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IRB Net Submission
All documents are submitted electronically on IRB Net. Information on how to register for this online submission method can be found in Energizer Researcher Registration. Contact Research Support Services for the log on and password to access the video and print the training tools for researchers available on this site.
When submitting documents, please remember to hit the “submit” button when you are finished. RSS staff cannot view your submission until this is done.
I. Does the COM-R IRB need to be aware of my proposed activity?
No investigator can make an independent determination whether their proposed activity constitutes human subject research. At a minimum, a Determination of Whether an Activity Represents Human Subjects Research form should be submitted to Research Support Services (RSS) for an administrative review of your activity. For more information on when an activity should be formally reviewed by the COM-R IRB please read to Determining Whether a Performance Site or an Institution is Engaged or Not Engaged in Research. II. What types of documentation do I need to proceed with my proposed activity?
Levels of Review:
Step 1
Administrative Review: New investigators should start with filling out the form entitled, Determination of Whether an Activity Represents Human Subjects Research. This form will help guide you through the fundamental stages that will help to accurately define your activity. By using this form you will be able to officially document your activity or be referred to the appropriate application form. If you are not prompted to use another form (driven by the answers you provide) then submit this form to the IRB Chair on IRB Net for an administrative review. This action will prompt a formal decision and response letter that you may use as proof that IRB review was not required.
Step 2
Step 3
Exempt Review:
Please refer to the instructions and Checklist for more details on this application for Exempt Review. Please use any recruitment templates and/or consent templates that apply to your research.
Expedited Review:
There are two application forms to choose from; Initial Application Social and Behavioral Science or Initial Application Biomedical Science. Both forms have checklists that can be used to insure all accompanying support documents are submitted with the application. Please note that both of these forms detail the research activities that dictate whether your study qualifies for expedited review. Please check the box(s) for all categories that apply to your research activity. If no boxes are checked, or your target subject pool is federally protected as a protected population , then your application will go to the next level of review.
NOTE:
A representative of the IRB can recommend a higher level of review if the protocol would indicate that a greater than minimal risk might be present for the research subject.
Convened Board Review:
This level of review is determined by two main issues:
1) does the research activity focus on a protected population, or
2) does the activity have a greater than minimal risk?
Step 4
What other types of approval may be required for my IRB submission?
Student PI:
If you are a student, your faculty advisor MUST electronically sign your application packet on IRB Net. Please grant your advisor full access to your submission packet. He/she will be copied on all communications.
Faculty PI:
Please grant IRB Net access to your department head. The department head will need to electronically sign your study packet and may be copied on communications concerning your protocol.
Department Head PI:
Please grant the Dean of your College access to your IRB Net study packet. The Dean will need to electronically sign your study and may be copied on communications concerning your protocol.
How long does the review process take?
There are many steps involved in the IRB and the length of time it takes for a protocol to get through the process and be approved can be contingent on the number of revisions that may be necessary. The various steps are:
1. Pre-submission Review:
Research Support Services will review your submission packet and send written comments on items that need to be addressed before all documents are ready for the official IRB review. This process can vary depending on how many submissions are currently under review. Reviews are conducted in the order that they are received unless some extending circumstances are noted. This process can take from one to two weeks and could take longer if many modifications are required.
2. Formal Reviews:
Administrative and Exempt Reviews:
After the pre-submission stage is complete, protocols go to the IRB Chair for review. The goal of the IRB Chair is to have a decision within one week. At this point, check your e-mail for notices concerning your IRB Net submission packet. If changes are required, a Request for Modification Letter will be posted in your IRB Net study packet. E-mail notification will be sent to the PI that a letter has been posted.
Expedited Reviews:
After the pre-submission stage is complete, protocols go to the IRB Chair for review. After the assigned IRB reviewers have made written comments, RSS staff will notify the PI with the status of their submission. Check your e-mail regularly for updates. If changes are needed a Request for Modification Letter will be posted in IRB Net. The Expedited process can take up to a month depending on how many revisions are necessary prior to approval.
Convened Board Reviews (also called Full Review):
After the pre-submission stage is complete, protocols are assigned to the next IRB meeting. The IRB meets the first Friday of every month unless it is a holiday or there are no protocols to vote on. The submission deadlines are posted in the Research Calendar of Events.
Length of Approval Period:
IRB approval is valid for a maximum of one year. Based upon the risk of the research or the inclusion of a particularly vulnerable population, the IRB may determine that a shorter approval period is appropriate.
Step 5
Subsequent Reviews:
All subsequent reviews must be uploaded into the IRB Net study packet. Please submit to new study packet that will keep the same IRB Net ID number but will have the next sequential version packet. A tutorial is available in IRB Net subsequent applications.
Modifications to your protocol or documents:
An investigator must obtain prospective IRB approval for any change to any aspect of the research (design, subject number, subject population, eligibility criteria, procedures, questionnaire, consent document, recruitment material). Please refer to Instructions for Amendments.
Adverse or unanticipated events:
The investigator is required to promptly notify the IRB if any subject experiences an unanticipated problem. This includes: an additional risk to subjects or others (defined: physical injury, improper disclosure of private information, economic loss, other harmful or potentially harmful occurrences), subject complaints that involve unexpected risks, protocol violations, changes to the protocol made without prior IRB approval, immediate hazards to subjects, or any noncompliance. For more information go to AE Reporting.
You will receive e-mail notification at 90, 60, and 30 days prior to the expiration of IRB approval. If you want to continue your research activity you must submit a Continuing Review application with all required support documents into you IRB Net study packet. Please refer to Continuing Reviews .
Final Reports:
When you have completed your research you MUST submit a Final Report.
Graduating students will have a hold placed on their diplomas until their Final Report is received.
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