TC IRB Submission Document Templates & Samples

TC IRB Submission Document Templates & Samples

IRB Submission Document Templates & Samples

Researchers working with human subjects must submit their research plans and any research-related documents to Teachers College (TC) Institutional Review Board (IRB) for review and approval. Researchers may not begin recruitment or research until IRB has issued a final approval letter on the protocol. 

Submission Document Templates

TC IRB has designed templates for most documents required for IRB submission. The templates are located in MyTC/Resources/TC Mentor IRB (right hand side), or accessible through the Submitting a New Protocol page. 

Note: The Informed Consent, Parent Permission, and Assent Form templates are designed using a three-color-code-scheme: 

  • BLUE text includes suggestions from TC IRB where researchers can freely edit  
  • RED text is tailored for your study
  • BLACK text is standard and should be kept in the final consent form copy

The templates are not designed as one-size-fits-all documents. Instead, they are intended to help guide researchers through the most common submission contexts. Researchers should read through the templates carefully and consider their population of interest when creating final versions of documents. 

Researchers are responsible for informing individuals of the research study activities, expectations, risks, and potential benefits of study participation.

Sample Application Documents

When writing human subject research materials, investigators often use an academic writing style for both the IRB submission and participant materials. For information on distinguishing your writing style between a general and academic audience, please visit our Writing for an IRB Review page.

In addition to writing style, new researchers may struggle with knowing how to frame their research study within a TC IRB application. To assist researchers in the writing process, TC IRB has identified common types of studies frequently used among TC researchers and created sample applications with relevant explanations. Following these sample applications does not guarantee a protocol will be approved or that a researcher will have a flawless review process. It does, however, offer some suggestions on how to frame materials for a formal IRB review.

  • Exempt Category 4 - Existing Data Sample Application: This research does not involve new recruitment of human participants, and falls under Exempt Review. Researchers hoping to conduct this type of research must still submit an IRB protocol through TC Mentor IRB, however, many questions on the application related to participant recruitment and study activities should be marked “Not Applicable.” For more information on existing data studies, please visit our Exempt Existing Data Guide.
  • Multi-Activity Study Sample Application: Researchers with multi-part studies can combine these activities into one TC IRB application, so long as all activities relate to the research questions. Researchers planning to recruit participants must clearly outline each of the study activities that participants will engage in for TC IRB review. This sample application includes the following types of activities: 
    • Review of Public Data (Exempt Category 4)
    • Review of Existing Data (Exempt Category 4)
    • Anonymous Online Surveys
    • Audio-Recorded In-Person Interviews and Focus Groups

Sample Consent Documents

Language used on consent, parent permission, and assent forms should be tailored to the population of interest, taking into account the participants’ reading level and familiarity with research procedures. In all of these documents, researchers should aim to clearly state the following:

  1. The study activities
  2. The duration of time the activities will take
  3. Explanation of risks and benefits
  4. Compensation and any limits to receiving it
  5. Protections and limits of confidentiality

The consent samples outline different types of research studies and the information researchers should provide participants. Following these samples does not guarantee a protocol will be approved or that a researcher will have a flawless review process. It does, however, offer some suggestions on how to write consent materials for participants.

  • Online Survey Consent Sample Form: This consent form is for an online survey conducted with adults competent to consent. The following survey was part of an exempt study which posed minimal risk to participants. The sample demonstrates how to explain an online study to participants, as well as possible ways to obtain consent through digital platforms.
  • Audio Recorded Individual Interview and Focus Group Sample Form: This study pertains to in-person data collection with recorded elements. Researchers hoping to conduct interviews or focus groups over digital platforms (e.g., Zoom) may also use this sample as a guide.

For information specifically related to working with youth, please review The Assent Process with Minors Guide and the Obtaining Parent Permission Guide. TC IRB reviewers also provide their insights into the consenting process on TC IRB’s Blog, and in the TC Reviewer Questions.

Sample Memo Documents

Throughout the IRB process, circumstances may call for a Primary Investigator (PI) to follow-up with an IRB reviewer. These follow up actions may be required through modification memos or responses to IRB revision feedback. When planning to submit a new modification or respond to request for revisions, PIs should submit a memo style document describing their specific scenario, revisions to their protocol and documents, and a list of files associated with the change. To assist in the writing process and timeliness, the IRB has provided sample memos for PIs to follow. These samples do not guarantee a protocol approval or take place of the PIs specific responses, but can be used as a model for writing a memo.

  • Modification Memo Sample: This Modification Memo Sample can be used as a model for PIs when requesting modifications to an active protocol. This sample provides a format as well as examples of the adequate amount of information necessary for IRB administrators to review.
  • Revision Memo SampleThis Revision Memo Sample can be used as a model for PIs to respond to specific IRB administrator requested revisions. Following this format allows for both PIs and IRB administrators to effectively communicate protocol revisions and feedback.
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