After approval, investigators must fulfill certain obligations as identified in the Investigator Responsibilities section. In addition, individuals serving as a Research Advisor for a student investigation are subject to additional responsibilities attributed to that role.
When to contact the IRB
There are occasions when an additional IRB submission is required to either modify an approved project, continue the project beyond its initial term of approval, or to report an unanticipated or adverse event that occurred during the research.
To continue the study beyond the period for which it was initially approved, a Continuing Review Form must be submitted before the approval period expires.
Investigators must seek IRB approval before making any changes to an approved research study. Changes to the study protocol may not be implemented until approved by the IRB. Investigators must submit the Protocol Modification Form to initiate this process. When the IRB approves the amendment, the modified study replaces the previously approved study. However, when a change is necessary to eliminate an immediate hazard to the subject a change may be implemented without IRB approval and the IRB must then be notified right away.
Reporting Adverse Events or Unanticipated Problems
During the course of research, situations may occur that must be reported to the IRB. These include complaints from subjects, unanticipated problems involving risks to subjects, protocol deviations, adverse events, and significant new information or findings. If such situations arise, investigators must promptly submit an Adverse Event Report to the IRB. Reports should be submitted to the IRB chair within one week of their occurrence or within one week of the IRB’s request for such a report.
Reportable events include:
- Unanticipated problems– situations that are not foreseen in the approved protocol that present risks to subjects.
- Complaints- dissatisfaction, a breach of subjects rights/research ethics expressed by a subject or subject’s representative
- Protocol Deviation or Error- when research procedures are intentionally or accidentally not followed.
- If an apparent, immediate hazard to participants is identified, participants must be notified and corrective actions implemented as soon as possible. The IRB must be informed about these occurrences and the investigator must promptly submit a reportable event to the IRB.
- Adverse events- any untoward or unfavorable occurrence in a human subject temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
Investigators for studies approved through expedited and full review procedures must notify the IRB when human subjects research activities have concluded prior to the expiration date. Investigators should submit a Study Closure Report to the IRB when they have completed:
- obtaining data through intervention or interaction with subjects; and/or
- obtaining/using identifiable private information about subjects.