Forms and Guidelines
Below you will find the New Study Application Form, Informed Consent, Participant's Rights and Assent for Minors Forms, the HIPAA Authorizatin Form, the Continuing Review Application and information for sending a Memo to Modify an approved Protocol. You will also find Reference Materials for applying for TC and for NYC DOE IRB approval.
Any online, email and paper-based recruitment materials, announcements and text must include the study's IRB Protocol Number. This provides assurance to potential participants that the study and recruitment materials have been reviewed and approved, and also allows the IRB to identify the study and verify the study's validity. If the IRB learns of a study's posting or recruitment without this information, the posting or flyer will immediately be removed. The IRB would also like to remind researchers that all materials to be distributed to participants or potential participants in a study must include the IRB Protocol Number or be photocopied with the IRB stamp which includes the IRB Protocol Number and IRB Approval Expiration Date.
New Study Application Forms
Applicants who wish to have the IRB review proposals for new studies will need to download the following forms:
Investigators who will be collecting private, identifiable heath information (PHI) as part of their research are subject to the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA). Click here for more information on HIPAA. If your research is subject to HIPAA and you plan on obtaining HIPAA authorization from subjects, click here to download the HIPAA Authorization Form.
How to request changes to a previously approved protocol
Please submit a Memo to Modify your study, addressed to the IRB, that contains the following information:
- PI name, project title and protocol number
- Faculty advisor name, if applicable
- Briefly describe the changes you wish to make, making reference to the specific sections of the original protocol, and summarize both the original contents of those sections and the changes you wish to make, and explain why the changes are necessary
- Attach new consent forms, survey instruments, recruitment materials and/or IRB approvals/ permissions from cooperating institutions if new institutions have been added, as applicable.
Here's an example of how a revision memo should look:
To: TC Institutional Review Board
From: PI X, Biobehavioral Studies
Re: The Effects of Sleep Deprivation on Next Day willingness to perform (IRB 02-399).
The description of the subject population in the original protocol indicated that individuals who scored highly on a commonly used diagnostic test for depression would be excluded from the study. An unexpectedly high number of potential subjects were excluded on this basis, which led to questions regarding why they were excluded that the research team was unprepared to address. Attached is a debriefing script for individuals who are excluded on this basis that explains that a high score on the test does not indicate in and of itself a diagnosis of depression and includes referrals for individuals who wish more information on depression. Attached as well are a revised recruitment notice and informed consent document that explain in more detail why an individual may be excluded from the study.
Please note: The memo should be signed by both the PI and a faculty advisor when the researcher is a student. Faculty may submit directly to the IRB. Modifications no longer need Department Chair approval.
Applicants who wish to make changes to previously approved research should no longer use the IRB-2--Revisions to Previously Approved Research Application.
Continuing Review Application
All research approved under expedited or standard review procedures that continues beyond one year is subject to continuing review requirements. Please submit the continuing review form at least four (4) weeks before the expiration date stamped on your IRB application.
The New York City Board of Ed publishes guidelines for researchers within the NYC public schools.
- NYC DoE Researcher Forms and Guidelines
- NYC DOE IRB Submissions Information
- Tipsheet for Researchers in NYC Public Schools
If you are interested in conducting research with the Army, please contact the IRB office for information before you submit your application.