New researchers may underestimate the amount of time it will take for an application to go through the Teachers College Institutional Review Board (TC IRB) review. TC IRB recommends approximate review times on our Meetings & Deadlines page.
“Before you Begin” your IRB application, review resources to determine if your work needs IRB review. If you have determined your project is a systematic investigation with human subjects, you should review the “Submitting a New IRB Protocol” section on TC IRB’s website. All IRB protocol submissions are reviewed through TC Mentor IRB. To access Mentor IRB, login to the MyTC portal and click the Faculty, Student, or Employee Resources tab. On the right side, you will find a link to Mentor IRB. Researchers can visit this link for a master list of “How To” guides for navigating Mentor IRB.
Researchers can also prepare for their IRB protocol review by applying the following tips, guidelines, and checklists to their protocol submission documents.
1. Follow Templates, Guidelines, and Checklists to Develop IRB Documents
Prior to submitting an IRB application, researchers should ensure that they have prepared all the necessary documents for submission. All protocols require an but some may also require consent documents (e.g., Informed Consent Form Template), site permission forms (e.g., Site Permission COVID-19 Template), data sharing documents (e.g., Data Sharing Form Template; Data Release Form Template), translated documents, or other documents depending on the type of research and proposed study activities.
IRB Application Tips
When submitting an IRB protocol, researchers should include the IRB application. In the , researchers should be prepared to include at minimum...
- A summary statement detailing:
- that the project is research and participation is voluntary,
- a summary of the research, including the study purpose, duration, and list of procedures,
- reasonable, foreseeable risks, or discomforts,
- reasonable or expected benefits,
- alternative procedures or course of treatment, if any.
- The study activities, including:
- a description of what each participant will be asked to do,
- how long each activity will take,
- how often study participants will engage in each activity, and over what period of time (provide an estimated total duration).
- The type(s) of data to be collected and the ways in which it will be collected or transferred.
- How the researchers plan to minimize the risk of coercion, bias, conflict(s) of interest, or undue influence (especially if working with vulnerable populations).
- For intervention research and/or research with vulnerable populations, an explanation of how the study activity differs from typical daily routines.
- Recruitment methods and procedures, along with any recruitment materials (e.g., recruitment script, email text, flyers, etc.).
- A description of how participants will be compensated. If using a raffle, including the odds of receiving the gift (e.g., “At the end of the survey, you will have the option to enter your email address into a raffle for a $30 Amazon gift card. Your email address and survey responses will be stored separately. Your chances of receiving a gift card are 1/100. Only the person whose name is drawn for the raffle will be contacted via email.”)
Researchers can also consult the Protocol Guidance Checklist for new IRB application submissions.
2. Proofread All Documents
Before submitting any protocol documents to the IRB, it is important to ensure that there are no spelling errors or grammatical mistakes that could slow down the review process. Proofreading before submitting a protocol for review will allow IRB administrators to more easily and efficiently read through the materials.
Student researchers can also contact the Graduate Writing Center for writing support.
The Graduate Writing Center has trained consultants equipped to provide student researchers guidance on writing an IRB protocol.
In addition to proofreading for spelling errors, researchers should ensure readability for a general adult audience (6th to 8th-grade reading level) on documents that will be read by potential research participants (e.g., informed consent forms, parent permission forms). Assent forms should be written in age-appropriate and plain language tailored to the needs of the youth. The Flesch Reading Ease test and the Flesch-Kincaid Grade Level test can be used to check the document’s reading comprehension level. To use these tests in Microsoft Word, navigate to File menu > Options > Proofing tab. Under the “When correcting spelling and grammar in Microsoft Word” heading, check the box labeled “Show readability statistics.” Then, exit the options menu and return to the document. Next, run a standard spelling and grammar check to view the document’s readability scores. The first score is the Flesch Reading Ease test, and the second score is the Flesch-Kincaid Grade Level score.
