Welcome to your introduction to submitting a new protocol to the Institutional Review Board (IRB) at Teachers College (TC). On this page, you will find instructions on How to Submit a New Protocol, how to access the electronic application and template materials, and guidelines to ensure that you have provided a complete submission to the IRB.
Specifically, this page will provide you with the following information including how to complete the electronic applications. Click this guide for instructions on How to Submit a Modification, Continuing Review, Adverse Event, and Deviation. TC IRB Reviewers have created TC Reviewer Questions as an aid in both developing and reviewing your protocol prior to submission or making requested modifications. As an additional resource, please review our Preparing New Researchers for IRB document.
IRB protocols must be submitted before participant recruitment or research begins. Please review our Meetings & Deadlines page for information regarding the length of the review process. It is important that researchers allocate an adequate amount of time for the review process before scheduling to meet with participants.
Depending on the review category of your research, the review of a protocol will vary in length of time. A project requires IRB review if it includes both research and human subjects. TC IRB will make the final determination of whether a study requires review.
Identifiable private information includes "information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place,” (e.g. public bathroom) “and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be shared or made public" (e.g. health care record). (45 CFR 46.102(f)(2))
Identifiable means the information contains one or more data elements that can be combined with other reasonably available information to identify an individual (e.g. Social Security Number, name, and address). Researchers must take caution with identifiable data since disclosure of private information may place the subjects at risk of criminal or civil liability and/or damage their financial standing, employability, or reputation.
If you have questions about identifiable private information, please email IRB@tc.edu or call 212-678-4105.
Publicly available data is readily available to the broad public (e.g. census data, labor, or educational statistics). An investigator should not assume information qualifies as “publicly available” merely because it has been posted on an electronic website and can be accessed without authorization.
If you have questions about publically available data, please email IRB@tc.edu or call 212-678-4105.
TC’s Mentor IRB is the College’s IRB electronic protocol management system. TC Mentor IRB is designed to gather all the information and materials necessary for TC IRB reviewers to evaluate and approve the research in accordance with federal regulations and TC IRB policies. TC Mentor IRB can be accessed free-of-charge 24/7 from any computer with an internet connection.
You can access TC Mentor IRB by logging into the MyTC portal and clicking the Research tab. On the right side, you will find a link to TC Mentor IRB. Within TC Mentor IRB you will find forms, templates, and guidance documents including:
The research process begins long before an IRB protocol is ever submitted. The early process includes conceptualizing the different types of research subject to IRB review, getting human subject training certification, knowing your responsibilities, and preparing the correct personnel for your project.
This section includes the physical documents frequently submitted with an IRB protocol submission. It also outlines how to navigate TC Mentor IRB and further steps once an IRB protocol has been submitted.
Any changes to an approved protocol must be submitted as a modification. Here, you will find information regarding the different types of modifications and templates for submission to TC IRB.
Once an IRB protocol has been approved, it may be required to undergo continuing annual review.
When there is an unapproved minor or administrative departure from a study design, the primary investigator (PI) of a study will need to report a protocol deviation in order to remain compliant with federal and institutional regulations.
Though it is rare, a study may cause harm, increase in its risk of harm to participants, or result in a loss of privacy or confidentiality. These events must be reported immediately to TC IRB.
Once you have completed your data collection phase, you may terminate your protocol. The following section outlines the proper steps to closing a study.
For further information, please review the following sources:
Please be aware that not every document in this section is required when you submit your IRB protocol. These documents are intended to guide you towards submission. Please review the documents carefully and only upload materials for IRB review that pertain specifically to your research protocol.
Please note, using guides, checklists, or templates does not guarantee your protocol will be approved or that you will have a flawless review process. These documents will, however, offer some suggestions for how to frame your study materials for formal IRB review. Each protocol is reviewed on a case-by-case basis. For a detailed walk-through on how to submit a new protocol, please download How to Submit a New Protocol.