WU Research Integrity Policy 2010 Revision Presentation for the Committee on Research Integrity for the School of Medicine December 1, 2010 Attachment 9

Revisions Revision: Combined Policy and Procedures documents into single comprehensive Policy document Re-organized to achieve more understandable format Added new sections for further clarity History: WU maintained separate RI Policy and RI Procedures ORI Review of WU Policy ORI determined WU policy and practice are compliant ORI suggested revisions for clarity & inclusion of regulatory/procedure elements into Policy document Attachment 9

Policy Changes Suggested by ORI Created a specific Retaliation Protections Section Outline protections for all involved in RI proceedings Describe process for reviewing allegations of retaliation Include all elements of Federal Regulations at 42 CFR 50 and 93 – Some of the details were in our Procedures and not specifically in the Policy Notifications – Expanded to more closely match regulations Attachment 9

The core principles and requirements of the Policy remain unchanged. The primary revisions include the following: Format revisions to help with flow and usability Clarified the rights and responsibilities for all parties that may be involved in research misconduct proceedings Expanded protections from retaliation Expanded the details for sequestering and handling of evidence Added information on admissions of guilt to outline the steps taken if a respondent chooses to admit to the allegations against him/her Expanded the applicability and definitions Attachment 9

Rights and Responsibilities Expanded on elements from previous policy to provide further clarity: Covers all parties to a proceeding Requires confidentiality Requires good faith – Complainant who makes allegation – Respondent who must respond – Committee members who must deliberate Attachment 9

Sequestering & Handling Evidence Expanded on elements from previous policy to provide further clarity: Requires all parties to provide evidence material to the allegations Allows respondent copies of, or supervised access to, evidence in order to defend against allegations Requires maintenance of records by VCR Attachment 9

Voluntary Admissions of Guilt Added to the policy: All admissions of guilt required to be in writing CRI must be satisfied that no other misconduct exists apart from admission ORI requires prior notification if admission of guilt will close case Attachment 9

Protections from Retaliation Expanded on elements from previous policy to provide further clarity: The University will not tolerate acts of retaliation If any person involved in a research misconduct proceeding feels s/he has been adversely affected by retaliation, they should notify the RIO, RECO, CRI, or VCR immediately Review of allegations of potential retaliation will be a two step process as described in the following slides Attachment 9

Administrative Review process for Potential Retaliation RIO responsible for taking reasonable and practical steps to protect individuals from retaliation Based on observations and/or conversations with the individuals involved in the proceedings, including the CRI members, the RIO may determine administrative steps are needed to address any potential opportunities for retaliation Attachment 9

Administrative Review process for Potential Retaliation Administrative steps may include, but are not limited to, seeking intervention by Human Resources, discussions with the Department Head to develop actions to assure protection, consultation with OGC or other steps necessary to protect against retaliation. The RIO shall update the CRI on the steps taken to protect the individual. Attachment 9

Review Process for Formal Complaint of Retaliation If administrative steps have not provided adequate protection, s/he may submit a formal written complaint – Upon receipt of a formal complaint, the RIO will appoint a subcommittee of the CRI to review the compliant – The CRI subcommittee will Interview individuals as appropriate prepare a written report of their findings and recommendations for resolution and submit it to the Dean and VCR – If an individual is found to have committed retaliation, the VCR, in conjunction with the dean, will take corrective actions, which are final – The RIO will update the CRI on the decision of the dean and VCR and the corrective actions taken Attachment 9

QUESTIONS? Attachment 9