IRBMED - UMMS

ORIO Guidance: Complaints

When subjects or others make complaints directly to the Principal Investigator or Research Team, federal regulations require that these be reported to the IRBMED at the time of Scheduled Continuation Review (SCR) (along with complaints made directly to the IRBMED of which the investigator received notice).

If the nature of the complaint is such that it indicates a potential life-threatening risk and/or change in the risk/benefit assessment the complaint should be reported sooner, along with the appropriate amendments to the protocol and/or informed consent document. See ORIO Timetable.

In addition to the SCR report, the investigator should report a complaint, when:

Upon analysis of the complaint the investigator realizes it indicates a systemic problem involving unanticipated risks to subjects or others.
If the nature of the complaint is such that the investigator or research team requires advice or assistance from the IRBMED Office (763-4768) or Health System Legal Office (764-2178), or Public Relations (764-2220), immediate notification is encouraged.

To report a complaint prior to the time of Scheduled Continuation contact the IRBMED OFFICE.

Please note that, in eResearch, complaints labelled in the status bar as "Held for Scheduled Continuation" will not be reviewed until the scheduled continuation review (SCR) application is submitted.

• This does not mean that the SCR is due sooner than indicated by the expiration date of the study.

• If, in the opinion of the investigator, the IRBMED should review a particular complaint sooner, email or post correspondence advising the IRBMED of such. eResearch will not route it to the office's attention automatically.