REPORT – AMENDMENT – MODIFICATION FORM
The WSU IRB is responsible for monitoring ongoing human subjects research and any changes,
modifications, or significant events. Annual reports are required for full board review studies longer than
one year. Expedited review studies may require periodic status reports if mandated by the IRB.
Principal Investigator:
Study Title (as approved):
IRBNet Project Number:
Report Type:
☐ Amendment / Modification
☐ Continuing Review
☐ Closure / Final Report
☐ Reportable Event or Incident
☐ Special Request to IRB
☐ Other (specify)
1. Specify the number of adult, minor, and total subjects who have participated in the study to
date.
Number of adult subjects
Number of minor subjects (under 18 years old)
Total number of subjects (adults + minors)
2. Specify the number of vulnerable or special populations who have participated in the study
to date.
Marginalized groups
Economically or educationally disadvantaged
Impaired decision-making capacity
Pregnant women
Fetuses
Human ova
Prisoners
Other vulnerable groups (specify)
3. Have any of the following occurred?
Yes No
☐ ☐ Change in study ending dates
☐ ☐ Change in research procedures, instruments, surveys
☐ ☐ Change in informed consent form(s)
☐ ☐ Changes in treatment of human subjects
☐ ☐ Unanticipated harm to human subjects
☐ ☐ Unanticipated problems or adverse events
☐ ☐ Changes in your or family’s business or financial situation which cause conflicts
☐ ☐ Other (specify)
4. If the response to any of the above was “Yes,” provide a brief description of the request
and/or the changes and your response to them. Upload appropriate documentation to the
new version of the IRBNet project package.
