10.0 Procedures for Reporting and Responding to Concerns About Research Involving Human Participants
10.1 Adverse Event Reporting
10.1.1 Reporting Requirements
10.1.2 IRB Review of Adverse Event Reporting
10.2 Notification of Procedures Preformed in Variance with the Protocol
10.3 Protections for Whistleblowers
11.0 Notification of Conclusion of Research Project
11.1 Retention of Records
11.1.1 Principle Investigator
11.1.2 IRB
If during the course of a research study, an adverse reaction (including unexpected events) does occur, a full board of the IRB must review these adverse events and reassess the balance between the risks and benefits to the subjects. The Principal Investigator has the primary responsibility of evaluating each adverse event for severity, likelihood of occurrence and relationship, if any, to the study.
- Serious Adverse Events A serious adverse event is such that results in any of the following: 1) death, 2) a life-threatening adverse event, 3) inpatient hospitalization, 4) a significant disability/capacity, 5) a congenital anomaly/birth defect, 6) any medical event that requires treatment (21CFR312.32)
- Unexpected Adverse Events An unexpected adverse event is any adverse event the specificity or severity of which is not consistent with the consent document or protocol. Unexpected refers to an adverse event that has not been previously observed rather than from the perspective of such experience not being anticipated (21CFR312.32)
10.1.1 Reporting Requirements
It is the responsibility of the Principal investigator to report serious adverse events and unexpected adverse events that occur during the course of the research to the IRB, the sponsor and federal monitoring agencies, if applicable and appropriate.
10.1.2 IRB Review of Adverse Event Reports
The IRB Chair shall review all serious adverse events that occur under the jurisdiction of the IRB within one business day of receipt. All other reports of adverse events shall be initially reviewed by a member of the IRB within five business days of receipt by the IRB Chair. After initial review, the adverse event shall be reported to the IRB members at a scheduled meeting and the IRB shall take one of the following actions:
- Note the occurrence of the adverse event but take no action
- Request additional information
- Require modifications to the protocol or consent document
- Revise the continuing review timetable, or
- Suspend the project
The Principal Investigator will be immediately notified in writing if his/her protocol is suspended. The Principal Investigator will also be contacted should additional information be required at any stage of the IRB review process or if changes need to be made to the protocol or informed consent document.
It is the responsibility of the Principal Investigator to inform subjects participating in an ongoing study of the occurrence of any adverse events related to the research that were unknown at the time the original informed consent document was signed. The IRB may make a determination as to whether or not subjects need be informed. The Principal Investigator must notify the IRB of when and how subjects are to be informed. Modifications to the consent document that include this new information must be approved by the IRB.
10.2 NOTIFICATION OF PROCEDURES PERFORMED IN VARIANCE WITH THE PROTOCOL
The Principal Investigator must submit a written report to the IRB within five working days of any activity that is conducted in variance with the protocol. The IRB Chair shall review the deviations that occur under the jurisdiction of the IRB. After initial review, the deviation shall be reported to the IRB members at a scheduled meeting and the IRB shall take one of the following actions:
- Note the occurrence of the adverse event but take no action
- Request additional information
- Require modifications to the protocol or consent document
- Revise the continuing review timetable, or
- Suspend the project
The Principal Investigator will be immediately notified in writing if his/her protocol is suspended. The Principal Investigator will also be contacted should additional information be required at any stage of the IRB review process or if changes need to be made to the protocol or informed consent document.
10.3 PROTECTION FOR WHISTLEBLOWERS
Retaliation against whistleblowers is considered scientific misconduct. Therefore, it is the policy of Drake University that persons expressing concerns or making allegations about a protocol involving human subjects will not be subject to retaliation, disciplinary action or other actions by the University if they act in good faith. This protection holds even if the concerns or allegations are found, upon investigation, to be without merit.
CONCLUSIONS OF RESEARCH PROJECT
11.0 NOTIFICATION OF CONCLUSION OF RESEARCH PROJECT
The research investigator is responsible for notifying the IRB that a research project has been concluded at which point the IRB will close its file. The Principal Investigator must submit a completed "Continuing Review or Project Termination" form noting that the research project has been completed and should be closed.
11.1.1 Principal Investigator Research data remain the property of the Principal Investigator and should be retained for at least 3 years after completion of the project. Individually identifiable data should be safeguarded by the research investigator and destroyed in the period defined under the approved protocol. Individually identifiable data will not be relinquished to any sponsor or outside entity. Summarized research results remain the property of the research investigator.
11.1.2 IRB Protocols and approved informed consent forms will be retained by the IRB for in a central accessible location for at least 3 years after completion of the project. All minutes and IRB documentation of discussion will also be held for at least 3 years after project completion.
