Office of Primary Responsibility: Subject:
Vice Chancellor for Research and Engagement Institutional Biosafety Committee
1.0 Purpose
The University of Massachusetts Amherst (the University) has an Institutional Biosafety Committee (IBC) in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines, 2002) and in accordance with Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, 2007. The following sections describes the University’s policy and procedures for the IBC
2.0 Policy
The IBC follows NIH Guidelines for practices for reviewing projects that require constructing and handling: (i) rDNA molecules, and (ii) organisms and viruses containing rDNA molecules. The IBC also reviews activities involving use of Select Agents and Toxins and other biohazardous agents that must be handled at BSL3 and 4. The IBC will assist the Biosafety Officer (BSO) in the Department of Environmental Health & Safety (EH&S) in formulating policies and procedures related to the use of biohazards. The IBC is also charged with reviewing the biological and medical waste management program annually according to The Department of Public Health’s regulation on the minimum requirements for the management of medical and biological waste CMR 480.000 The IBC may advise the institution and the Principal Investigator (PI) concerning management of research that is classified as “dual use”.
3.0 Procedure
3.1 IBC members are appointed by the Vice Chancellor for Research and Engagement for 3-year terms. At the end of a member’s term he/she may be reappointed for a further term.
3.2 IBC membership conforms to NIH Guideline IV-B-2-a-(3).
3.3 The IBC meets no less than four times a year for review of projects using rDNA that require review at NIH review level IIIE and higher, or for any other matter within the scope of the committee. A meeting is conducted in person or via conference call. A quorum is a majority of the membership. When possible, and consistent with the protection of privacy and proprietary interests, IBC meetings are open to the public.
3.4 The Research Compliance Coordinator serves as Executive Secretary to the IBC including preparation of IBC minutes and filing reports with OBA. Annual Reports to OBA are filed on or before the anniversary of the previous Annual Report. Reports of significant problems or violations are reported to OBA within 30 days of the incident
3.5 An IBC member may not be involved in the review of any project in which he/she or a close relative or spouse has a personal or financial interest.
3.6 The IBC may approve a registration for a period of up to 5 years.
3.7 The PI is notified in writing that a registration has been approved by the IBC. The approval letter includes the registration number, expiration date, and any other pertinent information and special approval conditions. Approval letters for reviews conducted at NIH review level IIIE may be signed by the Executive Secretary. All other approval letters are signed by the IBC Chair.
3.8 The IBC has been granted authority to investigate potential violations or compliance problems related to its area of oversight
3.9 Requests from members of the public for documents relating to IBC activities are handled in accordance with provisions of the Massachusetts Open Records Law (M.G.L. c. 66, § 10) and University policy for handling requests for documents related to research. The University policy documents a process for review and redaction of research records before they are sent to a requestor. The institution’s response to a request for records is handled in consultation with Legal Counsel. The Vice Chancellor for Research and Engagement responds to the request.
Approved by Vice Chancellor for Research and Engagement Michael Malone
