adverse event reporting, reports from Data Safety Monitoring Boards, or reports from collaborators, employees, staff, research participants, patients, family members, IRB Members or others. Research noncompliance may often be due to faulty communication or systematic error rather than the negligent actions of a single individual. Identification and investigation of noncompliance provides an opportunity for the improvement of faulty communication paths and systems, while honoring the respect of those who participate in human research. It is to this end that individuals are encouraged to identify and report suspected occurrences of research noncompliance. IRB Any allegation of non-compliance can be reported to the IRB, Office of Compliance and Services (OCAS), or Institutional Official (IO). An allegation may be reported anonymously to the confidential Compliance Line (877-349-SUNY or via ); however, anonymous reports must provide sufficient information to conduct an investigation, as the IRB or other officials may not be able to re-contact an anonymous resource. Allegations of research misconduct, privacy violations, or security violations will be referred to the appropriate departments for further investigation. All allegations of non-compliance are seriously. In the unlikely event that a PI is not willing to report an incident that requires reporting to the IRB, a study team member or anyone else, including a research participant, can report it to the IRB. The IRB may require additional actions or sanctions for a PI who was not willing to report the incident. No one may retaliate against anyone making a report. If an individual is uncomfortable with reporting apparent non-compliance through the above mechanisms, allegations of non-compliance or complaints may be made directly to the appropriate regulatory authority, such as the , , or . Any possible serious or continuing non-compliance must be promptly reported by the IRB to the Institutional Official (IO), and OCAS. The IRB Chair or Vice-Chair may do any of the following: Take interim action as needed to eliminate apparent immediate hazards or protect the well-being of research participants; Determine whether the concern is non-compliance; Determine whether non-compliance is not-serious and not continuing; or Determine whether non-compliance appears to be serious or continuing and as such, defer the review to the convened IRB and promptly notify the IO.
adverse event reporting, reports from Data Safety Monitoring Boards, or reports from collaborators, employees, staff, research participants, patients, family members, IRB Members or others. Research noncompliance may often be due to faulty communication or systematic error rather than the negligent actions of a single individual. Identification and investigation of noncompliance provides an opportunity for the improvement of faulty communication paths and systems, while honoring the respect of those who participate in human research. It is to this end that individuals are encouraged to identify and report suspected occurrences of research noncompliance. IRB Any allegation of non-compliance can be reported to the IRB, Office of Compliance and Services (OCAS), or Institutional Official (IO). An allegation may be reported anonymously to the confidential Compliance Line (877-349-SUNY or via ); however, anonymous reports must provide sufficient information to conduct an investigation, as the IRB or other officials may not be able to re-contact an anonymous resource. Allegations of research misconduct, privacy violations, or security violations will be referred to the appropriate departments for further investigation. All allegations of non-compliance are seriously. In the unlikely event that a PI is not willing to report an incident that requires reporting to the IRB, a study team member or anyone else, including a research participant, can report it to the IRB. The IRB may require additional actions or sanctions for a PI who was not willing to report the incident. No one may retaliate against anyone making a report. If an individual is uncomfortable with reporting apparent non-compliance through the above mechanisms, allegations of non-compliance or complaints may be made directly to the appropriate regulatory authority, such as the , , or . Any possible serious or continuing non-compliance must be promptly reported by the IRB to the Institutional Official (IO), and OCAS. The IRB Chair or Vice-Chair may do any of the following: Take interim action as needed to eliminate apparent immediate hazards or protect the well-being of research participants; Determine whether the concern is non-compliance; Determine whether non-compliance is not-serious and not continuing; or Determine whether non-compliance appears to be serious or continuing and as such, defer the review to the convened IRB and promptly notify the IO.