• Purpose: To describe the policy for redacting the minutes of convened meetings of the Harvard University Institutional Biosafety Committee, commonly referred to as COMS (Committee on Microbiological Safety).
  • Applicability: The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) require that IBC minutes and documents be made available to the public on request. (Section IV-B-2-a-7)  The previous Section (IV-B-a-2-6) acknowledges that the protection of privacy and proprietary interests is sufficient to redact portions of minutes.  The NIH Office of Biotechnology Activities has issued two documents pertaining to minutes (Q&A 5/14/04; Guidance Memo 2/23/07).  In order to ensure redaction is performed consistently, the following procedure is adopted.
  • Definitions
    • Principal Investigator: The Principal Investigator (PI), or also known as a Project Director or Program Director, is one or more individuals designated by the institution to direct the project or program supported by the NIH grant.  Having more than one PI does not diminish the responsibility of the individual PI.  On behalf of the institution, the PI(s) is responsible for full compliance with the NIH Guidelines in the conduct of recombinant DNA research.
    • Office of Biological Safety: Records and ensures timely review of public comments.  Reports comments and COMS response to the NIH OBA and institutions.
  • Implementation Procedures
    • Information not redacted:
      • Statement that members recuse themselves from discussion/voting due to a conflict of interest.
      • Basic information related to risk assessment and containment levels required by the NIH Guidelines for proposed research
    • Information not released to the Public:
      • Home telephone numbers and home addresses of COMS members
      • Information that is likely to compromise institutional or national security.
      • Whether and/or where Select Agent work is ongoing.
      • Trade secret or other confidential information
      • Principal investigator names
      • Laboratory locations
      • COMS members names
      • Guests names
      • Proprietary information is received from sponsors of clinical gene transfer studies
      • Proprietary information is received from investigators with patents pending.
      • Proprietary information related to personnel matters.
    • COMS Provision of Public Comments to the NIH Office of Biotechnology Activities: In accordance with the NIH Guidelines, COMS shall allow for public review of its actions through the provision of meeting minutes to those that have requested such documentation. COMS, in consultation with the appropriate institutional Biosafety Officer and Office of General Counsel, shall review and respond to all written public comments received in response to public review of meeting minutes in a manner that is consistent with any redaction policy noted in these policies and procedures.  Public comments and COMS’ response shall be forwarded in writing to the NIH Office of Biotechnology Activities by the Director of COMS in a timely manner at the below address:
      • National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985 (20817 for non-USPS mail)
      • NIH guidelines require COMS to provide copies of its minutes to any member of the public, respond to public comments received, and report such comments and COMS’ response to the NIH. In addition the guidelines encourage COMS to have its meetings open to the public.
  • Policy Authority: The Office of Biological Safety of the Harvard Medical School is responsible for supporting the Committee on Microbiological Safety.  This includes preparation of IBC meeting minutes as well as the associated record keeping.
  • Related Policies
    • Policy on Minutes of IBC Meeting