Controlled Substance Policies Regarding Noncompliance
BU Controlled Substances Program Policies Regarding Noncompliance
Investigator’s Responsibility for Monitoring and Reporting
In the event that the Investigator becomes aware of any loss, diversion, or noncompliance with regard to controlled substances—through his or her own observation, reports from research staff, results of audits, or other avenues—the Investigator must notify the CS Officer within 24 hours after the occurrence, or first awareness of it. Investigators should have adequate systems in place to ensure that they will be made aware of any such matters known within the research staff.
If an Investigator or a member of his or her staff knows or suspects that a forced entry has occurred in a laboratory or CS storage area, the Investigator or staff member must immediately notify Security and the CS Officer.
CS Officer Response to Potential Loss, Diversion, or Noncompliance
- Preliminary Review: In the event that the CS Officer becomes or is made aware of a potential loss, diversion, or noncompliance with regard to controlled substances, the CS Officer will report all such matters to the Associate Vice President for Research Compliance.Upon receiving notice of the matter, the, Associate Vice President for Research Compliance in consultation with and assisted by the CS Officer, will take appropriate steps to attempt to obtain promptly any additional information needed to assess the seriousness of the matter and determine if:
- immediate suspension of Investigator’s CS Privileges is warranted, and
- the matter is reportable under Federal or MA regulations.
If it is determined that the matter is reportable, the Associate Vice President for Research Compliance or the CS Officer will so immediately notify the Institutional Official and legal counsel from Boston University or Boston Medical Center as appropriate. In most cases, the Associate Vice President for Research Compliance or CS Officer will also inform the Investigator of the matter and seek a response from the Investigator.
- Suspension by Associate Vice President for Research Compliance: As deemed warranted by the circumstances, including the seriousness and nature of the alleged noncompliance, the Associated Vice President for Research Compliance may immediately suspend the Investigator’s CS Privileges, including acquisition of and access to controlled substances.If, at any time, as a result of further review and assessment, circumstances that warrant suspension come to the attention of the Associate Vice President for Research Compliance, then suspension may be imposed in accordance with the foregoing paragraph.
- Further Review and Assessment by Associate Vice President for Research Compliance: Whether or not immediate suspension is deemed warranted, the Associate Vice President for Research Compliance will consult the CS Officer and legal counsel for Boston University or Boston Medical Center, as appropriate, and shall determine what, if any, further facts or information is required to assess the matter and the most appropriate method of doing so. Methods may include, but are not limited to, the following:
- special audit;
- and/or consultant review.
The Associate Vice President for Research Compliance, with assistance as indicated above, will gather further information as needed. The Investigator will ordinarily be given an opportunity to respond to information gathered in the course of such a review by the Associate Vice President for Research Compliance.
- Imposition of Corrective Action: The results of the review, including any response by the Investigator, will be assessed by the Associate Vice President for Research Compliance and the CS Officer. The Associate Vice President for Research Compliance will determine whether to accept the findings of the report or to request further review and assessment. The Associate Vice President for Research Compliance may take appropriate steps to impose corrective action, as necessary, to ensure that noncompliance is corrected and not repeated, including, but not limited to, the following:
- corrective action plan or educational measures;
- intensive CS Program monitoring including direct observation, short approval period or periodic special audits for a designated time;
- increased reporting by the Investigator of his/her controlled substance activities;
- suspension or revocation of approval or use of controlled substances in one or more of the Investigator’s studies; and/or
- suspension or revocation of the Investigator’s CS Privileges.
Reporting of Evidence or Allegations of Scientific Misconduct
In accordance with the Boston University and Boston Medical Center Policies and Procedures Concerning Allegations of Misconduct in Scholarship and Research, Associate Vice President for Research Compliance and all others involved in conducting and overseeing research should ensure that all evidence and allegations of scientific misconduct, as defined in the applicable institutional policies, are transmitted to the appropriate Dean or Director for handling under these separate institutional policies and procedures.