Who Needs to Submit?

Do I Need to Submit an Application to the:

Institutional Review Board (IRB) for the use of human participants in research?

Institutional Animal Care and Use Committee (IACUC) for the use of animals in research?

Institutional Biosafety Committee (IBC) for the use of biohazardous materials in research?

University Radioisotopes Committee (UIC) for the use of radioisotopes in research?

Do I need to submit an Institutional Review Board Application?

• Basically, if your research involves the use of human participants, submit an application to the Office for Research Protections (ORP).
• But, how do I know if it's really research? Research is a "systematic investigation designed to develop or contribute to generalizable knowledge (Title 45 CFR (Code of Federal Regulations) Part 46.102(d), Federal Register, 56, p.28013).
• When is someone considered to be human participant? A human participant is a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information. (Title 45 CFR, Part 46.102.f)
• According to Penn State University's Policy RA14 (http://guru.psu.edu/policies/RA14.html), research is the former plus "any dissemination of findings to a scientific audience including, but not limited to, honor's, master's, and doctoral theses; presentation at a scientific meeting or conference; submission to or publication, paper or electronic, in a scientific journal; and Internet postings. This policy is applicable to all research, whether sponsored or unsponsored, conducted under the auspices of the University.

Who Needs to Submit to the IRB for Review?

• If University faculty, staff, administrators, or students conduct research according to Penn State's definitions of research and human participants, an application must be submitted to the Office for Research Protections (ORP) for review and approval by the Institutional Review Board (IRB).
• Policy RA14 is applicable to all Penn State colleges and locations. Penn State has an assurance with the Office for Human Research Protections in compliance with 45CFR46. The College of Medicine maintains a separate assurance.
• Investigators should contact the ORP or the Human Subjects Protection Office at the College of Medicine when collaborative projects will occur between the College of Medicine and other Penn State campuses or researchers.
• Externally funded projects involving the use of human participants are to be approved by the IRB prior to acceptance of funding. (Some funding agencies require human subjects review and approval by IRB prior to consideration of a proposal for funding.)
• The ORP should be contacted for guidance whenever projects that have been approved by IRBs at other institutions involve University personnel or University resources.

Biomedical Research Versus Social Science Research:

Many biomedical research issues are not applicable to social science. However, many social science research issues involve biomedical elements. When social science research crosses the line into biomedical territory, the Application for the Use of Human Participants for Research must be submitted and reviewed by the Biomedical IRB since the members will have more knowledge of the side effects and/or other possible risks.

The biomedical IRB reviews human participant research that involves the scientific study of normal or abnormal physiology and development, studies that evaluate the safety, effectiveness, or usefulness of a medical product, procedure, or intervention, and studies that involve any procedures (e.g., collections of saliva, tissue, urine, or blood samples; dietary manipulation; exercise studies, etc.)

What are some examples of biomedical research?

Examples include (but are not limited to...)

• Feeding participants
• Injecting participants with various substances
• Having participants exercise in various ways
• Attaching electrodes to participants
• Performing X-rays, CT-scans, MRIs, sonograms, blood pressure readings, EMGs, EEGs, EKGs, etc. on participants
• Having participants perform tasks that involve physical manipulations or actions (such as having the participant place their hand in cold water or walk up and down steps, etc.)
• Having participants use experimental drugs or medical devices
• Having participants wear devices (such as helmets used to hold tiny cameras that measure eye movements) or vests that measure body temperature (or perhaps change the temperature of the body), etc.
• The researcher may be taking hair and nail clippings, collecting spit, blood, dental plaque, bodily excretions (e.g., urine or feces), human tissues, etc.

What Type of Animal Activities Requires IACUC Review and Approval?

• Basically, if your activity involves vertebrate animals conducted under the auspices of the University, submit an application to the Office for Research Protections for review and approval by the IACUC.
• But, what is a vertebrate animal? A vertebrate animal is any non-human animal possessing a well-developed nervous system as characterized by the presence of a dorsal notochord protected by a vertebral column.
• According to Penn State University's RA15 (http://guru.psu.edu/POLICIES/Ra15.html), all animal activities, whether sponsored or unsponsored, conducted under the auspices of the University fall under the jurisdiction of the IACUC.
• What if I'm using animal tissue or established cell lines?
  • Animal tissue or parts collected from euthanized animals covered by approved IACUC protocols or from USDA inspected slaughterhouses, are exempt from IACUC review and approval. The principal investigator of the IACUC protocol is still responsible for ensuring that all tissue is disposed of appropriately. Investigators collecting material from USDA slaughterhouses need to dispose of the tissue in an appropriate manner. The Office for Research Protections is to be contacted if there are any questions regarding tissue disposal.
  • Established cell lines, as well as biological fluids and foods available as standard inventory from a conventional commercial supplier.
• What about preserved whole animals? The use of whole animals (live or dead) requires IACUC review and approval.

