Complaints from Research Participants

Complaints from research participants must be addressed by members of the institution to ensure that suitable resolutions can be identified to protect the rights and welfare of research participants. A participant may voice a concern or complaint directly, or a representative of the participant may voice the concern or complaint on behalf of the participant. When addressing participant complaints, appropriate privacy and confidentiality protections must be in place throughout the process to ensure protection of the participant.

Participant complaints received by the PI and study team

If a participant complaint is received by the investigator or study team, the investigator must ensure that the complaint is addressed and resolved in a method that protects the rights and welfare of the participant and is consistent with the IRB-approved study. All complaints must be reported to the IRB, according to the following guidelines:

1. If the complaint meets the definition of an Unanticipated Problem, the investigator must report the complaint promptly to the IRB using a Report Form (see instructions below).
• It may not be possible to completely resolve the complaint prior to the prompt reporting deadline; however, the investigator must still report the complaint promptly and should describe the current status of the compliant resolution in the Report Form as well as a plan for future action toward resolution.
• If the complaint involves possible non-compliance or research misconduct, the Report Form will be reviewed according to IRB and institutional policy.
2. If the investigator is unable to resolve the complaint satisfactorily with the participant, the complaint should be reported to the IRB using a Report Form (see instructions below). The Report Form should be submitted promptly at such a time as it is determined that the problem cannot be resolved without additional help from the institution.
3. If the complaint does not meet either of the two criteria above, the investigator must report the complaint at next continuing review using the continuing review application.
• The investigator must provide a short summary of the complaint, how it was resolved, and why it did not meet criteria for prompt reporting as an Unanticipated Problem.

If the complaint results in the need to change the IRB-approved study, an amendment must be submitted to the IRB in order for these changes to be reviewed and approved in addition to the Report Form.

Participant complaints received by the IRB

If a participant complaint is received by the IRB, the IRB takes necessary steps to address the complaint. If the complaint identifies a specific study of concern, the investigator of the study is contacted to assist in addressing the complaint. The investigator must then complete a Report Form (see instructions below) to document receipt of the complaint as well as the process used to address the complaint in collaboration with the IRB. The IRB reviews these Report Forms according to the Unanticipated Problem and/or Non-Compliance policies, as appropriate.

Participant complaints received by an institutional official outside of the study team

Any participant complaints received by a member of the institution outside of the study team must be reported to the IRB by contacting the IRB Director. The IRB then follows the steps outlined in the section above to address the complaint.

How to Complete the Report Form

For complaints that require prompt reporting as described above, follow these instructions:

1. Open the study in ERICA
2. Click on the Report Forms tab
3. Click on the File a Report Form button
4. Indicate on the first page, question 2, that this is a report of "Information"
5. Indicate on the second page that this is a complaint report
6. Complete the report form entirely
7. Attach any supporting documentation to the report form in the indicated sections
8. If you are submitting an amendment in conjunction with the report, link the report form to the amendment in the "Report Forms" section of the amendment application
9. Submit the report form to the IRB for review