and Privacy Act (FERPA)
Unaffiliated Investigators
Data Security
Readability and Comprehension
General Data Protection Regulation (GDPR)
Electronic Informed Consent
Data and Safety Monitoring of Clinical Trials Research
Conducting Research in Schools