Who Needs to Submit for IACUC review and approval?

• If University faculty, staff, administrators, or students use vertebrate animals in a University activity, an application must be submitted to the Office for Research Protections (ORP) for review and approval by the Institutional Animal Care and Use Committee (IACUC).
• Policy RA15 is applicable to all Penn State colleges and locations except the College of Medicine located at the Hershey Medical Center. The College of Medicine maintains a separate assurance with the Office of Laboratory Animal Welfare for compliance.
• University activities involving the use of vertebrate animals at other institutions must receive IACUC approvals from both the cooperating institution and Penn State University. In the case of collaboration between the College of Medicine at Hershey and any other University location, the College of Medicine at Hershey will be treated as a cooperating institution.

Can I be a Principal Investigator on an IACUC Application?

• A principal investigator can be a faculty member, post-doctoral student, or staff member. For post-doctoral students serving as principal investigators, their supervising faculty member must be listed as an advisor and sign on the designated line. For staff serving as a principal investigator, their unit manager/leader must sign the application on the designated line. All principal investigators are required to have their department head sign the application on the designated line.
• Although graduate and undergraduate students cannot serve as principal investigators, they can be listed as co-investigators with a faculty member serving as the principal investigator.

Do I Need to Submit for IBC Review and Approval?

• You must submit an IBC application to the Office for Research Protections for review and approval by the Institutional Biosafety Committee (IBC) prior to the use of a biohazardous material in any activities conducted under the auspices of the University.
• What type of biohazardous material requires review? The categories below represent the areas of primary concern. Projects involving material(s) included in any of these categories must be submitted for review and approval by the IBC:
  1. Chemical Carcinogens used in conjunction with animals.
  2. Toxic/Infectious agents used in conjunction with animals.
  3. Oncogenic viruses used in conjunction with animals.
  4. Infectious agents requiring handling conditions above Biosafety Level-1. (Biosafety Level determinations are based on the recommendations outlined by the CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories .)
  5. Recombinant DNA (unless exempted by National Institutes of Health Guidelines).
  6. Human blood and blood products, human body fluids, and/or human tissue.
  7. Toxins produced by living organisms (>1 mg of pure toxin, or solutions with concentrations of >1 mg/ml pure toxin). This provision excludes toxins covered by the Select Agent regulations.
  8. Whenever a contractual agreement or grant proposal requires Institutional Biosafety Committee approval for the safe handling of a biological or chemical product.
  9. "Select Agents", as defined in Federal Regulation 42CFR72, Additional Requirements for Facilities Transferring or Receiving Select Agents, Public Law 107-188, Public Health Security and Bioterrorism Response Act, which are listed in Appendix A.
  10. Restricted Animal Pathogens/High Consequence Livestock Pathogens/Diseases, Toxins, and Listed Plant Pathogens, as determined by the United States Department of Agriculture (USDA), which are listed in Appendix B.
  11. Any research that requires a permit from USDA Animal and Plant Health Inspection Service (APHIS).
  12. Wild Poliovirus or materials that may contain wild poliovirus [contact Environmental Health and Safety (814) 865-6391 for additional information on this subject].Any research that requires a permit from USDA Animal and Plant Health Inspection Service (APHIS).

When is a University Isotopes Committee (UIC) Authorization Required?

• If you work with radioactive material, you must submit an authorization request to the UIC for review and approval.
• This does not cover naturally occurring radioactive materials in their normal concentrations and chemical states or those materials such as smoke detectors, luminous dials, or rare earths. Nor does this cover the purchase and use of Exempt radioactive materials such as sealed counting standards. However, the UIC may require authorization to possess or use such material if the potential hazard is comparable to licensed material. Environmental Health and Safety (EH&S) should be consulted before acquiring any radioactive material to determine whether an authorization is required.

What About Work at the Breazeale Nuclear Reactor?

• These rules do not apply to the operation of the reactor except as specifically made a part of the reactor's operating license. Radioactive material contained in reactor fuel elements, operating components, or supporting structure is exempted from these regulations and is covered by the reactor's operating license. Other radioactive material produced by the neutrons generated by the nuclear comes under control of the UIC upon removal from the reactor.

To Whom Does This Apply?

• These rules and procedures cover the possession, use, and transfer of all licensed radioactive material on University-controlled property by University personnel or others and by University personnel at other locations. This includes the non-University Park locations, but not the Hershey Medical Center. The medical center is covered by rules that are administered by committees separate from the University Isotopes Committee.