Human Participant Incident

12. Human Participant Incidents

If any human participant incurs injuries or experiences adverse events associated with study procedures, or any problems involving the conduct of the study arise the IRBPHP must be notified. In addition, if any individual of the Dominican community becomes aware of possible breach of human participant protection in any research activity at Dominican University of California they should report the incident to the Institutional Review Board for the Protection of Human Participants within ten working days. The Human Participant Incident Report Form is found in Appendix M.

The following problems having to do with human participant safety must be reported to the IRBPHP:

• adverse effects associated with study procedures.

• problems involving conduct of the study or participation of the human participants such as recruitment and/or consent processes

Any serious or recurring problem, any anticipated side effect, any adverse effect reported to a study sponsor, and adverse effect requiring treatment or any side effect about which the human participant is concerned should be reported to the IRBPHP.

A report is not an admission of liability. For adverse effects, the researcher should determine whether changes should be made to the study procedures. While the IRBPHP does not actively monitor compliance with the guidelines set forth for research with human participants, it is responsible for continuing review of research involving human participants involved in the annual review process for on-going research.

Serious adverse effects or incidents are forwarded to the Dean of the researcher’s school and to the Vice President for Academic Affairs. Failure to report adverse effects/incidents involving human participants in research at Dominican is a breach of the conditions of approval and can result in suspension or revocation of IRBPHP approval.

In addition, the IRBPHP, in cooperation with the Office of the Vice President for Academic Affairs, will conduct an inquiry following any report of possible misconduct that may be reported by members of the campus community relative to research involving human participants conducted at Dominican University of California. An inquiry will be made to the researcher conducting the study and if the investigator is a student, to the student’s faculty advisor, maintaining requested anonymity of the individual submitting the report whenever possible. The IRBPHP will forward information about the incident to the Dean of the researcher’s school and to the VPAA for appropriate resolution.