All problems involving risk to subjects or others, injury, or other adverse effects experienced by subjects in research and incidents of noncompliance must be immediately reported to the IRB via e-mail or phone. A report should be submitted as soon as possible, but NO LATER THAN 5 WORKING DAYS after first awareness of the problem.
While a Report of Adverse Event or Unanticipated Problem must be submitted by the principal investigator or the student researcher's faculty advisor through Cayuse IRB, a Report of Non-Compliance can be submitted to email@example.com by any person(s) aware of the non-compliance.
Noncompliance refers to conduct of research that is inconsistent with the requirements or determinations of the IRB (including but not limited to the IRB-approved research protocol, informed consent document or process) or an allegation of such noncompliance. Examples of noncompliance include but are not limited to the following:
- Research personnel did not obtain written consent for a study that involved collection of discarded tissue. While no harm occurred, failure to obtain consent violated the research participant's rights.
- Enrollment of participants prior to IRB approval or after IRB approval has expired.
- Continued treatment of participants without obtaining permission from the IRB after IRB approval expired.
- A researcher enrolls a participant that does not meet all of the inclusion criteria, while the unmet criteria puts the participant at risk of harm.
If you have any questions, please contact the IRB staff at firstname.lastname@example.org or (714) 628-7392.