109.3 Organization Policy on Complaints from Research Participants, Investigators and Research Staff, the Community, etc.

September 2020

It is the policy of the Organization that the Office of Human Subjects Research (OHSR) and the JHM IRBs will receive and respond to complaints or other concerns from research participants, investigators, research staff, and members of the community. Staff in the OHSR will work with the parties involved, obtaining information and if applicable contacting the Principal Investigator of the implicated study in order to achieve satisfactory resolution. Staff will also notify the Associate Dean for Human Research Protection of the complaint or concern.

The Associate Dean will make a determination as to whether the issues raised warrant additional action, including the scheduling of a review of the matter by the JHM IRB of record. When applicable, the Associate Dean may consult with the members of the JHM IRB of record, the General Counsels, the Vice Dean for Clinical Investigation, or other Organization officials.

Complaints from research participants must also be reported by Principal Investigators to the JHM IRBs at the time of continuing review and via a PER where the complaint meets the criteria for prompt reporting.