3. Name Files According to TC IRB’s Filing System
Researchers should name files in a clear and easily identifiable way; for example, “IRB Protocol#_Document Title_Date_Final (or “TrackedChanges”).”
- Example: 11-111_AssentForm_04212021_Final
- Example: 11-111_AssentForm_04212021_TrackedChanges
4. Allow Enough Time for an IRB Protocol Review
Researchers should allow 7 to 10 business days for a protocol to go through a pre-review at the Exempt and Expedited levels. Full Board reviews are conducted on a monthly basis; the deadlines to submit all materials are posted on our Meetings & Deadlines page. Pre-reviews are conducted to ensure all CITI certifications are up-to-date, appropriate files have been uploaded, and there are no outstanding questions that may hinder the formal review process.
A common misconception is that research studies under the Exempt review category do not need to be reviewed by a member of the IRB. Studies in this category must still be submitted to and reviewed by TC IRB, just not by the Full Board. Therefore, it is important to keep in mind that even for exempt protocols, the researcher should allocate an appropriate amount of time for the study to be reviewed. For more information on Exempt studies, please visit our IRB Blog and read our "Get to Know an Exempt Category" series.
5. Expect a Revision Process
The IRB review process is an ongoing exchange between the researcher and compliance administrators, in which both parties work together to ensure federal and institutional regulations are met and all participant protections are in place. As part of this engagement, researchers can expect to receive requests for revisions or questions from an IRB administrator about their submitted IRB protocol. These questions are not meant to dissuade or prevent the researcher from conducting their study activities; rather, IRB administrators are typically trying to gather more information in order to fully understand the study and confirm that the protocol meets the highest ethical standards. Revisions or questions that researchers may receive include:
- Clarifying questions about the study activities, data security measures, participant recruitment methods, and/or consenting procedures.
- Edits to the application and/or consent documents to more clearly articulate the study in a way that participants can understand.
- Requests for additional required documentation (such as site permission forms, data release forms, etc.).
Researchers can use messages within Mentor IRB (upper right-hand corner) to ask the IRB administrator questions about a specific protocol. Researchers can also consult the TC Reviewer Questions as they draft their IRB application.
6. Respond to Request for Revisions
Researchers who receive requests for revisions will sometimes need to make changes to existing protocol documents or upload new documents for review. Researchers can make the changes in the following ways:
- MEMO: Address each point in the request for revisions one-by-one in a memo format. Please copy each numbered item into the Request for Revisions Memo Template and include a response.
- TRACKED CHANGES: In response to requested revisions, researchers should submit all documents that they were asked to revise (e.g., consent forms, recruitment materials, application, etc.) using the “tracked changes” feature to clearly show changes within the document.
- FINAL VERSION: Researchers should include a clean copy (free of tracked changes or editor marks) of all the files in their final format.
Any revisions should be submitted through Mentor IRB/My Protocols using the Upload option on the appropriate file types. Researchers can find the Upload option on the context menu (little red notebook icon) in Mentor IRB to the immediate left of each file type title. Please check the "Submit Revisions for Review" check box on the protocol to submit revisions and email the IRB with "[Protocol Number], Submitted Revisions" in the subject line to have the protocol put back on queue for review.
7. Follow Through with the Review Process
Once revisions have been submitted, it is possible that the IRB reviewer may have additional questions or requests for revisions based on the updates to the protocol. After all revisions have been reconciled, the IRB will approve the protocol and send the researcher a copy of the official IRB approval letter via email. A copy of the approval letter is also saved within the protocol in Mentor IRB.
Recruitment of a site or use of recruitment materials may not be used until the IRB protocol is approved. All studies with informed consent forms (parent permission or assent forms) must contain an official IRB authorization stamp which will be applied to the documents after final approval. Copies of the official IRB authorized stamped consent form and supporting documents should be used for research work. TC IRB is the only authorized department to issue a TC IRB authorization stamp.
TC IRB is here to support researchers throughout the IRB process. Researchers who have questions can schedule a virtual meeting with an IRB administrator or contact us at IRB@tc.edu.