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.
Recruitment Materials: PRISM Fast Track
Guidelines for Composing Recruitment Documents
All advertisements, brochures, Websites and flyers used in the recruitment of research subjects must be approved by the IRB. The following guidelines should be used in composing recruitment documents:
- The word "research" must appear prominently in all recruitment materials.
- Flyers and postings to be used within PI or CPMC must include the PI-IRB protocol number.
- Advertisements should not promise benefit beyond what is contained in the Protocol Summary Form and the informed consent documents.
- Advertisements should not emphasize payment, but may indicate that modest compensation is offered for time and any inconvenience caused.
- Please see our guidance if you plan to use the phrase "free treatment" in your advertisements.
Review and Approval of Recruitment Materials
- What is the process for review and approval of recruitment materials?
All recruitment materials must be submitted to the IRB via PRISM for review and approval before they are used. For amendments that only involve revisions of recruitment materials, utilize the Fast Track submission process in PRISM. When the IRB completes its review, it will stamp the recruitment materials for approval. The stamp will indicate the date the material is approved and the date on which IRB approval of the study is due to expire.
Copies of all recruitment materials intended for use in the upcoming year should be included in the Application for Continuation of Research (ACAR) in PRISM. Only material that receives a NYSPI IRB approval stamp may be used.
- What needs to be reviewed by the IRB?
All direct public recruitment materials must be reviewed and approved by the IRB prior to the initiation of recruitment procedures. This includes newspaper advertisements, postings and flyers used in the community and within the NYSPI-Columbia Presbyterian campus, brochures to be distributed in clinics, enrollment in web-based or other forms of referral services, etc. This material should be submitted to the IRB with the initial protocol submission if possible.
- What material does not need to be reviewed by the IRB?
IRB review is not required for general material regarding a study or clinic. This type of material is usually oriented towards the general public and includes articles, informational websites, and press releases. Material not requiring review by the IRB should be sent to Rachel Yarmolinsky at Yarmoli@nyspi.columbia.edu.
To request a protocol exception ( a one time change to inclusion/exclusion criteria, procedures, or any other element of the study), write to IRBmail