Tuesday, October 1 3, 2 015 at 4 :28:32 PM M ountain Daylight Time Subject: CSM-­‐Faculty-­‐Announce: Out-­‐Of-­‐Cycle Handbook Changes: Conflict of Interest and Disclosure Requirements Date: Wednesday, October 7, 2015 at 9:02:55 AM Mountain Daylight Time From: Thomas M. Boyd <tboyd@mines.edu> (sent by faculty-­‐announce-­‐bounces@mailman.mines.edu <faculty-­‐announce-­‐bounces@mailman.mines.edu>) To: faculty-­‐announce@mines.edu <faculty-­‐announce@mines.edu> Dear Faculty, Please find aUached documents related to a request the AdministraVon has made of the Board to consider an out-­‐of-­‐ cycle Handbook revision. Details of the request are provided below. By way of this communicaVon, I would like to extend to the Faculty the opportunity to comment on the requested revisions. Please provide me your thoughts by close-­‐of-­‐business, Thursday, October 15. Immediate Impact to Faculty: To conform with federal requirements and conVnue to receive federal grants, faculty will be required to: 1) make conflict-­‐of-­‐interest (COI) disclosures on at least an annual basis that include financial conflict disclosures and cerVfy that these disclosures are complete as part of the annual faculty evaluaVon process and 2) complete federally mandated conflict-­‐of-­‐interest training. IniVally, COI disclosures will be made via an electronic (word and pdf document) disclosure form, as we implement a campus-­‐wide workflow product, the disclosure process will move to a fully on-­‐line process. Issue: In December 2014 new federal regulaVons regarding the governance of federally-­‐funded research became effecVve (Uniform Guidance). This guidance mandates stricter requirements for award recipients to monitor their sub-­‐ recipient compliance with federal regulaVons, including conflict of interest (COI). In response to requests by prime award recipients to verify our compliance with federal regulaVons, we have found that our current conflict of interest policies and pracVces do not meet federal requirements. As a result we can: 1) no longer cerVfy on federal grants and contracts that our COI policies and pracVces meet federal requirements, and 2) faculty who have sub-­‐recipient awards are now being required to agree to, and meet, other insVtuVons’ COI policies and procedures. The former issue will ulVmately impact all research-­‐acVve faculty. The laUer issue currently impacts 15 faculty and is growing. COI Policy Deficiencies: The Office of Research AdministraVon (ORA) has done an exhausVve review of our current COI policies and pracVces. The following deficiencies have been idenVfied and require remediaVon to bring our COI policies and pracVces into compliance with federal regulaVons. We lack a documented requirement and procedure for the collecVon of annual COI disclosures, including required financial holdings disclosures. We lack a COI training program that meets federal requirements. We lack a centralized repository for all COI disclosures and COI management plans, and we have not idenVfied an insVtuVonal official to handle and retain all COI disclosures and management plans. We lack the required processes for monitoring and cerVfying compliance of subcontractors and sub-­‐ recipients. Changes Being Proposed: Given these shortcomings in our COI policies and pracVces we have recommended to the Board the following Page 1 of 2 Given these shortcomings in our COI policies and pracVces we have recommended to the Board the following acVons: Minor modificaVons to SecVons 6.3.4 and 12.14 of the Faculty Handbook that define separate COI and COC (Conflict of Commitment) disclosure pathways for faculty. DeleVon of SecVon 10.4 of the Faculty Handbook, which is the Board policy on “Research Conflict of Interest,” accompanied by the creaVon of a stand-­‐alone, insVtuVon-­‐wide, Board policy on “Conflict of Interest” that defines conflict of interest disclosure requirements that are in compliance with federal requirements. CreaVon of an annual conflict of interest disclosure form and review process. Faculty, on at least an annual basis, will be required to make COI disclosures and cerVfy these disclosures are complete as part of the annual faculty evaluaVon process. IdenVfy the Director of the Office of Compliance and Policy as centralized repository for all COI disclosure and management plans. Materials Included in this CommunicaAon: For your review and comment, I have aUached to this communicaVon the following documents: Redlined versions of SecVons 6 and 12 of the Faculty Handbook. Stand-­‐alone “Conflict of Interest” policy that would replace secVon 10.4 of the Faculty Handbook. Proposed annual COI disclosure form. Below are a few links to annual COI disclosure requirements, processes and forms used at other insVtuVons: Stanford University: hUps://doresearch.stanford.edu/research-­‐scholarship/conflicts-­‐interest/coi-­‐disclosure-­‐ and-­‐review-­‐procedures MIT: Website -­‐ hUp://coi.mit.edu, Worksheet -­‐ hUp://coi.mit.edu/research/sites/coi/files/coi-­‐pi-­‐worksheet-­‐ 2013-­‐0718.pdf CU-­‐Boulder: Website -­‐ hUp://www.colorado.edu/vcr/coi/gehng-­‐started, Worksheet -­‐ hUp://www.colorado.edu/vcr/coi/forms-­‐checklists CSU: Guidelines and Requirements -­‐ hUp://provost.colostate.edu/media/sites/75/2015/08/COI-­‐Guidelines-­‐ and-­‐Resources.pdf Thanks… Tom ___________ Thomas Boyd Associate Provost and Dean of Graduate Studies Colorado School of Mines Golden, CO 80401 (303) 273-­‐3020 (voice) (303) 273-­‐3244 (fax) Page 2 of 2