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Reporting Research Concerns and Complaints
We are concerned about the safety, rights and welfare of all individuals participating in research projects at CSUSM and its affiliated sites. We take all research concerns or complaints that are reported to us very seriously. Below, please find the information about how to report research concerns and complaints. Please review our CSUSM IRB policy that details the procedures here.
Study Participant or Other Individual who Wishes to Report a Concern or Complaint: Please fill out and submit the Research Concerns and Complaints Reporting Form for Participants or Other Individual to share your concern or complaint with the IRB Office.
Researcher/Principal Investigator/Study Investigator who Wishes to Report a Concern or Complaint by a Study Participant or Other Individual: Please fill out and submit the Research Concerns and Complaints Reporting Form for Researchers to share concern or complaint brought to your attention by a participant or other individual that you have resolved.
Reporting a Participant Concern or Complaint to the IRB
You must report any significant complaint or concern to the IRB as soon as possible. A complaint or concern is significant if it may adversely impact a participant's or a potential participant's safety, rights or welfare. Additionally, any complaint/concern that requires a change to the study protocol or consent form is considered significant.
Please note that most reported concerns and complaints are minor and routine, e.g. subject complaint about late study payment. You do not need to report minor or routine concerns that can be resolved quickly to the IRB office. When you have a concern or complaint about a study, the first step is to contact the researcher (also referred to as the "principal investigator" of the project/research study or "study investigator") directly.
Responding to Participant Concerns or Complaints as the Researcher/Principal Investigator
As the researcher/principal investigator/study investigator, you and/or your research team are obligated to make a good faith effort to promptly respond to - and to try to resolve - any study-related concern or complaint you receive or of which you are aware promptly. You are obligated to fill out the reporting form (through the link provided above) and document the concern or complaint by a participant or other individual and the resolution on your Minor Revisions Form if and when you make revisions to your research study.
When CSUSM IRB Office Receives Concerns or Complaints Directly
We are obligated to receive and respond to concerns and complaints reported to us directly by study participants or other individuals. When this occurs, we will attempt to resolve minor concerns or complaints with the complainant informally. If the participant or other individual has not reached out to the researcher prior to filling out the reporting form, then we will refer the participant or other individual back to the study team as a first step. If the participant or other individual reached out to the researcher, and did not hear back from the researcher or the resolution was not satisfactory and we judge the concern or complaint to be significant, then we will contact the researcher.