What Every Researcher Needs to Know

Responding to Subject Complaints

Researchers and research staff must be open to subject complaints or requests for information.   If a research subject voices concerns about your research, you should promptly respond to those concerns and notify the IRB of the issue. When applicable, you should seek assistance from the Committeee and guidance from IRB staff.  Research subject concerns, regardless of seriousness, must be promptly addressed and the study must be further evaluated to mitigate future concerns of additional participants.

Reporting

Research subject concerns should be reported to the IRB office within 10 days. Researchers should utilize UPIRTSO reporting guidelines and they should provide support materials when submitting information concerning subject concerns.  Refer to the following link for UPIRTSO reporting guidelines). 

Researchers must take into account departmental policies and procedures when resolving any complaints or concerns arising from the conduct of research.  

Response

If HRPP staff contact you in response to a research subject concern, you should respond to that request at the first possible opportunity and address the questions posed by HRPP staff.  Complaints from subjects must be addressed immediately.  Researcher responsibilities included responsiveness to subject complaints.

Assistance

Yes, HRPP and IRB members are available to assist researchers in addressing any research subject complaint or concern.  Please contact the IRB office at 612-626-5654 or irb@umn.edu for assistance.  You may also refer to the following link for additional contact information: http://www.research.umn.edu/hrpp/directory.html