Federal laws governing the regulation of research require that universities appoint a high- ranking official, such as a CEO, COO, Director of Research, or Dean as the Institutional Official (IO). The Vice President for Research at OHSU is the OHSU IO. By federal law, the IO bears ultimate responsibility for OHSU research programs and their regulatory boards, including:
Institutional Care and Use Committee (IACUC) for animal research
Institutional Review Board (IRB) for human subjects research
Institutional Biohazard Committee (IBC) for recombinant or synthetic nucleic acid research and management of select agents
Conflict of Interest in Research Committee (COIR) for conflicts of interest in research
OHSU Stem Cell Research Oversight Committee (OSCRO)
Scientific Integrity Committee (SIC) for research misconduct
The IO, sometimes in collaboration with the Provost, selects members of research oversight committees. The committees report directly to the IO. The IO appoints the Chairs or Co-chairs. The committees have direct responsibility for decision-making and policy approval for research activities under their authority. The OHSU Office of Research Integrity (ORIO) provides administrative development and staff support to these committees. For more information please refer to the OHSU Policy Manual, the OHSU Research Integrity website, or federal regulatory resources such as NIH and Office for Human Research Protections.
An institutional review board (IRB), also known as an independent ethics committee (IEC), is a committee that approves, monitors, and reviews biomedical and behavioral research that involves humans. The IRB is charged with protecting the rights and welfare of the research subjects. The IRB may approve, require modifications in (to secure approval), or disapprove research. At OHSU, the IRB must review and approve all human subject research regardless of funding source.
IRBs must have at least five members who have varying backgrounds and diversity including, gender, race, cultural backgrounds, sensitivity to such issues as community attitudes. The IRB must include a member with a nonscientific background and a member who is not affiliated with the institution. For more information, visit CFR 46.107.
The primary function of the Institutional Animal Care and Use Committee (IACUC) is to oversee the care and use of laboratory animals for research, testing, and teaching, and for evaluating all aspects of the care and use program. The IACUC assists our faculty, students and staff in upholding the finest care and most humane utilization of animals at OHSU.As a result, every research, testing, and teaching project involving the use of a live vertebrate animal must be reviewed and approved by the IACUC prior to initiation. OHSU's IACUC is bound by two federal mandates, namely the Animal Welfare Act and the Health Research Extension Act.The Institutional Animal Care and Use Committee (IACUC) consist of at least one veterinarian who has training in laboratory animal science and expertise in the species under review and consideration, at least one practicing research scientist, at least one member whose primary concerns are in a nonscientific area (i.e., ethicist, lawyer, member of the clergy), and at least one person not affiliated with the institution to represent community interests in proper care and use of animals.
The Institutional Biosafety Committee (IBC) is an institutional committee created under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to review research involving recombinant DNA or synthetic nucleic acid molecules. The role of IBCs has evolved over time, and now also includes the review of research involving non-recombinant infectious agents and biological toxins. The IBC is responsible for ensuring compliance with the NIH Guidelines and assigning appropriate biosafety levels for the safe conduct of research.
The IBC must consist of at least five members, and must include expertise in recombinant DNA technology, biosafety and physical containment, persons knowledgeable in institutional policies and applicable laws, representative members from laboratory staff, two members not affiliated with the institution, and an animal expert.
The Conflict of Interest in Research Committee (CoIRC) is charged with the review of investigators' Conflict of Interest in Research (CoIR) disclosures to determine how to manage, reduce, or eliminate the potential conflict. As an institution that receives NIH grants, OHSU must comply with the Public Health Service regulation 42 CFR Part 50 Subpart F. This regulation promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under NIH grants, cooperative agreements or contracts will be biased by any conflicting financial interest of an Investigator.
Approval Timeframes - Service Level Understanding
ORIO is committed to service. Effective October 1, 2006, ORIO agreed to a Service Level Understanding, which helps it meet OHSU’s research needs as timely and efficiently as possible.