Submitting a Protocol

All studies that fulfill the federal definition of "research" and involve "human subjects" (click for definition) must be reviewed and approved by the IRB before any procedures are initiated. All research must be re-reviewed at least annually, and any changes to an approved protocol require prior review and approval.

Adverse events, protocol violations, complaints, and other new information relevant to the research must be reported to the IRB in a timely fashion as each may alter the assessment of study risks or benefits.

 

At the time of submission, all studies are assigned a level of review based on risk, subject vulnerability, and to some extent the complexity of the proposed work.

  • Studies that involve procedures that are "more than minimal risk" can only be approved by the convened IRB, also known as the Full Board.

  • Minimal risk research and minor changes to approved research studies can be approved by the IRB Chair, or delegated to an IRB member for review and approval. This is referred to as expedited review.

  • The PI-IRB utilizes a subcommittee review process for initial review of studies that require final review by the Full Board. The subcommittee also reviews and can approve other, minimal risk research.

New Protocols

The duration of the review process varies according to study complexity and level of review. In order to streamline the process, we advise you to familiarize yourself with submission deadlines and consult with colleagues in your Division, IRB members, and IRB staff as needed. Carefully prepared protocols speed review for you and your colleagues. Get to know Federal and NYSPI guidelines and check our News and New Requirement page regularly.

  • Protocol Summary Forms are submitted online using PRISM. To speed review, first look at the subcommittee review dates and submission deadlines posted on the Calendar.

  • Next, the IRB's Director of Operations or designee reviews the study and assigns the "level of review" in accordance with federal regulations and local policy and procedures. The IRB will     forward your protocol for required review and approval by NYSPI Administration.  

  • The IRB will forward your protocol for required review and approval by NYSPI Administration.

  • Research that meets criteria for expedited review is reviewed by the Chair, an IRB member, or a Subcommittee, depending on the study's complexity, topic, and population.

  • Research that requires Full Board review is always pre-reviewed first at one of the subcommittees which meet four times a month. 

  • Protocols are assigned to IRB members who serve as primary and secondary reviewers at the subcommittee and later at the Full Board.

  • After the subcommittee meeting, we will  send you a memo in PRISM summarizing the subcommittee’s review and detailing the next steps in the review process.

  • When the subcommittee indicates that approval can be granted on an expedited basis, submit your point by point response to the subcommittee memo along with the revised protocol summary form and consent form.  To facilitate review, we ask that you highlight or bold all changes to protocol materials. 

  • For studies that require review at the Full Board, please pay attention to Full Board meeting dates and mailing deadlines.  Submit your response to the Subcommittee along with all revised and highlighted or bolded protocol materials.

  • Following Full Board review, you will receive a memo in PRISM detailing all additional steps and protocol and consent changes that are required for study approval. 

  • Once the IRB Analyst assigned to your study and the Chair have reviewed your response to the Full Board memo, and once any additional  requirements for approval are met, the IRB will issue a formal approval notice and stamped consent forms.  Consent forms are stamped on each page with the IRB stamp, the protocol number, and start and expiration dates. Only consent forms stamped with the most recent approval dates may be used to document consent.

  • Subject enrollment can be initiated only once you receive the stamped and dated consent forms.