NIU Institutional Review Board (IRB)
The Institutional Review Board (IRB) reviews research proposals that involve human participants to provide oversight in protecting the rights, welfare and wellbeing of subjects in research.
Applications for New Studies
In addition to completing the e-form application, a complete IRB submission package must also contain any of the following content that is relevant for a given study:
- All recruitment materials, such as flyers, advertisements, letters and/or the text of any emails or oral presentations.
- A copy of any letters or emails that will be used to seek permission from research sites, such as schools or medical facilities.
- Copies of all consent forms, parent permission forms, and/or assent forms.
- Copies of all measures used, such as surveys, focus group or interview questions, or visual image examples.
- A copy of any debriefing procedures, if applicable.
- A copy of any support service information that will be provided, if applicable.
All personnel on research projects involving human subjects who will interact with participants or have access to identifiable data must complete the CITI "Social and Behavioral Research - Basic/Refresher, Refresher Course" training program or provide documentation of equivalent training before beginning the research.
Please note that IRB policy now requires updated CITI training every five years.
IRB applications should be submitted through the InfoEd system a minimum of 20 business days prior to the date when the research will begin. Although it is often possible to receive IRB approval in less than 20 business days, approval times vary depending on the completeness of the application, the level of review required, and the volume of protocols under review.
Changes to Approved Study
Investigators are responsible for ongoing requirements in the conduct of approved research. This includes obtaining prior approval from the IRB for any modifications of the previously approved research before implementing the proposed modification unless the change is made to eliminate an immediate risk to the participants. More >
If the investigators change the research in order to eliminate apparent immediate hazards to subjects without prior IRB approval, they should report those changes promptly to the IRB.
Changes to a previously approved protocol may include adding or removing research personnel, changing the study population, requesting a greater number of participants, changes in compensation, changes in recruitment materials, or changes in study procedures or instruments. These and other changes to approved protocols should be submitted to the IRB for review on the amendment application form:
Please attach copies of any study materials which have been revised to the amendment application before forwarding it to the Office of Research Compliance, Integrity and Safety.
If you are unsure whether your changes can be handled as an amendment to your existing study, or would require a new application, please contact the Office of Research Compliance, Integrity and Safety (815-753-8588, email@example.com) for guidance.
Annual continuation of IRB approval is required for all human subjects research projects which are not Exempt. The Principal Investigator is responsible for fulfilling requirements associated with continuing review in time for the IRB to carry out review prior to the expiration date of the current IRB approval. The form should be submitted at least 15 days before the study’s expiration date for expedited review projects and 30 days before expiration for projects requiring full board review to ensure adequate time for the IRB to process the continuing review.
The expiration date for your project is located on the initial IRB approval letter for your project, or on the last continuing review approval letter. More >
The Office of Research Compliance, Integrity & Safety generates continuing review reminder notices for each active study. The Principal Investigator (and advisor, if this is a student project) will receive the continuation reminder by email, typically at least 30 days in advance for expedited review projects and at least 60 days in advance for projects requiring full board review.
Investigators are strongly encouraged to devise an additional system for ensuring the submission of continuing reviews. It is your responsibility to ensure that your project approval does not expire. If you misplace the continuation form or do not receive a continuation form from the Office of Research Compliance, you may either contact them for a replacement or use the following form:
Closing a Study
If all research-related interventions or interactions with human subjects have been completed and all data has been de-identified, the research project can now be closed. A continuation form should be completed for projects which are closed so that the IRB has a record of the final subject numbers for your project and can close out the file for your project.
Termination of a Study
If IRB approval expires before continuing review and approval occur, investigators must stop all research activities involving human subjects related to that study, except where they judge that it is in the best interests of already enrolled subjects to continue to participate. When investigators make this judgment, they must promptly notify the IRB. When the IRB reviews the investigator’s decision, it may decide whether it is in the best interests of already enrolled subjects to continue to participate in the research by considering the best interests of subjects either one at a time or as a group. If an IRB determines that it is not in the best interests of already enrolled subjects to continue to participate, investigators must stop all human subjects research activities, including intervening or interacting with subjects, or obtaining or analyzing identifiable private information about human subjects. Investigators may resume the human subjects research activity once continuing review and approval by the IRB has occurred.
