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.
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:
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.
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.
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:
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.
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.
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.