Following initial IRB approval, you must inform the IRB of study changes and progress at least once per year by submitting reports for Continuing Review, Amendments, Adverse and Serious Adverse Events.
Every approved study must undergo Continuing Review well in advance of the IRB approval expiration date in order to avoid study interruptions. For Full Board studies, this is approximately one to two months in advance. Time intervals for such reviews shall be made at the discretion of the IRB but shall occur no less than annually, for Expedited and Full Board approvals. As a courtesy, reminders are sent to the study PI approximately 60 days in advance of the IRB approval expiration date.
Lapsed Studies Must Halt!
Studies that are not renewed prior to the IRB approval expiration date are considered lapsed, meaning no further research activities related to that study may be conducted, and the study may be terminated by the IRB if no action is taken by the PI within 30 days of the lapse date.
Any and all changes to an approved research study must be submitted to the IRB for review and approval prior to implementing the change(s) into the research study. Investigators with approved projects must submit an Amendment when any study design, informed consent content related to procedures, or the investigator team within an IRB approved research protocol is revised.
If immediate changes are necessary to eliminate apparent immediate hazards to the subjects, the investigator must submit a report to IRB to explain the protocol deviation, any subsequent outcomes to study subjects and the impact (if any) to the research. If permanent changes are necessary, a Protocol Amendment should be formally submitted for IRB review at the earliest opportunity.
Amendments involving minor changes that pose no more than minimal risk to subjects will be reviewed on an expedited basis. Amendments involving changes that pose more than minimal risk will be reviewed by the full board, at the next available IRB meeting. In general, amendments to protocols considered to be more than minimal risk, are reviewed by the full committee. Similarly, amendments to protocols considered to involve no more than minimal risk, are reviewed via an expedited review process. Changes may not be implemented until the PI receives final written IRB approval for the change. Below are some examples of situations that require that Amendment for IRB review:
- New or substantially rewritten questions or other changes in the content of a previously-approved interview or questionnaire
- Addition of or changes to new consent, assent forms or scripts
- Changes to the aspect of the informed consent process, including oral consent
- Changes in the population studied (minors as well as adults)
- Addition of or changes in study recruitment procedures, methods, or materials
- Change in the amount of compensation or method or time frame of providing compensation
- Changes in the principal investigator, adding a co-investigator or key personnel
- Addition of study personnel who will interact with human subjects or have responsibility for research data
- Data set enhancements, such as merging community, company or neighborhood-level data into survey records
- Any changes in research design, arms, duration or study locations
Serious Adverse Event (SAE) & Adverse Event (AE)
During the course of a research study, the principal investigator is responsible for keeping the IRB informed of any adverse events or problems that may affect the risk/benefit ratio (i.e. an increase in anticipated risk or a decrease in anticipated benefit). This includes any local adverse events as well as non-local serious adverse events that are unexpected, possibly or probably related to the research interventions, procedures or assessments, and place the subjects or others at increased risk of harm. The following provides guidance on which types of adverse events are required to be reported to the IRB and indicates the timeline for reporting.
An adverse event is defined as any untoward or unfavorable medical occurrence in a human research study participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, clinical event, or disease, that occurs during the subject’s participation in the research, whether or not it is considered related to the subject’s participation in the research. Adverse events encompass clinical, physical and psychological harms. Adverse events occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research. Adverse events, protocol deviations, unanticipated problem reports must be submitted to the IRB within the allotted reporting time frame.
The completion or termination of a study is a change in activity and must be reported to the IRB. A final report to the IRB allows the closure of all files as well as providing information that may be used by the IRB in the evaluation and approval of related studies in the future. Final study closures are required to be submitted to the IRB once your study is completed.
Contribution Release Request
The PI must budget for all salary support to cover study team time and effort, including coordinator time needed to use the required Clinical Trial Management System (e.g. data entry into CTMS). All budgeted salaries are inclusive of Fringe.
When developing a research budget, it is important to understand what percentage of effort the PI anticipates a study team member will have on a specific project over a precise time frame, especially when projects span several fiscal years. The PI should be aware of the hourly salary of that individual and what expected revenue from the project would be sufficient to cover that percentage effort on a yearly basis.
Consider that most trial revenue is based on per-subject enrollment. A percentage effort being paid out of a specified cost-center account will be debited regardless of any subject enrollment or revenue collection. This may lead to unintended study account deficits. This form may be requested as needed from Ascension Seton Sponsored Projects Finance.