Human Subjects and Biospecimens

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At Lehigh, human subjects research can range from interviewing participants to using biological samples for research. Lehigh University is committed to providing the highest level of ethical protections to research participants.

What is essential?

The University is guided by the ethical principles, and obligated to comply with applicable federal laws and regulations regarding the use of humans (human subjects, bio-specimens, or related data) in research. The minimum standard is set by the Department of Health and Human Services regulations at 45 CFR 46 (the “Common Rule”). The University has additional provisions beyond that standard, which help to establish the highest expectations for performance and oversight by both individuals in our research community and by the University.

Why it’s Important

The University has the legal and ethical obligation, shared among all faculty, staff, and students, to use human subjects, human material, and human data in research responsibly.

How to Comply

The Lehigh University IRB reviews, approves, exempts, and monitors activity that meets the definition of human subjects research and is conducted by University faculty, staff, or students.

All University faculty, staff, and students must obtain IRB approval/exemption prior to conducting research with human subjects.

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