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, other biohazardous materials, and outside financial/business interests. Formally appointed committees comprised of faculty and administrators review 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, other biohazardous materials, and outside financial/business interests 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 and university policy require projects that involve human participants to be reviewed and approved by Penn State’s Institutional Review Board (IRB) before they are initiated. Although certain categories of human participant research are exempt from IRB review; Penn State policy dictates that ORP must make exempt determinations. In general, if an activity meets the definition of a "human participant" AND "research" as defined in 45CFR46.1 02, the activity must have prior IRB/ORP review. See the Web: https://guru.psu.edu/policies/RA14.html and www.research.psu.edu/orp/humans.
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: Federal regulations and university policy regulate activities involving vertebrate animals. Approval by the University's Institutional Animal Care and Use Committee (IACUC) is required prior to the actual involvement of a vertebrate animal in any University research, testing or teaching procedures. Any such project involving an external sponsor must be reviewed and approved by the IACUC before funding is accepted. Failure to obtain proper IACUC approval for activities involving vertebrate animals may result in the suspension of animal care and use privileges. 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.htmland www.research.psu.edu/orp/animals.
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 any radioactive 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/radioisotopes.
Biosafety:Any activities involving biohazardous materials as described in Penn State Policy SY24 must be reviewed by Penn State’s Institutional Biosafety Committee (IBC). The IBC reviews, for example, research and teaching activities involving recombinant DNA technology, the use of carcinogens and/or toxins in conjunction with animal research, pathogens, and Select Agents. 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/lbiohazardous.
Outside Financial/Business Interests (also known as “conflicts of interest”): Federal regulations and Penn State policy, RA20, require researchers to disclose “significant financial or business interests” (“SFBI”) (e.g. consulting relationships, equity/ownership interests in a start-up or publicly-traded company, intellectual property rights (such as royalty rights, patents, etc.) and management/business positions (such as BOD, CTO, scientific advisory boards, etc.)) that are related to the researchers’ Penn State research and other scholarly activities. The Individual COI Committee at University Park and the Conflict of Interest Review Committee (“CIRC”) at the College of Medicine review all disclosures of SFBI’s in order to determine whether there is the potential for a real or perceived conflict of interest that could introduce or be perceived to introduce bias or lack of objectivity in the related research. Release of awarded funds for the research and/or IRB approval of the associated protocol will not be approved until the University has put into place a plan to minimize, reduce or eliminate the identified conflict. See RA20.