AB21--Intent to Sole Source: Institutional Biosafety Committee (IBC) at Dartmouth College

Performance Work Statement

Project 1: Provide the services of the Institutional Biosafety Committee (IBC) and Institutional Biosafety Committee for Clinical Gene Transfer (IBC CGT) at Dartmouth College to the White River Junction Veterans Affairs Medical Center (WRJVAMC) for the purpose of maintaining compliance under the executed Memorandum of Understanding between White River Junction Veterans Affairs Medical Center and Trustees of Dartmouth College.

Description: The IBC and IBC CGT at Dartmouth College report to the Vice Provost for Research and are managed by the department of Environmental Health & Safety (EHS). The IBC, or IBC CGT where appropriate, reviews all WRJVAMC protocols that use recombinant or synthetic nucleic acids (r/sNA) subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) and approves or disapproves the proposals based on compliance with the NIH Guidelines. The IBC/IBC CGT report their findings to the WRJVAMC Subcommittee for Research Safety (SRS) and the SRS cannot approve a protocol that uses r/sNA without prior approval by the IBC or IBC CGT. All additional specific obligations of both the IBC/IBC CGT and WRJVAMC detailed in the Memorandum of Understanding shall be adhered to.

It is mandated by VHA Handbook 1200.08 to have these committees (IBC and SRS), and that these committees are comprised of members with sufficient expertise. The WRJVAMC does not have sufficient expertise in the area of r/sNA to constitute its own committee. The vendor shall ensure all members are highly qualified.

WRJVAMC will pay Dartmouth for the support and oversight outlined above and shall automatically increase an annual amount equal to three percent (3%) upon each subsequent year.

Notwithstanding the foregoing, if the cumulative number of hours expended by Dartmouth in performing any Services described herein exceeds forty (40) hours in any twelve (12) month period during the term of this SOW, Dartmouth will charge the VA for each additional hour or portion thereof. Should the number of hours expended by Dartmouth exceed forty (40) hours, a modification will be prepared to compensate Dartmouth for the increased hours.