RIC Procedures Table of Contents

Procedures for Responding to Allegations of Scientific Misconduct

	(MUSC Policies and Procedures are currently under revision to reflect changes in the revised PHS Policies which became effective June 16, 2005)
I.	Introduction
II.	Definitions
III.	General Procedures and Principles
	Responsibility to Report Misconduct Protecting the Complainant Protecting the Respondent Confidentiality Responding to Allegations Employee Cooperation Evidentiary standards Burden of Proof Standard of Proof Completion of Process Early Termination Referral of Non-Scientific Misconduct Issues HHS Criminal Violations Violation of Human and Animal Subject Regulations Violation of FDA Regulations Fiscal Irregularities Requirements for Reporting of ORI
IV.	Preliminary Assessment of Allegations
	Allegation Assessment PHS Support PHS Definition Sufficient evident to proceed Referral of Other Issues
V.	Conducting the Inquiry
	Initiation and Purpose of the Inquiry First Steps If an Inquiry is Necessary Sequestration of the Research Records Immediate Sequestration Institutional Access Original Records Sequestration of the Records from the Respondent Inventory of the Records Security and Chain of Custody Notification of the Respondent Contents of Notification Potential Respondents Designation of an Official or a Committee to Conduct the Inquiry Use of an Inquiry Committee Use of an Inquiry Official Inquiry Process Appointment of the Inquiry Committee Committee Membership Experts Bias or Conflict of Interest Objection by Respondent Condifentiality Provision of Assistance Charge to the Committee and the First Meeting General Approaches to Conducting the Inquiry Avoid Bias or Conflict of Interest Refer Other Issues General Approaches to Conducting an Interview Purpose of the Interview Issues to Cover Confrontation Using Experts Transcribing Interviews Confidentiality of Interviews Access to Counsel Order of Interviews Interviewing the Complainant Interviewing the Respondent Recording Admissions Committee Deliberations
VI.	The Inquiry Report
	Elements of the Inquiry Report Comments on the Draft Report by the Respondent and the Complainant Confidentiality Receipt of Comments Inquiry Decision and Notification Decision by Deciding Official Notification Time Limit for Completing the Inquiry Report
VII.	ORI Oversight
	Decision to Investigate Decision Not to Investigate Access to Evidence
VIII.	Referral to Other Agencies
IX.	Conducting the Investigation
	Purpose of the Investigation Sequestration of the Research Records Notification of the Respondent Designation of an Official or a Committee to Conduct the Investigation Use of an Investigation Committee Use of an Investigation Official Appointment of the Investigative Committee Committee Membership Experts Bias or Conflict of Interest Objection to Committee or Experts by Respondent Confidentiality Charge to the Committee and the First Meeting Charge to the Committee The First Meeting Developing an Investigation Plan General Approaches to Conducting the Investigation Avoid Bias or Conflict of Interest Refer Other Issues Consult with the Research Integrity Officer and Institutional Counsel Reviewing the Evidence The Interview Process Conducting the Interviews Preparing for Interviews Objectivity Transcribing Interviews Recording Admissions Committee Deliberations Burden and Standard of Proof Definition of Scientific Misconduct Sufficient Evidence
X.	The Investigation Report
	Elements of the Investigation Report Background Allegations PHS SUpport Respondent's Claims Analysis Findings PHS Issues Misconduct under the Institution's Policies Institutional Actions Summary Standard Format of the Investigation Report Overview and Summary of Findings PHS Funding Background List of allegations and othe issues identified by the investigation committee Institutional Inquiry: Process and Recommendations Institutional Investigation: Process Institutional Investigation: Analysis Conclusions and Recommended Institutional Actions Attachments Documenting the Investigative File Index of Evidence Purpose of Documentation Record Retention Comments of the Draft Report Respondent Complainant Institutional Counsel Confidentiality Institutional Review and Decision Transmittal of the Final Investigation Report to ORI Time Limit for Completing the Investigation Report
XI.	Institutional Administrative Actions
XII.	Other Considerations
	Termination of Institutional Employment or Resignation Prior to Completing Inquiry of Investigation Restoration of the Respondent's Reputation Protection of the Complainant and Others Allegations Not Made in Good Faith Interim Administrative Actions
XIII.	ORI Review of the Investigation Report and Follow-up
	Purpose of ORI Review Cooperation with ORI Review Request for Additional Documents and Information Notification of ORI Determination ORI Concurrence ORI Nonconcurrence Cooperation in Appealed Cases
XIV	Record Retention
APPENDIX
	Responsibilities of the Deciding Official Responsibilities of the Research Integrity Officer Receipt of Allegations Assessment of Allegations Conduct of Inquiry Conduct of Investigation Pre-Investigation Post-Investigation Responsibilities of the Research Integrity Commmittee Conduct of Inquiry Conduct of Investigation Resource to Constituent College
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Last Update: 2/7/07