Guidance

Complaints from Subject or Others about a Research Study

IRBMED
Nov 14, 2011 12:30 pm

The table below presents instructions and guidance on reporting complaints from subjects or others.

  • Guidance on Reporting Complaints to IRBMED

    Type of ORIO Brief Description, Examples and Additional Information Reporting (calendar days) eR Section
    Complaint

    When subjects or others make complaints (to the principal investigator, the study team, or IRBMED), federal regulations require that investigators report those complaints to IRBMED at the time of the scheduled continuation review.

    If the nature of a complaint suggests a life-threatening risk and/or a change in the risk/benefit assessment, you should report the complaint as soon as possible, along with any appropriate amendments to the protocol and/or informed consent document.

    You should also report any complaint that highlights a systemic problem involving unanticipated risks to subjects or others.

    Please notify IRBMED if, in addressing the complaint, the investigator or research team requires advice or assistance from the IRBMED office (734-763-4768), Health System Legal Office (734-764-2178), or Public Relations (734-764-2220).

    To report a complaint prior to the time of scheduled continuing review, contact the IRBMED office and submit the report as an ORIO in eResearch.

    Please note that complaints whose eResearch status is Held for Scheduled Continuation will not be reviewed until you submit a scheduled continuing review application. The system is not designed to route the complaint automatically to the IRBMED’s inbox. If you would like IRBMED to review th

    SCR for routine or Contact IRBMED with potentially serious issue(s). 12

     

    Guidance Updated: 10/20/2011; Website Updated: 11/14/11

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-280

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: June 1, 2018 2:00 PM