The forms and guidelines on this page have been created for use by TC Researchers effective January 24, 2008. Please discard any old forms you may have. All forms are available here in MS Word Format.
Please note that effective May 19, 2009 the TC IRB no longer requires a department chair signature on a new study application.
New Study Application Forms
Applicants who wish to have the IRB review proposals for new studies will need to download two forms:
Strongly suggested:
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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 make changes to a previously approved protocol
The TC IRB will no longer require a specific form to request modifications. Effective immediately, investigators should submit a memo addressed to the IRB that contains the following information:
PI name, project title and protocol number.
Faculty advisor name, if applicable.
Making reference to the specific sections of the original protocol, summarize both the original contents of those sections and the changes you wish to make, accompanied by a justification of 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.
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 4 weeks before the expiration date stamped on your IRB application.
New York City Department of Education Guidelines
The New York City Board of Ed publishes guidelines for researchers within the NYC public schools.