The Pennsylvania State University Embryonic Stem Cell Research Oversight (ESCRO) Committee is charged with reviewing, approving and overseeing human embryonic stem cell (hESC) research. 

Anyone handling regulated biohazardous materials in teaching or research at Penn State must submit an application to Institutional Biosafety Committee (IBC) before handling the materials. Biohazardous materials include human biological specimens, infectious agents, recombinant material, and gene therapy. Biological toxins and carcinogens are also included if they are used in conjunction with animals.

The role of the IRB is to review and to make determinations on all research involving human subjects. All Penn State employees (faculty/staff/administrators) and students conducting human subjects research need to submit required materials to the IRB for review and approval before beginning any research activity.  For an overview of the IRB submission and approval process, see the IRB website.

In addition to the information below, please see RPG03 Payments to Human Participants in Research for Penn State guidance on payment methods.

For privately sponsored studies that are conducted pursuant to a private sponsor’s protocol (industry sponsor), the sponsor of the study is required to pay for the reasonable cost of treating injuries or complications directly resulting from participation in the study, including injuries or complications resulting from the study material or research procedures performed pursuant to the study protocol, to the extent that injuries/complications were not a result of negligence, willful misconduct or failure to reasonably act on the part of the study personnel.

The Office for Research Protections Quality Assurance Program is available to assist with IND preparation, submission, and maintenance. Contact them at orp-qm@psu.edu.

For guidance and templates for your IND application, see the Quality Assurance Program’s resources.

Sponsor-Investigator responsibilities under an IND or IDE are covered in 21 CFR 312 (for drugs) and 21 CFR 812 (for devices).

For more information on Humanitarian Use Devices, see the information provided by the College of Medicine.