Research Application Process
Prior to submission, investigators should contact the IRB office at
718-670-2840 to inquire as to what type of review the project will
undergo. This will be determined by the level of risk involved in the
project and the decision will be made by the IRB administrator. Projects
that qualify for an expedited or exempt review are required to submit
one (1) copy of each of the items listed in the submission process, as
applicable. Projects that will receive a full board review require eight
(8) copies of each of the items listed in the submission process, as
Following are some general guidelines for what is required in an
application. All of the guidelines and forms needed to develop a
research application are available on this website under Policies
and Procedures and Forms.
What to Submit: Protocol
The protocol must include:
A complete description of the purpose of the research, including
the hypothesis and why the research is important.
The background to the proposed research, including the
purpose of the study and the study design. Include a summary of
previously published data and pilot studies related to the
A complete description of the research study design and
The inclusion/exclusion criteria of the research subject
population, including the selection rationale, sex, age, racial
and ethnic characteristics, including information about any
A risk assessment that includes the assumed level of risk to
subjects, types of risks associated with the research, and how
the study design will help to minimize those risks.
Any benefits to the subjects that might reasonably be expected
from their participation in the study.
Procedures for recruiting subjects.
A description of the consent process or rationale for requesting
a waiver of consent. If any vulnerable populations are going to
be enrolled in the study, the issue of their capacity to give
consent should be addressed.
Number of subjects to be studied.
A detailed description of how subjects will be monitored for
safety throughout the study and procedures for stopping the
research and withdrawing subjects, if necessary.
Procedures to be employed to maintain confidentiality of
personally identifiable research data. Include any special
privacy and confidentiality issues if applicable, such as the
use of genetic information.
Location where the research is to take place.
What to Submit: Attachments
In addition to the protocol, investigators must submit the following
documents to the IRB administration:
A completed Institutional Review Board Application for Initial and
Protocol lay summary
Investigator’s and all key personnel’s curriculum vitae
Proposed Consent/Assent form(s) or a Request for Waiver of
Recruitment materials, including ads, posters and radio
Subject materials, including all surveys and questionnaires
Data collection forms
Investigator drug or device brochures
Determination of Risk for Device Studies
FDA form 1572 for Investigational New Drugs
CITI Program for Human Subjects Protection for investigator and
all key personnel
Financial Disclosure Forms for investigator and all key
Human Research Billing Analysis Form
On receipt of the research protocol and supporting documents, the IRB
Verify that the research activity constitutes human participant
Verify the completeness of the materials or coordinate with the
protocol’s principal investigator to achieve completion.
Review the protocol and attached materials to determine whether
they will undergo the expedited or convened committee process.
Enter selected information from the Initial Approval Request
Form into the IRB manager database.
Determine whether there is a need for the project’s
investigators and key personnel to undergo training in the use
of human participants in research.
After the application has been determined to be complete, the IRB
administrator will submit the materials for IRB review and approval. If
an IRB member requires additional information to complete the review,
that IRB reviewer may contact the investigator directly or may contact
the IRB Administrator, who may contact the investigator.