Adverse event reporting to the IRB, and in some circumstances, Federal agencies and the Sponsor, is required by Federal regulation. The UMASS IRB has established the following policies and procedures for the reporting of adverse events as a means of ensuring that the risks and benefits relationship to subjects participating in research studies remains acceptable, and the consent form contains information necessary for subjects to make an informed decision about their participation or continuation in a study. Adverse event reporting requirements differ depending on the nature of the study.
Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] require the IRB to ensure that investigators promptly report "any unanticipated problems in involving risk to subjects or others." All adverse events as defined below must be reported to the IRB. The type of event as defined below determines the reporting requirements:
1. Significant Adverse Events
Investigators must report the event as soon as possible, but no later than five (5) weekdays after first awareness of the problem. Significant adverse events include, but are not limited to:
a. any death, excluding death due to the progression of a disease process; OR
b. the combination of the following three conditions:
unexpected - any adverse experience that is not identified in nature, severity, or frequency in the consent form, and is not due to the progression of a disease process.
serious – includes, for example, any experience that is fatal or life threatening, is permanently or significantly disabling (physically or psychologically), requires inpatient hospitalization or prolongation of hospitalization, contributes to a congenital anomaly/birth defect or is any medical event that requires treatment to prevent one of the medical outcomes listed above.
related/possibly related – as determined by the research team.
The same type of events from another study site should also be reported to the IRB within ten (10) weekdays of receipt.
The IRB relies a great deal on the expertise of our investigators to assess SAEs. Therefore, the investigator must provide advice concerning:
the relationship of the SAE to the drug, device, intervention, or study protocol
whether or not a change in protocol is necessary to minimize risks, and
whether or not information about the SAE is relevant to consent and/or re-consent of participants already enrolled.
Once the Principal Investigator (PI) determines that an adverse event meets the IRBs’ reporting requirements, he/she must report the SAE, and related safety information, to the IRB on the required Significant Adverse Event Report Form provided for this purpose. Supporting documents, including a copy of the Informed Consent (IC), should also be attached. For reasons of confidentiality, subjects names must not be included in the report. If the adverse event results in the need to revise the informed consent, or other study documents, the PI must submit a study amendment to the IRB.
2. Trends in One Type of Event
Any new trend toward one type of adverse event within a protocol, serious or not, should be reported to the IRB as soon as the trend is noted. This includes a trend in an expected side effect or noted risk that has created concern. Reporting Requirements: To report a trend, submit the Event Tracking Log with an explanatory cover letter.
3. Other Adverse Events
All events that do not meet the criteria of significant or trends as listed in numbers 1 and 2 above, should be recorded in summary form. Reporting Requirements All non-significant adverse events occurring in the research and judged by the research team to be related/possibly related to the research protocol should be recorded in summary form and included with the yearly Continuing Progress Report and at the close of the study. To create the summary, use the Event Tracking Log.
4. IRB Actions
Significant Adverse Events reports are immediately forwarded to Human Subject Administrator and IRB Chair. Reports result in the following actions:
Accept the report – no further action required.
Request additional information pending final action.
Recommend review by the original IRB reviewer(s) or the full IRB for possible action.
Require information concerning the adverse event be provided to subjects or others when such information may relate to their willingness to continue to take part in the research. In some cases, this may require changes in the informed consent, protocol, or other study documents, which may require reconsenting currently enrolled subjects.
If reviewed at a full IRB meeting, the Board may reconsider approval of the study, including suspension and/or termination, if it is determined that the adverse event has resulted in an increased risk to the subjects. In some cases, this could mean modifying (shortening) the continuing review cycle.
5. Reporting to the Sponsor
In accordance with the terms of the Federal Wide Assurance, the Office for Human Research Protections (OHRP) and the Federal Drug Administration (FDA) are notified in a timely manner of 1) serious or continuing noncompliance; 2) significant adverse events involving risk to participants or others; or 3) suspension or termination of IRB approval for a study. Unexpected problems involving risk, unless the event is serious and related to the research, are not routinely submitted to the sponsor.