Investigators have up to 30 days after the study expires to obtain approval. Otherwise, the IRB will close the study and a new IRB application will have to be submitted in order to resume the research.
Reporting Adverse Events or Unanticipated Problems
An adverse event is defined as: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (the event can be physical and/or psychological)
An unanticipated problem is defined as any incident, experience, or outcome that meets all three of the following criteria:
- Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents and the characteristics of the subject population being studied.
- Related or possibly related to participation in the research (there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).
- Suggests that the research places subjects or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized More >
The primary investigator of research approved for the use of human subjects is responsible for reporting any adverse events or unanticipated problems to the Office of Research Compliance (using the Reporting Form) as soon as possible, but no later than 7 days after first becoming aware of the problem. The principal investigator must independently begin initiation of any measures necessary to ensure subject safety while preparing and submitting the required reports.
The report must contain sufficient information for the IRB to make an assessment of risk. The IRB may request additional information from the PI, which should be provided within one business week, or sooner if specified by the IRB.
Event reports will be reviewed by one or more IRB members, typically the Chair or Vice-Chair or member designated by the Chair. Upon receiving a report of an unanticipated problem or adverse event, the IRB reviewer(s) may take one or more of the following actions:
- Acknowledge the report, with no changes to the informed consent and/or protocol necessary.
- Request additional information.
- Request changes to the informed consent and/or protocol in response to the report.
- Approve changes to the informed consent and/or protocol submitted by the PI in response to the report as long as these modifications are minor changes..
- Refer the report to the next convened IRB meeting.
- The research study may be temporarily suspended and/or the research study procedures discontinued/terminated. The IRB has the authority to suspend or terminate its approval of a study. When practical, such action will be taken by vote of the members at a convened IRB meeting. In the case of an emergency, in order to protect the safety of the study subject(s) the IRB Chair or a Vice-Chair may suspend enrollment and/or any portion of a study without waiting for a convened meeting of the IRB; however, the Chair or a Vice-Chair may not terminate the study. In such cases, the IRB Chair (or Vice-Chair, as appropriate) will notify the IRB members of the suspension at the next regularly scheduled meetings of the IRB.
A suspension/termination may be appropriate for any of the following reasons:
- Unexpected death or serious harm to a study subject.
- Unanticipated problems involving serious harm or risk of serious harm to a study subject, such as known or suspected contamination of a study drug.
- Failure of the Principal Investigator to provide information requested by the IRB.
- Known or potential non-compliance of the Principal Investigator and/or a research team member with human subject regulations or the requirements or determinations of the IRB.
- Other circumstances that, in the judgment of the IRB, the IRB Chair, or a Vice-Chair necessitate suspension/termination to protect study subjects from harm.
In all cases, in a timely manner, the IRB Chair or Vice-Chair will inform the Principal Investigator in writing of the suspension/termination. The letter to the Principal Investigator must state the reason for the suspension/termination. In cases of immediate, significant risk to human subjects, the IRB Chair or designee may communicate the suspension/termination orally while written materials are prepared. In the case of a suspension, the letter is to specify whether the suspension applies only to the enrollment of new subjects, or also requires the cessation of all study procedures on subjects who have already been enrolled.
In the case of a termination, no new subjects may be enrolled and all study activities involving enrolled subjects must cease. Exceptions may be made by the Chair or Vice-Chair in circumstances where subjects are receiving an intervention that cannot be discontinued for safety reasons. These potential instances will be reviewed on a case-by-case basis. The IRB Chair or Vice-Chair will immediately notify the Institutional Officials and the Research Compliance Coordinator of the suspension or termination.
IRB applications should be submitted to the Office of Research Compliance, Integrity and Safety (ORCIS) a minimum of 20 business days prior to the date when the research will begin. Please note that additional lead time is required for departmental review of applications prior to sending it to ORCIS. Although it is often possible to receive IRB approval in less than 20 business days, approval times vary depending on the completeness of the application, the level of review required and the volume of protocols under review.