IRB Biomedical Research

Information and resources related to conducting biomedical research with human participants

UPDATED September 7, 2022

COVID-19: Cornell IRB COVID-19 guidance and FAQs have been updated (Sept. 7, 2022). Face masks are still required for in-person, on-campus human participant research activities similar to clinical exams or procedures. Review the revised guidance in its entirety here.

TRAINING UPDATE: Effective October 1, 2022, all Cornell study personnel involved in Exempt research protocols will be required to complete CITI training in human participant research ethics. See details here. For more information about Cornell IRB training requirements, visit the IRB Training webpage.

IRB PROTOCOLS: As of February 1, 2022, we are using the RASS-IRB system for new protocol submissions, continuing reviews, amendments, and adverse event and protocol deviation reporting. See more details about the transition to RASS-IRB here. Find how-to documentation and recordings of Zoom training sessions on the RASS Guide Site. For help or feedback about the system, contact the RASS team at: rass@research.cornell.edu. For content-related questions about your IRB protocol or other human participant research topics, email irbhp@cornell.edu per usual. You can also schedule a Zoom meeting with members of the RASS or IRB teams via Microsoft Bookings.

A limited number of biomedical procedures are used in human participant studies on the Ithaca campus. These procedures must be conducted in a manner that assures the safety and privacy of participants. Many such procedures must be conducted in specialized spaces on campus, to ensure that research support is appropriately provided, with trained and qualified personnel conducting the procedures. For detailed information on working with these facilities or conducting any biomedical research on campus, please review IRB Policy #19.

General Guidance for Preparing an IRB Application with Biomedical Procedures

When submitting an IRB application involving biomedical procedures, follow the steps and include the information and documents described below:

Create a new protocol in RASS-IRB

How-to documentation for how to create a new protocol or complete other tasks in RASS-IRB is available on the RASS Guide Site.

All IRB applications involving active collection of specimens must include a consent form. Below please find a general biomedical consent form template that can be adapted for your needs. Note, if your application involves blood draws or fMRI, specific consent forms for these procedures need to be used. You can find these consent templates in the section below concerning specific biomedical procedures.

Editable consent form for biomedical procedures (general)

Guides and Templates for Specific Biomedical Procedures

Review the guidance below before you start planning for blood draws for research. It contains useful links and resources that will help to make the application and review process go smoothly and fast. We strongly recommend that researchers use the research support services for blood draws offered by Gannett Health Services or the HMRU.

The standard, IRB-approved consent language and standard operating procedures (SOP) for blood draws are provided in the templates below. Researchers are welcome to edit the templates for their project, but are encouraged only to make those changes to standard language that are truly necessary, as any material changes will need to be reviewed by Occupational Medicine and the IRB, and may add additional time to the protocol approval process.

The standard, IRB-approved consent language and standard operating procedures (SOP) for capillary blood draws (also known as finger sticks) are provided in the templates below. Researchers are welcome to edit the templates for their project, but are encouraged only to make those changes to standard language that are truly necessary, as any material changes will need to be reviewed by Occupational Medicine and the IRB, and may add additional time to the protocol approval process.

The Cornell MRI Facility (CMRIF) is a university-wide resource located on the ground floor of Martha Van Rensselaer Hall. For all scans with human participants performed in the CMRIF, use this CMRIF- and IRB-approved informed consent form template.

Please edit the consent template for your project, but only make those changes that are truly necessary; any material changes will need to be reviewed by Occupational Medicine and the IRB, and will add additional time to the protocol review process. When submitting your IRB protocol application, please provide both a tracked-changes and clean version of your CMRIF consent form.

Please contact the CMRIF directly for more information about how the facility works and other resources for researchers.

    Contact the Human Metabolic Research Unit (HMRU) for guidance on urine sample collection, pregnancy testing, and respiratory tracking studies.

    Contact the IRB office for guidance on conducting research involving fecal sample collection and blood pressure measurements.

    Contact the EEG lab for guidance on EDA (ElectroDermal Activity), Bioelectrical Impedance, ECG/EEG, and eye-tracking studies.

    Cornell Facilities for Biomedical Procedures