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 applicable.

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 proposed study.
• A complete description of the research study design and procedures.
• The inclusion/exclusion criteria of the research subject population, including the selection rationale, sex, age, racial and ethnic characteristics, including information about any vulnerable populations.
• 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 Expedited Review.

• Protocol lay summary
• Investigator’s and all key personnel’s curriculum vitae
• Proposed Consent/Assent form(s) or a Request for Waiver of Consent
• Recruitment materials, including ads, posters and radio commercials
• 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 personnel
• Human Research Billing Analysis Form

On receipt of the research protocol and supporting documents, the IRB Administrator will:

• Verify that the research activity constitutes human participant research.
• 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.