Compliance Committees

HHRI convenes a number of committees for compliance and oversight of research including the Institutional Review Board (IRB), Conflict of Interest (COI), and Institutional Biosafety Committee (IBC), among others. Principal Investigators are asked to disclose their engagement with these various groups on the Application for External Support (App Ex) which starts the proposal or contracting process within the HHRI Grants and Contracts Office.

The purpose of the HHRI IBC is to ensure that research at HHRI is in compliance with NIH policies that provide for safe experimental conduct. The committee is chaired by researcher Dr. Andrew Harris with HHRI staff representation as well as external committee members, and is a member of the Biosafety Administrators Association. IBC approval is required for research that involves:

1. National Institutes of Health (NIH) non-exempt recombinant and synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing such molecules. Research using NIH exempt recombinant and synthetic nucleic acid molecules requires IBC approval when these molecules are used in combination with NIH non-exempt recombinant and synthetic nucleic acid molecules or other biohazardous agents (see below).
2. Other biohazardous agents including biological toxins, CDC/HHS/USDA-APHIS select agents and toxins, or infectious materials.
3. Human materials (e.g., blood, saliva, urine, tissue, cell lines). Studies involving collection of human materials using routine laboratory procedures do not require IBC approval.

Researchers planning to use the above materials must register their work with the IBC by submitting an application for IBC committee review and approval. Not sure if your work qualifies for IBC review and approval? Send your questions and/or applications to IBC@hhrinstitute.org. The IBC meets as needed to review submitted projects. The IBC application form and further information on the IBC can be found at: https://www.hhrinstitute.org/researcher-resources/institutional-biosafety-committee-forms-and-instructions/.

HHRI convenes a number of committees for compliance and oversight of research including the Institutional Review Board (IRB), Conflict of Interest (COI), and Institutional Biosafety Committee (IBC), among others. Principal Investigators are asked to disclose their engagement with these various groups on the Application for External Support (App Ex), which starts the proposal or contracting process within the HHRI Grants and Contracts Office.

The purpose of the HHRI Safety Committee is to ensure that research at HHRI is in compliance with NIH policies that provide for safe experimental conduct, as well as ensuring HHRI follows appropriate OSHA standards for safety by providing safety and training programs to train laboratory personnel in safe practices to protect workers from laboratory hazards. The committee is chaired by HHRI’s Laboratory Services Supervisor, Pa Houa Thor, with representatives from the administration, operations, and human resources departments, as well as a representative from each bench/preclinical laboratory operating in Shapiro. While the safety committee does not review and assign approvals for research studies like other committees do, the safety committee does actively review and promote safe usage of lab resources. The safety committee reviews workplace injuries and Great Catch! reports, conducts annual mock audits in preparation for the annual safety audits and safety fair, assists labs in ensuring compliance with sponsor requirements and monitoring, maintains the laboratory safety manual, and assists researchers in engaging with the HHS Radiation committee as needed.

Researchers planning to actively analyze or store research samples can get in touch by sending questions to HHRI-Operations@hhrinstitute.org.

HHRI convenes a number of committees for compliance and oversight of research, including the Institutional Review Board (IRB), Conflict of Interest (COI), and Institutional Biosafety Committee (IBC), among others. Principal Investigators are asked to disclose their engagement with these various groups on the Application for External Support (App Ex), which starts the proposal or contracting process within the HHRI Grants and Contracts Office.

The HHS Radiation Safety and Radioactive Materials Committee (RSRMC) manages the radiation safety programs at HHS and HHRI. The committee is responsible for developing the necessary written policies, procedures, and instructions to foster the "As Low As Reasonably Achievable" (ALARA) concept, where the institutions will limit the Ionizing Radiation exposures of employees, patients, and visitors. The RSRMC also authorizes the use of radioactive materials in HHRI research laboratories and is responsible for the approval of all proposals for radionuclide use and x-ray users.

Responsibilities that the committee has provided for HHRI include NEO/annual radiation training for HHRI personnel, maintaining the radiation safety manual, authorizing permit holders, receiving incoming radioactive packages, performing monthly wipes and surveys, performing lead apron testing, providing radiation safety badges, and decommissioning areas that no longer use radioactive material. For questions, please email HHRI-Operations@hhrinstitute.org.

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The purpose of the HHRI Intellectual Property and Technology Transfer Office (TTO) is to assist inventors in ascertaining, protecting, and commercializing intellectual property; complying with requirements for intellectual property developed under federal awards; and guiding employees through the patent application process with assistance from legal counsel.  The types of guidance and support that the TTO provides to potential inventors include:

1. Review inventions that have been disclosed by employees and work with them to determine the appropriate next steps.
2. Communicate with legal counsel about inventions to submit patent applications and respond to Office Actions by the United States Patent and Trademark Office (USPTO).
3. Discuss available options with the employee-inventor to develop a business and licensing process. The TTO can also provide Confidentiality Agreements, Material Transfer Agreements, and Licensing Agreements to facilitate the above.

Under the HHS and HHRI Intellectual Property policies, it is the responsibility of employees to disclose in writing new intellectual property to the TTO. Such disclosures should describe the innovation/invention but also detail any public disclosures and funding sources that contributed to the innovation/invention.  If you have an invention to disclose or if you would like more information about the TTO, please visit its webpage at: https://www.hhrinstitute.org/researcher-resources/intellectual-property-and-technology-transfer/

For general inquiries and questions about intellectual property or technology transfer, please email TTO@hhrinstitute.org