This section of the Investigator Manual describes research that requires a standalone protocol, including clinical trials, more than minimal risk studies, registry and repository studies, studies requiring scientific review, and non-exempt multi-site studies. The section also provide protocol guidelines.


Studies that do meet the federal definitions of human research require IRB review. For some of these studies, the IRB requires a standalone protocol that you will upload in the IRB application. The IRB has protocol templates that can be used for these types of studies, as described in the sections below.

You are not required to use these templates if you already have a protocol that addresses the same elements found in the templates. All studies requiring a protocol should be submitted using the protocol-based application (for studies likely to be single site) or the single IRB application (for studies where the UW will be serving as the single IRB for multiple sites) in ARROW.


Clinical Trials and More Than Minimal Risk Studies

The following protocol templates are available to assist you in developing a standalone protocol:

If you have a protocol document that includes the relevant sections of the protocol template most appropriate for your study, you are not required to use the IRB-provided protocol template.

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.

Registry and Repository Studies

While these studies are likely to be minimal risk, the registry and repository protocol-template is the most efficient way for you to provide the information the IRB needs to make the relevant regulatory determinations. See HRP 503a-PROTCOL TEMPLATE-Registries and Repositories.

Studies Requiring Review by the ICTR Scientific Review Committee (SRC)

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:

a) 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
b) 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
c) 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)
d) Collection of data from voice, video, digital, or image recordings made for research purposes
e) Surveys
f) Interviews, including focus groups
g) Wearable devices, such as accelerometers and fitbits, or tests that use external sensors that do not otherwise result in physical stimulation (e.g., EEGs)
h) Walking tests
i) 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.

Non-Exempt Studies for Which UW-Madison Will Serve as the Reviewing IRB for Other Sites

If UW-Madison will serve as the reviewing IRB for other sites, a standalone protocol is typically required. Exceptions include minimal risk studies involving only one other site that do not involve interventions with subjects or subject interventions are limited in nature.

Projects jointly conducted at UW-Madison and UnityPoint Health Meriter do not typically require a standalone protocol.

The IRB-provided protocol template includes instructions for sections specifically addressing single IRB review requirement as well as the Reliance Manual.

You may also contact the Reliance and Navigation Team (RELIANT) for assistance (irbreliance@wisc.edu).

Protocol Guidelines

If you do not already have a protocol that addresses the relevant elements included in the protocol templates, use the appropriate protocol templates as a starting point. Reference the instructions in italic text for the information the IRB looks for when reviewing research. Here are some key points to remember when developing a protocol:

  • In the protocol templates, the italicized bullet points serve as guidance to study teams. All italicized comments should be deleted prior to submission.
  • When writing a protocol, always keep your own electronic copy. You will need to modify this copy when making changes to the protocol.
  • Note that, depending on the nature of your research, certain sections of the template may not be applicable to your study. Indicate this as appropriate.
  • The protocol should be uploaded to the application in Word format, as this allows for reviewer edits and comments to be easily placed in the document.
  • If you plan to involve any individuals who are members of the populations listed below as participants in your research, you must indicate this in your protocol and address the regulatory requirements that need to be met for including these populations. You are encouraged to consult the checklists referenced below to assist you in addressing these regulatory requirements.