All studies that require SRC review must have a standalone protocol to provide the level of detail required to evaluate the study’s scientific design. If you are designing an investigator-initiated study that requires SRC review, see the Protocol Template section for recommendations on the appropriate template to use.

Per institutional policy, non-oncology-related applications for full initial IRB review require ICTR SRC unless they a) are otherwise reviewed and determined to be highly meritorious by an alternate internal or external scientific review or b) solely involve these procedures:

• Collection of blood samples by finger stick, heel stick, ear stick or venipuncture, unless the purpose of the biospecimen collection is to perform large scale genetic analyses such as whole genome or whole exome sequencing
• Prospective collection of biological specimens for research purposes by noninvasive means unless the purpose of the biospecimen collection is to perform large scale genetic analyses such as whole genome or whole exome sequencing
• Use of materials (data, documents, records, images, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis)
• Collection of data from voice, video, digital, or image recordings made for research purposes
• Surveys
• Interviews, including focus groups
• Wearable devices, such as accelerometers and fitbits, or tests that use external sensors that do not otherwise result in physical stimulation (e.g., EEGs)
• Walking tests
• Imaging (MRIs, ultrasounds) with FDA-approved devices (hardware and software) when the imaging is performed within the FDA indications and evaluation of the device is not the focus of the research. This does not include PET-MRI.

If you are designing an investigator-initiated study and do not have an existing protocol template, you are encouraged to use the IRB-provided protocol template.

For more information on scientific review requirements, see the SRC section.