IV. Research, Scholarship, and Creative Endeavors

Office for Research Protections

The Office for Research Protections (ORP) coordinates review and approval of academic activities involving human participants, vertebrate animals, radioisotopes, and other biohazardous materials. Formally appointed committees deal with these issues and provide compliance assurances for Penn State projects. The purpose of compliance review is both to protect the University community from potential research-associated risks, and to provide documentation of these assurances as required by certain federal and state regulations.

Regardless of funding source, all University research projects involving human participants, vertebrate animals, radioisotopes, and other biohazardous materials must be considered for peer review by the relevant committees. Most public granting agencies require compliance documentation to accompany grant proposal submissions, which leads to approval by possibly more than one committee. In addition, certain instructional and organizational activities may also require review. For further information, call 814-865-1775, or visit www.research.psu.edu/orp.

Human Participants: Federal regulations require the use of humans as participants in research be reviewed by an Institutional Review Board (IRB). There are certain categories of research that are exempt from IRB review; however, according to Penn State policy, these must be reviewed and determined to be exempt by the ORP. In general, if an activity meets the definition of a “human participant” AND “research” as defined in 45CFR46.102, the activity must have prior IRB/ORP review. See the Web: http://guru.psu.edu/policies/RA14.html and www.research.psu.edu/orp/areas/humans/index.asp.

Health Insurance Portability & Accountability Act (HIPAA): Researchers utilizing health information obtained from a third party and not directly from the research participant may be accessing protected health information (PHI). In order to utilize PHI in connection with research, researchers must (a) obtain written authorization from the research participant, (b) obtain a waiver of the authorization requirement from the IRB/Privacy Board, (c) obtain approval for such use as preparatory to research, or (d) notify the IRB of such use as research on decedents' information. See the Web: http//guru.psu.edu/policies/RA22.html.

Vertebrate Animals: All uses of vertebrate animals conducted under the auspices of Penn State must receive review and approval from the University's Institutional Animal Care and Use Committee (IACUC) prior to any animal involvement. Failure to obtain proper IACUC project approval may result in the suspension of privileges for the use of animal facilities controlled by the University. The University Park and College of Medicine locations are both accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International. See the Web: http://guru.psu.edu/policies/RA15.html and www.research.psu.edu/orp/areas/animals/index.asp.

Radioisotopes: The University Isotopes Committee (UIC) reviews all projects using radioactive materials at the University. UIC authorization to use radioactive materials must be obtained prior to ordering these materials. Arrangements for the receipt and delivery of all radioactive materials must be made through Environmental Health and Safety. See the Web: www.research.psu.edu/orp/areas/radioisotopes/index.asp.

Biosafety: Any activities involving biohazardous materials as described in Penn State Policy SY24 must be reviewed by one of Penn State's biosafety committees. The Recombinant DNA Institutional Biosafety Committee (IBC) reviews research involving recombinant DNA technology. Research proposals involving the use of carcinogens and/or toxins in conjunction with animal research, pathogens, Select Agents, and oncogenic viruses are reviewed by the IBC. Laboratories using these materials are inspected by the University's Office of Environmental Health and Safety and the ORP. See the Web: http://guru.psu.edu/policies/SY24.html and www.research.psu.edu/orp/areas/biohazardous/index.asp.