University of Hawai‘i
Research Compliance

Institutional Biosafety Committee (IBC)

Purpose and Responsibilities

The IBC is required to comply with NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) administered by the NIH-Office of Scientific Policy (OSP).

The purpose of the NIH Guidelines is to specify the practices for constructing and handling:

  • Recombinant nucleic acid molecules.
  • Synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules.
  • Cells, organisms, and viruses containing such molecules.

By NIH Guidelines, recombinant and synthetic nucleic acids are defined as:

  • Molecules that 1) are constructed by joining nucleic acid molecules and 2) that can replicate in a living cell,
  • Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acids, and
  • Molecules that result from the replication of those previously described.

As a condition for NIH funding of recombinant or synthetic nucleic acid molecule research, institutions must ensure that such research conducted at or sponsored by the institution, irrespective of funding shall comply with NIH Guidelines.

Failure to comply risks suspension, limitation, or termination of financial assistance of NIH projects or all NIH funding for recombinant DNA research projects (NIH Guidelines, section I-D).

To ensure compliance with this condition, institutions should establish and implement policies that provide safe conduct of recombinant synthetic nucleic acid molecules.  The NIH Guidelines call upon institutions to establish an Institutional Biosafety Committee (IBC) which carries out these responsibilities:

  • Review research projects involving subjects bioengineered using recombinant or synthetic nucleic acid molecules for conformity with NIH Guidelines.
  • Evaluate potential risks to environment and public health by determining appropriate containment levels per NIH Guidelines, adequacy of facilities, standard operating procedures, and personnel training.
  • Report institutional and investigator compliance (e.g. adverse incident reporting).
  • In basic and pre-clinical research, the committee has the authority to:
    • Lower containment levels for certain experiments in which nucleic acid from Risk Group 2-4 is cloned in non-pathogenic organisms.
    • Set containment levels for experiments involving transgenic or cloned whole plants and animals.
    • Adopt emergency plans covering spills, contamination, and other accidents.
  • For Human Gene Transfer (HGT) research, committees must ensure:
    • No participant is enrolled in a trial until Recombinant DNA Advisory Committee (RAC) review, IBC, and IRB approvals are obtained.
    • Issues raised by the RAC in public review are considered.
    • Final IBC approval occurs only after RAC review.
    • Investigator compliance with surveillance, data reporting, and adverse incident reporting.
  • Consider exempting research on a case-by-case basis for studies which are eligible in accordance with the NIH Guidelines.
  • Aside from reviewing studies using recombinant or synthetic nucleic acid molecules, the UH committee as with other institutional IBCs are assigned additional project review responsibilities not limited to these others areas:
    • Select Agents and Toxins
    • Bloodborne Pathogens
    • Xenotransplantation
    • Stem Cell Research
    • “Dual Use” Research of Concern
    • Nanotechnology
  • The UH committee is also required to comply with the State of Hawai‘i requirements which include the Hawai‘i Department of Agriculture importation regulations.

In fulfilling the requirements of ensuring research, testing, and instructional activities which use biological materials of recombinant or synthetic nucleic acid origin, the IBC evaluates biosafety registrations (proposals) for appropriateness of the activities to determine necessity of the work through scientific justification and the impact on the safety of personnel conducting the research, public safety, and effects on the Hawai‘i environment.

Composition of University of Hawai‘i Institutional Biosafety Committee

The University of Hawaii’s IBC is comprised of volunteer faculty and staff represented from its campuses and community colleges.  The University of Hawaii IBC is also represented by volunteer members from local government and community members unaffiliated to the University that express an interest is ensuring the research, testing, and instruction is conducted safely, compliant with regulations, and utilizes the best biosafety practices.

All members are appointed by the Office of the Vice President for Research and Innovation serving a three-year term.  The three-year term is subject to re-appointment upon satisfactory contribution to the University’s mission of ensuring the safety of personnel conducting the research, testing, and instruction.  The IBC members are genuinely concerned with the welfare of public safety and the effects on the Hawaii environment.

Pursuant to section IV-B-2-a, NIH Guidelines for Research Involving Recombinant Moleculethe IBC membership roster consists of the following representation below.

Member Composition

Member Designation Area of Expertise Number of Members
University Scientist Animal Medicine 2
University Scientist Infectious Disease 2
University Scientist Plant Pathology 1
University Scientist Plant Scientist 1
University Scientist Reproductive Biology 1
University Scientist Microbiology 2
University Scientist Biochemistry 1
University Scientist Human Subjects 1
University Scientist Marine Biology Scientist 1
University Scientist Arthropod 1
Non-Affiliated Member Animal Medicine 1
Non-Affiliated Member Infectious Disease 1
Institutional Member Animal Care Supervisor 1
Institutional Member Policy Consultant 1
Institutional Member Biosafety Officer 1
Institutional Member 1 Responsible Official 1
Institutional Member 2 Biosafety Program Manager 1

1 Responsible Official, Voting, Designated NIH IBC Biosafety Representative
2 Ex-offico, Non-Voting, Biosafety Program Manager

Biosafety Program Leadership

Institutional Biosafety Committee Officers

IBC Chairman
Eric Ako, DVM
Veterinary Practitioner

IBC Vice Chairman
Brandon Yoza, PhD
Assistant Researcher

Administration and Research Support

Responsible Official
Victoria G. Rivera, MPH
Director, Office of Research Compliance 

Program Manager
Norman K. Magno, MS
Compliance Officer, Office of Research Compliance

Biosafety Officer
Hubert B. Olipares, MSPH, SLC (ASCP)
Biosafety Professional, Office of Research Compliance

Acting IBC Coordinator
Stephen E. Case, MSPH

Education Coordinator
Stephen E. Case, MSPH
Biosafety Professional, Office of Research Compliance